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115th Congress } { Rept. 115-933
HOUSE OF REPRESENTATIVES
2d Session } { Part 1
======================================================================
LOCAL COVERAGE DETERMINATION CLARIFICATION ACT OF 2018
_______
September 10, 2018.--Committed to the Committee of the Whole House on
the State of the Union and ordered to be printed
_______
Mr. Brady of Texas, from the Committee on Ways and Means, submitted the
following
R E P O R T
[To accompany H.R. 3635]
[Including cost estimate of the Congressional Budget Office]
The Committee on Ways and Means, to whom was referred the
bill (H.R. 3635) to amend title XVIII of the Social Security
Act in order to improve the process whereby medicare
administrative contractors issue local coverage determinations
under the Medicare program, and for other purposes, having
considered the same, report favorably thereon with an amendment
and recommend that the bill as amended do pass.
CONTENTS
Page
I. SUMMARY AND BACKGROUND...........................................5
A. Purpose and Summary................................. 5
B. Background and Need for Legislation................. 5
C. Legislative History................................. 6
II. EXPLANATION OF THE BILL..........................................6
A. Local Coverage Determination Clarification Act of
2018............................................... 6
III. VOTES OF THE COMMITTEE...........................................7
IV. BUDGET EFFECTS OF THE BILL.......................................7
A. Committee Estimate of Budgetary Effects............. 7
B. Statement Regarding New Budget Authority and Tax
Expenditures Budget Authority...................... 7
C. Cost Estimate Prepared by the Congressional Budget
Office............................................. 8
V. OTHER MATTERS TO BE DISCUSSED UNDER THE RULES OF THE HOUSE.......9
A. Committee Oversight Findings and Recommendations.... 9
B. Statement of General Performance Goals and
Objectives......................................... 9
C. Information Relating to Unfunded Mandates........... 9
D. Congressional Earmarks, Limited Tax Benefits, and
Limited Tariff Benefits............................ 9
E. Duplication of Federal Programs..................... 10
F. Disclosure of Directed Rule Makings................. 10
VI. CORRESPONDENCE..................................................11
VII. CHANGES IN EXISTING LAW MADE BY THE BILL, AS REPORTED...........14
A. Changes in Existing Law Proposed by the Bill, as
Reported........................................... 14
The amendment is as follows:
Strike all after the enacting clause and insert the
following:
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Local Coverage Determination
Clarification Act of 2018''.
SEC. 2. IMPROVEMENTS IN THE MEDICARE LOCAL COVERAGE DETERMINATION (LCD)
PROCESS FOR SPECIFIED LCDS.
(a) LCD Development Process.--Section 1862(l)(5)(D) of the Social
Security Act (42 U.S.C. 1395y(l)(5)(D)) is amended to read as follows:
``(D) Process for issuing specified local coverage
determinations.--
``(i) In general.--In the case of a specified
local coverage determination (as defined in
clause (iii)) within an area by a fiscal
intermediary or carrier that has entered into a
contract with the Secretary under section
1874A, such intermediary or carrier must take
the following actions with respect to such
determination before such determination may
take effect:
``(I) Publish on the public Internet
website of the intermediary or carrier
a proposed version of the specified
local coverage determination (in this
subparagraph referred to as a `draft
determination'), a written rationale
for the draft determination, and a
description of all evidence relied upon
and considered by the intermediary or
carrier in the development of the draft
determination.
``(II) Not later than 60 days after
the date on which the intermediary or
carrier publishes the draft
determination in accordance with
subclause (I), convene one or more
open, public meetings to review the
draft determination, receive comments
with respect to the draft
determination, and secure the advice of
an expert panel (such as a carrier
advisory committee described in chapter
13 of the Medicare Program Integrity
Manual in effect on August 31, 2015)
with respect to the draft
determination. The intermediary or
carrier shall make available means for
the public to attend such meetings
remotely, such as via teleconference.
``(III) With respect to each meeting
convened pursuant to subclause (II),
post on the public Internet website of
the intermediary or carrier, not later
than 14 days after such meeting is
convened, a record of the meeting
minutes for such meeting.
``(IV) Provide a period for
submission of written public comment on
such draft determination that begins on
the date on which all records required
to be posted with respect to such draft
determination under subclause (III) are
so posted and that is not fewer than 30
days in duration.
``(ii) Finalizing a specified local coverage
determination.--A fiscal intermediary or
carrier that has entered into a contract with
the Secretary under section 1874A shall, with
respect to a specified local coverage
determination, post on the public Internet
website of the fiscal intermediary or carrier
the following information before the specified
local coverage determination (in this
subparagraph referred to as the `final
determination') takes effect--
``(I) a response to the issues raised
at meetings convened pursuant to clause
(i)(II) with respect to the draft
determination;
``(II) the rationale for the final
determination;
``(III) in the case that the
intermediary or carrier considered
qualifying evidence in the development
of the determination that was not
described in the written notice
provided pursuant to clause (i)(I), a
description of such qualifying
evidence; and
``(IV) an effective date for the
final determination that is not less
than 30 days after the date on which
such determination is so posted.
``(iii) Specified local coverage
determination defined.--For purposes of this
subparagraph, the term `specified local
coverage determination' means, with respect to
a geographic area--
``(I) a new local coverage
determination (regardless of whether
such determination made by a fiscal
intermediary or carrier that has
entered into a contract with the
Secretary under section 1874A and is
based upon a specified local coverage
determination that previously has been
made with respect to another geographic
area, or by another such intermediary
or carrier);
``(II) a revised local coverage
determination for such geographic area
that restricts one or more existing
coverage criteria for such area (such
as by adding non-covered indications to
an existing local coverage
determination or by deleting previously
covered ICD-9 or ICD-10 codes);
``(III) a revised local coverage
determination that makes a substantive
revision to one or more existing local
coverage determinations; or
``(IV) any other local coverage
determination specified by the
Secretary pursuant to regulations.
``(iv) Qualifying evidence defined.--For
purposes of this subparagraph, the term
`qualifying evidence' means either of the
following:
``(I) Scientific evidence published
in peer-reviewed medical literature,
such as randomized clinical trials or
other studies.
``(II) A general consensus of the
applicable medical community (such as a
consensus evinced through a recognized
standard of practice in such medical
community) that is supported by
information provided by a recognized
medical authority, such as a
professional medical society.''.
(b) LCD Reconsideration Process.--Section 1869(f) of the Social
Security Act (42 U.S.C. 1395ff(f)) is amended--
(1) in paragraph (2)(A), by inserting ``(other than the
reconsideration process described in paragraphs (8) and (9))''
after ``local coverage determination'';
(2) in paragraph (5), by inserting ``(other than under the
reconsideration process described in paragraphs (8) and (9))''
after ``local coverage determination'';
(3) by redesignating paragraph (8) as paragraph (13); and
(4) by inserting after paragraph (7) the following new
paragraphs:
``(8) Carrier or fiscal intermediary reconsideration process
for specified local coverage determinations.--Upon the filing
of a request by an interested party with respect to a specified
local coverage determination by a fiscal intermediary or
carrier that has entered into a contract with the Secretary
under section 1874A, the intermediary or carrier shall
reconsider such determination in accordance with the following
process:
``(A) Not later than 30 days after such a request is
filed with the fiscal intermediary or carrier by the
interested party with respect to such determination,
the intermediary or carrier shall--
``(i) determine whether the request is an
applicable request; and
``(ii) in the case that the request is not an
applicable request, inform the interested party
of the reasons why such request is not an
applicable request.
``(B) In the case that the intermediary or carrier
determines under subparagraph (A) that the request
described in such subparagraph is an applicable
request, the intermediary or carrier shall, not later
than 90 days after the date on which the request was
filed with the intermediary or carrier, take the
actions described in subparagraphs (C), (D), and (E)
with respect to the determination.
``(C) The action described in this subparagraph is
the action of specifying whether any of the following
statements is applicable to the determination:
``(i) The determination did not apply, or
inaccurately applied, qualifying evidence
relevant to such determination.
``(ii) The determination used language that
exceeded the scope of the intended purpose of
the determination.
``(iii) The determination was incorrect in
its determination of whether such item or
service is reasonable and necessary for the
diagnosis or treatment of illness or injury
under section 1862(a)(1)(A).
``(iv) The determination failed to describe,
with respect to such an item or service, the
clinical conditions to be used for purposes of
determining whether such item or service is
reasonable and necessary for the diagnosis or
treatment of illness or injury under section
1862(a)(1)(A).
``(v) The determination does not apply with
respect to items or services to which it was
intended to apply.
``(vi) The determination is erroneous for
another reason that the intermediary or carrier
identifies.
``(D) The action described in this subparagraph, with
respect to the determination, is the action of taking,
based on the specification under subparagraph (C) of
whether any of the statements in such subparagraph
applied to such determination, one or more of the
following actions:
``(i) Making no change in the determination.
``(ii) Rescinding a part of the determination
(including, as applicable, the entire
determination).
``(iii) Modifying the determination to
restrict the coverage provided under this title
for an item or service that is subject to the
determination.
``(iv) Modifying the determination to expand
the coverage provided under this title for an
item or service that is subject to the
determination.
``(E) The action described in this subparagraph is
the action of making publicly available a written
description of the action taken under subparagraph (D)
with respect to the determination.
``(9) Agency evaluation of reconsideration decision.--In the
case that an interested party that filed an applicable request
under paragraph (8) with respect to a specified local coverage
determination files with the Secretary, on a date that is not
later than 120 days after the date on which an intermediary or
carrier takes an action described under paragraph (8)(D) with
respect to such determination, an appeal with respect to such
decision in such form and manner as the Secretary may require,
the Secretary shall, not later than 30 days after such appeal
is filed--
``(A) specify which, if any, of the statements in
subparagraph (C) of paragraph (8) is applicable to the
determination; and
``(B) based on such specification, take one of the
actions described in subparagraph (D) of such paragraph
with respect to the determination.
The Secretary shall apply subparagraph (A) as though the
reference to `the intermediary or carrier' in clause (vi) of
paragraph (8)(C) were a reference to the Secretary.
``(10) Rule of construction.--Nothing in paragraph (8) or (9)
may be construed as affecting the right of an aggrieved party
to file a complaint under paragraph (2)(A) and receive a
determination in accordance with the provisions of such
paragraph.
``(11) Definitions applicable to paragraphs (8) and (9).--For
purposes of paragraphs (8) and (9):
``(A) The term `applicable request' means a request
that is submitted in fiscal year 2019 or a subsequent
fiscal year, that is solely with respect to a specified
local coverage determination, and that includes a
description of the rationale for such request and any
evidence supporting such request. For purposes of the
preceding sentence, the Secretary may not require, as a
condition of treating a request with respect to such a
determination as an applicable request, that the
request contain qualifying evidence that was not
considered in the development of such determination.
``(B) The term `interested party' means, with respect
to a specified local coverage determination within an
area by a fiscal intermediary or carrier that has
entered into a contract with the Secretary under
section 1874A--
``(i) a provider of services or supplier
that, in such area, furnishes, provides, or
supplies items or services that are subject to
such determination; or
``(ii) an organization that represents such a
provider of services or supplier.
