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Title 42 — The Public Health and Welfare

Part E · Chapter 7 — Social Security

§ 1395ff. Determinations; appeals

Statutory text

(a)

Initial determinations

(1)

Promulgations of regulations

The Secretary shall promulgate regulations and make initial determinations with respect to benefits under part A or part B in accordance with those regulations for the following:

(A)

The initial determination of whether an individual is entitled to benefits under such parts.

(B)

The initial determination of the amount of benefits available to the individual under such parts.

(C)

Any other initial determination with respect to a claim for benefits under such parts, including an initial determination by the Secretary that payment may not be made, or may no longer be made, for an item or service under such parts, an initial determination made by a quality improvement organization under section 1320c–3(a)(2) of this title, and an initial determination made by an entity pursuant to a contract (other than a contract under section 1395w–22 of this title) with the Secretary to administer provisions of this subchapter or subchapter XI.

(2)

Deadlines for making initial determinations

(A)

In general

Subject to subparagraph (B), in promulgating regulations under paragraph (1), initial determinations shall be concluded by not later than the 45-day period beginning on the date the fiscal intermediary or the carrier, as the case may be, receives a claim for benefits from an individual as described in paragraph (1). Notice of such determination shall be mailed to the individual filing the claim before the conclusion of such 45-day period.

(B)

Clean claims

Subparagraph (A) shall not apply with respect to any claim that is subject to the requirements of section 1395h(c)(2) or 1395u(c)(2) of this title.

(3)

Redeterminations

(A)

In general

In promulgating regulations under paragraph (1) with respect to initial determinations, such regulations shall provide for a fiscal intermediary or a carrier to make a redetermination with respect to a claim for benefits that is denied in whole or in part.

(B)

Limitations

(i)

Appeal rights

No initial determination may be reconsidered or appealed under subsection (b) unless the fiscal intermediary or carrier has made a redetermination of that initial determination under this paragraph.

(ii)

Decisionmaker

No redetermination may be made by any individual involved in the initial determination.

(C)

Deadlines

(i)

Filing for redetermination

A redetermination under subparagraph (A) shall be available only if notice is filed with the Secretary to request the redetermination by not later than the end of the 120-day period beginning on the date the individual receives notice of the initial determination under paragraph (2).

(ii)

Concluding redeterminations

Redeterminations shall be concluded by not later than the 60-day period beginning on the date the fiscal intermediary or the carrier, as the case may be, receives a request for a redetermination. Notice of such determination shall be mailed to the individual filing the claim before the conclusion of such 60-day period.

(D)

Construction

For purposes of the succeeding provisions of this section a redetermination under this paragraph shall be considered to be part of the initial determination.

(4)

Requirements of notice of determinations

With respect to an initial determination insofar as it results in a denial of a claim for benefits—

(A)

the written notice on the determination shall include—

(i)

the reasons for the determination, including whether a local medical review policy or a local coverage determination was used;

(ii)

the procedures for obtaining additional information concerning the determination, including the information described in subparagraph (B); and

(iii)

notification of the right to seek a redetermination or otherwise appeal the determination and instructions on how to initiate such a redetermination under this section;

(B)

such written notice shall be provided in printed form and written in a manner calculated to be understood by the individual entitled to benefits under part A or enrolled under part B, or both; and

(C)

the individual provided such written notice may obtain, upon request, information on the specific provision of the policy, manual, or regulation used in making the redetermination.

(5)

Requirements of notice of redeterminations

With respect to a redetermination insofar as it results in a denial of a claim for benefits—

(A)

the written notice on the redetermination shall include—

(i)

the specific reasons for the redetermination;

(ii)

as appropriate, a summary of the clinical or scientific evidence used in making the redetermination;

(iii)

a description of the procedures for obtaining additional information concerning the redetermination; and

(iv)

notification of the right to appeal the redetermination and instructions on how to initiate such an appeal under this section;

(B)

such written notice shall be provided in printed form and written in a manner calculated to be understood by the individual entitled to benefits under part A or enrolled under part B, or both; and

(C)

the individual provided such written notice may obtain, upon request, information on the specific provision of the policy, manual, or regulation used in making the redetermination.

(b)

Appeal rights

(1)

In general

(A)

Reconsideration of initial determination

Subject to subparagraph (D), any individual dissatisfied with any initial determination under subsection (a)(1) shall be entitled to reconsideration of the determination, and, subject to subparagraphs (D) and (E), a hearing thereon by the Secretary to the same extent as is provided in section 405(b) of this title and, subject to paragraph (2), to judicial review of the Secretary’s final decision after such hearing as is provided in section 405(g) of this title. For purposes of the preceding sentence, any reference to the “Commissioner of Social Security” or the “Social Security Administration” in subsection (g) or (l) of section 405 of this title shall be considered a reference to the “Secretary” or the “Department of Health and Human Services”, respectively.

(B)

Representation by provider or supplier

(i)

In general

Sections 406(a), 1302, and 1395hh of this title shall not be construed as authorizing the Secretary to prohibit an individual from being represented under this section by a person that furnishes or supplies the individual, directly or indirectly, with services or items, solely on the basis that the person furnishes or supplies the individual with such a service or item.

(ii)

Mandatory waiver of right to payment from beneficiary

Any person that furnishes services or items to an individual may not represent an individual under this section with respect to the issue described in section 1395pp(a)(2) of this title unless the person has waived any rights for payment from the beneficiary with respect to the services or items involved in the appeal.

(iii)

Prohibition on payment for representation

If a person furnishes services or items to an individual and represents the individual under this section, the person may not impose any financial liability on such individual in connection with such representation.

(iv)

Requirements for representatives of a beneficiary

The provisions of section 405(j) of this title and of section 406 of this title (other than subsection (a)(4) of such section) regarding representation of claimants shall apply to representation of an individual with respect to appeals under this section in the same manner as they apply to representation of an individual under those sections.

(C)

Succession of rights in cases of assignment

The right of an individual to an appeal under this section with respect to an item or service may be assigned to the provider of services or supplier of the item or service upon the written consent of such individual using a standard form established by the Secretary for such an assignment.

(D)

Time limits for filing appeals

(i)

Reconsiderations

Reconsideration under subparagraph (A) shall be available only if the individual described in subparagraph (A) files notice with the Secretary to request reconsideration by not later than the end of the 180-day period beginning on the date the individual receives notice of the redetermination under subsection (a)(3), or within such additional time as the Secretary may allow.

(ii)

Hearings conducted by the Secretary

The Secretary shall establish in regulations time limits for the filing of a request for a hearing by the Secretary in accordance with provisions in sections 405 and 406 of this title.

(E)

Amounts in controversy

(i)

In general

A hearing (by the Secretary) shall not be available to an individual under this section if the amount in controversy is less than $100, and judicial review shall not be available to the individual if the amount in controversy is less than $1,000.

(ii)

Aggregation of claims

In determining the amount in controversy, the Secretary, under regulations, shall allow two or more appeals to be aggregated if the appeals involve—

(I)

the delivery of similar or related services to the same individual by one or more providers of services or suppliers, or

(II)

common issues of law and fact arising from services furnished to two or more individuals by one or more providers of services or suppliers.

(iii)

Adjustment of dollar amounts

For requests for hearings or judicial review made in a year after 2004, the dollar amounts specified in clause (i) shall be equal to such dollar amounts increased by the percentage increase in the medical care component of the consumer price index for all urban consumers (U.S. city average) for July 2003 to the July preceding the year involved. Any amount determined under the previous sentence that is not a multiple of $10 shall be rounded to the nearest multiple of $10.

(F)

Expedited proceedings

(i)

Expedited determination

In the case of an individual who has received notice from a provider of services that such provider plans—

(I)

to terminate services provided to an individual and a physician certifies that failure to continue the provision of such services is likely to place the individual’s health at significant risk, or

(II)

to discharge the individual from the provider of services,

 the individual may request, in writing or orally, an expedited determination or an expedited reconsideration of an initial determination made under subsection (a)(1), as the case may be, and the Secretary shall provide such expedited determination or expedited reconsideration.

(ii)

Reference to expedited access to judicial review

For the provision relating to expedited access to judicial review, see paragraph (2).

(G)

Reopening and revision of determinations

The Secretary may reopen or revise any initial determination or reconsidered determination described in this subsection under guidelines established by the Secretary in regulations.

(2)

Expedited access to judicial review

(A)

In general

The Secretary shall establish a process under which a provider of services or supplier that furnishes an item or service or an individual entitled to benefits under part A or enrolled under part B, or both, who has filed an appeal under paragraph (1) (other than an appeal filed under paragraph (1)(F)(i)) may obtain access to judicial review when a review entity (described in subparagraph (D)), on its own motion or at the request of the appellant, determines that the Departmental Appeals Board does not have the authority to decide the question of law or regulation relevant to the matters in controversy and that there is no material issue of fact in dispute. The appellant may make such request only once with respect to a question of law or regulation for a specific matter in dispute in a case of an appeal.

(B)

Prompt determinations

If, after or coincident with appropriately filing a request for an administrative hearing, the appellant requests a determination by the appropriate review entity that the Departmental Appeals Board does not have the authority to decide the question of law or regulations relevant to the matters in controversy and that there is no material issue of fact in dispute, and if such request is accompanied by the documents and materials as the appropriate review entity shall require for purposes of making such determination, such review entity shall make a determination on the request in writing within 60 days after the date such review entity receives the request and such accompanying documents and materials. Such a determination by such review entity shall be considered a final decision and not subject to review by the Secretary.

(C)

Access to judicial review

(i)

In general

If the appropriate review entity—

(I)

determines that there are no material issues of fact in dispute and that the only issues to be adjudicated are ones of law or regulation that the Departmental Appeals Board does not have authority to decide; or

(II)

fails to make such determination within the period provided under subparagraph (B),

 then the appellant may bring a civil action as described in this subparagraph.

(ii)

Deadline for filing

Such action shall be filed, in the case described in—

(I)

clause (i)(I), within 60 days of the date of the determination described in such clause; or

(II)

clause (i)(II), within 60 days of the end of the period provided under subparagraph (B) for the determination.

(iii)

Venue

Such action shall be brought in the district court of the United States for the judicial district in which the appellant is located (or, in the case of an action brought jointly by more than one applicant, the judicial district in which the greatest number of applicants are located) or in the District Court for the District of Columbia.

(iv)

Interest on any amounts in controversy

Where a provider of services or supplier is granted judicial review pursuant to this paragraph, the amount in controversy (if any) shall be subject to annual interest beginning on the first day of the first month beginning after the 60-day period as determined pursuant to clause (ii) and equal to the rate of interest on obligations issued for purchase by the Federal Supplementary Medical Insurance Trust Fund for the month in which the civil action authorized under this paragraph is commenced, to be awarded by the reviewing court in favor of the prevailing party. No interest awarded pursuant to the preceding sentence shall be deemed income or cost for the purposes of determining reimbursement due providers of services or suppliers under this subchapter.

(D)

Review entity defined

For purposes of this subsection, the term “review entity” means an entity of up to three reviewers who are administrative law judges or members of the Departmental Appeals Board selected for purposes of making determinations under this paragraph.

(3)

Requiring full and early presentation of evidence by providers

A provider of services or supplier may not introduce evidence in any appeal under this section that was not presented at the reconsideration conducted by the qualified independent contractor under subsection (c), unless there is good cause which precluded the introduction of such evidence at or before that reconsideration.

(c)

Conduct of reconsiderations by independent contractors

(1)

In general

The Secretary shall enter into contracts with qualified independent contractors to conduct reconsiderations of initial determinations made under subparagraphs (B) and (C) of subsection (a)(1). Contracts shall be for an initial term of three years and shall be renewable on a triennial basis thereafter.

(2)

Qualified independent contractor

For purposes of this subsection, the term “qualified independent contractor” means an entity or organization that is independent of any organization under contract with the Secretary that makes initial determinations under subsection (a)(1), and that meets the requirements established by the Secretary consistent with paragraph (3).

(3)

Requirements

Any qualified independent contractor entering into a contract with the Secretary under this subsection shall meet all of the following requirements:

(A)

In general

The qualified independent contractor shall perform such duties and functions and assume such responsibilities as may be required by the Secretary to carry out the provisions of this subsection, and shall have sufficient medical, legal, and other expertise (including knowledge of the program under this subchapter) and sufficient staffing to make reconsiderations under this subsection.

(B)

Reconsiderations

(i)

In general

The qualified independent contractor shall review initial determinations. Where an initial determination is made with respect to whether an item or service is reasonable and necessary for the diagnosis or treatment of illness or injury (under section 1395y(a)(1)(A) of this title), such review shall include consideration of the facts and circumstances of the initial determination by a panel of physicians or other appropriate health care professionals and any decisions with respect to the reconsideration shall be based on applicable information, including clinical experience (including the medical records of the individual involved) and medical, technical, and scientific evidence.

(ii)

Effect of national and local coverage determinations

(I)

National coverage determinations

If the Secretary has made a national coverage determination pursuant to the requirements established under the third sentence of section 1395y(a) of this title, such determination shall be binding on the qualified independent contractor in making a decision with respect to a reconsideration under this section.

(II)

Local coverage determinations

If the Secretary has made a local coverage determination, such determination shall not be binding on the qualified independent contractor in making a decision with respect to a reconsideration under this section. Notwithstanding the previous sentence, the qualified independent contractor shall consider the local coverage determination in making such decision.

(III)

Absence of national or local coverage determination

In the absence of such a national coverage determination or local coverage determination, the qualified independent contractor shall make a decision with respect to the reconsideration based on applicable information, including clinical experience and medical, technical, and scientific evidence.

(C)

Deadlines for decisions

(i)

Reconsiderations

Except as provided in clauses (iii) and (iv), the qualified independent contractor shall conduct and conclude a reconsideration under subparagraph (B), and mail the notice of the decision with respect to the reconsideration by not later than the end of the 60-day period beginning on the date a request for reconsideration has been timely filed.

(ii)

Consequences of failure to meet deadline

In the case of a failure by the qualified independent contractor to mail the notice of the decision by the end of the period described in clause (i) or to provide notice by the end of the period described in clause (iii), as the case may be, the party requesting the reconsideration or appeal may request a hearing before the Secretary, notwithstanding any requirements for a reconsidered determination for purposes of the party’s right to such hearing.

(iii)

Expedited reconsiderations

The qualified independent contractor shall perform an expedited reconsideration under subsection (b)(1)(F) as follows:

(I)

Deadline for decision

Notwithstanding section 416(j) of this title and subject to clause (iv), not later than the end of the 72-hour period beginning on the date the qualified independent contractor has received a request for such reconsideration and has received such medical or other records needed for such reconsideration, the qualified independent contractor shall provide notice (by telephone and in writing) to the individual and the provider of services and attending physician of the individual of the results of the reconsideration. Such reconsideration shall be conducted regardless of whether the provider of services or supplier will charge the individual for continued services or whether the individual will be liable for payment for such continued services.

(II)

Consultation with beneficiary

In such reconsideration, the qualified independent contractor shall solicit the views of the individual involved.

(III)

Special rule for hospital discharges

A reconsideration of a discharge from a hospital shall be conducted under this clause in accordance with the provisions of paragraphs (2), (3), and (4) of section 1320c–3(e) of this title as in effect on the date that precedes .

(iv)

Extension

An individual requesting a reconsideration under this subparagraph may be granted such additional time as the individual specifies (not to exceed 14 days) for the qualified independent contractor to conclude the reconsideration. The individual may request such additional time orally or in writing.

(D)

Qualifications for reviewers

The requirements of subsection (g) shall be met (relating to qualifications of reviewing professionals).

(E)

Explanation of decision

Any decision with respect to a reconsideration of a qualified independent contractor shall be in writing, be written in a manner calculated to be understood by the individual entitled to benefits under part A or enrolled under part B, or both, and shall include (to the extent appropriate) and shall include 1 a detailed explanation of the decision as well as a discussion of the pertinent facts and applicable regulations applied in making such decision, and 2 a notification of the right to appeal such determination and instructions on how to initiate such appeal under this section 3 and 3 in the case of a determination of whether an item or service is reasonable and necessary for the diagnosis or treatment of illness or injury (under section 1395y(a)(1)(A) of this title) 3 an explanation of the medical and scientific rationale for the decision.

(F)

Notice requirements

Whenever a qualified independent contractor makes a decision with respect to a reconsideration under this subsection, the qualified independent contractor shall promptly notify the entity responsible for the payment of claims under part A or part B of such decision.

(G)

Dissemination of decisions on reconsiderations

Each qualified independent contractor shall make available all decisions with respect to reconsiderations of such qualified independent contractors to fiscal intermediaries (under section 1395h of this title), carriers (under section 1395u of this title), quality improvement organizations (under part B of subchapter XI), Medicare+Choice organizations offering Medicare+Choice plans under part C, other entities under contract with the Secretary to make initial determinations under part A or part B or subchapter XI, and to the public. The Secretary shall establish a methodology under which qualified independent contractors shall carry out this subparagraph.

(H)

Ensuring consistency in decisions

Each qualified independent contractor shall monitor its decisions with respect to reconsiderations to ensure the consistency of such decisions with respect to requests for reconsideration of similar or related matters.

(I)

Data collection

(i)

In general

Consistent with the requirements of clause (ii), a qualified independent contractor shall collect such information relevant to its functions, and keep and maintain such records in such form and manner as the Secretary may require to carry out the purposes of this section and shall permit access to and use of any such information and records as the Secretary may require for such purposes.

(ii)

Type of data collected

Each qualified independent contractor shall keep accurate records of each decision made, consistent with standards established by the Secretary for such purpose. Such records shall be maintained in an electronic database in a manner that provides for identification of the following:

(I)

Specific claims that give rise to appeals.

(II)

Situations suggesting the need for increased education for providers of services, physicians, or suppliers.

(III)

Situations suggesting the need for changes in national or local coverage determination.

(IV)

Situations suggesting the need for changes in local coverage determinations.

(iii)

Annual reporting

Each qualified independent contractor shall submit annually to the Secretary (or otherwise as the Secretary may request) records maintained under this paragraph for the previous year.

(J)

Hearings by the Secretary

The qualified independent contractor shall (i) submit such information as is required for an appeal of a decision of the contractor, and (ii) participate in such hearings as required by the Secretary.

(K)

Independence requirements

(i)

In general

Subject to clause (ii), a qualified independent contractor shall not conduct any activities in a case unless the entity—

(I)

is not a related party (as defined in subsection (g)(5));

(II)

does not have a material familial, financial, or professional relationship with such a party in relation to such case; and

(III)

does not otherwise have a conflict of interest with such a party.

(ii)

Exception for reasonable compensation

Nothing in clause (i) shall be construed to prohibit receipt by a qualified independent contractor of compensation from the Secretary for the conduct of activities under this section if the compensation is provided consistent with clause (iii).

(iii)

Limitations on entity compensation

Compensation provided by the Secretary to a qualified independent contractor in connection with reviews under this section shall not be contingent on any decision rendered by the contractor or by any reviewing professional.

(4)

Number of qualified independent contractors

The Secretary shall enter into contracts with a sufficient number of qualified independent contractors (but not fewer than 4 such contractors) to conduct reconsiderations consistent with the timeframes applicable under this subsection.

(5)

Limitation on qualified independent contractor liability

No qualified independent contractor having a contract with the Secretary under this subsection and no person who is employed by, or who has a fiduciary relationship with, any such qualified independent contractor or who furnishes professional services to such qualified independent contractor, shall be held by reason of the performance of any duty, function, or activity required or authorized pursuant to this subsection or to a valid contract entered into under this subsection, to have violated any criminal law, or to be civilly liable under any law of the United States or of any State (or political subdivision thereof) provided due care was exercised in the performance of such duty, function, or activity.

(d)

Deadlines for hearings by the Secretary; notice

(1)

Hearing by administrative law judge

(A)

In general

Except as provided in subparagraph (B), an administrative law judge shall conduct and conclude a hearing on a decision of a qualified independent contractor under subsection (c) and render a decision on such hearing by not later than the end of the 90-day period beginning on the date a request for hearing has been timely filed.

(B)

Waiver of deadline by party seeking hearing

The 90-day period under subparagraph (A) shall not apply in the case of a motion or stipulation by the party requesting the hearing to waive such period.

(2)

Departmental Appeals Board review

(A)

In general

The Departmental Appeals Board of the Department of Health and Human Services shall conduct and conclude a review of the decision on a hearing described in paragraph (1) and make a decision or remand the case to the administrative law judge for reconsideration by not later than the end of the 90-day period beginning on the date a request for review has been timely filed.

(B)

DAB hearing procedure

In reviewing a decision on a hearing under this paragraph, the Departmental Appeals Board shall review the case de novo.

(3)

Consequences of failure to meet deadlines

(A)

Hearing by administrative law judge

In the case of a failure by an administrative law judge to render a decision by the end of the period described in paragraph (1), the party requesting the hearing may request a review by the Departmental Appeals Board of the Department of Health and Human Services, notwithstanding any requirements for a hearing for purposes of the party’s right to such a review.

(B)

Departmental Appeals Board review

In the case of a failure by the Departmental Appeals Board to render a decision by the end of the period described in paragraph (2), the party requesting the hearing may seek judicial review, notwithstanding any requirements for a hearing for purposes of the party’s right to such judicial review.

(4)

Notice

Notice of the decision of an administrative law judge shall be in writing in a manner calculated to be understood by the individual entitled to benefits under part A or enrolled under part B, or both, and shall include—

(A)

the specific reasons for the determination (including, to the extent appropriate, a summary of the clinical or scientific evidence used in making the determination);

(B)

the procedures for obtaining additional information concerning the decision; and

(C)

notification of the right to appeal the decision and instructions on how to initiate such an appeal under this section.

(e)

Administrative provisions

(1)

Limitation on review of certain regulations

A regulation or instruction that relates to a method for determining the amount of payment under part B and that was initially issued before , shall not be subject to judicial review.

(2)

Outreach

The Secretary shall perform such outreach activities as are necessary to inform individuals entitled to benefits under this subchapter and providers of services and suppliers with respect to their rights of, and the process for, appeals made under this section. The Secretary shall use the toll-free telephone number maintained by the Secretary under section 1395b–2(b) of this title to provide information regarding appeal rights and respond to inquiries regarding the status of appeals.

(3)

Continuing education requirement for qualified independent contractors and administrative law judges

The Secretary shall provide to each qualified independent contractor, and, in consultation with the Commissioner of Social Security, to administrative law judges that decide appeals of reconsiderations of initial determinations or other decisions or determinations under this section, such continuing education with respect to coverage of items and services under this subchapter or policies of the Secretary with respect to part B of subchapter XI as is necessary for such qualified independent contractors and administrative law judges to make informed decisions with respect to appeals.

(4)

Reports

(A)

Annual report to Congress

The Secretary shall submit to Congress an annual report describing the number of appeals for the previous year, identifying issues that require administrative or legislative actions, and including any recommendations of the Secretary with respect to such actions. The Secretary shall include in such report an analysis of determinations by qualified independent contractors with respect to inconsistent decisions and an analysis of the causes of any such inconsistencies.

(B)

Survey

Not less frequently than every 5 years, the Secretary shall conduct a survey of a valid sample of individuals entitled to benefits under this subchapter who have filed appeals of determinations under this section, providers of services, and suppliers to determine the satisfaction of such individuals or entities with the process for appeals of determinations provided for under this section and education and training provided by the Secretary with respect to that process. The Secretary shall submit to Congress a report describing the results of the survey, and shall include any recommendations for administrative or legislative actions that the Secretary determines appropriate.

(f)

Review of coverage determinations

(1)

National coverage determinations

(A)

In general

Review of any national coverage determination shall be subject to the following limitations:

(i)

Such a determination shall not be reviewed by any administrative law judge.

(ii)

Such a determination shall not be held unlawful or set aside on the ground that a requirement of section 553 of title 5 or section 1395hh(b) of this title, relating to publication in the Federal Register or opportunity for public comment, was not satisfied.

(iii)

Upon the filing of a complaint by an aggrieved party, such a determination shall be reviewed by the Departmental Appeals Board of the Department of Health and Human Services. In conducting such a review, the Departmental Appeals Board—

(I)

shall review the record and shall permit discovery and the taking of evidence to evaluate the reasonableness of the determination, if the Board determines that the record is incomplete or lacks adequate information to support the validity of the determination;

(II)

may, as appropriate, consult with appropriate scientific and clinical experts; and

(III)

shall defer only to the reasonable findings of fact, reasonable interpretations of law, and reasonable applications of fact to law by the Secretary.

(iv)

The Secretary shall implement a decision of the Departmental Appeals Board within 30 days of receipt of such decision.

(v)

A decision of the Departmental Appeals Board constitutes a final agency action and is subject to judicial review.

(B)

Definition of national coverage determination

For purposes of this section, the term “national coverage determination” means a determination by the Secretary with respect to whether or not a particular item or service is covered nationally under this subchapter, but does not include a determination of what code, if any, is assigned to a particular item or service covered under this subchapter or a determination with respect to the amount of payment made for a particular item or service so covered.

(2)

Local coverage determination

(A)

In general

Review of any local coverage determination shall be subject to the following limitations:

(i)

Upon the filing of a complaint by an aggrieved party, such a determination shall be reviewed by an administrative law judge. The administrative law judge—

(I)

shall review the record and shall permit discovery and the taking of evidence to evaluate the reasonableness of the determination, if the administrative law judge determines that the record is incomplete or lacks adequate information to support the validity of the determination;

(II)

may, as appropriate, consult with appropriate scientific and clinical experts; and

(III)

shall defer only to the reasonable findings of fact, reasonable interpretations of law, and reasonable applications of fact to law by the Secretary.

(ii)

Upon the filing of a complaint by an aggrieved party, a decision of an administrative law judge under clause (i) shall be reviewed by the Departmental Appeals Board of the Department of Health and Human Services.

(iii)

The Secretary shall implement a decision of the administrative law judge or the Departmental Appeals Board within 30 days of receipt of such decision.

(iv)

A decision of the Departmental Appeals Board constitutes a final agency action and is subject to judicial review.

(B)

Definition of local coverage determination

For purposes of this section, the term “local coverage determination” means a determination by a fiscal intermediary or a carrier under part A or part B, as applicable, respecting whether or not a particular item or service is covered on an intermediary- or carrier-wide basis under such parts, in accordance with section 1395y(a)(1)(A) of this title.

(C)

Local coverage determinations for clinical diagnostic laboratory tests

For provisions relating to local coverage determinations for clinical diagnostic laboratory tests, see section 1395m–1(g) of this title.

(3)

No material issues of fact in dispute

In the case of a determination that may otherwise be subject to review under paragraph (1)(A)(iii) or paragraph (2)(A)(i), where the moving party alleges that—

(A)

there are no material issues of fact in dispute, and

(B)

the only issue of law is the constitutionality of a provision of this subchapter, or that a regulation, determination, or ruling by the Secretary is invalid,

the moving party may seek review by a court of competent jurisdiction without filing a complaint under such paragraph and without otherwise exhausting other administrative remedies.

(4)

Pending national coverage determinations

(A)

In general

In the event the Secretary has not issued a national coverage or noncoverage determination with respect to a particular type or class of items or services, an aggrieved person (as described in paragraph (5)) may submit to the Secretary a request to make such a determination with respect to such items or services. By not later than the end of the 90-day period beginning on the date the Secretary receives such a request (notwithstanding the receipt by the Secretary of new evidence (if any) during such 90-day period), the Secretary shall take one of the following actions:

(i)

Issue a national coverage determination, with or without limitations.

(ii)

Issue a national noncoverage determination.

(iii)

Issue a determination that no national coverage or noncoverage determination is appropriate as of the end of such 90-day period with respect to national coverage of such items or services.

