II 
Calendar No. 521 
116TH CONGRESS 
2D SESSION 
H. R. 3 
IN THE SENATE OF THE UNITED STATES 
DECEMBER 16, 2019 
Received 
AUGUST 13, 2020 
Read the first time 
SEPTEMBER 8, 2020 
Read the second time and placed on the calendar 
AN ACT 
To establish a fair price negotiation program, protect the 
Medicare program from excessive price increases, and 
establish an out-of-pocket maximum for Medicare part 
D enrollees, and for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 
(a) SHORT TITLE.—This Act may be cited as the 
‘‘Elijah E. Cummings Lower Drug Costs Now Act’’. 
(b) TABLE OF CONTENTS.—The table of contents is 
as follows: 
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Sec. 1. Short title; table of contents. 
TITLE I—LOWERING PRICES THROUGH FAIR DRUG PRICE 
NEGOTIATION 
Sec. 101. Providing for lower prices for certain high-priced single source drugs. 
Sec. 102. Selected drug manufacturer excise tax imposed during noncompliance 
periods. 
Sec. 103. Fair Price Negotiation Implementation Fund. 
TITLE II—MEDICARE PARTS B AND D PRESCRIPTION DRUG 
INFLATION REBATES 
Sec. 201. Medicare part B rebate by manufacturers. 
Sec. 202. Medicare part D rebate by manufacturers. 
Sec. 203. Provision regarding inflation rebates for group health plans and 
group health insurance coverage. 
Sec. 204. Annual report on drug costs in group health plans and group health 
insurance coverage. 
Sec. 205. Collection of data. 
TITLE III—PART D IMPROVEMENTS AND MAXIMUM OUT-OF- 
POCKET CAP FOR MEDICARE BENEFICIARIES 
Sec. 301. Medicare part D benefit redesign. 
Sec. 302. Allowing certain enrollees of prescription drugs plans and MA–PD 
plans under Medicare program to spread out cost-sharing 
under certain circumstances. 
Sec. 303. Establishment of pharmacy quality measures under Medicare part D. 
TITLE IV—DRUG PRICE TRANSPARENCY 
Sec. 401. Drug price transparency. 
TITLE V—PROGRAM IMPROVEMENTS FOR MEDICARE LOW- 
INCOME BENEFICIARIES 
Sec. 501. Dissemination to Medicare part D subsidy eligible individuals of in-
formation comparing premiums of certain prescription drug 
plans. 
Sec. 502. Providing for intelligent assignment of certain subsidy eligible individ-
uals auto-enrolled under Medicare prescription drug plans and 
MA–PD plans. 
Sec. 503. Expanding eligibility for low-income subsidies under part D of the 
Medicare program. 
Sec. 504. Automatic eligibility of certain low-income territorial residents for 
premium and cost-sharing subsidies under the Medicare pro-
gram; Sunset of enhanced allotment program. 
Sec. 505. Automatic qualification of certain Medicaid beneficiaries for premium 
and cost-sharing subsidies under part D of the Medicare pro-
gram. 
Sec. 506. Providing for certain rules regarding the treatment of eligible retire-
ment plans in determining the eligibility of individuals for pre-
mium and cost-sharing subsidies under part D of the Medicare 
program. 
Sec. 507. Reducing cost-sharing and other program improvements for low-in-
come beneficiaries. 
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TITLE VI—PROVIDING FOR DENTAL, VISION, AND HEARING 
COVERAGE UNDER THE MEDICARE PROGRAM 
Sec. 601. Dental and oral health care. 
Sec. 602. Providing coverage for hearing care under the Medicare program. 
Sec. 603. Providing coverage for vision care under the Medicare program. 
TITLE VII—NIH, FDA, AND OPIOIDS FUNDING 
Subtitle A—Biomedical Innovation Expansion 
Sec. 701. NIH Innovation Initiatives. 
Sec. 702. NIH clinical trial. 
Sec. 703. Innovation Network. 
Subtitle B—Investing in Safety and Innovation 
Sec. 711. Food and Drug Administration. 
Sec. 712. Study on high-risk, high-reward drugs. 
Subtitle C—Opioid Epidemic Response 
Sec. 721. Opioid Epidemic Response Fund. 
Sec. 722. Substance Abuse and Mental Health Services Administration. 
Sec. 723. Centers for Disease Control and Prevention. 
Sec. 724. Food and Drug Administration. 
Sec. 725. National Institutes of Health. 
Sec. 726. Health Resources and Services Administration. 
Sec. 727. Administration for Children and Families. 
Subtitle D—Reducing Administrative Costs and Burdens in Health Care 
Sec. 731. Reducing administrative costs and burdens in health care. 
TITLE VIII—MISCELLANEOUS 
Sec. 801. Guaranteed issue of certain Medigap policies. 