``(C) The term `qualifying evidence' has the meaning
given such term by clause (iv) of section
1862(l)(5)(D).
``(D) The term `specified local coverage
determination' has the meaning given such term by
clause (iii) of such section.
``(12) Report.--Not later than December 31 of each year
(beginning with 2019), the Secretary shall submit to Congress a
report containing the following:
``(A) The number of requests filed with fiscal
intermediaries and carriers under paragraph (8), and
the number of appeals filed with the Secretary under
paragraph (9), during the 1-year period ending on such
date.
``(B) With respect to such requests filed with such
intermediaries and carriers under paragraph (8) during
such period, the number of times that intermediaries
and carriers took, with respect to the actions
described in subparagraphs (C) through (E) of such
paragraph, each such action.
``(C) With respect to such appeals filed with the
Secretary under paragraph (9) during such period, the
number of times that the Secretary took, with respect
to the actions described in subparagraph (D) of
paragraph (8), each such action.
``(D) Recommendations on ways to improve--
``(i) the efficacy and the efficiency of the
process described in paragraph (8); and
``(ii) communication with individuals
entitled to benefits under part A or enrolled
under part B, providers of services, and
suppliers regarding such process.''.
SEC. 3. PROMULGATION OF REGULATIONS; APPLICATION DATE.
The Secretary of Health and Human Services shall promulgate
regulations to carry out paragraph (5)(D) of section 1862(l) of the
Social Security Act (42 U.S.C. 1395y(l)), as amended by subsection (a),
and paragraphs (8) and (9) of section 1869(f) of such Act (42 U.S.C.
1395ff(f)), as inserted by subsection (b), in such a manner as to
ensure that the processes described in such paragraphs are fully
implemented by July 1, 2019.
I. SUMMARY AND BACKGROUND
A. Purpose and Summary
The bill, H.R. 3635, the ``Local Coverage Determination
Clarification Act of 2018,'' as ordered reported by the
Committee on Ways and Means on September 5, 2018, would
establish transparency, certainty, and consistency for Medicare
beneficiaries and providers through codifying and improving the
process through which Medicare Administrative Contractors
(MACs) make local coverage determinations (LCDs).
The bill would require MACs to institute an open process
for developing LCDs, including publicly posting online proposed
LCDs and the rationale and evidence relied on for making such
determinations; convene open public meetings; solicit input
from the public, including an expert panel; and establish a
public comment period for developing draft policies and posting
responses to comments received. H.R. 3635 would offer
beneficiaries, providers, and suppliers a meaningful
reconsideration process. Finally, H.R. 3635 would require the
Secretary of Health and Human Services (HHS) to provide an
annual report detailing the LCD process including the amount of
applications and actions taken with respect to reconsideration.
B. Background and Need for Legislation
The Medicare Prescription Drug Improvement and
Modernization Act of 2003 made reforms to the Medicare
contracting process, including requiring the Secretary to
replace private health insurers, previously known as Part A
Fiscal Intermediaries (FI), and Part B carriers into a single
organization called Medicare Administrative Contractors (MACs).
MACs are responsible for processing both Part A and Part B
claims and issuing local coverage determinations (LCDs), among
other responsibilities.
There are 12 MAC regions throughout the country. MACs use
LCDs to determine whether an item or service is covered under
Medicare in the particular MAC region. When issuing an LCD,
MACs evaluate whether an item or service is reasonable and
necessary for Medicare beneficiaries, as required under Section
1862(a)(1)(A) of the Social Security Act. Additionally, MACs
enroll providers, educate them on the program's billing
requirements, and answer provider and beneficiary inquiries.
The Committee reiterates that each MAC should review
evidence independently before issuing a local coverage
determination.While the reported legislation does not
specifically address this issue, the Committee remains
concerned that action may be necessary to ensure a thorough
evidentiary review occurs for LCDs in each region.
C. Legislative History
Background
H.R. 3635 was introduced on August 4, 2017, and was
referred to the Committee on Ways and Means and additionally
the Committee on Energy and Commerce.
Committee hearings
On March 21, 2018, the Subcommittee on Health held a
hearing on the implementation of MACRA, where members engaged
the Administration on issues surrounding coverage decisions in
Medicare.
On July 17, 2018, the Subcommittee on Oversight held a
hearing on combatting fraud in Medicare, where MACs play a key
role.
Committee action
The Committee on Ways and Means marked up H.R. 3635, the
``Local Coverage Determination Act of 2018,'' on September 5,
2018, and ordered the bill, as amended, favorably reported
(with a quorum being present).
II. EXPLANATION OF THE BILL
A. Local Coverage Determination Clarification Act of 2018
PRESENT LAW
Present law allows for the LCD process to be determined
through regulation by the Centers for Medicare and Medicaid
Services (CMS).
REASONS FOR CHANGE
While the regulations for the LCD process are described in
detail in the CMS Program Integrity Manual, enhanced clarity
and transparency is necessary in the LCD process, whether
issuing a positive or negative determination.Placing these
transparency requirements into statute will ensure that the
process is fair.
EXPLANATION OF PROVISIONS
Section 1: Short Title: ``Local Coverage Determination
Clarification Act of 2018''.
Section 2: Improvements in the Medicare Local Coverage
(LCD) Process for Specified LCDs.
LCD development process
Open Meetings and Comment Period: This provision would
require MACs to convene open, public meetings on a draft LCD,
receive comments, and solicit expert advice, such as a Carrier
Advisory Committee. The public meetings would be recorded, with
minutes posted on the MAC's website.
Upfront Disclosure: This provision would require MACs to
make publicly available online a description of the rationale
for the LCD, the evidence the MAC considered when developing
the LCD, and a response to public comments on the LCD.
Meaningful reconsideration and options for appeal
This provision would create a reconsideration process for
providers and suppliers to appeal a MAC's decision. The bill
would also create a pathway for providers and suppliers to
appeal an LCD to the Secretary of the Department of HHS.
Nothing in this bill prevents an eligible aggrieved party,
including patients, from availing themselves of an
administrative law judge.
Report to Congress
This provision requires an annual report that would:
Publicize information about the number of
appeals filed with the MAC and CMS each year and the
actions MACs take with respect to: (1) the appeals
filed, (2) the number of times the Secretary took
action in response to appeals filed with HHS, and (3)
the responsiveness of the MACs
Deliver recommendations to the Secretary on
ways to improve the efficiency of the appeals process.
Section 3: Promulgation of Regulations; Application Date.
EFFECTIVE DATE
The Secretary will ensure that these processes are
implemented by January 1, 2020.
III. VOTES OF THE COMMITTEE
In compliance with clause 3(b) of rule XIII of the Rules of
the House of Representatives, the following statement is made
concerning the vote of the Committee on Ways and Means in its
consideration of H.R. 3635, the``Local Coverage Determination
Clarification Act of 2018,'' on September 5, 2018.
The Chairman's amendment in the nature of a substitute was
adopted by a voice vote (with a quorum being present).
The bill, H.R. 3635, was ordered favorably reported as
amended by voice vote (with a quorum being present).
IV. BUDGET EFFECTS OF THE BILL
A. Committee Estimate of Budgetary Effects
In compliance with clause 3(d) of rule XIII of the Rules of
the House of Representatives, the following statement is made
concerning the effects on the budget of the bill, H.R. 3635, as
reported. The Committee agrees with the estimate prepared by
the Congressional Budget Office (CBO), which is included below.
B. Statement Regarding New Budget Authority and Tax Expenditures Budget
Authority
In compliance with clause 3(c)(2) of rule XIII of the Rules
of the House of Representatives, the Committee states that the
bill involves no new or increased budget authority. The
Committee states further that the bill involves no new or
increased tax expenditures.
C. Cost Estimate Prepared by the Congressional Budget Office
In compliance with clause 3(c)(3) of rule XIII of the Rules
of the House of Representatives, requiring a cost estimate
prepared by the CBO, the following statement by CBO is
provided.
U.S. Congress,
Congressional Budget Office,
Washington, DC, September 10, 2018.
Hon. Kevin Brady,
Chairman, Committee on Ways and Means,
House of Representatives, Washington, DC.
Dear Mr. Chairman: The Congressional Budget Office has
prepared the enclosed cost estimate for H.R. 3635, the Local
Coverage Determination Clarification Act of 2017.
If you wish further details on this estimate, we will be
pleased to provide them. The CBO staff contact is Lara
Robillard.
Sincerely,
Keith Hall,
Director.
Enclosure.
H.R. 3635--Local Coverage Determination Clarification Act of 2017
Summary: H.R. 3635 would modify some processes by which
private contractors develop coverage and payment policies
within the Medicare program. CBO estimates that enacting the
bill would not affect direct spending or revenues; therefore,
pay-as-you-go procedures do not apply. H.R. 3635 would not
affect spending subject to appropriation.
CBO estimates that enacting H.R. 3635 would not increase
net direct spending or on-budget deficits in any of the four
consecutive 10-year periods beginning in 2029.
H.R. 3635 contains no intergovernmental or private-sector
mandates as defined in the Unfunded Mandates Reform Act (UMRA).
Basis of estimate: Under current law, private entities
known as Medicare Administrative Contractors (MACs) perform
many activities necessary to manage Parts A and B of Medicare--
the parts of the program that cover hospitalization, physician
visits, and other inpatient and outpatient care.\1\ The MACs
determine Medicare coverage and payment parameters (local
coverage decisions or LCDs) for health care services when there
is no nationwide policy (national coverage decision or NCD). A
contractor's LCDs are effective only for its geographic region
and they must be consistent with the Medicare statute and NCDs.
---------------------------------------------------------------------------
\1\Private health plans and firms separately manage Medicare
Advantage (Part C) and the outpatient drug benefit (Part D). More
information on MACs is available at https://www.cms.gov/Medicare/
Medicare-Contracting/Medicare-Administrative-Contractors/What-is-a-
MAC.html.
---------------------------------------------------------------------------
H.R. 3635 would modify some of the processes that MACs use
when promulgating LCDs. For example, MACs would be required to
publish draft LCDs on a public website and convene public
meetings about draft decisions within 60 days. MACs would also
have to publish responses to public comments and establish a
process for responding to requests for review and
reconsideration of LCDs. Some of the bill's requirements, such
as public posting of draft LCDs, are substantially similar to
existing MAC activities.
CBO estimates that the Centers for Medicare and Medicaid
Services (CMS) and the MACs would not spend significant
additional resources to meet the requirements of H.R. 3635. In
addition, CBO does not expect any change in coverage of or
payment for Medicare services, so H.R. 3635 would not affect
direct spending.
Pay-As-You-Go considerations: None.
Increase in long-term direct spending and deficits: CBO
estimates that enacting H.R. 3635 would not increase net direct
spending or on-budget deficits in any of the four consecutive
10-year periods beginning in 2029.
Mandates: H.R. 3635 contains no intergovernmental or
private-sector mandates as defined in UMRA.
