148 
(2) EXCISE TAX.—The amendments made by 
subsections (a) and (b) shall apply to sales after the 
date of the enactment of this Act. 
SEC. 210. REPEAL OF EXCISE TAX ON HIGH-COST EM-
PLOYER-SPONSORED HEALTH COVERAGE. 
(a) IN GENERAL.—Chapter 43 of the Internal Rev-
enue Code of 1986 is amended by striking section 4980I. 
(b) CONFORMING AMENDMENT.—Section 6051 of 
such Code is amended— 
(1) in paragraph (14) of subsection (a), by 
striking ‘‘section 4980I(d)(1)’’ and inserting ‘‘sub-
section (g)’’, and 
(2) by adding at the end the following: 
‘‘(g) APPLICABLE
EMPLOYER-SPONSORED
COV-
ERAGE.—For purposes of subsection (a)(14)— 
‘‘(1) IN GENERAL.—The term ‘applicable em-
ployer-sponsored coverage’ means, with respect to 
any employee, coverage under any group health plan 
made available to the employee by an employer 
which is excludable from the employee’s gross in-
come under section 106, or would be so excludable 
if it were employer-provided coverage (within the 
meaning of such section 106). 
‘‘(2) EXCEPTIONS.—The term ‘applicable em-
ployer-sponsored coverage’ shall not include— 
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‘‘(A) any coverage (whether through insur-
ance 
or 
otherwise) 
described 
in 
section 
9832(c)(1) (other than subparagraph (G) there-
of) or for long-term care; 
‘‘(B) any coverage under a separate policy, 
certificate, or contract of insurance which pro-
vides benefits substantially all of which are for 
treatment of the mouth (including any organ or 
structure within the mouth) or for treatment of 
the eye; or 
‘‘(C) any coverage described in section 
9832(c)(3) the payment for which is not exclud-
able from gross income and for which a deduc-
tion under section 162(l) is not allowable. 
‘‘(3) COVERAGE
INCLUDES
EMPLOYEE
PAID 
PORTION.—Coverage shall be treated as applicable 
employer-sponsored coverage without regard to 
whether the employer or employee pays for the cov-
erage. 
‘‘(4) GOVERNMENTAL PLANS INCLUDED.—Ap-
plicable employer-sponsored coverage shall include 
coverage under any group health plan established 
and maintained primarily for its civilian employees 
by the Government of the United States, by the gov-
ernment of any State or political subdivision thereof, 
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or by any agency or instrumentality of any such gov-
ernment. 
‘‘(5) COST OF COVERAGE.— 
‘‘(A) HEALTH FSAS.—In the case of appli-
cable employer-sponsored coverage consisting of 
coverage under a flexible spending arrangement 
(as defined in section 2205(g)), the cost of the 
coverage shall be equal to the amount deter-
mined under rules similar to the rules of section 
4980B(f)(4) with respect to any reimbursement 
under the arrangement reduced by the contribu-
tions described in subsection (a)(14)(B). 
‘‘(B) ARCHER
MSAS
AND
HSAS.—In the 
case of applicable employer-sponsored coverage 
consisting of coverage under an arrangement 
under which the employer makes contributions 
described in subsection (b) or (d) of section 
106, the cost of the coverage shall be equal to 
the amount of employer contributions under the 
arrangement until the termination of HSAs as 
described under section 206 of such Act. 
‘‘(C) 
ALLOCATION
ON
A
MONTHLY 
BASIS.—If cost is determined on other than a 
monthly basis, the cost shall be allocated to 
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151 
months in a taxable period on such basis as the 
Secretary may prescribe.’’. 
(c) CLERICAL AMENDMENT.—The table of sections 
for chapter 43 of such Code is amended by striking the 
item relating to section 4980I. 
(d) EFFECTIVE DATE.—The amendments made by 
this section shall apply to taxable years beginning after 
December 31, 2019. 
TITLE III—DRUG-RELATED 
PROVISIONS 
SEC. 301. ESTABLISHMENT OF THE PRESCRIPTION DRUG 
AND MEDICAL DEVICE REVIEW BOARD. 
There is established in the Department of Health and 
Human Services a board to be known as the Prescription 
Drug and Medical Device Price Review Board (in this Act 
referred to as the ‘‘Board’’). 
SEC. 302. MEMBERSHIP; STAFF. 
(a) MEMBERS.—The Board shall be composed of the 
members as follows: 
(1) The Assistant Secretary for Planning and 
Evaluation of the Department of Health and Human 
Services (or the Assistant Secretary’s designee). 
(2) The Administrator of the Centers for Medi-
care & Medicaid Services or, beginning with 2022, 
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the Administrator of the Center for Health Care (or 
the Administrator’s designee). 
(3) The Assistant Director for the Health Serv-
ices Division of the Federal Bureau of Prisons (or 
the Assistant Director’s designee). 
(4) The Secretary of Defense (or the Sec-
retary’s designee). 
(5) The Secretary of Veterans Affairs (or the 
Secretary’s designee). 
(6) The Commissioner of Food and Drugs (or 
the Commissioner’s designee). 
(7) The Director of the National Institutes of 
Health (or the Director’s designee). 
(b) CHAIRPERSON.—The Board shall designate 1 
member of the Board to serve as the chairperson. 
