128
ary 1, 2006, from continuing to receive benefits 
under such policy on and after such date. 
‘‘(2) ISSUANCE OF SUBSTITUTE POLICIES FOR 
BENEFICIARIES
ENROLLED
WITH
A
PLAN
UNDER 
PART D.—
‘‘(A) IN GENERAL.—The issuer of a medi-
care supplemental policy—
‘‘(i) may not deny or condition the 
issuance or effectiveness of a medicare 
supplemental policy that has a benefit 
package classified as ‘A’, ‘B’, ‘C’, ‘D’, ‘E’, 
‘F’, or ‘G’ (under the standards estab-
lished under subsection (p)(2)) and that is 
offered and is available for issuance to new 
enrollees by such issuer; 
‘‘(ii) may not discriminate in the pric-
ing of such policy, because of health sta-
tus, claims experience, receipt of health 
care, or medical condition; and 
‘‘(iii) may not impose an exclusion of 
benefits based on a pre-existing condition 
under such policy, 
in the case of an individual described in sub-
paragraph (B) who seeks to enroll under the 
policy not later than 63 days after the date of
129
the termination of enrollment described in such 
paragraph and who submits evidence of the 
date of termination or disenrollment along with 
the application for such medicare supplemental 
policy. 
‘‘(B) INDIVIDUAL
COVERED.—An indi-
vidual described in this subparagraph is an in-
dividual who—
‘‘(i) enrolls in a prescription drug plan 
under part D; and 
‘‘(ii) at the time of such enrollment 
was enrolled and terminates enrollment in 
a medicare supplemental policy which has 
a benefit package classified as ‘H’, ‘I’, or 
‘J’ under the standards referred to in sub-
paragraph (A)(i) or terminates enrollment 
in a policy to which such standards do not 
apply but which provides benefits for pre-
scription drugs. 
‘‘(C) ENFORCEMENT.—The provisions of 
paragraph (4) of subsection (s) shall apply with 
respect to the requirements of this paragraph in 
the same manner as they apply to the require-
ments of such subsection.
130
‘‘(3) NEW STANDARDS.—In applying subsection 
(p)(1)(E) (including permitting the NAIC to revise 
its model regulations in response to changes in law) 
with respect to the change in benefits resulting from 
title I of the Medicare Prescription Drug and Mod-
ernization Act of 2003, with respect to policies 
issued to individuals who are enrolled in a plan 
under part D, the changes in standards shall only 
provide for substituting (for the benefit packages de-
scribed in paragraph (2)(B)(ii) that included cov-
erage for prescription drugs) two benefit packages 
that may provide for coverage of cost-sharing (other 
than the prescription drug deductible) with respect 
to qualified prescription drug coverage under such 
part. The two benefit packages shall be consistent 
with the following: 
‘‘(A) FIRST NEW POLICY.—The policy de-
scribed in this subparagraph has the following 
benefits, notwithstanding any other provision of 
this section relating to a core benefit package: 
‘‘(i) Coverage of 50 percent of the 
cost-sharing otherwise applicable under 
parts A and B, except coverage of 100 per-
cent of any cost-sharing otherwise applica-
ble for preventive benefits.
131
‘‘(ii) No coverage of the part B de-
ductible. 
‘‘(iii) Coverage for all hospital coin-
surance for long stays (as in the current 
core benefit package). 
‘‘(iv) A limitation on annual out-of-
pocket expenditures under parts A and B 
to $4,000 in 2005 (or, in a subsequent 
year, to such limitation for the previous 
year increased by an appropriate inflation 
adjustment specified by the Secretary). 
‘‘(B) SECOND
NEW
POLICY.—The policy 
described in this subparagraph has the same 
benefits as the policy described in subparagraph 
(A), except as follows: 
‘‘(i) Substitute ‘75 percent’ for ‘50 
percent’ in clause (i) of such subpara-
graph. 
‘‘(ii) Substitute ‘$2,000’ for ‘$4,000’ 
in clause (iv) of such subparagraph. 
‘‘(4) CONSTRUCTION.—Any provision in this 
section or in a medicare supplemental policy relating 
to guaranteed renewability of coverage shall be 
deemed to have been met through the offering of 
other coverage under this subsection.’’.
132
(b) NAIC REPORT TO CONGRESS ON MEDIGAP MOD-
ERNIZATION.—The Secretary shall request the National 
Association of Insurance Commissioners to submit to Con-
gress, not later than 18 months after the date of the en-
actment of this Act, a report that includes recommenda-
tions on the modernization of coverage under the medigap 
program under section 1882 of the Social Security Act (42 
U.S.C. 1395ss).
SEC. 105. MEDICARE PRESCRIPTION DRUG DISCOUNT 
CARD AND ASSISTANCE PROGRAM. 
(a) IN GENERAL.—Title XVIII is amended by insert-
ing after section 1806 the following new sections: 
‘‘MEDICARE PRESCRIPTION DRUG DISCOUNT CARD 
ENDORSEMENT AND ASSISTANCE PROGRAM 
‘‘SEC. 1807. (a) ESTABLISHMENT OF PROGRAM.—
‘‘(1) IN GENERAL.—The Secretary shall estab-
lish a program—
‘‘(A) to endorse prescription drug discount 
card programs (each such program referred to 
as an ‘endorsed program’) that meet the re-
quirements of this section in order to provide 
access to prescription drug discounts through 
eligible 
entities 
for 
medicare 
beneficiaries 
throughout the United States; and
133
‘‘(B) to provide for prescription drug ac-
counts and public contributions into such ac-
counts. 
The Secretary shall make available to medicare 
beneficiaries information regarding endorsed pro-
grams and accounts under this section. 
‘‘(2) LIMITED
PERIOD
OF
OPERATION.—The 
Secretary shall begin—
‘‘(A) the card endorsement part of the pro-
gram under paragraph (1)(A) as soon as pos-
sible, but in no case later than 90 days after 
the date of the enactment of this section; and 
‘‘(B) the prescription drug account part of 
the program under paragraph (1)(B) as soon as 
possible, but in no case later than September 
2004. 
‘‘(3) TRANSITION.—The program under this 
section shall continue through 2005 throughout the 
United States. The Secretary shall provide for an 
appropriate transition and termination of such pro-
gram on January 1, 2006. 
‘‘(4) VOLUNTARY
NATURE
OF
PROGRAM.—
Nothing in this section shall be construed as requir-
ing an eligible beneficiary to enroll in the program 
under this section.
135
‘‘(c) ENROLLMENT IN ENDORSED PLAN.—
‘‘(1) ESTABLISHMENT OF PROCESS.—
‘‘(A) IN
GENERAL.—The Secretary shall 
establish a process through which an eligible 
beneficiary may make an election to enroll 
under this section with an endorsed program. 
‘‘(B) REQUIREMENT
OF
ENROLLMENT.—
An eligible beneficiary must enroll under this 
section for a year in order to be eligible to re-
ceive the benefits under this section for that 
year. 
‘‘(C) LIMITATION ON ENROLLMENT.—
‘‘(i) IN
GENERAL.—Except as pro-
vided under this subparagraph and under 
such exceptional circumstances as the Sec-
retary may provide, an eligible individual 
shall have the opportunity to enroll under 
this section during an initial, general en-
rollment period as soon as possible after 
the date of the enactment of this section 
and annually thereafter. The Secretary 
shall specify the form, manner, and timing 
of such election but shall permit the exer-
cise of such election at the time the indi-
vidual is eligible to enroll. The annual open
136
enrollment periods shall be coordinated 
with those provided under the Medicare 
Advantage program under part C. 
‘‘(ii) 
REELECTION
AFTER
TERMI-
NATION OF ENROLLMENT IN A MEDICARE 
ADVANTAGE PLAN.—In the case of an indi-
vidual who is enrolled under this section 
and who subsequently enrolls in a Medi-
care Advantage plan that provides quali-
fied prescription drug coverage under part 
C, the individual shall be given the oppor-
tunity to reenroll under this section at the 
time the individual discontinues the enroll-
ment under such part. 
‘‘(iii) LATE ENROLLMENT.—The Sec-
retary shall permit individuals to elect to 
enroll under this section at times other 
than as permitted under the previous pro-
visions of this paragraph. 
‘‘(D) TERMINATION
OF
ENROLLMENT.—
An enrollee under this section shall be 
disenrolled—
‘‘(i) upon enrollment in a Medicare 
Advantage plan under part C that provides 
qualified prescription drug coverage;
137
‘‘(ii) upon failure to pay the applicable 
enrollment fee under subsection (f); 
‘‘(iii) upon termination of coverage 
under part A or part B; or 
‘‘(iv) upon notice submitted to the 
Secretary in such form, manner, and time 
as the Secretary shall provide. 
Terminations of enrollment under this subpara-
graph shall be effective as specified by the Sec-
retary in regulations. 
‘‘(2) ENROLLMENT PERIODS.—
‘‘(A) IN
GENERAL.—Except as provided 
under this paragraph, an eligible beneficiary 
may not enroll in the program under this part 
during any period after the beneficiary’s initial 
enrollment period under part B (as determined 
under section 1837). 
‘‘(B) OPEN
ENROLLMENT
PERIOD
FOR 
CURRENT BENEFICIARIES.—The Secretary shall 
establish a period, which shall begin on the date 
on which the Secretary first begins to accept 
elections for enrollment under this section and 
shall end not earlier than 3 months later, dur-
ing which any eligible beneficiary may enroll 
under this section.
138
‘‘(C) SPECIAL
ENROLLMENT
PERIOD
IN 
CASE OF TERMINATION OF COVERAGE UNDER A 
GROUP
HEALTH
PLAN.—The Secretary shall 
provide for a special enrollment period under 
this section in the same manner as is provided 
under section 1837(i) with respect to part B, 
except that for purposes of this subparagraph 
any reference to ‘by reason of the individual’s 
(or the individual’s spouse’s) current employ-
ment status’ shall be treated as being deleted. 
‘‘(3) PERIOD OF COVERAGE.—
‘‘(A) IN GENERAL.—Except as provided in 
subparagraph (B) and subject to subparagraph 
(C), an eligible beneficiary’s coverage under the 
program under this section shall be effective for 
the period provided under section 1838, as if 
that section applied to the program under this 
section. 
‘‘(B) ENROLLMENT
DURING
OPEN
AND 
SPECIAL
ENROLLMENT.—Subject to subpara-
graph (C), an eligible beneficiary who enrolls 
under the program under this section under 
subparagraph (B) or (C) of paragraph (2) shall 
be entitled to the benefits under this section be-
139
ginning on the first day of the month following 
the month in which such enrollment occurs. 
‘‘(d) SELECTION OF AN ELIGIBLE ENTITY FOR AC-
CESS TO NEGOTIATED PRICES.—
‘‘(1) PROCESS.—
‘‘(A) IN
GENERAL.—The Secretary shall 
establish a process through which an eligible 
beneficiary who is enrolled under this section 
shall select any eligible entity, that has been 
awarded a contract under this section and 
serves the State in which the beneficiary re-
sides, to provide access to negotiated prices 
under subsection (i). 
‘‘(B) RULES.—In establishing the process 
under subparagraph (A), the Secretary shall 
use rules similar to the rules for enrollment and 
disenrollment with a Medicare Advantage plan 
under section 1851 (including the special elec-
tion periods under subsection (e)(4) of such sec-
tion), including that—
‘‘(i) an individual may not select more 
than one eligible entity at any time; and 
‘‘(ii) an individual shall only be per-
mitted (except for unusual circumstances)
140
to change the selection of the entity once 
a year. 
In carrying out clause (ii), the Secretary may 
consider a change in residential setting (such as 
placement in a nursing facility) to be an un-
usual circumstance. 
‘‘(C) DEFAULT
SELECTION.—In estab-
lishing such process, the Secretary shall provide 
an equitable method for selecting an eligible en-
tity for individuals who enroll under this section 
and fail to make such a selection. 
‘‘(2) COMPETITION.—Eligible entities with a 
contract under this section shall compete for bene-
ficiaries on the basis of discounts, formularies, phar-
macy networks, and other services provided for 
under the contract. 
‘‘(e) PROVIDING ENROLLMENT, SELECTION, AND 
COVERAGE INFORMATION TO BENEFICIARIES.—
‘‘(1) ACTIVITIES.—The Secretary shall provide 
for activities under this section to broadly dissemi-
nate information to eligible beneficiaries (and pro-
spective eligible beneficiaries) regarding enrollment 
under this section, the selection of eligible entities, 
and the prescription drug coverage made available 
by eligible entities with a contract under this section.
141
‘‘(2) SPECIAL RULE FOR FIRST ENROLLMENT 
UNDER THE PROGRAM.—To the extent practicable, 
the activities described in paragraph (1) shall ensure 
that eligible beneficiaries are provided with such in-
formation at least 60 days prior to the first enroll-
ment period described in subsection (c). 
‘‘(f) ENROLLMENT FEE.—
‘‘(1) AMOUNT.—Except as provided in para-
graph (3), enrollment under the program under this 
section is conditioned upon payment of an annual 
enrollment fee of $30. Such fee for 2004 shall in-
clude any portion of 2003 in which the program is 
implemented under this section. 
‘‘(2) COLLECTION OF ENROLLMENT FEE.—The 
annual enrollment fee shall be collected and credited 
to the Federal Supplementary Medical Insurance 
Trust Fund in the same manner as the monthly pre-
mium determined under section 1839 is collected 
and credited to such Trust Fund under section 
1840, except that it shall be collected only 1 time 
per year. 
‘‘(3) PAYMENT OF ENROLLMENT FEE BY STATE 
FOR CERTAIN BENEFICIARIES.—
‘‘(A) IN
GENERAL.—The Secretary shall 
establish an arrangement under which a State
142
may provide for payment of some or all of the 
enrollment fee for some or all low income en-
rollees in the State, as specified by the State 
under the arrangement. Insofar as such a pay-
ment arrangement is made with respect to an 
enrollee, the amount of the enrollment fee shall 
be paid directly by the State and shall not be 
collected under paragraph (2). In carrying out 
this paragraph, the Secretary may apply proce-
dures similar to that applied under state agree-
ments under section 1843. 
‘‘(B) NO FEDERAL MATCHING AVAILABLE 
UNDER
MEDICAID
OR
SCHIP.—Expenditures 
made by a State described in subparagraph (A) 
shall not be treated as State expenditures for 
purposes of Federal matching payments under 
titles XIX and XXI insofar as such expendi-
tures are for an enrollment fee under this sub-
section. 
‘‘(4) DISTRIBUTION OF PORTION OF ENROLL-
MENT FEE.—Of the enrollment fee collected by the 
Secretary under this subsection with respect to a 
beneficiary, 2⁄3 of that fee shall be made available to 
the eligible entity selected by the eligible beneficiary.
143
‘‘(g) ISSUANCE
OF CARD
AND COORDINATION.—
Each eligible entity shall—
‘‘(1) issue, in a uniform standard format 
specified by the Secretary, to each enrolled ben-
eficiary a card and an enrollment number that 
establishes proof of enrollment and that can be 
used in a coordinated manner—
‘‘(A) to identify the eligible entity selected 
to provide access to negotiated prices under 
subsection (i); and 
‘‘(B) to make deposits to and withdrawals 
from a prescription drug account under section 
1807A; and 
‘‘(2) provide for electronic methods to coordi-
nate with the accounts established under section 
1807A. 
‘‘(h) ENROLLEE PROTECTIONS.—
‘‘(1) GUARANTEED ISSUE AND NONDISCRIMINA-
TION.—
‘‘(A) GUARANTEED ISSUE.—
‘‘(i) IN GENERAL.—An eligible bene-
ficiary who is eligible to select an eligible 
entity under subsection (b) for prescription 
drug coverage under this section at a time 
during which selections are accepted under
144
this section with respect to the coverage 
shall not be denied selection based on any 
health status-related factor (described in 
section 2702(a)(1) of the Public Health 
Service Act) or any other factor and may 
not be charged any selection or other fee 
as a condition of such acceptance. 
‘‘(ii) MEDICARE ADVANTAGE LIMITA-
TIONS
PERMITTED.—The provisions of 
paragraphs (2) and (3) (other than sub-
paragraph (C)(i), relating to default enroll-
ment) of section 1851(g) (relating to pri-
ority and limitation on termination of elec-
tion) shall apply to selection of eligible en-
tities under this paragraph. 
‘‘(B) NONDISCRIMINATION.—An eligible 
entity offering prescription drug coverage under 
this section shall not establish a service area in 
a manner that would discriminate based on 
health or economic status of potential enrollees. 
‘‘(C) COVERAGE OF ALL PORTIONS OF A 
STATE.—If an eligible entity with a contract 
under this section serves any part of a State it 
shall serve the entire State. 
‘‘(2) DISSEMINATION OF INFORMATION.—
145
‘‘(A) GENERAL INFORMATION.—An eligible 
entity with a contract under this section shall 
disclose, in a clear, accurate, and standardized 
form to each eligible beneficiary who has se-
lected the entity to provide access to negotiated 
prices under this section at the time of selection 
and at least annually thereafter, the informa-
tion described in section 1852(c)(1) relating to 
such prescription drug coverage. Such informa-
tion includes the following (in a manner de-
signed to permit and promote competition 
among eligible entities): 
‘‘(i) Summary information regarding 
negotiated prices (including discounts) for 
covered outpatient drugs. 
‘‘(ii) Access to such prices through 
pharmacy networks. 
‘‘(iii) How any formulary used by the 
eligible entity functions. 
‘‘(B) DISCLOSURE
UPON
REQUEST
OF 
GENERAL COVERAGE, UTILIZATION, AND GRIEV-
ANCE INFORMATION.—Upon request of an eligi-
ble beneficiary, the eligible entity shall provide 
the information described in section 1852(c)(2)
146
(other than subparagraph (D)) to such bene-
ficiary. 
‘‘(C) RESPONSE
TO
BENEFICIARY
QUES-
TIONS.—Each eligible entity offering prescrip-
tion drug coverage under this section shall have 
a mechanism (including a toll-free telephone 
number) for providing upon request specific in-
formation (such as negotiated prices, including 
discounts) to individuals who have selected the 
entity. The entity shall make available, through 
an Internet website and in writing upon re-
quest, information on specific changes in its 
formulary. 
‘‘(D) COORDINATION WITH PRESCRIPTION 
DRUG ACCOUNT BENEFITS.—Each such eligible 
entity shall provide for coordination of such in-
formation as the Secretary may specify to carry 
out section 1807A. 
‘‘(3) ACCESS TO COVERED BENEFITS.—
‘‘(A) ENSURING PHARMACY ACCESS.—The 
provisions of subsection (c)(1) of section 
1860D–3 (other than payment provisions under 
section 1860D–8 with respect to sponsors under 
such subsection) shall apply to an eligible entity
147
under this section in the same manner as they 
apply to a PDP sponsor under such section. 
‘‘(B) ACCESS TO NEGOTIATED PRICES FOR 
PRESCRIPTION
DRUGS.—For requirements re-
lating to the access of an eligible beneficiary to 
negotiated prices (including applicable dis-
counts), see subsection (i). 
‘‘(C) REQUIREMENTS
ON
DEVELOPMENT 
AND APPLICATION OF FORMULARIES.—Insofar 
as an eligible entity with a contract under this 
part uses a formulary, the entity shall comply 
with the requirements of section 1860D–
3(c)(3), insofar as the Secretary determines 
that such requirements can be implemented on 
a timely basis. 
‘‘(4) COST
AND
UTILIZATION
MANAGEMENT; 
QUALITY ASSURANCE; MEDICATION THERAPY MAN-
AGEMENT PROGRAM.—
‘‘(A) IN GENERAL.—For purposes of pro-
viding access to negotiated benefits under sub-
section (i), the eligible entity shall have in place 
the programs and measure described in section 
1860D–3(d), including an effective cost and 
drug utilization management program, quality 
assurance measures and systems, and a pro-
148
gram to control fraud, abuse, and waste, inso-
far as the Secretary determines that such provi-
sions can be implemented on a timely basis. 
‘‘(B) TREATMENT
OF
ACCREDITATION.—
Section 1852(e)(4) (relating to treatment of ac-
creditation) shall apply to the requirements for 
an endorsed program under this section with 
respect to the following requirements, in the 
same manner as they apply to Medicare Advan-
tage plans under part C with respect to the re-
quirements described in a clause of section 
1852(e)(4)(B): 
‘‘(i) Paragraph (3)(A) (relating to ac-
cess to covered benefits). 
‘‘(ii) Paragraph (7) (relating to con-
fidentiality 
and 
accuracy 
of 
enrollee 
records). 
‘‘(5) GRIEVANCE
MECHANISM.—Each eligible 
entity shall provide meaningful procedures for hear-
ing and resolving grievances between the organiza-
tion consistent with the requirements of section 
1860D–3(e) insofar as they relate to PDP sponsors 
of prescription drug plans. 
‘‘(6) BENEFICIARY SERVICES.—An eligible enti-
ty shall provide for its enrollees pharmaceutical sup-
149
port services, such as education and counseling, and 
services to prevent adverse drug interactions. 
‘‘(7) COVERAGE DETERMINATIONS AND RECON-
SIDERATIONS.—An eligible entity shall meet the re-
quirements of paragraphs (1) through (3) of section 
1852(g) with respect to covered benefits under the 
prescription drug coverage it offers under this sec-
tion in the same manner as such requirements apply 
to a Medicare Advantage organization with respect 
to benefits it offers under a Medicare Advantage 
plan under part C. 
‘‘(8) CONFIDENTIALITY AND ACCURACY OF EN-
ROLLEE RECORDS.—An eligible entity shall meet the 
requirements of section 1852(h) with respect to en-
rollees under this section in the same manner as 
such requirements apply to a Medicare Advantage 
organization with respect to enrollees under part C. 
The eligible entity shall implement policies and pro-
cedures to safeguard the use and disclosure of en-
rollees’ individually identifiable health information in 
a manner consistent with the Federal regulations 
(concerning the privacy of individually identifiable 
health information) promulgated under section 
264(c) of the Health Insurance Portability and Ac-
countability Act of 1996. The eligible entity shall be
150
treated as a covered entity for purposes of the provi-
sions of subpart E of part 164 of title 45, Code of 
Federal Regulations, adopted pursuant to the au-
thority of the Secretary under section 264(c) of the 
Health Insurance Portability and Accountability Act 
of 1996 (42 U.S. C. 1320d-2 note). 
‘‘(9) PERIODIC
REPORTS
AND
OVERSIGHT.—
The eligible entity shall submit to the Secretary peri-
odic reports on performance, utilization, finances, 
and such other matters as the Secretary may speci-
fy. The Secretary shall provide appropriate oversight 
to ensure compliance of eligible entities with the re-
quirements of this subsection, including verification 
of the discounts and services provided. 
‘‘(10) 
ADDITIONAL
BENEFICIARY
PROTEC-
TIONS.—The eligible entity meets such additional re-
quirements as the Secretary identifies to protect and 
promote the interest of enrollees, including require-
ments that ensure that enrollees are not charged 
more than the lower of the negotiated retail price or 
the usual and customary price. 
‘‘(i) BENEFITS UNDER
THE PROGRAM THROUGH 
SAVINGS
TO
ENROLLEES
THROUGH
NEGOTIATED 
PRICES.—
151
‘‘(1) IN GENERAL.—Subject to paragraph (2), 
each eligible entity with a contract under this section 
shall provide each eligible beneficiary enrolled with 
the entity with access to negotiated prices (including 
applicable discounts). For purposes of this para-
graph, the term ‘prescription drugs’ is not limited to 
covered outpatient drugs, but does not include any 
over-the-counter drug that is not a covered out-
patient drug. The prices negotiated by an eligible en-
tity under this paragraph shall (notwithstanding any 
other provision of law) not be taken into account for 
the purposes of establishing the best price under sec-
tion 1927(c)(1)(C). 
‘‘(2) FORMULARY
RESTRICTIONS.—Insofar as 
an eligible entity with a contract under this part 
uses a formulary, the negotiated prices (including 
applicable discounts) for prescription drugs shall 
only be available for drugs included in such for-
mulary. 
‘‘(3) PROHIBITION ON APPLICATION ONLY TO 
MAIL ORDER.—The negotiated prices under this sub-
section shall apply to prescription drugs that are 
available other than solely through mail order. 
‘‘(4) PROHIBITION ON CHARGES FOR REQUIRED 
SERVICES.—An eligible entity (and any pharmacy
152
contracting with such entity for the provision of a 
discount under this section) may not charge a bene-
ficiary any amount for any services required to be 
provided by the entity under this section. 
‘‘(5) DISCLOSURE.—The eligible entity offering 
the endorsed program shall disclose to the Secretary 
(in a manner specified by the Secretary) the extent 
to which discounts or rebates or other remuneration 
or price concessions made available to the entity by 
a manufacturer are passed through to enrollees 
through pharmacies and other dispensers or other-
wise. The provisions of section 1927(b)(3)(D) shall 
apply to information disclosed to the Secretary 
under this paragraph in the same manner as such 
provisions apply to information disclosed under such 
section. 
‘‘(6) PUBLIC DISCLOSURE OF PHARMACEUTICAL 
PRICES FOR EQUIVALENT DRUGS.—Each eligible en-
tity shall provide that each pharmacy or other dis-
penser that arranges for the dispensing of a covered 
outpatient drug in connection with its endorsed pro-
gram shall inform the enrollee in that program at 
the time of purchase of the drug of any differential 
between the price of the prescribed drug to the en-
rollee and the price of the lowest cost available ge-
153
neric drug covered under the program that is thera-
peutically equivalent and bioequivalent. 
‘‘(j) CONTRIBUTION INTO PRESCRIPTION DRUG AC-
COUNT.—
‘‘(1) IN GENERAL.—In the case of an individual 
enrolled under this section, the Secretary shall—
‘‘(A) establish a prescription drug account 
for the individual under section 1807A; and 
‘‘(B) subject to paragraph (5), deposit into 
such account on a monthly or other periodic 
basis an amount that, on an annual basis, is 
equivalent to the annual Federal contribution 
amount specified in paragraph (2) for the en-
rollee involved. 