Estimate prepared by: Federal costs: Lara Robillard,
Mandates: Andrew Laughlin.
Estimate reviewed by: Tom Bradley, Chief, Medicare and
Health Systems Cost Estimate Unit; Susan Willie, Chief,
Mandates Unit; Theresa Gullo, Assistant Director for Budget
Analysis.
V. OTHER MATTERS TO BE DISCUSSED UNDER THE RULES OF THE HOUSE
A. Committee Oversight Findings and Recommendations
With respect to clause 3(c)(1) of rule XIII of the Rules of
the House of Representatives, the Committee made findings and
recommendations that are reflected in this report.
B. Statement of General Performance Goals and Objectives
With respect to clause 3(c)(4) of rule XIII of the Rules of
the House of Representatives, the Committee advises that the
bill contains no measure that authorizes funding, so no
statement of general performance goals and objectives for which
any measure authorizes funding is required.
C. Information Relating to Unfunded Mandates
This information is provided in accordance with section 423
of the Unfunded Mandates Reform Act of 1995 (Pub. L. No. 104-
4).
The Committee has determined that the bill does not contain
Federal mandates on the private sector. The Committee has
determined that the bill does not impose a Federal
intergovernmental mandate on State, local, or tribal
governments.
D. Congressional Earmarks, Limited Tax Benefits, and Limited Tariff
Benefits
With respect to clause 9 of rule XXI of the Rules of the
House of Representatives, the Committee has carefully reviewed
the provisions of the bill, and states that the provisions of
the bill do not contain any congressional earmarks, limited tax
benefits, or limited tariff benefits within the meaning of the
rule.
E. Duplication of Federal Programs
In compliance with Sec. 3(g)(2) of H. Res. 5 (114th
Congress), the Committee states that no provision of the bill
establishes or reauthorizes: (1) a program of the Federal
Government known to be duplicative of another Federal program;
(2) a program included in any report from the Government
Accountability Office to Congress pursuant to section 21 of
Public Law 111-139; or (3) a program related to a program
identified in the most recent Catalog of Federal Domestic
Assistance, published pursuant to the Federal Program
Information Act (Pub. L. No. 95-220, as amended by Pub. L. No.
98-169).
F. Disclosure of Directed Rule Makings
In compliance with Sec. 3(i) of H. Res. 5 (114th Congress),
the following statement is made concerning directed rule
makings: The Committee estimates that the bill requires no
directed rule makings within the meaning of such section.
VII. CHANGES IN EXISTING LAW MADE BY THE BILL, AS REPORTED
A. Changes in Existing Law Proposed by the Bill, as Reported
In compliance with clause 3(e)(1)(B) of rule XIII of the
Rules of the House of Representatives, changes in existing law
proposed by the bill, as reported, are shown as follows
(existing law proposed to be omitted is enclosed in black
brackets, new matter is printed in italic, existing law in
which no change is proposed is shown in roman):
Changes in Existing Law Made by the Bill, as Reported
In compliance with clause 3(e) of rule XIII of the Rules of
the House of Representatives, changes in existing law made by
the bill, as reported, are shown as follows (existing law
proposed to be omitted is enclosed in black brackets, new
matter is printed in italic, and existing law in which no
change is proposed is shown in roman):
SOCIAL SECURITY ACT
* * * * * * *
TITLE XVIII--HEALTH INSURANCE FOR THE AGED AND DISABLED
* * * * * * *
Part E--Miscellaneous Provisions
* * * * * * *
exclusions from coverage and medicare as secondary payer
Sec. 1862. (a) Notwithstanding any other provision of this
title, no payment may be made under part A or part B for any
expenses incurred for items or services--
(1)(A) which, except for items and services described
in a succeeding subparagraph or additional preventive
services (as described in section 1861(ddd)(1)), are
not reasonable and necessary for the diagnosis or
treatment of illness or injury or to improve the
functioning of a malformed body member,
(B) in the case of items and services described in
section 1861(s)(10), which are not reasonable and
necessary for the prevention of illness,
(C) in the case of hospice care, which are not
reasonable and necessary for the palliation or
management of terminal illness,
(D) in the case of clinical care items and services
provided with the concurrence of the Secretary and with
respect to research and experimentation conducted by,
or under contract with, the Medicare Payment Advisory
Commission or the Secretary, which are not reasonable
and necessary to carry out the purposes of section
1886(e)(6),
(E) in the case of research conducted pursuant to
section 1142, which is not reasonable and necessary to
carry out the purposes of that section,
(F) in the case of screening mammography, which is
performed more frequently than is covered under section
1834(c)(2) or which is not conducted by a facility
described in section 1834(c)(1)(B), in the case of
screening pap smear and screening pelvic exam, which is
performed more frequently than is provided under
section 1861(nn), and, in the case of screening for
glaucoma, which is performed more frequently than is
provided under section 1861(uu),
(G) in the case of prostate cancer screening tests
(as defined in section 1861(oo)), which are performed
more frequently than is covered under such section,
(H) in the case of colorectal cancer screening tests,
which are performed more frequently than is covered
under section 1834(d),
(I) the frequency and duration of home health
services which are in excess of normative guidelines
that the Secretary shall establish by regulation,
(J) in the case of a drug or biological specified in
section 1847A(c)(6)(C) for which payment is made under
part B that is furnished in a competitive area under
section 1847B, that is not furnished by an entity under
a contract under such section,
(K) in the case of an initial preventive physical
examination, which is performed more than 1 year after
the date the individual's first coverage period begins
under part B,
(L) in the case of cardiovascular screening blood
tests (as defined in section 1861(xx)(1)), which are
performed more frequently than is covered under section
1861(xx)(2),
(M) in the case of a diabetes screening test (as
defined in section 1861(yy)(1)), which is performed
more frequently than is covered under section
1861(yy)(3),
(N) in the case of ultrasound screening for abdominal
aortic aneurysm which is performed more frequently than
is provided for under section 1861(s)(2)(AA),
(O) in the case of kidney disease education services
(as defined in paragraph (1) of section 1861(ggg)),
which are furnished in excess of the number of sessions
covered under paragraph (4) of such section, and
(P) in the case of personalized prevention plan
services (as defined in section 1861(hhh)(1)), which
are performed more frequently than is covered under
such section;
(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, except in the case of
Federally qualified health center services;
(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
the case of rural health clinic services, as defined in
section 1861(aa)(1), in the case of Federally qualified
health center services, as defined in section
1861(aa)(3), in the case of services for which payment
may be made under section 1880(e), and in such other
cases as the Secretary may specify;
(4) which are not provided within the United States
(except for inpatient hospital services furnished
outside the United States under the conditions
described in section 1814(f) and, subject to such
conditions, limitations, and requirements as are
provided under or pursuant to this title, physicians'
services and ambulance services furnished an individual
in conjunction with such inpatient hospital services
but only for the period during which such inpatient
hospital services were furnished);
(5) which are required as a result of war, or of an
act of war, occurring after the effective date of such
individual's current coverage under such part;
(6) which constitute personal comfort items (except,
in the case of hospice care, as is otherwise permitted
under paragraph (1)(C));
(7) where such expenses are for routine physical
checkups, eyeglasses (other than eyewear described in
section 1861(s)(8)) or eye examinations for the purpose
of prescribing, fitting, or changing eyeglasses,
procedures performed (during the course of any eye
examination) to determine the refractive state of the
eyes, hearing aids or examinations therefor, or
immunizations (except as otherwise allowed under
section 1861(s)(10) and subparagraph (B), (F), (G),
(H), (K), or (P) of paragraph (1));
(8) where such expenses are for orthopedic shoes or
other supportive devices for the feet, other than shoes
furnished pursuant to section 1861(s)(12);
(9) where such expenses are for custodial care
(except, in the case of hospice care, as is otherwise
permitted under paragraph (1)(C));
(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;
(12) where such expenses are for services in
connection with the care, treatment, filling, removal,
or replacement of teeth or structures directly
supporting teeth, except that payment may be made under
part A in the case of inpatient hospital services in
connection with the provision of such dental services
if the individual, because of his underlying medical
condition and clinical status or because of the
severity of the dental procedure, requires
hospitalization in connection with the provision of
such services;
(13) where such expenses are for--
(A) the treatment of flat foot conditions and
the prescription of supportive devices
therefor,
(B) the treatment of subluxations of the
foot, or
(C) routine foot care (including the cutting
or removal of corns or calluses, the trimming
of nails, and other routine hygienic care);
(14) which are other than physicians' services (as
defined in regulations promulgated specifically for
purposes of this paragraph), services described by
section 1861(s)(2)(K), certified nurse-midwife
services, qualified psychologist services, and services
of a certified registered nurse anesthetist, and which
are furnished to an individual who is a patient of a
hospital or critical access hospital by an entity other
than the hospital or critical access hospital, unless
the services are furnished under arrangements (as
defined in section 1861(w)(1)) with the entity made by
the hospital or critical access hospital;
(15)(A) which are for services of an assistant at
surgery in a cataract operation (including subsequent
insertion of an intraocular lens) unless, before the
surgery is performed, the appropriate quality
improvement organization (under part B of title XI) or
a carrier under section 1842 has approved of the use of
such an assistant in the surgical procedure based on
the existence of a complicating medical condition, or
(B) which are for services of an assistant at surgery
to which section 1848(i)(2)(B) applies;
(16) in the case in which funds may not be used for
such items and services under the Assisted Suicide
Funding Restriction Act of 1997;
(17) where the expenses are for an item or service
furnished in a competitive acquisition area (as
established by the Secretary under section 1847(a)) by
an entity other than an entity with which the Secretary
has entered into a contract under section 1847(b) for
the furnishing of such an item or service in that area,
unless the Secretary finds that the expenses were
incurred in a case of urgent need, or in other
circumstances specified by the Secretary;
(18) which are covered skilled nursing facility
services described in section 1888(e)(2)(A)(i) and
which are furnished to an individual who is a resident
of a skilled nursing facility during a period in which
the resident is provided covered post-hospital extended
care services (or, for services described in section
1861(s)(2)(D), which are furnished to such an
individual without regard to such period), by an entity
other than the skilled nursing facility, unless the
services are furnished under arrangements (as defined
in section 1861(w)(1)) with the entity made by the
skilled nursing facility;
(19) which are for items or services which are
furnished pursuant to a private contract described in
section 1802(b);
(20) in the case of outpatient physical therapy
services, outpatient speech-language pathology
services, or outpatient occupational therapy services
furnished as an incident to a physician's professional
services (as described in section 1861(s)(2)(A)), that
do not meet the standards and conditions (other than
any licensing requirement specified by the Secretary)
under the second sentence of section 1861(p) (or under
such sentence through the operation of subsection (g)
or (ll)(2) of section 1861) as such standards and
conditions would apply to such therapy services if
furnished by a therapist;
(21) where such expenses are for home health services
(including medical supplies described in section
1861(m)(5), but excluding durable medical equipment to
the extent provided for in such section) furnished to
an individual who is under a plan of care of the home
health agency if the claim for payment for such
services is not submitted by the agency;
(22) subject to subsection (h), for which a claim is
submitted other than in an electronic form specified by
the Secretary;
(23) which are the technical component of advanced
diagnostic imaging services described in section
1834(e)(1)(B) for which payment is made under the fee
schedule established under section 1848(b) and that are
furnished by a supplier (as defined in section
1861(d)), if such supplier is not accredited by an
accreditation organization designated by the Secretary
under section 1834(e)(2)(B);
(24) where such expenses are for renal dialysis
services (as defined in subparagraph (B) of section
1881(b)(14)) for which payment is made under such
section unless such payment is made under such section
to a provider of services or a renal dialysis facility
for such services; or
(25) not later than January 1, 2014, for which the
payment is other than by electronic funds transfer
(EFT) or an electronic remittance in a form as
specified in ASC X12 835 Health Care Payment and
Remittance Advice or subsequent standard.
