datamatters24/research-document-archive huggingface dataset:
of enrollment and at least annually thereafter, the 
information described in section 1852(c)(1) relating 
to such plan. Such information includes the fol-
lowing: 
‘‘(A) Access to specific covered outpatient 
drugs, including access through pharmacy net-
works. 
‘‘(B) How any formulary used by the spon-
sor functions, including the drugs included in 
the formulary. 
‘‘(C) Co-payments and deductible require-
ments, including the identification of the tiered 
or other co-payment level applicable to each 
drug (or class of drugs). 
‘‘(D) Grievance and appeals procedures. 
Such information shall also be made available upon 
request to prospective enrollees. 
‘‘(2) DISCLOSURE UPON REQUEST OF GENERAL 
COVERAGE, UTILIZATION, AND GRIEVANCE INFORMA-
TION.—Upon request of an individual eligible to en-
roll under a prescription drug plan, the PDP spon-
sor shall provide the information described in section 
1852(c)(2) (other than subparagraph (D)) to such 
individual.
‘‘(3) RESPONSE TO BENEFICIARY QUESTIONS.—
Each PDP sponsor offering a prescription drug plan 
shall have a mechanism for providing specific infor-
mation to enrollees upon request. The sponsor shall 
make available on a timely basis, through an Inter-
net website and in writing upon request, information 
on specific changes in its formulary. 
‘‘(4) CLAIMS INFORMATION.—Each PDP spon-
sor offering a prescription drug plan must furnish to 
each enrollee in a form easily understandable to such 
enrollees an explanation of benefits (in accordance 
with section 1806(a) or in a comparable manner) 
and a notice of the benefits in relation to initial cov-
erage limit and the annual out-of-pocket threshold 
applicable to such enrollee for the current year, 
whenever prescription drug benefits are provided 
under this part (except that such notice need not be 
provided more often than monthly).
‘‘(c) ACCESS TO COVERED BENEFITS.—
‘‘(1) ASSURING PHARMACY ACCESS.—
‘‘(A) PARTICIPATION
OF
ANY
WILLING 
PHARMACY.—A PDP sponsor and an entity of-
fering a MA-EFFS Rx plan shall permit the 
participation of any pharmacy that meets terms 
and conditions that the plan has established.
‘‘(B) DISCOUNTS ALLOWED FOR NETWORK 
PHARMACIES.—A prescription drug plan and a 
MA-EFFS Rx plan may, notwithstanding sub-
paragraph (A), reduce coinsurance or copay-
ments for its enrolled beneficiaries below the 
level otherwise provided for covered outpatient 
drugs dispensed through in-network phar-
macies, but in no case shall such a reduction re-
sult in an increase in payments made by the 
Administrator under section 1860D–8 to a 
plan. 
‘‘(C) CONVENIENT ACCESS FOR NETWORK 
PHARMACIES.—The PDP sponsor of the pre-
scription drug plan and the entity offering a 
MA-EFFS Rx plan shall secure the participa-
tion in its network of a sufficient number of 
pharmacies that dispense (other than by mail 
order) drugs directly to patients to ensure con-
venient access (consistent with rules of the Ad-
ministrator). The Administrator shall establish 
convenient access rules under this subpara-
graph that are no less favorable to enrollees 
than the rules for convenient access to phar-
macies of the Secretary of Defense established 
as of June 1, 2003, for purposes of the
TRICARE Retail Pharmacy (TRRx) program. 
Such rules shall include adequate emergency ac-
cess for enrolled beneficiaries. 
‘‘(D) LEVEL
PLAYING
FIELD.—Such a 
sponsor shall permit enrollees to receive benefits 
(which may include a 90-day supply of drugs or 
biologicals) through a community pharmacy, 
rather than through mail order, with any dif-
ferential in charge paid by such enrollees. 
‘‘(E) NOT REQUIRED TO ACCEPT INSUR-
ANCE RISK.—The terms and conditions under 
subparagraph (A) may not require participating 
pharmacies to accept insurance risk as a condi-
tion of participation. 
