42 USC 1395ff - Determinations; appeals

U.S Code last checked for updates: Nov 22, 2024

§ 1395ff.

Determinations; appeals

(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

(B)

Clean claims

(3)

Redeterminations

(A)

In general

(B)

Limitations

(i)

Appeal rights

(ii)

Decisionmaker

(C)

Deadlines

(i)

Filing for redetermination

(ii)

Concluding redeterminations

(D)

Construction

(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

(B)

Representation by provider or supplier

(i)

In general

(ii)

Mandatory waiver of right to payment from beneficiary

(iii)

Prohibition on payment for representation

(iv)

Requirements for representatives of a beneficiary

(C)

Succession of rights in cases of assignment

(D)

Time limits for filing appeals

(i)

Reconsiderations

(ii)

Hearings conducted by the Secretary

(E)

Amounts in controversy

(i)

In general

(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

(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

(G)

Reopening and revision of determinations

(2)

Expedited access to judicial review

(A)

In general

(B)

Prompt determinations

(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

(iv)

Interest on any amounts in controversy

(D)

Review entity defined

(3)

Requiring full and early presentation of evidence by providers

(c)

Conduct of reconsiderations by independent contractors

(1)

In general

(2)

Qualified independent contractor

(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

(B)

Reconsiderations

(i)

In general

(ii)

Effect of national and local coverage determinations

(I)

National coverage determinations

(II)

Local coverage determinations

(III)

Absence of national or local coverage determination

(C)

Deadlines for decisions

(i)

Reconsiderations

(ii)

Consequences of failure to meet deadline

(iii)

Expedited reconsiderations

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

(I)

Deadline for decision

(II)

Consultation with beneficiary

(III)

Special rule for hospital discharges

(iv)

Extension

(D)

Qualifications for reviewers

(E)

Explanation of decision

(F)

Notice requirements

(G)

Dissemination of decisions on reconsiderations

(H)

Ensuring consistency in decisions

(I)

Data collection

(i)

In general

(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

(J)

Hearings 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

(iii)

Limitations on entity compensation

(4)

Number of qualified independent contractors

(5)

Limitation on qualified independent contractor liability

(d)

Deadlines for hearings by the Secretary; notice

(1)

Hearing by administrative law judge

(A)

In general

(B)

Waiver of deadline by party seeking hearing

(2)

Departmental Appeals Board review

(A)

In general

(B)

DAB hearing procedure

(3)

Consequences of failure to meet deadlines

(A)

Hearing by administrative law judge

(B)

Departmental Appeals Board 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

(2)

Outreach

(3)

Continuing education requirement for qualified independent contractors and administrative law judges

(4)

Reports

(A)

Annual report to Congress

(B)

Survey

(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

(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

(C)

Local coverage determinations for clinical diagnostic laboratory tests

(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

(C)

Explanation of determination

(5)

Standing

(6)

Publication on the Internet of decisions of hearings of the Secretary

(7)

Annual report on national coverage determinations

(A)

In general

(B)

Publication of reports on the Internet

(8)

Construction

(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

(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

(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

(3)

Request for prior determination

(A)

In general

(B)

Accompanying documentation

(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

(ii)

Insufficient information

(C)

Deadline to respond

(D)

Informing beneficiary in case of physician request

(5)

Binding nature of positive determination

(6)

Limitation on further review

(A)

In general

(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

(i)

Mediation process for local coverage determinations

(1)

Establishment of process

(2)

Responsibility of mediator

(Aug. 14, 1935, ch. 531, title XVIII, § 1869, as added Pub. L. 89–97, title I, § 102(a), July 30, 1965, 79 Stat. 330; amended Pub. L. 92–603, title II, § 299O(a), Oct. 30, 1972, 86 Stat. 1464; Pub. L. 98–369, div. B, title III, § 2354(b)(35), July 18, 1984, 98 Stat. 1102; Pub. L. 99–509, title IX, §§ 9313(a)(1), (b)(1), 9341(a)(1), Oct. 21, 1986, 100 Stat. 2002, 2037; Pub. L. 100–93, § 8(e), Aug. 18, 1987, 101 Stat. 694; Pub. L. 100–203, title IV, §§ 4082(a), (b), 4085(i)(18), (19), Dec. 22, 1987, 101 Stat. 1330–128, 1330–133; Pub. L. 103–296, title I, § 108(c)(5), Aug. 15, 1994, 108 Stat. 1485; Pub. L. 105–33, title IV, § 4611(c), Aug. 5, 1997, 111 Stat. 473; Pub. L. 106–554, § 1(a)(6) [title V, §§ 521(a), 522(a)], Dec. 21, 2000, 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), Dec. 8, 2003, 117 Stat. 2399, 2402–2406, 2413, 2416, 2417, 2426; Pub. L. 112–40, title II, § 261(a)(3)(A), (F), Oct. 21, 2011, 125 Stat. 423; Pub. L. 113–93, title II, § 216(b)(2), Apr. 1, 2014, 128 Stat. 1060.)

cite as: 42 USC 1395ff

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