H. R. 1—144
(c) EFFECTIVE DATE.—The amendments made by this subsection
shall take effect on the date of the enactment of this Act.
SEC. 233. MEDICARE MSAS.
(a) EXEMPTION FROM REPORTING REQUIREMENT.—
(1) IN
GENERAL.—Section 1852(e)(1) (42 U.S.C. 1395w–
22(e)(1)) is amended by inserting ‘‘(other than MSA plans)’’
after ‘‘plans’’.
(2) CONFORMING AMENDMENTS.—Section 1852 (42 U.S.C.
1395w–22) is amended—
(A) in subsection (c)(1)(I), by inserting before the period
at the end the following: ‘‘, if required under such section’’;
(B) in subsection (e)(2)(A), by striking ‘‘, a non-network
MSA plan,’’; and
(C) in subsection (e)(2)(B), by striking ‘‘, NON-NETWORK
MSA PLANS,’’ and ‘‘, a non-network MSA plan,’’.
(3) EFFECTIVE DATE.—The amendments made by this sub-
section shall apply on and after the date of the enactment
of this Act but shall not apply to contract years beginning
on or after January 1, 2006.
(b) MAKING PROGRAM PERMANENT
AND ELIMINATING CAP.—
Section 1851(b)(4) (42 U.S.C. 1395w–21(b)(4)) is amended—
(1) in the heading, by striking ‘‘ON
A
DEMONSTRATION
BASIS’’;
(2) by striking the first sentence of subparagraph (A); and
(3) by striking the second sentence of subparagraph (C).
(c) APPLYING
LIMITATIONS
ON
BALANCE
BILLING.—Section
1852(k)(1) (42 U.S.C. 1395w–22(k)(1)) is amended by inserting ‘‘or
with an organization offering an MSA plan’’ after ‘‘section
1851(a)(2)(A)’’.
(d) ADDITIONAL AMENDMENT.—Section 1851(e)(5)(A) (42 U.S.C.
1395w–21(e)(5)(A)) is amended—
(1) by adding ‘‘or’’ at the end of clause (i);
(2) by striking ‘‘, or’’ at the end of clause (ii) and inserting
a semicolon; and
(3) by striking clause (iii).
SEC. 234. EXTENSION OF REASONABLE COST CONTRACTS.
Subparagraph 
(C) 
of 
section 
1876(h)(5) 
(42 
U.S.C.
1395mm(h)(5)) is amended to read as follows:
‘‘(C)(i) Subject to clause (ii), a reasonable cost reimbursement
contract under this subsection may be extended or renewed indefi-
nitely.
‘‘(ii) For any period beginning on or after January 1, 2008,
a reasonable cost reimbursement contract under this subsection
may not be extended or renewed for a service area insofar as
such area during the entire previous year was within the service
area of—
‘‘(I) 2 or more MA regional plans described in clause (iii);
or
‘‘(II) 2 or more MA local plans described in clause (iii).
‘‘(iii) A plan described in this clause for a year for a service
area is a plan described in section 1851(a)(2)(A)(i) if the service
area for the year meets the following minimum enrollment require-
ments:
‘‘(I) With respect to any portion of the area involved that
is within a Metropolitan Statistical Area with a population
H. R. 1—145
of more than 250,000 and counties contiguous to such Metropoli-
tan Statistical Area, 5,000 individuals.
‘‘(II) With respect to any other portion of such area, 1,500
individuals.’’.
SEC. 235. TWO-YEAR EXTENSION OF MUNICIPAL HEALTH SERVICE
DEMONSTRATION PROJECTS.
The last sentence of section 9215(a) of the Consolidated Omni-
bus Budget Reconciliation Act of 1985 (42 U.S.C. 1395b–1 note),
as amended by section 6135 of the Omnibus Budget Reconciliation
Act of 1989, section 13557 of the Omnibus Budget Reconciliation
Act of 1993, section 4017 of BBA, section 534 of BBRA (113 Stat.
1501A–390), and section 633 of BIPA, is amended by striking
‘‘December 31, 2004’’ and inserting ‘‘December 31, 2006’’.
SEC. 236. PAYMENT BY PACE PROVIDERS FOR MEDICARE AND MED-
ICAID SERVICES FURNISHED BY NONCONTRACT PRO-
VIDERS.
(a) MEDICARE SERVICES.—
(1) MEDICARE SERVICES FURNISHED BY PROVIDERS OF SERV-
ICES.—Section 1866(a)(1)(O) (42 U.S.C. 1395cc(a)(1)(O)) is
amended—
(A) by striking ‘‘part C or’’ and inserting ‘‘part C,
with a PACE provider under section 1894 or 1934, or’’;
(B) by striking ‘‘(i)’’;
(C) by striking ‘‘and (ii)’’;
(D) by inserting ‘‘(or, in the case of a PACE provider,
contract or other agreement)’’ after ‘‘have a contract’’; and
(E) by striking ‘‘members of the organization’’ and
inserting ‘‘members of the organization or PACE program
eligible individuals enrolled with the PACE provider,’’.
(2) MEDICARE
SERVICES
FURNISHED
BY
PHYSICIANS
AND
OTHER
ENTITIES.—Section 1894(b) (42 U.S.C. 1395eee(b)) is
amended by adding at the end the following new paragraphs:
‘‘(3) TREATMENT OF MEDICARE SERVICES FURNISHED BY NON-
CONTRACT PHYSICIANS AND OTHER ENTITIES.—
‘‘(A) APPLICATION OF MEDICARE ADVANTAGE REQUIRE-
MENT WITH RESPECT TO MEDICARE SERVICES FURNISHED BY
NONCONTRACT PHYSICIANS AND OTHER ENTITIES.—Section
1852(k)(1) (relating to limitations on balance billing against
MA organizations for noncontract physicians and other
entities with respect to services covered under this title)
shall apply to PACE providers, PACE program eligible
individuals enrolled with such PACE providers, and physi-
cians and other entities that do not have a contract or
other agreement establishing payment amounts for services
furnished to such an individual in the same manner as
such section applies to MA organizations, individuals
enrolled with such organizations, and physicians and other
entities referred to in such section.
‘‘(B) REFERENCE TO RELATED PROVISION FOR NONCON-
TRACT PROVIDERS OF SERVICES.—For the provision relating
to limitations on balance billing against PACE providers
for services covered under this title furnished by noncon-
tract providers of services, see section 1866(a)(1)(O).
H. R. 1—146
‘‘(4) REFERENCE TO RELATED PROVISION FOR SERVICES COV-
ERED UNDER TITLE XIX BUT NOT UNDER THIS TITLE.—For provi-
sions relating to limitations on payments to providers partici-
pating under the State plan under title XIX that do not have
a contract or other agreement with a PACE provider estab-
lishing payment amounts for services covered under such plan
(but not under this title) when such services are furnished
to enrollees of that PACE provider, see section 1902(a)(66).’’.
(b) MEDICAID SERVICES.—
(1) REQUIREMENT UNDER STATE PLAN.—Section 1902(a) (42
U.S.C. 1396a(a)), as amended by section 103(a), is amended—
(A) in paragraph (65), by striking ‘‘and’’ at the end;
(B) in paragraph (66), by striking the period at the
end and inserting ‘‘; and’’; and
(C) by inserting after paragraph (66) the following
new paragraph:
‘‘(67) provide, with respect to services covered under the
State plan (but not under title XVIII) that are furnished to
a PACE program eligible individual enrolled with a PACE
provider by a provider participating under the State plan that
does not have a contract or other agreement with the PACE
provider that establishes payment amounts for such services,
that such participating provider may not require the PACE
provider to pay the participating provider an amount greater
than the amount that would otherwise be payable for the
service to the participating provider under the State plan for
the State where the PACE provider is located (in accordance
with regulations issued by the Secretary).’’.
(2) APPLICATION
UNDER
MEDICAID.—Section 1934(b) (42
U.S.C. 1396u–4(b)) is amended by adding at the end the fol-
lowing new paragraphs:
‘‘(3) TREATMENT OF MEDICARE SERVICES FURNISHED BY NON-
CONTRACT PHYSICIANS AND OTHER ENTITIES.—
‘‘(A) APPLICATION OF MEDICARE ADVANTAGE REQUIRE-
MENT WITH RESPECT TO MEDICARE SERVICES FURNISHED BY
NONCONTRACT PHYSICIANS AND OTHER ENTITIES.—Section
1852(k)(1) (relating to limitations on balance billing against
MA organizations for noncontract physicians and other
entities with respect to services covered under title XVIII)
shall apply to PACE providers, PACE program eligible
individuals enrolled with such PACE providers, and physi-
cians and other entities that do not have a contract or
other agreement establishing payment amounts for services
furnished to such an individual in the same manner as
such section applies to MA organizations, individuals
enrolled with such organizations, and physicians and other
entities referred to in such section.
‘‘(B) REFERENCE TO RELATED PROVISION FOR NONCON-
TRACT PROVIDERS OF SERVICES.—For the provision relating
to limitations on balance billing against PACE providers
for services covered under title XVIII furnished by noncon-
tract providers of services, see section 1866(a)(1)(O).