(iv)

Issue a notice that states that the Secretary has not completed a review of the request for a national coverage determination and that includes an identification of the remaining steps in the Secretary’s review process and a deadline by which the Secretary will complete the review and take an action described in clause (i), (ii), or (iii).

(B)

Deemed action by the Secretary

In the case of an action described in subparagraph (A)(iv), if the Secretary fails to take an action referred to in such clause by the deadline specified by the Secretary under such clause, then the Secretary is deemed to have taken an action described in subparagraph (A)(iii) as of the deadline.

(C)

Explanation of determination

When issuing a determination under subparagraph (A), the Secretary shall include an explanation of the basis for the determination. An action taken under subparagraph (A) (other than clause (iv)) is deemed to be a national coverage determination for purposes of review under paragraph (1)(A).

(5)

Standing

An action under this subsection seeking review of a national coverage determination or local coverage determination may be initiated only by individuals entitled to benefits under part A, or enrolled under part B, or both, who are in need of the items or services that are the subject of the coverage determination.

(6)

Publication on the Internet of decisions of hearings of the Secretary

Each decision of a hearing by the Secretary with respect to a national coverage determination shall be made public, and the Secretary shall publish each decision on the Medicare 4 Internet site of the Department of Health and Human Services. The Secretary shall remove from such decision any information that would identify any individual, provider of services, or supplier.

(7)

Annual report on national coverage determinations

(A)

In general

Not later than December 1 of each year, beginning in 2001, the Secretary shall submit to Congress a report that sets forth a detailed compilation of the actual time periods that were necessary to complete and fully implement national coverage determinations that were made in the previous fiscal year for items, services, or medical devices not previously covered as a benefit under this subchapter, including, with respect to each new item, service, or medical device, a statement of the time taken by the Secretary to make and implement the necessary coverage, coding, and payment determinations, including the time taken to complete each significant step in the process of making and implementing such determinations.

(B)

Publication of reports on the Internet

The Secretary shall publish each report submitted under clause (i) on the medicare Internet site of the Department of Health and Human Services.

(8)

Construction

Nothing in this subsection shall be construed as permitting administrative or judicial review pursuant to this section insofar as such review is explicitly prohibited or restricted under another provision of law.

(g)

Qualifications of reviewers

(1)

In general

In reviewing determinations under this section, a qualified independent contractor shall assure that—

(A)

each individual conducting a review shall meet the qualifications of paragraph (2);

(B)

compensation provided by the contractor to each such reviewer is consistent with paragraph (3); and

(C)

in the case of a review by a panel described in subsection (c)(3)(B) composed of physicians or other health care professionals (each in this subsection referred to as a “reviewing professional”), a reviewing professional meets the qualifications described in paragraph (4) and, where a claim is regarding the furnishing of treatment by a physician (allopathic or osteopathic) or the provision of items or services by a physician (allopathic or osteopathic), a reviewing professional shall be a physician (allopathic or osteopathic).

(2)

Independence

(A)

In general

Subject to subparagraph (B), each individual conducting a review in a case shall—

(i)

not be a related party (as defined in paragraph (5));

(ii)

not have a material familial, financial, or professional relationship with such a party in the case under review; and

(iii)

not otherwise have a conflict of interest with such a party.

(B)

Exception

Nothing in subparagraph (A) shall be construed to—

(i)

prohibit an individual, solely on the basis of a participation agreement with a fiscal intermediary, carrier, or other contractor, from serving as a reviewing professional if—

(I)

the individual is not involved in the provision of items or services in the case under review;

(II)

the fact of such an agreement is disclosed to the Secretary and the individual entitled to benefits under part A or enrolled under part B, or both, or such individual’s authorized representative, and neither party objects; and

(III)

the individual is not an employee of the intermediary, carrier, or contractor and does not provide services exclusively or primarily to or on behalf of such intermediary, carrier, or contractor;

(ii)

prohibit an individual who has staff privileges at the institution where the treatment involved takes place from serving as a reviewer merely on the basis of having such staff privileges if the existence of such privileges is disclosed to the Secretary and such individual (or authorized representative), and neither party objects; or

(iii)

prohibit receipt of compensation by a reviewing professional from a contractor if the compensation is provided consistent with paragraph (3).

For purposes of this paragraph, the term “participation agreement” means an agreement relating to the provision of health care services by the individual and does not include the provision of services as a reviewer under this subsection.

(3)

Limitations on reviewer compensation

Compensation provided by a qualified independent contractor to a reviewer in connection with a review under this section shall not be contingent on the decision rendered by the reviewer.

(4)

Licensure and expertise

Each reviewing professional shall be—

(A)

a physician (allopathic or osteopathic) who is appropriately credentialed or licensed in one or more States to deliver health care services and has medical expertise in the field of practice that is appropriate for the items or services at issue; or

(B)

a health care professional who is legally authorized in one or more States (in accordance with State law or the State regulatory mechanism provided by State law) to furnish the health care items or services at issue and has medical expertise in the field of practice that is appropriate for such items or services.

(5)

Related party defined

For purposes of this section, the term “related party” means, with respect to a case under this subchapter involving a specific individual entitled to benefits under part A or enrolled under part B, or both, any of the following:

(A)

The Secretary, the medicare administrative contractor involved, or any fiduciary, officer, director, or employee of the Department of Health and Human Services, or of such contractor.

(B)

The individual (or authorized representative).

(C)

The health care professional that provides the items or services involved in the case.

(D)

The institution at which the items or services (or treatment) involved in the case are provided.

(E)

The manufacturer of any drug or other item that is included in the items or services involved in the case.

(F)

Any other party determined under any regulations to have a substantial interest in the case involved.

(h)

Prior determination process for certain items and services

(1)

Establishment of process

(A)

In general

With respect to a medicare administrative contractor that has a contract under section 1395kk–1 of this title that provides for making payments under this subchapter with respect to physicians’ services (as defined in section 1395w–4(j)(3) of this title), the Secretary shall establish a prior determination process that meets the requirements of this subsection and that shall be applied by such contractor in the case of eligible requesters.

(B)

Eligible requester

For purposes of this subsection, each of the following shall be an eligible requester:

(i)

A participating physician, but only with respect to physicians’ services to be furnished to an individual who is entitled to benefits under this subchapter and who has consented to the physician making the request under this subsection for those physicians’ services.

(ii)

An individual entitled to benefits under this subchapter, but only with respect to a physicians’ service for which the individual receives, from a physician, an advance beneficiary notice under section 1395pp(a) of this title.

(2)

Secretarial flexibility

The Secretary shall establish by regulation reasonable limits on the physicians’ services for which a prior determination of coverage may be requested under this subsection. In establishing such limits, the Secretary may consider the dollar amount involved with respect to the physicians’ service, administrative costs and burdens, and other relevant factors.

(3)

Request for prior determination

(A)

In general

Subject to paragraph (2), under the process established under this subsection an eligible requester may submit to the contractor a request for a determination, before the furnishing of a physicians’ service, as to whether the physicians’ service is covered under this subchapter consistent with the applicable requirements of section 1395y(a)(1)(A) of this title (relating to medical necessity).

(B)

Accompanying documentation

The Secretary may require that the request be accompanied by a description of the physicians’ service, supporting documentation relating to the medical necessity for the physicians’ service, and any other appropriate documentation. In the case of a request submitted by an eligible requester who is described in paragraph (1)(B)(ii), the Secretary may require that the request also be accompanied by a copy of the advance beneficiary notice involved.

(4)

Response to request

(A)

In general

Under such process, the contractor shall provide the eligible requester with written notice of a determination as to whether—

(i)

the physicians’ service is so covered;

(ii)

the physicians’ service is not so covered; or

(iii)

the contractor lacks sufficient information to make a coverage determination with respect to the physicians’ service.

(B)

Contents of notice for certain determinations

(i)

Noncoverage

If the contractor makes the determination described in subparagraph (A)(ii), the contractor shall include in the notice a brief explanation of the basis for the determination, including on what national or local coverage or noncoverage determination (if any) the determination is based, and a description of any applicable rights under subsection (a).

(ii)

Insufficient information

If the contractor makes the determination described in subparagraph (A)(iii), the contractor shall include in the notice a description of the additional information required to make the coverage determination.

(C)

Deadline to respond

Such notice shall be provided within the same time period as the time period applicable to the contractor providing notice of initial determinations on a claim for benefits under subsection (a)(2)(A).

(D)

Informing beneficiary in case of physician request

In the case of a request by a participating physician under paragraph (1)(B)(i), the process shall provide that the individual to whom the physicians’ service is proposed to be furnished shall be informed of any determination described in subparagraph (A)(ii) (relating to a determination of non-coverage) and the right (referred to in paragraph (6)(B)) to obtain the physicians’ service and have a claim submitted for the physicians’ service.

(5)

Binding nature of positive determination

If the contractor makes the determination described in paragraph (4)(A)(i), such determination shall be binding on the contractor in the absence of fraud or evidence of misrepresentation of facts presented to the contractor.

(6)

Limitation on further review

(A)

In general

Contractor determinations described in paragraph (4)(A)(ii) or (4)(A)(iii) (relating to pre-service claims) are not subject to further administrative appeal or judicial review under this section or otherwise.

(B)

Decision not to seek prior determination or negative determination does not impact right to obtain services, seek reimbursement, or appeal rights

Nothing in this subsection shall be construed as affecting the right of an individual who—

(i)

decides not to seek a prior determination under this subsection with respect to physicians’ services; or

(ii)

seeks such a determination and has received a determination described in paragraph (4)(A)(ii),

from receiving (and submitting a claim for) such physicians’ services and from obtaining administrative or judicial review respecting such claim under the other applicable provisions of this section. Failure to seek a prior determination under this subsection with respect to physicians’ service shall not be taken into account in such administrative or judicial review.

(C)

No prior determination after receipt of services

Once an individual is provided physicians’ services, there shall be no prior determination under this subsection with respect to such physicians’ services.

(i)

Mediation process for local coverage determinations

(1)

Establishment of process

The Secretary shall establish a mediation process under this subsection through the use of a physician trained in mediation and employed by the Centers for Medicare & Medicaid Services.

(2)

Responsibility of mediator

Under the process established in paragraph (1), such a mediator shall mediate in disputes between groups representing providers of services, suppliers (as defined in section 1395x(d) of this title), and the medical director for a medicare administrative contractor whenever the regional administrator (as defined by the Secretary) involved determines that there was a systematic pattern and a large volume of complaints from such groups regarding decisions of such director or there is a complaint from the co-chair of the advisory committee for that contractor to such regional administrator regarding such dispute.

Footnotes

  1. 1 So in original.
  2. 2 So in original. The word “and” probably should not appear.
  3. 3 So in original. A comma probably should appear.
  4. 4 So in original. Probably should not be capitalized.

Legislative history

Reconstructed from this section’s Code source credit and amendment notes, resolved against the local Statutes at Large. Editorial notes are evidence, not the law that made the change.

  1. Health Insurance for the Aged Act

    Pub. L. 89–97 title I § 102(a) · 79 Stat. 288

    Enacted · 42 U.S.C. § 1395ff

    Aug. 14, 1935, ch. 531, title XVIII, § 1869, as added Pub. L. 89–97, title I, § 102(a), July 30, 1965, 79 Stat. 330

    Source evidence

    Code source credit
    Aug. 14, 1935, ch. 531, title XVIII, § 1869, as added Pub. L. 89–97, title I, § 102(a), July 30, 1965, 79 Stat. 330

