42 U.S.C. § 1395ff : US Code - Section 1395FF: Determinations; appeals

Search 42 U.S.C. § 1395ff : US Code - Section 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 of this
subchapter or part B of this subchapter 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 utilization and quality
control peer review 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 of this chapter.
(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) of this section 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 of this subchapter
or enrolled under part B of this subchapter, 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 of this subchapter
or enrolled under part B of this subchapter, 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) of this
section 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) of this section, 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) of this
section, 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 of
this subchapter or enrolled under part B of this subchapter, 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) of this section, 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) of this section. 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) of this
section, 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) of this
section 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
December 21, 2000.
(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) of this section 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 of this subchapter or enrolled under
part B of this subchapter, 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 of
this subchapter or part B of this subchapter 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), peer review organizations (under part B
of subchapter XI of this chapter), Medicare+Choice
organizations offering Medicare+Choice plans under part C of
this subchapter, other entities under contract with the
Secretary to make initial determinations under part A of this
subchapter or part B of this subchapter or subchapter XI of
this chapter, 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) of this section);
(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) of this
section 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 of this subchapter
or enrolled under part B of this subchapter, 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 of this subchapter
and that was initially issued before January 1, 1981, 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 of this chapter 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 of this subchapter or part B of this
subchapter, 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.
(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
of this subchapter, or enrolled under part B of this subchapter,
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) of this section 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 of this subchapter or enrolled under part B of this
subchapter, 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 of this subchapter
or enrolled under part B of this subchapter, 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) of this section.
(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) of this section.
(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.