Sec. 802. Reporting requirements for PDP sponsors regarding point-of-sale re-
jections under Medicare part D. 
Sec. 803. Providing access to annual Medicare notifications in multiple lan-
guages. 
Sec. 804. Temporary increase in Medicare part B payment for certain bio-
similar biological products. 
Sec. 805. Waiving medicare coinsurance for colorectal cancer screening tests. 
Sec. 806. Medicare coverage of certain lymphedema compression treatment 
items. 
Sec. 807. Physician fee update. 
Sec. 808. Additional community health center funding. 
Sec. 809. Grants to improve trauma support services and mental health care 
for children and youth in educational settings. 
Sec. 810. Pathway to Health Careers Act. 
Sec. 811. Home Visiting to Reduce Maternal Mortality and Morbidity Act. 
Sec. 812. Addition of new measures based on access to biosimilar biological 
products to the 5-star rating system under medicare advan-
tage. 
Sec. 813. Sense of Congress regarding the impact of the high cost of prescrip-
tion drugs on communities of color and persons living in rural 
or sparsely populated areas of the United States. 
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Sec. 814. Regulations requiring direct-to-consumer advertisements for prescrip-
tion drugs and biological products to include truthful and not 
misleading pricing information. 
Sec. 815. Improving transparency and preventing the use of abusive spread 
pricing and related practices in Medicaid. 
Sec. 816. Graduate medical education improvements in rural and underserved 
communities. 
TITLE 
I—LOWERING 
PRICES 
THROUGH FAIR DRUG PRICE 
NEGOTIATION 
SEC. 101. PROVIDING FOR LOWER PRICES FOR CERTAIN 
HIGH-PRICED SINGLE SOURCE DRUGS. 
(a) PROGRAM TO LOWER PRICES
FOR CERTAIN 
HIGH-PRICED SINGLE SOURCE DRUGS.—Title XI of the 
Social Security Act (42 U.S.C. 1301 et seq.) is amended 
by adding at the end the following new part: 
‘‘PART E—FAIR PRICE NEGOTIATION PROGRAM 
TO LOWER PRICES FOR CERTAIN HIGH- 
PRICED SINGLE SOURCE DRUGS 
‘‘SEC. 1191. ESTABLISHMENT OF PROGRAM. 
‘‘(a) IN GENERAL.—The Secretary shall establish a 
Fair Price Negotiation Program (in this part referred to 
as the ‘program’). Under the program, with respect to 
each price applicability period, the Secretary shall— 
‘‘(1) publish a list of selected drugs in accord-
ance with section 1192; 
‘‘(2) enter into agreements with manufacturers 
of selected drugs with respect to such period, in ac-
cordance with section 1193; 
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‘‘(3) negotiate and, if applicable, renegotiate 
maximum fair prices for such selected drugs, in ac-
cordance with section 1194; and 
‘‘(4) carry out the administrative duties de-
scribed in section 1196. 
‘‘(b) DEFINITIONS RELATING TO TIMING.—For pur-
poses of this part: 
‘‘(1) INITIAL PRICE APPLICABILITY YEAR.—The 
term ‘initial price applicability year’ means a plan 
year (beginning with plan year 2023) or, if agreed 
to in an agreement under section 1193 by the Sec-
retary and manufacturer involved, a period of more 
than one plan year (beginning on or after January 
1, 2023). 
‘‘(2) PRICE APPLICABILITY PERIOD.—The term 
‘price applicability period’ means, with respect to a 
drug, the period beginning with the initial price ap-
plicability year with respect to which such drug is a 
selected drug and ending with the last plan year 
during which the drug is a selected drug. 
‘‘(3) SELECTED
DRUG
PUBLICATION
DATE.— 
The term ‘selected drug publication date’ means, 
with respect to each initial price applicability year, 
April 15 of the plan year that begins 2 years prior 
to such year. 
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‘‘(4) VOLUNTARY NEGOTIATION PERIOD.—The 
term ‘voluntary negotiation period’ means, with re-
spect to an initial price applicability year with re-
spect to a selected drug, the period— 
‘‘(A) beginning on the sooner of— 
‘‘(i) the date on which the manufac-
turer of the drug and the Secretary enter 
into an agreement under section 1193 with 
respect to such drug; or 
‘‘(ii) June 15 following the selected 
drug publication date with respect to such 
selected drug; and 
‘‘(B) ending on March 31 of the year that 
begins one year prior to the initial price appli-
cability year. 