    Enacted provision · exact public law section
    (a) The Social Security Act is amended by adding after title XVII the following new title: 42 USC 1305. “TITLE XVIII— HEALTH INSURANCE FOR THE AGED “Sec. 1801. “prohibition against any federal interference Nothing in this title shall be construed to authorize any Federal officer or employee to exercise any supervision or control over the practice of medicine or the manner in which medical services are provided, or over the selection, tenure, or compensation of any officer or employee of any institution, agency, or person providing health services; or to exercise any supervision or control over the administration or operation of any such institution, agency, or person. “Sec. 1802. “free choice by patient guaranteed Any individual entitled to insurance benefits under this title may obtain health services from any institution, agency, or person qualified to participate under this title if such institution, agency, or person undertakes to provide him such services. “Sec. 1803. “option to individuals to obtain other health insurance protection Nothing contained in this title shall be construed to preclude any State from providing, or any individual from purchasing or oilier wise securing, protection against the cost of any health services. “Part A— Hospital Insurance Benefits for the Aged “Sec. 1811. “description of program The insurance program for which entitlement is established by section 226 provides basic protection against the costs of hospital Ante, p. 290. and related post-hospital services in accordance with this part for individuals who are age 65 or over and are entitled to retirement 42 USC 401–425. benefits under title II of this Act or under the railroad retirement system. “Sec. 1812. “scope of benefits (a) The benefits provided to an individual by the insurance program under this part shall consist of entitlement to have payment made on his behalf (subject to the provisions of this part) for— “(1) inpatient hospital services for up to 90 days during any spell of illness; “(2) post-hospital extended care services for up to 100 days during any spell of illness; “(3) post-hospital home health services for up to 100 visits (during the one-year period described in section 1861(h)) after the beginning of one spell of illness and before the beginning of the next; and “(4) outpatient hospital diagnostic services. “(b) Payment under this part for services furnished an individual during a spell of illness may not (subject to subsection (c)) be made for— “(1) inpatient hospital services furnished to him during such spell after such services have been furnished to him for 90 days (luring such spell; “(2) post-hospital extended care services furnished to him during such spell after such services have been furnished to him for 100 days during such spell; or “(3) inpatient psychiatric hospital services furnished to him after such services have been furnished to him for a total of 190 days during his lifetime. “(c) If an individual is an inpatient of a psychiatric hospital or a tuberculosis hospital on the first day of the first month for which lie is entitled to benefits under this part, the days on which he was an inpatient of such a hospital in the 90-day period immediately before such first day shall be included in determining the 90-day limit under subsection (b)(1)(but not in determining the 190-day limit under subsection (b)(3)). “(d) Payment under this part may be made for post-hospital home health services furnished an individual only during the one-year period described in section 1861 (n) following his most recent hospital discharge which meets the requirements of such section, and only for the first 100 visits in such period. The number of visits to be charged for purposes of the limitation in the preceding sentence, in connection with items or services described in section 1861 (m), shall be determined in accordance with regulations. “(e) For purposes of subsections (b), (c), and (d), inpatient hospital services, inpatient psychiatric hospital services, post-hospital extended care services, and post-hospital home health services shall be taken into account only if payment is or would be, except for this section or the failure to comply with the request and certification requirements of or under section 1814(a), made with respect to such services under this part. “(f) For definition of ‘spell of illness’, and for definitions of other terms used in this part, see section 1861. “Sec. 1813. “deductibles and coinsurance (a) (1) The amount payable for inpatient hospital services furnished an individual during any spell of illness shall be reduced by a deduction equal to the inpatient hospital deductible or, if less, the charges imposed with respect to such individual for such services, except that, if the customary charges for such services are greater than the charges so imposed, such customary charges shall be considered to be the charges so imposed. Such amount shall be further reduced by a coinsurance amount equal to one-fourth of the inpatient hospital deductible for each day (before the 91st day) on which such individual is furnished such services during such spell of illness after such services have been furnished to him for 60 days during such spell. “(2) The amount payable for outpatient hospital diagnostic Outpatient hospital diagnostic services. services furnished an individual during a diagnostic study shall be reduced by a deduction equal to the sum of (A) one-half of the inpatient hospital deductible which is applicable to spells of illness beginning in the same calendar year as such diagnostic study and (B) 20 per centum of the remainder of such amount. For purposes of the preceding sentence, a diagnostic study for any individual consists of the outpatient hospital diagnostic services provided by (or under arrangements made by) the same hospital during the 20-day period beginning on the first day (not included in a previous diagnostic study) on which he is entitled to hospital insurance benefits under section 226 and on which outpatient hospital diagnostic services are Ante, p. 290. furnished him. “(3) The amount payable to any provider of services under this part, for services furnished an individual during any spell of illness shall be further reduced by an amount equal to the cost of the first three pints of whole blood furnished to him as part of such services during such spell of illness. “(4) The amount payable for post-hospital extended care services furnished an individual during any spell of illness shall lie reduced by a coinsurance amount equal to one-eighth of the inpatient hospital deductible for each day (before the 101st day) on which he is furnished such services after such services have been furnished to him for 20 days during such spell. “(b) (1) The inpatient hospital deductible which shall be applicable Inpatient hospital deductible. for the purposes of subsection (a) shall be $40 in the case of any spell of illness or diagnostic study beginning before 1969. “(2) The Secretary shall, between July 1 and October 1 of 1968, and of each year thereafter, determine and promulgate the inpatient hospital deductible which shall be applicable for the purposes of subsection (a) in the case of any spell of illness or diagnostic study beginning during the succeeding calendar year. Such inpatient hospital deductible shall be equal to $40 multiplied by the ratio of (A) the current average per diem rate for inpatient hospital services for the calendar year preceding the promulgation, to (B) the current average per diem rate for such services for 1966. Any amount determined under the preceding sentence which is not a multiple of $4 shall be rounded to the nearest multiple of $4 (or, if it is midway between two multiples of $4, to the next, higher multiple of $4). The current average per diem rate for any year shall be determined by the Secretary on the basis of the best information available to him (at the time the determination is made) as to the amounts paid under this part on account of inpatient hospital services furnished during such year, by hospitals which have agreements in effect under section 1866, to individuals who are entitled Post, p. 327. to hospital insurance benefits under section 226, plus the amount which would have been so paid but for subsection (a)(1) of this section. “Sec. 1814. “conditions of and limitations on payment for services “Requirement of Requests and Certifications (a) Except as provided in subsection (d), payment for services furnished an individual may be made only to providers of services which are eligible therefor under section 1866 and only Post, p. 327. if— “(1) written request, signed by such individual except in cases in which the Secretary finds it impracticable for the individual to do so, is filed for such payment in such form, in such manner, within such time, and by such person or persons as the Secretary may by regulation prescribe; “(2) a physician certifies (and recertifies, where such services are furnished over a period of time, in such cases, with such frequency, and accompanied by such supporting material, appropriate to the case involved, as may be provided by regulations, except that the first of such recertifications shall be required in each case of inpatient hospital services not later than the 20th day of such period) that— “(A) in the case of inpatient hospital services (other than inpatient psychiatric hospital services and inpatient tuberculosis hospital services), such services are or were required to be given on an inpatient basis for such individual’s medical treatment, or that inpatient diagnostic study is or was medically required and such services are or were necessary for such purpose; “(B) in the case of inpatient psychiatric hospital services, such services are or were required to be given on an inpatient basis, by or under the supervision of a physician, tor the psychiatric treatment of an individual; and (i) such treatment can or could reasonably be expected to improve the condition for which such treatment is or was necessary or (ii) inpatient diagnostic study is or was medically required and such services are or were necessary for such purposes; “(C) in the case of inpatient tuberculosis hospital services, such services are or were required to be given on an inpatient basis, by or under the supervision of a physician, for the treatment of an individual for tuberculosis; and such treatment can or could reasonably be expected to (i) improve the condition for which such treatment is or was necessary or (ii) render the condition noncommunicable; “(D) in the case of post-hospital extended care services, such services are or were required to be given on an inpatient basis because the individual needs or needed skilled nursing care on a continuing basis for any of the conditions with respect to which he was receiving inpatient hospital services (or. services which would constitute inpatient hospital services if the institution met the requirements of paragraphs Post, p. 314. (6) and (8) of section 1861(e)) prior to transfer to the extended care facility or for a condition requiring such extended care services which arose after such transfer and while he was still in the facility for treatment of the condition or conditions for which he was receiving such inpatient hospital services; “(E) in the case of post-hospital home health services, such services are or were required because the individual is or was confined to his home (except when receiving items and services referred to in section 1861 (m)(7)) and Post, p. 319. needed skilled nursing care on an intermittent basis, or physical or speech therapy, for any of the conditions with respect to which he was receiving inpatient hospital services (or services which would constitute inpatient hospital services if the institution met the requirements of paragraphs (6) and (8) of section 1861(e)) or post-hospital extended care services; a plan for furnishing such services to such individual has been established and is periodically reviewed by a physician; and such services are or were furnished while the individual was under the care of a physician; or “(F) in the case of outpatient hospital diagnostic services, such services are or were required for diagnostic study; “(3) in the case of inpatient psychiatric hospital services, the services are those which the records of the hospital indicate were furnished to the individual during periods when he was receiving (A) intensive treatment services, (B) admission and related services necessary for a diagnostic study, or (C) equivalent services; “(4) in the case of inpatient tuberculosis hospital services, the services are those which the records of the hospital indicate were furnished to the individual during periods when he was receiving treatment which could reasonably be expected to (A) improve his condition or (B) render it noncommunicable; “(5) with respect to inpatient hospital services furnished such individual after the 20th day of a continuous period of such services and with respect to post-hospital extended care services furnished sifter such day of a continuous period of such services as may be prescribed in or pursuant to regulations, there was not in effect, at the time of admission of such individual to the hospital or extended care facility, as the case may be, a decision under section 1866(d)(based on a finding that utilization Post, p. 327. review of long-stay cases is not being made in such hospital or facility); and “(6) with respect to inpatient hospital services or post-hospital extended care services furnished such individual during a continuous period, a finding has not been made (by the physician members of the committee or group, as described in section 1861(h)(4)) pursuant to the system of utilization review that further inpatient hospital services or further post-hospital extended care services, as the case may be, are not medically necessary; except that, if such a finding has been made, payment may be made for such services furnished before the 4th day after the day on which the hospital or extended care facility, as the case may be, received notice of such finding. To the extent provided by regulations, the certification and recertification requirements of paragraph (2) shall be deemed satisfied where, at a later date, a physician makes certification of the kind provided in subparagraph (A), (B), (C), (D), (E), or (F) of paragraph (2) (whichever would have applied), but only where such certification is accompanied by such medical and other evidence as may be required by such regulations. “(b) “Reasonable Cost of Services The amount paid to any provider of services with respect to services for which payment may be made under this part shall, subject Ante, p. 292. Post, p. 322. to the provisions of section 1813, be the reasonable cost of such services, as determined under section 1861 (v). “(c) “No Payments to Federal Providers of Services No payment may be made under this part (except under subsection (d)) to any Federal provider of services, except a provider of services which the Secretary determines is providing services to the public generally as a community institution or agency; and no such payment may be made to any provider of services for any item or service which such provider is obligated by a law of, or a contract with, the United States to render at public expense. “(d) “Payments for Emergency Hospital Services Payments shall also be made to any hospital for inpatient hospital services or outpatient hospital diagnostic services furnished, by the hospital or under arrangements (as defined in section 1861 (w)) with it, to an individual entitled to hospital insurance benefits under Ante, p. 290. section 226 even though such hospital does not have an agreement in effect under this title if (A) such services were emergency services and (B) the Secretary would be required to make such payment if the hospital had such an agreement in effect and otherwise met the conditions of payment hereunder. Such payments shall be made only in the amounts provided under subsection (b) and then only if such hospital agrees to comply, with respect to the emergency services provided, Post, p. 327. with the provisions of section 1866(a). “(e) “Payment for Inpatient Hospital Services Prior to Notification of Noneligibility Notwithstanding that an individual is not entitled to have payment made under this part for inpatient hospital services furnished by any hospital, payment shall be made to such hospital (unless it elects not to receive such payment or, if payment has already been made by or on behalf of such individual, fails to refund such payment within the time specified by the Secretary) for such services which are furnished to the individual prior to notification to such hospital from the Secretary of his lack of entitlement, if such payments are precluded Ante, p. 291. only by reason of section 1812 and if such hospital complies with the requirements of and regulations under this title with respect to such payments, has acted in good faith and without knowledge of such lack of entitlement, and has acted reasonably in assuming entitlement existed. Payment under the preceding sentence may not be made for services furnished an individual pursuant, to any admission after the 6th elapsed day (not including as an elapsed day Saturday, Sunday, or a legal holiday) after the day on which such admission occurred. “(f) “Payment for Certain Emergency Hospital Services Furnished Outside the United States The authority contained in subsection (d) shall be applicable to emergency inpatient hospital services furnished an individual by a hospital located outside the United States if— “(1) such individual was physically present in a place within the United States at the time the emergency which necessitated such inpatient hospital services occurred; and “(2) such hospital was closer to, or substantially more accessible from, such place than the nearest hospital within the United States which was adequately equipped to deal with, and was available for the treatment of, such individual’s illness or injury. “Sec. 1815. “payment to providers or services The Secretary shall periodically determine the amount which should be paid under this part to each provider of services with respect to the services furnished by it, and the provider of services shall be paid, at such time or times as the Secretary believes appropriate (but not less often than monthly) and prior to audit or settlement by the General Accounting Office, from the Federal Hospital Insurance Trust Fund, the amounts so determined, with necessary Post, p. 299. adjustments on account of previously made overpayments or underpayments; except that no such payments shall be made to any provider unless it has furnished such information as the Secretary may request in order to determine the amounts due such provider under this part, for the period with respect to which the amounts are being paid or any prior period. “Sec. 1816. “use of public agencies or private organizations to facilitate payment to providers of services (a) If any group or association of providers of services wishes to have payments under this part to such providers made through a national, State, or other public or private agency or organization and nominates such agency or organization for this purpose, the Secretary is authorized to enter into an agreement with such agency or organization providing for the determination by such agency or organization (subject to such review by the Secretary as may be provided for by the agreement.) of the amount of the payments required pursuant to this part, to be made to such providers, and for the making of such payments by such agency or organization to such providers. Such agreement may also include provision for the agency or organization to do all or any part of the following: (1) to provide consultative services to institutions or agencies to enable them to establish and maintain fiscal records necessary for purposes of this part and otherwise to qualify as hospitals, extended care facilities, or home health agencies, and (2) with respect to the providers of services which are to receive payments through it (A) to serve as a center for, and communicate to providers, any information or instructions furnished to it by the Secretary, and serve as a channel of communication from providers to the Secretary; (B) to make such audits of the records of providers as may be necessary to insure that proper payments are made under this part; and (C) to perform such other functions as are necessary to carry out this subsection. “(b) The Secretary shall not enter into an agreement with any agency or organization under this section unless (1) he finds (A) that to do so is consistent with the effective and efficient administration of this part, and (B) that such agency or organization is willing and able to assist the providers to which payments are made through it under this part in the application of safeguards against unnecessary utilization of services furnished by them to individuals entitled Ante, p. 290. to Hospital insurance benefits under section 226, and the agreement provides for such assistance, and (2) such agency or organization agrees to furnish to the Secretary such of the information acquired by it in carrying out its agreement under this section as the Secretary may find necessary in performing his functions under this part. “(c) An agreement with any agency or organization under this section may contain such terms and conditions as the Secretary finds necessary or appropriate, may provide for advances of funds to the agency or organization for the making of payments by it under subsection (a), and shall provide for payment of so much of the cost of administration of the agency or organization as is determined by the Secretary to be necessary and proper for carrying out the functions covered by the agreement. “(d) If the nomination of an agency or organization as provided in this section is made by a group or association of providers of services, it shall not be binding on members of the group or association which notify the Secretary of their election to that effect Any provider may, upon such notice as may be specified in the agreement under this section with an agency or organization, withdraw its nomination to receive payments through such agency or organization. Any provider which has withdrawn its nomination, and any provider which has not made a nomination, may elect to receive payments from any agency or organization which has entered into an agreement with the Secretary under this section if the Secretary and such agency or organization agree to it. “(e) An agreement with the Secretary under this section may be terminated— “(1) by the agency or organization which entered into such agreement at such time and upon such notice to the Secretary, to the public, and to the providers as may be provided in regulations, or “(2) by the Secretary at such time and upon such notice to the agency or organization, to the providers which have nominated it for purposes of this section, and to the public, as may be provided in regulations, but only if he finds, after reasonable notice and opportunity for hearing to the agency or organization, that (A) the agency or organization has failed substantially to carry out the agreement, or (B) the continuation of some or all of the functions provided for in the agreement with the agency or organization is disadvantageous or is inconsistent with the efficient administration of this part. “(f) An agreement with an agency or organization under this section may require any of its officers or employees certifying payments or disbursing funds pursuant to the agreement, or otherwise participating in carrying out the agreement, to give surety bond to the United States in such amount as the Secretary may deem appropriate. “(g) (1) No individual designated pursuant to an agreement, under this section as a certifying officer shall, in the absence of gross negligence or intent to defraud the United States, be liable with respect to any payments certified by him under this section. “(2) No disbursing officer shall, in the absence of gross negligence or intent to defraud the United States, be liable with respect, to any payment by him under this section if it was based upon a voucher signed by a certifying officer designated as provided in paragraph (1) of this subsection. “(3) No such agency or organization shall be liable to the United States for any payments referred to in paragraph (1) or (2). “Sec. 1817. “federal hospital insurance trust fund (a) There is hereby created on the books of the Treasury of the United States a trust, fund to be known as the ‘Federal Hospital Insurance Trust Fund’ (hereinafter in this section referred to as the ‘Trust Fund’). The Trust Fund shall consist of such amounts as may be deposited in, or appropriated to, such fund as provided in this part. There are hereby appropriated to the Trust Fund for the fiscal year ending June 30, 1966, and for each fiscal year thereafter, out of any moneys in the Treasury not otherwise appropriated, amounts equivalent to 100 per centum of— “(1) the taxes imposed by sections 3101 (b) and 3111(b) of the Internal Revenue Code of 1954 with respect to wages reported Post, pp, 395, 396. to the Secretary of the Treasury or his delegate pursuant to subtitle F of such Code after December 31, 1965, as determined by 26 USC 6001 et seq. the Secretary of the Treasury by applying the applicable rates of tax under such sections to such wages, which wages shall be certified by the Secretary of Health, Education, and Welfare on the basis of records of wages established and maintained by the Secretary of Health, Education, and Welfare in accordance with such reports; and “(2) the taxes imposed by section 1401(b) of the Infernal Revenue Code of 1954 with respect to self-employment income Post, p. 394. reported to the Secretary of the Treasury or his delegate on tax returns under subtitle F of such Code, as determined by the Secretary of the Treasury by applying the applicable rate of tax under such section to such self-employment income, which self-employment income shall be certified by the Secretary of Health, Education, and Welfare on the basis of records of self-employment established and maintained by the Secretary of Health, Education, and Welfare in accordance with such returns. The amounts appropriated by the preceding sentence shall be transferred from time to time from the general fund in the Treasury to the Trust Fund, such amounts to be determined on the basis of estimates by the Secretary of the Treasury of the taxes, specified in the preceding sentence, paid to or deposited into the Treasury; and proper adjustments shall be made in amounts subsequently transferred to the extent prior estimates were in excess of or were less than the taxes specified in such sentence. “(b) With respect to the Trust Fund, there is hereby created a Board of Trustees. body to be known as the Board of Trustees of the Trust Fund (hereinafter in this section referred to as the ‘Board of Trustees’) composed of the Secretary of the Treasury, the Secretary of Labor, and the Secretary of Health, Education, and Welfare, all ex officio. The Secretary of the Treasury shall be the Managing Trustee of the Board of Trustees (hereinafter in this section referred to as the ‘Managing Trustee’), The Commissioner of Social Security shall Reports to Congress. serve as the Secretary of the Board of Trustees. The Board of Trustees shall meet not less frequently than once each calendar year. It shall be the duty of the Board of Trustees to— “(1) Hold the Trust. Fund; “(2) Report to the Congress not later than the first day of March of each year on the operation and status of the Trust Fund during the preceding fiscal year and on its expected operation and status during the current fiscal year and the next 2 fiscal years; “(3) Report immediately to the Congress whenever the Board is of the opinion that the amount of the Trust Fund is unduly small; and “(4) Review the general policies followed in managing the Trust Fund, and recommend changes in such policies, including necessary changes in the provisions of law which govern the way in which the Trust Fund is to be managed. The report, provided for in paragraph (2) shall include a statement of the assets of, and the disbursements made from, the Trust Fund during the preceding fiscal year, an estimate of the expected income to, and disbursements to be made from, the Trust Fund during the current fiscal year and each of the next 2 fiscal years, and a statement of the actuarial status of the Trust Fund. Such report shall be printed as a House document of the session of the Congress to which the report is made. “(c) It shall be the duty of the Managing Trustee to invest such portion of the Trust. Fund as is not, in his judgment, required to meet current withdrawals. Such investments may be made only in interest-bearing obligations of the United States or in obligations guaranteed as to both principal and interest by the United States. For such purpose such obligations may be acquired (1) on original issue at the issue price, or (2) by purchase of outstanding obligations at the market price. The purposes for which obligations of the 40 Stat. 288. 31 USC 774. United States may be issued under the Second Liberty Bond Act, as amended, are hereby extended to authorize the issuance at par of public-debt obligations for purchase by the Trust Fund. Such obligations issued for purchase by the Trust Fund shall have maturities fixed with due regard for the needs of the Trust. Fund and shall bear interest at a rate equal to the average market yield (computed by the Managing Trustee on the basis of market quotations as of the end of the calendar month next preceding the date of such issue) on all marketable interest-bearing obligations of the United States then forming a part of the public debt which are not due or callable until after the expiration of 4 years from the end of such calendar month; except that where such average market yield is not a multiple of one--eighth of 1 per centum, the rate of interest on such obligations shall be the multiple of one-eighth of 1 per centum nearest such market yield. The Managing Trustee may purchase other interest-bearing obligations of the United States or obligations guaranteed as to both principal and interest by the United States, on original issue or at the market, price, only where he determines that the purchase of such other obligations is in the public interest. “(d) Any obligations acquired by the Trust Fund (except public-debt obligations issued exclusively to the Trust Fund) may be sold by the Managing Trustee at the market price, and such public-debt obligations may be redeemed at par plus accrued interest. “(e) The interest on, and the proceeds from the sale or redemption of, any obligations held in the Trust Fund shall be credited to and form a part of the Trust Fund. _ “(f) (1) The Managing Trustee is directed to pay from time to time from the Trust Fund into the Treasury the amount estimated by him as taxes imposed under section 3101(b) which are subject to Post, p. 395. Post, p. 393. refund under section 6413(c) of the Internal Revenue Code of 1954 with respect to wages paid after December 31, 1965. Such taxes shall be determined on the basis of the records of wages established and maintained by the Secretary of Health, Education, and Welfare in accordance with the wages reported to the Secretary of the Treasury or his delegate pursuant to subtitle F of the Internal Revenue Code 26 USC 6001 et seq. of 1954, and the Secretary of Health, Education, and Welfare shall furnish the Managing Trustee such information as may be required by the Managing Trustee for such purpose. The payments by the Managing Trustee shall be covered into the Treasury as repayments to the account for refunding internal revenue collections. “(2) Repayments made under paragraph (1) shall not be available for expenditures but shall be carried to the surplus fund of the Treasury. If it subsequently appears that the estimates under such paragraph in any particular period were too high or too low, appropriate adjustments shall be made by the Managing Trustee in future payments. “(g) There shall be transferred periodically (but not less often than once each fiscal year) to the Trust Fund from the Federal Old-Age and Survivors Insurance Trust Fund and from the Federal Disability Insurance Trust Fund amounts equivalent to the amounts not previously so transferred which the Secretary of Health, Education, and Welfare shall have certified as overpayments (other than amounts so certified to the Railroad Retirement Board) pursuant to section 1870(b) of this Act. There shall be transferred periodically Post, p. 331. (but not less often than once each fiscal year) to the Trust Fund from the Railroad Retirement Account amounts equivalent to the amounts not previously so transferred which the Secretary of Health, Education, and Wei fare shall have certified as overpayments to the Railroad Retirement Board pursuant to section 1870(b) of this Act. “(h) The Managing Trustee shall also pay from time to time from the Trust Fund such amounts as the Secretary of Health, Education, and Welfare certifies are necessary to make the payments provided for by this part, and the payments with respect to administrative expenses in accordance with section 201 (g)(1). Post, p. 338. “Part B— Supplementary Medical Insurance Benefits for the Aged “Sec. 1831. “establishment of supplementary medical insurance program for the aged There is hereby established a voluntary insurance program to provide medical insurance benefits in accordance with the provisions of this part for individuals 65 years of age or over who elect to enroll under such program, to be financed from premium payments by enrollees together with contributions from funds appropriated by the Federal Government. “Sec. 1832. “scope of benefits (a) The benefits provided to an individual by the insurance program established by this part shall consist of— “(1) entitlement to have payment made to him or on his behalf (subject to the provisions of this part) for medical and other health services, except those described in paragraph (2)(B);and “(2) entitlement to have payment made on his behalf (subject to the provisions of this part) for— “(A) home health services for up to 100 visits during a calendar year; and “(B) medical and other health services (other than physicians services unless furnished by a resident or intern of a hospital) furnished by a provider of services or by others under arrangements with them made by a provider of services. “(b) For definitions of ‘spell of illness’, ‘medical and other health services’, and other terms used in this part, see section 1861. “Sec. 1833. “payment of benefits (a) Subject to the succeeding provisions of this section, there shall be paid from the Federal Supplementary Medical Post, p. 308. Insurance Trust Fund, in the case of each individual who is covered under the insurance program established by this part and incurs expenses for services with respect to which benefits are payable under this part, amounts equal to— “(1) in the case of services described in section 1832(a)(1)—80 percent of the reasonable charges for the services; except that an organization which provides medical and other health services (or arranges for their availability) on a prepayment basis may elect to be paid 80 percent of the reasonable cost of services for which payment may be made under this part on behalf of individuals enrolled in such organization in lieu of 80 percent of the reasonable charges for such services if the organization undertakes to charge such individuals no more than 20 percent of such reasonable cost plus any amounts payable by them as a result of subsection (b); and “(2) in the case of services described in section 1832(a)(2)—80 percent of the reasonable cost of the services (as determined Post, p. 322. under section 1861 (v)). “(b) Before applying subsection (a) with respect to expenses incurred by an individual during any calendar year, the total amount of the expenses incurred by such individual during such year (which would, except for this subsection, constitute incurred expenses from which benefits payable under subsection (a) are determinable) shall be reduced by a deductible of $50; except that (1) the amount of the deductible for such calendar year as so determined shall first be reduced by the amount of any expenses incurred by such individual in the last three months of the preceding calendar year (or regarded under clause (2) as incurred in such preceding year with respect to services furnished in such last three months) and applied toward such individual’s deductible under this section for such preceding year, and (2) the Ante, p. 292. amount of any deduction imposed under section 1813(a)(2)(A) with respect to outpatient hospital diagnostic services furnished in any calendar year shall be regarded as an incurred expense under this part for such year. “(c) Notwithstanding any other provision of this part, with respect Mental disorders. to expenses incurred in any calendar year in connection with the treatment of mental, psychoneurotic, and personality disorders of an individual who is not an inpatient of a hospital at the time such expenses are incurred, there shall be considered as incurred expenses for purposes of subsections (a) and (b) only whichever of the following amounts is the smaller: “(1) $312.50, or “(2) 62½ percent of such expenses. “(d) No payment may be made under this part with respect be any services furnished an individual to the extent that such individual is entitled (or would be entitled except for section 1813 other than Ante, p. 292. subsection (a)(2)(A) thereof) to have payment made with respect to such services under part A. “(e) No payment shall be made to any provider of services or other person under this part unless there has been furnished such information as may be necessary in order to determine the amounts due such provider or other person under this part for the period with respect to which the amounts are being paid or for any prior period. “Sec. 1834. “limitation on home health services (a) Payment under this part may be made for home health services furnished an individual during any calendar year only for 100 visits during such year. The number of visits to be charged for purposes of the limitation in the preceding sentence, in connection with items and services described in section 1861 (m), shall be determined Post, p. 319. in accordance with regulations. “(b) For purposes of subsection (a), home health services shall be taken into account only if payment under this part is or would be, except for this section or the failure to comply with the request and certification requirements of or under section 1835(a), made with respect to such services. “Sec. 1835. “procedure for payment of claims of providers of services (a) Payment for services described in section 1832(a)(2) furnished an individual may be made only to providers of services which are eligible therefor under section 1866(a), and only if— Post, p. 327. “(1) written request, signed by such individual except in cases in which the Secretary finds it impracticable for the individual to do so, is filed for such payment in such form, in such manner, within such time, and by such person or persons as the Secretary may by regulations prescribe; and “(2) a physician certifies (and recertifies, where such services are furnished over a period of time, in such cases, with such frequency, and accompanied by such supporting material, appropriate to the case involved, as may be provided by regulations) that— “(A) in the case of home health services (i) such services are or were required because the individual is or was confined to his home (except when receiving items and services referred to in section 1861 (m)(7)) and needed skilled nursing care on an intermittent basis, or physical or speech therapy , (ii) a plan for furnishing such services to such individual has been established and is periodically reviewed by a physician, and (iii) such services are or were furnished while the individual is or was under the care of a physician; and “(B) in the case of medical and other health services, such services are or were medically required. To the extent provided by regulations, the certification and recertification requirements of paragraph (2) shall be deemed satisfied where, at a later date, a physician makes a certification of the kind provided in subparagraph (A) or (B) of paragraph (2)(whichever would have applied), but only where such certification is accompanied by such medical and other evidence as may be required by such regulations. “(b) No payment may be made under this part to any Federal provider of services or other Federal agency, except a provider of services which the Secretary determines is providing services to the public generally as a community institution or agency; and no such payment may be made to any provider of services or other person for any item or service which such provider or person is obligated by a law of, or a contract with, the United States to render at public expense. “Sec. 1836. “eligible individuals Every individual who— “(1) has attained the age of 65, and “(2) (A) is a resident of the United States, and is either (i) a citizen or (ii) an alien lawfully admitted for permanent residence who has resided in the United States continuously during the 5 years immediately preceding the month in which he applies for enrollment under this part, or (B) is entitled to hospital insurance benefits under part A, is eligible to enroll in the insurance program established by this part. “Sec. 1837. “enrollment periods (a) An individual may enroll in the insurance program established by this part only in such manner and form as may be prescribed by regulations, and only during an enrollment period prescribed in or under this section. “(b) (1) No individual may enroll for the first time under this part more than 3 years after the close of the first enrollment period during which he could have enrolled under this part. “(2) An individual whose enrollment under this part has terminated may not enroll for the second time under this part unless he does so in a general enrollment period (as provided in subsection (e)) which begins within 3 years after the effective date of such termination. No individual may enroll under this part more than twice. “(c) In the case of individuals who first, satisfy paragraphs (1) and (2) of section 1836 before January 1, 1966, the initial general enrollment period shall begin on the first day of the second month which begins after the date of enactment of this title and shall end on March 31, 1966. For purposes of this subsection and subsection (d), an individual who satisfies paragraph (2) of section 1836 solely by reason of subparagraph (B) thereof shall be treated as satisfying such paragraph (2) on the first day on which he is (or on filing application would be) entitled to hospital insurance benefits under part A. “(d) In the case of an individual who first satisfies paragraphs (1) and (2) of section 1836 on or after January 1, 1966, his initial enroll- ment period shall begin on the first day of the third month before the month in which he first satisfies such paragraphs and shall end seven months later. “(e) There shall be a general enrollment period, after the period described in subsection (c), during the period beginning on October 1 and ending on December 31 of each odd-numbered year beginning with 1967. “Sec. 1838. “coverage period (a) The period during which an individual is entitled to benefits under the insurance program established by this part (hereinafter referred to as his ‘coverage period’) shall begin on whichever of the following is the latest: “(1) July 1, 1966; or “(2) (A) in the case of an individual who enrolls pursuant to subsection (d) of section 1837 before the month in which he first satisfies paragraphs (1) and (2) of section 1836, the first day of such month, or “(B) in the case of an individual who enrolls pursuant to such subsection (d) in the month in which he first satisfies such paragraphs, the first day of the month following the month in which he so enrolls, Or “(C) in the case of an individual who enrolls pursuant to such subsection (d) in the month following the month in which he first satisfies such paragraphs, the first day of the second month following the month in which he so enrolls, or “(D) in the case of an individual who enrolls pursuant to such subsection (d) more than one month following the month in which he satisfies such paragraphs, the first day of the third month following the month in which he so enrolls, or “(E) in the case of an individual who enrolls pursuant to subsection (e) of section 1837, the July 1 following the month in which he so enrolls. “(b) An individual’s coverage period shall continue until his enrollment has been terminated— “(1) by the filing of notice, during a general enrollment period described in section 1837(e), that the individual no longer wishes to participate in the insurance program established by this part, or “(2) for nonpayment of premiums. The termination of a coverage period under paragraph (1) shall take effect at the close of December 31 of the year in which the notice is filed. The termination of a coverage period under paragraph (2) shall take effect on a date determined under regulations, which may be determined so as to provide a grace period (not in excess of 90 days) in which overdue premiums may be paid and coverage continued. “(c) No payments may be made under this part with respect to the expenses of an individual mi less such expenses were incurred by such individual during a period which, with respect to him, is a coverage period. “Sec. 1839. “amounts of premiums (a) The monthly premium of each individual enrolled under this part for each month before 1968 shall be $3. “(b) (1) The monthly premium of each individual enrolled under this part for each month after 1967 shall be the amount determined under paragraph (2), “(2) The Secretary shall, between July 1 and October 1 of 1967 and of each odd-numbered year thereafter, determine and promulgate the dollar amount which shall be applicable for premiums for months occurring in either of the two succeeding calendar years. Such dollar amount shall be such amount as the Secretary estimates to be necessary so that the aggregate premiums for such two succeeding calendar years will equal one-half of the total of the benefits and administrative costs which he estimates will be payable from the Federal Supplementary Post, p. 308. Medical Insurance Trust Fund for such two succeeding calendar years. In estimating aggregate benefits payable for any period, the Secretary shall include an appropriate amount for a contingency margin. “(c) In the case of an individual whose coverage period began pursuant to an enrollment after his initial enrollment period (determined pursuant to subsection (c) or (d) of section 1837), the monthly premium determined under subsection (b) shall be increased by 10 percent of the monthly premium so determined for each full 12 months in which he could have been but was not enrolled. For purposes of the preceding sentence, there shall be taken into account (1) the months which elapsed between the close of his initial enrollment period and the close of the enrollment period in which he enrolled, plus (in the case of an individual who enrolls for a second time)(2) the month which elapsed between the date of the termination of his first coverage period and the close of the enrollment period in which he enrolled for the second time. “(d) If any monthly premium determined under the foregoing provisions of this section is not a multiple of 10 cents, such premium shall be rounded to the nearest multiple of 10 cents. “Sec. 1840. “payment of premiums (a) (1) In the case of an individual who is entitled to monthly benefits under section 202, his monthly premiums under this part shall (except, as provided in subsection (d)) be collected by deducting the amount thereof from the amount of such monthly benefits. Such deduction shall be made in such manner and at such times as the Secretary shall by regulation prescribe. “(2) The Secretary of the Treasury shall, from time to time, transfer from the Federal Old-Age and Survivors Insurance Trust Fund or the Federal Disability Insurance Trust Fund to the Federal Supplementary Post, p. 308. Medical Insurance Trust Fund the aggregate amount deducted under paragraph (1) for the period to which such transfer relates from benefits under section 202 which are payable from such Trust Fund. Such transfer shall be made on the basis of a certification by the Secretary of Health, Education, and Welfare and shall be appropriately adjusted to the extent that prior transfers were too great or too small. “(b) (1) In the case of an individual who is entitled to receive for a month an annuity or pension under the Railroad Retirement Act of 1937, Ids monthly premiums under this part shall (except as provided in subsection (d)) be collected by deducting the amount thereof from such annuity or pension. Such deduction shall be made in such manner and at such times as the Secretary shall by regulations prescribe. Such regulations shall be prescribed only after consultation with the Railroad Retirement Board. “(2) The Secretary of the Treasury shall, from time to time, transfer from the Railroad Retirement Account to the Federal Supplementary Medical Insurance Trust Fund the aggregate amount deducted under paragraph (1) for the period to which such transfer relates. Such transfers shall be made on the basis of a certification by the Railroad Retirement Board and shall be appropriately adjusted to the extent that prior transfers were too great or too small. “(c) In the case of an individual who is entitled both to monthly benefits under section 202 and to an annuity or pension under the Railroad Retirement Act of 1937 at the time he enrolls under this part, subsection (a) shall apply so long as lie continues to be entitled both to such benefits and such annuity or pension. In the case of an individual who becomes entitled both to such benefits and such an annuity or pension after 42 USC 402. Post, pp. 335, 340, 400. he enrolls under this part-, subsection (a) shall apply if the first month for which he was entitled to such benefits was the same as or earlier than the first month for which he was entitled to such annuity or pension, and otherwise subsection (b) shall apply. “(d) If an individual to whom subsection (a) or (b) applies estimates that the amount which will be available for deduction under such subsection for any premium payment period will be less than the amount of the monthly premiums for such period, he may (under regulations) pay to the Secretary such portion of the monthly premiums for such period as he desires. “(e) (1) In the case of an individual receiving an annuity under the Civil Service Retirement Act annuitants. 70 Stat. 743. 5 USC 2251 note. Civil Service Retirement Act, or other Act. administered by the Civil Service Commission providing retirement or survivorship protection, to whom neither subsection (a) nor subsection (b) applies, his monthly premiums under this part (and the monthly premiums of the spouse of such individual under this part if neither subsection (a) nor subsection (b) applies to such spouse and if such individual agrees) shall, upon notice from the Secretary of Health, Education, and Welfare to the Civil Service Commission, be collected by deducting the amount thereof from each installment of such annuity. Such deduction shall be made in such manner and at such times as the Civil Service Commission may determine. The Civil Service Commission shall furnish such information as the Secretary of Health, Education, and Welfare may reasonably request in order to carry out his functions under this part with respect to individuals to whom this subsection applies. “(2) The Secretary of the Treasury shall, from time to time, but not less often than quarterly, transfer from the Civil Service Retirement and Disability Fund, or the account (if any) applicable in the case of such other Act administered by the Civil Service Commission, to the Federal Supplementary Medical Insurance Trust Fund the aggregate amount deducted under paragraph (1) for the period to which such transfer relates. Such transfer shall be made on the basis of a certification by the Civil Service Commission and shall be appropriately adjusted to the extent that prior transfers were too great or too small. “(f) In the case of an individual who participates in the insurance program established by this part, but with respect to whom none of the preceding provisions of this section applies, or with respect to whom subsection (d) applies, the premiums shall be paid to the Secretary at such times, and in such manner, as the Secretary shall by regulations prescribe. “(g) Amounts paid to the Secretary under subsection (d) or (f) shall be deposited in the Treasury to the credit of the Federal Supplementary Medical Insurance Trust Fund. “(h) In the case of an individual who participates in the insurance program established by this part, premiums shall be payable for the period commencing with the first month of his coverage period and ending with the month in which he dies or, if earlier, in which his coverage under such program terminates. “Sec. 1841. “federal supplementary medical insurance trust fund (a) There is hereby created on the books of the Treasury of the United States a trust fund to be known as the ‘Federal Supplementary Medical Insurance Trust Fund’ (hereinafter in this section referred to as the ‘Trust Fund’). The Trust Fund shall consist of such amounts as may be deposited in, or appropriated to, such fund as provided in this part. “(b) With respect to the Trust. Fund, there is hereby created a body to lie known as the Board of Trustees of the Trust Fund (hereinafter in this section referred to as the ‘Board of Trustees’) composed of the Secretary of the Treasury, the Secretary of Labor, and the Secretary of Health, Education, and Welfare, all ex officio. The Secretary of the Treasury shall be the Managing Trustee of the Board of Trustees (hereinafter in this section referred to as the ‘Managing Trustee’). The Commissioner of Social Security shall serve as the Secretary of the Board of Trustees. The Board of Trustees shall meet not less Reports to Congress. frequently than once each calendar year. It shall be the duty of the Board of Trustees to— “(1) Hold the Trust Fund; “(2) Report, to the Congress not later than the first day of March of each year on the operation and status of the Trust Fund during the preceding fiscal year and on its expected operation and status during the current fiscal year and the next 2 fiscal years; “(3) Report immediately to the Congress whenever the Board is of the opinion that the amount of the Trust Fund is unduly small; and “(4) Review the general policies followed in managing the Trust Fund, and recommend changes in such polities, including necessary changes in the provisions of law which govern the way in which the Trust Fund is to be managed. The report provided for in paragraph (2) shall include a statement of the assets of, and the disbursements made from, the Trust Fund during the preceding fiscal year, an estimate of the expected income to, and disbursements to be made from, the Trust Fund during the current fiscal year and each of the next 2 fiscal years, and a statement, of the actuarial status of the Trust Fund. Such report shall be printed as a House document of the session of the Congress to which the report is made. “(c) It shall be the duty of the Managing Trustee to invest such portion of the Trust Fund as is not, in his judgment, required to meet current withdrawals. Such investments may be made only in interest-bearing obligations of the United States or in obligations guaranteed as to both principal and interest by the United States. For such purpose such obligations may be acquired (1) on original issue at the issue price, or (2) by purchase of outstanding obligations at the market price. The purposes for which obligations of the 40 Stat. 288. 31 USC 774. United States may be issued under the Second Liberty Bond Act, as amended, are hereby extended to authorize the issuance at par of public-debt obligations for purchase by the Trust Fund. Such obligations issued for purchase by the Trust Fund shall have matu-rities fixed with due regard for the needs of the Trust Fund and shall bear interest at a rate equal to the average market yield (computed by the Managing Trustee on the basis of market quotations as of the end of the calendar month next preceding the date of such issue) on all marketable interest-bearing obligations of the United States then forming a part of the public debt which are not due or callable until after the expiration of 4 years from the end of such calendar month; except that where such average market yield is not a multiple of one-eighth of 1 per centum, the rate of interest on such obligations shall be the multiple of one-eighth of 1 per centum nearest such market yield. The Managing Trustee may purchase other interest-bearing obligations of the United States or obligations guaranteed as to both principal and interest by the United States, on original issue or at the market price, only where he determines that the purchase of such other obligations is in the public interest. “(d) Any obligations acquired by the Trust Fund (except public-debt obligations issued exclusively to the Trust Fund) may be sold by the Managing Trustee at the market price, and such public-debt obligations may be redeemed at par plus accrued interest. “(e) The interest on, and the proceeds from the sale or redemption of, any obligations held in the Trust Fund shall be credited to and form a part of the Trust Fund. “(f) There shall be transferred periodically (but not less often than once each fiscal year) to the Trust Fund from the Federal Old-Age and Survivors Insurance Trust Fund and from the Federal Disability Insurance Trust Fund amounts equivalent to the amounts not previously so transferred which the Secretary of Health, Education, and Welfare shall have certified as overpayments (other than amounts so certified to the Railroad Retirement Board) pursuant to section 1870(b) of this Act. There shall be transferred periodically (but Post, p. 331. not less often than once each fiscal year) to the Trust Fund from the Railroad Retirement Account amounts equivalent to the amounts not previously so transferred which the Secretary of Health, Education, and Welfare shall have certified as overpayments to the Railroad Retirement Board pursuant to section 1870(b) of this Act. “(g) The Managing Trustee shall pay from time to time from the Trust Fund such amounts as the Secretary of Health, Education, and Welfare certifies are necessary to make the payments provided for by this part, and the payments with respect to administrative expenses in accordance with section 201(g)(1). Post, p. 338. “(h) The Managing Trustee shall pay from time to time from the Trust Fund such amounts as the Secretary of Health, Education, and Welfare certifies are necessary to pay the costs incurred by the. Civil Service Commission in making deductions pursuant to section 1840(e). During each fiscal year, or after the close of such fiscal year, the Civil Service Commission shall certify to the Secretary the amount of the costs it incurred in making such deductions, and such certified amount shall be the basis for the amount of such costs certified by the Secretary to the Managing Trustee. “Sec. 1842. “use of carriers for administration of benefits (a) In order to provide for the administration of the benefits under this part with maximum efficiency and convenience for individuals entitled to benefits under this part and for providers of services and other persons furnishing services to such individuals, and with a view to furthering coordination of the administration of the benefits under part A and under this part, the Secretary is authorized to enter into contracts with carriers, including carriers with which Ante, p. 297. agreements under section 1816 are in effect, which will perform some or all of the following functions (or, to the extent provided in such Contracts, will secure performance thereof by other organizations); and, with respect to any of the following functions which involve payments for physicians’ services, the Secretary shall to the extent possible enter into such contracts: “(1) (A) make determinations of the rates and amounts of payments required pursuant to this part to be made to providers of services and other persons on a reasonable cost or reasonable charge basis (as maybe applicable); “(B) receive, disburse, and account for funds in making such payments; and “(C) make such audits of the records of providers of services as may be necessary to assure that proper payments are made under this part; “(2) (A) determine compliance with the requirements of section 1861 (k) as to utilization review; and “(B) assist providers of services and other persons who furnish services for which payment may be made under this part in the development of procedures relating to utilization practices, make studies of the effectiveness of such procedures and methods for their improvement, assist in the application of safeguards against unnecessary utilization of services furnished by providers of services and other persons to individuals entitled to benefits under this part, and provide procedures for and assist in arranging, where necessary, the establishment of groups outside hospitals Post, p. 318. (meeting the requirements of section 1861(k)(2)) to make reviews of utilization; “(3) serve as a channel of communication of information relating to the administration of this part; and “(4) otherwise assist, in such manner as the contract may provide, in discharging administrative duties necessary to carry out the purposes of this part. “(b) (1) Contracts with carriers under subsection (a) may be entered into without regard to section 3769 of the Revised Statutes or any other provision of law requiring competitive bidding. “(2) No such contract shall be entered into with any carrier unless the Secretary finds that such carrier will perform its obligations under the contract efficiently and effectively and will meet such requirements as to financial responsibility, legal authority, and other matters as he finds pertinent. “(3) Each such contract shall provide that the carrier— “(A) will take such action as may be necessary to assure that, where payment under this part for a service is on a cost, basis, the cost is reasonable cost (as determined under section 1861 (v)); “(B) will take such action as may be necessary to assure that, where payment under this part for a service is on a charge basis, (i) such charge will be reasonable and not higher than the charge applicable, for a comparable service and under comparable circumstances, to the policyholders and subscribers of the carrier, and (ii) such payment will be made on the basis of a receipted bill, or on the basis of an assignment, under the terms of which the reasonable charge is the full charge for the service; “(C) will establish and maintain procedures pursuant to which an individual enrolled under this part will be granted an oppor-tunity for a fair hearing by the carrier when requests for payment under this part with respect to services furnished him are denied or are not acted upon with reasonable promptness or when the amount of such payment is in controversy; “(D) will furnish to the Secretary such timely information and reports as he may find necessary in performing his functions under this part; and “(E) will maintain such records and afford such access thereto as the Secretary finds necessary to assure the correctness and verification of the information and reports under subparagraph (D) and otherwise to carry out the purposes of this part; and shall contain such other terms and conditions not inconsistent with this section as the Secretary may find necessary or appropriate. In determining the reasonable charge for services for purposes of this paragraph, there shall be taken into consideration the customary charges for similar services generally made by the physician or other person furnishing such services, as well as the prevailing charges in the locality for similar services. “(4) Each contract under this section shall be for a term of at least one year, and may be made automatically renewable from term to term in the absence of notice by either party of intention to terminate at the end of the current term; except that the Secretary may terminate any such contract at any time (after such reasonable notice and opportunity for hearing to the carrier involved as he may provide in regulations) if he finds that the carrier has failed substantially to carry out the contract or is carrying out the contract in a manner inconsistent with the efficient and effective administration of the insurance program established by this part. “(c) Any contract entered into with a carrier under this section shall provide for advances of funds to the carrier for the making of payments by it under this part, and shall provide for payment of the cost of administration of the carrier, as determined by the Secretary to be necessary and proper for carrying out the functions covered by the contract. “(d) Any contract with a carrier under this section may require such carrier or any of its officers or employees certifying payments or disbursing funds pursuant to the contract, or otherwise participating in carrying out the contract, to give surety bond to the United States in such amount as the Secretary may deem appropriate. “(e) (1) No individual designated pursuant to a contract under this section as a certifying officer shall, in the absence of gross negligence or intent to defraud the United States, be liable with respect to any payments certified by him under this section. “(2) No disbursing officer shall, in the absence of gross negligence or intent to defraud the United States, be liable with respect to any payment by him under this section if it was based upon a voucher signed by a certifying officer designated as provided in paragraph (1) of this subsection. “(3) No such carrier shall be liable to the United States for any payments referred to in paragraph (1) or (2). “(f) For purposes of this part, the term ‘carrier’ means— “Carrier.” “(1) with respect to providers of services and other persons, a voluntary association, corporation, partnership, or other non-governmental organization which is lawfully engaged in providing, paying for, or reimbursing the cost of, health services under group insurance policies or contracts, medical or hospital service agreements, membership or subscription contracts, or similar group arrangements, in consideration of premiums or other periodic charges payable to the carrier, including a health benefits plan duly sponsored or underwritten by an employee organization; and “(2) with respect to provider’s of services only, any agency or organization (not described in paragraph (1)) with which an Ante, p. 297. agreement is in effect under section 1816. “Sec. 1843. “state agreements for coverage of eligible individuals who are receiving money payments under public assistance programs (a) The Secretary shall, at the request of a State made before January 1, 1968, enter into an agreement with such State pursuant to which all eligible individuals in either of the coverage groups described in subsection (b)(as specified in the agreement) will be enrolled under the program established by this part. “(b) An agreement entered into with any State pursuant to subsection (a) may be applicable to either of the following coverage groups: “(1) individuals receiving money payments under the plan of such State approved under title I or title XVI; or “(2) individuals receiving money payments under all of the plans of such State approved under titles I, IV, X, XIV, and 42 USC 301, 601, 1201, 1351, 1381. XVI; except that there shall be excluded from any coverage group any 42 USC 401. individual who is entitled to monthly insurance benefits under title II or who is entitled to receive an annuity or pension under the Railroad Post, pp. 335, 340, 400. Retirement Act of 1937. “(c) For purposes of this section, an individual shall be treated as an eligible individual only if he is an eligible individual (within Ante, p. 304. the meaning of section 1836) on the date an agreement covering him is entered into under subsection (a) or he becomes an eligible individual (within the meaning of such section) at any time after such date and before January 1, 1968; and he shall be treated as receiving money payments described in subsection (b) if he receives such payments for the month in which the agreement is entered into or any month thereafter before January 1968. “(d) In the case of any individual enrolled pursuant to this section— “(1) the monthly premium to be paid by the State shall be determined under section 1839 (without any increase under subsection (c) thereof); “(2) his coverage period shall begin on whichever of the following is the latest: “(A) July 1, 1966; “(B) the first day of the third month following the month in which the State agreement, is entered into; “(C) the first day of the first month in which he is both an eligible individual and a member of a coverage group specified in the agreement under this section; or “(D) such date (not later than January 1, 1968) as may be specified in the agreement; and “(3) his coverage period attributable to the agreement with the State under this section shall end on the last day of whichever of the following first occurs: “(A) the month in which he is determined by the State agency to have become ineligible for money payments of a kind specified in the agreement, or “(B) the month preceding the first month for which lie becomes entitled to monthly benefits under title II or to an 42 USC 401. annuity or pension under the Railroad Retirement Act of 1937. Post, pp. 335, 340, 400. “(e) Any individual whose coverage period attributable to the State agreement is terminated pursuant to subsection (d)(3) shall be deemed for purposes of this part (including the continuation of his coverage period under this part) to have enrolled under section 1837 in the initial general enrollment period provided by section Ante, p. 304. 