‘‘(4) REFERENCE TO RELATED PROVISION FOR SERVICES COV-
ERED UNDER THIS TITLE BUT NOT UNDER TITLE XVIII.—For provi-
sions relating to limitations on payments to providers partici-
pating under the State plan under this title that do not have
H. R. 1—147
a contract or other agreement with a PACE provider estab-
lishing payment amounts for services covered under such plan
(but not under title XVIII) when such services are furnished
to enrollees of that PACE provider, see section 1902(a)(67).’’.
(c) EFFECTIVE DATE.—The amendments made by this section
shall apply to services furnished on or after January 1, 2004.
SEC. 237. REIMBURSEMENT FOR FEDERALLY QUALIFIED HEALTH CEN-
TERS PROVIDING SERVICES UNDER MA PLANS.
(a) REIMBURSEMENT.—Section 1833(a)(3) (42 U.S.C. 1395l(a)(3))
is amended to read as follows:
‘‘(3) 
in 
the 
case 
of 
services 
described 
in 
section
1832(a)(2)(D)—
‘‘(A) except as provided in subparagraph (B), the costs
which are reasonable and related to the cost of furnishing
such services or which are based on such other tests of
reasonableness as the Secretary may prescribe in regula-
tions, 
including 
those 
authorized 
under 
section
1861(v)(1)(A), less the amount a provider may charge as
described in clause (ii) of section 1866(a)(2)(A), but in no
case may the payment for such services (other than for
items and services described in section 1861(s)(10)(A))
exceed 80 percent of such costs; or
‘‘(B) with respect to the services described in clause
(ii) of section 1832(a)(2)(D) that are furnished to an indi-
vidual enrolled with a MA plan under part C pursuant
to a written agreement described in section 1853(a)(4),
the amount (if any) by which—
‘‘(i) the amount of payment that would have other-
wise been provided under subparagraph (A) (calculated
as if ‘100 percent’ were substituted for ‘80 percent’
in such subparagraph) for such services if the indi-
vidual had not been so enrolled; exceeds
‘‘(ii) the amount of the payments received under
such written agreement for such services (not including
any financial incentives provided for in such agreement
such as risk pool payments, bonuses, or withholds),
less the amount the federally qualified health center may
charge as described in section 1857(e)(3)(B);’’.
(b) CONTINUATION OF MONTHLY PAYMENTS.—
(1) IN GENERAL.—Section 1853(a) (42 U.S.C. 1395w–23(a))
is amended by adding at the end the following new paragraph:
‘‘(4) PAYMENT
RULE
FOR
FEDERALLY
QUALIFIED
HEALTH
CENTER SERVICES.—If an individual who is enrolled with an
MA plan under this part receives a service from a federally
qualified health center that has a written agreement with the
MA organization that offers such plan for providing such a
service (including any agreement required under section
1857(e)(3))—
‘‘(A) the Secretary shall pay the amount determined
under section 1833(a)(3)(B) directly to the federally quali-
fied health center not less frequently than quarterly; and
‘‘(B) the Secretary shall not reduce the amount of the
monthly payments under this subsection as a result of
the application of subparagraph (A).’’.
(2) CONFORMING AMENDMENTS.—
H. R. 1—148
(A) 
Section 
1851(i) 
(42 
U.S.C. 
1395w–21(i)) 
is
amended—
(i) in paragraph (1), by inserting ‘‘1853(a)(4),’’ after
‘‘Subject to sections 1852(a)(5),’’; and
(ii) in paragraph (2), by inserting ‘‘1853(a)(4),’’ after
‘‘Subject to sections’’.
(B) Section 1853(c)(5) is amended by striking ‘‘sub-
sections (a)(3)(C)(iii) and (i)’’ and inserting ‘‘subsections
(a)(3)(C)(iii), (a)(4), and (i)’’.
(c) ADDITIONAL CONTRACT REQUIREMENTS.—Section 1857(e) (42
U.S.C. 1395w–27(e)) is amended by adding at the end the following
new paragraph:
‘‘(3) AGREEMENTS WITH FEDERALLY QUALIFIED HEALTH CEN-
TERS.—
‘‘(A) PAYMENT LEVELS AND AMOUNTS.—A contract under
this section with an MA organization shall require the
organization to provide, in any written agreement described
in section 1853(a)(4) between the organization and a feder-
ally qualified health center, for a level and amount of
payment to the federally qualified health center for services
provided by such health center that is not less than the
level and amount of payment that the plan would make
for such services if the services had been furnished by
a entity providing similar services that was not a federally
qualified health center.
‘‘(B) COST-SHARING.—Under the written agreement
referred to in subparagraph (A), a federally qualified health
center must accept the payment amount referred to in
such subparagraph plus the Federal payment provided for
in section 1833(a)(3)(B) as payment in full for services
covered by the agreement, except that such a health center
may collect any amount of cost-sharing permitted under
the contract under this section, so long as the amounts
of any deductible, coinsurance, or copayment comply with
the requirements under section 1854(e).’’.
(d) SAFE HARBOR.—Section 1128B(b)(3) (42 U.S.C. 1320a–
7b(b)(3)), as amended by section 101(f)(2), is amended—
(1) in subparagraph (F), by striking ‘‘and’’ after the semi-
colon at the end;
(2) in subparagraph (G), by striking the period at the
end and inserting ‘‘; and’’; and
(3) by adding at the end the following new subparagraph:
‘‘(H) any remuneration between a federally qualified
health center (or an entity controlled by such a health
center) and an MA organization pursuant to a written
agreement described in section 1853(a)(4).’’.
(e) EFFECTIVE DATE.—The amendments made by this section
shall apply to services provided on or after January 1, 2006, and
contract years beginning on or after such date.
SEC. 238. INSTITUTE OF MEDICINE EVALUATION AND REPORT ON
HEALTH CARE PERFORMANCE MEASURES.
(a) EVALUATION.—
(1) IN GENERAL.—Not later than the date that is 2 months
after the date of the enactment of this Act, the Secretary
shall enter into an arrangement under which the Institute
of Medicine of the National Academy of Sciences (in this section
H. R. 1—149
referred to as the ‘‘Institute’’) shall conduct an evaluation of
leading health care performance measures in the public and
private sectors and options to implement policies that align
performance with payment under the medicare program under
title XVIII of the Social Security Act (42 U.S.C. 1395 et seq.).
(2) SPECIFIC
MATTERS
EVALUATED.—In conducting the
evaluation under paragraph (1), the Institute shall—
(A) catalogue, review, and evaluate the validity of
leading health care performance measures;
(B) catalogue and evaluate the success and utility of
alternative performance incentive programs in public or
private sector settings; and
(C) identify and prioritize options to implement policies
that align performance with payment under the medicare
program that indicate—
(i) the performance measurement set to be used
and how that measurement set will be updated;
(ii) the payment policy that will reward perform-
ance; and
(iii) the key implementation issues (such as data
and information technology requirements) that must
be addressed.
(3) SCOPE OF HEALTH CARE PERFORMANCE MEASURES.—The
health care performance measures described in paragraph
(2)(A) shall encompass a variety of perspectives, including
physicians, hospitals, other health care providers, health plans,
purchasers, and patients.
(4) CONSULTATION WITH MEDPAC.—In evaluating the mat-
ters described in paragraph (2)(C), the Institute shall consult
with the Medicare Payment Advisory Commission established
under section 1805 of the Social Security Act (42 U.S.C. 1395b–
6).
(b) REPORT.—Not later than the date that is 18 months after
the date of enactment of this Act, the Institute shall submit to
the Secretary and appropriate committees of jurisdiction of the
Senate and House of Representatives a report on the evaluation
conducted under subsection (a)(1) describing the findings of such
evaluation and recommendations for an overall strategy and
approach for aligning payment with performance, including options
for updating performance measures, in the original medicare fee-
for-service program under parts A and B of title XVIII of the
Social Security Act, the Medicare Advantage program under part
C of such title, and any other programs under such title XVIII.
(c) AUTHORIZATION OF APPROPRIATIONS.—There are authorized
to be appropriated such sums as may be necessary for purposes
of conducting the evaluation and preparing the report required
by this section.
Subtitle E—Comparative Cost Adjustment
(CCA) Program
SEC. 241. COMPARATIVE COST ADJUSTMENT (CCA) PROGRAM.
(a) IN GENERAL.—Part C of title XVIII is amended by adding
at the end the following new section:
H. R. 1—150
‘‘COMPARATIVE COST ADJUSTMENT (CCA) PROGRAM
‘‘SEC. 1860C–1. (a) ESTABLISHMENT OF PROGRAM.—
‘‘(1) IN GENERAL.—The Secretary shall establish a program
under this section (in this section referred to as the ‘CCA
program’) for the application of comparative cost adjustment
in CCA areas selected under this section.
‘‘(2) DURATION.—The CCA program shall begin January
1, 2010, and shall extend over a period of 6 years, and end
on December 31, 2015.
‘‘(3) REPORT.—Upon the completion of the CCA program,
the Secretary shall submit a report to Congress. Such report
shall include the following, with respect to both this part and
the original medicare fee-for-service program:
‘‘(A) An evaluation of the financial impact of the CCA
program.
‘‘(B) An evaluation of changes in access to physicians
and other health care providers.
‘‘(C) Beneficiary satisfaction.
‘‘(D) Recommendations regarding any extension or
expansion of the CCA program.