Paragraph (7) shall not apply to Federally qualified health
center services described in section 1861(aa)(3)(B). In making
a national coverage determination (as defined in paragraph
(1)(B) of section 1869(f)) the Secretary shall ensure
consistent with subsection (l) that the public is afforded
notice and opportunity to comment prior to implementation by
the Secretary of the determination; meetings of advisory
committees with respect to the determination are made on the
record; in making the determination, the Secretary has
considered applicable information (including clinical
experience and medical, technical, and scientific evidence)
with respect to the subject matter of the determination; and in
the determination, provide a clear statement of the basis for
the determination (including responses to comments received
from the public), the assumptions underlying that basis, and
make available to the public the data (other than proprietary
data) considered in making the determination.
(b) Medicare as Secondary Payer.--
(1) Requirements of group health plans.--
(A) Working aged under group health plans.--
(i) In general.--A group health
plan--
(I) may not take into account
that an individual (or the
individual's spouse) who is
covered under the plan by
virtue of the individual's
current employment status with
an employer is entitled to
benefits under this title under
section 226(a), and
(II) shall provide that any
individual age 65 or older (and
the spouse age 65 or older of
any individual) who has current
employment status with an
employer shall be entitled to
the same benefits under the
plan under the same conditions
as any such individual (or
spouse) under age 65.
(ii) Exclusion of group health plan
of a small employer.--Clause (i) shall
not apply to a group health plan unless
the plan is a plan of, or contributed
to by, an employer that has 20 or more
employees for each working day in each
of 20 or more calendar weeks in the
current calendar year or the preceding
calendar year.
(iii) Exception for small employers
in multiemployer or multiple employer
group health plans.--Clause (i) also
shall not apply with respect to
individuals enrolled in a multiemployer
or multiple employer group health plan
if the coverage of the individuals
under the plan is by virtue of current
employment status with an employer that
does not have 20 or more individuals in
current employment status for each
working day in each of 20 or more
calendar weeks in the current calendar
year and the preceding calendar year;
except that the exception provided in
this clause shall only apply if the
plan elects treatment under this
clause.
(iv) Exception for individuals with
end stage renal disease.--Subparagraph
(C) shall apply instead of clause (i)
to an item or service furnished in a
month to an individual if for the month
the individual is, or (without regard
to entitlement under section 226) would
upon application be, entitled to
benefits under section 226A.
(v) Group health plan defined.--In
this subparagraph, and subparagraph
(C), the term ``group health plan'' has
the meaning given such term in section
5000(b)(1) of the Internal Revenue Code
of 1986, without regard to section
5000(d) of such Code
(B) Disabled individuals in large group
health plans.--
(i) In general.--A large group health
plan (as defined in clause (iii)) may
not take into account that an
individual (or a member of the
individual's family) who is covered
under the plan by virtue of the
individual's current employment status
with an employer is entitled to
benefits under this title under section
226(b).
(ii) Exception for individuals with
end stage renal disease.--Subparagraph
(C) shall apply instead of clause (i)
to an item or service furnished in a
month to an individual if for the month
the individual is, or (without regard
to entitlement under section 226) would
upon application be, entitled to
benefits under section 226A.
(iii) Large Group Health Plan
Defined.--In this subparagraph, the
term ``large group health plan'' has
the meaning given such term in section
5000(b)(2) of the Internal Revenue Code
of 1986, without regard to section
5000(d) of such Code.
(C) Individuals with end stage renal
disease.--A group health plan (as defined in
subparagraph (A)(v))--
(i) may not take into account that an
individual is entitled to or eligible
for benefits under this title under
section 226A during the 12-month period
which begins with the first month in
which the individual becomes entitled
to benefits under part A under the
provisions of section 226A, or, if
earlier, the first month in which the
individual would have been entitled to
benefits under such part under the
provisions of section 226A if the
individual had filed an application for
such benefits; and
(ii) may not differentiate in the
benefits it provides between
individuals having end stage renal
disease and other individuals covered
by such plan on the basis of the
existence of end stage renal disease,
the need for renal dialysis, or in any
other manner;
except that clause (ii) shall not prohibit a
plan from paying benefits secondary to this
title when an individual is entitled to or
eligible for benefits under this title under
section 226A after the end of the 12-month
period described in clause (i). Effective for
items and services furnished on or after
February 1, 1991, and before the date of
enactment of the Balanced Budget Act of 1997
(with respect to periods beginning on or after
February 1, 1990), this subparagraph shall be
applied by substituting ``18- month'' for ``12-
month'' each place it appears. Effective for
items and services furnished on or after the
date of enactment of the Balanced Budget Act of
1997, (with respect to periods beginning on or
after the date that is 18 months prior to such
date), clauses (i) and (ii) shall be applied by
substituting ``30-month'' for ``12-month'' each
place it appears.
(D) Treatment of certain members of religious
orders.--In this subsection, an individual
shall not be considered to be employed, or an
employee, with respect to the performance of
services as a member of a religious order which
are considered employment only by virtue of an
election made by the religious order under
section 3121(r) of the Internal Revenue Code of
1986.
(E) General Provisions.--For purposes of this
subsection:
(i) Aggregation Rules.--
(I) All employers treated as
a single employer under
subsection (a) or (b) of
section 52 of the Internal
Revenue Code of 1986 shall be
treated as a single employer.
(II) All employees of the
members of an affiliated
service group (as defined in
section 414(m) of such Code)
shall be treated as employed by
a single employer.
(III) Leased employees (as
defined in section 414(n)(2) of
such Code) shall be treated as
employees of the person for
whom they perform services to
the extent they are so treated
under section 414(n) of such
Code.
In applying sections of the Internal
Revenue Code of 1986 under this clause,
the Secretary shall rely upon
regulations and decisions of the
Secretary of the Treasury respecting
such sections.
(ii) Current employment status
defined.--An individual has ``current
employment status'' with an employer if
the individual is an employee, is the
employer, or is associated with the
employer in a business relationship.
(iii) Treatment of self-employed
persons as employers.--The term
``employer'' includes a self-employed
person.
(F) Limitation on beneficiary liability.--An
individual who is entitled to benefits under
this title and is furnished an item or service
for which such benefits are incorrectly paid is
not liable for repayment of such benefits under
this paragraph unless payment of such benefits
was made to the individual.
(2) Medicare secondary payer.--
(A) In general.--Payment under this title may
not be made, except as provided in subparagraph
(B), with respect to any item or service to the
extent that--
(i) payment has been made, or can
reasonably be expected to be made, with
respect to the item or service as
required under paragraph (1), or
(ii) payment has been made or can
reasonably be expected to be made under
a workmen's compensation law or plan of
the United States or a State or under
an automobile or liability insurance
policy or plan (including a self-
insured plan) or under no fault
insurance.
In the subsection, the term ``primary plan''
means a group health plan or large group health
plan, to the extent that clause (i) applies,
and a workmen's compensation law or plan, an
automobile or liability insurance policy or
plan (including a self-insured plan) or no
fault insurance, to the extent that clause (ii)
applies. An entity that engages in a business,
trade, or profession shall be deemed to have a
self-insured plan if it carries its own risk
(whether by a failure to obtain insurance, or
otherwise) in whole or in part.
(B) Conditional payment.--
(i) Authority to make conditional
payment.--The Secretary may make
payment under this title with respect
to an item or service if a primary plan
described in subparagraph (A)(ii) has
not made or cannot reasonably be
expected to make payment with respect
to such item or service promptly (as
determined in accordance with
regulations). Any such payment by the
Secretary shall be conditioned on
reimbursement to the appropriate Trust
Fund in accordance with the succeeding
provisions of this subsection.
(ii) Repayment required.--Subject to
paragraph (9), a primary plan, and an
entity that receives payment from a
primary plan, shall reimburse the
appropriate Trust Fund for any payment
made by the Secretary under this title
with respect to an item or service if
it is demonstrated that such primary
plan has or had a responsibility to
make payment with respect to such item
or service. A primary plan's
responsibility for such payment may be
demonstrated by a judgment, a payment
conditioned upon the recipient's
compromise, waiver, or release (whether
or not there is a determination or
admission of liability) of payment for
items or services included in a claim
against the primary plan or the primary
plan's insured, or by other means. If
reimbursement is not made to the
appropriate Trust Fund before the
expiration of the 60-day period that
begins on the date notice of, or
information related to, a primary
plan's responsibility for such payment
or other information is received, the
Secretary may charge interest
(beginning with the date on which the
notice or other information is
received) on the amount of the
reimbursement until reimbursement is
made (at a rate determined by the
Secretary in accordance with
regulations of the Secretary of the
Treasury applicable to charges for late
payments).
(iii) Action by united states.--In
order to recover payment made under
this title for an item or service, the
United States may bring an action
against any or all entities that are or
were required or responsible (directly,
as an insurer or self-insurer, as a
third-party administrator, as an
employer that sponsors or contributes
to a group health plan, or large group
health plan, or otherwise) to make
payment with respect to the same item
or service (or any portion thereof)
under a primary plan. The United States
may, in accordance with paragraph
(3)(A) collect double damages against
any such entity. In addition, the
United States may recover under this
clause from any entity that has
received payment from a primary plan or
from the proceeds of a primary plan's
payment to any entity. The United
States may not recover from a third-
party administrator under this clause
in cases where the third-party
administrator would not be able to
recover the amount at issue from the
employer or group health plan and is
not employed by or under contract with
the employer or group health plan at
the time the action for recovery is
initiated by the United States or for
whom it provides administrative
services due to the insolvency or
bankruptcy of the employer or plan. An
action may not be brought by the United
States under this clause with respect
to payment owed unless the complaint is
filed not later than 3 years after the
date of the receipt of notice of a
settlement, judgment, award, or other
payment made pursuant to paragraph (8)
relating to such payment owed.
(iv) Subrogation rights.--The United
States shall be subrogated (to the
extent of payment made under this title
for such an item or service) to any
right under this subsection of an
individual or any other entity to
payment with respect to such item or
service under a primary plan.
(v) Waiver of rights.--The Secretary
may waive (in whole or in part) the
provisions of this subparagraph in the
case of an individual claim if the
Secretary determines that the waiver is
in the best interests of the program
established under this title.