‘‘(2) USE OF STANDARDIZED TECHNOLOGY.—
‘‘(A) IN GENERAL.—The PDP sponsor of 
a prescription drug plan and an entity offering 
a MA-EFFS Rx plan shall issue (and reissue, 
as appropriate) such a card (or other tech-
nology) that may be used by an enrollee to as-
sure access to negotiated prices under section 
1860D–2(d) for the purchase of prescription 
drugs for which coverage is not otherwise pro-
vided under the plan. 
‘‘(B) STANDARDS.—
‘‘(i) DEVELOPMENT.—The Adminis-
trator shall provide for the development or 
utilization of uniform standards relating to 
a standardized format for the card or 
other technology referred to in subpara-
graph (A). Such standards shall be com-
patible with standards established under 
part C of title XI. 
‘‘(ii) APPLICATION OF ADVISORY TASK 
FORCE.—The advisory task force estab-
lished under subsection (d)(3)(B)(ii) shall 
provide recommendations to the Adminis-
trator under such subsection regarding the 
standards developed under clause (i). 
‘‘(3) REQUIREMENTS
ON
DEVELOPMENT
AND 
APPLICATION OF FORMULARIES.—If a PDP sponsor 
of a prescription drug plan or an entity offering a 
MA-EFFS Rx plan uses a formulary, the following 
requirements must be met: 
‘‘(A) PHARMACY AND THERAPEUTIC (P&T) 
COMMITTEE.—The sponsor or entity must es-
tablish a pharmacy and therapeutic committee 
that develops and reviews the formulary. Such 
committee shall include at least one practicing 
physician and at least one practicing phar-
macist independent and free of conflict with re-
spect to the committee both with expertise in 
the care of elderly or disabled persons and a 
majority of its members shall consist of individ-
uals who are practicing physicians or practicing 
pharmacists (or both). 
‘‘(B) FORMULARY DEVELOPMENT.—In de-
veloping and reviewing the formulary, the com-
mittee shall—
‘‘(i) base clinical decisions on the 
strength of scientific evidence and stand-
ards of practice, including assessing peer-
reviewed medical literature, such as ran-
domized clinical trials, pharmacoeconomic 
studies, outcomes research data, and on 
such other information as the committee 
determines to be appropriate; and 
‘‘(ii) shall take into account whether 
including in the formulary particular cov-
ered outpatient drugs has therapeutic ad-
vantages in terms of safety and efficacy. 
‘‘(C) INCLUSION OF DRUGS IN ALL THERA-
PEUTIC CATEGORIES.—The formulary must in-
clude drugs within each therapeutic category 
and class of covered outpatient drugs (although
not necessarily for all drugs within such cat-
egories and classes). In establishing such class-
es, the committee shall take into account the 
standards published in the United States Phar-
macopeia-Drug Information. The committee 
shall make available to the enrollees under the 
plan through the Internet or otherwise the 
bases for the exclusion of coverage of any drug 
from the formulary. 
‘‘(D) 
PROVIDER
AND
PATIENT
EDU-
CATION.—The committee shall establish policies 
and procedures to educate and inform health 
care providers and enrollees concerning the for-
mulary. 
‘‘(E) NOTICE
BEFORE
REMOVING
DRUG 
FROM FORMULARY FOR CHANGING PREFERRED 
OR TIER STATUS OF DRUG.—Any removal of a 
covered outpatient drug from a formulary and 
any change in the preferred or tier cost-sharing 
status of such a drug shall take effect only 
after appropriate notice is made available to 
beneficiaries and physicians. 
‘‘(F) PERIODIC
EVALUATION
OF
PROTO-
COLS.—In connection with the formulary, a pre-
scription drug plan shall provide for the peri-
odic evaluation and analysis of treatment proto-
cols and procedures. 
‘‘(G) GRIEVANCES AND APPEALS RELAT-
ING TO APPLICATION OF FORMULARIES.—For 
provisions relating to grievances and appeals of 
coverage, see subsections (e) and (f). 