‘‘(b) REQUIREMENTS FOR SELECTION OF CCA AREAS.—
‘‘(1) CCA AREA DEFINED.—
‘‘(A) IN GENERAL.—For purposes of this section, the
term ‘CCA area’ means an MSA that meets the require-
ments of paragraph (2) and is selected by the Secretary
under subsection (c).
‘‘(B) MSA DEFINED.—For purposes of this section, the
term ‘MSA’ means a Metropolitan Statistical Area (or such
similar area as the Secretary recognizes).
‘‘(2) REQUIREMENTS FOR CCA AREAS.—The requirements of
this paragraph for an MSA to be a CCA area are as follows:
‘‘(A) MA ENROLLMENT
REQUIREMENT.—For the ref-
erence month (as defined under section 1858(f)(4)(B)) with
respect to 2010, at least 25 percent of the total number
of MA eligible individuals who reside in the MSA were
enrolled in an MA local plan described in section
1851(a)(2)(A)(i).
‘‘(B) 2 PLAN REQUIREMENT.—There will be offered in
the MSA during the annual, coordinated election period
under section 1851(e)(3)(B) before the beginning of 2010
at 
least 
MA 
local 
plans 
described 
in 
section
1851(a)(2)(A)(i) (in addition to the fee-for-service program
under parts A and B), each offered by a different MA
organization and each of which met the minimum enroll-
ment requirements of paragraph (1) of section 1857(b) (as
applied without regard to paragraph (3) thereof) as of the
reference month.
‘‘(c) SELECTION OF CCA AREAS.—
‘‘(1) GENERAL
SELECTION
CRITERIA.—The Secretary shall
select CCA areas from among those MSAs qualifying under
subsection (b) in a manner that—
‘‘(A) seeks to maximize the opportunity to test the
application of comparative cost adjustment under this title;
‘‘(B) does not seek to maximize the number of MA
eligible individuals who reside in such areas; and
H. R. 1—151
‘‘(C) provides for geographic diversity consistent with
the criteria specified in paragraph (2).
‘‘(2) SELECTION CRITERIA.—With respect to the selection
of MSAs that qualify to be CCA areas under subsection (b),
the following rules apply, to the maximum extent feasible:
‘‘(A) MAXIMUM NUMBER.—The number of such MSAs
selected may not exceed the lesser of (i) 6, or (ii) 25 percent
of the number of MSAs that meet the requirement of sub-
section (b)(2)(A).
‘‘(B) ONE
OF
LARGEST
AREAS
BY
POPULATION.—At
least one such qualifying MSA shall be selected from among
the 4 such qualifying MSAs with the largest total popu-
lation of MA eligible individuals.
‘‘(C) ONE OF 4 AREAS WITH LOWEST POPULATION DEN-
SITY.—At least one such qualifying MSA shall be selected
from among the 4 such qualifying MSAs with the lowest
population density (as measured by residents per square
mile or similar measure of density).
‘‘(D) MULTISTATE AREA.—At least one such qualifying
MSA shall be selected that includes a multi-State area.
Such an MSA may be an MSA described in subparagraph
(B) or (C).
‘‘(E) LIMITATION WITHIN SAME GEOGRAPHIC REGION.—
No more than 2 such MSAs shall be selected that are,
in whole or in part, within the same geographic region
(as specified by the Secretary) of the United States.
‘‘(F) PRIORITY
TO
AREAS
NOT
WITHIN
CERTAIN
DEM-
ONSTRATION PROJECTS.—Priority shall be provided for those
qualifying MSAs that do not have a demonstration project
in effect as of the date of the enactment of this section
for medicare preferred provider organization plans under
this part.
‘‘(d) APPLICATION OF COMPARATIVE COST ADJUSTMENT.—
‘‘(1) IN GENERAL.—In the case of a CCA area for a year—
‘‘(A) for purposes of applying this part with respect
to payment for MA local plans, any reference to an MA
area-specific non-drug monthly benchmark amount shall
be treated as a reference to such benchmark computed
as if the CCA area-specific non-drug monthly benchmark
amount (as defined in subsection (e)(1)) were substituted
for the amount described in section 1853(j)(1)(A) for the
CCA area and year involved, as phased in under paragraph
(3); and
‘‘(B) with respect to months in the year for individuals
residing in the CCA area who are not enrolled in an MA
plan, the amount of the monthly premium under section
1839 is subject to adjustment under subsection (f).
‘‘(2) EXCLUSION
OF
MA
LOCAL
AREAS
WITH
FEWER
THAN
2 ORGANIZATIONS OFFERING MA PLANS.—
‘‘(A) IN GENERAL.—In no case shall an MA local area
that is within an MSA be included as part of a CCA
area unless for 2010 (and, except as provided in subpara-
graph (B), for a subsequent year) there is offered in each
part of such MA local area at least 2 MA local plans
described in section 1851(a)(2)(A)(i) each of which is offered
by a different MA organization.
H. R. 1—152
‘‘(B) CONTINUATION.—If an MA local area meets the
requirement of subparagraph (A) and is included in a CCA
area for 2010, such local area shall continue to be included
in such CCA area for a subsequent year notwithstanding
that it no longer meets such requirement so long as there
is at least one MA local plan described in section
1851(a)(2)(A)(i) that is offered in such local area.
‘‘(3) PHASE-IN OF CCA BENCHMARK.—
‘‘(A) IN GENERAL.—In applying this section for a year
before 2013, paragraph (1)(A) shall be applied as if the
phase-in fraction under subparagraph (B) of the CCA non-
drug monthly benchmark amount for the year were sub-
stituted for such fraction of the MA area-specific non-drug
monthly benchmark amount.
‘‘(B) PHASE-IN FRACTION.—The phase-in fraction under
this subparagraph is—
‘‘(i) for 2010 1⁄4; and
‘‘(ii) for a subsequent year is the phase-in fraction
under this subparagraph for the previous year
increased by 1⁄4, but in no case more than 1.
‘‘(e) COMPUTATION OF CCA BENCHMARK AMOUNT.—
‘‘(1) CCA NON-DRUG MONTHLY BENCHMARK AMOUNT.—For
purposes of this section, the term ‘CCA non-drug monthly
benchmark amount’ means, with respect to a CCA area for
a month in a year, the sum of the 2 components described
in paragraph (2) for the area and year. The Secretary shall
compute such benchmark amount for each such CCA area
before the beginning of each annual, coordinated election period
under section 1851(e)(3)(B) for each year (beginning with 2010)
in which the CCA area is so selected.
‘‘(2) 2 COMPONENTS.—For purposes of paragraph (1), the
2 components described in this paragraph for a CCA area
and a year are the following:
‘‘(A) MA LOCAL COMPONENT.—The product of the fol-
lowing:
‘‘(i) WEIGHTED AVERAGE OF MEDICARE ADVANTAGE
PLAN BIDS IN AREA.—The weighted average of the plan
bids for the area and year (as determined under para-
graph (3)(A)).
‘‘(ii) NON-FFS MARKET SHARE.—One minus the fee-
for-service market share percentage, determined under
paragraph (4) for the area and year.
‘‘(B) FEE-FOR-SERVICE COMPONENT.—The product of the
following:
‘‘(i) FEE-FOR-SERVICE
AREA-SPECIFIC
NON-DRUG
AMOUNT.—The fee-for-service area-specific non-drug
amount (as defined in paragraph (5)) for the area and
year.
‘‘(ii) FEE-FOR-SERVICE MARKET SHARE.—The fee-for-
service market share percentage, determined under
paragraph (4) for the area and year.
‘‘(3) DETERMINATION OF WEIGHTED AVERAGE MA BIDS FOR
A CCA AREA.—
‘‘(A) IN GENERAL.—For purposes of paragraph (2)(A)(i),
the weighted average of plan bids for a CCA area and
a year is, subject to subparagraph (D), the sum of the
H. R. 1—153
following products for MA local plans described in subpara-
graph (C) in the area and year:
‘‘(i) MONTHLY
MEDICARE
ADVANTAGE
STATUTORY
NON-DRUG BID AMOUNT.—The accepted unadjusted MA
statutory non-drug monthly bid amount.
‘‘(ii) PLAN’S
SHARE
OF
MEDICARE
ADVANTAGE
ENROLLMENT
IN
AREA.—The number of individuals
described in subparagraph (B), divided by the total
number of such individuals for all MA plans described
in subparagraph (C) for that area and year.
‘‘(B) COUNTING OF INDIVIDUALS.—The Secretary shall
count, for each MA local plan described in subparagraph
(C) for an area and year, the number of individuals who
reside in the area and who were enrolled under such plan
under this part during the reference month for that year.
‘‘(C) EXCLUSION OF PLANS NOT OFFERED IN PREVIOUS
YEAR.—For an area and year, the MA local plans described
in this subparagraph are MA local plans described in sec-
tion 1851(a)(2)(A)(i) that are offered in the area and year
and were offered in the CCA area in the reference month.
‘‘(D) COMPUTATION
OF
WEIGHTED
AVERAGE
OF
PLAN
BIDS.—In calculating the weighted average of plan bids
for a CCA area under subparagraph (A)—
‘‘(i) in the case of an MA local plan that has
a service area only part of which is within such CCA
area, the MA organization offering such plan shall
submit a separate bid for such plan for the portion
within such CCA area; and
‘‘(ii) the Secretary shall adjust such separate bid
(or, in the case of an MA local plan that has a service
area entirely within such CCA area, the plan bid)
as may be necessary to take into account differences
between the service area of such plan within the CCA
area and the entire CCA area and the distribution
of plan enrollees of all MA local plans offered within
the CCA area.