‘‘(2) 
ANNUAL
FEDERAL
CONTRIBUTION 
AMOUNT.—Subject to paragraph (3), in the case of 
an accountholder whose income is—
‘‘(A) not more than 135 percent of the 
poverty line, the annual Federal contribution 
amount for a year is $800; 
‘‘(B) more than 135 percent, but not more 
than 150 percent, of the poverty line, the an-
nual Federal contribution amount for a year is 
$500; or
154
‘‘(C) more than 150 percent of the poverty 
line, the annual Federal contribution amount 
for a year is $100. 
‘‘(3) INCOME ELIGIBILITY DETERMINATIONS.—
The determination of whether an individual residing 
in a State is a eligible for a contribution under para-
graph (1) shall be determined under the State med-
icaid plan for the State under section 1935(a) or by 
the Social Security Administration. In the case of a 
State that does not operate such a medicaid plan 
(either under title XIX or under a statewide waiver 
granted under section 1115), such determination 
shall be made under arrangements made by the Sec-
retary. There are authorized to be appropriated to 
the Social Security Administration such sums as 
may be necessary for the determination of eligibility 
under this paragraph. 
‘‘(4) PARTIAL YEAR.—Insofar as the provisions 
of this subsection and section 1807A are not imple-
mented for all months in 2004, the annual contribu-
tion amount under this subsection for 2004 shall be 
prorated to reflect the portion of that year in which 
such provisions are in effect. 
‘‘(5) RESTRICTION ON CONTRIBUTIONS.—There 
shall only be an annual Federal contribution under
155
paragraph (1) for an individual if the individual is 
not eligible for coverage of, or assistance for, out-
patient prescription drugs under any of the fol-
lowing: 
‘‘(A) A medicaid plan under title XIX (in-
cluding under any waiver approved under sec-
tion 1115). 
‘‘(B) Enrollment under a group health 
plan or health insurance coverage. 
‘‘(C) Enrollment under a medicare supple-
mental insurance policy. 
‘‘(D) Chapter 55 of title 10, United States 
Code (relating to medical and dental care for 
members of the uniformed services). 
‘‘(E) Chapter 17 of title 38, United States 
Code (relating to Veterans’ medical care). 
‘‘(F) Enrollment under a plan under chap-
ter 89 of title 5, United States Code (relating 
to the Federal employees’ health benefits pro-
gram). 
‘‘(G) The Indian Health Care Improve-
ment Act (25 U.S.C. 1601 et seq.). 
‘‘(6) APPROPRIATION TO COVER NET PROGRAM 
EXPENDITURES.—There are authorized to be appro-
priated from time to time, out of any moneys in the
156
Treasury not otherwise appropriated, to the Federal 
Supplementary Medical Insurance Trust Fund es-
tablished under section 1841, an amount equal to 
the amount by which the benefits and administrative 
costs of providing the benefits under this section ex-
ceed the sum of the portion of the enrollment fees 
retained by the Secretary. 
‘‘(k) DEFINITIONS.—In this part and section 1807A: 
‘‘(1) COVERED OUTPATIENT DRUG.—
‘‘(A) IN GENERAL.—Except as provided in 
this paragraph, for purposes of this section, the 
term ‘covered outpatient drug’ means—
‘‘(i) a drug that may be dispensed 
only upon a prescription and that is de-
scribed in subparagraph (A)(i) or (A)(ii) of 
section 1927(k)(2); or 
‘‘(ii) a biological product described in 
clauses (i) through (iii) of subparagraph 
(B) of such section or insulin described in 
subparagraph (C) of such section and med-
ical supplies associated with the injection 
of insulin (as defined in regulations of the 
Secretary), 
and such term includes a vaccine licensed under 
section 351 of the Public Health Service Act
157
and any use of a covered outpatient drug for a 
medically accepted indication (as defined in sec-
tion 1927(k)(6)). 
‘‘(B) EXCLUSIONS.—
‘‘(i) IN
GENERAL.—Such term does 
not include drugs or classes of drugs, or 
their medical uses, which may be excluded 
from coverage or otherwise restricted 
under section 1927(d)(2), other than sub-
paragraph (E) thereof (relating to smoking 
cessation 
agents), 
or 
under 
section 
1927(d)(3). 
‘‘(ii) AVOIDANCE OF DUPLICATE COV-
ERAGE.—A drug prescribed for an indi-
vidual that would otherwise be a covered 
outpatient drug under this section shall 
not be so considered if payment for such 
drug is available under part A or B for an 
individual entitled to benefits under part A 
and enrolled under part B. 
‘‘(C) APPLICATION
OF
FORMULARY
RE-
STRICTIONS.—A drug prescribed for an indi-
vidual that would otherwise be a covered out-
patient drug under this section shall not be so 
considered under an endorsed program if the el-
158
igible entity offering the program excludes the 
drug under a formulary and a review of such 
exclusion is not successfully resolved under sub-
section (h)(5). 
‘‘(D) APPLICATION OF GENERAL EXCLU-
SION PROVISIONS.—An eligible entity offering 
an endorsed program may exclude from quali-
fied prescription drug coverage any covered out-
patient drug—
‘‘(i) for which payment would not be 
made if section 1862(a) applied to part D; 
or 
‘‘(ii) which are not prescribed in ac-
cordance with the program or this section. 
Such exclusions are determinations subject to 
review pursuant to subsection (h)(5). 
‘‘(2) POVERTY LINE.—The term ‘poverty line’ 
means the income official poverty line (as defined by 
the Office of Management and Budget, and revised 
annually in accordance with section 673(2) of the 
Omnibus Budget Reconciliation Act of 1981) appli-
cable to a family of the size involved. 
‘‘(l) AUTHORIZATION OF APPROPRIATIONS.—There 
are authorized to be appropriated such sums as may be 
necessary to carry out this section and section 1807A.
159
‘‘(e) INTERIM, FINAL REGULATORY AUTHORITY.—In 
order to carry out this section and section 1807A in a 
timely manner, the Secretary may promulgate regulations 
that take effect on an interim basis, after notice and pend-
ing opportunity for public comment. 
‘‘PRESCRIPTION DRUG ACCOUNTS 
‘‘SEC. 1807A. ‘‘(a) ESTABLISHMENT
OF
AC-
COUNTS.—
‘‘(1) IN GENERAL.—The Secretary shall estab-
lish and maintain for each eligible beneficiary who is 
enrolled under section 1807 at the time of enroll-
ment a prescription drug account (in this section 
and section 1807 referred to as an ‘account’). 
‘‘(2) RESERVE ACCOUNTS.—In cases described 
in 
subsections 
(b)(3)(A), 
(b)(3)(B)(i), 
and 
(b)(3)(B)(ii)(I), the Secretary shall establish and 
maintain for each surviving spouse who is not en-
rolled under section 1807 a reserve prescription drug 
account (in this section referred to as an ‘reserve ac-
count’). 
‘‘(3) ACCOUNTHOLDER DEFINED.—In this sec-
tion and section 1807A, the term ‘accountholder’ 
means an individual for whom an account or reserve 
account has been established under this section. 
‘‘(4) EXPENDITURES
FROM
ACCOUNT.—Noth-
ing in this section shall be construed as requiring
160
the Federal Government to obligate funds for 
amounts in any account until such time as a with-
drawal from such account is authorized under this 
section. 
‘‘(b) USE OF ACCOUNTS.—
‘‘(1) APPLICATION
OF
ACCOUNT.—Except as 
provided in this subsection, amounts credited to an 
account shall only be used for the purchase of cov-
ered outpatient drugs for the accountholder. Any 
amounts remaining at the end of a year remain 
available for expenditures in succeeding years. 
‘‘(2) ACCOUNT RULES FOR PUBLIC AND PRI-
VATE CONTRIBUTIONS.—The Secretary shall estab-
lish a ongoing process for the determination of the 
amount in each account that is attributable to public 
and private contributions (including spousal rollover 
contributions) based on the following rules: 
‘‘(A) TREATMENT
OF
EXPENDITURES.—
Expenditures from the account shall—
‘‘(i) first be counted against any pub-
lic contribution; and 
‘‘(ii) next be counted against private 
contributions. 
‘‘(B) TREATMENT OF SPOUSAL ROLLOVER 
CONTRIBUTIONS.—With respect to any spousal
161
rollover contribution, the portions of such con-
tribution that were attributable to public and 
private contributions at the time of its distribu-
tion under subsection (b)(3) shall be treated 
under this paragraph as if it were a direct pub-
lic or private contribution, respectively, into the 
account of the spouse. 
‘‘(3) DEATH OF ACCOUNTHOLDER.—In the case 
of the death of an accountholder, the balance in any 
account (taking into account liabilities accrued be-
fore the time of death) shall be distributed as fol-
lows: 
‘‘(A) TREATMENT OF PUBLIC CONTRIBU-
TIONS.—If the accountholder is married at the 
time of death, the amount in the account that 
is attributable to public contributions shall be 
credited to the account (if any) of the surviving 
spouse of the accountholder (or, if the surviving 
spouse is not an eligible beneficiary, into a re-
serve account to be held for when that spouse 
becomes an eligible beneficiary). 
‘‘(B) TREATMENT OF PRIVATE CONTRIBU-
TIONS.—The amount in the account that is at-
tributable to private contributions shall be dis-
tributed as follows:
162
‘‘(i) 
DESIGNATION
OF
DIS-
TRIBUTEE.—If 
the 
accountholder 
has 
made a designation, in a form and manner 
specified by the Secretary, for the distribu-
tion of some or all of such amount, such 
amount shall be distributed in accordance 
with the designation. Such designation 
may provide for the distribution into an 
account (including a reserve account) of a 
surviving spouse. 
‘‘(ii) ABSENCE OF DESIGNATION.—In-
sofar as the accountholder has not made 
such a designation—
‘‘(I) SURVIVING SPOUSE.—If the 
accountholder was married at the time 
of death, the remainder shall be cred-
ited to an account (including a reserve 
account) of the accountholder’s sur-
viving spouse. 
‘‘(II) NO SURVIVING SPOUSE.—If 
the accountholder was not so married, 
the remainder shall be distributed to 
the estate of the accountholder and 
distributed as provided by law.
163
‘‘(4) USE OF ACCOUNT FOR PREMIUMS FOR EN-
ROLLMENT
IN
A
MEDICARE
ADVANTAGE
PLAN.—
During any period in which an accountholder is en-
rolled in a Medicare Advantage plan under part C, 
the balance in the account may be used and applied 
only to reimburse the amount of the premium (if 
any) established for enrollment under the plan. 
‘‘(5) APPLICATION TO MEDICAID EXPENSES IN 
CERTAIN CASES.—
‘‘(A) IN GENERAL.—Except as provided in 
this paragraph, an account shall be treated as 
an asset for purposes of establishing eligibility 
for medical assistance under title XIX. 
‘‘(B) 
APPLICATION
TOWARDS 
SPENDDOWN.—In the case of an accountholder 
who is applying for such medical assistance and 
who would, but for the application of subpara-
graph (A), be eligible for such assistance—
‘‘(i) subparagraph (A) shall not apply; 
and 
‘‘(ii) the account shall be available (in 
accordance with a procedure established by 
the Secretary) to the State to reimburse 
the State for any expenditures made under 
the plan for such medical assistance.
164
‘‘(c) AMOUNTS CREDITED IN ACCOUNT.—The Sec-
retary shall credit to a prescription drug account of an 
eligible beneficiary the following amounts: 
‘‘(1) PUBLIC
CONTRIBUTIONS.—The following 
contributions (each referred to in this section as a 
‘public contribution’): 
‘‘(A) FEDERAL CONTRIBUTIONS.—Federal 
contributions provided under subsection (d). 
‘‘(B) STATE
CONTRIBUTIONS.—Contribu-
tions made by a State under subsection (f). 
‘‘(2) SPOUSAL
ROLLOVER
CONTRIBUTION.—A 
distribution from a deceased spouse under sub-
section (b)(3) (referred to in this section as a ‘spous-
al rollover contribution’). 
‘‘(3) PRIVATE CONTRIBUTIONS.—The following 
contributions (each referred to in this section as a 
‘private contribution’): 
‘‘(A) EMPLOYER
AND
INDIVIDUAL
CON-
TRIBUTIONS.—Contributions made under sub-
section (e). 
‘‘(B) 
OTHER
INDIVIDUAL
CONTRIBU-
TIONS.—Contributions made by accountholder 
other than under subsection (e). 
‘‘(C) CONTRIBUTIONS BY NONPROFIT OR-
GANIZATIONS.—Contributions made by a chari-
165
table, not-for-profit organization (that may be a 
religious organization). 
Except as provided in this subsection, no amounts may 
be contributed to, or credited to, a prescription drug ac-
count. 
‘‘(d) FEDERAL CONTRIBUTION.—For Federal con-
tributions in the case of accountholders, see section 
1807(j). 
‘‘(e) 
EMPLOYER
AND
INDIVIDUAL
CONTRIBU-
TIONS.—
‘‘(1) EMPLOYMENT-RELATED CONTRIBUTION.—
‘‘(A) IN
GENERAL.—In the case of any 
accountholder who is a beneficiary or partici-
pant in a group health plan (including a multi-
employer plan), whether as an employee, former 
employee or otherwise, including as a dependent 
of an employee or former employee, the plan 
may 
make 
a 
contribution 
into 
the 
accountholder’s account (but not into a reserve 
account of the accountholder). 
‘‘(B) LIMITATION.—The total amount that 
may be contributed under subparagraph (A) 
under a plan to an account during any year 
may not exceed $5,000.
166
‘‘(C) CONDITION.—A group health plan 
may condition a contribution with respect to an 
accountholder under this paragraph on the 
accountholder’s enrollment under section 1807 
with an eligible entity that is recognized or ap-
proved by that plan. 
‘‘(2) OTHER INDIVIDUALS.—
‘‘(A) IN
GENERAL.—Any individual may 
also contribute to the account of that individual 
or the account of any other individual under 
this subsection. 
‘‘(B) LIMITATION.—The total amount that 
may be contributed to an account under sub-
paragraph (A) during any year may not exceed 
$5,000, regardless of who makes such contribu-
tion. 
‘‘(3) NO
CONTRIBUTION
PERMITTED
TO
RE-
SERVE
ACCOUNT.—No contribution may be made 
under this subsection to a reserve account. 
‘‘(4) FORM AND MANNER OF CONTRIBUTION.—
The Secretary shall specify the form and manner of 
contributions under this subsection. 
‘‘(f) STATE CONTRIBUTIONS.—
167
‘‘(1) IN GENERAL.—A State may enter into ar-
rangements with the Secretary for the crediting of 
amounts for accountholders. 
‘‘(2) FORM AND MANNER OF CONTRIBUTION.—
The Secretary shall specify the form and manner of 
contributions under this subsection. 
‘‘(3) MEDICAID
TREATMENT.—Amounts cred-
ited under this subsection shall not be treated as 
medical assistance for purposes of title XIX or child 
health assistance for purposes of title XXI for indi-
viduals who are not qualifying low income enroll-
ees.’’. 
(b) EXCLUSION OF COSTS FROM DETERMINATION OF 
PART B MONTHLY PREMIUM.—Section 1839(g) (42 
U.S.C. 1395r(g)) is amended—
(1) by striking ‘‘attributable to the application 
of section’’ and inserting ‘‘attributable to—
‘‘(1) the application of section’’; 
(2) by striking the period and inserting ‘‘; 
and’’; and 
(3) by adding at the end the following new 
paragraph: 
‘‘(2) the Voluntary Medicare Outpatient Pre-
scription Drug Discount and Security Program 
under sections 1807 and 1807A.’’.
168
(c) STATE ELIGIBILITY DETERMINATIONS.—Section 
1935, as added by section 103(a)(2), is amended—
(1) in subsection (a)(1), by inserting ‘‘and of 
eligibility for an annual Federal contribution amount 
under section 1807A(j)(2)’’ before the semicolon; 
and 
(2) in subsection (a)(3), by inserting ‘‘and sec-
tions 1807 and 1807A’’ after ‘‘1860D–7)’’.
(d) REPORT ON PROGRESS IN IMPLEMENTATION OF 
PRESCRIPTION DRUG BENEFIT.—Not later than March 1, 
2005, the Administrator shall submit a report to Congress 
on the progress that has been made in implementing the 
prescription drug benefit under this title. The Adminis-
trator shall include in the report specific steps that have 
been taken, and that need to be taken, to ensure a timely 
start of the program on January 1, 2006. 
SEC. 106. DISCLOSURE OF RETURN INFORMATION FOR 
PURPOSES OF CARRYING OUT MEDICARE 
CATASTROPHIC PRESCRIPTION DRUG PRO-
GRAM. 
(a) DISCLOSURE.—
(1) IN
GENERAL.—Subsection (l) of section 
6103 of the Internal Revenue Code of 1986 (relating 
to disclosure of returns and return information for
169
purposes other than tax administration) is amended 
by adding at the end the following new paragraph: 
‘‘(19) DISCLOSURE OF RETURN INFORMATION 
FOR PURPOSES OF CARRYING OUT MEDICARE CATA-
STROPHIC PRESCRIPTION DRUG PROGRAM.—
‘‘(A) IN
GENERAL.—The Secretary may, 
upon written request from the Secretary of 
Health and Human Services under section 
1860D–2(b)(4)(E)(i) of the Social Security Act, 
disclose to officers and employees of the De-
partment of Health and Human Services with 
respect to a specified taxpayer for the taxable 
year specified by the Secretary of Health and 
Human Services in such request—
‘‘(i) the taxpayer identity information 
with respect to such taxpayer, and 
‘‘(ii) the adjusted gross income of 
such taxpayer for the taxable year (or, if 
less, the income threshold limit specified in 
section 1860D–2(b)(4)(D)(ii) for the cal-
endar year specified by such Secretary in 
such request). 
‘‘(B) SPECIFIED
TAXPAYER.—For pur-
poses of this paragraph, the term ‘specified tax-
payer’ means any taxpayer who—
170
‘‘(i) is identified by the Secretary of 
Health and Human Services in the request 
referred to in subparagraph (A), and 
‘‘(ii) either—
‘‘(I) has an adjusted gross in-
come for the taxable year referred to 
in subparagraph (A) in excess of the 
income threshold specified in section 
1860D–2(b)(4)(D)(ii) of such Act for 
the calendar year referred to in such 
subparagraph, or 
‘‘(II) is identified by such Sec-
retary under subparagraph (A) as 
being an individual who elected to use 
more recent information under section 
1860D–2(b)(4)(D)(v) of such Act. 
‘‘(C) JOINT RETURNS.—In the case of a 
joint return, the Secretary shall, for purposes of 
applying this paragraph, treat each spouse as a 
separate taxpayer having an adjusted gross in-
come equal to one-half of the adjusted gross in-
come determined with respect to such return. 
‘‘(D) RESTRICTION ON USE OF DISCLOSED 
INFORMATION.—Return information disclosed 
under subparagraph (A) may be used by offi-
171
cers and employees of the Department of 
Health and Human Services only for the pur-
pose of administering the prescription drug ben-
efit under title XVIII of the Social Security 
Act. Such officers and employees may disclose 
the annual out-of-pocket threshold which ap-
plies to an individual under such part to the en-
tity that offers the plan referred to in section 
1860D–2(b)(4)(E)(ii) of such Act in which such 
individual is enrolled. Such sponsor may use 
such information only for purposes of admin-
istering such benefit.’’. 
(2) JOINT
RETURN
PERMITTED
IN
CASE
OF 
SURVIVING SPOUSES.—Under section 6103(a)(3) of 
the Internal Revenue Code of 1986, a surviving 
spouse may file a joint return for the taxable year 
in which one spouse dies. 
(b) CONFIDENTIALITY.—Paragraph (3) of section 
6103(a) of such Code is amended by striking ‘‘or (16)’’ 
and inserting ‘‘(16), or (19)’’. 
(c) PROCEDURES AND RECORDKEEPING RELATED 
TO DISCLOSURES.—Subsection (p)(4) of section 6103 of 
such Code is amended by striking ‘‘any other person de-
scribed in subsection (l)(16) or (17)’’ each place it appears
172
and inserting ‘‘any other person described in subsection 
(l)(16), (17), or (19)’’. 
(d) UNAUTHORIZED DISCLOSURE.—Paragraph (2) of 
section 7213(a) of such Code is amended by striking ‘‘or 
(16)’’ and inserting ‘‘(16), or (19)’’. 
(e) UNAUTHORIZED
INSPECTION.—Subparagraph 
(B) of section 7213A(a)(1) of such Code is amended by 
inserting ‘‘or (19)’’ after ‘‘subsection (l)(18)’’.
SEC. 107. STATE PHARMACEUTICAL ASSISTANCE TRANSI-
TION COMMISSION. 
(a) ESTABLISHMENT.—
(1) IN GENERAL.—There is established, as of 
the first day of the third month beginning after the 
date of the enactment of this Act, a State Pharma-
ceutical Assistance Transition Commission (in this 
section referred to as the ‘‘Commission’’) to develop 
a proposal for addressing the unique transitional 
issues facing State pharmaceutical assistance pro-
grams, and program participants, due to the imple-
mentation of the medicare prescription drug pro-
gram under part D of title XVIII of the Social Secu-
rity Act. 
(2) DEFINITIONS.—For purposes of this sec-
tion:
173
(A) STATE PHARMACEUTICAL ASSISTANCE 
PROGRAM DEFINED.—The term ‘‘State pharma-
ceutical assistance program’’ means a program 
(other than the medicaid program) operated by 
a State (or under contract with a State) that 
provides as of the date of the enactment of this 
Act assistance to low-income medicare bene-
ficiaries for the purchase of prescription drugs. 
(B) PROGRAM
PARTICIPANT.—The term 
‘‘program participant’’ means a low-income 
medicare beneficiary who is a participant in a 
State pharmaceutical assistance program. 
(b) COMPOSITION.—The Commission shall include 
the following: 
(1) A representative of each governor of each 
State that the Secretary identifies as operating on a 
statewide basis a State pharmaceutical assistance 
program that provides for eligibility and benefits 
that are comparable or more generous than the low-
income assistance eligibility and benefits offered 
under part D of title XVIII of the Social Security 
Act. 
(2) Representatives from other States that the 
Secretary identifies have in operation other State
174
pharmaceutical assistance programs, as appointed by 
the Secretary. 
(3) Representatives of organizations that have 
an inherent interest in program participants or the 
program itself, as appointed by the Secretary but 
not to exceed the number of representatives under 
paragraphs (1) and (2). 
(4) Representatives of Medicare Advantage or-
ganizations and other private health insurance plans, 
as appointed by the Secretary. 
(5) The Secretary (or the Secretary’s designee) 
and such other members as the Secretary may speci-
fy 
The Secretary shall designate a member to serve as chair 
of the Commission and the Commission shall meet at the 
call of the chair. 
(c) DEVELOPMENT OF PROPOSAL.—The Commission 
shall develop the proposal described in subsection (a) in 
a manner consistent with the following principles: 
(1) Protection of the interests of program par-
ticipants in a manner that is the least disruptive to 
such participants and that includes a single point of 
contact for enrollment and processing of benefits.
175
(2) Protection of the financial and flexibility in-
terests of States so that States are not financially 
worse off as a result of the enactment of this title. 
(3) Principles of medicare modernization pro-
vided under title II of this Act. 
(d) REPORT.—By not later than January 1, 2005, 
the Commission shall submit to the President and the 
Congress a report that contains a detailed proposal (in-
cluding specific legislative or administrative recommenda-
tions, if any) and such other recommendations as the 
Commission deems appropriate. 
(e) SUPPORT.—The Secretary shall provide the Com-
mission with the administrative support services necessary 
for the Commission to carry out its responsibilities under 
this section. 
(f) TERMINATION.—The Commission shall terminate 
30 days after the date of submission of the report under 
subsection (d). 
SEC. 108. ADDITIONAL REQUIREMENTS FOR ANNUAL FI-
NANCIAL REPORT AND OVERSIGHT ON MEDI-
CARE PROGRAM, INCLUDING PRESCRIPTION 
DRUG SPENDING. 
(a) IN GENERAL.—Section 1817 (42 U.S.C. 1395i) 
is amended by adding at the end the following new sub-
section:
176
‘‘(l) COMBINED REPORT ON OPERATION AND STATUS 
OF THE TRUST FUND, THE FEDERAL SUPPLEMENTARY 
MEDICAL INSURANCE TRUST FUND, AND MEDICARE 
PRESCRIPTION DRUG TRUST FUND.—
‘‘(1) IN GENERAL.—In addition to the duty of 
the Board of Trustees to report to Congress under 
subsection (b), on the date the Board submits the 
report required under subsection (b)(2), the Board 
shall submit to Congress a report on the operation 
and status of the Trust Fund, the Federal Supple-
mentary Medical Insurance Trust Fund established 
under section 1841, and the Medicare Prescription 
Drug Trust Fund under section 1860D–9(a) (in this 
subsection collectively referred to as the ‘Trust 
Funds’). Such report shall included the following in-
formation: 
‘‘(A) OVERALL SPENDING FROM THE GEN-
ERAL FUND OF THE TREASURY.—A statement 
of total amounts obligated during the preceding 
fiscal year from the General Revenues of the 
Treasury to the Trust Funds for payment for 
benefits covered under this title, stated in terms 
of the total amount and in terms of the per-
centage such amount bears to all other amounts
177
obligated from such General Revenues during 
such fiscal year. 
‘‘(B) HISTORICAL
OVERVIEW
OF
SPEND-
ING.—From the date of the inception of the 
program of insurance under this title through 
the fiscal year involved, a statement of the total 
amounts referred to in subparagraph (A). 