1837(c). “(f) With respect to eligible individuals receiving money payments under the plan of a State approved under title I, IV, X, XlV, 42 USC 301, 601, 1201, 1351, 1381. or XVI, if the agreement entered into under this section so provides, the term ‘carrier’ as defined in section 18–12 (f) also includes the State agency, specified in such agreement, which administers or supervises the administration of the plan of such State approved under title I, XVI, or XIX. The agreement shall also contain such provisions as will facilitate the financial transactions of the State and the carrier with respect to deductions, coinsurance, and otherwise, and as will lead to economy and efficiency of operation, with respect to individuals receiving money payments under plans of the State approved under titles I, IV, X, XIV, and XVI. “Sec. 1844. “appropriations to cover government contributions and contingency reserve (a) There are authorized to be appropriated from time to time, out of any moneys in the Treasury not otherwise appropriated, to the Federal Supplementary Medical Insurance Trust Fund, a Government. contribution equal to the aggregate premiums payable under this part. “(b) In order to assure prompt payment of benefits provided under this part and the administrative expenses thereunder during the early months of the program established by this part, and to provide a contingency reserve, there is also authorized to be appropriated, out of any moneys in the Treasury not otherwise appropriated, to remain available through the calendar year 1967 for repayable advances (without interest) to the Trust Fund, an amount equal to $18 multiplied by the number of individuals (as estimated by the Secretary) who could be covered in July 1966 by the insurance program established by this part if they had theretofore enrolled under this part. “Part C— Miscellaneous Provisions “Sec. 1861. “definitions of services, institutions, etc. For purposes of this title— “(a) “Spell of Illness The term ‘spell of illness’ with respect to any individual means a period of consecutive days— “(1) beginning with the first day (not included in a previous spell of illness)(A) on which such individual is furnished inpatient hospital services or extended care services, and (B) which occurs in a month for which he is entitled to benefits under part A, and Ante, p. 291. “(2) ending with the close of the first period of 60 consecutive days thereafter on each of which he is neither an inpatient of a hospital nor an inpatient of an extended care facility. “(b) “Inpatient Hospital Services The term ‘inpatient hospital services’ means the following items and services furnished to an inpatient of a hospital and (except as provided in paragraph (3)) by the hospital— “(1) bed and board; “(2) such nursing services and other related services, such use of hospital facilities, and such medical social services as are ordinarily furnished by the hospital for the care and treatment of inpatients, and such drugs, biologicals, supplies, appliances, and equipment, for use in the hospital, as are ordinarily furnished by such hospital for the care and treatment of inpatients; and “(3) such other diagnostic or therapeutic items or services, furnished by the hospital or by others under arrangements with them made by the hospital, as are ordinarily furnished to inpatients either by such hospital or by others under such arrangements; excluding, however— “(4) medical or surgical services provided by a physician, resident, or intern: and “(5) the services of a private-duty nurse or other private-duty attendant. Paragraph (4) shall not apply to services provided in the hospital by an intern or a resident-in-training under a teaching program approved by the Council on Medical Education of the American Medical Association or, in the case of an osteopathic hospital, approved by the Committee on Hospitals of the Bureau of Professional Education of the American Osteopathic Association, or, in the case of services in a hospital or osteopathic hospital by an intern or resident-in-training in the field of dentistry, approved by the Council on Dental Education of the American Dental Association. “(c) “Inpatient Psychiatric Hospital Services The term ‘inpatient psychiatric hospital services’ means inpatient hospital services furnished to an inpatient of a psychiatric hospital. “(d) “Inpatient Tuberculosis Hospital Services The term ‘inpatient tuberculosis hospital services’ means inpatient hospital services furnished to an inpatient of a tuberculosis hospital “(e) “Hospital The term ‘hospital’ (except for purposes of section 1814(d), subsection (a)(2) of this section, paragraph (7) of this subsection, and subsections (i) and (n) of this section) means an institution which— “(1) is primarily engaged in providing, by or under the supervision of physicians, to inpatients (A) diagnostic services and therapeutic services for medical diagnosis, treatment, and care of injured, disabled, or sick persons, or (B) rehabilitation services for the rehabilitation of injured, disabled, or sick persons; “(2) maintains clinical records on all patients; “(3) has bylaws in effect with respect to its staff of physicians; “(4) has a requirement that every patient must be under the care of a physician; “(5) provides 24-hour nursing service rendered or supervised by a registered professional nurse, and has a licensed practical nurse or registered professional nurse on duty at all times; “(6) has in effect a hospital utilization review plan which meets the requirements of subsection (k); “(7) in the case of an institution in any State in which State or applicable local law provides for the licensing of hospitals, (A) is licensed pursuant to such law or (B) is approved, by the agency of such State or locality responsible for licensing hospitals, as meeting the standards established for such licensing; and “(8) meets such other requirements as the Secretary finds necessary in the interest of the health and safety of individuals who are furnished services in the institution, except that such other requirements may not be higher than the comparable requirements prescribed for the accreditation of hospitals by the Joint Commission on Accreditation of Hospitals (subject to the second sentence of section 1863). Post, p. 326. For purposes of subsection (a)(2), such term includes any institution which meets the requirements of paragraph (1) of this subsection. For purposes of sections 1814(d)(including determination of whether Ante, p. 296. an individual received inpatient hospital services for purposes of such section and subsections (i) and (n) of this section, such term includes any institution which meets the requirements of paragraphs (1), (2), (3), (4), (5), and (7) of this subsection. Notwithstanding the preceding provisions of this subsection, such term shall not, except for purposes of subsection (a)(2), include any institution which is primarily for the care and treatment of mental diseases or tuberculosis unless it is a tuberculosis hospital (as defined in subsection (g)) or unless it is a psychiatric hospital (as defined in subsection (f)). The term ‘hospital’ also includes a Christian Science sanatorium operated, or listed and certified, by the First Church of Christ, Scientist, Boston, Massachusetts, but only with respect to items and services ordinarily furnished by such institution to inpatients, and payment may be made with respect to services provided by or in such an institution only to such extent and under such conditions, limitations, and requirements (in addition to or in lieu of the conditions, limitations, and requirements otherwise applicable) as may be provided in regulations. For provisions deeming certain requirements of this subsection to be met in the case of accredited institutions, see section 1865. “(f) “Psychiatric Hospital The term ‘psychiatric hospital’ means an institution which— “(1) is primarily engaged in providing, by or under the supervision of a physician, psychiatric services for the diagnosis and treatment of mentally ill persons; “(2) satisfies the requirements of paragraphs (3) through (8) of subsection (e); “(3) maintains clinical records on all patients and maintains such records as the Secretary finds to be necessary to determine the degree and intensity of the treatment provided to individuals entitled to hospital insurance benefits under part A; “(4) meets such staffing requirements as the Secretary finds necessary for the institution to carry out an active program of treatment for individuals who are furnished services in the institution; and “(5) is accredited by the Joint Commission on Accreditation of Hospitals. In the case of an institution which satisfies paragraphs (1) and (2) of the preceding sentence and which contains a distinct part which also satisfies paragraphs (3) and (4) of such sentence, such distinct part shall be considered to be a ‘psychiatric hospital’ if the institution is accredited by the Joint Commission on Accreditation of Hospitals or if such distinct part meets requirements equivalent to such accreditation requirements as determined by the Secretary. “(g) “Tuberculosis Hospital The term ‘tuberculosis hospital’ means an institution which— “(1) is primarily engaged in providing, by or under the supervision of a physician, medical services for the diagnosis and treatment of tuberculosis; “(2) satisfies the requirements of paragraphs (3) through (8) of subsection (e); “(3) maintains clinical records on all patients and maintains such records as the Secretary finds to be necessary to determine the degree and intensity of the treatment provided to individuals covered by the insurance program established by part A; “(4) meets such staffing requirements as the Secretary finds necessary for the institution to carry out an active program of treatment for individuals who are furnished services in the institution; and “(5) is accredited by the Joint Commission on Accreditation of Hospitals. In the case of an institution which satisfies paragraphs (1) and (2) of the preceding sentence and which contains a distinct part which also satisfies paragraphs (3) and (4) of such sentence, such distinct part, shall be considered to be a. ‘tuberculosis hospital’ if the institution is accredited by the Joint Commission on Accreditation of Hospitals or if such distinct part meets requirements equivalent to such accreditation requirements as determined by the Secretary. “(h) “Extended Care Services The term ‘extended care services’ means the following items and services furnished to an inpatient of an extended care facility and (except as provided in paragraphs (3) and (6)) by such extended care facility— “(1) nursing care provided by or under the supervision of a registered professional nurse; “(2) bed and board in connection with the furnishing of such nursing care; “(3) physical, occupational, or speech therapy furnished by the extended care facility or by others under arrangements with them made by the facility; “(4) medical social services; “(5) such drugs, biologicals, supplies, appliances, and equipment, furnished for use in the extended care facility, as are ordinarily furnished by such facility for the care and treatment of inpatients; “(6) medical services provided by an intern or resident-in-training or a hospital with which the facility has in effect a transfer agreement (meeting the requirements of subsection (1)), under a teaching program of such hospital approved as provided in the last sentence of subsection (b), and other diagnostic or therapeutic services provided by a hospital with which the facility has such an agreement in effect; and “(7) such other services necessary to the health of the patients as are generally provided by extended care facilities; excluding, however, any item or service if it. would not be included under subsection (b) if furnished to an inpatient of a hospital. “(i) “Post-Hospital Extended Care Services The term ‘post-hospital extended care services’ means extended care services furnished an individual after transfer from a hospital hi which he was an inpatient for not less than 3 consecutive days before his discharge from the hospital in connection with such transfer. For purposes of the preceding sentence, items and services shall be deemed to have been furnished to an individual after transfer from a hospital, and he shall be deemed to have been an inpatient in the hospital immediately before transfer therefrom, if he is admitted to the extended care facility within 14 days after discharge from such hospital; and an individual shall be deemed not to have been discharged from an extended care facility if, within 14 days after discharge therefrom, he is admitted to such facility or any other extended care facility. “(j) “Extended Care Facility The term ‘extended care facility’ means (except for purposes of subsection (a)(2)) an institution (or a distinct part of an institution) which has in effect a transfer agreement (meeting the requirements of subsection (1)) with one or more hospitals having agreements in effect under section 1866 and which— Post, p. 327. “(1) is primarily engaged in providing to inpatients (A) skilled nursing care and related services for patients who require medical or nursing care, or (B) rehabilitation services for the rehabilitation of injured, disabled, or sick persons; “(2) has policies, which are developed with the advice of (and with provision of review of such policies from time to time by) a group of professional personnel, including one or more physicians and one or more registered professional nurses, to govern the skilled nursing care and related medical or other services it provides; “(3) has a physician, a registered professional nurse, or a medical staff responsible for the execution of such policies; “(4) (A) has a requirement that the health care of every patient must be under the supervision of a physician, and (B) provides for having a physician available to furnish necessary medical care in case of emergency; “(5) maintains clinical records on all patients; “(6) provides 24-hour nursing service which is sufficient to meet nursing needs in accordance with the policies developed as provided in paragraph (2), and has at least one registered professional nurse employed full time; “(7) provides appropriate methods and procedures for the dispensing and administering of drugs and biologicals; “(8) has in effect a utilization review plan which meets the requirements of subsection (k); “(9) in the case of an institution in any State in which State or applicable local law provides for the licensing of institutions of this nature, (A) is licensed pursuant to such law, or (B) is approved, by the agency of such State or locality responsible for licensing institutions of this nature, as meeting the standards established for such licensing; and “(10) meets such other conditions relating to the health and safety of individuals who are furnished services in such institution or relating to the physical facilities thereof as the Secretary may find necessary (subject to the second sentence of section 1863); except that such term shall not (other than for purposes of subsection (a)(2)) include any institution which is primarily for the care and treatment of mental diseases or tuberculosis. For purposes of subsection (a)(2), such term includes any institution which meets the requirements of paragraph (1) of this subsection. The term ‘extended care facility’ also includes an institution described in paragraph (1) of subsection (y), to the extent and subject to the limitations provided in such subsection. “(k) “Utilization Review A utilization review plan of a hospital or extended care facility shall be considered sufficient if it is applicable to services furnished by the institution to individuals entitled to insurance benefits under this title and if it provides— “(1) for the review, on a sample or other basis, of admissions to the institution, the duration of stays therein, and the professional services (including drugs and biologicals) furnished, (A) with respect to the medical necessity of the services, and (B) for the purpose of promoting the most efficient use of available health facilities and services; “(2) for such review to be made by either (A) a staff committee of the institution composed of two or more physicians, with or without participation of other professional personnel, or (B) a group outside the institution which is similarly composed and (i) which is established by the local medical society and some or all of the hospitals and extended care facilities in the locality, or (ii) if (and for as long as) there has not been established such a group which serves such institution, which is established in such other manner as may be approved by the Secretary; “(3) for such review, in each case of inpatient hospital services or extended care services furnished to such an individual during a continuous period of extended duration, as of such days of such period (which may differ for different classes of cases) as may be specified in regulations, with such review to be made as promptly as possible, after each day so specified, and in no event later than one week following such day; and “(4) for prompt notification to the institution, the individual, and his attending physician of any finding (made after opportunity for consultation to such attending physician) by the physician members of such committee or group that any further stay in the institution is not medically necessary. The review committee must be composed as provided in clause (B) of paragraph (2) rather than as provided in clause (A) of such paragraph in the case of any hospital or extended care facility where, because of the small size of the institution, or (in the case of an extended care facility) because of lack of an organized medical staff, or for such other reason or reasons as may be included in regulations, it is impracticable for the institution to nave a properly functioning staff committee for the purposes of this subsection. “(l) “Agreements for Transfer Between Extended Care Facilities and Hospitals A hospital and an extended care facility shall be considered to have a transfer agreement in effect if, by reason of a written agreement between them or (in case, the two institutions are under common control) by reason of a written undertaking by the person or body which controls them, there is reasonable assurance that— “(1) transfer of patients will be effected between the hospital and the extended care facility whenever such transfer is medically appropriate as determined by the attending physician; and “(2) there will be interchange of medical and other information necessary or useful in the care and treatment of individuals transferred between the institutions, or in determining whether such individuals can be adequately cared for otherwise than in either of such institutions. Any extended care facility which does not have such an agreement in effect, but which is found by a State agency (of the State in which such facility is situated) with which an agreement under section 1864 Post, p. 326. is in effect (or, in the case of a State in which no such agency has an agreement under section 1864, by the Secretary) to have attempted in good faith to enter into such an agreement with a hospital sufficiently close to the facility to make feasible the transfer between them of patients and the information referred to in paragraph (2), shall be considered to have such an agreement in effect if and for so long as such agency (or the Secretary, as the case may be) finds that to do so is in the public interest and essential to assuring extended care services for persons in the community who are eligible for payments with respect to such services under this title. “(m) “Home Health Services The term ‘home health services’ means the following items and services furnished to an individual, who is under the care of a physician, by a home health agency or by others under arrangements with them made by such agency, under a plan (for furnishing such items and services to such individual) established and periodically reviewed by a physician, which items and services are, except as provided in paragraph (7), provided on a visiting basis in a place of residence used as such individual’s home— “(1) part-time or intermittent nursing care provided by or under the supervision of a registered professional nurse; “(2) physical, occupational, or speech therapy; “(3) medical social services under the direction of a physician; “(4) to the extent permitted in regulations, part-time or intermittent services of a home health aide; “(5) medical supplies (other than drugs and biologicals), and the use of medical appliances, while under such a plan; “(6) in the ease of a home health agency which is affiliated or under common control with a hospital, medical services provided by an intern or resident-in-training of such hospital, under a teaching program of such hospital approved as provided in the last sentence or subsection (b); and “(7) any of the foregoing items and services which are provided on an outpatient basis, under arrangements made by the home health agency, at a hospital or extended care facility, or at a rehabilitation center which meets such standards as may be prescribed in regulations, and— “(A) the furnishing of which involves the use of equipment of such a nature that the items and services cannot readily be made available to the individual in such place of residence, or “(B) which are furnished at such facility while he is there to receive any such item or service described in clause (A), but not including transportation of the individual in connection with any such item or service; excluding, however, any item or service if it would not be included under subsection (b) if furnished to an inpatient of a hospital. “(n) “Post-Hospital Home Health Services The term ‘post-hospital home health services’ means home health services furnished an individual within one year after his most recent discharge from a hospital of which he was an inpatient for not less than 3 consecutive days or (if later) within one year after his most recent discharge from an extended care facility of which he was an inpatient, entitled to payment under part A for post-hospital extended care services, but only if the plan covering the home health services (as described in subsection (m)) is established within 14 days after his discharge from such hospital or extended care facility. “(o) “Home Health Agency The term ‘home health agency’ means a public agency or private organization, or a subdivision of such an agency or organization. which— “(1) is primarily engaged in providing skilled nursing services and other therapeutic services; “(2) has policies, established by a group of professional personnel (associated with the agency or organization), including one or more physicians and one or more registered professional nurses, to govern the services (referred to in paragraph (1)) which it provides, and provides for supervision of such services by a physician or registered professional nurse; “(3) maintains clinical records on all patients; “(4) in the case of an agency or organization in any State in which State or applicable local law provides for the licensing of agencies or organizations of this nature, (A) is licensed pursuant to such law, or (B) is approved, by the agency of such State or locality responsible for licensing agencies or organizations of this nature, as meeting the standards established for such licensing; and “(5) meets such other conditions of participation as the Secretary may find necessary in the interest of the health and safety of individuals who are furnished services by such agency or organization; except that such term shall not include a private organization which is not a nonprofit organization exempt from Federal income taxation 68A Stat. 163. 26 USC 501. under section 501 of the Internal Revenue Code of 1954 (or a subdivision of such organization) unless it is licensed pursuant to State law and it meets such additional standards and requirements as may be prescribed in regulations; and except that for purposes of part A such term shall not include any agency or organization which is primarily for the care and treatment or mental diseases. “(p) “Outpatient Hospital Diagnostic Services The term ‘outpatient hospital diagnostic services’ means diagnostic services— “(1) which are furnished to an individual as an outpatient by a hospital or by others under arrangements with them made by a hospital; and “(2) which are ordinarily furnished by such hospital (or by others under such arrangements) to its outpatients for the purpose of diagnostic study; excluding, however— “(3) any item or service if it would not be included under subsection (b) if furnished to an inpatient of a hospital; and “(4) any services furnished under such arrangements unless furnished m the hospital or in other facilities operated by or under the supervision of the hospital or its organized medical staff. “(q) “Physicians’ Services The term ‘physicians’ services’ means professional services performed by physicians, including surgery, consultation, anti home, office, and institutional calls (but not. including services described in the last sentence of subsection (b)). “(r) “Physician The term ‘physician’, when used in connection with the performance of any function or action, means (1) a doctor of medicine or osteopathy legally authorized to practice medicine and surgery by the State in which he performs such function or action (including a physician within the meaning of section 1101(a)(7)), or (2) a doctor of 64 Stat. 559. 42 USC 1301. dentistry or of dental or oral surgery who is legally authorized to practice dentistry by the State in which he performs such function but only with respect to (A) surgery related to the jaw or any structure contiguous to the jaw or (B) the reduction of any fracture of the jaw or any facial bone, “(s) “Medical and Other Health Services The term ‘medical and other health services’ means any of the following items pr services (unless they would otherwise constitute inpatient hospital services, extended care services, or home health services) : “(1) physicians’ services; “(2) services and supplies (including drugs and biologicals which cannot, as determined in accordance with regulations, be self-administered) furnished as an incident, to a physician’s professional service, of kinds which are commonly furnished in physicians’ offices and are commonly either rendered without charge or included in the physicians’ bills, and hospital services (including drugs and biologicals which cannot, as determined in accordance with regulations, be self-administered) incident to physicians’ services rendered to outpatients; “(3) diagnostic X-ray tests, diagnostic laboratory tests, and other diagnostic tests; “(4) X-ray, radium, and radioactive isotope therapy, including materials and services of technicians; “(5) surgical dressings, and splints, casts, and other devices used for reduction of fractures and dislocations; “(6) rental of durable medical equipment, including iron lungs, oxygen tents, hospital beds, and wheelchairs used in the patient’s home (including an institution used as his home) : “(7) ambulance service where the use of other methods of transportation is contraindicated by the individual’s condition, but only to the extent provided in regulations; “(8) prosthetic devices (other than dental) which replace all or part of an internal body organ, including replacement of such devices; and “(9) leg, arm, back, and neck braces, and artificial legs, arms, and eyes, including replacements if required because of a change in the patient’s physical condition. No diagnostic tests performed in any laboratory which is independent of a physician’s office or a hospital shall lie included within paragraph (3) unless such laboratory— “(10) if situated in any State in which State or applicable local law provides for licensing of establishments of this nature, (A) is licensed pursuant to such law, or (B) is approved, by the agency of such State or locality responsible for licensing establishments of this nature, as meeting the standards established for such licensing; and “(11) meets such other conditions relating to the health and safety of individuals with respect to whom such tests are performed as the Secretary may find necessary. “(t) “Drugs and Biologicals The term ‘drugs’ and the term ‘biologicals’, except for purposes of subsection (m)(5) of this section, include only such drugs and biologicals, respectively, as are included (or approved for inclusion) in the United States Pharmacopoeia, the National Formulary, or the United States Homeopathic Pharmacopoeia, or in New Drugs or Accepted Dental Remedies (except for any drugs and biologicals unfavorably evaluated therein), or as are approved by the pharmacy and drug therapeutics committee (or equivalent committee) of the medical staff of the hospital furnishing such drugs and biologicals for use in such hospital. “(u) “Provider of Services The term ‘provider of services’ means a hospital, extended care facility, or home health agency. “(v) “Reasonable Cost (1) The reasonable cost of any services shall be determined in accordance with regulations establishing the method or methods to be used, and the items to be included, in determining such costs for various types or classes of institutions, agencies, and services; except that in any case to which paragraph (2) or (3) applies, the amount of the payment determined under such paragraph with respect to the services involved shall be considered the reasonable cost of such services. In prescribing the regulations referred to in the preceding sentence, the Secretary shall consider, among other things, the principles generally applied by national organizations or established prepayment organizations (which have developed such principles) in computing the amount of payment, to be made by persons other than the recipients of services, to providers of services on account of services furnished to such recipients by such providers. Such regulations may provide for determination of the costs of services on a per diem, per unit, per capita, or other basis, may provide for using different methods in different circumstances, may provide for the use of estimates of costs of particular items or services, and may provide for the use of charges or a percentage of charges where this method reasonably reflects the costs. Such regulations shall (A) take into account both direct and indirect costs of providers of services in order that, under the methods of determining costs, the costs with respect to individuals covered by the insurance programs established by this title will not be borne by individuals not so covered, and the costs with respect to individuals not so covered will not be borne by such insurance programs, and (B) provide for the making of suitable retroactive corrective adjustments where, for a provider of services for any fiscal period, the aggregate reimbursement produced by the methods of determining costs proves to be either inadequate or excessive. “(2) (A) If the bed and board furnished as part of inpatient hospital services (including inpatient tuberculosis hospital services and inpatient psychiatric hospital services) or post-hospital extended care services is in accommodations more expensive than semiprivate accommodations, the amount taken into account for purposes of payment under this title with respect to such services may not exceed an amount equal to the reasonable cost of such services if furnished in such semiprivate accommodations unless the more expensive accommodations were required for medical reasons. “(B) Where a provider of services which has an agreement in effect under this title furnishes to an individual items or services which are in excess of or more expensive than the items or services with respect to which payment may be made under part A or part B, as the case may Ante, pp. 291, 301. be, the Secretary shall take into account for purposes of payment to such provider of services only the equivalent of the reasonable cost of the items or services with respect to which such payment may be made. “(3) If the bed and board furnished as part of inpatient hospital services (including inpatient tuberculosis hospital services and inpatient psychiatric hospital services) or post-hospital extended care services is in accommodations other than, but not more expensive than, semiprivate accommodations and the use of such other accommodations rather than semiprivate accommodations was neither at the request of the patient nor for a reason which the Secretary determines is consistent with the purposes of this title, the amount of the payment with respect to such bed and board under part A shall be the reasonable cost of such bed and board furnished in semiprivate accommodations (determined pursuant to paragraph (1)) minus the difference between the charge customarily made by the hospital or extended care facility for bed and board in semiprivate accommodations and the charge customarily made by it for bed and board in the accommodations furnished. “(4) For purposes of this subsection, the term ‘semiprivate accommodations’ “Semi-private accommodations.” means two-bed, three-bed, or four-bed accommodations. “(w) “Arrangements for Certain Services The term ‘arrangements’ is limited to arrangements under which receipt of payment by the hospital, extended care facility, or home health agency (whether in its own right or as agent), with respect to services for which an individual is entitled to have payment made under this title, discharges the liability of such individual or any other person to pay for the services. “(x) “State and United States The terms ‘State’ and ‘United States’ have the meaning given to them by subsections (h) and (i), respectively, of section 210. “(y) “Post-Hospital Extended Care in Christian Science Extended Care Facilities (1) The term ‘extended care facility’ also includes a Christian Science sanatorium operated, or listed and certified, by the First Church of Christ, Scientist, Boston, Massachusetts, but only (except for purposes of subsection (a)(2)) with respect to items and services ordinarily furnished by such an institution to inpatients, and payment may be made with respect to services provided by or in such an institution only to such extent and under such conditions, limitations, and requirements (in addition to or in lieu of the conditions, limitations, and requirements otherwise applicable) as may be provided in regulations. “(2) Notwithstanding any other provision of this title., payment under part A may not be made for services furnished an individual in an extended care facility to which paragraph (1) applies unless such individual elects, in accordance with regulations, for a spell of illness to have such services treated as post-hospital extended care services for purposes of such part; and payment under part-A may not be made for post-hospital extended care services— “(A) furnished an individual during such spell of illness in an extended care facility to which paragraph (1) applies after— “(i) such services have been furnished to him in such a facility for 30 days during such spell, or “(ii) such services have been furnished to him during such spell in an extended care facility to which such paragraph does not apply; or “(B) furnished an individual during such spell of illness in an extended care facility to which paragraph (1) does not apply after such services have been furnished to him during such spell in an extended care facility to which such paragraph applies. “(3) The amount payable under part A for post-hospital extended care services furnished an individual during any spell of illness in an extended care facility to which paragraph (1) applies shall be reduced by a coinsurance amount equal to one-eighth of the inpatient hospital deductible for each day before the 31st day on which he is furnished such services in such a facility during such spell (and the reduction under this paragraph shall be in lieu of any reduction under section Ante, p. 292. 1813(a)(4)). “(4) For purposes of subsection (i), the determination of whether services furnished by or in an institution described in paragraph (1) constitute post-hospital extended care services shall be made in accordance with and subject to such conditions, limitations, and requirements as may be provided in regulations. “Sec. 1862. “exclusions from coverage (a) Notwithstanding any other provision of this title, no payment may be made under part A or part B for any expenses Ante, pp, 291, 301. incurred for items or services— “(1) which are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member; “(2) for which the individual furnished such items or services has no legal obligation to pay, and which no other person (by reason of such individual’s membership in a prepayment plan or otherwise) has a legal obligation to provide or pay for; “(3) which are paid for directly or indirectly by a governmental entity (other than under this Act and other than under a health benefits or insurance plan established for employees of such an entity), except in such cases as the Secretary may specify; “(4) which are not provided within the United States (except for emergency inpatient hospital services furnished outside the United States under the conditions described in section 1814 (f)); Ante, p. 294. “(5) which are required as a result of war, or of an act of w, occurring after the effective date of such individual’s current coverage under such part; “(6) which constitute personal comfort items; “(7) where such expenses are for routine physical checkups, eyeglasses or eye examinations for the purpose of prescribing, fitting, or changing eyeglasses, hearing aids or examinations therefor, or immunizations; “(8) where such expenses are for orthopedic shoes or other supportive devices for the feet; “(9) where such expenses are for custodial care; “(10) where such expenses are for cosmetic surgery or are incurred in connection therewith, except as required for the prompt repair of accidental injury or for improvement of the functioning of a malformed body member; “(11) where such expenses constitute charges imposed by immediate relatives of such individual or members of his household; or “(12) where such expenses are for services in connection with the care, treatment, filling, removal, or replacement of teeth or structures directly supporting teeth. “(b) Payment under this title may not be made with respect to any item or service to the extent that payment has been made, or can reasonably be expected to be made (as determined in accordance with regulations), with respect to such item or service, under a workmen’s compensation law or plan of the United States or a State. Any payment under this title with respect to any item or service shall be conditioned on reimbursement to the appropriate Trust Fund established by this title when notice or other information is received that payment for such item or service has been made under such a law or plan. “Sec. 1863. “consultation with state agencies and other organizations to develop conditions of participation for providers of services In carrying out his functions, relating to determination of conditions of participation by providers of services, under subsections (e)(8), (f)(4), (g)(4), (j)(10), and (o)(5) of section 1861, the Secretary shall consult with the Health Insurance Benefits Advisory Council established by section 1867, appropriate State agencies, and recognized national listing or accrediting bodies, and may consult with appropriate local agencies. Such conditions prescribed under any of such subsections may be varied for different areas or different classes of institutions or agencies and may, at the request-of a State, provide higher requirements for such State than for other States; except that, in the case of any State or political subdivision of a State which imposes higher requirements on institutions as a condition to the purchase of services (or of certain specified services) in such institutions 42 USC 301, Post, p. 343. under a State plan approved under title I, XVI, or XIX, the Secretary shall impose like requirements as a condition to the payment for services (or for the services specified by the State or subdivision) in such institutions in such State or subdivision. “Sec. 1864. “use of state agencies to determine compliance by providers of services with conditions of participation (a) The Secretary shall make an agreement with any State which is able and willing to do so under which the services of the State health agency or other appropriate State agency (or the appropriate local agencies) will be utilized by him for the purpose of determining whether an institution therein is a hospital or extended care facility, or whether an agency therein is a home health agency, or whether a laboratory meets the requirements of paragraphs (10) Ante, p. 321. and (11) of section 1861 (s). To the extent that the Secretary finds it appropriate, an institution or agency which such a State (or local) agency certifies is a hospital, extended care facility, or home health agency (as those terms are defined in section 1861) may be treated as such by the Secretary. The Secretary may also, pursuant to agreement, utilize the services of State health agencies and other appropriate State agencies (and the appropriate local agencies) to do any one or more of the following: (1) to provide consultative services to institutions or agencies to assist them (A) to establish and maintain fiscal records necessary for purposes of this title, or otherwise to qualify as hospitals, extended care facilities, or home health agencies, or (B) to provide information which may be necessary to permit determination under this title as to whether payments are due and the amounts thereof, and (2) to provide consultative services to institutions, agencies, or organizations to assist in the establishment of utilization review procedures meeting the requirements of section 1861 (k) and in evaluating their effectiveness. “(b) The Secretary shall pay any such Stale, in advance or by way of reimbursement, as may be provided in the agreement with it (and may make adjustments in such payments on account-of overpayments or underpayments previously made), for the reasonable cost of performing the functions specified in subsection (a), and for the Federal Ante, p. 299. Hospital Insurance Trust Fund’s fair share of the costs attributable to the planning and other efforts directed toward coordination of activities in carrying out its agreement and other activities related to the provision of services similar to those for which payment may be made under part A, or related to the facilities and personnel required for the provision of such services, or related to improving the quality of such services. “Sec. 1865, “effect of accreditation Except as provided in the second sentence of section 1863, an institution shall be deemed to meet the requirements of the numbered paragraphs of section 1861(e)(except paragraph (6) thereof) if such institution is accredited as a hospital by the Joint Commission on Accreditation of Hospitals. If such Commission, as a condition for accreditation of a hospital, requires a utilization review plan or imposes another requirement which serves substantially the same purpose, the Secretary is authorized to find that all institutions so accredited by the Commission comply also with section 1861 (e)(6), In addition, if the Secretary finds that accreditation of an institution or agency by the American Osteopathic Association or any other national accreditation body provides reasonable assurance that, any or all of the conditions of section 1861 (e), (]), or (o), as the case may be, are met, he may, to the extent he deems it appropriate, treat such institution or agency as meeting the condition or conditions with respect to which he made such finding. “Sec. 1866. “agreements with providers of services (a) (1) Any provider of services shall be qualified to participate under this title and shall be eligible for payments under this title if it files with the Secretary an agreement— “(A) not to charge, except as provided in paragraph (2), any individual or any other person for items or services for which such individual is entitled to have payment made under this title (or for which he would be so entitled if such provider of services had complied with the procedural and other requirements under or pursuant to this title or for which such provider is paid pursuant to the provisions of section 1814(e)), and Ante, p. 296. “(B) to make adequate provision for return (or other disposition, in accordance with regulations) of any moneys incorrectly collected from such individual or other person. “(2) (A) A provider of services may charge such individual or other person (i) the amount of any deduction or coinsurance amount imposed pursuant to section 1813 (a)(1), (a)(2), or (a)(4), section 1833 (b),or section 1861 (y)(3) with respect to such items and services (not in excess of the amount customarily charged for such items and services by such provider), and (ii) an amount equal to 20 per centum of the reasonable charges for such items and services (not in excess of 20 per centum of the amount customarily charged for such items and services by such provider) for which payment is made under part B or, in the case of outpatient hospital diagnostic services, for which payment is made under part A. In the case of items and services described in section 1833(c), clause (ii) of the preceding sentence shall be applied by substituting for 20 percent the proportion which is appropriate under such section. “(B) Where a provider of services has furnished, at the request of such individual, items or services which are in excess of or more expensive than the items or services with respect to which payment may be made under this title, such provider of services may also charge such individual or other person for such more expensive items or services to the extent that the amount customarily charged by it for the items or services furnished at such request exceeds the amount customarily charged by it for the items or services with respect to which payment may be made under this title. “(C) A provider of services may also charge any such individual for any whole blood furnished him with respect to which a deductible is imposed under section 1813(a)(3), except that (i) any excess of such charge over the cost to such provider for the blood shall be deducted from any payment to such provider under this title, (ii) no such charge may be imposed for the cost of administration of such blood, and (iii) such charge may not be made to the extent such blood has been replaced on behalf of such individual or arrangements have been made for its replacement on his behalf. “(b) An agreement with the Secretary under this section may be terminated— “(1) by the provider of services at such time and upon such notice to the Secretary and the public as may be provided in regulations, except that notice of more than 6 months shall not be required, or “(2) by the Secretary at such time and upon such reasonable notice to the provider of services and the public as may be specified in regulations, but only after the Secretary has determined (A) that such provider of services is not complying substantially with the provisions of such agreement, or with the provisions of this title and regulations thereunder, or (B) that such provider of services no longer substantially meets the applicable provisions of section 1861, or (C) that such provider of services has failed to provide such information as the Secretary finds necessary to determine whether payments are or were due under this title and the amounts thereof, or has refused to permit such examination of its fiscal and other records by or on behalf of the Secretary as may be necessary to verify such information. Any termination shall be applicable— “(3) in the case of inpatient hospital services (including inpatient tuberculosis hospital services and inpatient psychiatric hospital services) or post-hospital extended care services, with respect to such services furnished to any individual who is admitted to the hospital or extended care facility furnishing such services on or after the effective date of such termination, “(4) (A) with respect to home health services furnished to an individual under a plan therefor established on or after the effective date of such termination, or (B) if a plan is established before such effective date, with respect to such services furnished to such individual after the calendar year in which such termination is effective, and “(5) with respect, to any other items and services furnished on or after the effective date of such termination. “(c) Where an agreement, filed under this title by a provider of services has been terminated by the Secretary, such provider may not file another agreement under this title unless the Secretary finds that the reason for the termination has been removed and that there is reasonable assurance that it will not recur. “(d) If the Secretary finds that there is a substantial failure to make timely review in accordance with section 1861(k) of long-stay cases in a hospital or extended care facility, he may, in lieu of terminating his agreement with such hospital or facility, decide that, with respect to any individual admitted to such hospital or facility after a subsequent date specified by him, no payment shall be made under this title for inpatient hospital services (including inpatient tuberculosis hospital services and inpatient psychiatric hospital services) after the 20th day of a continuous period of such services or for post-hospital extended care services after such day of a continuous period of such care as is prescribed in or pursuant to regulations, as the case may be. Such decision may lie made effective only after such notice to the hospital, or (in the case of an extended care facility) to the facility and the hospital or hospitals with which it has a transfer agreement, and to the public, as may be prescribed by regulations, and its effectiveness shall terminate when the Secretary finds that the reason therefor has been removed and that there is reasonable assurance that it will not recur. The Secretary shall not make any such decision except after reasonable notice and opportunity for hearing to the institution or agency affected thereby. “Sec. 1867. “health insurance benefits advisory council For the purpose of advising the Secretary on matters of general policy in the administration of this title and in the formulation of regulations under this title, there is hereby created a Health Insurance Benefits Advisory Council which shall consist, of 16 persons, not otherwise in the employ of the United States, appointed by the Secretary without, regard to the civil service laws. The Secretary shall from time to time appoint one of the members to serve as Chairman. The members shall include persons who are outstanding in fields related to hospital, medical, and other health activities, and at least one person who is representative of the general public. Each member shall hold office for a term of 4 years, except that any member appointed to fill a vacancy occurring prior to the expiration of the term for which his predecessor was appointed shall be appointed for the remainder of such term, and except that the terms of office of the members first, taking office shall expire, as designated by the Secretary at. the time of appointment, four at the end of the first year, four at the end of the second year, four at the end of the third year, and four at the end of the fourth year after the date of appointment. A member shall not be eligible to serve continuously for more than 2 terms. The Secretary may, at the request of the Council or otherwise, appoint such special advisory professional or technical committees as may be useful in carrying out this title. Members of the Advisory Council and members of any such advisory or technical committee, while attending meetings or conferences thereof or otherwise serving on business of the Advisory Council or of such committee, shall be entitled to receive compensation at rates fixed by the Secretary, but not exceeding $100 per day, including travel time, and while so serving away from their homes or regular places of business they may be allowed travel expenses, including per diem in lieu of subsistence, as authorized by section 5 of the Administrative Expenses Act of 1946 (5 U.S.C. 73b–2) for persons in the 60 Stat. 808; 75 Stat. 339, 340. Government service employed intermittently. The Advisory Council shall meet as frequently as the Secretary deems necessary. Upon request of 4 or more members, it shall be the duty of the Secretary to call a meeting of the Advisory’ Council. “Sec. 1868. “national medical review committee (a) There is hereby created a National Medical Review Committee (hereinafter in this section referred to as the ‘Committee’) which shall consist of nine persons, not otherwise in the employ of the United States, appointed by the Secretary without regard to the civil service laws. The Secretary shall from time to time appoint one of the members to serve as chairman. The members shall be selected from among individuals who are representative of organizations and associations of professional personnel in the field of medicine and other individuals who are outstanding in the field of medicine or in related fields; except that at least one member shall be representative of the general public, and at least a majority of the members shall be physicians. Each member shall hold office for a term of three years, except that any member appointed to fill a vacancy occurring prior to the expiration of the term for which his predecessor was appointed shall be appointed for the remainder of such term, and except that the terms of office of the members first taking office shall expire, as designated by the Secretary at the time of appointment, three at the end of the first year, three at the end of the second year, and three at the end of the third year after the date of appointment. A member shall not be eligible to serve continuously for more than two terms. “(b) Members of the Committee, while attending meetings or conferences thereof or otherwise serving on business of the Committee, shall be entitled to receive compensation at rates fixed by the Secretary, but not exceeding $100 per day, including travel time, and while so serving away from their homes or regular places of business they may be allowed travel expenses, including per diem in lieu of subsistence, as authorized by section 5 of the Administrative Expenses Act 60 Stat. 808; 75 Stat. 339, 340. of 1946 (5 U.S.C. 73b–2) for persons in the Government service employed intermittently. “(c) It shall be the function of the Committee to study the utilization of hospital and other medical care and services for which payment may be made under this title with a view to recommending any changes which may seem desirable in the way in which such care and services are utilized or in the administration of the programs established by this title, or in the provisions of this title. The Committee Report to Congress. shall make an annual report to the Secretary of the results of its study, including any recommendations it may have with respect thereto, and such report shall be transmitted promptly by the Secretary to the Congress. “(d) The Committee is authorized to engage such technical assistance as may be required to carry out its functions, and the Secretary shall, in addition, make available to the Committee such secretarial, clerical, and other assistance and such pertinent data obtained and prepared by the Department of Health, Education, and Welfare as the Committee may require to carry out its functions. “Sec. 1869. “determinations; appeals (a) The determination of whether an individual is entitled to benefits under part. A or part B, and the determination of the amount of benefits under part A, shall be made by the Secretary in accordance with regulations prescribed by him. “(b) Any individual dissatisfied with any determination under subsection (a) as to entitlement under part A or part B, or as to amount of benefits under part A where the matter in controversy is $100 or more, shall be entitled to a hearing thereon by the Secretary 42 USC 405. to the same extent as is provided in section 205(b), and, in the case of a determination as to entitlement or as to amount of benefits where the amount in controversy is $1,000 or more, to judicial review of the Secretary’s final decision after such hearing as is provided in section 205(g). “(c) Any institution or agency dissatisfied with any determination by the Secretary that it is not a provider of services, or with any determination described in section 1866(b)(2), shall be entitled to a hearing thereon by the Secretary (after reasonable notice and opportunity for hearing) to the same extent as is provided in section 205(b), and to judicial review of the Secretary’s final decision after such hearing as is provided in section 205(g). “Sec. 1870. “overpayments on behalf of individuals (a) Any payment under this title to any provider of services or other person with respect to any items or services furnished any individual shall be regarded as a payment to such individual. “(b) Where— “(1) more than the correct amount is paid under this title to a provider of services or other person for items or services furnished an individual end the Secretary determines that, within such period as he may specify, the excess over the correct amount cannot be recouped from such provider of services or other person, or “(2) any payment has been made under section 1814(e) to a Ante, p. 294. provider of services or other person for items or services furnished on individual, proper adjustments shall be made, under regulations prescribed (after consultation with the Railroad Retirement Board) by the Secretary, by decreasing subsequent payments— “(3) to which such individual is entitled under title II of this Act or under the Railroad Retirement Act of 1937, as the case 42 USC 401. Post, pp. 335, 340, 400. may be, or “(4) if such individual dies before such adjustment has been completed, to which any other individual is entitled under title II of this Act or under the Railroad Retirement Act of 1937, as the case may be, with respect to the wages and self-employment income or the compensation constituting the basis of the benefits of such deceased individual under title II of such Act. As soon as practicable after any adjustment under paragraph (3) or (4) is determined to be necessary, the Secretary, for purposes of this section, section 1817(g), and section 1841(f), shall certify (to the Railroad Retirement Board if the adjustment, is to be made by decreasing subsequent payments under the Railroad Retirement Act of 1937) the amount of the overpayment as to which the adjustment is to be made. “(c) There shall be no adjustment as provided in subsection (b)(nor shall there be recovery) in any case where the incorrect payment has been made (including payments under section 1814(e)) with respect to an individual who is without fault and where such adjustment (or recovery) would defeat the purposes of title II or would be against equity and good conscience. “(d) No certifying or disbursing officer shall be held liable for any amount certified or paid by him to any provider of services or other person where the adjustment or recovery of such amount is waived under subsection (c) or where adjustment under subsection (b) is not completed prior to the death of all persons against whose benefits such adjustment is authorized. “Sec. 1871. “regulations The Secretary shall prescribe such regulations as may be necessary to carry out the administration of the insurance programs under this title. When used in this title, the term ‘regulations’ means, unless the context otherwise requires, regulations prescribed by the Secretary. “Sec. 1872. “application of certain provisions of title ii The provisions of sections 206, 208, and 216(j), and of subsections (a), (d), (e), (f), (h), (i), (j), (k), and (l) of section 205, shall also apply with respect to this title to the same extent as they are applicable with respect to title II. “Sec. 1873. “designation of organization or publication by name Designation in this title, by name, of any nongovernmental organization or publication shall not be affected by change of name or such organization or publication, and shall apply to any successor organization or publication which the Secretary finds serves the purpose for which such designation is made. “Sec. 1874. “administration (a) Except as otherwise provided in this title, the insurance programs established by this title shall be administered by the Secretary. The Secretary may perform any of his functions under this title directly, or by contract providing for payment in .advance or by way of reimbursement, and in such installments, as the Secretary may deem necessary. “(b) The Secretary may contract with any person, agency, or institution to secure on a reimbursable basis such special data, actuarial information, and other information as may be necessary in the carrying out of his functions under this title. “Sec. 1875. “studies and recommendations (a) The Secretary shall carry on studies and develop recommendations to be submitted from time to time to the Congress relating to health care of the aged, including studies and recommendations concerning (1) the adequacy of existing personnel and facilities for health care for purposes of the programs under parts A and B; Ante, pp. 291, 301. (2) methods for encouraging the further development of efficient and economical forms of health care which are a constructive alternative to inpatient hospital care; and (3) the effects of the deductibles and coinsurance provisions upon beneficiaries, persons who provide health services, and the financing, of the program. “(b) The Secretary shall make a continuing study of the operation and administration of the insurance programs under parts A and B, and shall transmit to the Congress annually a report concerning the operation of such programs.”