‘‘(4) COMPUTATION
OF
FEE-FOR-SERVICE
MARKET
SHARE
PERCENTAGE.—The Secretary shall determine, for a year and
a CCA area, the proportion (in this subsection referred to
as the ‘fee-for-service market share percentage’) equal to—
‘‘(A) the total number of MA eligible individuals
residing in such area who during the reference month
for the year were not enrolled in any MA plan; divided
by
‘‘(B) the sum of such number and the total number
of MA eligible individuals residing in such area who during
such reference month were enrolled in an MA local plan
described in section 1851(a)(2)(A)(i),
or, if greater, such proportion determined for individuals nation-
ally.
‘‘(5) FEE-FOR-SERVICE AREA-SPECIFIC NON-DRUG AMOUNT.—
‘‘(A) IN GENERAL.—For purposes of paragraph (2)(B)(i)
and subsection (f)(2)(A), subject to subparagraph (C), the
term ‘fee-for-service area-specific non-drug amount’ means,
for a CCA area and a year, the adjusted average per
capita cost for such area and year involved, determined
under section 1876(a)(4) and adjusted as appropriate for
H. R. 1—154
the purpose of risk adjustment for benefits under the
original medicare fee-for-service program option for individ-
uals entitled to benefits under part A and enrolled under
part B who are not enrolled in an MA plan for the year,
but adjusted to exclude costs attributable to payments
under section 1886(h).
‘‘(B) USE OF FULL RISK ADJUSTMENT TO STANDARDIZE
FEE-FOR-SERVICE COSTS TO TYPICAL BENEFICIARY.—In deter-
mining the adjusted average per capita cost for an area
and year under subparagraph (A), such costs shall be
adjusted to fully take into account the demographic and
health status risk factors established under section
1853(a)(1)(A)(iv) so that such per capita costs reflect the
average costs for a typical beneficiary residing in the CCA
area.
‘‘(C) INCLUSION OF COSTS OF VA AND DOD MILITARY
FACILITY SERVICES TO MEDICARE-ELIGIBLE BENEFICIARIES.—
In determining the adjusted average per capita cost under
subparagraph (A) for a year, such cost shall be adjusted
to include the Secretary’s estimate, on a per capita basis,
of the amount of additional payments that would have
been made in the area involved under this title if individ-
uals entitled to benefits under this title had not received
services from facilities of the Department of Veterans
Affairs or the Department of Defense.
‘‘(f) PREMIUM ADJUSTMENT.—
‘‘(1) APPLICATION.—
‘‘(A) IN GENERAL.—Except as provided in subparagraph
(B), in the case of an individual who is enrolled under
part B, who resides in a CCA area, and who is not enrolled
in an MA plan under this part, the monthly premium
otherwise applied under part B (determined without regard
to subsections (b), (f), and (i) of section 1839 or any adjust-
ment under this subsection) shall be adjusted in accordance
with paragraph (2), but only in the case of premiums
for months during the period in which the CCA program
under this section for such area is in effect.
‘‘(B) NO PREMIUM ADJUSTMENT FOR SUBSIDY ELIGIBLE
BENEFICIARIES.—No premium adjustment shall be made
under this subsection for a premium for a month if the
individual is determined to be a subsidy eligible individual
(as defined in section 1860D–14(a)(3)(A)) for the month.
‘‘(2) AMOUNT OF ADJUSTMENT.—
‘‘(A) IN GENERAL.—Under this paragraph, subject to
the exemption under paragraph (1)(B) and the limitation
under subparagraph (B), if the fee-for-service area-specific
non-drug amount (as defined in section (e)(5)) for a CCA
area in which an individual resides for a month—
‘‘(i) does not exceed the CCA non-drug monthly
benchmark amount (as determined under subsection
(e)(1)) for such area and month, the amount of the
premium for the individual for the month shall be
reduced, by an amount equal to 75 percent of the
amount by which such CCA benchmark exceeds such
fee-for-service area-specific non-drug amount; or
H. R. 1—155
‘‘(ii) exceeds such CCA non-drug benchmark, the
amount of the premium for the individual for the
month shall be adjusted to ensure, that—
‘‘(I) the sum of the amount of the adjusted
premium and the CCA non-drug benchmark for
the area; is equal to
‘‘(II) the sum of the unadjusted premium plus
the amount of such fee-for-service area-specific
non-drug amount for the area.
‘‘(B) LIMITATION.—In no case shall the actual amount
of an adjustment under subparagraph (A) for an area and
month in a year result in an adjustment that exceeds
the maximum adjustment permitted under subparagraph
(C) for the area and year, or, if less, the maximum annual
adjustment permitted under subparagraph (D) for the area
and year.
‘‘(C) PHASE-IN
OF
ADJUSTMENT.—The amount of an
adjustment under subparagraph (A) for a CCA area and
year may not exceed the product of the phase-in fraction
for the year under subsection (d)(3)(B) multiplied by the
amount of the adjustment otherwise computed under
subparagraph (A) for the area and year, determined with-
out regard to this subparagraph and subparagraph (D).
‘‘(D) 5-PERCENT
LIMITATION
ON
ADJUSTMENT.—The
amount of the adjustment under this subsection for months
in a year shall not exceed 5 percent of the amount of
the monthly premium amount determined for months in
the year under section 1839 without regard to subsections
(b), (f), and (i) of such section and this subsection.’’.
(b) CONFORMING AMENDMENTS.—
(1) MA LOCAL PLANS.—
(A) Section 1853(j)(1)(A) (42 U.S.C. 1395w–23(j)(1)(A)),
as added by section 222(d), is amended by inserting ‘‘subject
to section 1860C–1(d)(2)(A),’’ after ‘‘within an MA local
area,’’.
(B) Section 1853(b)(1)(B), as amended by section
222(f)(1), is amended by adding at the end the following
new clause:
‘‘(iii) BENCHMARK ANNOUNCEMENT FOR CCA LOCAL
AREAS.—The Secretary shall determine, and shall
announce (in a manner intended to provide notice to
interested parties), on a timely basis before the cal-
endar year concerned, with respect to each CCA area
(as defined in section 1860C–1(b)(1)(A)), the CCA non-
drug monthly benchmark amount under section
1860C–1(e)(1) for that area for the year involved.’’.
(2) PREMIUM ADJUSTMENT.—
(A) Section 1839 (42 U.S.C. 1395r) is amended by
adding at the end the following new subsection:
‘‘(h) POTENTIAL APPLICATION OF COMPARATIVE COST ADJUST-
MENT IN CCA AREAS.—
‘‘(1) IN
GENERAL.—Certain individuals who are residing
in a CCA area under section 1860C–1 who are not enrolled
in an MA plan under part C may be subject to a premium
adjustment under subsection (f) of such section for months
in which the CCA program under such section is in effect
in such area.
H. R. 1—156
‘‘(2) NO EFFECT ON LATE ENROLLMENT PENALTY OR INCOME-
RELATED ADJUSTMENT IN SUBSIDIES.—Nothing in this subsection
or section 1860C–1(f) shall be construed as affecting the amount
of any premium adjustment under subsection (b) or (i). Sub-
section (f) shall be applied without regard to any premium
adjustment referred to in paragraph (1).
‘‘(3) IMPLEMENTATION.—In order to carry out a premium
adjustment under this subsection and section 1860C–1(f)
(insofar as it is effected through the manner of collection of
premiums under section 1840(a)), the Secretary shall transmit
to the Commissioner of Social Security—
‘‘(A) at the beginning of each year, the name, social
security account number, and the amount of the premium
adjustment (if any) for each individual enrolled under this
part for each month during the year; and
‘‘(B) periodically throughout the year, information to
update the information previously transmitted under this
paragraph for the year.’’.
(B) Section 1844(c) (42 U.S.C. 1395w(c)) is amended
by inserting ‘‘and without regard to any premium adjust-
ment effected under sections 1839(h) and 1860C–1(f)’’
before the period at the end.
(c) NO CHANGE IN MEDICARE’S DEFINED BENEFIT PACKAGE.—
Nothing in this part (or the amendments made by this part) shall
be construed as changing the entitlement to defined benefits under
parts A and B of title XVIII of the Social Security Act.
TITLE III—COMBATTING WASTE,
FRAUD, AND ABUSE
SEC. 301. MEDICARE SECONDARY PAYOR (MSP) PROVISIONS.
(a) 
TECHNICAL
AMENDMENT
CONCERNING
SECRETARY’S
AUTHORITY TO MAKE CONDITIONAL PAYMENT WHEN CERTAIN PRI-
MARY PLANS DO NOT PAY PROMPTLY.—Section 1862(b)(2) (42 U.S.C.
1395y(b)(2)) is amended—
(1) in subparagraph (A)(ii), by striking ‘‘promptly (as deter-
mined in accordance with regulations)’’; and
(2) in subparagraph (B)—
(A) by redesignating clauses (i) through (v) as clauses
(ii) through (vi), respectively; and
(B) by inserting before clause (ii), as so redesignated,
the following new clause:
‘‘(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 reimburse-
ment to the appropriate Trust Fund in accordance
with the succeeding provisions of this subsection.’’.