‘‘(d) COST AND UTILIZATION MANAGEMENT; QUAL-
ITY ASSURANCE; MEDICATION THERAPY MANAGEMENT 
PROGRAM.—
‘‘(1) IN GENERAL.—The PDP sponsor or entity 
offering a MA-EFFS Rx plan shall have in place, di-
rectly or through appropriate arrangements, with re-
spect to covered outpatient drugs—
‘‘(A) an effective cost and drug utilization 
management program, including medically ap-
propriate incentives to use generic drugs and 
therapeutic interchange, when appropriate; 
‘‘(B) quality assurance measures and sys-
tems to reduce medical errors and adverse drug 
interactions, including side-effects, and improve 
medication use, including a medication therapy 
management program described in paragraph 
(2) and for years beginning with 2007, an elec-
tronic prescription program described in para-
graph (3); and
‘‘(C) a program to control fraud, abuse, 
and waste. 
Nothing in this section shall be construed as impair-
ing a PDP sponsor or entity from utilizing cost 
management tools (including differential payments) 
under all methods of operation. 
‘‘(2) MEDICATION THERAPY MANAGEMENT PRO-
GRAM.—
‘‘(A) IN GENERAL.—A medication therapy 
management program described in this para-
graph is a program of drug therapy manage-
ment and medication administration that may 
be furnished by a pharmacy provider and that 
is designed to assure, with respect to bene-
ficiaries at risk for potential medication prob-
lems, such as beneficiaries with complex or 
chronic diseases (such as diabetes, asthma, hy-
pertension, and congestive heart failure) or 
multiple prescriptions, that covered outpatient 
drugs under the prescription drug plan are ap-
propriately used to optimize therapeutic out-
comes through improved medication use and re-
duce the risk of adverse events, including ad-
verse drug interactions. Such programs may
distinguish between services in ambulatory and 
institutional settings. 
‘‘(B) ELEMENTS.—Such program may in-
clude—
‘‘(i) 
enhanced 
beneficiary 
under-
standing to promote the appropriate use of 
medications by beneficiaries and to reduce 
the risk of potential adverse events associ-
ated with medications, through beneficiary 
education, counseling, case management, 
disease state management programs, and 
other appropriate means; 
‘‘(ii) increased beneficiary adherence 
with 
prescription 
medication 
regimens 
through medication refill reminders, special 
packaging, and other compliance programs 
and other appropriate means; and 
‘‘(iii) detection of patterns of overuse 
and underuse of prescription drugs. 
‘‘(C) DEVELOPMENT OF PROGRAM IN CO-
OPERATION
WITH
LICENSED
PHARMACISTS.—
The program shall be developed in cooperation 
with licensed and practicing pharmacists and 
physicians.
‘‘(D) 
CONSIDERATIONS
IN
PHARMACY 
FEES.—The PDP sponsor of a prescription 
drug program and an entity offering a MA-
EFFS Rx plan shall take into account, in es-
tablishing fees for pharmacists and others pro-
viding services under the medication therapy 
management program, the resources and time 
used in implementing the program. Each such 
sponsor or entity shall disclose to the Adminis-
trator upon request the amount of any such 
management or dispensing fees and such fees 
shall be confidential in the same manner as pro-
vided under section 1927(b)(3)(D) for informa-
tion disclosed under section 1927(b)(3)(A). 
‘‘(3) ELECTRONIC PRESCRIPTION PROGRAM.—
‘‘(A) IN GENERAL.—An electronic prescrip-
tion drug program described in this paragraph 
is a program that includes at least the following 
components, consistent with uniform standards 
established under subparagraph (B): 
‘‘(i) ELECTRONIC
TRANSMITTAL
OF 
PRESCRIPTIONS.—Prescriptions must be 
written 
and 
transmitted 
electronically 
(other than by facsimile), except in emer-
gency cases and other exceptional cir-
covered under the plan that is therapeutically equiv-
alent and bioequivalent.