(vi) Claims-filing period.--
Notwithstanding any other time limits
that may exist for filing a claim under
an employer group health plan, the
United States may seek to recover
conditional payments in accordance with
this subparagraph where the request for
payment is submitted to the entity
required or responsible under this
subsection to pay with respect to the
item or service (or any portion
thereof) under a primary plan within
the 3-year period beginning on the date
on which the item or service was
furnished.
(vii) Use of website to determine
final conditional reimbursement
amount.--
(I) Notice to secretary of
expected date of a settlement,
judgment, etc.--In the case of
a payment made by the Secretary
pursuant to clause (i) for
items and services provided to
the claimant, the claimant or
applicable plan (as defined in
paragraph (8)(F)) may at any
time beginning 120 days before
the reasonably expected date of
a settlement, judgment, award,
or other payment, notify the
Secretary that a payment is
reasonably expected and the
expected date of such payment.
(II) Secretarial providing
access to claims information
through a website.--The
Secretary shall maintain and
make available to individuals
to whom items and services are
furnished under this title (and
to authorized family or other
representatives recognized
under regulations and to an
applicable plan which has
obtained the consent of the
individual) access to
information on the claims for
such items and services
(including payment amounts for
such claims), including those
claims that relate to a
potential settlement, judgment,
award, or other payment. Such
access shall be provided to an
individual, representative, or
plan through a website that
requires a password to gain
access to the information. The
Secretary shall update the
information on claims and
payments on such website in as
timely a manner as possible but
not later than 15 days after
the date that payment is made.
Information related to claims
and payments subject to the
notice under subclause (I)
shall be maintained and made
available consistent with the
following:
(aa) The information
shall be as complete as
possible and shall
include provider or
supplier name,
diagnosis codes (if
any), dates of service,
and conditional payment
amounts.
(bb) The information
accurately identifies
those claims and
payments that are
related to a potential
settlement, judgment,
award, or other payment
to which the provisions
of this subsection
apply.
(cc) The website
provides a method for
the receipt of secure
electronic
communications with the
individual,
representative, or plan
involved.
(dd) The website
provides that
information is
transmitted from the
website in a form that
includes an official
time and date that the
information is
transmitted.
(ee) The website
shall permit the
individual,
representative, or plan
to download a statement
of reimbursement
amounts (in this clause
referred to as a
``statement of
reimbursement amount'')
on payments for claims
under this title
relating to a potential
settlement, judgment,
award, or other
payment.
(III) Use of timely web
download as basis for final
conditional amount.--If an
individual (or other claimant
or applicable plan with the
consent of the individual)
obtains a statement of
reimbursement amount from the
website during the protected
period as defined in subclause
(V) and the related settlement,
judgment, award or other
payment is made during such
period, then the last statement
of reimbursement amount that is
downloaded during such period
and within 3 business days
before the date of the
settlement, judgment, award, or
other payment shall constitute
the final conditional amount
subject to recovery under
clause (ii) related to such
settlement, judgment, award, or
other payment.
(IV) Resolution of
discrepancies.--If the
individual (or authorized
representative) believes there
is a discrepancy with the
statement of reimbursement
amount, the Secretary shall
provide a timely process to
resolve the discrepancy. Under
such process the individual (or
representative) must provide
documentation explaining the
discrepancy and a proposal to
resolve such discrepancy.
Within 11 business days after
the date of receipt of such
documentation, the Secretary
shall determine whether there
is a reasonable basis to
include or remove claims on the
statement of reimbursement. If
the Secretary does not make
such determination within the
11 business-day period, then
the proposal to resolve the
discrepancy shall be accepted.
If the Secretary determines
within such period that there
is not a reasonable basis to
include or remove claims on the
statement of reimbursement, the
proposal shall be rejected. If
the Secretary determines within
such period that there is a
reasonable basis to conclude
there is a discrepancy, the
Secretary must respond in a
timely manner by agreeing to
the proposal to resolve the
discrepancy or by providing
documentation showing with good
cause why the Secretary is not
agreeing to such proposal and
establishing an alternate
discrepancy resolution. In no
case shall the process under
this subclause be treated as an
appeals process or as
establishing a right of appeal
for a statement of
reimbursement amount and there
shall be no administrative or
judicial review of the
Secretary's determinations
under this subclause.
(V) Protected period.--In
subclause (III), the term
``protected period'' means,
with respect to a settlement,
judgment, award or other
payment relating to an injury
or incident, the portion (if
any) of the period beginning on
the date of notice under
subclause (I) with respect to
such settlement, judgment,
award, or other payment that is
after the end of a Secretarial
response period beginning on
the date of such notice to the
Secretary. Such Secretarial
response period shall be a
period of 65 days, except that
such period may be extended by
the Secretary for a period of
an additional 30 days if the
Secretary determines that
additional time is required to
address claims for which
payment has been made. Such
Secretarial response period
shall be extended and shall not
include any days for any part
of which the Secretary
determines (in accordance with
regulations) that there was a
failure in the claims and
payment posting system and the
failure was justified due to
exceptional circumstances (as
defined in such regulations).
Such regulations shall define
exceptional circumstances in a
manner so that not more than 1
percent of the repayment
obligations under this
subclause would qualify as
exceptional circumstances.
(VI) Effective date.--The
Secretary shall promulgate
final regulations to carry out
this clause not later than 9
months after the date of the
enactment of this clause.
(VII) Website including
successor technology.--In this
clause, the term ``website''
includes any successor
technology.
(viii) Right of appeal for secondary
payer determinations relating to
liability insurance (including self-
insurance), no fault insurance, and
workers' compensation laws and plans.--
The Secretary shall promulgate
regulations establishing a right of
appeal and appeals process, with
respect to any determination under this
subsection for a payment made under
this title for an item or service for
which the Secretary is seeking to
recover conditional payments from an
applicable plan (as defined in
paragraph (8)(F)) that is a primary
plan under subsection (A)(ii), under
which the applicable plan involved, or
an attorney, agent, or third party
administrator on behalf of such plan,
may appeal such determination. The
individual furnished such an item or
service shall be notified of the plan's
intent to appeal such determination
(C) Treatment of questionnaires.--The
Secretary may not fail to make payment under
subparagraph (A) solely on the ground that an
individual failed to complete a questionnaire
concerning the existence of a primary plan.
(3) Enforcement.--
(A) Private cause of action.--There is
established a private cause of action for
damages (which shall be in an amount double the
amount otherwise provided) in the case of a
primary plan which fails to provide for primary
payment (or appropriate reimbursement) in
accordance with paragraphs (1) and (2)(A).
(B) Reference to excise tax with respect to
nonconforming group health plans.--For
provision imposing an excise tax with respect
to nonconforming group health plans, see
section 5000 of the Internal Revenue Code of
1986.
(C) Prohibition of financial incentives not
to enroll in a group health plan or a large
group health plan.--It is unlawful for an
employer or other entity to offer any financial
or other incentive for an individual entitled
to benefits under this title not to enroll (or
to terminate enrollment) under a group health
plan or a large group health plan which would
(in the case of such enrollment) be a primary
plan (as defined in paragraph (2)(A)). Any
entity that violates the previous sentence is
subject to a civil money penalty of not to
exceed $5,000 for each such violation. The
provisions of section 1128A (other than
subsections (a) and (b)) shall apply to a civil
money penalty under the previous sentence in
the same manner as such provisions apply to a
penalty or proceeding under section 1128A(a).
(4) Coordination of benefits.--Where payment for an
item or service by a primary plan is less than the
amount of the charge for such item or service and is
not payment in full, payment may be made under this
title (without regard to deductibles and coinsurance
under this title) for the remainder of such charge,
but--
(A) payment under this title may not exceed
an amount which would be payable under this
title for such item or service if paragraph
(2)(A) did not apply; and
(B) payment under this title, when combined
with the amount payable under the primary plan,
may not exceed--
(i) in the case of an item or service
payment for which is determined under
this title on the basis of reasonable
cost (or other cost-related basis) or
under section 1886, the amount which
would be payable under this title on
such basis, and
(ii) in the case of an item or
service for which payment is authorized
under this title on another basis--
(I) the amount which would be
payable under the primary plan
(without regard to deductibles
and coinsurance under such
plan), or
(II) the reasonable charge or
other amount which would be
payable under this title
(without regard to deductibles
and coinsurance under this
title),
whichever is greater.
(5) Identification of secondary payer situations.--
(A) Requesting matching information.--
(i) Commissioner of social
security.--The Commissioner of Social
Security shall, not less often that
annually, transmit to the Secretary of
the Treasury a list of the names and
TINs of medicare beneficiaries (as
defined in section 6103(l)(12) of the
Internal Revenue Code of 1986) and
request that the Secretary disclose to
the Commissioner the information
described in subparagraph (A) of such
section.
(ii) Administrator.--The
Administrator of the Centers for
Medicare & Medicaid Services shall
request, not less often than annually,
the Commissioner of the Social Security
Administration to disclose to the
Administrator the information described
in subparagraph (B) of section
6103(l)(12) of the Internal Revenue
Code of 1986.
(B) Disclosure to fiscal intermediaries and
carriers.--In addition to any other information
provided under this title to fiscal
intermediaries and carriers, the Administrator
shall disclose to such intermediaries and
carriers (or to such a single intermediary or
carrier as the Secretary may designate) the
information received under subparagraph (A) for
purposes of carrying out this subsection.
(C) Contacting employers.--
(i) In general.--With respect to each
individual (in this subparagraph
referred to as an ``employee'') who was
furnished a written statement under
section 6051 of the Internal Revenue
Code of 1986 by a qualified employer
(as defined in section
6103(l)(12)(E)(iii) of such Code), as
disclosed under subparagraph (B), the
appropriate fiscal intermediary or
carrier shall contact the employer in
order to determine during what period
the employee or employee's spouse may
be (or have been) covered under a group
health plan of the employer and the
nature of the coverage that is or was
provided under the plan (including the
name, address, and identifying number
of the plan).
(ii) Employer response.--Within 30
days of the date of receipt of the
inquiry, the employer shall notify the
intermediary or carrier making the
inquiry as to the determinations
described in clause (i). An employer
(other than a Federal or other
governmental entity) who willfully or
repeatedly fails to provide timely and
accurate notice in accordance with the
previous sentence shall be subject to a
civil money penalty of not to exceed
$1,000 for each individual with respect
to which such an inquiry is made. The
provision of section 1128A (other than
subsections (a) and (b)) shall apply to
a civil money penalty under the
previous sentence in the same manner as
such provisions apply to a penalty or
proceeding under section 1128A(a).
(D) Obtaining information from
beneficiaries.--Before an individual applies
for benefits under part A or enrolls under part
B, the Administrator shall mail the individual
a questionnaire to obtain information on
whether the individual is covered under a
primary plan and the nature of the coverage
provided under the plan, including the name,
address, and identifying number of the plan.
(E) End date.--The provisions of this
paragraph shall not apply to information
required to be provided on or after July 1,
2016.