‘‘(c) OTHER DEFINITIONS.—For purposes of this 
part: 
‘‘(1) FAIR PRICE ELIGIBLE INDIVIDUAL.—The 
term ‘fair price eligible individual’ means, with re-
spect to a selected drug— 
‘‘(A) in the case such drug is furnished or 
dispensed to the individual at a pharmacy or by 
a mail order service— 
‘‘(i) an individual who is enrolled 
under a prescription drug plan under part 
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D of title XVIII or an MA–PD plan under 
part C of such title if coverage is provided 
under such plan for such selected drug; 
and 
‘‘(ii) an individual who is enrolled 
under a group health plan or health insur-
ance coverage offered in the group or indi-
vidual market (as such terms are defined 
in section 2791 of the Public Health Serv-
ice Act) with respect to which there is in 
effect an agreement with the Secretary 
under section 1197 with respect to such se-
lected drug as so furnished or dispensed; 
and 
‘‘(B) in the case such drug is furnished or 
administered to the individual by a hospital, 
physician, or other provider of services or sup-
plier— 
‘‘(i) an individual who is entitled to 
benefits under part A of title XVIII or en-
rolled under part B of such title if such se-
lected drug is covered under the respective 
part; and 
‘‘(ii) an individual who is enrolled 
under a group health plan or health insur-
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ance coverage offered in the group or indi-
vidual market (as such terms are defined 
in section 2791 of the Public Health Serv-
ice Act) with respect to which there is in 
effect an agreement with the Secretary 
under section 1197 with respect to such se-
lected drug as so furnished or adminis-
tered. 
‘‘(2) MAXIMUM FAIR PRICE.—The term ‘max-
imum fair price’ means, with respect to a plan year 
during a price applicability period and with respect 
to a selected drug (as defined in section 1192(c)) 
with respect to such period, the price published pur-
suant to section 1195 in the Federal Register for 
such drug and year. 
‘‘(3) AVERAGE INTERNATIONAL MARKET PRICE 
DEFINED.— 
‘‘(A) IN
GENERAL.—The terms ‘average 
international market price’ and ‘AIM price’ 
mean, with respect to a drug, the average price 
(which shall be the net average price, if prac-
ticable, and volume-weighted, if practicable) for 
a unit (as defined in paragraph (4)) of the drug 
for sales of such drug (calculated across dif-
ferent dosage forms and strengths of the drug 
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and not based on the specific formulation or 
package size or package type), as computed (as 
of the date of publication of such drug as a se-
lected drug under section 1192(a)) in all coun-
tries described in clause (ii) of subparagraph 
(B) that are applicable countries (as described 
in clause (i) of such subparagraph) with respect 
to such drug. 
‘‘(B) APPLICABLE COUNTRIES.— 
‘‘(i) IN
GENERAL.—For purposes of 
subparagraph (A), a country described in 
clause (ii) is an applicable country de-
scribed in this clause with respect to a 
drug if there is available an average price 
for any unit for the drug for sales of such 
drug in such country. 
‘‘(ii) COUNTRIES
DESCRIBED.—For 
purposes of this paragraph, the following 
are countries described in this clause: 
‘‘(I) Australia. 
‘‘(II) Canada. 
‘‘(III) France. 
‘‘(IV) Germany. 
‘‘(V) Japan. 
‘‘(VI) The United Kingdom. 
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‘‘(4) UNIT.—The term ‘unit’ means, with re-
spect to a drug, the lowest identifiable quantity 
(such as a capsule or tablet, milligram of molecules, 
or grams) of the drug that is dispensed. 
‘‘SEC. 1192. SELECTION OF NEGOTIATION-ELIGIBLE DRUGS 
AS SELECTED DRUGS. 
‘‘(a) IN GENERAL.—Not later than the selected drug 
publication date with respect to an initial price applica-
bility year, subject to subsection (h), the Secretary shall 
select and publish in the Federal Register a list of— 
‘‘(1)(A) with respect to an initial price applica-
bility year during 2023, at least 25 negotiation-eligi-
ble drugs described in subparagraphs (A) and (B), 
but not subparagraph (C), of subsection (d)(1) (or, 
with respect to an initial price applicability year dur-
ing such period beginning after 2023, the maximum 
number (if such number is less than 25) of such ne-
gotiation-eligible drugs for the year) with respect to 
such year; and 
‘‘(B) with respect to an initial price applica-
bility year during 2024 or a subsequent year, at 
least 50 negotiation-eligible drugs described in sub-
paragraphs (A) and (B), but not subparagraph (C), 
of subsection (d)(1) (or, with respect to an initial 
price applicability year during such period, the max-
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imum number (if such number is less than 50) of 
such negotiation-eligible drugs for the year) with re-
spect to such year; 
‘‘(2) all negotiation-eligible drugs described in 
subparagraph (C) of such subsection with respect to 
such year; and 
‘‘(3) all new-entrant negotiation-eligible drugs 
(as defined in subsection (g)(1)) with respect to such 
year. 