‘‘(e) GRIEVANCE MECHANISM, COVERAGE DETER-
MINATIONS, AND RECONSIDERATIONS.—
‘‘(1) IN GENERAL.—Each PDP sponsor shall 
provide meaningful procedures for hearing and re-
solving grievances between the organization (includ-
ing any entity or individual through which the spon-
sor provides covered benefits) and enrollees with pre-
scription drug plans of the sponsor under this part 
in accordance with section 1852(f). 
‘‘(2) APPLICATION OF COVERAGE DETERMINA-
TION AND RECONSIDERATION PROVISIONS.—A PDP 
sponsor shall meet the requirements of paragraphs 
(1) through (3) of section 1852(g) with respect to 
covered benefits under the prescription drug plan it 
offers under this part in the same manner as such 
requirements apply to an organization with respect 
to benefits it offers under a plan under part C. 
‘‘(3) REQUEST FOR REVIEW OF TIERED FOR-
MULARY DETERMINATIONS.—In the case of a pre-
scription drug plan offered by a PDP sponsor or a 
MA-EFFS Rx plan that provides for tiered cost-
sharing for drugs included within a formulary and 
provides lower cost-sharing for preferred drugs in-
cluded within the formulary, an individual who is en-
rolled in the plan may request coverage of a nonpre-
ferred drug under the terms applicable for preferred 
drugs if the prescribing physician determines that 
the preferred drug for treatment of the same condi-
tion either would not be as effective for the indi-
vidual or would have adverse effects for the indi-
vidual or both.
‘‘(f) APPEALS.—
‘‘(1) IN GENERAL.—Subject to paragraph (2), a 
PDP sponsor shall meet the requirements of para-
graphs (4) and (5) of section 1852(g) with respect 
to drugs (including a determination related to the 
application of tiered cost-sharing described in sub-
section (e)(3)) in the same manner as such require-
ments apply to an organization with respect to bene-
fits it offers under a plan under part C. 
‘‘(2) FORMULARY DETERMINATIONS.—An indi-
vidual who is enrolled in a prescription drug plan of-
fered by a PDP sponsor or in a MA-EFFS Rx plan 
may appeal to obtain coverage for a covered out-
patient drug that is not on a formulary of the spon-
sor or entity offering the plan if the prescribing phy-
sician determines that the formulary drug for treat-
ment of the same condition either would not be as
effective for the individual or would have adverse ef-
fects for the individual or both. 
‘‘(g) CONFIDENTIALITY
AND ACCURACY
OF EN-
ROLLEE RECORDS.—A PDP sponsor that offers a pre-
scription drug plan shall meet the requirements of section 
1852(h) with respect to enrollees under the plan in the 
same manner as such requirements apply to an organiza-
tion with respect to enrollees under part C. A PDP spon-
sor shall be treated as a business associate for purposes 
of the provisions of subpart E of part 164 of title 45, Code 
of Federal Regulations, adopted pursuant to the authority 
of the Secretary under section 264(c) of the Health Insur-
ance Portability and Accountability Act of 1996 (42 U.S. 
C. 1320d-2 note). 
‘‘SEC. 1860D–4. REQUIREMENTS FOR AND CONTRACTS WITH 
PRESCRIPTION DRUG PLAN (PDP) SPONSORS. 
‘‘(a) GENERAL REQUIREMENTS.—Each PDP sponsor 
of a prescription drug plan shall meet the following re-
quirements: 
‘‘(1) LICENSURE.—Subject to subsection (c), 
the sponsor is organized and licensed under State 
law as a risk-bearing entity eligible to offer health 
insurance or health benefits coverage in each State 
in which it offers a prescription drug plan.
288
HR 1 RDS 
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
SECTION 1. ADAMS MEMORIAL COMMISSION. 
(a) COMMISSION.—There is established a commission 
to be known as the ‘‘Adams Memorial Commission’’ (re-
ferred to in this section as the ‘‘Commission’’) for the pur-
pose of establishing a permanent memorial to honor John 
Adams and his legacy as authorized by Public Law 107– 
62, located in the city of Washington, District of Colum-
bia, including sites authorized by Public Law 107–315. 