(6) Screening requirements for providers and
suppliers.--
(A) In general.--Notwithstanding any other
provision of this title, no payment may be made
for any item or service furnished under part B
unless the entity furnishing such item or
service completes (to the best of its knowledge
and on the basis of information obtained from
the individual to whom the item or service is
furnished) the portion of the claim form
relating to the availability of other health
benefit plans.
(B) Penalties.--An entity that knowingly,
willfully, and repeatedly fails to complete a
claim form in accordance with subparagraph (A)
or provides inaccurate information relating to
the availability of other health benefit plans
on a claim form under such subparagraph shall
be subject to a civil money penalty of not to
exceed $2,000 for each such incident. The
provisions of section 1128A (other than
subsections (a) and (b)) shall apply to a civil
money penalty under the previous sentence in
the same manner as such provisions apply to a
penalty or proceeding under section 1128A(a).
(7) Required submission of information by group
health plans.--
(A) Requirement.--On and after the first day
of the first calendar quarter beginning after
the date that is 1 year after the date of the
enactment of this paragraph, an entity serving
as an insurer or third party administrator for
a group health plan, as defined in paragraph
(1)(A)(v), and, in the case of a group health
plan that is self-insured and self-
administered, a plan administrator or
fiduciary, shall--
(i) secure from the plan sponsor and
plan participants such information as
the Secretary shall specify for the
purpose of identifying situations where
the group health plan is or has been a
primary plan to the program under this
title; and
(ii) submit such information to the
Secretary in a form and manner
(including frequency) specified by the
Secretary.
(B) Enforcement.--
(i) In general.--An entity, a plan
administrator, or a fiduciary described
in subparagraph (A) that fails to
comply with the requirements under such
subparagraph shall be subject to a
civil money penalty of $1,000 for each
day of noncompliance for each
individual for which the information
under such subparagraph should have
been submitted. The provisions of
subsections (e) and (k) of section
1128A shall apply to a civil money
penalty under the previous sentence in
the same manner as such provisions
apply to a penalty or proceeding under
section 1128A(a). A civil money penalty
under this clause shall be in addition
to any other penalties prescribed by
law and in addition to any Medicare
secondary payer claim under this title
with respect to an individual.
(ii) Deposit of amounts collected.--
Any amounts collected pursuant to
clause (i) shall be deposited in the
Federal Hospital Insurance Trust Fund
under section 1817.
(C) Sharing of information.--Notwithstanding
any other provision of law, under terms and
conditions established by the Secretary, the
Secretary--
(i) shall share information on
entitlement under Part A and enrollment
under Part B under this title with
entities, plan administrators, and
fiduciaries described in subparagraph
(A);
(ii) may share the entitlement and
enrollment information described in
clause (i) with entities and persons
not described in such clause; and
(iii) may share information collected
under this paragraph as necessary for
purposes of the proper coordination of
benefits.
(D) Implementation.--Notwithstanding any
other provision of law, the Secretary may
implement this paragraph by program instruction
or otherwise.
(8) Required submission of information by or on
behalf of liability insurance (including self-
insurance), no fault insurance, and workers'
compensation laws and plans.--
(A) Requirement.--On and after the first day
of the first calendar quarter beginning after
the date that is 18 months after the date of
the enactment of this paragraph, an applicable
plan shall--
(i) determine whether a claimant
(including an individual whose claim is
unresolved) is entitled to benefits
under the program under this title on
any basis; and
(ii) if the claimant is determined to
be so entitled, submit the information
described in subparagraph (B) with
respect to the claimant to the
Secretary in a form and manner
(including frequency) specified by the
Secretary.
(B) Required information.--The information
described in this subparagraph is--
(i) the identity of the claimant for
which the determination under
subparagraph (A) was made; and
(ii) such other information as the
Secretary shall specify in order to
enable the Secretary to make an
appropriate determination concerning
coordination of benefits, including any
applicable recovery claim.
Not later than 18 months after the date of
enactment of this sentence, the Secretary shall
modify the reporting requirements under this
paragraph so that an applicable plan in
complying with such requirements is permitted
but not required to access or report to the
Secretary beneficiary social security account
numbers or health identification claim numbers,
except that the deadline for such modification
shall be extended by one or more periods
(specified by the Secretary) of up to 1 year
each if the Secretary notifies the committees
of jurisdiction of the House of Representatives
and of the Senate that the prior deadline for
such modification, without such extension,
threatens patient privacy or the integrity of
the secondary payer program under this
subsection. Any such deadline extension notice
shall include information on the progress being
made in implementing such modification and the
anticipated implementation date for such
modification.
(C) Timing.--Information shall be submitted
under subparagraph (A)(ii) within a time
specified by the Secretary after the claim is
resolved through a settlement, judgment, award,
or other payment (regardless of whether or not
there is a determination or admission of
liability).
(D) Claimant.--For purposes of subparagraph
(A), the term ``claimant'' includes--
(i) an individual filing a claim
directly against the applicable plan;
and
(ii) an individual filing a claim
against an individual or entity insured
or covered by the applicable plan.
(E) Enforcement.--
(i) In general.--An applicable plan
that fails to comply with the
requirements under subparagraph (A)
with respect to any claimant may be
subject to a civil money penalty of up
to $1,000 for each day of noncompliance
with respect to each claimant. The
provisions of subsections (e) and (k)
of section 1128A shall apply to a civil
money penalty under the previous
sentence in the same manner as such
provisions apply to a penalty or
proceeding under section 1128A(a). A
civil money penalty under this clause
shall be in addition to any other
penalties prescribed by law and in
addition to any Medicare secondary
payer claim under this title with
respect to an individual.
(ii) Deposit of amounts collected.--
Any amounts collected pursuant to
clause (i) shall be deposited in the
Federal Hospital Insurance Trust Fund.
(F) Applicable plan.--In this paragraph, the
term ``applicable plan'' means the following
laws, plans, or other arrangements, including
the fiduciary or administrator for such law,
plan, or arrangement:
(i) Liability insurance (including
self-insurance).
(ii) No fault insurance.
(iii) Workers' compensation laws or
plans.
(G) Sharing of information.--The Secretary
may share information collected under this
paragraph as necessary for purposes of the
proper coordination of benefits.
(H) Implementation.--Notwithstanding any
other provision of law, the Secretary may
implement this paragraph by program instruction
or otherwise.
(I) Regulations.--Not later than 60 days
after the date of the enactment of this
subparagraph, the Secretary shall publish a
notice in the Federal Register soliciting
proposals, which will be accepted during a 60-
day period, for the specification of practices
for which sanctions will and will not be
imposed under subparagraph (E), including not
imposing sanctions for good faith efforts to
identify a beneficiary pursuant to this
paragraph under an applicable entity
responsible for reporting information. After
considering the proposals so submitted, the
Secretary, in consultation with the Attorney
General, shall publish in the Federal Register,
including a 60-day period for comment, proposed
specified practices for which such sanctions
will and will not be imposed. After considering
any public comments received during such
period, the Secretary shall issue final rules
specifying such practices.
(9) Exception.--
(A) In general.--Clause (ii) of paragraph
(2)(B) and any reporting required by paragraph
(8) shall not apply with respect to any
settlement, judgment, award, or other payment
by an applicable plan arising from liability
insurance (including self-insurance) and from
alleged physical trauma-based incidents
(excluding alleged ingestion, implantation, or
exposure cases) constituting a total payment
obligation to a claimant of not more than the
single threshold amount calculated by the
Secretary under subparagraph (B) for the year
involved.
(B) Annual computation of threshold.--
(i) In general.--Not later than
November 15 before each year, the
Secretary shall calculate and publish a
single threshold amount for
settlements, judgments, awards, or
other payments for obligations arising
from liability insurance (including
self-insurance) and for alleged
physical trauma-based incidents
(excluding alleged ingestion,
implantation, or exposure cases)
subject to this section for that year.
The annual single threshold amount for
a year shall be set such that the
estimated average amount to be credited
to the Medicare trust funds of
collections of conditional payments
from such settlements, judgments,
awards, or other payments arising from
liability insurance (including self-
insurance) and for such alleged
incidents subject to this section shall
equal the estimated cost of collection
incurred by the United States
(including payments made to
contractors) for a conditional payment
arising from liability insurance
(including self-insurance) and for such
alleged incidents subject to this
section for the year. At the time of
calculating, but before publishing, the
single threshold amount for 2014, the
Secretary shall inform, and seek review
of, the Comptroller General of the
United States with regard to such
amount.
(ii) Publication.--The Secretary
shall include, as part of such
publication for a year--
(I) the estimated cost of
collection incurred by the
United States (including
payments made to contractors)
for a conditional payment
arising from liability
insurance (including self-
insurance) and for such alleged
incidents; and
(II) a summary of the
methodology and data used by
the Secretary in computing such
threshold amount and such cost
of collection.
(C) Exclusion of ongoing expenses.--For
purposes of this paragraph and with respect to
a settlement, judgment, award, or other payment
not otherwise addressed in clause (ii) of
paragraph (2)(B) that includes ongoing
responsibility for medical payments (excluding
settlements, judgments, awards, or other
payments made by a workers' compensation law or
plan or no fault insurance), the amount
utilized for calculation of the threshold
described in subparagraph (A) shall include
only the cumulative value of the medical
payments made under this title.
(D) Report to congress.--Not later than
November 15 before each year, the Secretary
shall submit to the Congress a report on the
single threshold amount for settlements,
judgments, awards, or other payments for
conditional payment obligations arising from
liability insurance (including self-insurance)
and alleged incidents described in subparagraph
(A) for that year and on the establishment and
application of similar thresholds for such
payments for conditional payment obligations
arising from worker compensation cases and from
no fault insurance cases subject to this
section for the year. For each such report, the
Secretary shall--
(i) calculate the threshold amount by
using the methodology applicable to
certain liability claims described in
subparagraph (B); and
(ii) include a summary of the
methodology and data used in
calculating each threshold amount and
the amount of estimated savings under
this title achieved by the Secretary
implementing each such threshold.
(c) No payment may be made under part B for any expenses
incurred for--
(1) a drug product--
(A) which is described in section 107(c)(3)
of the Drug Amendments of 1962,
(B) which may be dispensed only upon
prescription,
(C) for which the Secretary has issued a
notice of an opportunity for a hearing under
subsection (e) of section 505 of the Federal
Food, Drug, and Cosmetic Act on a proposed
order of the Secretary to withdraw approval of
an application for such drug product under such
section because the Secretary has determined
that the drug is less than effective for all
conditions of use prescribed, recommended, or
suggested in its labeling, and
(D) for which the Secretary has not
determined there is a compelling justification
for its medical need; and
(2) any other drug product--
(A) which is identical, related, or similar
(as determined in accordance with section 310.6
of title 21 of the Code of Federal Regulations)
to a drug product described in paragraph (1),
and
(B) for which the Secretary has not
determined there is a compelling justification
for its medical need,
until such time as the Secretary withdraws such proposed order.