  2. Social Security Amendments of 1972

    Pub. L. 92–603 title II § 299O(a) · 86 Stat. 1329

    1. Redesignated · 42 U.S.C. § 1395ff(b)

      Pub. L. 92–603 redesignated existing provisions as par. (1), generally amended conditions under which a dissatisfied individual shall be entitled to a hearing by Secretary and to judicial review of final decision of Secretary after such hearing

    2. Added · 42 U.S.C. § 1395ff(b)

      Pub. L. 92–603 added par. (2)

    Source evidence

    Code amendment note
    Subsec. (b). Pub. L. 92–603 redesignated existing provisions as par. (1), generally amended conditions under which a dissatisfied individual shall be entitled to a hearing by Secretary and to judicial review of final decision of Secretary after such hearing, and added par. (2).

    Enacted provision · exact public law section
    (a) Section 1869(b) of the Social Security Act is amended to read as follows: “(b) (1) Any individual dissatisfied with any determination under subsection (a) as to— “(A) whether he meets the conditions of section 226 of this Act 79 Stat. 333; 81 Stat. 854. 42 USC 426a. 42 USC 1395j. Ante, p. 1374. or section 103 of the Social Security Amendments of 1965, or “(B) whether he is eligible to enroll and has enrolled pursuant to the provisions of part B of this title, or section 1818, or section 1819, or “(C) the amount of benefits under part A (including a determination where such amount is determined to be zero) shall be entitled to a hearing thereon by the Secretary to the same extent as is provided in section 205(b) and to judicial review of the Secretary’s 42 USC 405. final decision after such hearing as is provided in section 205 (g). “(2) Notwithstanding the provisions of subparagraph (C) of paragraph (1) of this subsection, a hearing shall not be available to an individual by reason of such subparagraph (C) if the amount in controversy is less than $100; nor shall judicial review be available to an individual by reason of such subparagraph (C) if the amount in controversy is less than $1,000.”