Each drug published on the list pursuant to the previous 
sentence shall be subject to the negotiation process under 
section 1194 for the voluntary negotiation period with re-
spect to such initial price applicability year (and the re-
negotiation process under such section as applicable for 
any subsequent year during the applicable price applica-
bility period). In applying this subsection, any negotiation- 
eligible drug that is selected under this subsection for an 
initial price applicability year shall not count toward the 
required minimum amount of drugs to be selected under 
paragraph (1) for any subsequent year, including such a 
drug so selected that is subject to renegotiation under sec-
tion 1194. 
‘‘(b) SELECTION OF DRUGS.—In carrying out sub-
section (a)(1) the Secretary shall select for inclusion on 
the published list described in subsection (a) with respect 
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to a price applicability period, the negotiation-eligible 
drugs that the Secretary projects will result in the greatest 
savings to the Federal Government or fair price eligible 
individuals during the price applicability period. In making 
this projection of savings for drugs for which there is an 
AIM price for a price applicability period, the savings shall 
be projected across different dosage forms and strengths 
of the drugs and not based on the specific formulation or 
package size or package type of the drugs, taking into con-
sideration both the volume of drugs for which payment 
is made, to the extent such data is available, and the 
amount by which the net price for the drugs exceeds the 
AIM price for the drugs. 
‘‘(c) SELECTED DRUG.—For purposes of this part, 
each drug included on the list published under subsection 
(a) with respect to an initial price applicability year shall 
be referred to as a ‘selected drug’ with respect to such 
year and each subsequent plan year beginning before the 
first plan year beginning after the date on which the Sec-
retary determines two or more drug products— 
‘‘(1) are approved or licensed (as applicable)— 
‘‘(A) under section 505(j) of the Federal 
Food, Drug, and Cosmetic Act using such drug 
as the listed drug; or 
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‘‘(B) under section 351(k) of the Public 
Health Service Act using such drug as the ref-
erence product; and 
‘‘(2) continue to be marketed. 
‘‘(d) NEGOTIATION-ELIGIBLE DRUG.— 
‘‘(1) IN GENERAL.—For purposes of this part, 
the term ‘negotiation-eligible drug’ means, with re-
spect to the selected drug publication date with re-
spect to an initial price applicability year, a quali-
fying single source drug, as defined in subsection 
(e), that meets any of the following criteria: 
‘‘(A) COVERED PART D DRUGS.—The drug 
is among the 125 covered part D drugs (as de-
fined in section 1860D–2(e)) for which there 
was an estimated greatest net spending under 
parts C and D of title XVIII, as determined by 
the Secretary, during the most recent plan year 
prior to such drug publication date for which 
data are available. 
‘‘(B) OTHER DRUGS.—The drug is among 
the 125 drugs for which there was an estimated 
greatest net spending in the United States (in-
cluding the 50 States, the District of Columbia, 
and the territories of the United States), as de-
termined by the Secretary, during the most re-
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cent plan year prior to such drug publication 
date for which data are available. 
‘‘(C) INSULIN.—The drug is a qualifying 
single source drug described in subsection 
(e)(3). 
‘‘(2) CLARIFICATION.—In determining whether 
a qualifying single source drug satisfies any of the 
criteria described in paragraph (1), the Secretary 
shall, to the extent practicable, use data that is ag-
gregated across dosage forms and strengths of the 
drug and not based on the specific formulation or 
package size or package type of the drug. 
‘‘(3) PUBLICATION.—Not later than the se-
lected drug publication date with respect to an ini-
tial price applicability year, the Secretary shall pub-
lish in the Federal Register a list of negotiation-eli-
gible drugs with respect to such selected drug publi-
cation date. 
‘‘(e) QUALIFYING SINGLE SOURCE DRUG.—For pur-
poses of this part, the term ‘qualifying single source drug’ 
means any of the following: 
‘‘(1) DRUG PRODUCTS.—A drug that— 
‘‘(A) is approved under section 505(c) of 
the Federal Food, Drug, and Cosmetic Act and 
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continues to be marketed pursuant to such ap-
proval; and 
‘‘(B) is not the listed drug for any drug 
that is approved and continues to be marketed 
under section 505(j) of such Act. 
‘‘(2) BIOLOGICAL
PRODUCTS.—A biological 
product that— 
‘‘(A) is licensed under section 351(a) of 
the Public Health Service Act, including any 
product that has been deemed to be licensed 
under section 351 of such Act pursuant to sec-
tion 7002(e)(4) of the Biologics Price Competi-
tion and Innovation Act of 2009, and continues 
to be marketed under section 351 of such Act; 
and 
‘‘(B) is not the reference product for any 
biological product that is licensed and continues 
to be marketed under section 351(k) of such 
Act. 
‘‘(3) 
INSULIN
PRODUCT.—Notwithstanding 
paragraphs (1) and (2), any insulin product that is 
approved under subsection (c) or (j) of section 505 
of the Federal Food, Drug, and Cosmetic Act or li-
censed under subsection (a) or (k) of section 351 of 
the Public Health Service Act and continues to be 
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