(d) For purposes of subsection (a)(1)(A), in the case of any
item or service that is required to be provided pursuant to
section 1867 to an individual who is entitled to benefits under
this title, determinations as to whether the item or service is
reasonable and necessary shall be made on the basis of the
information available to the treating physician or practitioner
(including the patient's presenting symptoms or complaint) at
the time the item or service was ordered or furnished by the
physician or practitioner (and not on the patient's principal
diagnosis). When making such determinations with respect to
such an item or service, the Secretary shall not consider the
frequency with which the item or service was provided to the
patient before or after the time of the admission or visit.
(e)(1) No payment may be made under this title with respect
to any item or service (other than an emergency item or
service, not including items or services furnished in an
emergency room of a hospital) furnished--
(A) by an individual or entity during the period when
such individual or entity is excluded pursuant to
section 1128, 1128A, 1156 or 1842(j)(2) from
participation in the program under this title; or
(B) at the medical direction or on the prescription
of a physician during the period when he is excluded
pursuant to section 1128, 1128A, 1156 or 1842(j)(2)
from participation in the program under this title and
when the person furnishing such item or service knew or
had reason to know of the exclusion (after a reasonable
time period after reasonable notice has been furnished
to the person).
(2) Where an individual eligible for benefits under this
title submits a claim for payment for items or services
furnished by an individual or entity excluded from
participation in the programs under this title, pursuant to
section 1128, 1128A, 1156, 1160 (as in effect on September 2,
1982), 1842(j)(2), 1862(d) (as in effect on the date of the
enactment of the Medicare and Medicaid Patient and Program
Protection Act of 1987), or l866, and such beneficiary did not
know or have reason to know that such individual or entity was
so excluded, then, to the extent permitted by this title, and
notwithstanding such exclusion, payment shall be made for such
items or services. In each such case the Secretary shall notify
the beneficiary of the exclusion of the individual or entity
furnishing the items or services. Payment shall not be made for
items or services furnished by an excluded individual or entity
to a beneficiary after a reasonable time (as determined by the
Secretary in regulations) after the Secretary has notified the
beneficiary of the exclusion of that individual or entity.
(f) The Secretary shall establish utilization guidelines for
the determination of whether or not payment may be made,
consistent with paragraph (1)(A) of subsection (a), under part
A or part B for expenses incurred with respect to the provision
of home health services, and shall provide for the
implementation of such guidelines through a process of
selective postpayment coverage review by intermediaries or
otherwise.
(g) The Secretary shall, in making the determinations under
paragraphs (1) and (9) of subsection (a), and for the purposes
of promoting the effective, efficient, and economical delivery
of health care services, and of promoting the quality of
services of the type for which payment may be made under this
title, enter into contracts with quality improvement
organizations pursuant to part B of title XI of this Act.
(h)(1) The Secretary--
(A) shall waive the application of subsection (a)(22)
in cases in which--
(i) there is no method available for the
submission of claims in an electronic form; or
(ii) the entity submitting the claim is a
small provider of services or supplier; and
(B) may waive the application of such subsection in
such unusual cases as the Secretary finds appropriate.
(2) For purposes of this subsection, the term ``small
provider of services or supplier'' means--
(A) a provider of services with fewer than 25 full-
time equivalent employees; or
(B) a physician, practitioner, facility, or supplier
(other than provider of services) with fewer than 10
full-time equivalent employees.
(i) In order to supplement the activities of the Medicare
Payment Advisory Commission under section 1886(e) in assessing
the safety, efficacy, and cost-effectiveness of new and
existing medical procedures, the Secretary may carry out, or
award grants or contracts for, original research and
experimentation of the type described in clause (ii) of section
1886(e)(6)(E) with respect to such a procedure if the Secretary
finds that--
(1) such procedure is not of sufficient commercial
value to justify research and experimentation by a
commercial organization;
(2) research and experimentation with respect to such
procedure is not of a type that may appropriately be
carried out by an institute, division, or bureau of the
National Institutes of Health; and
(3) such procedure has the potential to be more cost-
effective in the treatment of a condition than
procedures currently in use with respect to such
condition.
(j)(1) Any advisory committee appointed to advise the
Secretary on matters relating to the interpretation,
application, or implementation of subsection (a)(1) shall
assure the full participation of a nonvoting member in the
deliberations of the advisory committee, and shall provide such
nonvoting member access to all information and data made
available to voting members of the advisory committee, other
than information that--
(A) is exempt from disclosure pursuant to subsection
(a) of section 552 of title 5, United States Code, by
reason of subsection (b)(4) of such section (relating
to trade secrets); or
(B) the Secretary determines would present a conflict
of interest relating to such nonvoting member.
(2) If an advisory committee described in paragraph (1)
organizes into panels of experts according to types of items or
services considered by the advisory committee, any such panel
of experts may report any recommendation with respect to such
items or services directly to the Secretary without the prior
approval of the advisory committee or an executive committee
thereof.
(k)(1) Subject to paragraph (2), a group health plan (as
defined in subsection (a)(1)(A)(v)) providing supplemental or
secondary coverage to individuals also entitled to services
under this title shall not require a medicare claims
determination under this title for dental benefits specifically
excluded under subsection (a)(12) as a condition of making a
claims determination for such benefits under the group health
plan.
(2) A group health plan may require a claims determination
under this title in cases involving or appearing to involve
inpatient dental hospital services or dental services expressly
covered under this title pursuant to actions taken by the
Secretary.
(l) National and Local Coverage Determination Process.--
(1) Factors and evidence used in making national
coverage determinations.--The Secretary shall make
available to the public the factors considered in
making national coverage determinations of whether an
item or service is reasonable and necessary. The
Secretary shall develop guidance documents to carry out
this paragraph in a manner similar to the development
of guidance documents under section 701(h) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C.
371(h)).
(2) Timeframe for decisions on requests for national
coverage determinations.--In the case of a request for
a national coverage determination that--
(A) does not require a technology assessment
from an outside entity or deliberation from the
Medicare Coverage Advisory Committee, the
decision on the request shall be made not later
than 6 months after the date of the request; or
(B) requires such an assessment or
deliberation and in which a clinical trial is
not requested, the decision on the request
shall be made not later than 9 months after the
date of the request.
(3) Process for public comment in national coverage
determinations.--
(A) Period for proposed decision.--Not later
than the end of the 6-month period (or 9-month
period for requests described in paragraph
(2)(B)) that begins on the date a request for a
national coverage determination is made, the
Secretary shall make a draft of proposed
decision on the request available to the public
through the Internet website of the Centers for
Medicare & Medicaid Services or other
appropriate means.
(B) 30-day period for public comment.--
Beginning on the date the Secretary makes a
draft of the proposed decision available under
subparagraph (A), the Secretary shall provide a
30-day period for public comment on such draft.
(C) 60-day period for final decision.--Not
later than 60 days after the conclusion of the
30-day period referred to under subparagraph
(B), the Secretary shall--
(i) make a final decision on the
request;
(ii) include in such final decision
summaries of the public comments
received and responses to such
comments;
(iii) make available to the public
the clinical evidence and other data
used in making such a decision when the
decision differs from the
recommendations of the Medicare
Coverage Advisory Committee; and
(iv) in the case of a final decision
under clause (i) to grant the request
for the national coverage
determination, the Secretary shall
assign a temporary or permanent code
(whether existing or unclassified) and
implement the coding change.
(4) Consultation with outside experts in certain
national coverage determinations.--With respect to a
request for a national coverage determination for which
there is not a review by the Medicare Coverage Advisory
Committee, the Secretary shall consult with appropriate
outside clinical experts.
(5) Local coverage determination process.--
(A) Plan to promote consistency of coverage
determinations.--The Secretary shall develop a
plan to evaluate new local coverage
determinations to determine which
determinations should be adopted nationally and
to what extent greater consistency can be
achieved among local coverage determinations.
(B) Consultation.--The Secretary shall
require the fiscal intermediaries or carriers
providing services within the same area to
consult on all new local coverage
determinations within the area.
(C) Dissemination of information.--The
Secretary should serve as a center to
disseminate information on local coverage
determinations among fiscal intermediaries and
carriers to reduce duplication of effort.
[(D) Local coverage determinations.--The
Secretary shall require each Medicare
administrative contractor that develops a local
coverage determination to make available on the
Internet website of such contractor and on the
Medicare Internet website, at least 45 days
before the effective date of such
determination, the following information:
[(i) Such determination in its
entirety.
[(ii) Where and when the proposed
determination was first made public.
[(iii) Hyperlinks to the proposed
determination and a response to
comments submitted to the contractor
with respect to such proposed
determination.
[(iv) A summary of evidence that was
considered by the contractor during the
development of such determination and a
list of the sources of such evidence.
[(v) An explanation of the rationale
that supports such determination.]
(D) Process for issuing specified local
coverage determinations.--
(i) In general.--In the case of a
specified local coverage determination
(as defined in clause (iii)) within an
area by a fiscal intermediary or
carrier that has entered into a
contract with the Secretary under
section 1874A, such intermediary or
carrier must take the following actions
with respect to such determination
before such determination may take
effect:
(I) Publish on the public
Internet website of the
intermediary or carrier a
proposed version of the
specified local coverage
determination (in this
subparagraph referred to as a
``draft determination''), a
written rationale for the draft
determination, and a
description of all evidence
relied upon and considered by
the intermediary or carrier in
the development of the draft
determination.
(II) Not later than 60 days
after the date on which the
intermediary or carrier
publishes the draft
determination in accordance
with subclause (I), convene one
or more open, public meetings
to review the draft
determination, receive comments
with respect to the draft
determination, and secure the
advice of an expert panel (such
as a carrier advisory committee
described in chapter 13 of the
Medicare Program Integrity
Manual in effect on August 31,
2015) with respect to the draft
determination. The intermediary
or carrier shall make available
means for the public to attend
such meetings remotely, such as
via teleconference.
(III) With respect to each
meeting convened pursuant to
subclause (II), post on the
public Internet website of the
intermediary or carrier, not
later than 14 days after such
meeting is convened, a record
of the meeting minutes for such
meeting.
(IV) Provide a period for
submission of written public
comment on such draft
determination that begins on
the date on which all records
required to be posted with
respect to such draft
determination under subclause
(III) are so posted and that is
not fewer than 30 days in
duration.
(ii) Finalizing a specified local
coverage determination.--A fiscal
intermediary or carrier that has
entered into a contract with the
Secretary under section 1874A shall,
with respect to a specified local
coverage determination, post on the
public Internet website of the fiscal
intermediary or carrier the following
information before the specified local
coverage determination (in this
subparagraph referred to as the ``final
determination'') takes effect--
(I) a response to the issues
raised at meetings convened
pursuant to clause (i)(II) with
respect to the draft
determination;
(II) the rationale for the
final determination;
(III) in the case that the
intermediary or carrier
considered qualifying evidence
in the development of the
determination that was not
described in the written notice
provided pursuant to clause
(i)(I), a description of such
qualifying evidence; and
(IV) an effective date for
the final determination that is
not less than 30 days after the
date on which such
determination is so posted.