(b) CLARIFYING AMENDMENTS TO CONDITIONAL PAYMENT PROVI-
SIONS.—Section 1862(b)(2) (42 U.S.C. 1395y(b)(2)), as amended by
subsection (a), is amended—
H. R. 1—157
(1) in subparagraph (A), in the matter following clause
(ii), by inserting the following sentence at the end: ‘‘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.’’;
(2) in subparagraph (B)(ii), as redesignated by subsection
(a)(2)(A)—
(A) by striking the first sentence and inserting the
following: ‘‘A primary plan, and an entity that receives
payment from a primary plan, shall reimburse the appro-
priate 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 condi-
tioned 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.’’; and
(B) in the final sentence, by striking ‘‘on the date
such notice or other information is received’’ and inserting
‘‘on the date notice of, or information related to, a primary
plan’s responsibility for such payment or other information
is received’’; and
(3) in subparagraph (B)(iii), as redesignated by subsection
(a)(2)(A), by striking the first sentence and inserting the fol-
lowing: ‘‘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 respon-
sible (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.’’.
(c) CLERICAL
AMENDMENTS.—Section 1862(b) (42 U.S.C.
1395y(b)) is amended—
(1) in paragraph (1)(A), by moving the indentation of
clauses (ii) through (v) 2 ems to the left; and
(2) in paragraph (3)(A), by striking ‘‘such’’ before ‘‘para-
graphs’’.
(d) EFFECTIVE DATES.—The amendments made by this section
shall be effective—
(1) in the case of subsection (a), as if included in the
enactment of title III of the Medicare and Medicaid Budget
Reconciliation Amendments of 1984 (Public Law 98–369); and
(2) in the case of subsections (b) and (c), as if included
in the enactment of section 953 of the Omnibus Reconciliation
Act of 1980 (Public Law 96–499; 94 Stat. 2647).
H. R. 1—158
SEC. 302. PAYMENT FOR DURABLE MEDICAL EQUIPMENT; COMPETI-
TIVE ACQUISITION OF CERTAIN ITEMS AND SERVICES.
(a) QUALITY ENHANCEMENT AND FRAUD REDUCTION.—
(1) ESTABLISHMENT OF QUALITY STANDARDS AND ACCREDITA-
TION REQUIREMENTS FOR DURABLE MEDICAL EQUIPMENT SUP-
PLIERS.—Section 1834(a) (42 U.S.C. 1395m(a)) is amended—
(A) by transferring paragraph (17), as added by section
4551(c)(1) of the Balanced Budget Act of 1997 (111 Stat.
458), to the end of such section and redesignating such
paragraph as paragraph (19); and
(B) by adding at the end the following new paragraph:
‘‘(20) IDENTIFICATION OF QUALITY STANDARDS.—
‘‘(A) IN GENERAL.—Subject to subparagraph (C), the
Secretary shall establish and implement quality standards
for suppliers of items and services described in subpara-
graph (D) to be applied by recognized independent accredi-
tation organizations (as designated under subparagraph
(B)) and with which such suppliers shall be required to
comply in order to—
‘‘(i) furnish any such item or service for which
payment is made under this part; and
‘‘(ii) receive or retain a provider or supplier number
used to submit claims for reimbursement for any such
item or service for which payment may be made under
this title.
‘‘(B) DESIGNATION
OF
INDEPENDENT
ACCREDITATION
ORGANIZATIONS.—Not later than the date that is 1 year
after the date on which the Secretary implements the
quality standards under subparagraph (A), notwith-
standing section 1865(b), the Secretary shall designate and
approve one or more independent accreditation organiza-
tions for purposes of such subparagraph.
‘‘(C) QUALITY
STANDARDS.—The quality standards
described in subparagraph (A) may not be less stringent
than the quality standards that would otherwise apply
if this paragraph did not apply and shall include consumer
services standards.
‘‘(D) ITEMS AND SERVICES DESCRIBED.—The items and
services described in this subparagraph are the following
items and services, as the Secretary determines appro-
priate:
‘‘(i) Covered items (as defined in paragraph (13))
for which payment may otherwise be made under this
subsection.
‘‘(ii) Prosthetic devices and orthotics and pros-
thetics described in section 1834(h)(4).
‘‘(iii) Items and services described in section
1842(s)(2).
‘‘(E) IMPLEMENTATION.—The Secretary may establish
by program instruction or otherwise the quality standards
under this paragraph, after consultation with representa-
tives of relevant parties. Such standards shall be applied
prospectively and shall be published on the Internet
website of the Centers for Medicare & Medicaid Services.’’.
H. R. 1—159
(2) ESTABLISHMENT OF CLINICAL CONDITIONS OF COVERAGE
STANDARDS FOR ITEMS OF DURABLE MEDICAL EQUIPMENT.—Sec-
tion 1834(a)(1) (42 U.S.C. 1395m(a)(1)) is amended by adding
at the end the following new subparagraph:
‘‘(E) CLINICAL CONDITIONS FOR COVERAGE.—
‘‘(i) IN
GENERAL.—The Secretary shall establish
standards for clinical conditions for payment for cov-
ered items under this subsection.
‘‘(ii) REQUIREMENTS.—The standards established
under clause (i) shall include the specification of types
or classes of covered items that require, as a condition
of payment under this subsection, a face-to-face exam-
ination of the individual by a physician (as defined
in section 1861(r)(1)), a physician assistant, nurse
practitioner, or a clinical nurse specialist (as those
terms are defined in section 1861(aa)(5)) and a
prescription for the item.
‘‘(iii) PRIORITY OF ESTABLISHMENT OF STANDARDS.—
In establishing the standards under this subparagraph,
the Secretary shall first establish standards for those
covered items for which the Secretary determines there
has been a proliferation of use, consistent findings
of charges for covered items that are not delivered,
or consistent findings of falsification of documentation
to provide for payment of such covered items under
this part.
‘‘(iv) STANDARDS FOR POWER WHEELCHAIRS.—Effec-
tive on the date of the enactment of this subparagraph,
in the case of a covered item consisting of a motorized
or power wheelchair for an individual, payment may
not be made for such covered item unless a physician
(as defined in section 1861(r)(1)), a physician assistant,
nurse practitioner, or a clinical nurse specialist (as
those terms are defined in section 1861(aa)(5)) has
conducted a face-to-face examination of the individual
and written a prescription for the item.
‘‘(v) 
LIMITATION
ON
PAYMENT
FOR
COVERED
ITEMS.—Payment may not be made for a covered item
under this subsection unless the item meets any stand-
ards established under this subparagraph for clinical
condition of coverage.’’.
(b) COMPETITIVE ACQUISITION.—
(1) IN
GENERAL.—Section 1847 (42 U.S.C. 1395w–3) is
amended to read as follows:
‘‘COMPETITIVE ACQUISITION OF CERTAIN ITEMS AND SERVICES
‘‘SEC. 1847. (a) ESTABLISHMENT OF COMPETITIVE ACQUISITION
PROGRAMS.—
‘‘(1) IMPLEMENTATION OF PROGRAMS.—
‘‘(A) IN GENERAL.—The Secretary shall establish and
implement programs under which competitive acquisition
areas are established throughout the United States for
contract award purposes for the furnishing under this part
of competitively priced items and services (described in
paragraph (2)) for which payment is made under this part.
Such areas may differ for different items and services.
‘‘(B) PHASED-IN IMPLEMENTATION.—The programs—
H. R. 1—165
paid shall be the amounts described in section 1847(b)(5)’’;
and
(C) in clause (D)—
(i) by striking ‘‘or (ii)’’ and inserting ‘‘(ii)’’; and
(ii) by adding at the end the following: ‘‘or (iii)
on the basis of a rate established under a demonstra-
tion project under section 1847(e), the amount paid
shall be equal to 100 percent of such rate,’’.
(3) GAO REPORT ON IMPACT OF COMPETITIVE ACQUISITION
ON SUPPLIERS.—
(A) STUDY.—The Comptroller General of the United
States shall conduct a study on the impact of competitive
acquisition of durable medical equipment under section
1847 of the Social Security Act, as amended by paragraph
(1), on suppliers and manufacturers of such equipment
and on patients. Such study shall specifically examine the
impact of such competitive acquisition on access to, and
quality of, such equipment and service related to such
equipment.
(B) REPORT.—Not later than January 1, 2009, the
Comptroller General shall submit to Congress a report
on the study conducted under subparagraph (A) and shall
include in the report such recommendations as the Comp-
troller General determines appropriate.
(c) TRANSITIONAL FREEZE.—
(1) DME.—
(A) IN
GENERAL.—Section 1834(a)(14) (42 U.S.C.