‘‘(C) 
10-YEAR
AND
75-YEAR
PROJEC-
TIONS.—An estimate of total amounts referred 
to in subparagraph (A) required to be obligated 
for payment for benefits covered under this title 
for each of the 10 fiscal years succeeding the 
fiscal year involved and for the 75-year period 
beginning with the succeeding fiscal year. 
‘‘(D) RELATION
TO
GDP
GROWTH.—A 
comparison of the rate of growth of the total 
amounts referred to in subparagraph (A) to the 
rate of growth in the gross domestic product for 
the same period. 
‘‘(2) PUBLICATION.—Each report submitted 
under paragraph (1) shall be published jointly by the 
Committee on Ways and Means and the Committee 
on Energy and Commerce as a public document and 
shall be made available by such Committees on the 
Internet.’’.
178
(b) EFFECTIVE DATE.—The amendment made by 
subsection (a) shall apply with respect to fiscal years be-
ginning on or after the date of the enactment of this Act.
TITLE II—MEDICARE ENHANCED 
FEE-FOR-SERVICE AND MEDI-
CARE 
ADVANTAGE 
PRO-
GRAMS; MEDICARE COMPETI-
TION 
SEC. 200. MEDICARE MODERNIZATION AND REVITALIZA-
TION. 
This title provides for—
(1) establishment of the medicare enhanced fee-
for-service (EFFS) program under which medicare 
beneficiaries are provided access to a range of en-
hanced fee-for-service (EFFS) plans that may use 
preferred provider networks to offer an enhanced 
range of benefits; 
(2) establishment of a Medicare Advantage pro-
gram that offers improved managed care plans with 
coordinated care; and 
(3) competitive bidding, in the style of the Fed-
eral Employees Health Benefits program (FEHBP), 
among enhanced fee-for-service plans and Medicare 
Advantage plans in order to promote greater effi-
ciency and responsiveness to medicare beneficiaries.
179
Subtitle A—Medicare Enhanced 
Fee-for-Service Program 
SEC. 201. ESTABLISHMENT OF ENHANCED FEE-FOR-SERV-
ICE (EFFS) PROGRAM UNDER MEDICARE. 
(a) IN GENERAL.—Title XVIII, as amended by sec-
tion 101(a), is amended—
(1) by redesignating part E as part F; and 
(2) by inserting after part D the following new 
part:
‘‘PART E—ENHANCED FEE-FOR-SERVICE PROGRAM 
‘‘OFFERING OF ENHANCED FEE-FOR-SERVICE PLANS 
THROUGHOUT THE UNITED STATES 
‘‘SEC. 1860E–1. (a) ESTABLISHMENT
OF
PRO-
GRAM.—
‘‘(1) IN GENERAL.—The Administrator shall es-
tablish under this part beginning January 1, 2006, 
an enhanced fee-for-service program under which en-
hanced fee-for-service plans (as defined in subsection 
(b)) are offered to EFFS-eligible individuals (as so 
defined) in EFFS regions throughout the United 
States. 
‘‘(2) EFFS REGIONS.—For purposes of this 
part the Administrator shall establish EFFS regions 
throughout the United States by dividing the entire 
United States into at least 10 such regions. Before
180
establishing such regions, the Administrator shall 
conduct a market survey and analysis, including an 
examination of current insurance markets, to deter-
mine how the regions should be established. The re-
gions shall be established in a manner to take into 
consideration maximizing full access for all EFFS-
eligible individuals, especially those residing in rural 
areas. 
‘‘(b) DEFINITIONS.—For purposes of this part: 
‘‘(1) EFFS ORGANIZATION.—The ‘EFFS orga-
nization’ means an entity that the Administrator 
certifies as meeting the requirements and standards 
applicable to such organization under this part. 
‘‘(2) ENHANCED FEE-FOR-SERVICE PLAN; EFFS 
PLAN.—The terms ‘enhanced fee-for-service plan’ 
and ‘EFFS plan’ mean health benefits coverage of-
fered under a policy, contract, or plan by an EFFS 
organization pursuant to and in accordance with a 
contract pursuant to section 1860E–4(c), but only if 
the plan provides either fee-for-service coverage de-
scribed in the following subparagraph (A) or pre-
ferred provider coverage described in the following 
subparagraph (B): 
‘‘(A) FEE-FOR-SERVICE
COVERAGE.—The 
plan—
181
‘‘(i) reimburses hospitals, physicians, 
and other providers at a rate determined 
by the plan on a fee-for-service basis with-
out placing the provider at financial risk; 
‘‘(ii) does not vary such rates for such 
a provider based on utilization relating to 
such provider; and 
‘‘(iii) does not restrict the selection of 
providers among those who are lawfully au-
thorized to provide the covered services 
and agree to accept the terms and condi-
tions of payment established by the plan. 
‘‘(B) PREFERRED PROVIDER COVERAGE.—
The plan—
‘‘(i) has a network of providers that 
have agreed to a contractually specified re-
imbursement for covered benefits with the 
organization offering the plan; and 
‘‘(ii) provides for reimbursement for 
all covered benefits regardless of whether 
such benefits are provided within such net-
work of providers. 
‘‘(3) EFFS ELIGIBLE INDIVIDUAL.—The term 
‘EFFS eligible individual’ means an eligible indi-
vidual described in section 1851(a)(3).
182
‘‘(4) EFFS REGION.—The term ‘EFFS region’ 
means a region established under subsection (a)(2). 
‘‘(c) APPLICATION OF CERTAIN ELIGIBILITY, EN-
ROLLMENT, ETC. REQUIREMENTS.—The provisions of 
section 1851 (other than subsection (h)(4)(A)) shall apply 
to EFFS plans offered by an EFFS organization in an 
EFFS region, including subsection (g) (relating to guar-
anteed issue and renewal). 
‘‘OFFERING OF ENHANCED FEE-FOR-SERVICE (EFFS) 
PLANS 
‘‘SEC. 1860E–2. (a) PLAN REQUIREMENTS.—No 
EFFS plan may be offered under this part in an EFFS 
region unless the requirements of this part are met with 
respect to the plan and EFFS organization offering the 
plan. 
‘‘(b) AVAILABLE TO ALL EFFS BENEFICIARIES IN 
THE ENTIRE REGION.—With respect to an EFFS plan 
offered in an EFFS region—
‘‘(1) IN GENERAL.—The plan must be offered 
to all EFFS-eligible individuals residing in the re-
gion. 
‘‘(2) ASSURING
ACCESS
TO
SERVICES.—The 
plan shall comply with the requirements of section 
1852(d)(4). 
‘‘(c) BENEFITS.—
183
‘‘(1) IN GENERAL.—Each EFFS plan shall pro-
vide to members enrolled in the plan under this part 
benefits, through providers and other persons that 
meet the applicable requirements of this title and 
part A of title XI—
‘‘(A) for the items and services described 
in section 1852(a)(1); 
‘‘(B) that are uniform for the plan for all 
EFFS eligible individuals residing in the same 
EFFS region; 
‘‘(C) that include a single deductible appli-
cable to benefits under parts A and B and in-
clude a catastrophic limit on out-of-pocket ex-
penditures for such covered benefits; and 
‘‘(D) that include benefits for prescription 
drug coverage for each enrollee who elects 
under part D to be provided qualified prescrip-
tion drug coverage through the plan.
‘‘(2) DISAPPROVAL AUTHORITY.—The Adminis-
trator shall not approve a plan of an EFFS organi-
zation if the Administrator determines (pursuant to 
the last sentence of section 1852(b)(1)(A)) that the 
benefits are designed to substantially discourage en-
rollment by certain EFFS eligible individuals with 
the organization.
184
‘‘(d) 
OUTPATIENT
PRESCRIPTION
DRUG
COV-
ERAGE.—For rules concerning the offering of prescription 
drug coverage under EFFS plans, see the amendment 
made by section 102(b) of the Medicare Prescription Drug 
and Modernization Act of 2003. 
‘‘(e) OTHER ADDITIONAL PROVISIONS.—The provi-
sions of section 1852 (other than subsection (a)(1)) shall 
apply under this part to EFFS plans. For the application 
of chronic care improvement provisions, see the amend-
ment made by section 722(b). 
‘‘SUBMISSION OF BIDS; BENEFICIARY SAVINGS; PAYMENT 
OF PLANS 
‘‘SEC. 1860E–3. (a) SUBMISSION OF BIDS.—
‘‘(1) REQUIREMENT.—
‘‘(A) EFFS MONTHLY BID AMOUNT.—For 
each year (beginning with 2006), an EFFS or-
ganization shall submit to the Administrator an 
EFFS monthly bid amount for each EFFS 
plan offered in each region. Each such bid is re-
ferred to in this section as the ‘EFFS monthly 
bid amount’. 
‘‘(B) FORM.—Such bid amounts shall be 
submitted for each such plan and region in a 
form and manner and time specified by the Ad-
ministrator, and shall include information de-
scribed in paragraph (3)(A).
185
‘‘(2) UNIFORM
BID
AMOUNTS.—Each EFFS 
monthly bid amount submitted under paragraph (1) 
by an EFFS organization under this part for an 
EFFS plan in an EFFS region may not vary among 
EFFS eligible individuals residing in the EFFS re-
gion involved. 
‘‘(3) SUBMISSION OF BID AMOUNT INFORMA-
TION BY EFFS ORGANIZATIONS.—
‘‘(A) INFORMATION TO BE SUBMITTED.—
The information described in this subparagraph 
is as follows: 
‘‘(i) The EFFS monthly bid amount 
for provision of all items and services 
under this part, which amount shall be 
based on average costs for a typical bene-
ficiary residing in the region, and the actu-
arial basis for determining such amount. 
‘‘(ii) The proportions of such bid 
amount that are attributable to—
‘‘(I) the provision of statutory 
non-drug benefits (such portion re-
ferred 
to 
in 
this 
part 
as 
the 
‘unadjusted EFFS statutory non-drug 
monthly bid amount’);
186
‘‘(II) the provision of statutory 
prescription drug benefits; and 
‘‘(III) the provision of non-statu-
tory benefits; 
and the actuarial basis for determining 
such proportions. 
‘‘(iii) Such additional information as 
the Administrator may require to verify 
the actuarial bases described in clauses (i) 
and (ii). 
‘‘(B) STATUTORY
BENEFITS
DEFINED.—
For purposes of this part: 
‘‘(i) The term ‘statutory non-drug 
benefits’ means benefits under section 
1852(a)(1). 
‘‘(ii) The term ‘statutory prescription 
drug benefits’ means benefits under part 
D. 
‘‘(iii) The term ‘statutory benefits’ 
means statutory prescription drug benefits 
and statutory non-drug benefits.
‘‘(C) ACCEPTANCE AND NEGOTIATION OF 
BID AMOUNTS.—The Administrator has the au-
thority to negotiate regarding monthly bid 
amounts submitted under subparagraph (A)
187
(and the proportion described in subparagraph 
(A)(ii)), and for such purpose, the Adminis-
trator has negotiation authority that the Direc-
tor of the Office of Personnel Management has 
with respect to health benefits plans under 
chapter 89 of title 5, United States Code. The 
Administrator may reject such a bid amount or 
proportion if the Administrator determines that 
such amount or proportion is not supported by 
the actuarial bases provided under subpara-
graph (A). 
‘‘(D) CONTRACT
AUTHORITY.—The Ad-
ministrator may, taking into account the 
unadjusted EFFS statutory non-drug monthly 
bid amounts accepted under subparagraph (C), 
enter into contracts for the offering of EFFS 
plans by up to 3 EFFS organizations in any re-
gion.
‘‘(b) PROVISION OF BENEFICIARY SAVINGS FOR CER-
TAIN PLANS.—
‘‘(1) BENEFICIARY REBATE RULE.—
‘‘(A) REQUIREMENT.—The EFFS plan 
shall provide to the enrollee a monthly rebate 
equal to 75 percent of the average per capita
188
savings (if any) described in paragraph (2) ap-
plicable to the plan and year involved. 
‘‘(B) FORM
OF
REBATE.—A rebate re-
quired under this paragraph shall be provided—
‘‘(i) through the crediting of the 
amount of the rebate towards the EFFS 
monthly prescription drug beneficiary pre-
mium (as defined in section 1860E–
4(a)(3)(B)) and the EFFS monthly sup-
plemental beneficiary premium (as defined 
in section 1860E–4(a)(3)(C)); 
‘‘(ii) through a direct monthly pay-
ment (through electronic funds transfer or 
otherwise); or 
‘‘(iii) through other means approved 
by the Medicare Benefits Administrator, 
or any combination thereof. 
‘‘(2) COMPUTATION OF AVERAGE PER CAPITA 
MONTHLY
SAVINGS.—For purposes of paragraph 
(1)(A), the average per capita monthly savings re-
ferred to in such paragraph for an EFFS plan and 
year is computed as follows: 
‘‘(A) DETERMINATION
OF
REGION-WIDE 
AVERAGE RISK ADJUSTMENT.—
189
‘‘(i) IN
GENERAL.—The Medicare 
Benefits Administrator shall determine, at 
the same time rates are promulgated under 
section 1853(b)(1) (beginning with 2006), 
for each EFFS region the average of the 
risk adjustment factors described in sub-
section (c)(3) to be applied to enrollees 
under this part in that region. In the case 
of an EFFS region in which an EFFS 
plan was offered in the previous year, the 
Administrator may compute such average 
based upon risk adjustment factors applied 
under subsection (c)(3) in that region in a 
previous year. 
‘‘(ii) 
TREATMENT
OF
NEW
RE-
GIONS.—In the case of a region in which 
no EFFS plan was offered in the previous 
year, the Administrator shall estimate such 
average. In making such estimate, the Ad-
ministrator may use average risk adjust-
ment factors applied to comparable EFFS 
regions or applied on a national basis. 
‘‘(B) DETERMINATION OF RISK ADJUSTED 
BENCHMARK
AND
RISK-ADJUSTED
BID.—For
190
each EFFS plan offered in an EFFS region, 
the Administrator shall—
‘‘(i) adjust the EFFS region-specific 
non-drug monthly benchmark amount (as 
defined in paragraph (3)) by the applicable 
average risk adjustment factor computed 
under subparagraph (A); and 
‘‘(ii) adjust the unadjusted EFFS 
statutory non-drug monthly bid amount by 
such applicable average risk adjustment 
factor. 
‘‘(C) DETERMINATION
OF
AVERAGE
PER 
CAPITA MONTHLY SAVINGS.—The average per 
capita monthly savings described in this sub-
paragraph is equal to the amount (if any) by 
which—
‘‘(i) 
the 
risk-adjusted 
benchmark 
amount computed under subparagraph 
(B)(i), exceeds 
‘‘(ii) the risk-adjusted bid computed 
under subparagraph (B)(ii). 
‘‘(3) COMPUTATION OF EFFS REGION-SPECIFIC 
NON-DRUG
MONTHLY
BENCHMARK
AMOUNT.—For 
purposes of this part, the term ‘EFFS region-spe-
cific non-drug monthly benchmark amount’ means,
191
with respect to an EFFS region for a month in a 
year, an amount equal to 1⁄12 of the average (weight-
ed by number of EFFS eligible individuals in each 
payment area described in section 1853(d)) of the 
annual capitation rate as calculated under section 
1853(c)(1) for that area. 
‘‘(c) 
PAYMENT
OF
PLANS
BASED
ON
BID 
AMOUNTS.—
‘‘(1) NON-DRUG BENEFITS.—Under a contract 
under section 1860E–4(c) and subject to section 
1853(g) (as made applicable under subsection (d)), 
the Administrator shall make monthly payments 
under this subsection in advance to each EFFS or-
ganization, with respect to coverage of an individual 
under this part in an EFFS region for a month, in 
an amount determined as follows: 
‘‘(A) PLANS
WITH
BIDS
BELOW
BENCH-
MARK.—In the case of a plan for which there 
are average per capita monthly savings de-
scribed in subsection (b)(2)(C), the payment 
under this subsection is equal to the unadjusted 
EFFS statutory non-drug monthly bid amount, 
adjusted under paragraphs (3) and (4), plus the 
amount of the monthly rebate computed under 
subsection (b)(1)(A) for that plan and year.
192
‘‘(B) PLANS
WITH
BIDS
AT
OR
ABOVE 
BENCHMARK.—In the case of a plan for which 
there are no average per capita monthly savings 
described in subsection (b)(2)(C), the payment 
amount under this subsection is equal to the 
EFFS region-specific non-drug monthly bench-
mark amount, adjusted under paragraphs (3) 
and (4). 
‘‘(2) FOR FEDERAL DRUG SUBSIDIES.—In the 
case in which an enrollee who elects under part D 
to be provided qualified prescription drug coverage 
through the plan, the EFFS organization offering 
such plan also is entitled—
‘‘(A) to direct subsidy payment under sec-
tion 1860D–8(a)(1); 
‘‘(B) to reinsurance subsidy payments 
under section 1860D–8(a)(2); and 
‘‘(C) to reimbursement for premium and 
cost-sharing reductions for low-income individ-
uals under section 1860D–7(c)(3). 
‘‘(3) DEMOGRAPHIC
RISK
ADJUSTMENT, IN-
CLUDING ADJUSTMENT FOR HEALTH STATUS.—The 
Administrator shall adjust under paragraph (1)(A) 
the unadjusted EFFS statutory non-drug monthly 
bid amount and under paragraph (1)(B) the EFFS
193
region-specific non-drug monthly benchmark amount 
for such risk factors as age, disability status, gen-
der, institutional status, and such other factors as 
the Administrator determines to be appropriate, in-
cluding adjustment for health status under section 
1853(a)(3) (as applied under subsection (d)), so as 
to ensure actuarial equivalence. The Administrator 
may add to, modify, or substitute for such adjust-
ment factors if such changes will improve the deter-
mination of actuarial equivalence. 
‘‘(4) ADJUSTMENT FOR INTRA-REGIONAL GEO-
GRAPHIC VARIATIONS.—The Administrator shall also 
adjust such amounts in a manner to take into ac-
count variations in payments rates under part C 
among the different payment areas under such part 
included in each EFFS region. 
‘‘(d) 
APPLICATION
OF
ADDITIONAL
PAYMENT 
RULES.—The provisions of section 1853 (other than sub-
sections (a)(1)(A), (d), and (e)) shall apply to an EFFS 
plan under this part, except as otherwise provided in this 
section. 
‘‘PREMIUMS; ORGANIZATIONAL AND FINANCIAL REQUIRE-
MENTS; 
ESTABLISHMENT
OF
STANDARDS; 
CON-
TRACTS WITH EFFS ORGANIZATIONS 
‘‘SEC. 1860E–4. (a) PREMIUMS.—
194
‘‘(1) IN GENERAL.—The provisions of section 
1854 (other than subsections (a)(6)(C) and (h)), in-
cluding subsection (b)(5) relating to the consolida-
tion of drug and non-drug beneficiary premiums and 
subsection (c) relating to uniform bids and pre-
miums, shall apply to an EFFS plan under this 
part, subject to paragraph (2). 
‘‘(2) CROSS-WALK.—In applying paragraph (1), 
any reference in section 1854(b)(1)(A) or 1854(d) 
to—
‘‘(A) a Medicare Advantage monthly basic 
beneficiary premium is deemed a reference to 
the EFFS monthly basic beneficiary premium 
(as defined in paragraph (3)(A)); 
‘‘(B) a Medicare Advantage monthly pre-
scription drug beneficiary premium is deemed a 
reference to the EFFS monthly prescription 
drug beneficiary premium (as defined in para-
graph (3)(B)); and 
‘‘(C) a Medicare Advantage monthly sup-
plemental beneficiary premium is deemed a ref-
erence to the EFFS monthly supplemental ben-
eficiary premium (as defined in paragraph 
(3)(C)). 
‘‘(3) DEFINITIONS.—For purposes of this part:
195
‘‘(A) EFFS MONTHLY BASIC BENEFICIARY 
PREMIUM.—The term ‘EFFS monthly basic 
beneficiary premium’ means, with respect to an 
EFFS plan—
‘‘(i) described in section 1860E–
3(c)(1)(A) (relating to plans providing re-
bates), zero; or 
‘‘(ii) described in section 1860E–
3(c)(1)(B), the amount (if any) by which 
the unadjusted EFFS statutory non-drug 
monthly bid amount exceeds the EFFS re-
gion-specific non-drug monthly benchmark 
amount (as defined in section 1860E–
3(b)(3)). 
‘‘(B) 
EFFS 
MONTHLY
PRESCRIPTION 
DRUG
BENEFICIARY
PREMIUM.—The 
term 
‘EFFS monthly prescription drug beneficiary 
premium’ means, with respect to an EFFS 
plan, the portion of the aggregate monthly bid 
amount submitted under clause (i) of section 
1860E–3(a)(3)(A) for the year that is attrib-
utable under such section to the provision of 
statutory prescription drug benefits. 
‘‘(C) EFFS 
MONTHLY
SUPPLEMENTAL 
BENEFICIARY
PREMIUM.—The term ‘EFFS
196
monthly supplemental beneficiary premium’ 
means, with respect to an EFFS plan, the por-
tion of the aggregate monthly bid amount sub-
mitted under clause (i) of section 1860E–
3(a)(3)(A) for the year that is attributable 
under such section to the provision of nonstatu-
tory benefits.
‘‘(b) ORGANIZATIONAL
AND FINANCIAL REQUIRE-
MENTS.—The provisions of section 1855 shall apply to an 
EFFS plan offered by an EFFS organization under this 
part. 
‘‘(c) STANDARDS.—The provisions of paragraphs (1), 
(3), and (4) of section 1856(b) shall apply to an EFFS 
plan offered by an EFFS organization under this part. 
‘‘(d) CONTRACTS
WITH EFFS ORGANIZATIONS.—
The provisions of section 1857 shall apply to an EFFS 
plan offered by an EFFS organization under this part, 
except that any reference in such section to part C is 
deemed a reference to this part.’’. 
(b) APPLICATION
OF
MEDIGAP
PROVISIONS
TO 
EFFS PLANS.—Section 1882 of the Social Security Act 
(42 U.S.C. 1395ss) shall be administered as if any ref-
erence to a Medicare+Choice organization offering a 
Medicare+Choice plan under part C of title XVIII of such 
Act were a reference both to a Medicare Advantage orga-
197
nization offering a Medicare Advantage plan under such 
part and an EFFS organization offering an EFFS plan 
under part E of such title. 
Subtitle B—Medicare Advantage 
Program 
CHAPTER 1—IMPLEMENTATION OF 
PROGRAM 
SEC. 211. IMPLEMENTATION OF MEDICARE ADVANTAGE 
PROGRAM. 
(a) IN GENERAL.—There is hereby established the 
Medicare Advantage program. The Medicare Advantage 
program shall consist of the program under part C of title 
XVIII of the Social Security Act, as amended by this title. 
(b) REFERENCES.—Any reference to the program 
under part C of title XVIII of the Social Security Act shall 
be deemed a reference to the Medicare Advantage program 
and, with respect to such part, any reference to 
‘‘Medicare+Choice’’ is deemed a reference to ‘‘Medicare 
Advantage’’.
SEC. 212. MEDICARE ADVANTAGE IMPROVEMENTS. 
(a) EQUALIZING PAYMENTS WITH FEE-FOR-SERV-
ICE.—
(1) IN
GENERAL.—Section 1853(c)(1) (42 
U.S.C. 1395w–23(c)(1)) is amended by adding at 
the end the following:
198
‘‘(D) BASED
ON
100
PERCENT
OF
FEE-
FOR-SERVICE COSTS.—
‘‘(i) IN GENERAL.—For 2004, the ad-
justed average per capita cost for the year 
involved, 
determined 
under 
section 
1876(a)(4) for the Medicare Advantage 
payment area for services covered under 
parts A and B for individuals entitled to 
benefits under part A and enrolled under 
part B who are not enrolled in a Medicare 
Advantage under this part for the year, 
but adjusted to exclude costs attributable 
to payments under section 1886(h). 
‘‘(ii) INCLUSION OF COSTS OF VA AND 
DOD
MILITARY
FACILITY
SERVICES
TO 
MEDICARE-ELIGIBLE
BENEFICIARIES.—In 
determining the adjusted average per cap-
ita cost under clause (i) for a year, such 
cost shall be adjusted to include the Sec-
retary’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 individuals entitled to 
benefits under this title had not received 
services from facilities of the Department
199
of Veterans Affairs or the Department of 
Defense.’’.
(2) CONFORMING AMENDMENT.—Such section 
is further amended, in the matter before subpara-
graph (A), by striking ‘‘or (C)’’ and inserting ‘‘(C), 
or (D)’’. 
(b) 
CHANGE
IN
BUDGET
NEUTRALITY
FOR 
BLEND.—Section 1853(c) (42 U.S.C. 1395w–23(c)) is 
amended—
(1) in paragraph (1)(A), by inserting ‘‘(for a 
year other than 2004)’’ after ‘‘multiplied’’; and 
(2) in paragraph (5), by inserting ‘‘(other than 
2004)’’ after ‘‘for each year’’.
(c) INCREASING MINIMUM PERCENTAGE INCREASE 
TO NATIONAL GROWTH RATE.—
(1) IN
GENERAL.—Section 1853(c)(1) (42 
U.S.C. 1395w–23(c)(1)) is amended—
(A) in subparagraph (A), by striking ‘‘The 
sum’’ and inserting ‘‘For a year before 2005, 
the sum’’; 
(B) in subparagraph (B)(iv), by striking 
‘‘and each succeeding year’’ and inserting ‘‘, 
2003, and 2004’’;
200
(C) in subparagraph (C)(iv), by striking 
‘‘and each succeeding year’’ and inserting ‘‘and 
2003’’; and 
(D) by adding at the end of subparagraph 
(C) the following new clause: 
‘‘(v) For 2004 and each succeeding 
year, the greater of—
‘‘(I) 102 percent of the annual 
Medicare Advantage capitation rate 
under this paragraph for the area for 
the previous year; or 
‘‘(II) the annual Medicare Ad-
vantage capitation rate under this 
paragraph for the area for the pre-
vious year increased by the national 
per 
capita 
Medicare 
Advantage 
growth percentage, described in para-
graph (6) for that succeeding year, 
but not taking into account any ad-
justment under paragraph (6)(C) for 
a year before 2004.’’. 