(iii) Specified local coverage
determination defined.--For purposes of
this subparagraph, the term ``specified
local coverage determination'' means,
with respect to a geographic area--
(I) a new local coverage
determination (regardless of
whether such determination made
by a fiscal intermediary or
carrier that has entered into a
contract with the Secretary
under section 1874A and is
based upon a specified local
coverage determination that
previously has been made with
respect to another geographic
area, or by another such
intermediary or carrier);
(II) a revised local coverage
determination for such
geographic area that restricts
one or more existing coverage
criteria for such area (such as
by adding non-covered
indications to an existing
local coverage determination or
by deleting previously covered
ICD-9 or ICD-10 codes);
(III) a revised local
coverage determination that
makes a substantive revision to
one or more existing local
coverage determinations; or
(IV) any other local coverage
determination specified by the
Secretary pursuant to
regulations.
(iv) Qualifying evidence defined.--
For purposes of this subparagraph, the
term ``qualifying evidence'' means
either of the following:
(I) Scientific evidence
published in peer-reviewed
medical literature, such as
randomized clinical trials or
other studies.
(II) A general consensus of
the applicable medical
community (such as a consensus
evinced through a recognized
standard of practice in such
medical community) that is
supported by information
provided by a recognized
medical authority, such as a
professional medical society.
(6) National and local coverage determination
defined.--For purposes of this subsection--
(A) National coverage determination.--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 title.
(B) Local coverage determination.--The term
``local coverage determination'' has the
meaning given that in section 1869(f)(2)(B).
(m) Coverage of Routine Costs Associated With Certain
Clinical Trials of Category A Devices.--
(1) In general.--In the case of an individual
entitled to benefits under part A, or enrolled under
part B, or both who participates in a category A
clinical trial, the Secretary shall not exclude under
subsection (a)(1) payment for coverage of routine costs
of care (as defined by the Secretary) furnished to such
individual in the trial.
(2) Category a clinical trial.--For purposes of
paragraph (1), a ``category A clinical trial'' means a
trial of a medical device if--
(A) the trial is of an experimental/
investigational (category A) medical device (as
defined in regulations under section 405.201(b)
of title 42, Code of Federal Regulations (as in
effect as of September 1, 2003));
(B) the trial meets criteria established by
the Secretary to ensure that the trial conforms
to appropriate scientific and ethical
standards; and
(C) in the case of a trial initiated before
January 1, 2010, the device involved in the
trial has been determined by the Secretary to
be intended for use in the diagnosis,
monitoring, or treatment of an immediately
life-threatening disease or condition.
(n) Requirement of a Surety Bond for Certain Providers of
Services and Suppliers.--
(1) In general.--The Secretary may require a provider
of services or supplier described in paragraph (2) to
provide the Secretary on a continuing basis with a
surety bond in a form specified by the Secretary in an
amount (not less than $50,000) that the Secretary
determines is commensurate with the volume of the
billing of the provider of services or supplier. The
Secretary may waive the requirement of a bond under the
preceding sentence in the case of a provider of
services or supplier that provides a comparable surety
bond under State law.
(2) Provider of services or supplier described.--A
provider of services or supplier described in this
paragraph is a provider of services or supplier the
Secretary determines appropriate based on the level of
risk involved with respect to the provider of services
or supplier, and consistent with the surety bond
requirements under sections 1834(a)(16)(B) and
1861(o)(7)(C).
(o) Suspension of Payments Pending Investigation of Credible
Allegations of Fraud.--
(1) In general.--The Secretary may suspend payments
to a provider of services or supplier under this title
pending an investigation of a credible allegation of
fraud against the provider of services or supplier,
unless the Secretary determines there is good cause not
to suspend such payments.
(2) Consultation.--The Secretary shall consult with
the Inspector General of the Department of Health and
Human Services in determining whether there is a
credible allegation of fraud against a provider of
services or supplier.
(3) Promulgation of regulations.--The Secretary shall
promulgate regulations to carry out this subsection and
section 1903(i)(2)(C).
* * * * * * *
determinations; appeals
Sec. 1869. (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 1154(a)(2), and an initial
determination made by an entity pursuant to a
contract (other than a contract under section
1852) with the Secretary to administer
provisions of this title or title 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 1816(c)(2) or
1842(c)(2).
(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
205(b) and, subject to paragraph (2), to
judicial review of the Secretary's final
decision after such hearing as is provided in
section 205(g). 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 205 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 206(a),
1102, and 1871 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 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.
(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 205(j) and of section 206
(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 205 and
206.
(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 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.
(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 title) 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 1862(a)(1)(A)),
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 1862(a), 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 216(j)
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 1154(e) as in effect
on the date that precedes the
date of the enactment of this
subparagraph.
(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 a detailed
explanation of the decision as well as a
discussion of the pertinent facts and
applicable regulations applied in making such
decision, and a notification of the right to
appeal such determination and instructions on
how to initiate such appeal under this section
and 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 1862(a)(1)(A)) 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 1816), carriers
(under section 1842), quality improvement
organizations (under part B of title 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 title 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 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 title 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 1804(b) 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 title or policies of the Secretary
with respect to part B of title 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 title 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, United States Code, or
section 1871(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 title,
but does not include a determination of what
code, if any, is assigned to a particular item
or service covered under this title 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 (other than the reconsideration
process described in paragraphs (8) and (9))
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 1862(a)(1)(A).
(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).
(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 title,
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 clause (i) (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 (other than under the
reconsideration process described in paragraphs (8) and
(9)) 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 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 title, 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) Carrier or fiscal intermediary reconsideration
process for specified local coverage determinations.--
Upon the filing of a request by an interested party
with respect to a specified local coverage
determination by a fiscal intermediary or carrier that
has entered into a contract with the Secretary under
section 1874A, the intermediary or carrier shall
reconsider such determination in accordance with the
following process:
(A) Not later than 30 days after such a
request is filed with the fiscal intermediary
or carrier by the interested party with respect
to such determination, the intermediary or
carrier shall--
(i) determine whether the request is
an applicable request; and
(ii) in the case that the request is
not an applicable request, inform the
interested party of the reasons why
such request is not an applicable
request.
(B) In the case that the intermediary or
carrier determines under subparagraph (A) that
the request described in such subparagraph is
an applicable request, the intermediary or
carrier shall, not later than 90 days after the
date on which the request was filed with the
intermediary or carrier, take the actions
described in subparagraphs (C), (D), and (E)
with respect to the determination.
(C) The action described in this subparagraph
is the action of specifying whether any of the
following statements is applicable to the
determination:
(i) The determination did not apply,
or inaccurately applied, qualifying
evidence relevant to such
determination.
(ii) The determination used language
that exceeded the scope of the intended
purpose of the determination.
(iii) The determination was incorrect
in its determination of whether such
item or service is reasonable and
necessary for the diagnosis or
treatment of illness or injury under
section 1862(a)(1)(A).
(iv) The determination failed to
describe, with respect to such an item
or service, the clinical conditions to
be used for purposes of determining
whether such item or service is
reasonable and necessary for the
diagnosis or treatment of illness or
injury under section 1862(a)(1)(A).
(v) The determination does not apply
with respect to items or services to
which it was intended to apply.
(vi) The determination is erroneous
for another reason that the
intermediary or carrier identifies.
(D) The action described in this
subparagraph, with respect to the
determination, is the action of taking, based
on the specification under subparagraph (C) of
whether any of the statements in such
subparagraph applied to such determination, one
or more of the following actions:
(i) Making no change in the
determination.
(ii) Rescinding a part of the
determination (including, as
applicable, the entire determination).
(iii) Modifying the determination to
restrict the coverage provided under
this title for an item or service that
is subject to the determination.
(iv) Modifying the determination to
expand the coverage provided under this
title for an item or service that is
subject to the determination.
(E) The action described in this subparagraph
is the action of making publicly available a
written description of the action taken under
subparagraph (D) with respect to the
determination.
(9) Agency evaluation of reconsideration decision.--
In the case that an interested party that filed an
applicable request under paragraph (8) with respect to
a specified local coverage determination files with the
Secretary, on a date that is not later than 120 days
after the date on which an intermediary or carrier
takes an action described under paragraph (8)(D) with
respect to such determination, an appeal with respect
to such decision in such form and manner as the
Secretary may require, the Secretary shall, not later
than 30 days after such appeal is filed--
(A) specify which, if any, of the statements
in subparagraph (C) of paragraph (8) is
applicable to the determination; and
(B) based on such specification, take one of
the actions described in subparagraph (D) of
such paragraph with respect to the
determination.
The Secretary shall apply subparagraph (A) as though
the reference to ``the intermediary or carrier'' in
clause (vi) of paragraph (8)(C) were a reference to the
Secretary.
(10) Rule of construction.--Nothing in paragraph (8)
or (9) may be construed as affecting the right of an
aggrieved party to file a complaint under paragraph
(2)(A) and receive a determination in accordance with
the provisions of such paragraph.
(11) Definitions applicable to paragraphs (8) and
(9).--For purposes of paragraphs (8) and (9):
(A) The term ``applicable request'' means a
request that is submitted in fiscal year 2019
or a subsequent fiscal year, that is solely
with respect to a specified local coverage
determination, and that includes a description
of the rationale for such request and any
evidence supporting such request. For purposes
of the preceding sentence, the Secretary may
not require, as a condition of treating a
request with respect to such a determination as
an applicable request, that the request contain
qualifying evidence that was not considered in
the development of such determination.
(B) The term ``interested party'' means, with
respect to a specified local coverage
determination within an area by a fiscal
intermediary or carrier that has entered into a
contract with the Secretary under section
1874A--
(i) a provider of services or
supplier that, in such area, furnishes,
provides, or supplies items or services
that are subject to such determination;
or
(ii) an organization that represents
such a provider of services or
supplier.
(C) The term ``qualifying evidence'' has the
meaning given such term by clause (iv) of
section 1862(l)(5)(D).
(D) The term ``specified local coverage
determination'' has the meaning given such term
by clause (iii) of such section.
(12) Report.--Not later than December 31 of each year
(beginning with 2019), the Secretary shall submit to
Congress a report containing the following:
(A) The number of requests filed with fiscal
intermediaries and carriers under paragraph
(8), and the number of appeals filed with the
Secretary under paragraph (9), during the 1-
year period ending on such date.
(B) With respect to such requests filed with
such intermediaries and carriers under
paragraph (8) during such period, the number of
times that intermediaries and carriers took,
with respect to the actions described in
subparagraphs (C) through (E) of such
paragraph, each such action.
(C) With respect to such appeals filed with
the Secretary under paragraph (9) during such
period, the number of times that the Secretary
took, with respect to the actions described in
subparagraph (D) of paragraph (8), each such
action.
(D) Recommendations on ways to improve--
(i) the efficacy and the efficiency
of the process described in paragraph
(8); and
(ii) communication with individuals
entitled to benefits under part A or
enrolled under part B, providers of
services, and suppliers regarding such
process.
[(8)] (13) 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 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.
(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 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
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.
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