  3. Spending Reduction Act of 1984

    Pub. L. 98–369 div. B title III § 2354(b)(35) · 98 Stat. 494

    1. Struck · 42 U.S.C. § 1395ff(b)(1)(B)

      Pub. L. 98–369 struck out the comma before “or section 1395i–2”

    2. Struck · 42 U.S.C. § 1395ff(b)(1)(B)

      Pub. L. 98–369 struck out “, or section 1819” after “section 1395i–2 of this title”

    Source evidence

    Code amendment note
    Subsec. (b)(1)(B). Pub. L. 98–369 struck out the comma before “or section 1395i–2” and struck out “, or section 1819” after “section 1395i–2 of this title”.

    Enacted provision · exact public law section
    (35) Section 1869(b)(1)(B) of such Act is amended by striking out “, or section 1818, or section 1819” and inserting in lieu thereof “or section 1818”.

  4. Omnibus Budget Reconciliation Act of 1986

    Pub. L. 99–509 § 9341(a)(1)(A) · 100 Stat. 1874

    Inserted · 42 U.S.C. § 1395ff(a)

    Pub. L. 99–509, § 9341(a)(1)(A), inserted “or part B” after “amount of benefits under part A”

    Source evidence

    Code amendment note
    Subsec. (a). Pub. L. 99–509, § 9341(a)(1)(A), inserted “or part B” after “amount of benefits under part A”.

    Enacted provision · exact public law section
    (A) by inserting “or part B” in subsection (a) after “amount of benefits under part A”,

  5. Omnibus Budget Reconciliation Act of 1986

    Pub. L. 99–509 § 9313(b)(1)(A) · 100 Stat. 1874

    Inserted · 42 U.S.C. § 1395ff(a)

    Pub. L. 99–509, § 9313(b)(1)(A), inserted “and any other determination with respect to a claim for benefits under part A of this subchapter” before “shall”

    Target inherited from the preceding amendment note.

    Source evidence

    Code amendment note
    Pub. L. 99–509, § 9313(b)(1)(A), inserted “and any other determination with respect to a claim for benefits under part A of this subchapter” before “shall”.

    Enacted provision · exact public law section
    (A) in subsection (a), by inserting before “shall” the following: “and any other determination with respect to a claim for benefits under part A”, and

  6. Omnibus Budget Reconciliation Act of 1986

    Pub. L. 99–509 § 9313(a)(1) · 100 Stat. 1874

    Inserted · 42 U.S.C. § 1395ff(b)(1)

    Pub. L. 99–509, § 9313(a)(1), in concluding provisions, inserted at end “Sections 406(a), 1302, and 1395hh of this title shall not be construed as authorizing the Secretary to prohibit an individual from being represented under this subsection by a person that furnishes or supplies the individual, directly or indirectly, with services or items solely on the basis that the person furnishes or supplies the individual with such a service or item. Any person that furnishes services or items to an individual may not represent an individual under this subsection with respect to the issue described in section 1395pp(a)(2) of this title unless the person has waived any rights for payment from the beneficiary with respect to the services or items involved in the appeal. If a person furnishes services or items to an individual and represents the individual under this subsection, the person may not impose any financial liability on such individual in connection with such representation.”

    Source evidence

    Code amendment note
    Subsec. (b)(1). Pub. L. 99–509, § 9313(a)(1), in concluding provisions, inserted at end “Sections 406(a), 1302, and 1395hh of this title shall not be construed as authorizing the Secretary to prohibit an individual from being represented under this subsection by a person that furnishes or supplies the individual, directly or indirectly, with services or items solely on the basis that the person furnishes or supplies the individual with such a service or item. Any person that furnishes services or items to an individual may not represent an individual under this subsection with respect to the issue described in section 1395pp(a)(2) of this title unless the person has waived any rights for payment from the beneficiary with respect to the services or items involved in the appeal. If a person furnishes services or items to an individual and represents the individual under this subsection, the person may not impose any financial liability on such individual in connection with such representation.”

    Enacted provision · exact public law section
    (1) In General.— Section 1869(b)(1) of the Social Security Act (42 U.S.C. 1395ff(b)(1)) is amended by adding at the end the 42 USC 406, 1302, 1395hh. following new sentence: “Sections 206(a), 1102, and 1871 shall not be construed as authorizing the Secretary to prohibit an individual from being represented under this subsection by a person that furnishes or supplies the individual, directly or indirectly, with services or items solely on the basis that the person furnishes or supplies the individual with such a service or item. Any person that furnishes services or items to an individual may not represent an individual under this subsection 42 USC 1395pp. with respect to the issue described in section 1879(a)(2) unless the person has waived any rights for payment from the beneficiary with respect to the services or items involved in the appeal. If a person furnishes services or items to an individual and represents the individual under this subsection, the person may not impose any financial liability on such individual in connection with such representation.”.

  7. Omnibus Budget Reconciliation Act of 1986

    Pub. L. 99–509 § 9341(a)(1)(B) · 100 Stat. 1874

    Inserted · 42 U.S.C. § 1395ff(b)(1)(C)

    Pub. L. 99–509, § 9341(a)(1)(B), inserted “or part B”

    Source evidence

    Code amendment note
    Subsec. (b)(1)(C). Pub. L. 99–509, § 9341(a)(1)(B), inserted “or part B”.

    Enacted provision · exact public law section
    (B) by inserting “or part B” in subsection (b)(1)(C) after “part A”,

  8. Omnibus Budget Reconciliation Act of 1986

    Pub. L. 99–509 § 9313(b)(1)(B) · 100 Stat. 1874

    Added · 42 U.S.C. § 1395ff(b)(1)(D)

    Pub. L. 99–509, § 9313(b)(1)(B), added subpar. (D)

    Source evidence

    Code amendment note
    Subsec. (b)(1)(D). Pub. L. 99–509, § 9313(b)(1)(B), added subpar. (D).

    Enacted provision · exact public law section
    (B) in subsection (b)(1)— (i) by striking “or” at the end of subparagraph (B), (ii) by inserting “, or” at the end of subparagraph (C), and (iii) by inserting after subparagraph (C) the following new subparagraph: “(D) any other denial (other than under part B of title XI) of a 42 USC 1320c. claim for benefits under part A or a claim for benefits with respect to home health services under part B,”.

  9. Omnibus Budget Reconciliation Act of 1986

    Pub. L. 99–509 § 9341(a)(1)(C) · 100 Stat. 1874

    Amended · 42 U.S.C. § 1395ff(b)(2)

    Pub. L. 99–509, § 9341(a)(1)(C), amended par. (2) generally. Prior to amendment, par. (2) read as follows: “Notwithstanding the provisions of subparagraph (C) of paragraph (1) of this subsection, a hearing shall not be available to an individual by reason of such subparagraph (C) if the amount in controversy is less than $100; nor shall judicial review be available to an individual by reason of such subparagraph (C) if the amount in controversy is less than $1,000.”

    Source evidence

    Code amendment note
    Subsec. (b)(2). Pub. L. 99–509, § 9341(a)(1)(C), amended par. (2) generally. Prior to amendment, par. (2) read as follows: “Notwithstanding the provisions of subparagraph (C) of paragraph (1) of this subsection, a hearing shall not be available to an individual by reason of such subparagraph (C) if the amount in controversy is less than $100; nor shall judicial review be available to an individual by reason of such subparagraph (C) if the amount in controversy is less than $1,000.”

    Enacted provision · exact public law section
    (C) by amending paragraph (2) of subsection (b) to read as follows: “(2) Notwithstanding paragraph (1)(C), in the case of a claim arising— “(A) under part A, a hearing shall not be available to an individual under paragraph (1)(C) if the amount in controversy is less than $100 and judicial review shall not be available to the individual under that paragraph if the amount in controversy is less than $1,000; or “(B) under part B, a hearing shall not be available to an individual under paragraph (1)(C) if the amount in controversy is less than $500 and judicial review shall not be available to the individual under that paragraph if the aggregate amount in controversy is less than $1,000. In determining the amount in controversy, the Secretary, under Regulations. Claims. regulations, shall allow two or more claims to be aggregated if the claims involve the delivery of similar or related services to the same individual or involve common issues of law and fact arising from services furnished to two or more individuals.”, and

  10. Omnibus Budget Reconciliation Act of 1986

    Pub. L. 99–509 § 9341(a)(1)(D) · 100 Stat. 1874

    Added · 42 U.S.C. § 1395ff(b)(3); 42 U.S.C. § 1395ff(b)(4)

    Pub. L. 99–509, § 9341(a)(1)(D), added pars. (3) and (4)

    Source evidence

    Code amendment note
    Subsec. (b)(3), (4). Pub. L. 99–509, § 9341(a)(1)(D), added pars. (3) and (4).

    Enacted provision · exact public law section
    (D) by adding at the end the following new paragraphs: “(3) Review of any national coverage determination under section 42 USC 1395y. 1862(a)(1) respecting whether or not a particular type or class of items or services is covered under this title shall be subject to the following limitations: “(A) Such a determination shall not be reviewed by any administrative law judge. “(B) Such a determination shall not be held unlawful or set aside on the ground that a requirement of chapter 5 of title 5, 5 USC 500 et seq; Ante, p. 2017. United States Code, or section 1871(b), relating to publication in the Federal Register or opportunity for public comment, was not satisfied. “(C) In any case in which a court determines that the record is incomplete or otherwise lacks adequate information to support the validity of the determination, it shall remand the matter to the Secretary for additional proceedings to supplement the record and the court may not determine that an item or service is covered except upon review of the supplemented record. “(4) A regulation or instruction which relates to a method for determining the amount of payment under part B and which was initially issued before January 1, 1981, shall not be subject to judicial review.”.

  11. Medicare and Medicaid Patient and Program Protection Act of 1987

    Pub. L. 100–93 § 8(e) · 101 Stat. 680

    Struck · 42 U.S.C. § 1395ff(c)

    Pub. L. 100–93 struck out subsec. (c) which read as follows: “Any institution or agency dissatisfied with any determination by the Secretary that it is not a provider of services, or with any determination described in section 1395cc(b)(2) of this title, shall be entitled to a hearing thereon by the Secretary (after reasonable notice and opportunity for hearing) to the same extent as is provided in section 405(b) of this title, and to judicial review of the Secretary’s final decision after such hearing as is provided in section 405(g) of this title.”

    Source evidence

    Code amendment note
    Subsec. (c). Pub. L. 100–93 struck out subsec. (c) which read as follows: “Any institution or agency dissatisfied with any determination by the Secretary that it is not a provider of services, or with any determination described in section 1395cc(b)(2) of this title, shall be entitled to a hearing thereon by the Secretary (after reasonable notice and opportunity for hearing) to the same extent as is provided in section 405(b) of this title, and to judicial review of the Secretary’s final decision after such hearing as is provided in section 405(g) of this title.”

    Enacted provision · exact public law section
    (e) Conforming Amendment.— Section 1869 (42 U.S.C. 1395ff) is amended by striking subsection (c).

  12. Pub. L. 100–203 § 4085(i)(18) · 101 Stat. 1330

    Inserted · 42 U.S.C. § 1395ff(a)

    Pub. L. 100–203, § 4085(i)(18), inserted “or a claim for benefits with respect to home health services under part B of this subchapter” before “shall”

    Source evidence

    Code amendment note
    Subsec. (a). Pub. L. 100–203, § 4085(i)(18), inserted “or a claim for benefits with respect to home health services under part B of this subchapter” before “shall”.

    Enacted provision · exact public law section
    (18) Section 1869(a) of the Social Security Act (42 U.S.C. 1395ff(a)) is amended by inserting “or a claim for benefits with respect to home health services under part B” before “shall”.

  13. Pub. L. 100–203 § 4085(i)(19) · 101 Stat. 1330

    Inserted · 42 U.S.C. § 1395ff(b)(2)

    Pub. L. 100–203, § 4085(i)(19), inserted “and (1)(D)” after “paragraph (1)(C)” in two places

    Source evidence

    Code amendment note
    Subsec. (b)(2). Pub. L. 100–203, § 4085(i)(19), inserted “and (1)(D)” after “paragraph (1)(C)” in two places.

    Enacted provision · exact public law section
    (19) Section 1869(b)(2) of such Act (42 U.S.C. 1395ff(b)(2)) is amended by inserting “and (1)(D)” after “paragraph (1)(C)” each place it appears.

  14. Pub. L. 100–203 § 4082(a) · 101 Stat. 1330

    Substituted · 42 U.S.C. § 1395ff(b)(3)(B)

    Pub. L. 100–203, § 4082(a), substituted “section 553” for “chapter 5”

    Source evidence

    Code amendment note
    Subsec. (b)(3)(B). Pub. L. 100–203, § 4082(a), substituted “section 553” for “chapter 5”.

    Enacted provision · exact public law section
    (a) Clarification of OBRA Amendment.— Section 1869(b)(3)(B) of the Social Security Act (42 U.S.C. 1395ff(b)(3)(B)) is amended 43a43aCopy read “is amended is amended”. by striking “chapter 5” and inserting “section 553”.

  15. Pub. L. 100–203 § 4082(b) · 101 Stat. 1330

    Added · 42 U.S.C. § 1395ff(b)(5)

    Pub. L. 100–203, § 4082(b), added par. (5)

    Source evidence

    Code amendment note
    Subsec. (b)(5). Pub. L. 100–203, § 4082(b), added par. (5).

    Enacted provision · exact public law section
    (b) Expedited Administrative Hearing Where Only Issues of Law.— Section 1869(b) of such Act (42 U.S.C. 1395ffrb)) is amended by adding at the end the following new paragraph: “(5) In an administrative hearing pursuant to paragraph (1), where the moving party alleges that there are no material issues of fact in dispute, the administrative law judge shall make an expedited determination as to whether any such facts are in dispute and, if not, shall determine the case expeditiously.”.

  16. Pub. L. 103–296 title I § 108(c)(5) · 108 Stat. 1464

    Inserted · 42 U.S.C. § 1395ff(b)(1)

    Pub. L. 103–296 inserted “, except that, in so applying such sections and in applying section 405(l) of this title thereto, any reference therein to the Commissioner of Social Security or the Social Security Administration shall be considered a reference to the Secretary or the Department of Health and Human Services, respectively” after “section 405(g) of this title” in closing provisions

    Source evidence

    Code amendment note
    Subsec. (b)(1). Pub. L. 103–296 inserted “, except that, in so applying such sections and in applying section 405(l) of this title thereto, any reference therein to the Commissioner of Social Security or the Social Security Administration shall be considered a reference to the Secretary or the Department of Health and Human Services, respectively” after “section 405(g) of this title” in closing provisions.

    Enacted provision · exact public law section
    SEC. 108. ADDITIONAL CONFORMING AMENDMENTS. (a) Amendments to Title VII.— (1) Title VII of the Social Security Act (42 U.S.C. 901 et seq.) is amended by adding at the end the following new section:

  17. Balanced Budget Act of 1997

    Pub. L. 105–33 title IV § 4611(c) · 111 Stat. 251

    Inserted · 42 U.S.C. § 1395ff(b)(2)(B)

    Pub. L. 105–33 inserted “(or $100 in the case of home health services)” after “$500”

    Source evidence

    Code amendment note
    Subsec. (b)(2)(B). Pub. L. 105–33 inserted “(or $100 in the case of home health services)” after “$500”.

    Enacted provision · exact public law section
    (c) Maintaining Appeal Rights for Home Health Services.— Section 1869(b)(2)(B) (42 U.S.C. 1395f(b)(2)(B)) is amended by inserting “(or $100 in the case of home health services)” after “$500”.

  18. Consolidated Appropriations Act, 2001

    Pub. L. 106–554 § 1(a)(6)(tV)(s521)(a) · 114 Stat. 2763

    Amended · 42 U.S.C. § 1395ff

    Pub. L. 106–554, § 1(a)(6) [title V, § 521(a)], amended section generally, completely revising and expanding provisions relating to determinations with respect to benefits under part A or part B of this subchapter, changing the structure of the section from two subsecs. lettered (a) and (b) to five subsecs. lettered (a) to (e)

    Source evidence

    Code amendment note
    Pub. L. 106–554, § 1(a)(6) [title V, § 521(a)], amended section generally, completely revising and expanding provisions relating to determinations with respect to benefits under part A or part B of this subchapter, changing the structure of the section from two subsecs. lettered (a) and (b) to five subsecs. lettered (a) to (e).

    Enacted provision · exact public law section
    (6) H.R. 5661, as introduced on December 14, 2000.

  19. Consolidated Appropriations Act, 2001

    Pub. L. 106–554 § 1(a)(6)(tV)(s522)(a) · 114 Stat. 2763

    Added · 42 U.S.C. § 1395ff(f)

    Pub. L. 106–554, § 1(a)(6) [title V, § 522(a)], added subsec. (f)

    Source evidence

    Code amendment note
    Subsec. (f). Pub. L. 106–554, § 1(a)(6) [title V, § 522(a)], added subsec. (f).

    Enacted provision · exact public law section
    (6) H.R. 5661, as introduced on December 14, 2000.

  20. Medicare Prescription Drug, Improvement, and Modernization Act of 2003

    Pub. L. 108–173 § 940(a)(1) · 117 Stat. 2066

    Substituted · 42 U.S.C. § 1395ff(a)(3)(C)(ii)

    Pub. L. 108–173, § 940(a)(1), substituted “60-day period” for “30-day period” in two places

    Source evidence

    Code amendment note
    Subsec. (a)(3)(C)(ii). Pub. L. 108–173, § 940(a)(1), substituted “60-day period” for “30-day period” in two places.

    Enacted provision · exact public law section
    (1) in subsection (a)(3)(C)(ii), by striking “30-day period” each place it appears and inserting “60-day period”; and

  21. Medicare Prescription Drug, Improvement, and Modernization Act of 2003

    Pub. L. 108–173 § 933(c)(1) · 117 Stat. 2066

    Added · 42 U.S.C. § 1395ff(a)(4); 42 U.S.C. § 1395ff(a)(5)

    Pub. L. 108–173, § 933(c)(1), added pars. (4) and (5)

    Source evidence

    Code amendment note
    Subsec. (a)(4), (5). Pub. L. 108–173, § 933(c)(1), added pars. (4) and (5).

    Enacted provision · exact public law section
    (1) Initial determinations and redeterminations.— Section 1869(a) (42 U.S.C. 1395ff(a)) is amended by adding at the end the following new paragraphs: “(4) Requirements of notice of determinations.— With respect to an initial determination insofar as it results in a denial of a claim for benefits— “(A) the written notice on the determination shall include— “(i) the reasons for the determination, including whether a local medical review policy or a local coverage determination was used; “(ii) the procedures for obtaining additional information concerning the determination, including the information described in subparagraph (B); and “(iii) notification of the right to seek a redetermination or otherwise appeal the determination and instructions on how to initiate such a redetermination under this section; “(B) such written notice shall be provided in printed form and written in a manner calculated to be understood by the individual entitled to benefits under part A or enrolled under part B, or both; and “(C) the individual provided such written notice may obtain, upon request, information on the specific provision of the policy, manual, or regulation used in making the redetermination. “(5) Requirements of notice of redeterminations.— With respect to a redetermination insofar as it results in a denial of a claim for benefits— “(A) the written notice on the redetermination shall include— “(i) the specific reasons for the redetermination; “(ii) as appropriate, a summary of the clinical or scientific evidence used in making the redetermination; “(iii) a description of the procedures for obtaining additional information concerning the redetermination; and “(iv) notification of the right to appeal the redetermination and instructions on how to initiate such an appeal under this section; “(B) such written notice shall be provided in printed form and written in a manner calculated to be understood by the individual entitled to benefits under part A or enrolled under part B, or both; and “(C) the individual provided such written notice may obtain, upon request, information on the specific provision of the policy, manual, or regulation used in making the redetermination.” .

  22. Medicare Prescription Drug, Improvement, and Modernization Act of 2003

    Pub. L. 108–173 § 932(a)(1)(A) · 117 Stat. 2066

    Inserted · 42 U.S.C. § 1395ff(b)(1)(A)

    Pub. L. 108–173, § 932(a)(1)(A), inserted “, subject to paragraph (2),” before “to judicial review of the Secretary’s final decision”

    Source evidence

    Code amendment note
    Subsec. (b)(1)(A). Pub. L. 108–173, § 932(a)(1)(A), inserted “, subject to paragraph (2),” before “to judicial review of the Secretary’s final decision”.

    Enacted provision · exact public law section
    (A) in paragraph (1)(A), by inserting “, subject to paragraph (2),” before “to judicial review of the Secretary’s final decision”; and

  23. Medicare Prescription Drug, Improvement, and Modernization Act of 2003

    Pub. L. 108–173 § 940(b)(1) · 117 Stat. 2066

    Added · 42 U.S.C. § 1395ff(b)(1)(E)(iii)

    Pub. L. 108–173, § 940(b)(1), added cl. (iii)

    Source evidence

    Code amendment note
    Subsec. (b)(1)(E)(iii). Pub. L. 108–173, § 940(b)(1), added cl. (iii).

    Enacted provision · exact public law section
    (1) In general.— Section 1869(b)(1)(E) (42 U.S.C. 1395ff(b)(1)(E)) is amended by adding at the end the following new clause: “(iii) Adjustment of dollar amounts.— For requests for hearings or judicial review made in a year after 2004, the dollar amounts specified in clause (i) shall be equal to such dollar amounts increased by the percentage increase in the medical care component of the consumer price index for all urban consumers (U.S. city average) for July 2003 to the July preceding the year involved. Any amount determined under the previous sentence that is not a multiple of $10 shall be rounded to the nearest multiple of $10.” .

  24. Medicare Prescription Drug, Improvement, and Modernization Act of 2003

    Pub. L. 108–173 § 932(a)(2) · 117 Stat. 2066

    Amended · 42 U.S.C. § 1395ff(b)(1)(F)(ii)

    Pub. L. 108–173, § 932(a)(2), amended heading and text of cl. (ii) generally. Prior to amendment, text read as follows: “In a hearing by the Secretary under this section, in which the moving party alleges that no material issues of fact are in dispute, the Secretary shall make an expedited determination as to whether any such facts are in dispute and, if not, shall render a decision expeditiously.”

    Source evidence

    Code amendment note
    Subsec. (b)(1)(F)(ii). Pub. L. 108–173, § 932(a)(2), amended heading and text of cl. (ii) generally. Prior to amendment, text read as follows: “In a hearing by the Secretary under this section, in which the moving party alleges that no material issues of fact are in dispute, the Secretary shall make an expedited determination as to whether any such facts are in dispute and, if not, shall render a decision expeditiously.”

    Enacted provision · exact public law section
    (2) Conforming amendment.— Section 1869(b)(1)(F)(ii) (42 U.S.C. 1395ff(b)(1)(F)(ii)) is amended to read as follows: “(ii) Reference to expedited access to judicial review.— For the provision relating to expedited access to judicial review, see paragraph (2).” .

  25. Medicare Prescription Drug, Improvement, and Modernization Act of 2003

    Pub. L. 108–173 § 932(a)(1)(B) · 117 Stat. 2066

    Added · 42 U.S.C. § 1395ff(b)(2)

    Pub. L. 108–173, § 932(a)(1)(B), added par. (2)

    Source evidence

    Code amendment note
    Subsec. (b)(2). Pub. L. 108–173, § 932(a)(1)(B), added par. (2).

    Enacted provision · exact public law section
    (B) by adding at the end the following new paragraph: “(2) Expedited access to judicial review.— “(A) In general.— The Secretary shall establish a process under which a provider of services or supplier that furnishes an item or service or an individual entitled to benefits under part A or enrolled under part B, or both, who has filed an appeal under paragraph (1) (other than an appeal filed under paragraph (1)(F)(i)) may obtain access to judicial review when a review entity (described in subparagraph (D)), on its own motion or at the request of the appellant, determines that the Departmental Appeals Board does not have the authority to decide the question of law or regulation relevant to the matters in controversy and that there is no material issue of fact in dispute. The appellant may make such request only once with respect to a question of law or regulation for a specific matter in dispute in a case of an appeal. “(B) Prompt determinations.— If, after or coincident with appropriately filing a request for an administrative hearing, the appellant requests a determination by the appropriate review entity that the Departmental Appeals Board does not have the authority to decide the question of law or regulations relevant to the matters in controversy and that there is no material issue of fact in dispute, and if such request is accompanied by the documents and materials as the appropriate review entity shall require for purposes of making such determination, such review entity shall make a determination on the request in writing within 60 days after the date such review entity receives the request and such accompanying documents and materials. Such a determination by such review entity shall be considered a final decision and not subject to review by the Secretary. “(C) Access to judicial review.— “(i) In general.— If the appropriate review entity— “(I) determines that there are no material issues of fact in dispute and that the only issues to be adjudicated are ones of law or regulation that the Departmental Appeals Board does not have authority to decide; or “(II) fails to make such determination within the period provided under subparagraph (B), then the appellant may bring a civil action as described in this subparagraph. “(ii) Deadline for filing.— Such action shall be filed, in the case described in— “(I) clause (i)(I), within 60 days of the date of the determination described in such clause; or “(II) clause (i)(II), within 60 days of the end of the period provided under subparagraph (B) for the determination. “(iii) Venue.— Such action shall be brought in the district court of the United States for the judicial district in which the appellant is located (or, in the case of an action brought jointly by more than one applicant, the judicial district in which the greatest number of applicants are located) or in the District Court for the District of Columbia. “(iv) Interest on any amounts in controversy.— Where a provider of services or supplier is granted judicial review pursuant to this paragraph, the amount in controversy (if any) shall be subject to annual interest beginning on the first day of the first month beginning after the 60-day period as determined pursuant to clause (ii) and equal to the rate of interest on obligations issued for purchase by the Federal Supplementary Medical Insurance Trust Fund for the month in which the civil action authorized under this paragraph is commenced, to be awarded by the reviewing court in favor of the prevailing party. No interest awarded pursuant to the preceding sentence shall be deemed income or cost for the purposes of determining reimbursement due providers of services or suppliers under this title. “(D) Review entity defined.— For purposes of this subsection, the term ‘review entity’ means an entity of up to three reviewers who are administrative law judges or members of the Departmental Appeals Board selected for purposes of making determinations under this paragraph.” .

  26. Medicare Prescription Drug, Improvement, and Modernization Act of 2003

    Pub. L. 108–173 § 933(a)(1) · 117 Stat. 2066

    Added · 42 U.S.C. § 1395ff(b)(3)

    Pub. L. 108–173, § 933(a)(1), added par. (3)

    Source evidence

    Code amendment note
    Subsec. (b)(3). Pub. L. 108–173, § 933(a)(1), added par. (3).

    Enacted provision · exact public law section
    (1) In general.— Section 1869(b) (42 U.S.C. 1395ff(b)), as amended by section 932(a), is further amended by adding at the end the following new paragraph: “(3) Requiring full and early presentation of evidence by providers.— A provider of services or supplier may not introduce evidence in any appeal under this section that was not presented at the reconsideration conducted by the qualified independent contractor under subsection (c), unless there is good cause which precluded the introduction of such evidence at or before that reconsideration.” .

  27. Medicare Prescription Drug, Improvement, and Modernization Act of 2003

    Pub. L. 108–173 § 933(d)(1)(A) · 117 Stat. 2066

    Substituted · 42 U.S.C. § 1395ff(c)(3)(A)

    Pub. L. 108–173, § 933(d)(1)(A), substituted “sufficient medical, legal, and other expertise (including knowledge of the program under this subchapter) and sufficient staffing” for “sufficient training and expertise in medical science and legal matters”

    Source evidence

    Code amendment note
    Subsec. (c)(3)(A). Pub. L. 108–173, § 933(d)(1)(A), substituted “sufficient medical, legal, and other expertise (including knowledge of the program under this subchapter) and sufficient staffing” for “sufficient training and expertise in medical science and legal matters”.