1395m(a)(14)) is amended—
(i) in subparagraph (E), by striking ‘‘and’’ at the
end;
(ii) in subparagraph (F)—
(I) by striking ‘‘a subsequent year’’ and
inserting ‘‘2003’’; and
(II) by striking ‘‘the previous year.’’ and
inserting ‘‘2002;’’; and
(iii) by adding at the end the following new sub-
paragraphs:
‘‘(G) for 2004 through 2006—
‘‘(i) subject to clause (ii), in the case of class III
medical devices described in section 513(a)(1)(C) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360(c)(1)(C)), the percentage increase described in
subparagraph (B) for the year involved; and
‘‘(ii) in the case of covered items not described
in clause (i), 0 percentage points;
‘‘(H) for 2007—
‘‘(i) subject to clause (ii), in the case of class III
medical devices described in section 513(a)(1)(C) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360(c)(1)(C)), the percentage change determined by the
Secretary to be appropriate taking into account rec-
ommendations contained in the report of the Comp-
troller General of the United States under section
302(c)(1)(B) 
of 
the 
Medicare 
Prescription 
Drug,
Improvement, and Modernization Act of 2003; and
‘‘(ii) in the case of covered items not described
in clause (i), 0 percentage points; and
H. R. 1—200
(b) CONFORMING AMENDMENTS.—Section 1886(d) (42 U.S.C.
1395ww(d)) is amended—
(1) in paragraph (5)(F)—
(A) in each of subclauses (II), (III), (IV), (V), and (VI)
of clause (iv), by inserting ‘‘subject to clause (xiv) and’’
before ‘‘for discharges occurring’’;
(B) in clause (viii), by striking ‘‘The formula’’ and
inserting ‘‘Subject to clause (xiv), the formula’’; and
(C) in each of clauses (x), (xi), (xii), and (xiii), by
striking ‘‘For purposes’’ and inserting ‘‘Subject to clause
(xiv), for purposes’’; and
(2) in paragraph (2)(C)(iv)—
(A) by striking ‘‘or’’ before ‘‘the enactment of section
303’’; and
(B) by inserting before the period at the end the fol-
lowing: ‘‘, or the enactment of section 402(a)(1) of the Medi-
care Prescription Drug, Improvement, and Modernization
Act of 2003’’.
SEC. 403. ADJUSTMENT TO THE MEDICARE INPATIENT HOSPITAL
PROSPECTIVE 
PAYMENT 
SYSTEM 
WAGE 
INDEX 
TO
REVISE THE LABOR-RELATED SHARE OF SUCH INDEX.
(a) ADJUSTMENT.—
(1) 
IN
GENERAL.—Section 
1886(d)(3)(E) 
(42 
U.S.C.
1395ww(d)(3)(E)) is amended—
(A) by striking ‘‘WAGE LEVELS.—The Secretary’’ and
inserting ‘‘WAGE LEVELS.—
‘‘(i) IN GENERAL.—Except as provided in clause (ii),
the Secretary’’; and
(B) by adding at the end the following new clause:
‘‘(ii) ALTERNATIVE PROPORTION TO BE ADJUSTED BEGIN-
NING IN FISCAL YEAR 2005.—For discharges occurring on
or after October 1, 2004, the Secretary shall substitute
‘62 percent’ for the proportion described in the first sen-
tence of clause (i), unless the application of this clause
would result in lower payments to a hospital than would
otherwise be made.’’.
(2) WAIVING
BUDGET
NEUTRALITY.—Section 1886(d)(3)(E)
(42 U.S.C. 1395ww(d)(3)(E)), as amended by subsection (a),
is amended by adding at the end of clause (i) the following
new sentence: ‘‘The Secretary shall apply the previous sentence
for any period as if the amendments made by section 403(a)(1)
of the Medicare Prescription Drug, Improvement, and Mod-
ernization Act of 2003 had not been enacted.’’.
(b) 
APPLICATION
TO
PUERTO
RICO
HOSPITALS.—Section
1886(d)(9)(C)(iv) (42 U.S.C. 1395ww(d)(9)(C)(iv)) is amended—
(1) by inserting ‘‘(I)’’ after ‘‘(iv)’’;
(2) by striking ‘‘paragraph (3)(E)’’ and inserting ‘‘paragraph
(3)(E)(i)’’; and
(3) by adding at the end the following new subclause:
‘‘(II) For discharges occurring on or after October 1, 2004,
the Secretary shall substitute ‘62 percent’ for the proportion
described in the first sentence of clause (i), unless the applica-
tion of this subclause would result in lower payments to a
hospital than would otherwise be made.’’.
H. R. 1—307
(I) in section 1857(d)(4)(A)(ii) (42 U.S.C. 1395w–
27(d)(4)(A)(ii)), 
by 
striking 
‘‘Health 
Care 
Financing
Administration’’ and inserting ‘‘Secretary’’;
(J) 
in 
section 
1862(b)(5)(A)(ii) 
(42 
U.S.C.
1395y(b)(5)(A)(ii)), by striking ‘‘Health Care Financing
Administration’’ and inserting ‘‘Centers for Medicare &
Medicaid Services’’;
(K) in section 1927(e)(4) (42 U.S.C. 1396r–8(e)(4)), by
striking ‘‘HCFA’’ and inserting ‘‘The Secretary’’;
(L) in section 1927(f)(2) (42 U.S.C. 1396r–8(f)(2)), by
striking ‘‘HCFA’’ and inserting ‘‘The Secretary’’; and
(M) in section 2104(g)(3) (42 U.S.C. 1397dd(g)(3)) by
inserting ‘‘or CMS Form 64 or CMS Form 21, as the case
may be,’’ after ‘‘HCFA Form 64 or HCFA Form 21’’.
(2) AMENDMENTS TO THE PUBLIC HEALTH SERVICE ACT.—
The Public Health Service Act is amended—
(A) in section 501(d)(18) (42 U.S.C. 290aa(d)(18)), by
striking ‘‘Health Care Financing Administration’’ and
inserting ‘‘Centers for Medicare & Medicaid Services’’;
(B) in section 507(b)(6) (42 U.S.C. 290bb(b)(6)), by
striking ‘‘Health Care Financing Administration’’ and
inserting ‘‘Centers for Medicare & Medicaid Services’’;
(C) in section 916 (42 U.S.C. 299b–5)—
(i) in subsection (b)(2), by striking ‘‘Health Care
Financing Administration’’ and inserting ‘‘Centers for
Medicare & Medicaid Services’’; and
(ii) in subsection (c)(2), by striking ‘‘Health Care
Financing Administration’’ and inserting ‘‘Centers for
Medicare & Medicaid Services’’;
(D) in section 921(c)(3)(A) (42 U.S.C. 299c(c)(3)(A)),
by striking ‘‘Health Care Financing Administration’’ and
inserting ‘‘Centers for Medicare & Medicaid Services’’;
(E) in section 1318(a)(2) (42 U.S.C. 300e–17(a)(2)), by
striking ‘‘Health Care Financing Administration’’ and
inserting ‘‘Centers for Medicare & Medicaid Services’’;
(F) in section 2102(a)(7) (42 U.S.C. 300aa–2(a)(7)), by
striking ‘‘Health Care Financing Administration’’ and
inserting ‘‘Centers for Medicare & Medicaid Services’’; and
(G) in section 2675(a) (42 U.S.C. 300ff–75(a)), by
striking ‘‘Health Care Financing Administration’’ in the
first sentence and inserting ‘‘Centers for Medicare & Med-
icaid Services’’.
(3) AMENDMENTS
TO
THE
INTERNAL
REVENUE
CODE
OF
1986.—Section 6103(l)(12) of the Internal Revenue Code of 1986
is amended—
(A) in subparagraph (B), by striking ‘‘Health Care
Financing Administration’’ in the matter preceding clause
(i) and inserting ‘‘Centers for Medicare & Medicaid Serv-
ices’’; and
(B) in subparagraph (C)—
(i) by striking ‘‘HEALTH CARE FINANCING ADMINIS-
TRATION’’ in the heading and inserting ‘‘CENTERS FOR
MEDICARE & MEDICAID SERVICES’’; and
(ii) by striking ‘‘Health Care Financing Adminis-
tration’’ in the matter preceding clause (i) and inserting
‘‘Centers for Medicare & Medicaid Services’’.
H. R. 1—308
(4) AMENDMENTS TO TITLE 10, UNITED STATES CODE.—Title
10, United States Code, is amended—
(A) in section 1086(d)(4), by striking ‘‘administrator
of the Health Care Financing Administration’’ in the last
sentence and inserting ‘‘Administrator of the Centers for
Medicare & Medicaid Services’’; and
(B) in section 1095(k)(2), by striking ‘‘Health Care
Financing Administration’’ in the second sentence and
inserting ‘‘Centers for Medicare & Medicaid Services’’.
(5) AMENDMENTS TO THE ALZHEIMER’S DISEASE AND RELATED
DEMENTIAS SERVICES RESEARCH ACT OF 1992.—The Alzheimer’s
Disease and Related Dementias Research Act of 1992 (42 U.S.C.
11271 et seq.) is amended—
(A) in the heading of subpart 3 of part D to read
as follows:
‘‘Subpart 3—Responsibilities of the Centers for Medicare &
Medicaid Services’’;
(B) in section 937 (42 U.S.C. 11271)—
(i) in subsection (a), by striking ‘‘National Health
Care Financing Administration’’ and inserting ‘‘Centers
for Medicare & Medicaid Services’’;
(ii) in subsection (b)(1), by striking ‘‘Health Care
Financing Administration’’ and inserting ‘‘Centers for
Medicare & Medicaid Services’’;
(iii) in subsection (b)(2), by striking ‘‘Health Care
Financing Administration’’ and inserting ‘‘Centers for
Medicare & Medicaid Services’’; and
(iv) in subsection (c), by striking ‘‘Health Care
Financing Administration’’ and inserting ‘‘Centers for
Medicare & Medicaid Services’’; and
(C) in section 938 (42 U.S.C. 11272), by striking
‘‘Health Care Financing Administration’’ and inserting
‘‘Centers for Medicare & Medicaid Services’’.