(2) 
CONFORMING
AMENDMENT.—Section 
1853(c)(6)(C) (42 U.S.C. 1395w–23(c)(6)(C)) is 
amended by inserting before the period at the end 
the following: ‘‘, except that for purposes of para-
201
graph (1)(C)(v)(II), no such adjustment shall be 
made for a year before 2004’’.
(d) INCLUSION OF COSTS OF DOD AND VA MILI-
TARY
FACILITY
SERVICES
TO
MEDICARE-ELIGIBLE 
BENEFICIARIES IN CALCULATION OF MEDICARE+CHOICE 
PAYMENT
RATES.—Section 
1853(c)(3) 
(42 
U.S.C. 
1395w–23(c)(3)) is amended—
(1) in subparagraph (A), by striking ‘‘subpara-
graph (B)’’ and inserting ‘‘subparagraphs (B) and 
(E)’’, and 
(2) by adding at the end the following new sub-
paragraph: 
‘‘(E) INCLUSION OF COSTS OF DOD AND 
VA MILITARY FACILITY SERVICES TO MEDICARE-
ELIGIBLE BENEFICIARIES.—In determining the 
area-specific Medicare+Choice capitation rate 
under subparagraph (A) for a year (beginning 
with 2004), the annual per capita rate of pay-
ment for 1997 determined under section 
1876(a)(1)(C) shall be adjusted to include in 
the rate the Secretary’s estimate, on a per cap-
ita basis, of the amount of additional payments 
that would have been made in the area involved 
under this title if individuals entitled to benefits 
under this title had not received services from
202
facilities of the Department of Defense or the 
Department of Veterans Affairs.’’. 
(e) EXTENDING SPECIAL RULE FOR CERTAIN INPA-
TIENT
HOSPITAL
STAYS
TO
REHABILITATION
HOS-
PITALS.—
(1) IN GENERAL.—Section 1853(g) (42 U.S.C. 
1395w–23(g)) is amended—
(A) by inserting ‘‘or from a rehabilitation 
facility (as defined in section 1886(j)(1)(A))’’ 
after ‘‘1886(d)(1)(B))’’; and 
(B) in paragraph (2)(B), by inserting ‘‘or 
section 1886(j), as the case may be,’’ after 
‘‘1886(d)’’. 
(2) EFFECTIVE DATE.—The amendments made 
by paragraph (1) shall apply to contract years begin-
ning on or after January 1, 2004. 
(f) MEDPAC STUDY OF AAPCC.—
(1) STUDY.—The Medicare Payment Advisory 
Commission shall conduct a study that assesses the 
method used for determining the adjusted average 
per capita cost (AAPCC) under section 1876(a)(4) 
of 
the 
Social 
Security 
Act 
(42 
U.S.C. 
1395mm(a)(4)) 
as 
applied 
under 
section 
1853(c)(1)(A) of such Act (as amended by sub-
203
section (a)). Such study shall include an examination 
of—
(A) the bases for variation in such costs 
between different areas, including differences in 
input prices, utilization, and practice patterns; 
(B) the appropriate geographic area for 
payment under the Medicare Advantage pro-
gram under part C of title XVIII of such Act; 
and 
(C) the accuracy of risk adjustment meth-
ods in reflecting differences in costs of pro-
viding care to different groups of beneficiaries 
served under such program. 
(2) REPORT.—Not later than 18 months after 
the date of the enactment of this Act, the Commis-
sion shall submit to Congress a report on the study 
conducted under paragraph (1). 
(g) REPORT ON IMPACT OF INCREASED FINANCIAL 
ASSISTANCE
TO MEDICARE ADVANTAGE PLANS.—Not 
later than July 1, 2006, the Medicare Benefits Adminis-
trator shall submit to Congress a report that describes the 
impact of additional financing provided under this Act and 
other Acts (including the Medicare, Medicaid, and SCHIP 
Balanced Budget Refinement Act of 1999 and BIPA) on 
the availability of Medicare Advantage plans in different
204
areas and its impact on lowering premiums and increasing 
benefits under such plans. 
(h) ANNOUNCEMENT OF REVISED MEDICARE AD-
VANTAGE PAYMENT RATES.—Within 6 weeks after the 
date of the enactment of this Act, the Secretary shall de-
termine, and shall announce (in a manner intended to pro-
vide notice to interested parties) Medicare Advantage capi-
tation rates under section 1853 of the Social Security Act 
(42 U.S.C. 1395w–23) for 2004, revised in accordance 
with the provisions of this section. 
CHAPTER 2—IMPLEMENTATION OF 
COMPETITION PROGRAM
SEC. 221. COMPETITION PROGRAM BEGINNING IN 2006. 
(a) SUBMISSION OF EFFS-LIKE BIDDING INFORMA-
TION BEGINNING
IN 2006.—Section 1854 (42 U.S.C. 
1395w–24) is amended—
(1) by amending the section heading to read as 
follows: 
‘‘PREMIUMS AND BID AMOUNT’’; 
(2) in subsection (a)(1)(A)—
(A) by striking ‘‘(A)’’ and inserting ‘‘(A)(i) 
if the following year is before 2006,’’; and 
(B) by inserting before the semicolon at 
the end the following: ‘‘or (ii) if the following 
year is 2006 or later, the information described
205
in paragraph (3) or (6)(A) for the type of plan 
involved’’; and 
(3) by adding at the end of subsection (a) the 
following: 
‘‘(6) SUBMISSION OF BID AMOUNTS BY MEDI-
CARE ADVANTAGE ORGANIZATIONS.—
‘‘(A) INFORMATION TO BE SUBMITTED.—
The information described in this subparagraph 
is as follows: 
‘‘(i) 
The 
monthly 
aggregate 
bid 
amount for provision of all items and serv-
ices under this part, which amount shall be 
based on average costs for a typical bene-
ficiary residing in the area, and the actu-
arial basis for determining such amount. 
‘‘(ii) The proportions of such bid 
amount that are attributable to—
‘‘(I) the provision of statutory 
non-drug benefits (such portion re-
ferred 
to 
in 
this 
part 
as 
the 
‘unadjusted Medicare Advantage stat-
utory non-drug monthly bid amount’); 
‘‘(II) the provision of statutory 
prescription drug benefits; and
206
‘‘(III) the provision of non-statu-
tory benefits; 
and the actuarial basis for determining 
such proportions. 
‘‘(iii) Such additional information as 
the Administrator may require to verify 
the actuarial bases described in clauses (i) 
and (ii). 
‘‘(B) STATUTORY
BENEFITS
DEFINED.—
For purposes of this part: 
‘‘(i) The term ‘statutory non-drug 
benefits’ means benefits under section 
1852(a)(1). 
‘‘(ii) The term ‘statutory prescription 
drug benefits’ means benefits under part 
D. 
‘‘(iii) The term ‘statutory benefits’ 
means statutory prescription drug benefits 
and statutory non-drug benefits.
‘‘(C) ACCEPTANCE AND NEGOTIATION OF 
BID AMOUNTS.—
‘‘(i) IN GENERAL.—Subject to clause 
(ii)—
‘‘(I) the Administrator has the 
authority 
to 
negotiate 
regarding
207
monthly bid amounts submitted under 
subparagraph (A) (and the proportion 
described in subparagraph (A)(ii)), 
and for such purpose and subject to 
such clause, the Administrator has ne-
gotiation authority that the Director 
of the Office of Personnel Manage-
ment has with respect to health bene-
fits plans under chapter 89 of title 5, 
United States Code; and 
‘‘(II) the Administrator may re-
ject such a bid amount or proportion 
if the Administrator determines that 
such amount or proportion is not sup-
ported by the actuarial bases provided 
under subparagraph (A). 
‘‘(ii) EXCEPTION.—In the case of a 
plan described in section 1851(a)(2)(C), 
the provisions of clause (i) shall not apply 
and the provisions of paragraph (5)(B), 
prohibiting the review, approval, or dis-
approval of amounts described in such 
paragraph, shall apply to the negotiation 
and rejection of the monthly bid amounts
208
and proportion referred to in subparagraph 
(A).’’. 
(b) PROVIDING
FOR BENEFICIARY SAVINGS
FOR 
CERTAIN PLANS.—
(1) IN GENERAL.—Section 1854(b) (42 U.S.C. 
1395w–24(b)) is amended—
(A) by adding at the end of paragraph (1) 
the following new subparagraph: 
‘‘(C) BENEFICIARY REBATE RULE.—
‘‘(i) REQUIREMENT.—The Medicare 
Advantage plan shall provide to the en-
rollee a monthly rebate equal to 75 percent 
of the average per capita savings (if any) 
described in paragraph (3) applicable to 
the plan and year involved. 
‘‘(iii) FORM
OF
REBATE.—A rebate 
required under this subparagraph shall be 
provided—
‘‘(I) through the crediting of the 
amount of the rebate towards the 
Medicare Advantage monthly supple-
mentary beneficiary premium or the 
premium imposed for prescription 
drug coverage under part D;
209
‘‘(II) through a direct monthly 
payment (through electronic funds 
transfer or otherwise); or 
‘‘(III) through other means ap-
proved by the Medicare Benefits Ad-
ministrator, 
or any combination thereof.’’; and 
(B) by adding at the end the following new 
paragraphs: 
‘‘(3) COMPUTATION OF AVERAGE PER CAPITA 
MONTHLY
SAVINGS.—For purposes of paragraph 
(1)(C)(i), the average per capita monthly savings re-
ferred to in such paragraph for a Medicare Advan-
tage plan and year is computed as follows: 
‘‘(A) DETERMINATION OF STATE-WIDE AV-
ERAGE RISK ADJUSTMENT.—
‘‘(i) IN
GENERAL.—The Medicare 
Benefits Administrator shall determine, at 
the same time rates are promulgated under 
section 1853(b)(1) (beginning with 2006), 
for each State the average of the risk ad-
justment factors to be applied under sec-
tion 1853(a)(1)(A) to payment for enroll-
ees in that State. In the case of a State in 
which a Medicare Advantage plan was of-
210
fered in the previous year, the Adminis-
trator may compute such average based 
upon risk adjustment factors applied in 
that State in a previous year. 
‘‘(ii) TREATMENT OF NEW STATES.—
In the case of a State in which no Medi-
care Advantage plan was offered in the 
previous year, the Administrator shall esti-
mate such average. In making such esti-
mate, the Administrator may use average 
risk adjustment factors applied to com-
parable States or applied on a national 
basis. 
‘‘(B) DETERMINATION OF RISK ADJUSTED 
BENCHMARK
AND
RISK-ADJUSTED
BID.—For 
each Medicare Advantage plan offered in a 
State, the Administrator shall—
‘‘(i) adjust the Medicare Advantage 
area-specific non-drug monthly benchmark 
amount (as defined in subsection (j)) by 
the applicable average risk adjustment fac-
tor computed under subparagraph (A); and 
‘‘(ii) adjust the unadjusted Medicare 
Advantage statutory non-drug monthly bid
211
amount by such applicable average risk ad-
justment factor. 
‘‘(C) DETERMINATION
OF
AVERAGE
PER 
CAPITA MONTHLY SAVINGS.—The average per 
capita monthly savings described in this sub-
paragraph is equal to the amount (if any) by 
which—
‘‘(i) 
the 
risk-adjusted 
benchmark 
amount computed under subparagraph 
(B)(i), exceeds 
‘‘(ii) the risk-adjusted bid computed 
under subparagraph (B)(ii). 
‘‘(D) AUTHORITY TO DETERMINE RISK AD-
JUSTMENT FOR AREAS OTHER THAN STATES.—
The Administrator may provide for the deter-
mination and application of risk adjustment 
factors under this paragraph on the basis of 
areas other than States. 
‘‘(4) BENEFICIARY’S
OPTION
OF
PAYMENT 
THROUGH
WITHHOLDING
FROM
SOCIAL
SECURITY 
PAYMENT OR USE OF ELECTRONIC FUNDS TRANS-
FER MECHANISM.—In accordance with regulations, a 
Medicare Advantage organization shall permit each 
enrollee, at the enrollee’s option, to make payment 
of premiums under this part to the organization in-
212
directly through withholding from benefit payments 
in the manner provided under section 1840 with re-
spect to monthly premiums under section 1839 or 
through an electronic funds transfer mechanism 
(such as automatic charges of an account at a finan-
cial institution or a credit or debit card account) or 
otherwise. All premium payments that are withheld 
under this paragraph that are credited to the Fed-
eral Supplementary Medical Insurance Drug Trust 
Fund shall be paid to the Medicare Advantage orga-
nization involved.’’. 
(2) PROVISION OF SINGLE CONSOLIDATED PRE-
MIUM.—Section 1854(b) (42 U.S.C. 1395w–24(b)), 
as amended by paragraph (1), is further amended by 
adding at the end the following new paragraph: 
‘‘(5) SINGLE CONSOLIDATED PREMIUM.—In the 
case of an enrollee in a Medicare Advantage plan 
who elects under part D to be provided qualified 
prescription drug coverage through the plan, the Ad-
ministrator shall provide a mechanism for the con-
solidation of the beneficiary premium amount for 
non-drug benefits under this part with the premium 
amount for prescription drug coverage under part D 
provided through the plan.’’.
213
(3) COMPUTATION OF MEDICARE ADVANTAGE 
AREA-SPECIFIC
NON-DRUG
BENCHMARK.—Section 
1853 (42 U.S.C. 1395w–23) is amended by adding 
at the end the following new subsection: 
‘‘(j) COMPUTATION
OF
MEDICARE
ADVANTAGE 
AREA-SPECIFIC
NON-DRUG
MONTHLY
BENCHMARK 
AMOUNT.—For purposes of this part, the term ‘Medicare 
Advantage area-specific non-drug monthly benchmark 
amount’ means, with respect to a Medicare Advantage 
payment area for a month in a year, an amount equal 
to 1⁄12 of the annual Medicare Advantage capitation rate 
under section 1853(c)(1) for the area for the year.’’. 
(c) PAYMENT OF PLANS BASED ON BID AMOUNTS.—
(1) IN GENERAL.—Section 1853(a)(1)(A) (42 
U.S.C. 1395w–23) is amended by striking ‘‘in an 
amount’’ and all that follows and inserting the fol-
lowing: ‘‘in an amount determined as follows: 
‘‘(i) PAYMENT
BEFORE
2006.—For 
years before 2006, the payment amount 
shall be equal to 1⁄12 of the annual Medi-
care Advantage capitation rate (as cal-
culated under subsection (c)(1)) with re-
spect to that individual for that area, re-
duced by the amount of any reduction
214
elected under section 1854(f )(1)(E) and 
adjusted under clause (iv). 
‘‘(ii) PAYMENT FOR STATUTORY NON-
DRUG BENEFITS BEGINNING WITH 2006.—
For years beginning with 2006—
‘‘(I) PLANS
WITH
BIDS
BELOW 
BENCHMARK.—In the case of a plan 
for which there are average per capita 
monthly savings described in section 
1854(b)(3)(C), the payment under 
this 
subsection 
is 
equal 
to 
the 
unadjusted Medicare Advantage statu-
tory non-drug monthly bid amount, 
adjusted under clause (iv), plus the 
amount of the monthly rebate com-
puted under section 1854(b)(1)(C)(i) 
for that plan and year. 
‘‘(II) PLANS WITH BIDS AT OR 
ABOVE BENCHMARK.—In the case of a 
plan for which there are no average 
per capita monthly savings described 
in section 1854(b)(3)(C), the payment 
amount under this subsection is equal 
to the Medicare Advantage area-spe-
215
cific non-drug monthly benchmark 
amount, adjusted under clause (iv). 
‘‘(iii) FOR
FEDERAL
DRUG
SUB-
SIDIES.—In the case in which an enrollee 
who elects under part D to be provided 
qualified 
prescription 
drug 
coverage 
through the plan, the Medicare Advantage 
organization offering such plan also is enti-
tled—
‘‘(I) to direct subsidy payment 
under section 1860D–8(a)(1); 
‘‘(II) to reinsurance subsidy pay-
ments under section 1860D–8(a)(2); 
and 
‘‘(III) to reimbursement for pre-
mium and cost-sharing reductions for 
low-income individuals under section 
1860D–7(c)(3). 
‘‘(iv) 
DEMOGRAPHIC
ADJUSTMENT, 
INCLUDING
ADJUSTMENT
FOR
HEALTH 
STATUS.—The Administrator shall adjust 
the payment amount under clause (i), the 
unadjusted Medicare Advantage statutory 
non-drug monthly bid amount under clause 
(ii)(I), and the Medicare Advantage area-
216
specific 
non-drug 
monthly 
benchmark 
amount under clause (ii)(II) for such risk 
factors as age, disability status, gender, in-
stitutional status, and such other factors 
as the Administrator determines to be ap-
propriate, including adjustment for health 
status under paragraph (3), so as to en-
sure actuarial equivalence. The Adminis-
trator may add to, modify, or substitute 
for such adjustment factors if such 
changes will improve the determination of 
actuarial equivalence.’’. 
(d) CONFORMING AMENDMENTS.—
(1) PROTECTION AGAINST BENEFICIARY SELEC-
TION.—Section 1852(b)(1)(A) (42 U.S.C. 1395w–
22(b)(1)(A)) is amended by adding at the end the 
following: ‘‘The Administrator shall not approve a 
plan of an organization if the Administrator deter-
mines that the benefits are designed to substantially 
discourage enrollment by certain Medicare Advan-
tage eligible individuals with the organization.’’. 
(2) CONFORMING
AMENDMENT
TO
PREMIUM 
TERMINOLOGY.—Section 1854(b)(2) (42 U.S.C. 
1395w–24(b)(2)) is amended by redesignating sub-
paragraph (C) as subparagraph (D) and by striking
217
subparagraphs (A) and (B) and inserting the fol-
lowing: 
‘‘(A) MEDICARE
ADVANTAGE
MONTHLY 
BASIC
BENEFICIARY
PREMIUM.—The 
term 
‘Medicare Advantage monthly basic beneficiary 
premium’ means, with respect to a Medicare 
Advantage plan—
‘‘(i) 
described 
in 
section 
1853(a)(1)(A)(ii)(I) (relating to plans pro-
viding rebates), zero; or 
‘‘(ii) 
described 
in 
section 
1853(a)(1)(A)(ii)(II), the amount (if any) 
by which the unadjusted Medicare Advan-
tage statutory non-drug monthly bid 
amount exceeds the Medicare Advantage 
area-specific non-drug monthly benchmark 
amount. 
‘‘(B) MEDICARE
ADVANTAGE
MONTHLY 
PRESCRIPTION DRUG BENEFICIARY PREMIUM.—
The term ‘Medicare Advantage monthly pre-
scription drug beneficiary premium’ means, 
with respect to a Medicare Advantage plan, that 
portion of the bid amount submitted under 
clause (i) of subsection (a)(6)(A) for the year 
that is attributable under such section to the
218
provision of statutory prescription drug bene-
fits. 
‘‘(C) MEDICARE
ADVANTAGE
MONTHLY 
SUPPLEMENTAL BENEFICIARY PREMIUM.—The 
term ‘Medicare Advantage monthly supple-
mental beneficiary premium’ means, with re-
spect to a Medicare Advantage plan, the portion 
of the aggregate monthly bid amount submitted 
under clause (i) of subsection (a)(6)(A) for the 
year that is attributable under such section to 
the provision of nonstatutory benefits.’’. 
(3) REQUIREMENT
FOR
UNIFORM
PREMIUM 
AND
BID
AMOUNTS.—Section 1854(c) (42 U.S.C. 
1395w–24(c)) is amended to read as follows: 
‘‘(c) UNIFORM PREMIUM AND BID AMOUNTS.—The 
Medicare Advantage monthly bid amount submitted under 
subsection (a)(6), the Medicare Advantage monthly basic, 
prescription drug, and supplemental beneficiary pre-
miums, and the Medicare Advantage monthly MSA pre-
mium charged under subsection (b) of a Medicare Advan-
tage organization under this part may not vary among in-
dividuals enrolled in the plan.’’. 
(4) PERMITTING BENEFICIARY REBATES.—
(A) Section 1851(h)(4)(A) (42 U.S.C. 
1395w–21(h)(4)(A)) is amended by inserting
219
‘‘except 
as 
provided 
under 
section 
1854(b)(1)(C)’’ after ‘‘or otherwise’’. 
(B) Section 1854(d) (42 U.S.C. 1395w–
24(d)) is amended by inserting ‘‘, except as pro-
vided under subsection (b)(1)(C),’’ after ‘‘and 
may not provide’’. 
(5) OTHER CONFORMING AMENDMENTS RELAT-
ING TO BIDS.—Section 1854 (42 U.S.C. 1395w–24) 
is amended—
(A) in the heading of subsection (a), by in-
serting ‘‘AND
BID
AMOUNTS’’ after ‘‘PRE-
MIUMS’’; and 
(B) in subsection (a)(5)(A), by inserting 
‘‘paragraphs (2), (3), and (4) of’’ after ‘‘filed 
under’’. 
(e) ADDITIONAL CONFORMING AMENDMENTS.—
(1) ANNUAL DETERMINATION AND ANNOUNCE-
MENT
OF
CERTAIN
FACTORS.—Section 1853(b)(1) 
(42 U.S.C. 1395w–23(b)(1)) is amended by striking 
‘‘the respective calendar year’’ and all that follows 
and inserting the following: ‘‘the calendar year con-
cerned with respect to each Medicare Advantage 
payment area, the following: 
‘‘(A) PRE-COMPETITION
INFORMATION.—
For years before 2006, the following:
220
‘‘(i) MEDICARE
ADVANTAGE
CAPITA-
TION
RATES.—The annual Medicare Ad-
vantage capitation rate for each Medicare 
Advantage payment area for the year. 
‘‘(ii) ADJUSTMENT
FACTORS.—The 
risk and other factors to be used in adjust-
ing such rates under subsection (a)(1)(A) 
for payments for months in that year. 
‘‘(B) COMPETITION
INFORMATION.—For 
years beginning with 2006, the following: 
‘‘(i) BENCHMARK.—The Medicare Ad-
vantage area-specific non-drug benchmark 
under section 1853(j). 
‘‘(ii) ADJUSTMENT
FACTORS.—The 
adjustment factors applied under section 
1853(a)(1)(A)(iv) (relating to demographic 
adjustment), section 1853(a)(1)(B) (relat-
ing to adjustment for end-stage renal dis-
ease), and section 1853(a)(3) (relating to 
health status adjustment).’’. 
(2) REPEAL OF PROVISIONS RELATING TO AD-
JUSTED COMMUNITY RATE (ACR).—
(A) IN GENERAL.—Subsections (e) and (f) 
of section 1854 (42 U.S.C. 1395w–24) are re-
pealed.
221
(B) CONFORMING AMENDMENTS.—(i) Sec-
tion 1839(a)(2) (42 U.S.C. 1395r(a)(2)) is 
amended by striking ‘‘, and to reflect’’ and all 
that follows and inserting a period. 
(ii) Section 1852(a)(1) (42 U.S.C. 1395w–
22(a)(1)) is amended by striking ‘‘title XI’’ and 
all that follows and inserting the following: 
‘‘title XI those items and services (other than 
hospice care) for which benefits are available 
under parts A and B to individuals residing in 
the area served by the plan.’’. 
(iii) 
Section 
1857(d)(1) 
(42 
U.S.C. 
1395w–27(d)(1)) is amended by striking ‘‘, 
costs, and computation of the adjusted commu-
nity rate’’ and inserting ‘‘and costs’’. 
(f) REFERENCES UNDER PART E.—Section 1859 (42 
U.S.C. 1395w–29) is amended by adding at the end the 
following new subsection: 
‘‘(f) APPLICATION UNDER PART E.—In the case of 
any reference under part E to a requirement or provision 
of this part in the relation to an EFFS plan or organiza-
tion under such part, except as otherwise specified any 
such requirement or provision shall be applied to such or-
ganization or plan in the same manner as such require-
ment or provision applies to a Medicare Advantage private
222
fee-for-service plan (and the Medicare Advantage organi-
zation that offers such plan) under this part.’’. 
(g) EFFECTIVE DATE.—The amendments made by 
this section shall apply to payments and premiums for 
months beginning with January 2006. 
CHAPTER 3—ADDITIONAL REFORMS
SEC. 231. MAKING PERMANENT CHANGE IN MEDICARE AD-
VANTAGE REPORTING DEADLINES AND AN-
NUAL, COORDINATED ELECTION PERIOD. 
(a) CHANGE
IN REPORTING DEADLINE.—Section 
1854(a)(1) (42 U.S.C. 1395w–24(a)(1)), as amended by 
section 532(b)(1) of the Public Health Security and Bio-
terrorism Preparedness and Response Act of 2002, is 
amended by striking ‘‘2002, 2003, and 2004 (or July 1 
of each other year)’’ and inserting ‘‘2002 and each subse-
quent year’’. 
(b) DELAY IN ANNUAL, COORDINATED ELECTION 
PERIOD.—Section 1851(e)(3)(B) (42 U.S.C. 1395w–
21(e)(3)(B)), as amended by section 532(c)(1)(A) of the 
Public Health Security and Bioterrorism Preparedness 
and Response Act of 2002, is amended—
(1) by striking ‘‘and after 2005’’; and 
(2) by striking ‘‘, 2004, and 2005’’ and insert-
ing ‘‘and any subsequent year’’.
223
(c) 
ANNUAL
ANNOUNCEMENT
OF
PAYMENT 
RATES.—Section 
1853(b)(1) 
(42 
U.S.C. 