    Enacted provision · exact public law section
    (A) in subparagraph (A), by striking “sufficient training and expertise in medical science and legal matters” and inserting “sufficient medical, legal, and other expertise (including knowledge of the program under this title) and sufficient staffing”; and

  28. Medicare Prescription Drug, Improvement, and Modernization Act of 2003

    Pub. L. 108–173 § 933(b) · 117 Stat. 2066

    Inserted · 42 U.S.C. § 1395ff(c)(3)(B)(i)

    Pub. L. 108–173, § 933(b), inserted “(including the medical records of the individual involved)” after “clinical experience”

    Source evidence

    Code amendment note
    Subsec. (c)(3)(B)(i). Pub. L. 108–173, § 933(b), inserted “(including the medical records of the individual involved)” after “clinical experience”.

    Enacted provision · exact public law section
    (b) Use of Patients’ Medical Records.— Section 1869(c)(3)(B)(i) (42 U.S.C. 1395ff(c)(3)(B)(i)) is amended by inserting “(including the medical records of the individual involved)” after “clinical experience”.

  29. Medicare Prescription Drug, Improvement, and Modernization Act of 2003

    Pub. L. 108–173 § 940(a)(2) · 117 Stat. 2066

    Substituted · 42 U.S.C. § 1395ff(c)(3)(C)(i)

    Pub. L. 108–173, § 940(a)(2), substituted “60-day period” for “30-day period”

    Source evidence

    Code amendment note
    Subsec. (c)(3)(C)(i). Pub. L. 108–173, § 940(a)(2), substituted “60-day period” for “30-day period”.

    Enacted provision · exact public law section
    (2) in subsection (c)(3)(C)(i), by striking “30-day period” and inserting “60-day period”.

  30. Medicare Prescription Drug, Improvement, and Modernization Act of 2003

    Pub. L. 108–173 § 933(d)(2)(A) · 117 Stat. 2066

    1. Amended · 42 U.S.C. § 1395ff(c)(3)(D)

      Pub. L. 108–173, § 933(d)(2)(A), amended heading and text of subpar. (D) generally

    2. Substituted · 42 U.S.C. § 1395ff(c)(3)(D)

      Pub. L. 108–173, § 933(d)(2)(A), substituting provisions directing that subsec. (g) requirements be met for provisions prohibiting a physician or health care professional from reviewing a determination where such physician or health care professional had been directly responsible for furnishing services or had had a significant financial interest in the institution, organization, or agency which provided the services

    Source evidence

    Code amendment note
    Subsec. (c)(3)(D). Pub. L. 108–173, § 933(d)(2)(A), amended heading and text of subpar. (D) generally, substituting provisions directing that subsec. (g) requirements be met for provisions prohibiting a physician or health care professional from reviewing a determination where such physician or health care professional had been directly responsible for furnishing services or had had a significant financial interest in the institution, organization, or agency which provided the services.

    Enacted provision · exact public law section
    (A) by amending subsection (c)(3)(D) to read as follows: “(D) Qualifications for reviewers.— The requirements of subsection (g) shall be met (relating to qualifications of reviewing professionals).” ; and

  31. Medicare Prescription Drug, Improvement, and Modernization Act of 2003

    Pub. L. 108–173 § 933(c)(2) · 117 Stat. 2066

    Inserted · 42 U.S.C. § 1395ff(c)(3)(E)

    Pub. L. 108–173, § 933(c)(2), inserted “be written in a manner calculated to be understood by the individual entitled to benefits under part A or enrolled under part B, or both, and shall include (to the extent appropriate)” after “in writing,” and “and a notification of the right to appeal such determination and instructions on how to initiate such appeal under this section” after “such decision,”

    Source evidence

    Code amendment note
    Subsec. (c)(3)(E). Pub. L. 108–173, § 933(c)(2), inserted “be written in a manner calculated to be understood by the individual entitled to benefits under part A or enrolled under part B, or both, and shall include (to the extent appropriate)” after “in writing,” and “and a notification of the right to appeal such determination and instructions on how to initiate such appeal under this section” after “such decision,”.

    Enacted provision · exact public law section
    (2) Reconsiderations.— Section 1869(c)(3)(E) (42 U.S.C. 1395ff(c)(3)(E)) is amended— (A) by inserting “be written in a manner calculated to be understood by the individual entitled to benefits under part A or enrolled under part B, or both, and shall include (to the extent appropriate)” after “in writing,”; and (B) by inserting “and a notification of the right to appeal such determination and instructions on how to initiate such appeal under this section” after “such decision,”.

  32. Medicare Prescription Drug, Improvement, and Modernization Act of 2003

    Pub. L. 108–173 § 948(b)(1)(A) · 117 Stat. 2066

    Substituted · 42 U.S.C. § 1395ff(c)(3)(I)(ii)(III)

    Pub. L. 108–173, § 948(b)(1)(A), substituted “determination” for “policy”

    Source evidence

    Code amendment note
    Subsec. (c)(3)(I)(ii)(III). Pub. L. 108–173, § 948(b)(1)(A), substituted “determination” for “policy”.

    Enacted provision · exact public law section
    (A) in subclause (III), by striking “policy” and inserting “determination”; and

  33. Medicare Prescription Drug, Improvement, and Modernization Act of 2003

    Pub. L. 108–173 § 948(b)(1)(B) · 117 Stat. 2066

    Substituted · 42 U.S.C. § 1395ff(c)(3)(I)(ii)(IV)

    Pub. L. 108–173, § 948(b)(1)(B), substituted “coverage determinations” for “medical review policies”

    Source evidence

    Code amendment note
    Subsec. (c)(3)(I)(ii)(IV). Pub. L. 108–173, § 948(b)(1)(B), substituted “coverage determinations” for “medical review policies”.

    Enacted provision · exact public law section
    (B) in subclause (IV), by striking “medical review policies” and inserting “coverage determinations”.

  34. Medicare Prescription Drug, Improvement, and Modernization Act of 2003

    Pub. L. 108–173 § 933(c)(4) · 117 Stat. 2066

    1. Substituted · 42 U.S.C. § 1395ff(c)(3)(J)(i)

      Pub. L. 108–173, § 933(c)(4), substituted “submit” for “prepare”

    2. Struck · 42 U.S.C. § 1395ff(c)(3)(J)(i)

      Pub. L. 108–173, § 933(c)(4), struck out “with respect to a reconsideration to the Secretary for a hearing, including as necessary, explanations of issues involved in the decision and relevant policies” after “decision of the contractor”

    Source evidence

    Code amendment note
    Subsec. (c)(3)(J)(i). Pub. L. 108–173, § 933(c)(4), substituted “submit” for “prepare” and struck out “with respect to a reconsideration to the Secretary for a hearing, including as necessary, explanations of issues involved in the decision and relevant policies” after “decision of the contractor”.

    Enacted provision · exact public law section
    (4) Submission of record for appeal.— Section 1869(c)(3)(J)(i) (42 U.S.C. 1395ff(c)(3)(J)(i)) is amended by striking “prepare” and inserting “submit” and by striking “with respect to” and all that follows through “and relevant policies”.

  35. Medicare Prescription Drug, Improvement, and Modernization Act of 2003

    Pub. L. 108–173 § 933(d)(1)(B) · 117 Stat. 2066

    Added · 42 U.S.C. § 1395ff(c)(3)(K)

    Pub. L. 108–173, § 933(d)(1)(B), added subpar. (K)

    Source evidence

    Code amendment note
    Subsec. (c)(3)(K). Pub. L. 108–173, § 933(d)(1)(B), added subpar. (K).

    Enacted provision · exact public law section
    (B) by adding at the end the following new subparagraph: “(K) Independence requirements.— “(i) In general.— Subject to clause (ii), a qualified independent contractor shall not conduct any activities in a case unless the entity— “(I) is not a related party (as defined in subsection (g)(5)); “(II) does not have a material familial, financial, or professional relationship with such a party in relation to such case; and “(III) does not otherwise have a conflict of interest with such a party. “(ii) Exception for reasonable compensation.— Nothing in clause (i) shall be construed to prohibit receipt by a qualified independent contractor of compensation from the Secretary for the conduct of activities under this section if the compensation is provided consistent with clause (iii). “(iii) Limitations on entity compensation.— Compensation provided by the Secretary to a qualified independent contractor in connection with reviews under this section shall not be contingent on any decision rendered by the contractor or by any reviewing professional.” .

  36. Medicare Prescription Drug, Improvement, and Modernization Act of 2003

    Pub. L. 108–173 § 933(d)(3) · 117 Stat. 2066

    Substituted · 42 U.S.C. § 1395ff(c)(4)

    Pub. L. 108–173, § 933(d)(3), substituted “a sufficient number of qualified independent contractors (but not fewer than 4 such contractors) to conduct reconsiderations consistent with the timeframes applicable under this subsection” for “not fewer than 12 qualified independent contractors under this subsection”

    Source evidence

    Code amendment note
    Subsec. (c)(4). Pub. L. 108–173, § 933(d)(3), substituted “a sufficient number of qualified independent contractors (but not fewer than 4 such contractors) to conduct reconsiderations consistent with the timeframes applicable under this subsection” for “not fewer than 12 qualified independent contractors under this subsection”.

    Enacted provision · exact public law section
    (3) Reducing minimum number of qualified independent contractors.— Section 1869(c)(4) (42 U.S.C. 1395ff(c)(4)) is amended by striking “not fewer than 12 qualified independent contractors under this subsection” and inserting “a sufficient number of qualified independent contractors (but not fewer than 4 such contractors) to conduct reconsiderations consistent with the timeframes applicable under this subsection”.

  37. Medicare Prescription Drug, Improvement, and Modernization Act of 2003

    Pub. L. 108–173 § 933(c)(3)(A) · 117 Stat. 2066

    Inserted · 42 U.S.C. § 1395ff(d)

    Pub. L. 108–173, § 933(c)(3)(A), inserted “; notice” after “Secretary” in heading

    Source evidence

    Code amendment note
    Subsec. (d). Pub. L. 108–173, § 933(c)(3)(A), inserted “; notice” after “Secretary” in heading.

    Enacted provision · exact public law section
    (A) in the heading, by inserting “; Notice” after “Secretary”; and

  38. Medicare Prescription Drug, Improvement, and Modernization Act of 2003

    Pub. L. 108–173 § 933(c)(3)(B) · 117 Stat. 2066

    Added · 42 U.S.C. § 1395ff(d)(4)

    Pub. L. 108–173, § 933(c)(3)(B), added par. (4)

    Source evidence

    Code amendment note
    Subsec. (d)(4). Pub. L. 108–173, § 933(c)(3)(B), added par. (4).

    Enacted provision · exact public law section
    (B) by adding at the end the following new paragraph: “(4) Notice.— Notice of the decision of an administrative law judge shall be in writing in a manner calculated to be understood by the individual entitled to benefits under part A or enrolled under part B, or both, and shall include— “(A) the specific reasons for the determination (including, to the extent appropriate, a summary of the clinical or scientific evidence used in making the determination); “(B) the procedures for obtaining additional information concerning the decision; and “(C) notification of the right to appeal the decision and instructions on how to initiate such an appeal under this section.” .

  39. Medicare Prescription Drug, Improvement, and Modernization Act of 2003

    Pub. L. 108–173 § 931(d) · 117 Stat. 2066

    Struck · 42 U.S.C. § 1395ff(f)(2)(A)(i)

    Pub. L. 108–173, § 931(d), struck out “of the Social Security Administration” after “an administrative law judge” in introductory provisions

    Source evidence

    Code amendment note
    Subsec. (f)(2)(A)(i). Pub. L. 108–173, § 931(d), struck out “of the Social Security Administration” after “an administrative law judge” in introductory provisions.

    Enacted provision · exact public law section
    (d) Conforming Amendment.— Section 1869(f)(2)(A)(i) (42 U.S.C. 1395ff(f)(2)(A)(i)) is amended by striking “of the Social Security Administration”.

  40. Medicare Prescription Drug, Improvement, and Modernization Act of 2003

    Pub. L. 108–173 § 948(c)(1) · 117 Stat. 2066

    Substituted · 42 U.S.C. § 1395ff(f)(4)(A)(iv)

    Pub. L. 108–173, § 948(c)(1), substituted “clause (i), (ii), or (iii)” for “subclause (I), (II), or (III)”

    Source evidence

    Code amendment note
    Subsec. (f)(4)(A)(iv). Pub. L. 108–173, § 948(c)(1), substituted “clause (i), (ii), or (iii)” for “subclause (I), (II), or (III)”.

    Enacted provision · exact public law section
    (1) in subparagraph (A)(iv), by striking “subclause (I), (II), or (III)” and inserting “clause (i), (ii), or (iii)”;

  41. Medicare Prescription Drug, Improvement, and Modernization Act of 2003

    Pub. L. 108–173 § 948(c)(2) · 117 Stat. 2066

    1. Substituted · 42 U.S.C. § 1395ff(f)(4)(B)

      Pub. L. 108–173, § 948(c)(2), substituted “subparagraph (A)(iv)” for “clause (i)(IV)”

    2. Substituted · 42 U.S.C. § 1395ff(f)(4)(B)

      Pub. L. 108–173, § 948(c)(2), substituted “subparagraph (A)(iii)” for “clause (i)(III)”

    Source evidence

    Code amendment note
    Subsec. (f)(4)(B). Pub. L. 108–173, § 948(c)(2), substituted “subparagraph (A)(iv)” for “clause (i)(IV)” and “subparagraph (A)(iii)” for “clause (i)(III)”.

    Enacted provision · exact public law section
    (2) in subparagraph (B), by striking “clause (i)(IV)” and “clause (i)(III)” and inserting “subparagraph (A)(iv)” and “subparagraph (A)(iii)”, respectively; and

  42. Medicare Prescription Drug, Improvement, and Modernization Act of 2003

    Pub. L. 108–173 § 948(c)(3) · 117 Stat. 2066

    1. Substituted · 42 U.S.C. § 1395ff(f)(4)(C)

      Pub. L. 108–173, § 948(c)(3), substituted “subparagraph (A)” for “clause (i)”

    2. Substituted · 42 U.S.C. § 1395ff(f)(4)(C)

      Pub. L. 108–173, § 948(c)(3), substituted “clause (iv)” for “subclause (IV)”

    3. Substituted · 42 U.S.C. § 1395ff(f)(4)(C)

      Pub. L. 108–173, § 948(c)(3), substituted “paragraph (1)(A)” for “subparagraph (A)”

    Source evidence

    Code amendment note
    Subsec. (f)(4)(C). Pub. L. 108–173, § 948(c)(3), substituted “subparagraph (A)” for “clause (i)” in two places, “clause (iv)” for “subclause (IV)”, and “paragraph (1)(A)” for “subparagraph (A)”.

    Enacted provision · exact public law section
    (3) in subparagraph (C), by striking “clause (i)”, “subclause (IV)” and “subparagraph (A)” and inserting “subparagraph (A)”, “clause (iv)” and “paragraph (1)(A)”, respectively each place it appears.

  43. Medicare Prescription Drug, Improvement, and Modernization Act of 2003

    Pub. L. 108–173 § 933(d)(2)(B) · 117 Stat. 2066

    Added · 42 U.S.C. § 1395ff(g)

    Pub. L. 108–173, § 933(d)(2)(B), added subsec. (g)

    Source evidence

    Code amendment note
    Subsec. (g). Pub. L. 108–173, § 933(d)(2)(B), added subsec. (g).

    Enacted provision · exact public law section
    (B) by adding at the end the following new subsection: “(g) Qualifications of Reviewers.— “(1) In general.— In reviewing determinations under this section, a qualified independent contractor shall assure that— “(A) each individual conducting a review shall meet the qualifications of paragraph (2); “(B) compensation provided by the contractor to each such reviewer is consistent with paragraph (3); and “(C) in the case of a review by a panel described in subsection (c)(3)(B) composed of physicians or other health care professionals (each in this subsection referred to as a ‘reviewing professional’), a reviewing professional meets the qualifications described in paragraph (4) and, where a claim is regarding the furnishing of treatment by a physician (allopathic or osteopathic) or the provision of items or services by a physician (allopathic or osteopathic), a reviewing professional shall be a physician (allopathic or osteopathic). “(2) Independence.— “(A) In general.— Subject to subparagraph (B), each individual conducting a review in a case shall— “(i) not be a related party (as defined in paragraph (5)); “(ii) not have a material familial, financial, or professional relationship with such a party in the case under review; and “(iii) not otherwise have a conflict of interest with such a party. “(B) Exception.— Nothing in subparagraph (A) shall be construed to— “(i) prohibit an individual, solely on the basis of a participation agreement with a fiscal intermediary, carrier, or other contractor, from serving as a reviewing professional if— “(I) the individual is not involved in the provision of items or services in the case under review; “(II) the fact of such an agreement is disclosed to the Secretary and the individual entitled to benefits under part A or enrolled under part B, or both, or such individual’s authorized representative, and neither party objects; and “(III) the individual is not an employee of the intermediary, carrier, or contractor and does not provide services exclusively or primarily to or on behalf of such intermediary, carrier, or contractor; “(ii) prohibit an individual who has staff privileges at the institution where the treatment involved takes place from serving as a reviewer merely on the basis of having such staff privileges if the existence of such privileges is disclosed to the Secretary and such individual (or authorized representative), and neither party objects; or “(iii) prohibit receipt of compensation by a reviewing professional from a contractor if the compensation is provided consistent with paragraph (3). For purposes of this paragraph, the term ‘participation agreement’ means an agreement relating to the provision of health care services by the individual and does not include the provision of services as a reviewer under this subsection. “(3) Limitations on reviewer compensation.— Compensation provided by a qualified independent contractor to a reviewer in connection with a review under this section shall not be contingent on the decision rendered by the reviewer. “(4) Licensure and expertise.— Each reviewing professional shall be— “(A) a physician (allopathic or osteopathic) who is appropriately credentialed or licensed in one or more States to deliver health care services and has medical expertise in the field of practice that is appropriate for the items or services at issue; or “(B) a health care professional who is legally authorized in one or more States (in accordance with State law or the State regulatory mechanism provided by State law) to furnish the health care items or services at issue and has medical expertise in the field of practice that is appropriate for such items or services. “(5) Related party defined.— For purposes of this section, the term ‘related party’ means, with respect to a case under this title involving a specific individual entitled to benefits under part A or enrolled under part B, or both, any of the following: “(A) The Secretary, the medicare administrative contractor involved, or any fiduciary, officer, director, or employee of the Department of Health and Human Services, or of such contractor. “(B) The individual (or authorized representative). “(C) The health care professional that provides the items or services involved in the case. “(D) The institution at which the items or services (or treatment) involved in the case are provided. “(E) The manufacturer of any drug or other item that is included in the items or services involved in the case. “(F) Any other party determined under any regulations to have a substantial interest in the case involved.” .

  44. Medicare Prescription Drug, Improvement, and Modernization Act of 2003

    Pub. L. 108–173 § 938(a) · 117 Stat. 2066

    Added · 42 U.S.C. § 1395ff(h)

    Pub. L. 108–173, § 938(a), added subsec. (h)

    Source evidence

    Code amendment note
    Subsec. (h). Pub. L. 108–173, § 938(a), added subsec. (h).

    Enacted provision · exact public law section
    (a) In General.— Section 1869 (42 U.S.C. 1395ff(b)), as amended by section 933(d)(2)(B), is further amended by adding at the end the following new subsection: “(h) Prior Determination Process for Certain Items and Services.— “(1) Establishment of process.— “(A) In general.— With respect to a medicare administrative contractor that has a contract under section 1874A that provides for making payments under this title with respect to physicians’ services (as defined in section 1848(j)(3)), the Secretary shall establish a prior determination process that meets the requirements of this subsection and that shall be applied by such contractor in the case of eligible requesters. “(B) Eligible requester.— For purposes of this subsection, each of the following shall be an eligible requester: “(i) A participating physician, but only with respect to physicians’ services to be furnished to an individual who is entitled to benefits under this title and who has consented to the physician making the request under this subsection for those physicians’ services. “(ii) An individual entitled to benefits under this title, but only with respect to a physicians’ service for which the individual receives, from a physician, an advance beneficiary notice under section 1879(a). “(2) Secretarial flexibility.— The Secretary shall establish by regulation reasonable limits on the physicians’ services for which a prior determination of coverage may be requested under this subsection. In establishing such limits, the Secretary may consider the dollar amount involved with respect to the physicians’ service, administrative costs and burdens, and other relevant factors. “(3) Request for prior determination.— “(A) In general.— Subject to paragraph (2), under the process established under this subsection an eligible requester may submit to the contractor a request for a determination, before the furnishing of a physicians’ service, as to whether the physicians’ service is covered under this title consistent with the applicable requirements of section 1862(a)(1)(A) (relating to medical necessity). “(B) Accompanying documentation.— The Secretary may require that the request be accompanied by a description of the physicians’ service, supporting documentation relating to the medical necessity for the physicians’ service, and any other appropriate documentation. In the case of a request submitted by an eligible requester who is described in paragraph (1)(B)(ii), the Secretary may require that the request also be accompanied by a copy of the advance beneficiary notice involved. “(4) Response to request.— “(A) In general.— Under Notification. such process, the contractor shall provide the eligible requester with written notice of a determination as to whether— “(i) the physicians’ service is so covered; “(ii) the physicians’ service is not so covered; or “(iii) the contractor lacks sufficient information to make a coverage determination with respect to the physicians’ service. “(B) Contents of notice for certain determinations.— “(i) Noncoverage.— If the contractor makes the determination described in subparagraph (A)(ii), the contractor shall include in the notice a brief explanation of the basis for the determination, including on what national or local coverage or noncoverage determination (if any) the determination is based, and a description of any applicable rights under subsection (a). “(ii) Insufficient information.— If the contractor makes the determination described in subparagraph (A)(iii), the contractor shall include in the notice a description of the additional information required to make the coverage determination. “(C) Deadline to respond.— Such notice shall be provided within the same time period as the time period applicable to the contractor providing notice of initial determinations on a claim for benefits under subsection (a)(2)(A). “(D) Informing beneficiary in case of physician request.— In the case of a request by a participating physician under paragraph (1)(B)(i), the process shall provide that the individual to whom the physicians’ service is proposed to be furnished shall be informed of any determination described in subparagraph (A)(ii) (relating to a determination of non-coverage) and the right (referred to in paragraph (6)(B)) to obtain the physicians’ service and have a claim submitted for the physicians’ service. “(5) Binding nature of positive determination.— If the contractor makes the determination described in paragraph (4)(A)(i), such determination shall be binding on the contractor in the absence of fraud or evidence of misrepresentation of facts presented to the contractor. “(6) Limitation on further review.— “(A) In general.— Contractor determinations described in paragraph (4)(A)(ii) or (4)(A)(iii) (relating to pre-service claims) are not subject to further administrative appeal or judicial review under this section or otherwise. “(B) Decision not to seek prior determination or negative determination does not impact right to obtain services, seek reimbursement, or appeal rights.— Nothing in this subsection shall be construed as affecting the right of an individual who— “(i) decides not to seek a prior determination under this subsection with respect to physicians’ services; or “(ii) seeks such a determination and has received a determination described in paragraph (4)(A)(ii), from receiving (and submitting a claim for) such physicians’ services and from obtaining administrative or judicial review respecting such claim under the other applicable provisions of this section. Failure to seek a prior determination under this subsection with respect to physicians’ service shall not be taken into account in such administrative or judicial review. “(C) No prior determination after receipt of services.— Once an individual is provided physicians’ services, there shall be no prior determination under this subsection with respect to such physicians’ services.” .

  45. Medicare Prescription Drug, Improvement, and Modernization Act of 2003

    Pub. L. 108–173 § 940A(a) · 117 Stat. 2066

    Added · 42 U.S.C. § 1395ff(i)

    Pub. L. 108–173, § 940A(a), added subsec. (i)

    Source evidence

    Code amendment note
    Subsec. (i). Pub. L. 108–173, § 940A(a), added subsec. (i).

    Enacted provision · exact public law section
    (a) In General.— Section 1869 (42 U.S.C. 1395ff), as amended by section 938(a), is amended by adding at the end the following new subsection: “(i) Mediation Process for Local Coverage Determinations.— “(1) Establishment of process.— The Secretary shall establish a mediation process under this subsection through the use of a physician trained in mediation and employed by the Centers for Medicare & Medicaid Services. “(2) Responsibility of mediator.— Under the process established in paragraph (1), such a mediator shall mediate in disputes between groups representing providers of services, suppliers (as defined in section 1861(d)), and the medical director for a medicare administrative contractor whenever the regional administrator (as defined by the Secretary) involved determines that there was a systematic pattern and a large volume of complaints from such groups regarding decisions of such director or there is a complaint from the co-chair of the advisory committee for that contractor to such regional administrator regarding such dispute.” .

  46. Trade Adjustment Assistance Extension Act of 2011

    Pub. L. 112–40 § 261(a)(3)(A) · 125 Stat. 423

    Substituted · 42 U.S.C. § 1395ff(a)(1)(C)

    Pub. L. 112–40, § 261(a)(3)(A), substituted “quality improvement” for “utilization and quality control peer review”

    Source evidence

    Code amendment note
    Subsec. (a)(1)(C). Pub. L. 112–40, § 261(a)(3)(A), substituted “quality improvement” for “utilization and quality control peer review”.

    Enacted provision · exact public law section
    (A) by 42 USC 1395y, 1395cc, 1395dd, 1395ff, 1395mm, 1395pp, 1395ww. striking “utilization and quality control peer review” and inserting “quality improvement” each place it appears;

    Effective date note
    Amendment by Pub. L. 112–40 applicable to contracts entered into or renewed on or after Jan. 1, 2012, see section 261(e) of Pub. L. 112–40, set out as a note under section 1320c of this title.

  47. Trade Adjustment Assistance Extension Act of 2011

    Pub. L. 112–40 § 261(a)(3)(F) · 125 Stat. 423

    Substituted · 42 U.S.C. § 1395ff(c)(3)(G)

    Pub. L. 112–40, § 261(a)(3)(F), substituted “quality improvement organizations” for “peer review organizations”

    Source evidence

    Code amendment note
    Subsec. (c)(3)(G). Pub. L. 112–40, § 261(a)(3)(F), substituted “quality improvement organizations” for “peer review organizations”.

    Enacted provision · exact public law section
    (F) in section 1869(c)(3)(G), 42 USC 1395ff. by striking “peer review organizations” and inserting “quality improvement organizations”.

    Effective date note
    Amendment by Pub. L. 112–40 applicable to contracts entered into or renewed on or after Jan. 1, 2012, see section 261(e) of Pub. L. 112–40, set out as a note under section 1320c of this title.

  48. Protecting Access to Medicare Act of 2014

    Pub. L. 113–93 title II § 216(b)(2) · 128 Stat. 1040

    Added · 42 U.S.C. § 1395ff(f)(2)(C)

    Pub. L. 113–93 added subpar. (C)

    Source evidence

    Code amendment note
    Subsec. (f)(2)(C). Pub. L. 113–93 added subpar. (C).

    Enacted provision · exact public law section
    (2) Section 1869(f)(2) of the Social Security Act (42 U.S.C. 1395ff(f)(2)) is amended by adding at the end the following new subparagraph: “(C) Local coverage determinations for clinical diagnostic laboratory tests.— For provisions relating to local coverage determinations for clinical diagnostic laboratory tests, see section 1834A(g).” .

55 of 55 references resolved to an enrolled provision

Editorial Notes

Amendments1972–2014 · 10 rounds

2014

Subsec. (f)(2)(C). Pub. L. 113–93 added subpar. (C).