(b) MEMBERSHIP.—The Commission shall be com-
posed of— 
(1) four persons appointed by the President, 
not more than two of whom may be members of the 
same political party; 
(2) four Members of the Senate appointed by 
the President pro tempore of the Senate in consulta-
tion with the Majority Leader and Minority Leader 
of the Senate, of which not more than two ap-
pointees may be members of the same political 
party; and 
(3) four Members of the House of Representa-
tives appointed by the Speaker of the House of Rep-
resentatives in consultation with the Majority Lead-
er and Minority Leader of the House of Representa-
tives, of which not more than two appointees may be 
members of the same political party.
115TH CONGRESS 
1ST SESSION H. R. 1235 
AN ACT 
To require the Secretary of the Treasury to mint coins 
in recognition of the 60th Anniversary of the Naismith 
Memorial Basketball Hall of Fame. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
115TH CONGRESS 
1ST SESSION H. R. 1238 
AN ACT 
To amend the Homeland Security Act of 2002 to make 
the Assistant Secretary of Homeland Security for Health 
Affairs responsible for coordinating the efforts of the 
Department of Homeland Security related to food, agri-
culture, and veterinary defense against terrorism, and 
for other purposes.
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Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLES. 
(a) DIVISION A.—Division A of this Act may be cited 
as the ‘‘Medicare Prescription Drug and Modernization 
Act of 2003’’. 
(b) DIVISION B.—Division B of this Act may be cited 
as the ‘‘Health Savings and Affordability Act of 2003’’. 
SEC. 2. ORGANIZATION OF ACT INTO DIVISIONS; AMEND-
MENTS TO SOCIAL SECURITY ACT; REF-
ERENCES TO BIPA AND SECRETARY; TABLE 
OF CONTENTS. 
(a) DIVISIONS.—This Act is organized into two divi-
sions as follows: 
(1) DIVISION A—Medicare Prescription Drug 
and Modernization Act of 2003. 
(2) DIVISION B—Health Savings and Afford-
ability Act of 2003. 
(b) AMENDMENTS TO SOCIAL SECURITY ACT.—Ex-
cept as otherwise specifically provided, whenever in divi-
sion A of this Act an amendment is expressed in terms 
of an amendment to or repeal of a section or other provi-
sion, the reference shall be considered to be made to that 
section or other provision of the Social Security Act. 
(c) BIPA; SECRETARY.—In division A of this Act:
483
HR 1 RDS 
ficiaries in the manner provided under subpara-
graph (A) a description of procedural rights (in-
cluding grievance and appeals procedures) of 
beneficiaries under the original medicare fee-
for-service program under parts A and B, the 
Medicare Advantage program under part C, the 
Voluntary Prescription Drug Benefit Program 
under part D, and the Enhanced Fee-for-Serv-
ice program under part E. 
‘‘(e) MEDICARE POLICY ADVISORY BOARD.—
‘‘(1) ESTABLISHMENT.—There is established 
within the Medicare Benefits Administration the 
Medicare Policy Advisory Board (in this section re-
ferred to the ‘Board’). The Board shall advise, con-
sult with, and make recommendations to the Admin-
istrator of the Medicare Benefits Administration 
with respect to the administration of parts C, D, 
and E, including the review of payment policies 
under such parts. 
‘‘(2) REPORTS.—
‘‘(A) IN GENERAL.—With respect to mat-
ters of the administration of parts C, D, and E 
the Board shall submit to Congress and to the 
Administrator of the Medicare Benefits Admin-
istration such reports as the Board determines
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‘‘(B) ADJUSTMENT.—The Administrator 
shall proportionally adjust the payments made 
under subsections (a)(2) and (c) for a coverage 
year in such manner so that the total of the 
payments made under such subsections for the 
year is equal to 30 percent of the total pay-
ments described in subparagraph (A)(ii). 