1395w–
23(b)(1)), as amended by section 532(d)(1) of the Public 
Health Security and Bioterrorism Preparedness and Re-
sponse Act of 2002, is amended—
(1) by striking ‘‘and after 2005’’; and 
(2) by striking ‘‘and 2005’’ and inserting ‘‘and 
each subsequent year’’. 
(d) REQUIRING PROVISION OF AVAILABLE INFORMA-
TION COMPARING PLAN OPTIONS.—The first sentence of 
section 
1851(d)(2)(A)(ii) 
(42 
U.S.C. 
1395w–
21(d)(2)(A)(ii)) is amended by inserting before the period 
the following: ‘‘to the extent such information is available 
at the time of preparation of materials for the mailing’’. 
SEC. 232. AVOIDING DUPLICATIVE STATE REGULATION. 
(a) IN GENERAL.—Section 1856(b)(3) (42 U.S.C. 
1395w–26(b)(3)) is amended to read as follows: 
‘‘(3) RELATION TO STATE LAWS.—The stand-
ards established under this subsection shall super-
sede any State law or regulation (other than State 
licensing laws or State laws relating to plan sol-
vency) with respect to Medicare Advantage plans 
which are offered by Medicare Advantage organiza-
tions under this part.’’.
224
(b) EFFECTIVE DATE.—The amendment made by 
subsection (a) shall take effect on the date of the enact-
ment of this Act. 
SEC. 233. SPECIALIZED MEDICARE ADVANTAGE PLANS FOR 
SPECIAL NEEDS BENEFICIARIES. 
(a) TREATMENT AS COORDINATED CARE PLAN.—
Section 1851(a)(2)(A) (42 U.S.C. 1395w–21(a)(2)(A)) is 
amended by adding at the end the following new sentence: 
‘‘Specialized Medicare Advantage plans for special needs 
beneficiaries (as defined in section 1859(b)(4)) may be 
any type of coordinated care plan.’’. 
(b) SPECIALIZED MEDICARE ADVANTAGE PLAN FOR 
SPECIAL
NEEDS
BENEFICIARIES
DEFINED.—Section 
1859(b) (42 U.S.C. 1395w–29(b)) is amended by adding 
at the end the following new paragraph: 
‘‘(4) 
SPECIALIZED
MEDICARE
ADVANTAGE 
PLANS FOR SPECIAL NEEDS BENEFICIARIES.—
‘‘(A) IN GENERAL.—The term ‘specialized 
Medicare Advantage plan for special needs 
beneficiaries’ means a Medicare Advantage plan 
that exclusively serves special needs bene-
ficiaries (as defined in subparagraph (B)). 
‘‘(B) SPECIAL NEEDS BENEFICIARY.—The 
term ‘special needs beneficiary’ means a Medi-
care Advantage eligible individual who—
225
‘‘(i) is institutionalized (as defined by 
the Secretary); 
‘‘(ii) is entitled to medical assistance 
under a State plan under title XIX; or 
‘‘(iii) meets such requirements as the 
Secretary may determine would benefit 
from enrollment in such a specialized 
Medicare Advantage plan described in sub-
paragraph (A) for individuals with severe 
or disabling chronic conditions.’’. 
(c) RESTRICTION ON ENROLLMENT PERMITTED.—
Section 1859 (42 U.S.C. 1395w–29) is amended by add-
ing at the end the following new subsection: 
‘‘(f) RESTRICTION ON ENROLLMENT FOR SPECIAL-
IZED MEDICARE ADVANTAGE PLANS FOR SPECIAL NEEDS 
BENEFICIARIES.—In the case of a specialized Medicare 
Advantage plan (as defined in subsection (b)(4)), notwith-
standing any other provision of this part and in accord-
ance with regulations of the Secretary and for periods be-
fore January 1, 2007, the plan may restrict the enrollment 
of individuals under the plan to individuals who are within 
one or more classes of special needs beneficiaries.’’. 
(d) AUTHORITY TO DESIGNATE OTHER PLANS AS 
SPECIALIZED MEDICARE ADVANTAGE PLANS.—In pro-
mulgating regulations to carry out the last sentence of sec-
226
tion 1851(a)(2)(A) of the Social Security Act (as added 
by subsection (a)) and section 1859(b)(4) of such Act (as 
added by subsection (b)), the Secretary may provide (not-
withstanding section 1859(b)(4)(A) of such Act) for the 
offering of specialized Medicare Advantage plans by Medi-
care Advantage plans that disproportionately serve special 
needs beneficiaries who are frail, elderly medicare bene-
ficiaries. 
(e) REPORT TO CONGRESS.—Not later than Decem-
ber 31, 2005, the Medicare Benefits Administrator shall 
submit to Congress a report that assesses the impact of 
specialized Medicare Advantage plans for special needs 
beneficiaries on the cost and quality of services provided 
to enrollees. Such report shall include an assessment of 
the costs and savings to the medicare program as a result 
of amendments made by subsections (a), (b), and (c). 
(f) EFFECTIVE DATES.—
(1) IN GENERAL.—The amendments made by 
subsections (a), (b), and (c) shall take effect upon 
the date of the enactment of this Act. 
(2) DEADLINE
FOR
ISSUANCE
OF
REQUIRE-
MENTS FOR SPECIAL NEEDS BENEFICIARIES; TRAN-
SITION.—No later than 6 months after the date of 
the enactment of this Act, the Secretary shall issue 
interim final regulations to establish requirements
227
for 
special 
needs 
beneficiaries 
under 
section 
1859(b)(4)(B)(iii) of the Social Security Act, as 
added by subsection (b). 
SEC. 234. MEDICARE MSAS. 
(a) EXEMPTION FROM REPORTING ENROLLEE EN-
COUNTER DATA.—
(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 be-
fore the period at the end the following: ‘‘if re-
quired under such section’’; and 
(B) in subparagraphs (A) and (B) of sub-
section (e)(2), by striking ‘‘, a non-network 
MSA 
plan,’’ 
and 
‘‘, 
NON-NETWORK
MSA 
PLANS,’’ each place it appears. 
(b) MAKING PROGRAM PERMANENT
AND ELIMI-
NATING CAP.—Section 1851(b)(4) (42 U.S.C. 1395w–
21(b)(4)) is amended—
(1) in the heading, by striking ‘‘ON A DEM-
ONSTRATION BASIS’’; 
(2) by striking the first sentence of subpara-
graph (A); and
228
(3) by striking the second sentence of subpara-
graph (C). 
(c) APPLYING LIMITATIONS
ON BALANCE BILL-
ING.—Section 1852(k)(1) (42 U.S.C. 1395w–22(k)(1)) is 
amended by inserting ‘‘or with an organization offering 
a 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 amend-
ed—
(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. 235. 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), may be extended or re-
newed under this subsection indefinitely. 
‘‘(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 serv-
ice area insofar as such area, during the entire previous 
year, was within the service area of 2 or more plans which 
were coordinated care Medicare Advantage plans under 
part C or 2 or more enhanced fee-for-service plans under
229
part E and each of which plan for that previous year for 
the area involved meets the following minimum enrollment 
requirements: 
‘‘(I) With respect to any portion of the area in-
volved that is within a Metropolitan Statistical Area 
with a population of more than 250,000 and coun-
ties contiguous to such Metropolitan Statistical 
Area, 5,000 individuals. 
‘‘(II) With respect to any other portion of such 
area, 1,500 individuals.’’. 
SEC. 236. EXTENSION OF MUNICIPAL HEALTH SERVICE 
DEMONSTRATION PROJECTS. 
Section 9215(a) of the Consolidated Omnibus Budget 
Reconciliation Act of 1985 (42 U.S.C. 1395b–1 note), as 
amended by section 6135 of the Omnibus Budget Rec-
onciliation 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, 2009’’. 
SEC. 237. STUDY OF PERFORMANCE-BASED PAYMENT SYS-
TEMS. 
(a) IN GENERAL.—The Secretary shall request the 
Institute of Medicine of the National Academy of Sciences 
to—
230
(1) conduct a study that reviews and evaluates 
public and private sector experiences in establishing 
performance measures and payment incentives under 
the medicare program and linking performance to 
payment; and 
(2) submit a report to the Secretary and Con-
gress, not later than 18 months after the date of the 
enactment of this Act, regarding such study. 
(b) STUDY.—The study under subsection (a)(1) 
shall—
(1) include a review and evaluation of incentives 
that have been or could be used to encourage quality 
performance, including those aimed at health plans 
and their enrollees, providers and their patients, and 
other incentives that encourage quality-based health 
care purchasing and collaborative efforts to improve 
performance; and 
(2) examine how these measures and incentives 
might be applied in the Medicare Advantage pro-
gram, the Enhanced Fee-For-Service (EFFS) pro-
gram, and traditional fee-for-service programs. 
(c) REPORT RECOMMENDATIONS.—The report under 
subsection (a)(2) shall—
231
(1) include recommendations regarding appro-
priate performance measures for use in assessing 
and paying for quality; and 
(2) identify options for updating performance 
measures.
Subtitle C—Application of FEHBP-
Style Competitive Reforms
SEC. 241. APPLICATION OF FEHBP-STYLE COMPETITIVE RE-
FORM BEGINNING IN 2010.
(a) IDENTIFICATION OF COMPETITIVE EFFS RE-
GIONS; COMPUTATION
OF COMPETITIVE EFFS NON-
DRUG BENCHMARKS UNDER EFFS PROGRAM.—
(1) IN GENERAL.—Section 1860E–3, as added 
by section 201(a), is amended by adding at the end 
the following new subsection: 
‘‘(e) APPLICATION OF COMPETITION.—
‘‘(1) DETERMINATION OF COMPETITIVE EFFS 
REGIONS.—
‘‘(A) IN GENERAL.—For purposes of this 
part, the term ‘competitive EFFS region’ 
means, for a year beginning with 2010, an 
EFFS region that the Administrator finds—
‘‘(i) there will be offered in the region 
during the annual, coordinated election pe-
riod under section 1851(e)(3)(B) (as ap-
232
plied under section 1860E–1(c)) before the 
beginning of the year at least 2 EFFS 
plans (in addition to the fee-for-service 
program under parts A and B), each of-
fered by a different EFFS organization 
and each of which met the minimum en-
rollment requirements of paragraph (1) of 
section 1857(b) (as applied without regard 
to paragraph (3) thereof) as of March of 
the previous year; and 
‘‘(ii) during March of the previous 
year at least the percentage specified in 
subparagraph (C) of the number of EFFS 
eligible individuals who reside in the region 
were enrolled in an EFFS plan. 
‘‘(B) PERCENTAGE SPECIFIED.—
‘‘(i) IN
GENERAL.—For purposes of 
subparagraph (A), subject to clause (ii), 
the percentage specified in this subpara-
graph for a year is equal the lesser of 20 
percent or to the sum of—
‘‘(I) the percentage, as estimated 
by the Administrator, of EFFS eligi-
ble individuals in the United States
233
who are enrolled in EFFS plans dur-
ing March of the previous year; and 
‘‘(II) the percentage, as esti-
mated by the Administrator, of Medi-
care Advantage eligible individuals in 
the United States who are enrolled in 
Medicare Advantage plans during 
March of the previous year. 
‘‘(ii) EXCEPTION.—In the case of an 
EFFS region that was a competitive 
EFFS region for the previous year, the 
Medicare Benefits Administrator may con-
tinue to treat the region as meeting the re-
quirement of subparagraph (A)(ii) if the 
region would meet such requirement but 
for a de minimis reduction below the per-
centage specified in clause (i). 
‘‘(2) COMPETITIVE EFFS NON-DRUG MONTHLY 
BENCHMARK AMOUNT.—For purposes of this part, 
the term ‘competitive EFFS non-drug monthly 
benchmark amount’ means, with respect to an 
EFFS region for a month in a year and subject to 
paragraph (8), the sum of the 2 components de-
scribed in paragraph (3) for the region and year. 
The Administrator shall compute such benchmark
234
amount for each competitive EFFS region before the 
beginning of each annual, coordinated election pe-
riod under section 1851(e)(3)(B) for each year (be-
ginning with 2010) in which it is designated as such 
a region. 
‘‘(3) 2 COMPONENTS.—For purposes of para-
graph (2), the 2 components described in this para-
graph for an EFFS region and a year are the fol-
lowing: 
‘‘(A) EFFS COMPONENT.—The product of 
the following: 
‘‘(i) WEIGHTED
AVERAGE
OF
PLAN 
BIDS IN REGION.—The weighted average of 
the EFFS plan bids for the region and 
year (as determined under paragraph 
(4)(A)). 
‘‘(ii) NON-FFS
MARKET
SHARE.—1 
minus the fee-for-service market share per-
centage determined under paragraph (5) 
for the region and the year. 
‘‘(B) 
FEE-FOR-SERVICE
COMPONENT.—
The product of the following: 
‘‘(i) FEE-FOR-SERVICE
REGION-SPE-
CIFIC
NON-DRUG
AMOUNT.—The fee-for-
service region-specific non-drug amount (as
235
defined in paragraph (6)) for the region 
and year. 
‘‘(ii) 
FEE-FOR-SERVICE
MARKET 
SHARE.—The fee-for-service market share 
percentage (determined under paragraph 
(5)) for the region and the year. 
‘‘(4) DETERMINATION OF WEIGHTED AVERAGE 
EFFS PLAN BIDS FOR A REGION.—
‘‘(A) IN GENERAL.—For purposes of para-
graph (3)(A)(i), the weighted average of EFFS 
plan bids for an EFFS region and a year is the 
sum of the following products for EFFS plans 
described in subparagraph (C) in the region 
and year: 
‘‘(i) UNADJUSTED
EFFS
STATUTORY 
NON-DRUG MONTHLY BID AMOUNT.—The 
unadjusted 
EFFS 
statutory 
non-drug 
monthly bid amount (as defined in sub-
section (a)(3)(A)(ii)(I)) for the region and 
year. 
‘‘(ii) PLAN’S SHARE OF EFFS ENROLL-
MENT IN REGION.—The number of individ-
uals described in subparagraph (B), di-
vided by the total number of such individ-
236
uals for all EFFS plans described in sub-
paragraph (C) for that region and year. 
‘‘(B) COUNTING
OF
INDIVIDUALS.—The 
Administrator shall count, for each EFFS plan 
described in subparagraph (C) for an EFFS re-
gion and year, the number of individuals who 
reside in the region and who were enrolled 
under such plan under this part during March 
of the previous year. 
‘‘(C) EXCLUSION OF PLANS NOT OFFERED 
IN PREVIOUS YEAR.—For an EFFS region and 
year, the EFFS plans described in this sub-
paragraph are plans that are offered in the re-
gion and year and were offered in the region in 
March of the previous year. 
‘‘(5) COMPUTATION OF FEE-FOR-SERVICE MAR-
KET SHARE PERCENTAGE.—The Administrator shall 
determine, for a year and an EFFS region, the pro-
portion (in this subsection referred to as the ‘fee-for-
service market share percentage’) of the EFFS eligi-
ble individuals who are residents of the region dur-
ing March of the previous year, of such individuals 
who were not enrolled in an EFFS plan or in a 
Medicare Advantage plan (or, if greater, such pro-
portion determined for individuals nationally).
237
‘‘(6) FEE-FOR-SERVICE REGION-SPECIFIC NON-
DRUG AMOUNT.—
‘‘(A) IN GENERAL.—For purposes of para-
graph (3)(B)(i) and section 1839(h)(2)(A), sub-
ject to subparagraph (C), the term ‘fee-for-serv-
ice region-specific non-drug amount’ means, for 
a competitive EFFS region and a year, the ad-
justed average per capita cost for the year in-
volved, determined under section 1876(a)(4) for 
such region for services covered under parts A 
and B for individuals entitled to benefits under 
part A and enrolled under this part who are not 
enrolled in an EFFS plan under part E or a 
Medicare Advantage plan under part C 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 TYP-
ICAL
BENEFICIARY.—In determining the ad-
justed average per capita cost for a region and 
year under subparagraph (A), such costs shall 
be adjusted to fully take into account the demo-
graphic and health status risk factors estab-
lished under subsection (c)(3) so that such per
238
capita costs reflect the average costs for a typ-
ical beneficiary residing in the region. 
‘‘(C) INCLUSION OF COSTS OF VA AND DOD 
MILITARY
FACILITY
SERVICES
TO
MEDICARE-
ELIGIBLE BENEFICIARIES.—In determining the 
adjusted average per capita cost under subpara-
graph (A) for a year, such cost shall be ad-
justed to include the Administrator’s estimate, 
on a per capita basis, of the amount of addi-
tional payments that would have been made in 
the region involved under this title if individuals 
entitled to benefits under this title had not re-
ceived services from facilities of the Department 
of Veterans Affairs or the Department of De-
fense. 
‘‘(7) APPLICATION
OF
COMPETITION.—In the 
case of an EFFS region that is a competitive EFFS 
region for a year, for purposes of applying sub-
sections (b) and (c)(1) and section 1860E–4(a), any 
reference to an EFFS region-specific non-drug 
monthly benchmark amount shall be treated as a 
reference to the competitive EFFS non-drug month-
ly benchmark amount under paragraph (2) for the 
region and year.
239
‘‘(8) PHASE-IN OF BENCHMARK FOR EACH RE-
GION.—
‘‘(A) USE OF BLENDED BENCHMARK.—In 
the case of a region that has not been a com-
petitive EFFS region for each of the previous 
4 years, the competitive EFFS non-drug 
monthly benchmark amount shall be equal to 
the sum of the following: 
‘‘(i) 
NEW
COMPETITIVE
COMPO-
NENT.—The product of—
‘‘(I) the weighted average phase-
in proportion for that area and year, 
as specified in subparagraph (B); and 
‘‘(II) the competitive EFFS non-
drug monthly benchmark amount for 
the region and year, determined under 
paragraph (2) without regard to this 
paragraph. 
‘‘(ii) 
OLD
COMPETITIVE
COMPO-
NENT.—The product of—
‘‘(I) 1 minus the weighted aver-
age phase-in proportion for that re-
gion and year; and
240
‘‘(II) the EFFS region-specific 
non-drug benchmark amount for the 
region and the year. 
‘‘(B) COMPUTATION OF WEIGHTED AVER-
AGE PHASE-IN PROPORTION.—For purposes of 
this paragraph, the ‘weighted average phase-in 
proportion’ for an EFFS region for a year shall 
be determined as follows: 
‘‘(i) FIRST YEAR (AND REGION NOT 
COMPETITIVE
REGION
IN
PREVIOUS 
YEAR).—If the area was not a competitive 
EFFS region in the previous year, the 
weighted average phase-in proportion for 
the region for the year is equal to 1⁄5. 
‘‘(ii) COMPETITIVE
REGION
IN
PRE-
VIOUS YEAR.—If the region was a competi-
tive EFFS region in the previous year, the 
weighted average phase-in proportion for 
the region for the year is equal to the 
weighted average phase-in proportion de-
termined under this subparagraph for the 
region for the previous year plus 1⁄5, but in 
no case more than 1.’’. 
(2) CONFORMING AMENDMENTS.—
241
(A) Such section 1860E–3 is further 
amended—
(i) in subsection (b), by adding at the 
end the following new paragraph: 
‘‘(4) APPLICATION
IN
COMPETITIVE
RE-
GIONS.—For special rules applying this sub-
section in competitive EFFS regions, see sub-
section (e)(7).’’; 
(ii) in subsection (c)(1), by inserting 
‘‘and subsection (e)(7)’’ after ‘‘(as made 
applicable under subsection (d))’’; and 
(iii) in subsection (d) , by striking 
‘‘and (e)’’ and inserting ‘‘(e), and (k) ’’. 
(B) Section 1860E–4(a)(1), as inserted by 
section 201(a)(2), is amended by inserting ‘‘, 
except as provided in section 1860E–3(e)(7)’’ 
after ‘‘paragraph (2)’’.
(b) IDENTIFICATION
OF COMPETITIVE MEDICARE 
ADVANTAGE
AREAS; APPLICATION
OF
COMPETITIVE 
MEDICARE
ADVANTAGE
NON-DRUG
BENCHMARKS 
UNDER MEDICARE ADVANTAGE PROGRAM.—
(1) IN GENERAL.—Section 1853, as amended 
by section 221(b)(3), is amended by adding at the 
end the following new subsection: 
‘‘(k) APPLICATION OF COMPETITION.—
242
‘‘(1) DETERMINATION OF COMPETITIVE MEDI-
CARE ADVANTAGE AREAS.—
‘‘(A) IN GENERAL.—For purposes of this 
part, the terms ‘competitive Medicare Advan-
tage area’ and ‘CMA area’ mean, for a year be-
ginning with 2010, an area (which is a metro-
politan statistical area or other area with a sub-
stantial number of Medicare Advantage enroll-
ees) that the Administrator finds—
‘‘(i) there will be offered during the 
annual, coordinated election period under 
section 1851(e)(3)(B) under this part be-
fore the beginning of the year at least 2 
Medicare Advantage plans (in addition to 
the fee-for-service program under parts A 
and B), each offered by a different Medi-
care Advantage organization and each of 
which met the minimum enrollment re-
quirements of paragraph (1) of section 
1857(b) (as applied without regard to 
paragraph (3) thereof) as of March of the 
previous year with respect to the area; and 
‘‘(ii) during March of the previous 
year at least the percentage specified in 
subparagraph (B) of the number of Medi-
243
care Advantage eligible individuals who re-
side in the area were enrolled in a Medi-
care Advantage plan. 
‘‘(B) PERCENTAGE SPECIFIED.—
‘‘(i) IN
GENERAL.—For purposes of 
subparagraph (A), subject to clause (ii), 
the percentage specified in this subpara-
graph for a year is equal the lesser of 20 
percent or to the sum of—
‘‘(I) the percentage, as estimated 
by the Administrator, of EFFS eligi-
ble individuals in the United States 
who are enrolled in EFFS plans dur-
ing March of the previous year; and 
‘‘(II) the percentage, as esti-
mated by the Administrator, of Medi-
care Advantage eligible individuals in 
the United States who are enrolled in 
Medicare Advantage plans during 
March of the previous year. 
‘‘(ii) EXCEPTION.—In the case of an 
area that was a competitive area for the 
previous year, the Medicare Benefits Ad-
ministrator may continue to treat the area 
as meeting the requirement of subpara-
244
graph (A)(ii) if the area would meet such 
requirement but for a de minimis reduction 
below the percentage specified in clause (i). 
‘‘(2) 
COMPETITIVE
MEDICARE
ADVANTAGE 
NON-DRUG
MONTHLY
BENCHMARK
AMOUNT.—For 
purposes of this part, the term ‘competitive Medi-
care 
Advantage 
non-drug 
monthly 
benchmark 
amount’ means, with respect to a competitive Medi-
care Advantage area for a month in a year subject 
to paragraph (8), the sum of the 2 components de-
scribed in paragraph (3) for the area and year. The 
Administrator 
shall 
compute 
such 
benchmark 
amount for each competitive Medicare Advantage 
area before the beginning of each annual, coordi-
nated election period under section 1851(e)(3)(B) 
for each year (beginning with 2010) in which it is 
designated as such an area. 
‘‘(3) 2 COMPONENTS.—For purposes of para-
graph (2), the 2 components described in this para-
graph for a competitive Medicare Advantage area 
and a year are the following: 
‘‘(A) 
MEDICARE
ADVANTAGE
COMPO-
NENT.—The product of the following: 
‘‘(i) WEIGHTED
AVERAGE
OF
MEDI-
CARE ADVANTAGE PLAN BIDS IN AREA.—
245
The weighted average of the plan bids for 
the area and year (as determined under 
paragraph (4)(A)). 
‘‘(ii) NON-FFS
MARKET
SHARE.—1 
minus the fee-for-service market share per-
centage, determined under paragraph (5) 
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 (6)) for the area and year. 
‘‘(ii) 
FEE-FOR-SERVICE
MARKET 
SHARE.—The fee-for-service market share 
percentage, determined under paragraph 
(5) for the area and year. 
‘‘(4) DETERMINATION OF WEIGHTED AVERAGE 
MEDICARE ADVANTAGE BIDS FOR AN AREA.—
‘‘(A) IN GENERAL.—For purposes of para-
graph (3)(A)(i), the weighted average of plan 
bids for an area and a year is the sum of the 
following products for Medicare Advantage 
plans described in subparagraph (C) in the area 
and year:
246
‘‘(i) MONTHLY MEDICARE ADVANTAGE 
STATUTORY NON-DRUG BID AMOUNT.—The 
unadjusted Medicare Advantage statutory 
non-drug monthly bid amount. 
‘‘(ii) PLAN’S SHARE OF MEDICARE AD-
VANTAGE
ENROLLMENT
IN
AREA.—The 
number of individuals described in sub-
paragraph (B), divided by the total num-
ber of such individuals for all Medicare Ad-
vantage plans described in subparagraph 
(C) for that area and year. 
‘‘(B) COUNTING
OF
INDIVIDUALS.—The 
Administrator shall count, for each Medicare 
Advantage 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 March 
of the previous year. 
‘‘(C) EXCLUSION OF PLANS NOT OFFERED 
IN PREVIOUS YEAR.—For an area and year, the 
Medicare Advantage plans described in this 
subparagraph are plans described in the first 
sentence of section 1851(a)(2)(A) that are of-
fered in the area and year and were offered in 
the area in March of the previous year.
247
‘‘(5) COMPUTATION OF FEE-FOR-SERVICE MAR-
KET SHARE PERCENTAGE.—The Administrator shall 
determine, for a year and a competitive Medicare 
Advantage area, the proportion (in this subsection 
referred to as the ‘fee-for-service market share per-
centage’) of Medicare Advantage eligible individuals 
residing in the area who during March of the pre-
vious year were not enrolled in a Medicare Advan-
tage plan or in an EFFS plan (or, if greater, such 
proportion determined for individuals nationally). 