2011

Subsec. (a)(1)(C). Pub. L. 112–40, § 261(a)(3)(A), substituted “quality improvement” for “utilization and quality control peer review”.

Subsec. (c)(3)(G). Pub. L. 112–40, § 261(a)(3)(F), substituted “quality improvement organizations” for “peer review organizations”.

2003

Subsec. (a)(3)(C)(ii). Pub. L. 108–173, § 940(a)(1), substituted “60-day period” for “30-day period” in two places.

Subsec. (a)(4), (5). Pub. L. 108–173, § 933(c)(1), added pars. (4) and (5).

Subsec. (b)(1)(A). Pub. L. 108–173, § 932(a)(1)(A), inserted “, subject to paragraph (2),” before “to judicial review of the Secretary’s final decision”.

Subsec. (b)(1)(E)(iii). Pub. L. 108–173, § 940(b)(1), added cl. (iii).

Subsec. (b)(1)(F)(ii). Pub. L. 108–173, § 932(a)(2), amended heading and text of cl. (ii) generally. Prior to amendment, text read as follows: “In a hearing by the Secretary under this section, in which the moving party alleges that no material issues of fact are in dispute, the Secretary shall make an expedited determination as to whether any such facts are in dispute and, if not, shall render a decision expeditiously.”

Subsec. (b)(2). Pub. L. 108–173, § 932(a)(1)(B), added par. (2).

Subsec. (b)(3). Pub. L. 108–173, § 933(a)(1), added par. (3).

Subsec. (c)(3)(A). Pub. L. 108–173, § 933(d)(1)(A), substituted “sufficient medical, legal, and other expertise (including knowledge of the program under this subchapter) and sufficient staffing” for “sufficient training and expertise in medical science and legal matters”.

Subsec. (c)(3)(B)(i). Pub. L. 108–173, § 933(b), inserted “(including the medical records of the individual involved)” after “clinical experience”.

Subsec. (c)(3)(C)(i). Pub. L. 108–173, § 940(a)(2), substituted “60-day period” for “30-day period”.

Subsec. (c)(3)(D). Pub. L. 108–173, § 933(d)(2)(A), amended heading and text of subpar. (D) generally, substituting provisions directing that subsec. (g) requirements be met for provisions prohibiting a physician or health care professional from reviewing a determination where such physician or health care professional had been directly responsible for furnishing services or had had a significant financial interest in the institution, organization, or agency which provided the services.

Subsec. (c)(3)(E). Pub. L. 108–173, § 933(c)(2), inserted “be written in a manner calculated to be understood by the individual entitled to benefits under part A or enrolled under part B, or both, and shall include (to the extent appropriate)” after “in writing,” and “and a notification of the right to appeal such determination and instructions on how to initiate such appeal under this section” after “such decision,”.

Subsec. (c)(3)(I)(ii)(III). Pub. L. 108–173, § 948(b)(1)(A), substituted “determination” for “policy”.

Subsec. (c)(3)(I)(ii)(IV). Pub. L. 108–173, § 948(b)(1)(B), substituted “coverage determinations” for “medical review policies”.

Subsec. (c)(3)(J)(i). Pub. L. 108–173, § 933(c)(4), substituted “submit” for “prepare” and struck out “with respect to a reconsideration to the Secretary for a hearing, including as necessary, explanations of issues involved in the decision and relevant policies” after “decision of the contractor”.

Subsec. (c)(3)(K). Pub. L. 108–173, § 933(d)(1)(B), added subpar. (K).

Subsec. (c)(4). Pub. L. 108–173, § 933(d)(3), substituted “a sufficient number of qualified independent contractors (but not fewer than 4 such contractors) to conduct reconsiderations consistent with the timeframes applicable under this subsection” for “not fewer than 12 qualified independent contractors under this subsection”.

Subsec. (d). Pub. L. 108–173, § 933(c)(3)(A), inserted “; notice” after “Secretary” in heading.

Subsec. (d)(4). Pub. L. 108–173, § 933(c)(3)(B), added par. (4).

Subsec. (f)(2)(A)(i). Pub. L. 108–173, § 931(d), struck out “of the Social Security Administration” after “an administrative law judge” in introductory provisions.

Subsec. (f)(4)(A)(iv). Pub. L. 108–173, § 948(c)(1), substituted “clause (i), (ii), or (iii)” for “subclause (I), (II), or (III)”.

Subsec. (f)(4)(B). Pub. L. 108–173, § 948(c)(2), substituted “subparagraph (A)(iv)” for “clause (i)(IV)” and “subparagraph (A)(iii)” for “clause (i)(III)”.

Subsec. (f)(4)(C). Pub. L. 108–173, § 948(c)(3), substituted “subparagraph (A)” for “clause (i)” in two places, “clause (iv)” for “subclause (IV)”, and “paragraph (1)(A)” for “subparagraph (A)”.

Subsec. (g). Pub. L. 108–173, § 933(d)(2)(B), added subsec. (g).

Subsec. (h). Pub. L. 108–173, § 938(a), added subsec. (h).

Subsec. (i). Pub. L. 108–173, § 940A(a), added subsec. (i).

2000

Pub. L. 106–554, § 1(a)(6) [title V, § 521(a)], amended section generally, completely revising and expanding provisions relating to determinations with respect to benefits under part A or part B of this subchapter, changing the structure of the section from two subsecs. lettered (a) and (b) to five subsecs. lettered (a) to (e).

Subsec. (f). Pub. L. 106–554, § 1(a)(6) [title V, § 522(a)], added subsec. (f).

1997

Subsec. (b)(2)(B). Pub. L. 105–33 inserted “(or $100 in the case of home health services)” after “$500”.

1994

Subsec. (b)(1). Pub. L. 103–296 inserted “, except that, in so applying such sections and in applying section 405(l) of this title thereto, any reference therein to the Commissioner of Social Security or the Social Security Administration shall be considered a reference to the Secretary or the Department of Health and Human Services, respectively” after “section 405(g) of this title” in closing provisions.

1987

Subsec. (a). Pub. L. 100–203, § 4085(i)(18), inserted “or a claim for benefits with respect to home health services under part B of this subchapter” before “shall”.

Subsec. (b)(2). Pub. L. 100–203, § 4085(i)(19), inserted “and (1)(D)” after “paragraph (1)(C)” in two places.

Subsec. (b)(3)(B). Pub. L. 100–203, § 4082(a), substituted “section 553” for “chapter 5”.

Subsec. (b)(5). Pub. L. 100–203, § 4082(b), added par. (5).

Subsec. (c). Pub. L. 100–93 struck out subsec. (c) which read as follows: “Any institution or agency dissatisfied with any determination by the Secretary that it is not a provider of services, or with any determination described in section 1395cc(b)(2) of this title, shall be entitled to a hearing thereon by the Secretary (after reasonable notice and opportunity for hearing) to the same extent as is provided in section 405(b) of this title, and to judicial review of the Secretary’s final decision after such hearing as is provided in section 405(g) of this title.”

1986

Subsec. (a). Pub. L. 99–509, § 9341(a)(1)(A), inserted “or part B” after “amount of benefits under part A”.

Pub. L. 99–509, § 9313(b)(1)(A), inserted “and any other determination with respect to a claim for benefits under part A of this subchapter” before “shall”.

Subsec. (b)(1). Pub. L. 99–509, § 9313(a)(1), in concluding provisions, inserted at end “Sections 406(a), 1302, and 1395hh of this title shall not be construed as authorizing the Secretary to prohibit an individual from being represented under this subsection by a person that furnishes or supplies the individual, directly or indirectly, with services or items solely on the basis that the person furnishes or supplies the individual with such a service or item. Any person that furnishes services or items to an individual may not represent an individual under this subsection with respect to the issue described in section 1395pp(a)(2) of this title unless the person has waived any rights for payment from the beneficiary with respect to the services or items involved in the appeal. If a person furnishes services or items to an individual and represents the individual under this subsection, the person may not impose any financial liability on such individual in connection with such representation.”

Subsec. (b)(1)(C). Pub. L. 99–509, § 9341(a)(1)(B), inserted “or part B”.

Subsec. (b)(1)(D). Pub. L. 99–509, § 9313(b)(1)(B), added subpar. (D).

Subsec. (b)(2). Pub. L. 99–509, § 9341(a)(1)(C), amended par. (2) generally. Prior to amendment, par. (2) read as follows: “Notwithstanding the provisions of subparagraph (C) of paragraph (1) of this subsection, a hearing shall not be available to an individual by reason of such subparagraph (C) if the amount in controversy is less than $100; nor shall judicial review be available to an individual by reason of such subparagraph (C) if the amount in controversy is less than $1,000.”

Subsec. (b)(3), (4). Pub. L. 99–509, § 9341(a)(1)(D), added pars. (3) and (4).

1984

Subsec. (b)(1)(B). Pub. L. 98–369 struck out the comma before “or section 1395i–2” and struck out “, or section 1819” after “section 1395i–2 of this title”.

1972

Subsec. (b). Pub. L. 92–603 redesignated existing provisions as par. (1), generally amended conditions under which a dissatisfied individual shall be entitled to a hearing by Secretary and to judicial review of final decision of Secretary after such hearing, and added par. (2).

Statutory Notes and Related Subsidiaries

Change of Name

References to Medicare+Choice deemed to refer to Medicare Advantage or MA, subject to an appropriate transition provided by the Secretary of Health and Human Services in the use of those terms, see section 201 of Pub. L. 108–173, set out as a note under section 1395w–21 of this title.

Effective Date of 2011 Amendment

Amendment by Pub. L. 112–40 applicable to contracts entered into or renewed on or after , see section 261(e) of Pub. L. 112–40, set out as a note under section 1320c of this title.

Effective Date of 2003 Amendment

Amendment by section 932(a) of Pub. L. 108–173 applicable to appeals filed on or after , see section 932(d) of Pub. L. 108–173, set out as a note under section 1395i–3 of this title.

Pub. L. 108–173, title IX, § 933(a)(2), , 117 Stat. 2402, provided that: “The amendment made by paragraph (1) [amending this section] shall take effect on .”

Pub. L. 108–173, title IX, § 933(d)(4), , 117 Stat. 2406, provided that: “The amendments made by paragraphs (1) and (2) [amending this section] shall be effective as if included in the enactment of the respective provisions of subtitle C of title V of BIPA [the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000, H.R. 5661, as enacted by section 1(a)(6) of Public Law 106–554] (114 Stat. 2763A–534).”

Pub. L. 108–173, title IX, § 938(b), , 117 Stat. 2415, provided that:

“(1)

Effective date.—

The Secretary [of Health and Human Services] shall establish the prior determination process under the amendment made by subsection (a) [amending this section] in such a manner as to provide for the acceptance of requests for determinations under such process filed not later than 18 months after the date of the enactment of this Act [].

“(2)

Sunset.—

Such prior determination process shall not apply to requests filed after the end of the 5-year period beginning on the first date on which requests for determinations under such process are accepted.

“(3)

Transition.—

During the period in which the amendment made by subsection (a) [amending this section] has become effective but contracts are not provided under section 1874A of the Social Security Act [42 U.S.C. 1395kk–1] with medicare administrative contractors, any reference in section 1869(g) [probably should be 1869(h)] of such Act [42 U.S.C. 1395ff(h)] (as added by such amendment) to such a contractor is deemed a reference to a fiscal intermediary or carrier with an agreement under section 1816, or contract under section 1842, respectively, of such Act [42 U.S.C. 1395h, 1395u].

“(4)

Limitation on application to sgr.—

For purposes of applying section 1848(f)(2)(D) of the Social Security Act (42 U.S.C. 1395w–4(f)(2)(D)), the amendment made by subsection (a) [amending this section] shall not be considered to be a change in law or regulation.”

Amendment by section 948(b)(1), (c) of Pub. L. 108–173 effective, except as otherwise provided, as if included in the enactment of BIPA [the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000, H.R. 5661, as enacted by section 1(a)(6) of Public Law 106–554], see section 948(e) of Pub. L. 108–173, set out as a note under section 1314 of this title.

Effective Date of 2000 Amendment

Amendment by section § 1(a)(6) [title V, § 521(a)] of Pub. L. 106–554 applicable with respect to initial determinations made on or after , see section 1(a)(6) [title V, § 521(d)] of Pub. L. 106–554, set out as a note under section 1320c–3 of this title.

Amendment by section 1(a)(6) [title V, § 522(a)] of Pub. L. 106–554 applicable with respect to a review of any national or local coverage determination filed, a request to make such a determination made, and a national coverage determination made, on or after , see section 1(a)(6) [title V, § 522(d)] of Pub. L. 106–554, set out as a note under section 1314 of this title.

Effective Date of 1997 Amendment

Amendment by Pub. L. 105–33 applicable to services furnished on or after , and for purposes of applying such amendment, any home health spell of illness that began, but did not end, before such date, to be considered to have begun as of such date, see section 4611(f) of Pub. L. 105–33, set out as a note under section 1395d of this title.

Effective Date of 1994 Amendment

Amendment by Pub. L. 103–296 effective , see section 110(a) of Pub. L. 103–296, set out as a note under section 401 of this title.

Effective Date of 1987 Amendment

Pub. L. 100–203, title IV, § 4082(e)(1), (2), , 101 Stat. 1330–128, provided that:

“(1)

The amendment made by subsection (a) [amending this section] shall take effect on the date of the enactment of this Act [].

“(2)

The amendment made by subsection (b) [amending this section] shall apply to requests for hearings filed after the end of the 60-day period beginning on the date of the enactment of this Act.”

Amendment by Pub. L. 100–93 effective at end of fourteen-day period beginning , and inapplicable to administrative proceedings commenced before end of such period, see section 15(a) of Pub. L. 100–93, set out as a note under section 1320a–7 of this title.

Effective Date of 1986 Amendment

Pub. L. 99–509, title IX, § 9313(b)(2), , 100 Stat. 2003, provided that: “The amendments made by this subsection [amending this section] take effect on the date of the enactment of this Act [].”

Pub. L. 99–509, title IX, § 9341(b), , 100 Stat. 2038, provided that: “The amendments made by subsection (a) [amending this section and sections 1395u and 1395pp of this title] shall apply to items and services furnished on or after .”

Effective Date of 1984 Amendment

Amendment by Pub. L. 98–369 effective , but not to be construed as changing or affecting any right, liability, status, or interpretation which existed (under the provisions of law involved) before that date, see section 2354(e)(1) of Pub. L. 98–369, set out as a note under section 1320a–1 of this title.

Effective Date of 1972 Amendment

Pub. L. 92–603, title II, § 299O(b), , 86 Stat. 1465, provided that:

“(1)

The provisions of subparagraphs (A) and (B) of section 1869(b)(1) of the Social Security Act [42 U.S.C. 1395ff(b)(1)(A), (B)], as amended by subsection (a) of this section, shall be effective on the date of enactment of this Act [].

“(2)

The provisions of paragraph (2) and subparagraph (C) of paragraph (1) of section 1869(b) of the Social Security Act [42 U.S.C. 1395ff(b)(2), (b)(1)(C)], as amended by subsection (a) of this section, shall be effective with respect to any claims under part A of title XVIII of such Act [42 U.S.C. 1395c et seq.], filed—

“(A)

in or after the month in which this Act is enacted [Oct. 1972], or

“(B)

before the month in which this Act is enacted [Oct. 1972], but only if a civil action with respect to a final decision of the Secretary of Health, Education, and Welfare on such claim has not been commenced under such section 1869(b) [42 U.S.C. 1395ff(b)] before such month.”

Transfer of Responsibility for Medicare Appeals

Pub. L. 108–173, title IX, § 931(a)–(c), , 117 Stat. 2396–2398, provided that:

“(a)

Transition Plan.—

“(1)

In general.—

Not later than , the Commissioner of Social Security and the Secretary [of Health and Human Services] shall develop and transmit to Congress and the Comptroller General of the United States a plan under which the functions of administrative law judges responsible for hearing cases under title XVIII of the Social Security Act [42 U.S.C. 1395 et seq.] (and related provisions in title XI of such Act [42 U.S.C. 1301 et seq.]) are transferred from the responsibility of the Commissioner and the Social Security Administration to the Secretary and the Department of Health and Human Services.

“(2)

Contents.—

The plan shall include information on the following:

“(A)

Workload.—

The number of such administrative law judges and support staff required now and in the future to hear and decide such cases in a timely manner, taking into account the current and anticipated claims volume, appeals, number of beneficiaries, and statutory changes.

“(B)

Cost projections and financing.—

Funding levels required for fiscal year 2005 and subsequent fiscal years to carry out the functions transferred under the plan.

“(C)

Transition timetable.—

A timetable for the transition.

“(D)

Regulations.—

The establishment of specific regulations to govern the appeals process.

“(E)

Case tracking.—

The development of a unified case tracking system that will facilitate the maintenance and transfer of case specific data across both the fee-for-service and managed care components of the medicare program.

“(F)

Feasibility of precedential authority.—

The feasibility of developing a process to give decisions of the Departmental Appeals Board in the Department of Health and Human Services addressing broad legal issues binding, precedential authority.

“(G)

Access to administrative law judges.—

The feasibility of—

“(i)

filing appeals with administrative law judges electronically; and

“(ii)

conducting hearings using tele- or video-conference technologies.

“(H)

Independence of administrative law judges.—

The steps that should be taken to ensure the independence of administrative law judges consistent with the requirements of subsection (b)(2).

“(I)

Geographic distribution.—

The steps that should be taken to provide for an appropriate geographic distribution of administrative law judges throughout the United States to carry out subsection (b)(3).

“(J)

Hiring.—

The steps that should be taken to hire administrative law judges (and support staff) to carry out subsection (b)(4).

“(K)

Performance standards.—

The appropriateness of establishing performance standards for administrative law judges with respect to timelines for decisions in cases under title XVIII of the Social Security Act [42 U.S.C. 1395 et seq.] taking into account requirements under subsection (b)(2) for the independence of such judges and consistent with the applicable provisions of title 5, United States Code[,] relating to impartiality.

“(L)

Shared resources.—

The steps that should be taken to carry out subsection (b)(6) (relating to the arrangements with the Commissioner of Social Security to share office space, support staff, and other resources, with appropriate reimbursement).

“(M)

Training.—

The training that should be provided to administrative law judges with respect to laws and regulations under title XVIII of the Social Security Act [42 U.S.C. 1395 et seq.].

“(3)

Additional information.—

The plan may also include recommendations for further congressional action, including modifications to the requirements and deadlines established under section 1869 of the Social Security Act (42 U.S.C. 1395ff) (as amended by this Act).

“(4)

GAO evaluation.—

The Comptroller General of the United States shall evaluate the plan and, not later than the date that is 6 months after the date on which the plan is received by the Comptroller General, shall submit to Congress a report on such evaluation.

“(b)

Transfer of Adjudication Authority.—

“(1)

In general.—

Not earlier than , and not later than , the Commissioner of Social Security and the Secretary shall implement the transition plan under subsection (a) and transfer the administrative law judge functions described in such subsection from the Social Security Administration to the Secretary.

“(2)

Assuring independence of judges.—

The Secretary shall assure the independence of administrative law judges performing the administrative law judge functions transferred under paragraph (1) from the Centers for Medicare & Medicaid Services and its contractors. In order to assure such independence, the Secretary shall place such judges in an administrative office that is organizationally and functionally separate from such Centers. Such judges shall report to, and be under the general supervision of, the Secretary, but shall not report to, or be subject to supervision by, another officer of the Department of Health and Human Services.

“(3)

Geographic distribution.—

The Secretary shall provide for an appropriate geographic distribution of administrative law judges performing the administrative law judge functions transferred under paragraph (1) throughout the United States to ensure timely access to such judges.

“(4)

Hiring authority.—

Subject to the amounts provided in advance in appropriations Acts, the Secretary shall have authority to hire administrative law judges to hear such cases, taking into consideration those judges with expertise in handling medicare appeals and in a manner consistent with paragraph (3), and to hire support staff for such judges.

“(5)

Financing.—

Amounts payable under law to the Commissioner for administrative law judges performing the administrative law judge functions transferred under paragraph (1) from the Federal Hospital Insurance Trust Fund and the Federal Supplementary Medical Insurance Trust Fund shall become payable to the Secretary for the functions so transferred.

“(6)

Shared resources.—

The Secretary shall enter into such arrangements with the Commissioner as may be appropriate with respect to transferred functions of administrative law judges to share office space, support staff, and other resources, with appropriate reimbursement from the Trust Funds described in paragraph (5).

“(c)

Increased Financial Support.—

In addition to any amounts otherwise appropriated, to ensure timely action on appeals before administrative law judges and the Departmental Appeals Board consistent with section 1869 of the Social Security Act (42 U.S.C. 1395ff) (as amended by this Act), there are authorized to be appropriated (in appropriate part from the Federal Hospital Insurance Trust Fund, established under section 1817 of the Social Security Act (42 U.S.C. 1395i), and the Federal Supplementary Medical Insurance Trust Fund, established under section 1841 of such Act (42 U.S.C. 1395t)) to the Secretary such sums as are necessary for fiscal year 2005 and each subsequent fiscal year to—

“(1)

increase the number of administrative law judges (and their staffs) under subsection (b)(4);

“(2)

improve education and training opportunities for administrative law judges (and their staffs); and

“(3)

increase the staff of the Departmental Appeals Board.”

Transition

Pub. L. 108–173, title IX, § 933(d)(5), , 117 Stat. 2406, provided that: “In applying section 1869(g) of the Social Security Act [42 U.S.C. 1395ff(g)] (as added by paragraph (2)), any reference to a medicare administrative contractor shall be deemed to include a reference to a fiscal intermediary under section 1816 of the Social Security Act (42 U.S.C. 1395h) and a carrier under section 1842 of such Act (42 U.S.C. 1395u).”

Process for Correction of Minor Errors and Omissions Without Pursuing Appeals Process

Pub. L. 108–173, title IX, § 937, , 117 Stat. 2412, provided that:

“(a)

Claims.—

The Secretary [of Health and Human Services] shall develop, in consultation with appropriate medicare contractors (as defined in section 1889(g) of the Social Security Act [42 U.S.C. 1395zz(g)], as inserted by section 301(a)(1) [probably should be 921(f)(1)]) and representatives of providers of services and suppliers, a process whereby, in the case of minor errors or omissions (as defined by the Secretary) that are detected in the submission of claims under the programs under title XVIII of such Act [42 U.S.C. 1395 et seq.], a provider of services or supplier is given an opportunity to correct such an error or omission without the need to initiate an appeal. Such process shall include the ability to resubmit corrected claims.

“(b)

Deadline.—

Not later than 1 year after the date of the enactment of this Act [], the Secretary shall first develop the process under subsection (a).”

Study of Aggregation Rule for Claims for Similar Physicians’ Services

Pub. L. 101–508, title IV, § 4113, , 104 Stat. 1388–64, directed Secretary of Health and Human Services to carry out a study of the effects of permitting the aggregation of claims that involve common issues of law and fact furnished in the same carrier area to two or more individuals by two or more physicians within the same 12-month period for purposes of appeals provided for under subsec. (b)(2) of this section, and to report on the results of such study and any recommendations to Congress by .

Medicare Hearings and Appeals

Pub. L. 100–203, title IV, § 4037, , 101 Stat. 1330–80, provided that:

“(a)

Maintaining Current System for Hearings and Appeals.—

Any hearing conducted under section 1869(b)(1) of the Social Security Act [42 U.S.C. 1395ff(b)(1)] prior to the earliest of the date on which the Secretary of Health and Human Services submits the report required to be submitted by the Secretary under subsection (b)(1) or September 1 shall be conducted by Administrative Law Judges of the Office of Hearings and Appeals of the Social Security Administration in the same manner as are hearings conducted under section 205(b)(1) of such Act [42 U.S.C. 405(b)(1)].

“(b)

Study and Report on Use of Telephone Hearings.—

“(1)

The Secretary of Health and Human Services and the Comptroller General of the United States shall each conduct a study on holding hearings under section 1869(b)(1) of the Social Security Act [42 U.S.C. 1395ff(b)(1)] by telephone and shall each report the results of the study not later than 6 months after the date of enactment of this Act [].

“(2)

The studies under paragraph (1) shall focus on whether telephone hearings allow for a full and fair evidentiary hearing, in general, or with respect to any particular category of claims and shall examine the possible improvements to the hearing process (such as cost-effectiveness, convenience to the claimant, and reduction in time under the process) resulting from the use of such hearings as compared to the adoption of other changes to the process (such as expansions in staff and resources).”

Credits

1935–2014 · 12 acts
  1. 1935Aug. 14, 1935, ch. 531, title XVIII, § 1869, as added Pub. L. 89–97, title I, § 102(a), , 79 Stat. 330
  2. 1972amended Pub. L. 92–603, title II, § 299O(a), , 86 Stat. 1464
  3. 1984Pub. L. 98–369, div. B, title III, § 2354(b)(35), , 98 Stat. 1102
  4. 1986Pub. L. 99–509, title IX, §§ 9313(a)(1), (b)(1), 9341(a)(1), , 100 Stat. 2002, 2037
  5. 1987Pub. L. 100–93, § 8(e), , 101 Stat. 694
  6. 1987Pub. L. 100–203, title IV, §§ 4082(a), (b), 4085(i)(18), (19), , 101 Stat. 1330–128, 1330–133
  7. 1994Pub. L. 103–296, title I, § 108(c)(5), , 108 Stat. 1485
  8. 1997Pub. L. 105–33, title IV, § 4611(c), , 111 Stat. 473
  9. 2000Pub. L. 106–554, § 1(a)(6) [title V, §§ 521(a), 522(a)], , 114 Stat. 2763, 2763A–534, 2763A–543
  10. 2003Pub. L. 108–173, title IX, §§ 931(d), 932(a), 933(a)(1), (b)–(d)(3), 938(a), 940(a), (b)(1), 940A(a), 948(b)(1), (c), , 117 Stat. 2399, 2402–2406, 2413, 2416, 2417, 2426
  11. 2011Pub. L. 112–40, title II, § 261(a)(3)(A), (F), , 125 Stat. 423
  12. 2014Pub. L. 113–93, title II, § 216(b)(2), , 128 Stat. 1060.
Show as published

(Aug. 14, 1935, ch. 531, title XVIII, § 1869, as added Pub. L. 89–97, title I, § 102(a), , 79 Stat. 330; amended Pub. L. 92–603, title II, § 299O(a), , 86 Stat. 1464; Pub. L. 98–369, div. B, title III, § 2354(b)(35), , 98 Stat. 1102; Pub. L. 99–509, title IX, §§ 9313(a)(1), (b)(1), 9341(a)(1), , 100 Stat. 2002, 2037; Pub. L. 100–93, § 8(e), , 101 Stat. 694; Pub. L. 100–203, title IV, §§ 4082(a), (b), 4085(i)(18), (19), , 101 Stat. 1330–128, 1330–133; Pub. L. 103–296, title I, § 108(c)(5), , 108 Stat. 1485; Pub. L. 105–33, title IV, § 4611(c), , 111 Stat. 473; Pub. L. 106–554, § 1(a)(6) [title V, §§ 521(a), 522(a)], , 114 Stat. 2763, 2763A–534, 2763A–543; Pub. L. 108–173, title IX, §§ 931(d), 932(a), 933(a)(1), (b)–(d)(3), 938(a), 940(a), (b)(1), 940A(a), 948(b)(1), (c), , 117 Stat. 2399, 2402–2406, 2413, 2416, 2417, 2426; Pub. L. 112–40, title II, § 261(a)(3)(A), (F), , 125 Stat. 423; Pub. L. 113–93, title II, § 216(b)(2), , 128 Stat. 1060.)

Parsed from the official OLRC USLM XML in data/usc_all/usc42.xml · release point 119-108 · OLRC build 2026-09-09

USLM identifier /us/usc/t42/s1395ff