(6) MISCELLANEOUS AMENDMENTS.—
(A) REHABILITATION ACT OF 1973.—Section 202(b)(8) of
the Rehabilitation Act of 1973 (29 U.S.C. 762(b)(8)) is
amended by striking ‘‘Health Care Financing Administra-
tion’’ and inserting ‘‘Centers for Medicare & Medicaid Serv-
ices’’.
(B) INDIAN HEALTH CARE IMPROVEMENT ACT.—Section
405(d)(1) of the Indian Health Care Improvement Act (25
U.S.C. 1645(d)(1)) is amended by striking ‘‘Health Care
Financing 
Administration’’ 
in 
the 
matter 
preceding
subparagraph (A) and inserting ‘‘Centers for Medicare &
Medicaid Services’’.
(C) INDIVIDUALS WITH DISABILITIES EDUCATION ACT.—
Section 644(b)(5) of the Individuals with Disabilities Edu-
cation Act (20 U.S.C. 1444(b)(5)) is amended by striking
‘‘Health Care Financing Administration’’ and inserting
‘‘Centers for Medicare & Medicaid Services’’.
(D) THE HOME HEALTH CARE AND ALZHEIMER’S DISEASE
AMENDMENTS
OF
1990.—Section 302(a)(9) of the Home
Health Care and Alzheimer’s Disease Amendments of 1990
(42 U.S.C. 242q–1(a)(9)) is amended by striking ‘‘Health
H. R. 1—339
(B) by adding at the end the following new subpara-
graph:
‘‘(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 sub-
section (g)(5));
‘‘(II) does not have a material familial, finan-
cial, 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 com-
pensation from the Secretary for the conduct of activi-
ties 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 deci-
sion rendered by the contractor or by any reviewing
professional.’’.
(2) ELIGIBILITY
REQUIREMENTS
FOR
REVIEWERS.—Section
1869 (42 U.S.C. 1395ff) is amended—
(A) by amending subsection (c)(3)(D) to read as follows:
‘‘(D) QUALIFICATIONS
FOR
REVIEWERS.—The require-
ments of subsection (g) shall be met (relating to qualifica-
tions of reviewing professionals).’’; and
(B) by adding at the end the following new subsection:
‘‘(g) QUALIFICATIONS OF REVIEWERS.—
‘‘(1) IN GENERAL.—In reviewing determinations under this
section, a qualified independent contractor shall assure that—
‘‘(A) each individual conducting a review shall meet
the qualifications of paragraph (2);
‘‘(B) compensation provided by the contractor to each
such reviewer is consistent with paragraph (3); and
‘‘(C) in the case of a review by a panel described
in subsection (c)(3)(B) composed of physicians or other
health care professionals (each in this subsection referred
to as a ‘reviewing professional’), a reviewing professional
meets the qualifications described in paragraph (4) and,
where a claim is regarding the furnishing of treatment
by a physician (allopathic or osteopathic) or the provision
of items or services by a physician (allopathic or osteo-
pathic), 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
H. R. 1—387
of confidential access, and those restrictions and
other terms of the offer of confidential access shall
be considered terms of an enforceable contract.
Any person provided an offer of confidential access
shall review the application for the sole and limited
purpose of evaluating possible infringement of the
patent that is the subject of the certification under
paragraph (2)(A)(vii)(IV) and for no other purpose,
and may not disclose information of no relevance
to any issue of patent infringement to any person
other than a person provided an offer of confiden-
tial access. Further, the application may be
redacted by the applicant to remove any informa-
tion of no relevance to any issue of patent infringe-
ment.
‘‘(ii) COUNTERCLAIM TO INFRINGEMENT ACTION.—
‘‘(I) IN GENERAL.—If an owner of the patent
or the holder of the approved application under
subsection (b) for the drug that is claimed by the
patent or a use of which is claimed by the patent
brings a patent infringement action against the
applicant, the applicant may assert a counterclaim
seeking an order requiring the holder to correct
or delete the patent information submitted by the
holder under subsection (b) or (c) on the ground
that the patent does not claim either—
‘‘(aa) the drug for which the application
was approved; or
‘‘(bb) an approved method of using the
drug.
‘‘(II) NO INDEPENDENT CAUSE OF ACTION.—Sub-
clause (I) does not authorize the assertion of a
claim described in subclause (I) in any civil action
or proceeding other than a counterclaim described
in subclause (I).
‘‘(iii) NO DAMAGES.—An applicant shall not be enti-
tled to damages in a civil action under clause (i) or
a counterclaim under clause (ii).’’.
(b) APPLICATIONS GENERALLY.—Section 505 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355) is amended—
(1) in subsection (b)—
(A) by striking paragraph (3) and inserting the fol-
lowing:
‘‘(3) NOTICE OF OPINION THAT PATENT IS INVALID OR WILL NOT
BE INFRINGED.—
‘‘(A) AGREEMENT TO GIVE NOTICE.—An applicant that makes
a certification described in paragraph (2)(A)(iv) shall include
in the application a statement that the applicant will give
notice as required by this paragraph.
‘‘(B) TIMING OF NOTICE.—An applicant that makes a certifi-
cation described in paragraph (2)(A)(iv) shall give notice as
required under this paragraph—
‘‘(i) if the certification is in the application, not later
than 20 days after the date of the postmark on the notice
with which the Secretary informs the applicant that the
application has been filed; or
H. R. 1—388
‘‘(ii) if the certification is in an amendment or supple-
ment to the application, at the time at which the applicant
submits the amendment or supplement, regardless of
whether the applicant has already given notice with respect
to another such certification contained in the application
or in an amendment or supplement to the application.
‘‘(C) RECIPIENTS OF NOTICE.—An applicant required under
this paragraph to give notice shall give notice to—
‘‘(i) each owner of the patent that is the subject of
the certification (or a representative of the owner des-
ignated to receive such a notice); and
‘‘(ii) the holder of the approved application under this
subsection for the drug that is claimed by the patent or
a use of which is claimed by the patent (or a representative
of the holder designated to receive such a notice).
‘‘(D) CONTENTS OF NOTICE.—A notice required under this
paragraph shall—
‘‘(i) state that an application that contains data from
bioavailability or bioequivalence studies has been sub-
mitted under this subsection for the drug with respect
to which the certification is made to obtain approval to
engage in the commercial manufacture, use, or sale of
the drug before the expiration of the patent referred to
in the certification; and
‘‘(ii) include a detailed statement of the factual and
legal basis of the opinion of the applicant that the patent
is invalid or will not be infringed.’’; and
(B)(i) by redesignating paragraph (4) as paragraph (5);
and
(ii) by inserting after paragraph (3) the following para-
graph:
‘‘(4)(A) An applicant may not amend or supplement an applica-
tion referred to in paragraph (2) to seek approval of a drug that
is a different drug than the drug identified in the application
as submitted to the Secretary.
‘‘(B) With respect to the drug for which such an application
is submitted, nothing in this subsection or subsection (c)(3) prohibits
an applicant from amending or supplementing the application to
seek approval of a different strength.’’; and
(2) in subsection (c)(3)—
(A) in the first sentence, by striking ‘‘under the fol-
lowing’’ and inserting ‘‘by applying the following to each
certification made under subsection (b)(2)(A)’’;
(B) in subparagraph (C)—
(i) in the first sentence, by striking ‘‘unless’’ and
all that follows and inserting ‘‘unless, before the expira-
tion of 45 days after the date on which the notice
described in subsection (b)(3) is received, an action
is brought for infringement of the patent that is the
subject of the certification and for which information
was submitted to the Secretary under paragraph (2)
or subsection (b)(1) before the date on which the
application (excluding an amendment or supplement
to the application) was submitted.’’;
(ii) in the second sentence—
(I) by striking ‘‘paragraph (3)(B)’’ and inserting
‘‘subsection (b)(3)’’;
H. R. 1—389
(II) by striking clause (i) and inserting the
following:
‘‘(i) if before the expiration of such period the district
court decides that the patent is invalid or not infringed
(including any substantive determination that there is no
cause of action for patent infringement or invalidity), the
approval shall be made effective on—
‘‘(I) the date on which the court enters judgment
reflecting the decision; or
‘‘(II) the date of a settlement order or consent
decree signed and entered by the court stating that
the patent that is the subject of the certification is
invalid or not infringed;’’;
(III) by striking clause (ii) and inserting the
following:
‘‘(ii) if before the expiration of such period the district
court decides that the patent has been infringed—
‘‘(I) if the judgment of the district court is appealed,
the approval shall be made effective on—
‘‘(aa) the date on which the court of appeals
decides that the patent is invalid or not infringed
(including any substantive determination that
there is no cause of action for patent infringement
or invalidity); or
‘‘(bb) the date of a settlement order or consent
decree signed and entered by the court of appeals
stating that the patent that is the subject of the
certification is invalid or not infringed; or
‘‘(II) if the judgment of the district court is not
appealed or is affirmed, the approval shall be made
effective on the date specified by the district court
in a court order under section 271(e)(4)(A) of title 35,
United States Code;’’;
(IV) in clause (iii), by striking ‘‘on the date
of such court decision.’’ and inserting ‘‘as provided
in clause (i); or’’;
(V) by inserting after clause (iii), the following:
‘‘(iv) if before the expiration of such period the court
grants a preliminary injunction prohibiting the applicant
from engaging in the commercial manufacture or sale of
the drug until the court decides the issues of patent validity
and infringement and if the court decides that such patent
has been infringed, the approval shall be made effective
as provided in clause (ii).’’; and
(VI) in the matter after and below clause (iv)
(as added by subclause (V)), by striking ‘‘Until
the expiration’’ and all that follows; and
(iii) in the third sentence, by striking ‘‘paragraph
(3)(B)’’ and inserting ‘‘subsection (b)(3)’’;
(C) by redesignating subparagraph (D) as subpara-
graph (E); and
(D) by inserting after subparagraph (C) the following:
‘‘(D) CIVIL ACTION TO OBTAIN PATENT CERTAINTY.—
‘‘(i) DECLARATORY
JUDGMENT
ABSENT
INFRINGE-
MENT ACTION.—
‘‘(I) IN GENERAL.—No action may be brought
under section 2201 of title 28, United States Code,
H. R. 1—390
by an applicant referred to in subsection (b)(2)
for a declaratory judgment with respect to a patent
which is the subject of the certification referred
to in subparagraph (C) unless—
‘‘(aa) the 45-day period referred to in such
subparagraph has expired;
‘‘(bb) neither the owner of such patent
nor the holder of the approved application
under subsection (b) for the drug that is
claimed by the patent or a use of which is
claimed by the patent brought a civil action
against the applicant for infringement of the
patent before the expiration of such period;
and
‘‘(cc) in any case in which the notice pro-
vided under paragraph (2)(B) relates to non-
infringement, the notice was accompanied by
a document described in subclause (III).