‘‘(6) FEE-FOR-SERVICE
AREA-SPECIFIC
NON-
DRUG AMOUNT.—
‘‘(A) IN GENERAL.—For purposes of para-
graph (3)(B)(i) and section 1839(h)(1)(A), sub-
ject to subparagraph (C), the term ‘fee-for-serv-
ice area-specific non-drug amount’ means, for a 
competitive Medicare Advantage area and a 
year, the adjusted average per capita cost for 
the year involved, determined under section 
1876(a)(4) for such area for services covered 
under parts A and B for individuals entitled to 
benefits under part A and enrolled under this 
part who are not enrolled in a Medicare Advan-
tage plan under part C or an EFFS plan under 
part E for the year, but adjusted to exclude
248
costs attributable to payments under section 
1886(h).
‘‘(B) USE OF FULL RISK ADJUSTMENT TO 
STANDARDIZE FEE-FOR-SERVICE COSTS TO TYP-
ICAL
BENEFICIARY.—In determining the ad-
justed average per capita cost for an area and 
year under subparagraph (A), such costs shall 
be adjusted to fully take into account the demo-
graphic and health status risk factors estab-
lished under subsection (a)(1)(A)(iv) so that 
such per capita costs reflect the average costs 
for a typical beneficiary residing in the 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 subpara-
graph (A) for a year, such cost shall be ad-
justed to include the Administrator’s estimate, 
on a per capita basis, of the amount of addi-
tional payments that would have been made in 
the area involved under this title if individuals 
entitled to benefits under this title had not re-
ceived services from facilities of the Department 
of Veterans Affairs or the Department of De-
fense.
249
‘‘(7) APPLICATION
OF
COMPETITION.—In the 
case of an area that is a competitive Medicare Ad-
vantage area for a year, for purposes of applying 
subsection 
(a)(1)(A)(ii) 
and 
sections 
1854(b)(2)(A)(ii) and 1854(b)(3)(B)(i), any ref-
erence to a Medicare Advantage area-specific non-
drug monthly benchmark amount shall be treated as 
a reference to the competitive Medicare Advantage 
non-drug monthly benchmark amount under para-
graph (2) for the area and year. 
‘‘(8) PHASE-IN
OF
BENCHMARK
FOR
EACH 
AREA.—
‘‘(A) USE OF BLENDED BENCHMARK.—In 
the case of an area that has not been a com-
petitive Medicare Advantage area for each of 
the previous 4 years, the competitive Medicare 
Advantage 
non-drug 
monthly 
benchmark 
amount shall be equal to the sum of the fol-
lowing: 
‘‘(i) 
NEW
COMPETITIVE
COMPO-
NENT.—The product of—
‘‘(I) the weighted average phase-
in proportion for that area and year, 
as specified in subparagraph (B); and
250
‘‘(II) the competitive Medicare 
Advantage non-drug monthly bench-
mark amount for the area and year, 
determined under paragraph (2) with-
out regard to this paragraph. 
‘‘(ii) 
OLD
COMPETITIVE
COMPO-
NENT.—The product of—
‘‘(I) 1 minus the weighted aver-
age phase-in proportion for that area 
and year; and 
‘‘(II) the Medicare Advantage 
area-wide 
non-drug 
benchmark 
amount for the area and the year. 
‘‘(B) COMPUTATION OF WEIGHTED AVER-
AGE PHASE-IN PROPORTION.—For purposes of 
this paragraph, the ‘weighted average phase-in 
proportion’ for a Medicare Advantage payment 
area for a year shall be determined as follows: 
‘‘(i) FIRST
YEAR
(AND
AREA
NOT 
COMPETITIVE AREA IN PREVIOUS YEAR).—
If the area was not a Medicare Advantage 
competitive area in the previous year, the 
weighted average phase-in proportion for 
the area for the year is equal to 1⁄5.
251
‘‘(ii) COMPETITIVE AREA IN PREVIOUS 
YEAR.—If the area was a competitive 
Medicare Advantage area in the previous 
year, the weighted average phase-in pro-
portion for the area for the year is equal 
to the weighted average phase-in propor-
tion determined under this subparagraph 
for the area for the previous year plus 1⁄5, 
but in no case more than 1. 
‘‘(C) MEDICARE
ADVANTAGE
AREA-WIDE 
NON-DRUG
BENCHMARK
AMOUNT.—For pur-
poses of subparagraph (A)(ii)(II), the term 
‘Medicare Advantage area-wide non-drug bench-
mark amount’ means, for an area and year, the 
weighted average of the amounts described in 
section 1853(j) for Medicare Advantage pay-
ment area or areas included in the area (based 
on the number of traditional fee-for-service en-
rollees in such payment area or areas) and 
year.’’. 
(2) APPLICATION.—Section 1854 (42 U.S.C. 
1395w–24) is amended—
(A) in subsection (b)(1)(C)(i), as added by 
section 221(b)(1)(A), by striking ‘‘(i) REQUIRE-
MENT.—The’’ and inserting ‘‘(i) REQUIREMENT
252
FOR NON-COMPETITIVE AREAS.—In the case of 
a Medicare Advantage payment area that is not 
a competitive Medicare Advantage area des-
ignated under section 1853(k)(1), the’’; 
(B) in subsection (b)(1)(C), as so added, 
by inserting after clause (i) the following new 
clause: 
‘‘(ii) REQUIREMENT
FOR
COMPETI-
TIVE
MEDICARE
ADVANTAGE
AREAS.—In 
the case of a Medicare Advantage payment 
area that is designated as a competitive 
Medicare Advantage area under section 
1853(k)(1), if there are average per capita 
monthly savings described in paragraph 
(6) for a Medicare Advantage plan and 
year, the Medicare Advantage plan shall 
provide to the enrollee a monthly rebate 
equal to 75 percent of such savings.’’; and 
(C) by adding at the end of subsection (b), 
as amended by sections 221(b)(1)(B) and 
221(b)(2), the following new paragraph: 
‘‘(6) COMPUTATION OF AVERAGE PER CAPITA 
MONTHLY
SAVINGS
FOR
COMPETITIVE
MEDICARE 
ADVANTAGE
AREAS.—For purposes of paragraph 
(1)(C)(ii), the average per capita monthly savings
253
referred to in such paragraph for a Medicare Advan-
tage plan and year shall be computed in the same 
manner as the average per capita monthly savings is 
computed under paragraph (3) except that the ref-
erence to the Medicare Advantage area-specific non-
drug monthly benchmark amount in paragraph 
(3)(B)(i) (or to the benchmark amount as adjusted 
under paragraph (3)(C)(i)) is deemed to be a ref-
erence to the competitive Medicare Advantage non-
drug monthly benchmark amount (or such amount 
as adjusted in the manner described in paragraph 
(3)(B)(i)).’’. 
(3) ADDITIONAL CONFORMING AMENDMENTS.—
(A) 
PAYMENT
OF
PLANS.—Section 
1853(a)(1)(A)(ii), 
as 
amended 
by 
section 
221(c)(1), is amended—
(i) in subclauses (I) and (II), by in-
serting ‘‘(or, insofar as such payment area 
is a competitive Medicare Advantage area, 
described in section 1854(b)(6))’’ after 
‘‘section 1854(b)(3)(C)’’; and 
(ii) in subclause (II), by inserting 
‘‘(or, insofar as such payment area is a 
competitive Medicare Advantage area, the 
competitive Medicare Advantage non-drug
254
monthly benchmark amount)’’ after ‘‘Medi-
care Advantage area-specific non-drug 
monthly benchmark amount’’; and 
(B) DISCLOSURE OF INFORMATION.—Sec-
tion 1853(b)(1)(B), as amended by section 
221(e)(1), is amended to read as follows: 
‘‘(B) COMPETITION
INFORMATION.—For 
years beginning with 2006, the following: 
‘‘(i) 
BENCHMARKS.—The 
Medicare 
Advantage area-specific non-drug bench-
mark under section 1853(j) and, if applica-
ble, the competitive Medicare Advantage 
non-drug 
benchmark 
under 
section 
1853(k)(2), for the year and competitive 
Medicare Advantage area involved and the 
national fee-for-service market share per-
centage for the area and year. 
‘‘(ii) ADJUSTMENT
FACTORS.—The 
adjustment factors applied under section 
1853(a)(1)(A)(iv) (relating to demographic 
adjustment), section 1853(a)(1)(B) (relat-
ing to adjustment for end-stage renal dis-
ease), and section 1853(a)(3) (relating to 
health status adjustment).
255
‘‘(iii) CERTAIN
BENCHMARKS
AND 
AMOUNTS.—In the case of a competitive 
Medicare Advantage area, the Medicare 
Advantage area-wide non-drug benchmark 
amount 
(as 
defined 
in 
subsection 
(k)(8)(C)) and the fee-for-service area-spe-
cific non-drug amount (as defined in sec-
tion 1853(k)(6)) for the area. 
‘‘(iv) INDIVIDUALS.—The number of 
individuals 
counted 
under 
subsection 
(k)(4)(B) and enrolled in each Medicare 
Advantage plan in the area.’’. 
(C) DEFINITION OF MONTHLY BASIC PRE-
MIUM.—Section 1854(b)(2)(A)(ii), as amended 
by section 221(d)(2), is amended by inserting 
‘‘(or, in the case of a competitive Medicare Ad-
vantage area, the competitive Medicare Advan-
tage non-drug monthly benchmark amount or, 
in applying this paragraph under part E in the 
case of a competitive EFFS region, the com-
petitive EFFS non-drug monthly benchmark 
amount)’’ after ‘‘benchmark amount’’. 
(c) PREMIUM ADJUSTMENT.—
256
(1) IN
GENERAL.—Section 1839 (42 U.S.C. 
1395r) is amended by adding at the end the fol-
lowing new subsection: 
‘‘(h)(1)(A) In the case of an individual who resides 
in a competitive Medicare Advantage area under section 
1853(k)(1) (regardless of whether such area is in a com-
petitive EFFS region under section 1860E–3(e)) and who 
is not enrolled in a Medicare Advantage plan under part 
C or in an EFFS plan under part E, the monthly premium 
otherwise applied under this part (determined without re-
gard to subsections (b) and (f) or any adjustment under 
this subsection) shall be adjusted as follows: If the fee-
for-service area-specific non-drug amount (as defined in 
section 1853(k)(6)) for the competitive Medicare Advan-
tage area in which the individual resides for a month—
‘‘(i) does not exceed the competitive Medicare 
Advantage non-drug benchmark (as determined 
under paragraph (2) of section 1853(k), without re-
gard to paragraph (8) thereof) for such area, the 
amount of the premium for the individual for the 
month shall be reduced by an amount equal to the 
product of the adjustment factor under subpara-
graph (C) and 75 percent of the amount by which 
such competitive benchmark exceeds such fee-for-
service area-specific non-drug amount; or
257
‘‘(ii) exceeds such competitive Medicare Advan-
tage non-drug benchmark, the amount of the pre-
mium for the individual for the month shall be ad-
justed to ensure, subject to subparagraph (B), 
that—
‘‘(I) the sum of the amount of the adjusted 
premium and the competitive Medicare Advan-
tage non-drug benchmark for the area, is equal 
to 
‘‘(II) the sum of the unadjusted premium 
plus amount of the fee-for-service area-specific 
non-drug amount for the area. 
‘‘(B) In no case shall the actual amount of an adjust-
ment under subparagraph (A)(ii) exceed the product of 
the adjustment factor under subparagraph (C) and the 
amount of the adjustment otherwise computed under sub-
paragraph (A)(ii) without regard to this subparagraph. 
‘‘(C) The adjustment factor under this subparagraph 
for an area for a year is equal to—
‘‘(i) the number of consecutive years (in the 5-
year period ending with the year involved) in which 
such area was a competitive Medicare Advantage 
area; divided by 
‘‘(ii) 5.
258
‘‘(2)(A) In the case of an individual who resides in 
an area that is within a competitive EFFS region under 
section 1860E–3(e) but is not within a competitive Medi-
care Advantage area under section 1853(k)(1) and who 
is not enrolled in a Medicare Advantage plan under part 
C or in an EFFS plan under part E, the monthly premium 
otherwise applied under this part (determined without re-
gard to subsections (b) and (f) or any adjustment under 
this subsection) shall be adjusted as follows: If the fee-
for-service region-specific non-drug amount (as defined in 
section 1860E–3(e)(6)) for a region for a month—
‘‘(i) does not exceed the competitive EFFS non-
drug monthly benchmark amount (as determined 
under paragraph (2) of section 1860E–3(e), without 
regard to paragraph (8) thereof) for such region, the 
amount of the premium for the individual for the 
month shall be reduced by an amount equal to the 
product of the adjustment factor under subpara-
graph (C) and 75 percent of the amount by which 
such competitive benchmark amount exceeds such 
fee-for-service region-specific non-drug benchmark 
amount; or 
‘‘(ii) exceeds such competitive EFFS non-drug 
monthly benchmark amount, the amount of the pre-
mium for the individual for the month shall be ad-
259
justed to ensure, subject to subparagraph (B), 
that—
‘‘(I) the sum of the amount of the adjusted 
premium and the competitive EFFS non-drug 
monthly benchmark amount for the region, is 
equal to 
‘‘(II) the sum of the unadjusted premium 
plus the amount of the EFFS region-specific 
non-drug monthly bidfor the region. 
‘‘(B) In no case shall the actual amount of an adjust-
ment under subparagraph (A)(ii) exceed the product of 
the adjustment factor under subparagraph (C) and the 
amount of the adjustment otherwise computed under sub-
paragraph (A)(ii) without regard to this subparagraph. 
‘‘(C) The adjustment factor under this subparagraph 
for an EFFS region for a year is equal to—
‘‘(i) the number of consecutive years (in the 5-
year period ending with the year involved) in which 
such region was a competitive EFFS region; divided 
by 
‘‘(ii) 5. 
‘‘(3) Nothing in this subsection shall be construed as 
preventing a reduction under paragraph (1)(A) or para-
graph (2)(A) in the premium otherwise applicable under 
this part to zero or from requiring the provision of a re-
260
bate to the extent such premium would otherwise be re-
quired to be less than zero. 
‘‘(4) The adjustment in the premium under this sub-
section shall be effected in such manner as the Medicare 
Benefits Administrator determines appropriate. 
‘‘(5) In order to carry out this subsection (insofar as 
it is effected through the manner of collection of premiums 
under 1840(a)), the Medicare Benefits Administrator 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 adjustment (if any) under this subsection for 
each individual enrolled under this part for each 
month during the year; and 
‘‘(B) periodically throughout the year, informa-
tion to update the information previously trans-
mitted under this paragraph for the year.’’. 
(2) NO CHANGE IN MEDICARE’S DEFINED BEN-
EFIT
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 Se-
curity Act. 
(3) 
CONFORMING
AMENDMENT.—Section 
1844(c) (42 U.S.C. 1395w(c)) is amended by insert-
261
ing ‘‘and without regard to any premium adjustment 
effected under section 1839(h)’’ before the period at 
the end. 
(d) EFFECTIVE DATE.—The amendments made by 
this section shall take effect on January 1, 2010.
TITLE III—COMBATTING WASTE, 
FRAUD, AND ABUSE 
SEC. 301. MEDICARE SECONDARY PAYOR (MSP) PROVI-
SIONS. 
(a) TECHNICAL AMENDMENT CONCERNING SEC-
RETARY’S AUTHORITY TO MAKE CONDITIONAL PAYMENT 
WHEN CERTAIN PRIMARY PLANS DO NOT PAY PROMPT-
LY.—
(1) IN
GENERAL.—Section 1862(b)(2) (42 
U.S.C. 1395y(b)(2)) is amended—
(A) in subparagraph (A)(ii), by striking 
‘‘promptly (as determined in accordance with 
regulations)’’; 
(B) in subparagraph (B)—
(i) 
by 
redesignating 
clauses 
(i) 
through (iii) as clauses (ii) through (iv), 
respectively; and 
(ii) by inserting before clause (ii), as 
so redesignated, the following new clause:
262
‘‘(i) AUTHORITY
TO
MAKE
CONDI-
TIONAL
PAYMENT.—The Secretary may 
make payment under this title with respect 
to an item or service if a primary plan de-
scribed 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 accord-
ance 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.’’. 
(2) EFFECTIVE DATE.—The amendments made 
by paragraph (1) shall be effective as if included in 
the enactment of title III of the Medicare and Med-
icaid Budget Reconciliation Amendments of 1984 
(Public Law 98-369). 
(b) CLARIFYING AMENDMENTS
TO CONDITIONAL 
PAYMENT PROVISIONS.—Section 1862(b)(2) (42 U.S.C. 
1395y(b)(2)) is further amended—
(1) in subparagraph (A), in the matter fol-
lowing 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-
263
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)(B)—
(A) by striking the first sentence and in-
serting the following: ‘‘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 serv-
ice 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 determina-
tion 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 re-
ceived’’ and inserting ‘‘on the date notice of, or
264
information related to, a primary plan’s respon-
sibility for such payment or other information is 
received’’; and 
(3) in subparagraph (B)(iii), , as redesignated 
by subsection (a)(2)(B), by striking the first sen-
tence and inserting the following: ‘‘In order to re-
cover 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 pay-
ment 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 enti-
ty. In addition, the United States may recover under 
this clause from any entity that has received pay-
ment 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 indenta-
tion of clauses (ii) through (v) 2 ems to the left; and
265
(2) in paragraph (3)(A), by striking ‘‘such’’ be-
fore ‘‘paragraphs’’. 
SEC. 302. COMPETITIVE ACQUISITION OF CERTAIN ITEMS 
AND SERVICES. 
(a) 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 shall be phased-in—
‘‘(i) among competitive acquisition 
areas over a period of not longer than 3 
years in a manner so that the competition 
under the programs occurs in—
266
‘‘(I) at least 1⁄3 of such areas in 
2005; and 
‘‘(II) at least 2⁄3 of such areas in 
2006; and 
‘‘(ii) among items and services in a 
manner such that the programs apply to 
the highest cost and highest volume items 
and services first. 
‘‘(C) WAIVER OF CERTAIN PROVISIONS.—
In carrying out the programs, the Secretary 
may waive such provisions of the Federal Ac-
quisition Regulation as are necessary for the ef-
ficient implementation of this section, other 
than provisions relating to confidentiality of in-
formation and such other provisions as the Sec-
retary determines appropriate. 
‘‘(2) ITEMS AND SERVICES DESCRIBED.—The 
items and services referred to in paragraph (1) are 
the following: 
‘‘(A) DURABLE MEDICAL EQUIPMENT AND 
MEDICAL SUPPLIES.—Covered items (as defined 
in section 1834(a)(13)) for which payment is 
otherwise made under section 1834(a), includ-
ing items used in infusion and drugs and sup-
plies used in conjunction with durable medical
267
equipment, but excluding class III devices 
under the Federal Food, Drug, and Cosmetic 
Act. 
‘‘(B) 
OTHER
EQUIPMENT
AND
SUP-
PLIES.—Items, equipment, and supplies (as de-
scribed in section 1842(s)(2)(D) other than en-
teral nutrients). 
‘‘(C) 
OFF-THE-SHELF
ORTHOTICS.—
Orthotics (described in section 1861(s)(9)) for 
which payment is otherwise made under section 
1834(h) which require minimal self-adjustment 
for appropriate use and does not require exper-
tise in trimming, bending, molding, assembling, 
or customizing to fit to the patient. 
‘‘(3) EXCEPTION AUTHORITY.—In carrying out 
the programs under this section, the Secretary may 
exempt—
‘‘(A) rural areas and areas with low popu-
lation density within urban areas that are not 
competitive, unless there is a significant na-
tional market through mail order for a par-
ticular item or service; and 
‘‘(B) items and services for which the ap-
plication of competitive acquisition is not likely 
to result in significant savings.
268
‘‘(4) SPECIAL
RULE
FOR
CERTAIN
RENTED 
ITEMS OF DURABLE MEDICAL EQUIPMENT.—In the 
case of a covered item for which payment is made 
on a rental basis under section 1834(a), the Sec-
retary shall establish a process by which rental 
agreements for the covered items entered into before 
the application of the competitive acquisition pro-
gram under this section for the item may be contin-
ued notwithstanding this section. In the case of any 
such continuation, the supplier involved shall provide 
for appropriate servicing and replacement, as re-
quired under section 1834(a). 
‘‘(5) PHYSICIAN
AUTHORIZATION.—The Sec-
retary may establish a process under which a physi-
cian may prescribe a particular brand or mode of de-
livery of an item or service if the item or service in-
volved is clinically more appropriate than other simi-
lar items or services. 
‘‘(6) APPLICATION.—For each competitive ac-
quisition area in which the program is implemented 
under this subsection with respect to items and serv-
ices, the payment basis determined under the com-
petition conducted under subsection (b) shall be sub-
stituted for the payment basis otherwise applied 
under section 1834(a).
269
‘‘(b) PROGRAM REQUIREMENTS.—
‘‘(1) IN GENERAL.—The Secretary shall con-
duct a competition among entities supplying items 
and services described in subsection (a)(2) for each 
competitive acquisition area in which the program is 
implemented under subsection (a) with respect to 
such items and services. 
‘‘(2) CONDITIONS FOR AWARDING CONTRACT.—
‘‘(A) IN
GENERAL.—The Secretary may 
not award a contract to any entity under the 
competition conducted in an competitive acqui-
sition area pursuant to paragraph (1) to fur-
nish such items or services unless the Secretary 
finds all of the following: 
‘‘(i) The entity meets quality and fi-
nancial standards specified by the Sec-
retary or developed by the Program Advi-
sory and Oversight Committee established 
under subsection (c). 
‘‘(ii) The total amounts to be paid 
under the contract (including costs associ-
ated with the administration of the con-
tract) are expected to be less than the total 
amounts that would otherwise be paid.
270
‘‘(iii) Beneficiary access to a choice of 
multiple suppliers in the area is main-
tained. 
‘‘(iv) Beneficiary liability is limited to 
20 percent of the applicable contract 
award price, except in such cases where a 
supplier has furnished an upgraded item 
and has executed an advanced beneficiary 
notice. 
‘‘(B) DEVELOPMENT OF QUALITY STAND-
ARDS FOR DME PRODUCTS.—
‘‘(i) IN GENERAL.—The quality stand-
ards specified under subparagraph (A)(i) 
shall not be less than the quality standards 
that would otherwise apply if this section 
did not apply and shall include consumer 
services standards. Not later than July 1, 
2004, the Secretary shall establish new 
quality standards for products subject to 
competitive acquisition under this section. 
Such standards shall be applied prospec-
tively and shall be published on the website 
of the Department of Health and Human 
Services.
271
‘‘(ii) CONSULTATION WITH PROGRAM 
ADVISORY AND OVERSIGHT COMMITTEE.—
The Secretary shall consult with the Pro-
gram Advisory and Oversight Committee 
(established under subsection (c)) to review 
(and advise the Secretary concerning) the 
quality standards referred to in clause (i). 
‘‘(iii) 
CONSTRUCTION.—Nothing 
in 
this subparagraph shall be construed as 
delaying the effective date of the imple-
mentation of the competitive acquisition 
program under this section. 
‘‘(3) CONTENTS OF CONTRACT.—
‘‘(A) IN
GENERAL.—A contract entered 
into with an entity under the competition con-
ducted pursuant to paragraph (1) is subject to 
terms and conditions that the Secretary may 
specify. 
‘‘(B) TERM
OF
CONTRACTS.—The Sec-
retary shall recompete contracts under this sec-
tion not less often than once every 3 years. 
‘‘(4) LIMIT ON NUMBER OF CONTRACTORS.—
‘‘(A) IN
GENERAL.—The Secretary may 
limit the number of contractors in a competitive 
acquisition area to the number needed to meet
272
projected demand for items and services covered 
under the contracts. In awarding contracts, the 
Secretary shall take into account the ability of 
bidding entities to furnish items or services in 
sufficient quantities to meet the anticipated 
needs of beneficiaries for such items or services 
in the geographic area covered under the con-
tract on a timely basis. 
‘‘(B) MULTIPLE WINNERS.—The Secretary 
shall award contracts to multiple entities sub-
mitting bids in each area for an item or service. 
‘‘(5) PAYMENT.—Payment under this part for 
competitively priced items and services described in 
subsection (a)(2) shall be based on the bids sub-
mitted and accepted under this section for such 
items and services. 
‘‘(6) PARTICIPATING CONTRACTORS.—Payment 
shall not be made for items and services described 
in subsection (a)(2) furnished by a contractor and 
for which competition is conducted under this sec-
tion unless—
‘‘(A) the contractor has submitted a bid 
for such items and services under this section; 
and
273
‘‘(B) the Secretary has awarded a contract 
to the contractor for such items and services 
under this section. 
In this section, the term ‘bid’ means a request for 
a proposal for an item or service that includes the 
cost of the item or service, and where appropriate, 
any services that are attendant to the provision of 
the item or service. 
‘‘(7) CONSIDERATION
IN
DETERMINING
CAT-
EGORIES FOR BIDS.—The Secretary shall consider 
the similarity of the clinical efficiency and value of 
specific codes and products, including products that 
may provide a therapeutic advantage to bene-
ficiaries, before delineating the categories and prod-
ucts that will be subject to bidding. 
‘‘(8) AUTHORITY
TO
CONTRACT
FOR
EDU-
CATION, MONITORING, OUTREACH AND COMPLAINT 
SERVICES.—The Secretary may enter into a contract 
with an appropriate entity to address complaints 
from beneficiaries who receive items and services 
from an entity with a contract under this section 
and to conduct appropriate education of and out-
reach to such beneficiaries and monitoring quality of 
services with respect to the program.
274
‘‘(c) PROGRAM ADVISORY
AND OVERSIGHT COM-
MITTEE.—
‘‘(1) ESTABLISHMENT.—There is established a 
Program Advisory and Oversight Committee (herein-
after in this section referred to as the ‘Committee’). 