‘‘(2) RISK
ADJUSTMENT
FOR
DIRECT
SUB-
SIDIES.—To the extent the Administrator deter-
mines it appropriate to avoid risk selection, the pay-
ments made for direct subsidies under subsection 
(a)(1) are subject to adjustment based upon risk 
factors specified by the Administrator. Any such risk 
adjustment shall be designed in a manner as to not 
result in a change in the aggregate payments made 
under such subsection. 
‘‘(e) PAYMENT METHODS.—
‘‘(1) IN GENERAL.—Payments under this sec-
tion shall be based on such a method as the Admin-
istrator determines. The Administrator may estab-
lish a payment method by which interim payments 
of amounts under this section are made during a 
year based on the Administrator’s best estimate of 
amounts that will be payable after obtaining all of 
the information.
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‘‘(C) APPLICATION.—In applying subpara-
graph (A)—
‘‘(i) incurred costs shall only include 
costs incurred for the annual deductible 
(described in paragraph (1)), cost-sharing 
(described in paragraph (2)), and amounts 
for which benefits are not provided because 
of the application of the initial coverage 
limit described in paragraph (3); and 
‘‘(ii) such costs shall be treated as in-
curred only if they are paid by the indi-
vidual (or by another individual, such as a 
family member, on behalf of the indi-
vidual), under section 1860D–7, under title 
XIX, or under a State pharmaceutical as-
sistance program and the individual (or 
other individual) is not reimbursed through 
insurance or otherwise, a group health 
plan, or other third-party payment ar-
rangement (other than under such title or 
such program) for such costs. 
‘‘(D) ADJUSTMENT
OF
ANNUAL
OUT-OF-
POCKET THRESHOLDS.—
‘‘(i) IN GENERAL.—Subject to clause 
(vii), for each enrollee in a prescription
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(1) BIPA.—The term ‘‘BIPA’’ means the 
Medicare, Medicaid, and SCHIP Benefits Improve-
ment and Protection Act of 2000, as enacted into 
law by section 1(a)(6) of Public Law 106–554. 
(2) SECRETARY.—The term ‘‘Secretary’’ means 
the Secretary of Health and Human Services. 
(d) TABLE OF CONTENTS.—The table of contents of 
this Act is as follows:
Sec. 1. Short titles. 
Sec. 2. Organization of Act into divisions; amendments to Social Security Act; 
references to BIPA and Secretary; table of contents. 
DIVISION A—MEDICARE PRESCRIPTION DRUG AND 
MODERNIZATION ACT OF 2003
TITLE I—MEDICARE PRESCRIPTION DRUG BENEFIT 
Sec. 101. Establishment of a medicare prescription drug benefit. 
Sec. 102. Offering of qualified prescription drug coverage under Medicare Ad-
vantage and enhanced fee-for-service (EFFS) program. 
Sec. 103. Medicaid amendments. 
Sec. 104. Medigap transition. 
Sec. 105. Medicare prescription drug discount card and assistance program. 
Sec. 106. Disclosure of return information for purposes of carrying out medi-
care catastrophic prescription drug program. 
Sec. 107. State Pharmaceutical Assistance Transition Commission. 
Sec. 108. Additional requirements for annual financial report and oversight on 
medicare program, including prescription drug spending. 
TITLE II—MEDICARE ENHANCED FEE-FOR-SERVICE AND 
MEDICARE ADVANTAGE PROGRAMS; MEDICARE COMPETITION 
Sec. 200. Medicare modernization and revitalization. 
Subtitle A—Medicare Enhanced Fee-for-Service Program 
Sec. 201. Establishment of enhanced fee-for-service (EFFS) program under 
medicare. 
Subtitle B—Medicare Advantage Program 
CHAPTER 1—IMPLEMENTATION OF PROGRAM 
Sec. 211. Implementation of medicare advantage program. 
Sec. 212. Medicare advantage improvements. 
CHAPTER 2—IMPLEMENTATION OF COMPETITION PROGRAM