‘‘(II) FILING OF CIVIL ACTION.—If the conditions
described in items (aa), (bb), and as applicable,
(cc) of subclause (I) have been met, the applicant
referred to in such subclause may, in accordance
with section 2201 of title 28, United States Code,
bring a civil action under such section against
the owner or holder referred to in such subclause
(but not against any owner or holder that has
brought such a civil action against the applicant,
unless that civil action was dismissed without
prejudice) for a declaratory judgment that the
patent is invalid or will not be infringed by the
drug for which the applicant seeks approval, except
that such civil action may be brought for a declara-
tory judgment that the patent will not be infringed
only in a case in which the condition described
in subclause (I)(cc) is applicable. A civil action
referred to in this subclause shall be brought in
the judicial district where the defendant has its
principal place of business or a regular and estab-
lished place of business.
‘‘(III) OFFER
OF
CONFIDENTIAL
ACCESS
TO
APPLICATION.—For purposes of subclause (I)(cc),
the document described in this subclause is a docu-
ment providing an offer of confidential access to
the application that is in the custody of the
applicant referred to in subsection (b)(2) for the
purpose of determining whether an action referred
to in subparagraph (C) should be brought. The
document providing the offer of confidential access
shall contain such restrictions as to persons enti-
tled to access, and on the use and disposition of
any information accessed, as would apply had a
protective order been entered for the purpose of
protecting trade secrets and other confidential
business information. A request for access to an
application under an offer of confidential access
shall be considered acceptance of the offer of con-
fidential access with the restrictions as to persons
H. R. 1—396
between the drug and the listed drug in safety and therapeutic
effect.’’.
(b) EFFECT OF AMENDMENT.—The amendment made by sub-
section (a) does not alter the standards for approval of drugs under
section 505(j) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355(j)).
SEC. 1104. CONFORMING AMENDMENTS.
Section 505A of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355a) is amended—
(1) in subsections (b)(1)(A)(i) and (c)(1)(A)(i), by striking
‘‘(j)(5)(D)(ii)’’ each place it appears and inserting ‘‘(j)(5)(F)(ii)’’;
(2) in subsections (b)(1)(A)(ii) and (c)(1)(A)(ii), by striking
‘‘(j)(5)(D)’’ each place it appears and inserting ‘‘(j)(5)(F)’’; and
(3) in subsections (e) and (l), by striking ‘‘505(j)(5)(D)’’ each
place it appears and inserting ‘‘505(j)(5)(F)’’.
Subtitle B—Federal Trade Commission
Review
SEC. 1111. DEFINITIONS.
In this subtitle:
(1) ANDA.—The term ‘‘ANDA’’ means an abbreviated drug
application, as defined under section 201(aa) of the Federal
Food, Drug, and Cosmetic Act.
(2) ASSISTANT ATTORNEY GENERAL.—The term ‘‘Assistant
Attorney General’’ means the Assistant Attorney General in
charge of the Antitrust Division of the Department of Justice.
(3) BRAND
NAME
DRUG.—The term ‘‘brand name drug’’
means a drug for which an application is approved under
section 505(c) of the Federal Food, Drug, and Cosmetic Act,
including an application referred to in section 505(b)(2) of such
Act.
(4) BRAND NAME DRUG COMPANY.—The term ‘‘brand name
drug company’’ means the party that holds the approved
application referred to in paragraph (3) for a brand name
drug that is a listed drug in an ANDA, or a party that is
the owner of a patent for which information is submitted for
such drug under subsection (b) or (c) of section 505 of the
Federal Food, Drug, and Cosmetic Act.
(5) COMMISSION.—The term ‘‘Commission’’ means the Fed-
eral Trade Commission.
(6) GENERIC DRUG.—The term ‘‘generic drug’’ means a drug
for which an application under section 505(j) of the Federal
Food, Drug, and Cosmetic Act is approved.
(7) GENERIC
DRUG
APPLICANT.—The term ‘‘generic drug
applicant’’ means a person who has filed or received approval
for an ANDA under section 505(j) of the Federal Food, Drug,
and Cosmetic Act.
(8) LISTED DRUG.—The term ‘‘listed drug’’ means a brand
name drug that is listed under section 505(j)(7) of the Federal
Food, Drug, and Cosmetic Act.
SEC. 1112. NOTIFICATION OF AGREEMENTS.
(a) AGREEMENT WITH BRAND NAME DRUG COMPANY.—
H. R. 1—397
(1) REQUIREMENT.—A generic drug applicant that has sub-
mitted an ANDA containing a certification under section
505(j)(2)(A)(vii)(IV) of the Federal Food, Drug, and Cosmetic
Act and a brand name drug company that enter into an agree-
ment described in paragraph (2) shall each file the agreement
in accordance with subsection (c). The agreement shall be filed
prior to the date of the first commercial marketing of the
generic drug that is the subject of the ANDA.
(2) SUBJECT
MATTER
OF
AGREEMENT.—An agreement
described in this paragraph between a generic drug applicant
and a brand name drug company is an agreement regarding—
(A) the manufacture, marketing or sale of the brand
name drug that is the listed drug in the ANDA involved;
(B) the manufacture, marketing, or sale of the generic
drug for which the ANDA was submitted; or
(C) 
the 
180-day 
period 
referred 
to 
in 
section
505(j)(5)(B)(iv) of the Federal Food, Drug, and Cosmetic
Act as it applies to such ANDA or to any other ANDA
based on the same brand name drug.
(b) AGREEMENT WITH ANOTHER GENERIC DRUG APPLICANT.—
(1) REQUIREMENT.—A generic drug applicant that has sub-
mitted an ANDA containing a certification under section
505(j)(2)(A)(vii)(IV) of the Federal Food, Drug, and Cosmetic
Act with respect to a listed drug and another generic drug
applicant that has submitted an ANDA containing such a cer-
tification for the same listed drug shall each file the agreement
in accordance with subsection (c). The agreement shall be filed
prior to the date of the first commercial marketing of either
of the generic drugs for which such ANDAs were submitted.
(2) SUBJECT
MATTER
OF
AGREEMENT.—An agreement
described in this paragraph between two generic drug
applicants is an agreement regarding the 180-day period
referred to in section 505(j)(5)(B)(iv) of the Federal Food, Drug,
and Cosmetic Act as it applies to the ANDAs with which
the agreement is concerned.
(c) FILING.—
(1) AGREEMENT.—The parties that are required in sub-
section (a) or (b) to file an agreement in accordance with this
subsection shall file with the Assistant Attorney General and
the Commission the text of any such agreement, except that
such parties are not required to file an agreement that solely
concerns—
(A) purchase orders for raw material supplies;
(B) equipment and facility contracts;
(C) employment or consulting contracts; or
(D) packaging and labeling contracts.
(2) OTHER
AGREEMENTS.—The parties that are required
in subsection (a) or (b) to file an agreement in accordance
with this subsection shall file with the Assistant Attorney Gen-
eral and the Commission the text of any agreements between
the parties that are not described in such subsections and
are contingent upon, provide a contingent condition for, or
are otherwise related to an agreement that is required in sub-
section (a) or (b) to be filed in accordance with this subsection.
(3) DESCRIPTION.—In the event that any agreement
required in subsection (a) or (b) to be filed in accordance with
this subsection has not been reduced to text, each of the parties