‘‘(2) MEMBERSHIP; TERMS.—The Committee 
shall consist of such members as the Secretary may 
appoint who shall serve for such term as the Sec-
retary may specify. 
‘‘(3) DUTIES.—
‘‘(A) TECHNICAL ASSISTANCE.—The Com-
mittee shall provide advice and technical assist-
ance to the Secretary with respect to the fol-
lowing functions: 
‘‘(i) The implementation of the pro-
gram under this section. 
‘‘(ii) The establishment of require-
ments for collection of data. 
‘‘(iii) The development of proposals 
for efficient interaction among manufac-
turers and distributors of the items and 
services and providers and beneficiaries. 
‘‘(B) ADDITIONAL
DUTIES.—The Com-
mittee shall perform such additional functions
275
to assist the Secretary in carrying out this sec-
tion as the Secretary may specify. 
‘‘(4) INAPPLICABILITY
OF
FACA.—The provi-
sions of the Federal Advisory Committee Act (5 
U.S.C. App.) shall not apply. 
‘‘(d) ANNUAL REPORTS.—The Secretary shall submit 
to Congress an annual management report on the pro-
grams under this section. Each such report shall include 
information on savings, reductions in beneficiary cost-
sharing, access to and quality of items and services, and 
beneficiary satisfaction. 
‘‘(e) DEMONSTRATION PROJECT FOR CLINICAL LAB-
ORATORY SERVICES.—
‘‘(1) IN GENERAL.—The Secretary shall con-
duct a demonstration project on the application of 
competitive acquisition under this section to clinical 
diagnostic laboratory tests—
‘‘(A) for which payment is otherwise made 
under section 1833(h) or 1834(d)(1) (relating 
to colorectal cancer screening tests); and 
‘‘(B) which are furnished by entities that 
did not have a face-to-face encounter with the 
individual.
276
‘‘(2) TERMS
AND
CONDITIONS.—Such project 
shall be under the same conditions as are applicable 
to items and services described in subsection (a)(2). 
‘‘(3) REPORT.—The Secretary shall submit to 
Congress—
‘‘(A) an initial report on the project not 
later than December 31, 2005; and 
‘‘(B) such progress and final reports on 
the project after such date as the Secretary de-
termines appropriate.’’. 
(b) CONFORMING AMENDMENTS.—
(1) DURABLE
MEDICAL
EQUIPMENT; ELIMI-
NATION OF INHERENT REASONABLENESS AUTHOR-
ITY.—Section 1834(a) (42 U.S.C. 1395m(a)) is 
amended—
(A) in paragraph (1)(B), by striking ‘‘The 
payment basis’’ and inserting ‘‘Subject to sub-
paragraph (E)(i), the payment basis’’; 
(B) in paragraph (1)(C), by striking ‘‘This 
subsection’’ and inserting ‘‘Subject to subpara-
graph (E)(ii), this subsection’’; 
(C) by adding at the end of paragraph (1) 
the following new subparagraph: 
‘‘(E) APPLICATION
OF
COMPETITIVE
AC-
QUISITION; ELIMINATION
OF
INHERENT
REA-
277
SONABLENESS AUTHORITY.—In the case of cov-
ered items and services that are included in a 
competitive acquisition program in a competi-
tive acquisition area under section 1847(a)—
‘‘(i) the payment basis under this sub-
section for such items and services fur-
nished in such area shall be the payment 
basis determined under such competitive 
acquisition program; and 
‘‘(ii) the Secretary may use informa-
tion on the payment determined under 
such competitive acquisition programs to 
adjust the payment amount otherwise rec-
ognized under subparagraph (B)(ii) for an 
area that is not a competitive acquisition 
area under section 1847 and in the case of 
such adjustment, paragraph (10)(B) shall 
not be applied.’’; and 
(D) in paragraph (10)(B), by inserting ‘‘in 
an area and with respect to covered items and 
services for which the Secretary does not make 
a payment amount adjustment under paragraph 
(1)(E)’’ after ‘‘under this subsection’’.
278
(2) OFF-THE-SHELF ORTHOTICS; ELIMINATION 
OF INHERENT REASONABLENESS AUTHORITY.—Sec-
tion 1834(h) (42 U.S.C. 1395m(h)) is amended—
(A) in paragraph (1)(B), by striking ‘‘and 
(E)’’ and inserting ‘‘, (E) , and (H)(i)’’; 
(B) in paragraph (1)(D), by striking ‘‘This 
subsection’’ and inserting ‘‘Subject to subpara-
graph (H)(ii), this subsection’’; 
(C) by adding at the end of paragraph (1) 
the following new subparagraph: 
‘‘(H) APPLICATION OF COMPETITIVE AC-
QUISITION TO ORTHOTICS; ELIMINATION OF IN-
HERENT
REASONABLENESS
AUTHORITY.—In 
the case of orthotics described in paragraph 
(2)(B) of section 1847(a) that are included in 
a competitive acquisition program in a competi-
tive acquisition area under such section—
‘‘(i) the payment basis under this sub-
section for such orthotics furnished in such 
area shall be the payment basis determined 
under such competitive acquisition pro-
gram; and 
‘‘(ii) the Secretary may use informa-
tion on the payment determined under 
such competitive acquisition programs to
279
adjust the payment amount otherwise rec-
ognized under subparagraph (B)(ii) for an 
area that is not a competitive acquisition 
area under section 1847, and in the case 
of such adjustment, paragraphs (8) and 
(9) of section 1842(b) shall not be ap-
plied.’’. 
(c) REPORT ON ACTIVITIES OF SUPPLIERS.—The 
Secretary shall conduct a study to determine the extent 
to which (if any) suppliers of covered items of durable 
medical equipment that are subject to the competitive ac-
quisition program under section 1847 of the Social Secu-
rity Act, as amended by subsection (a), are soliciting phy-
sicians to prescribe certain brands or modes of delivery 
of covered items based on profitability. 
(d) GAO STUDY ON SAFE AND EFFECTIVE HOME IN-
FUSION AND INHALATION THERAPY; STANDARDS.—
(1) STUDY.—The Comptroller General of the 
United States shall conduct a study of the stand-
ards, professional services, and related functions 
necessary for the provision of safe and effective 
home infusion therapy and home inhalation therapy. 
(2) REPORT.—Not later than May 1, 2004, the 
Comptroller General shall submit to Congress a re-
port on the study conducted under paragraph (1).
280
(3) USE OF FINDINGS IN DEVELOPING STAND-
ARDS.—In promulgating regulations to carry out 
section 1847 of the Social Security Act, as amended 
by subsection (a), the Secretary shall ensure that 
quality 
standards 
developed 
under 
subsection 
(b)(2)(B) of such section reflect the findings of the 
Comptroller General set forth in the report under 
paragraph (2).
SEC. 303. COMPETITIVE ACQUISITION OF COVERED OUT-
PATIENT DRUGS AND BIOLOGICALS.
(a) ADJUSTMENT TO PHYSICIAN FEE SCHEDULE.—
(1) ADJUSTMENT IN PRACTICE EXPENSE REL-
ATIVE
VALUE
UNITS.—Section 
1848(c)(2) 
(42 
U.S.C. 1395w–4(c)(2)) is amended—
(A) in subparagraph (B)—
(i) in clause (ii)(II), by striking ‘‘The 
adjustments’’ and inserting ‘‘Subject to 
clause (iv), the adjustments’’; and 
(ii) by adding at the end of subpara-
graph (B), the following new clause: 
‘‘(iv) EXCEPTION
TO
BUDGET
NEU-
TRALITY.—The additional expenditures at-
tributable to clauses (ii) and (iii) of sub-
paragraph (H) shall not be taken into ac-
281
count in applying clause (ii)(II) for 2005.’’; 
and 
(B) by adding at the end the following new 
subparagraph: 
‘‘(H) ADJUSTMENTS
IN
PRACTICE
EX-
PENSE RELATIVE VALUE UNITS FOR 2005.—
‘‘(i) IN GENERAL.—As part of the an-
nual process of establishing the physician 
fee schedule under subsection (b) for 2005, 
the Secretary shall increase the practice 
expense relative value units for 2005 con-
sistent with clauses (ii) and (iii). 
‘‘(ii) USE OF SUPPLEMENTAL SURVEY 
DATA.—For 2005 for any specialty that 
submitted survey data that included ex-
penses for the administration of drugs and 
biologicals for which payment is made 
under section 1842(o) (or section 1847A), 
the Secretary shall use such supplemental 
survey data in carrying out this subpara-
graph insofar as they are collected and 
provided by entities and organizations con-
sistent with the criteria established by the 
Secretary pursuant to section 212(a) of the 
Medicare, Medicaid, and SCHIP Balanced
282
Budget Refinement Act of 1999 and inso-
far as such data are submitted to the Sec-
retary by December 31, 2004.
‘‘(iii) PROVISIONS FOR APPROPRIATE 
REPORTING AND BILLING FOR PHYSICIANS’ 
SERVICES ASSOCIATED WITH THE ADMINIS-
TRATION OF COVERED OUTPATIENT DRUGS 
AND BIOLOGICALS.—
‘‘(I) EVALUATION
OF
CODES.—
The Secretary shall promptly evaluate 
existing codes for physicians’ services 
associated with the administration of 
covered 
outpatient 
drugs 
and 
biologicals (as defined in section 
1847A(a)(2)(A)) to ensure accurate 
reporting and billing for such services. 
‘‘(II) USE
OF
EXISTING
PROC-
ESSES.—In carrying out subclause (I), 
the Secretary shall use existing proc-
esses for the consideration of coding 
changes and, to the extent coding 
changes are made, shall use such 
processes in establishing relative val-
ues for such services.
283
‘‘(III) 
IMPLEMENTATION.—In 
carrying out subclause (I), the Sec-
retary shall consult with representa-
tives of physician specialties affected 
by the implementation of section 
1847A or section 1847B, and shall 
take such steps within the Secretary’s 
authority to expedite such consider-
ations under subclause (II). 
‘‘(iv) SUBSEQUENT, 
BUDGET
NEU-
TRAL
ADJUSTMENTS
PERMITTED.—Noth-
ing in this subparagraph shall be construed 
as preventing the Secretary from providing 
for adjustments in practice expense relative 
value units under (and consistent with) 
subparagraph (B) for years after 2005. 
‘‘(v) CONSULTATION.—Before pub-
lishing the notice of proposed rulemaking 
to carry out this subparagraph, the Sec-
retary shall consult with the Comptroller 
General of the United States and with 
groups representing the physician special-
ties involved. 
‘‘(vi) TREATMENT AS CHANGE IN LAW 
AND
REGULATION
IN
SUSTAINABLE
284
GROWTH RATE DETERMINATION.—The en-
actment of subparagraph (B)(iv) and this 
subparagraph shall be treated as a change 
in law for purposes of applying subsection 
(f)(2)(D).’’. 
(2) PROHIBITION OF ADMINISTRATIVE AND JU-
DICIAL
REVIEW.—Section 1848(i)(1) (42 U.S.C. 
1395w–4(i)(1)) is amended—
(A) by striking ‘‘and’’ at the end of subpara-
graph (D); 
(B) by striking the period at the end of sub-
paragraph (E) and inserting ‘‘, and’’; and 
(C) by adding at the end the following new sub-
paragraph: 
‘‘(F) adjustments in practice expense rel-
ative value units for 2005 under subsection 
(c)(2)(H).’’. 
(3) TREATMENT
OF
OTHER
SERVICES
CUR-
RENTLY IN THE NON-PHYSICIAN WORK POOL.—The 
Secretary shall make adjustments to the non-physi-
cian work pool methodology (as such term is used in 
the regulations promulgated by the Secretary in the 
Federal Register as of December 31, 2002) for de-
termination of practice expense relative value units 
under the physician fee schedule described in section
285
1848(c)(2)(C)(ii) of the Social Security Act so that 
the practice expense relative value units for services 
determined under such methodology are not affected 
relative to the practice expense relative value units 
of other services not determined under such non-
physician work pool methodology, as the result of 
amendments made by paragraph (1).
(b) PAYMENT
BASED
ON
COMPETITION.—Title 
XVIII is amended by inserting after section 1847 (42 
U.S.C. 1395w–3), as amended by section 302, the fol-
lowing new sections: 
‘‘COMPETITIVE ACQUISITION OF COVERED OUTPATIENT 
DRUGS AND BIOLOGICALS 
‘‘SEC. 1847A. (a) IMPLEMENTATION OF COMPETI-
TIVE ACQUISITION.—
‘‘(1) IMPLEMENTATION OF PROGRAM.—
‘‘(A) IN
GENERAL.—The Secretary shall 
establish and implement a competitive acquisi-
tion program under which—
‘‘(i) competitive acquisition areas are 
established throughout the United States 
for contract award purposes for acquisition 
of and payment for categories of covered 
outpatient drugs and biologicals (as de-
fined in paragraph (2)) under this part;
286
‘‘(ii) each physician is given the op-
portunity annually to elect to obtain drugs 
and biologicals under the program or 
under section 1847B; and 
‘‘(iii) each physician who elects to ob-
tain drugs and biologicals under the pro-
gram makes an annual selection under 
paragraph (5) of the contractor through 
which drugs and biologicals within a cat-
egory of drugs and biologicals will be ac-
quired and delivered to the physician under 
this part. 
‘‘(B) IMPLEMENTATION.—The Secretary 
shall implement the program so that the pro-
gram applies to—
‘‘(i) the oncology category beginning 
in 2005; and 
‘‘(ii) the non-oncology category begin-
ning in 2006. 
This section shall not apply in the case of a 
physician who elects section 1847B to apply. 
‘‘(C) WAIVER OF CERTAIN PROVISIONS.—
In order to promote competition, efficient serv-
ice, and product quality, in carrying out the 
program the Secretary may waive such provi-
287
sions of the Federal Acquisition Regulation as 
are necessary for the efficient implementation 
of this section, other than provisions relating to 
confidentiality of information and such other 
provisions as the Secretary determines appro-
priate. 
‘‘(D) EXCLUSION
AUTHORITY.—The Sec-
retary may exclude covered outpatient drugs 
and biologicals (including a class of such drugs 
and biologicals) from the competitive bidding 
system under this section if the drugs or 
biologicals (or class) are not appropriate for 
competitive bidding due to low volume of utili-
zation by beneficiaries under this part or a 
unique mode or method of delivery or similar 
reasons.
‘‘(2) 
COVERED
OUTPATIENT
DRUGS
AND 
BIOLOGICALS, CATEGORIES, PROGRAM
DEFINED.—
For purposes of this section—
‘‘(A) COVERED OUTPATIENT DRUGS AND 
BIOLOGICALS
DEFINED.—The term ‘covered 
outpatient drugs and biologicals’ means drugs 
and biologicals to which section 1842(o) applies 
and which are not covered under section 1847 
(relating to competitive acquisition for items of
288
durable medical equipment). Such term does 
not include the following: 
‘‘(i) Blood clotting factors. 
‘‘(ii) Drugs and biologicals furnished 
to individuals in connection with the treat-
ment of end stage renal disease. 
‘‘(iii) Radiopharmaceuticals. 
‘‘(iv) Vaccines. 
‘‘(B) 2 CATEGORIES.—Each of the fol-
lowing shall be a separate category of covered 
outpatient drugs and biologicals, as identified 
by the Secretary: 
‘‘(i) ONCOLOGY
CATEGORY.—A cat-
egory (in this section referred to as the 
‘oncology category’) consisting of those 
covered outpatient drugs and biologicals 
that, as determined by the Secretary, are 
typically primarily billed by oncologists or 
are otherwise used to treat cancer. 
‘‘(ii) NON-ONCOLOGY
CATEGORIES.—
Such numbers of categories (in this section 
referred to as the ‘non-oncology cat-
egories’) consisting of covered outpatient 
drugs and biologicals not described in 
clause (i), and appropriate subcategories of
289
such drugs and biologicals as the Secretary 
may specify. 
‘‘(C) 
PROGRAM.—The 
term 
‘program’ 
means the competitive acquisition program 
under this section. 
‘‘(D) COMPETITIVE
ACQUISITION
AREA; 
AREA.—The terms ‘competitive acquisition area’ 
and ‘area’ mean an appropriate geographic re-
gion established by the Secretary under the pro-
gram. 
‘‘(E) CONTRACTOR.—The term ‘contractor’ 
means an entity that has entered into a con-
tract with the Secretary under this section. 
‘‘(3) APPLICATION
OF
PROGRAM
PAYMENT 
METHODOLOGY.—With respect to covered outpatient 
drugs and biologicals which are supplied under the 
program in an area and which are prescribed by a 
physician who has not elected section 1847B to 
apply—
‘‘(A) the claim for such drugs and 
biologicals shall be submitted by the contractor 
that supplied the drugs and biologicals; 
‘‘(B) collection of amounts of any deduct-
ible and coinsurance applicable with respect to 
such drugs and biologicals shall be the responsi-
290
bility of such contractor and shall not be col-
lected unless the drug or biological is adminis-
tered to the beneficiary involved; and 
‘‘(C) the payment under this section (and 
related coinsurance amounts) for such drugs 
and biologicals—
‘‘(i) shall be made only to such con-
tractor; 
‘‘(ii) shall be conditioned upon the ad-
ministration of such drugs and biologicals; 
and 
‘‘(iii) shall be based on the average of 
the bid prices for such drugs and 
biologicals in the area, as computed under 
subsection (d). 
The Secretary shall provide a process for 
recoupment in the case in which payment is 
made for drugs and biologicals which were 
billed at the time of dispensing but which were 
not actually administered. 
‘‘(4) CONTRACT REQUIRED.—
‘‘(A) IN GENERAL.—Payment may not be 
made under this part for covered outpatient 
drugs and biologicals prescribed by a physician 
who has not elected section 1847B to apply
291
within a category and a competitive acquisition 
area with respect to which the program applies 
unless—
‘‘(i) the drugs or biologicals are sup-
plied by a contractor with a contract under 
this section for such category of drugs and 
biologicals and area; and 
‘‘(ii) the physician has elected such 
contractor under paragraph (5) for such 
category and area. 
‘‘(B) PHYSICIAN
CHOICE.—Subparagraph 
(A) shall not apply for a category of drugs for 
an area if the physician prescribing the covered 
outpatient drug in such category and area has 
elected to apply section 1847B instead of this 
section.
‘‘(5) CONTRACTOR SELECTION PROCESS.—
‘‘(A) IN
GENERAL.—The Secretary shall 
provide a process for the selection of a con-
tractor, on an annual basis and in such exigent 
circumstances as the Secretary may provide and 
with respect to each category of covered out-
patient drugs and biologicals for an area, by 
physicians 
prescribing 
such 
drugs 
and 
biologicals in the area of the contractor under
292
this section that will supply the drugs and 
biologicals within that category and area. Such 
selection shall also include the election de-
scribed in section 1847B(a). 
‘‘(B) INFORMATION
ON
CONTRACTORS.—
The Secretary shall make available to physi-
cians on an ongoing basis, through a directory 
posted on the Department’s Internet website or 
otherwise and upon request, a list of the con-
tractors under this section in the different com-
petitive acquisition areas. 
‘‘(C) SELECTING
PHYSICIAN
DEFINED.—
For purposes of this section, the term ‘selecting 
physician’ means, with respect to a contractor 
and category and competitive acquisition area, 
a physician who has not elected section 1847B 
to apply and has selected to apply under this 
section such contractor for such category and 
area. 
‘‘(b) PROGRAM REQUIREMENTS.—
‘‘(1) CONTRACT
FOR
COVERED
OUTPATIENT 
DRUGS AND BIOLOGICALS.—The Secretary shall con-
duct a competition among entities for the acquisition 
of a covered outpatient drug or biological within
293
each HCPCS code within each category for each 
competitive acquisition area. 
‘‘(2) CONDITIONS FOR AWARDING CONTRACT.—
‘‘(A) IN
GENERAL.—The Secretary may 
not award a contract to any entity under the 
competition conducted in a competitive acquisi-
tion area pursuant to paragraph (1) with re-
spect to the acquisition of covered outpatient 
drugs and biologicals within a category unless 
the Secretary finds that the entity meets all of 
the following with respect to the contract period 
involved: 
‘‘(i) CAPACITY TO SUPPLY COVERED 
OUTPATIENT DRUG OR BIOLOGICAL WITHIN 
CATEGORY.—
‘‘(I) IN
GENERAL.—The entity 
has sufficient arrangements to acquire 
and to deliver covered outpatient 
drugs and biologicals within such cat-
egory in the area specified in the con-
tract at the bid price specified in the 
contract for all physicians that may 
elect such entity. 
‘‘(II) 
SHIPMENT
METHOD-
OLOGY.—The entity has arrangements
294
in effect for the shipment at least 5 
days each week of covered outpatient 
drugs and biologicals under the con-
tract and for the timely delivery (in-
cluding for emergency situations) of 
such drugs and biologicals in the area 
under the contract. 
‘‘(ii) QUALITY, SERVICE, FINANCIAL 
PERFORMANCE
AND
SOLVENCY
STAND-
ARDS.—The entity meets quality, service, 
financial performance, and solvency stand-
ards specified by the Secretary, includ-
ing—
‘‘(I) the establishment of proce-
dures for the prompt response and 
resolution of physician and beneficiary 
complaints and inquiries regarding the 
shipment of covered outpatient drugs 
and biologicals; and 
‘‘(II) a grievance process for the 
resolution of disputes. 
‘‘(B) ADDITIONAL CONSIDERATIONS.—The 
Secretary may refuse to award a contract under 
this section, and may terminate such a con-
tract, with an entity based upon—
295
‘‘(i) the suspension or revocation, by 
the Federal Government or a State govern-
ment, of the entity’s license for the dis-
tribution of drugs or biologicals (including 
controlled substances); or 
‘‘(ii) the exclusion of the entity under 
section 1128 from participation under this 
title. 
‘‘(C) APPLICATION
OF
MEDICARE
PRO-
VIDER
OMBUDSMAN.—For provision providing 
for a program-wide Medicare Provider Ombuds-
man to review complaints, see section 1868(b), 
as added by section 923 of the Medicare Pre-
scription Drug and Modernization Act of 2003. 
‘‘(3) AWARDING MULTIPLE CONTRACTS FOR A 
CATEGORY AND AREA.—In order to provide a choice 
of at least 2 contractors in each competitive acquisi-
tion area for a category of drugs and biologicals, the 
Secretary may limit (but not below 2) the number 
of qualified entities that are awarded such contracts 
for any category and area. The Secretary shall select 
among qualified entities based on the following: 
‘‘(A) The bid prices for covered outpatient 
drugs and biologicals within the category and 
area.
296
‘‘(B) Bid price for distribution of such 
drugs and biologicals. 
‘‘(C) Ability to ensure product integrity. 
‘‘(D) Customer service. 
‘‘(E) Past experience in the distribution of 
drugs and biologicals, including controlled sub-
stances. 
‘‘(F) Such other factors as the Secretary 
may specify. 
‘‘(4) TERMS OF CONTRACTS.—
‘‘(A) IN
GENERAL.—A contract entered 
into with an entity under the competition con-
ducted pursuant to paragraph (1) is subject to 
terms and conditions that the Secretary may 
specify consistent with this section. 
‘‘(B) PERIOD OF CONTRACTS.—A contract 
under this section shall be for a term of 2 
years, but may be terminated by the Secretary 
or the entity with appropriate, advance notice. 
‘‘(C) INTEGRITY OF DRUG AND BIOLOGI-
CAL DISTRIBUTION SYSTEM.—The Secretary—
‘‘(i) shall require that for all drug and 
biological products distributed by a con-
tractor under this section be acquired di-
rectly from the manufacturer or from a
297
distributor that has acquired the products 
directly from the manufacturer; and 
‘‘(ii) may require, in the case of such 
products that are particularly susceptible 
to counterfeit or diversion, that the con-
tractor comply with such additional prod-
uct integrity safeguards as may be deter-
mined to be necessary. 
‘‘(D) IMPLEMENTATION
OF
ANTI-COUN-
TERFEITING, QUALITY, SAFETY, AND RECORD 
KEEPING REQUIREMENTS.—The Secretary shall 
require each contractor to implement (through 
its officers, agents, representatives, and employ-
ees) requirements relating to the storage and 
handling of covered outpatient drugs and 
biologicals and for the establishment and main-
tenance of distribution records for such drugs 
and biologicals. A contract under this section 
may include requirements relating to the fol-
lowing: 
‘‘(i) Secure facilities. 
‘‘(ii) Safe and appropriate storage of 
drugs and biologicals. 
‘‘(iii) Examination of drugs and 
biologicals received and dispensed.
298
‘‘(iv) Disposition of damaged and out-
dated drugs and biologicals. 
‘‘(v) Record keeping and written poli-
cies and procedures. 
‘‘(vi) Compliance personnel. 
‘‘(E) COMPLIANCE
WITH
CODE
OF
CON-
DUCT AND FRAUD AND ABUSE RULES.—Under 
the contract—
‘‘(i) the contractor shall comply with a 
code of conduct, specified or recognized by 
the Secretary, that includes standards re-
lating to conflicts of interest; and 
‘‘(ii) the contractor shall comply with 
all applicable provisions relating to preven-
tion of fraud and abuse, including compli-
ance with applicable guidelines of the De-
partment of Justice and the Inspector 
General of the Department of Health and 
Human Services. 
‘‘(F) DIRECT
DELIVERY
OF
DRUGS
AND 
BIOLOGICALS TO PHYSICIANS.—Under the con-
tract the contractor shall only supply covered 
outpatient drugs and biologicals directly to the 
selecting physicians and not directly to bene-
ficiaries, except under circumstances and set-
299
tings where a beneficiary currently receives a 
drug or biological in the beneficiary’s home or 
other non-physician office setting as the Sec-
retary may provide. The contractor shall not de-
liver drugs and biologicals to a selecting physi-
cian except upon receipt of a prescription for 
such drugs and biologicals, and such necessary 
data as may be required by the Secretary to 
carry out this section. This section does not—
‘‘(i) require a physician to submit a 
prescription for each individual treatment; 
or 
‘‘(ii) change a physician’s flexibility in 
terms of writing a prescription for drugs 
for a single treatment or a course of treat-
ment. 
‘‘(5) PERMITTING
ACCESS
TO
DRUGS
AND 
BIOLOGICALS.—The Secretary shall establish rules 
under this section under which drugs and biologicals 
which are acquired through a contractor under this 
section may be used to resupply inventories of such 
drugs and biologicals which are administered con-
sistent with safe drug practices and with adequate 
safeguards against fraud and abuse. The previous
300
sentence shall apply if the physicians can dem-
onstrate to the Secretary all of the following: 
‘‘(A) The drugs or biologicals are required 
immediately. 
‘‘(B) The physician could not have reason-
ably anticipated the immediate requirement for 
the drugs or biologicals. 
‘‘(C) The contractor could not deliver to 
the physician the drugs or biologicals in a time-
ly manner. 
‘‘(D) The drugs or biologicals were admin-
istered in an emergency situation. 
‘‘(6) CONSTRUCTION.—Nothing in this section 
shall be construed as waiving applicable State re-
quirements relating to licensing of pharmacies.
‘‘(c) BIDDING PROCESS.—
‘‘(1) IN GENERAL.—In awarding a contract for 
a category of drugs and biologicals in an area under 
the program, the Secretary shall consider with re-
spect to each entity seeking to be awarded a con-
tract the prices bid to acquire and supply the cov-
ered outpatient drugs and biologicals for that cat-
egory and area and the other factors referred to in 
subsection (b)(3).
301
‘‘(2) PRICES BID.—The prices bid by an entity 
under paragraph (1) shall be the prices in effect and 
available for the supply of contracted drugs and 
biologicals in the area through the entity for the 
contract period.
‘‘(3) REJECTION
OF
CONTRACT
OFFER.—The 
Secretary shall reject the contract offer of an entity 
with respect to a category of drugs and biologicals 
for an area if the Secretary estimates that the prices 
bid, in the aggregate on average, would exceed 100 
percent of the average sales price (as determined 
under section 1847B).
‘‘(4) BIDDING ON A NATIONAL OR REGIONAL 
BASIS.—Nothing in this section shall be construed 
as precluding a bidder from bidding for contracts in 
all areas of the United States or as requiring a bid-
der to submit a bid for all areas of the United 
States. 
‘‘(5) UNIFORMITY OF BIDS WITHIN AREA.—The 
amount of the bid submitted under a contract offer 
for any covered outpatient drug or biological for an 
area shall be the same for that drug or biological for 
all portions of that area. 
‘‘(6) CONFIDENTIALITY OF BIDS.—The provi-
sions of subparagraph (D) of section 1927(b)(3)
302
shall apply to a bid submitted in a contract offer for 
a covered outpatient drug or biological under this 
section in the same manner as it applies to informa-
tion disclosed under such section, except that any 
reference—
‘‘(A) in that subparagraph to a ‘manufac-
turer or wholesaler’ is deemed a reference to a 
‘bidder’ under this section; 
‘‘(B) in that section to ‘prices charged for 
drugs’ is deemed a reference to a ‘bid’ sub-
mitted under this section; and 
‘‘(C) in clause (i) of that section to ‘this 
section’, is deemed a reference to ‘part B of 
title XVIII’. 
‘‘(7) INCLUSION OF COSTS.—The bid price sub-
mitted in a contract offer for a covered outpatient 
drug or biological shall—
‘‘(A) include all costs related to the deliv-
ery of the drug or biological to the selecting 
physician (or other point of delivery); and 
‘‘(B) include the costs of dispensing (in-
cluding shipping) of such drug or biological and 
management fees, but shall not include any 
costs related to the administration of the drug 
or biological, or wastage, spillage, or spoilage.
303
‘‘(8) PRICE ADJUSTMENTS DURING CONTRACT 
PERIOD; DISCLOSURE
OF
COSTS.—Each contract 
awarded shall provide for—
‘‘(A) disclosure to the Secretary the con-
tractor’s reasonable, net acquisition costs for 
periods specified by the Secretary, not more 
often than quarterly, of the contract; and 
‘‘(B) appropriate price adjustments over 
the period of the contract to reflect significant 
increases or decreases in a contractor’s reason-
able, net acquisition costs, as so disclosed.
‘‘(d) COMPUTATION OF AVERAGE BID PRICES FOR 
A CATEGORY AND AREA.—
‘‘(1) IN GENERAL.—For each year or other con-
tract period for each covered outpatient drug or bio-
logical and area with respect to which a competition 
is conducted under the program, the Secretary shall 
compute an area average of the bid prices submitted, 
in contract offers accepted for the category and 
area, for that year or other contract period. 
‘‘(2) SPECIAL RULES.—The Secretary shall es-
tablish rules regarding the use under this section of 
the alternative payment amount provided under sec-
tion 1847B to the use of a price for specific covered
304
outpatient drugs and biologicals in the following 
cases: 
‘‘(A) NEW DRUGS AND BIOLOGICALS.—A 
covered outpatient drug or biological for which 
an average bid price has not been previously de-
termined. 
‘‘(B) OTHER
CASES.—Such other excep-
tional cases as the Secretary may specify in 
regulations, such as oral drugs under section 
1861(s)(2)(Q) and immmunosuppressives under 
section 1861(s)(2)(J). 
‘‘(e) COINSURANCE.—
‘‘(1) IN
GENERAL.—Coinsurance under this 
part with respect to a covered outpatient drug or bi-
ological for which payment is payable under this sec-
tion shall be based on 20 percent of the payment 
basis under this section. 
‘‘(2) COLLECTION.—Such coinsurance shall be 
collected by the contractor that supplies the drug or 
biological involved and, subject to subsection 
(a)(3)(B), in the same manner as coinsurance is col-
lected for durable medical equipment under this 
part. 
‘‘(f) SPECIAL PAYMENT RULES.—
305
‘‘(1) IN
GENERAL.—The Secretary may not 
provide for an adjustment to reimbursement for cov-
ered outpatient drugs and biologicals unless adjust-
ments to the practice expense payment adjustment 
are made on the basis of supplemental surveys under 
section 1848(c)(2)(H)(ii) of the Social Security Act, 
as added by subsection (a)(1)(B). 
(2) USE
IN
EXCLUSION
CASES.—If the Sec-
retary excludes a drug or biological (or class of 
drugs or biologicals) under subsection (a)(1)(D), the 
Secretary may provide for reimbursement to be 
made under this part for such drugs and biologicals 
(or class) using the payment methodology under sec-
tion 1847B. 
‘‘(3) COORDINATION RULES.—The provisions of 
section 1842(h)(3) shall apply to a contractor with 
respect to covered outpatients drugs and biologicals 
supplied by that contractor in the same manner as 
they apply to a participating supplier. In order to 
administer this section, the Secretary may condition 
payment under this part to a person for the admin-
istration of a drug or biological supplied under this 
section upon person’s provision of information on 
such administration.
306
‘‘(4) APPLICATION OF REQUIREMENT FOR AS-
SIGNMENT.—For provision requiring assignment of 
claims for covered outpatient drugs and biologicals, 
see section 1842(o)(3). 
‘‘(5) PROTECTION FOR BENEFICIARY IN CASE 
OF MEDICAL NECESSITY DENIAL.—For protection of 
beneficiaries against liability in the case of medical 
necessity 
determinations, 
see 
section 
1842(b)(3)(B)(ii)(III). 
‘‘(6) PHYSICIAN ROLE IN APPEALS PROCESS.—
The Secretary shall establish a procedure under 
which a physician who prescribes a drug or biologi-
cal for which payment is made under this section 
has appeal rights that are similar to those provided 
to a physician who prescribes durable medical equip-
ment or a laboratory test. 
‘‘(g) ADVISORY COMMITTEE.—The Secretary shall 
establish an advisory committee that includes representa-
tives of parties affected by the program under this section, 
including physicians, specialty pharmacies, distributors, 
manufacturers, and beneficiaries. The committee shall ad-
vise the Secretary on issues relating to the effective imple-
mentation of this section. 
‘‘(h) ANNUAL REPORTS.—The Secretary shall submit 
to Congress an annual report in each of 2005, 2006, and
307
2007, on the program. Each such report shall include in-
formation on savings, reductions in cost-sharing, access to 
covered outpatient drugs and biologicals, the range of 
choices of contractors available to providers, and bene-
ficiary and provider satisfaction. 
‘‘OPTIONAL USE OF AVERAGE SALES PRICE PAYMENT 
METHODOLOGY 
‘‘SEC. 1847B. (a) IN GENERAL.—
‘‘(1) ELECTION.—In connection with the an-
nual election made by a physician under section 
1847A(a)(5), the physician may elect to apply this 
section to the payment for covered outpatient drugs 
and biologicals instead of the payment methodology 
under section 1847A. 
‘‘(2) IMPLEMENTATION.—This section shall be 
implemented with respect to categories of covered 
outpatient drugs and biologicals described in section 
1847A(a)(2)(B). 
‘‘(3) 
COVERED
OUTPATIENT
DRUGS
AND 
BIOLOGICALS DEFINED.—For purposes of this sec-
tion, the term ‘covered outpatient drugs and 
biologicals’ has the meaning given such term in sec-
tion 1847A(a)(2)(A). 
‘‘(b) COMPUTATION OF PAYMENT AMOUNT.—
‘‘(1) IN GENERAL.—If this section applies with 
respect to a covered outpatient drug or biological,
308
the amount payable for the drug or biological (based 
on a minimum dosage unit) is, subject to applicable 
deductible and coinsurance—
‘‘(A) in the case of a multiple source drug 
(as defined in subsection (c)(6)(C)), 100 per-
cent (or in the case of covered outpatient drugs 
and biologicals furnished during 2005 and 
2006, 112 percent) of the amount determined 
under paragraph (3); or 
‘‘(B) in the case of a single source drug 
(as defined in subsection (c)(6)(D)), 100 per-
cent (or in the case of covered outpatient drugs 
and biologicals furnished during 2005 and 
2006, 112 percent) of the amount determined 
under paragraph (4). 
‘‘(2) SPECIFICATION OF UNIT.—
‘‘(A) 
SPECIFICATION
BY
MANUFAC-
TURER.—The manufacturer of a covered out-
patient drug shall specify the unit associated 
with each National Drug Code as part of the 
submission 
of 
data 
under 
section 
1927(b)(3)(A)(iii). 
‘‘(B) UNIT DEFINED.—In this section, the 
term ‘unit’ means, with respect to a covered 
outpatient drug, the lowest identifiable quantity
309
(such as a capsule or tablet, milligram of mol-
ecules, or grams) of the drug that is dispensed, 
exclusive of any diluent without reference to 
volume measures pertaining to liquids. 
‘‘(3) MULTIPLE SOURCE DRUG.—For all drug 
products included within the same multiple source 
drug, the amount specified in this paragraph is the 
volume-weighted average of the average sales prices 
reported under section 1927(b)(3)(A)(iii) computed 
as follows: 
‘‘(A) Compute the sum of the products (for 
each national drug code assigned to such drug 
products) of—
‘‘(i) the manufacturer’s average sales 
price (as defined in subsection (c)); and 
‘‘(ii) the total number of units speci-
fied under paragraph (2) sold, as reported 
under section 1927(b)(3)(A)(iii). 
‘‘(B) Divide the sum computed under sub-
paragraph (A) by the sum of the total number 
of units under subparagraph (A)(ii) for all na-
tional drug codes assigned to such drug prod-
ucts.
310
‘‘(4) SINGLE
SOURCE
DRUG.—The amount 
specified in this paragraph for a single source drug 
is the lesser of the following: 
‘‘(A) MANUFACTURER’S
AVERAGE
SALES 
PRICE.—The manufacturer’s average sales price 
for a national drug code, as computed using the 
methodology applied under paragraph (3). 
‘‘(B) 
WHOLESALE
ACQUISITION
COST 
(WAC).—The wholesale acquisition cost (as de-
fined in subsection (c)(6)(B)) reported for the 
single source drug. 
‘‘(5) BASIS
FOR
DETERMINATION.—The pay-
ment amount shall be determined under this sub-
section based on information reported under sub-
section (e) and without regard to any special pack-
aging, labeling, or identifiers on the dosage form or 
product or package. 
‘‘(c) MANUFACTURER’S AVERAGE SALES PRICE.—
‘‘(1) IN GENERAL.—For purposes of this sub-
section, subject to paragraphs (2) and (3), the man-
ufacturer’s ‘average sales price’ means, of a covered 
outpatient drug for a NDC code for a calendar quar-
ter for a manufacturer for a unit—
‘‘(A) the manufacturer’s total sales (as de-
fined by the Secretary in regulations for pur-
311
poses of section 1927(c)(1)) in the United 
States for such drug in the calendar quarter; 
divided by 
‘‘(B) the total number of such units of 
such drug sold by the manufacturer in such 
quarter. 
‘‘(2) CERTAIN SALES EXEMPTED FROM COM-
PUTATION.—In calculating the manufacturer’s aver-
age sales price under this subsection, the following 
sales shall be excluded: 
‘‘(A) SALES EXEMPT FROM BEST PRICE.—
Sales exempt from the inclusion in the deter-
mination 
of 
‘best 
price’ 
under 
section 
1927(c)(1)(C)(i). 
‘‘(B) SALES AT NOMINAL CHARGE.—Such 
other sales as the Secretary identifies by regula-
tion as sales to an entity that are nominal in 
price or do not reflect a market price paid by 
an entity to which payment is made under this 
section. 
‘‘(3) SALE PRICE NET OF DISCOUNTS.—In cal-
culating the manufacturer’s average sales price 
under this subsection, such price shall be determined 
taking into account volume discounts, prompt pay 
discounts, cash discounts, the free goods that are
312
contingent 
on 
any 
purchase 
requirement, 
chargebacks, and rebates (other than rebates under 
section 1927), that result in a reduction of the cost 
to the purchaser. A rebate to a payor or other entity 
that does not take title to a covered outpatient drug 
shall not be taken into account in determining such 
price unless the manufacturer has an agreement 
with the payor or other entity under which the pur-
chaser’s price for the drug is reduced as a con-
sequence of such rebate. 
‘‘(4) AUTHORITY
TO
DISREGARD
AVERAGE 
SALES PRICE DURING FIRST QUARTER OF SALES.—
In the case of a covered outpatient drug during an 
initial period (not to exceed a full calendar quarter) 
in which data on the prices for sales for the drug 
is not sufficiently available from the manufacturer to 
compute an average sales price for the drug, the 
Secretary may determine the amount payable under 
this section for the drug without considering the 
manufacturer’s average sales price of that manufac-
turer for that drug. 
‘‘(5) FREQUENCY OF DETERMINATIONS.—
‘‘(A) IN
GENERAL
ON
A
QUARTERLY 
BASIS.—The 
manufacturer’s 
average 
sales 
price, for a covered outpatient drug of a manu-
313
facturer, shall be determined by such manufac-
turer under this subsection on a quarterly basis. 
In making such determination insofar as there 
is a lag in the reporting of the information on 
rebates and chargebacks under paragraph (3) 
so that adequate data are not available on a 
timely basis, the manufacturer shall apply a 
methodology established by the Secretary based 
on a 12-month rolling average for the manufac-
turer to estimate costs attributable to rebates 
and chargebacks. 
‘‘(B) UPDATES IN RATES.—The payment 
rates under subsection (b)(1) and (b)(2)(A) 
shall be updated by the Secretary on a quar-
terly basis and shall be applied based upon the 
manufacturer’s average sales price determined 
for the most recent calendar quarter. 
‘‘(C) USE OF CONTRACTORS; IMPLEMENTA-
TION.—The Secretary may use a carrier, fiscal 
intermediary, or other contractor to determine 
the payment amount under subsection (b). Not-
withstanding any other provision of law, the 
Secretary may implement, by program memo-
randum or otherwise, any of the provisions of 
this section.
314
‘‘(6) DEFINITIONS AND OTHER RULES.—In this 
section: 
‘‘(A) MANUFACTURER.—The term ‘manu-
facturer’ means, with respect to a covered out-
patient drug, the manufacturer (as defined in 
section 1927(k)(5)) whose national drug code 
appears on such drug. 
‘‘(B) WHOLESALE
ACQUISITION
COST.—
The term ‘wholesale acquisition cost’ means, 
with respect to a covered outpatient drug, the 
manufacturer’s list price for the drug to whole-
salers or direct purchasers in the United States, 
not including prompt pay or other discounts, re-
bates or reductions in price, for the most recent 
month for which the information is available, as 
reported in wholesale price guides or other pub-
lications of drug pricing data. 
‘‘(C) MULTIPLE SOURCE DRUG.—The term 
‘multiple source drug’ means, for a calendar 
quarter, a covered outpatient drug for which 
there are 2 or more drug products which—
‘‘(i) are rated as therapeutically equiv-
alent (under the Food and Drug Adminis-
tration’s most recent publication of ‘Ap-
315
proved Drug Products with Therapeutic 
Equivalence Evaluations’), 
‘‘(ii) except as provided in subpara-
graph (E), are pharmaceutically equivalent 
and bioequivalent, as determined under 
subparagraph (F) and as determined by 
the Food and Drug Administration, and 
‘‘(iii) are sold or marketed in the 
United States during the quarter. 
‘‘(D) SINGLE
SOURCE
DRUG.—The term 
‘single source drug’ means a covered outpatient 
drug which is not a multiple source drug and 
which is produced or distributed under an origi-
nal new drug application approved by the Food 
and Drug Administration, including a drug 
product marketed by any cross-licensed pro-
ducers or distributors operating under the new 
drug application, or which is a biological. 
‘‘(E) EXCEPTION FROM PHARMACEUTICAL 
EQUIVALENCE AND BIOEQUIVALENCE REQUIRE-
MENT.—Subparagraph (C)(ii) shall not apply if 
the Food and Drug Administration changes by 
regulation the requirement that, for purposes of 
the publication described in subparagraph 
(C)(i), in order for drug products to be rated as
316
therapeutically equivalent, they must be phar-
maceutically equivalent and bioequivalent, as 
defined in subparagraph (F). 
‘‘(F) 
DETERMINATION
OF
PHARMA-
CEUTICAL
EQUIVALENCE
AND
BIOEQUIVA-
LENCE.—For purposes of this paragraph—
‘‘(i) drug products are pharmaceuti-
cally equivalent if the products contain 
identical amounts of the same active drug 
ingredient in the same dosage form and 
meet compendial or other applicable stand-
ards of strength, quality, purity, and iden-
tity; and 
‘‘(ii) drugs are bioequivalent if they do 
not present a known or potential bio-
equivalence problem, or, if they do present 
such a problem, they are shown to meet an 
appropriate standard of bioequivalence. 
‘‘(G) INCLUSION OF VACCINES.—In apply-
ing provisions of section 1927 under this sec-
tion, ‘other than a vaccine’ is deemed deleted 
from section 1927(k)(2)(B). 
‘‘(d) AUTHORITY TO USE ALTERNATIVE PAYMENT 
IN RESPONSE TO PUBLIC HEALTH EMERGENCY.—In the 
case of a public health emergency under section 319 of
317
the Public Health Service Act in which there is a docu-
mented inability to access covered outpatient drugs and 
biologicals, and a concomitant increase in the price, of a 
drug or biological which is not reflected in the manufac-
turer’s average sales price for one or more quarters, the 
Secretary may use the wholesale acquisition cost (or other 
reasonable measure of drug price) instead of the manufac-
turer’s average sales price for such quarters and for subse-
quent quarters until the price and availability of the drug 
or biological has stabilized and is substantially reflected 
in the applicable manufacturer’s average sales price. 
‘‘(e) REPORTS.—
‘‘(1) QUARTERLY REPORT ON AVERAGE SALES 
PRICE.—For requirements for reporting the manu-
facturer’s average sales price (and, if required to 
make payment, the manufacturer’s wholesale acqui-
sition cost) for the covered outpatient drug or bio-
logical, see section 1927(b)(3). 
‘‘(2) ANNUAL
REPORT
TO
CONGRESS.—The 
Secretary shall submit to the Committees on Energy 
and Commerce and Ways and Means of the House 
of Representatives and the Committee on Finance of 
the Senate an annual report on the operation of this 
section. Such report shall include information on the 
following:
318
‘‘(A) Trends in average sales price under 
subsection (b). 
‘‘(B) Administrative costs associated with 
compliance with this section. 
‘‘(C) Total value of payments made under 
this section. 
‘‘(D) Comparison of the average manufac-
turer price as applied under section 1927 for a 
covered outpatient drug or biological with the 
manufacturer’s average sales price for the drug 
or biological under this section. 
‘‘(f) RESTRICTION ON ADMINISTRATIVE AND JUDI-
CIAL REVIEW.—There shall be no administrative or judi-
cial review under section 1869, section 1878, or otherwise, 
of determinations of manufacturer’s average sales price 
under subsection (c).’’. 
(c) CONTINUATION
OF PAYMENT METHODOLOGY 
FOR RADIOPHARMACEUTICALS.—Nothing in the amend-
ments made by this section shall be construed as changing 
the payment methodology under part B of title XVIII of 
the Social Security Act for radiopharmaceuticals, includ-
ing the use by carriers of invoice pricing methodology.
(d) CONFORMING AMENDMENTS.—
(1) IN GENERAL.—Section 1842(o) (42 U.S.C. 
1395u(o)) is amended—
319
(A) in paragraph (1), by inserting ‘‘, sub-
ject to section 1847A and 1847B,’’ before ‘‘the 
amount payable for the drug or biological’’; and 
(B) by adding at the end of paragraph (2) 
the following: ‘‘This paragraph shall not apply 
in the case of payment under section 1847A or 
1847B.’’. 
(2) NO CHANGE IN COVERAGE BASIS.—Section 
1861(s)(2)(A) (42 U.S.C. 1395x(s)(2)(A)) is amend-
ed by inserting ‘‘(or would have been so included but 
for the application of section 1847A or 1847B)’’ 
after ‘‘included in the physicians’ bills’’. 
(3) 
PAYMENT.—Section 
1833(a)(1)(S) 
(42 
U.S.C. 1395l(a)(1)(S)) is amended by inserting ‘‘(or, 
if applicable, under section 1847A or 1847B)’’ after 
‘‘1842(o)’’. 
(4) CONSOLIDATED REPORTING OF PRICING IN-
FORMATION.—Section 1927 (42 U.S.C. 1396r–8) is 
amended—
(A) in subsection (a)(1), by inserting ‘‘or 
under part B of title XVIII’’ after ‘‘section 
1903(a)’’; 
(B) in subsection (b)(3)(A)—
(i) in clause (i), by striking ‘‘and’’ at 
the end;
320
(ii) in clause (ii), by striking the pe-
riod and inserting ‘‘; and’’; and 
(iii) by adding at the end the fol-
lowing new clause: 
‘‘(iii) for calendar quarters beginning 
on or after April 1, 2004, in conjunction 
with reporting required under clause (i) 
and by national drug code (NDC)—
‘‘(I) the manufacturer’s average 
sales price (as defined in section 
1847B(c)) and the total number of 
units 
specified 
under 
section 
1847B(b)(2)(A); 
‘‘(II) if required to make pay-
ment under section 1847B, the manu-
facturer’s wholesale acquisition cost, 
as defined in subsection (c)(6) of such 
section; and 
‘‘(III) information on those sales 
that were made at a nominal price or 
otherwise 
described 
in 
section 
1847B(c)(2)(B), which information is 
subject to audit by the Inspector Gen-
eral of the Department of Health and 
Human Services;
321
for a covered outpatient drug or biological 
for which payment is made under section 
1847B.’’; 
(C) in subsection (b)(3)(B)—
(i) in the heading, by inserting ‘‘AND 
MANUFACTURER’S AVERAGE SALES PRICE’’ 
after ‘‘PRICE’’; and 
(ii) by inserting ‘‘and manufacturer’s 
average sales prices (including wholesale 
acquisition cost) if required to make pay-
ment’’ after ‘‘manufacturer prices’’; and 
(D) in subsection (b)(3)(D)(i), by inserting 
‘‘and section 1847B’’ after ‘‘this section’’. 
(e) GAO STUDY.—
(1) STUDY.—The Comptroller General of the 
United States shall conduct a study to assess the 
impact of the amendments made by this section on 
the delivery of services, including their impact on—
(A) beneficiary access to drugs and 
biologicals for which payment is made under 
part B of title XVIII of the Social Security Act; 
and 
(B) the site of delivery of such services. 
(2) REPORT.—Not later than 2 years after the 
year in which the amendment made by subsection
322
(a)(1) first takes effect, the Comptroller General 
shall submit to Congress a report on the study con-
ducted under paragraph (1). 
(f) MEDPAC RECOMMENDATIONS ON BLOOD CLOT-
TING FACTORS.—The Medicare Payment Advisory Com-
mission shall submit to Congress, in its annual report in 
2004, specific recommendations regarding a payment 
amount (or amounts) for blood clotting factors and its ad-
ministration under the medicare program. 
(g) ESTABLISHMENT OF PHARMACEUTICAL MANAGE-
MENT FEE WHERE DRUGS PROVIDED THROUGH A CON-
TRACTOR.—Section 1848(a) (42 U.S.C. 1395w–4(a)) is 
amended by adding at the end the following new para-
graph: 
‘‘(5) RECOGNITION OF PHARMACEUTICAL MAN-
AGEMENT FEE IN CERTAIN CASES.—In establishing 
the fee schedule under this section, the Secretary 
shall provide for a separate payment with respect to 
physicians’ services consisting of the unique adminis-
trative and management costs associated with cov-
ered drugs and biologicals which are furnished to 
physicians through a contractor under section 
1847A (compared with such costs if such drugs and 
biologicals were acquired directly by such physi-
cians).’’.