(c) DIRECTOR AND STAFF.— 
(1) DIRECTOR.—The Board shall have a direc-
tor who shall be appointed by the chairperson of the 
Board, subject to rules prescribed by the Board. 
(2) STAFF.—The director may appoint and fix 
the pay of such additional personnel as the chair-
person considers appropriate, subject to rules pre-
scribed by the Board. 
(3) APPLICABILITY OF CERTAIN CIVIL SERVICE 
LAWS.—The director and staff of the Board shall be 
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153 
appointed subject to the provisions of title 5, United 
States Code, governing appointments in the competi-
tive service, and shall be paid in accordance with the 
requirements of chapter 51 and subchapter III of 
chapter 53 of such title relating to classification and 
General Schedule pay rates; except that an indi-
vidual so appointed may not receive pay in excess of 
the maximum annual rate of basic pay payable for 
grade GS–15 of the General Schedule. 
(d) ASSISTANCE FOR THE BOARD.—Subject to sec-
tion 306(g), in carrying out this title, the Board— 
(1) may seek assistance from outside experts in 
the fields of consumer advocacy, medicine, pharma-
cology, pharmacy, and prescription drug reimburse-
ment; and 
(2) shall establish and maintain an advisory 
group and a stakeholder group for purposes of seek-
ing such assistance. 
(e) INITIAL MEETING.—The Board shall hold its ini-
tial meeting not later than 90 days after the date of the 
enactment of this Act. 
(f) BANNED INDIVIDUALS.— 
(1) DRUG
COMPANY
LOBBYISTS.—No former 
registered drug manufacturer lobbyist— 
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(A) may be appointed to the position of 
Director of the Office; or 
(B) may be employed by the Office during 
the 6-year period beginning on the date on 
which the registered lobbyist terminates its reg-
istration in accordance with section 4(d) of the 
Lobbying Disclosure Act of 1995 (2 U.S.C. 
1603(d)) or the agent terminates its status, as 
applicable. 
(2) SENIOR
EXECUTIVES
OF
LAW-BREAKING 
COMPANIES.—No former senior executive of a cov-
ered entity— 
(A) may be appointed to the position of 
Director of the Office; or 
(B) may be employed by the Office during 
the 6-year period beginning on the later of— 
(i) the date of the settlement; and 
(ii) the date on which the enforcement 
action has concluded. 
(3) COVERED ENTITY.—The term ‘‘covered en-
tity’’ means any entity that is— 
(A) a drug manufacturer; and 
(B)(i) operating under Federal settlement, 
including a Federal consent decree; or 
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(ii) the subject of an enforcement action in 
a court of the United States or by an agency. 
SEC. 303. PROHIBITION AGAINST EXCESSIVE PRICE. 
(a) PROHIBITION.—Beginning on the effective date 
of the regulation required by subsection (b), the manufac-
turer of a prescription drug or medical device shall not 
charge an excessive price, as determined pursuant to such 
regulation, for such drug or device. 
(b) FORMULA.—The Board shall by regulation pre-
scribe a formula for determining whether the average 
manufacturer price of such drug or device over an annual 
quarter is an excessive price. 
(c) DETERMINATION OF EXCESSIVE PRICE.—If the 
Board determines, on its own initiative or in response to 
a petition submitted under subsection (d), that the manu-
facturer of a prescription drug or medical device charges 
an excessive price for such drug or device in violation of 
subsection (a)— 
(1) the Board shall give the manufacturer— 
(A) notice of such violation; and 
(B) subject to subsection (d), a period to 
correct such violation; and 
(2) if the manufacturer fails to correct the vio-
lation by the end of such period, the manufacturer 
shall 
be 
subject 
to 
section 
304, 
section 
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1927(c)(2)(E) of the Social Security Act (as added 
by subsection (c) of section 304), and section 4192 
of the Internal Revenue Code of 1986, as added by 
subsection (d) of section 304. 
(d) PETITIONS.—Any person may petition the Board 
to make a determination under subsection (c) regarding 
the pricing of a prescription drug or medical device. Not 
later than 90 days after the date of receipt of such a peti-
tion, the Board shall— 
(1) make a determination under subsection (c) 
regarding such pricing; or 
(2) decline to make such a determination. 
(e) CONTINUING VIOLATION.—The Board shall not 
be required to give a manufacturer an opportunity to cor-
rect a violation, as described in subsection (c)(1)(B), be-
fore the manufacturer becomes subject to the provisions 
described in subsection (c)(2) for such violation, if— 
(1) the Board has already provided such an op-
portunity to correct to the manufacturer; and 
(2) the Board finds that the violation of sub-
section (a) is a continuation of an earlier violation 
with respect to which such an opportunity was pro-
vided. 
(f) CONSIDERATIONS.—The formula required by sub-
section (a) shall at a minimum take into consideration— 
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(1) the average manufacturer price of the pre-
scription drug or medical device over the respective 
annual quarter or quarters; 
(2) the average manufacturer price of other 
prescription drugs or medical devices in the same 
therapeutic class over the same quarter or quarters; 
(3) the average price at which the prescription 
drug or medical device and other prescription drugs 
and medical devices in the same therapeutic class 
have been sold by manufacturers in countries other 
than the United States; 
(4) the costs associated with producing and 
marketing the prescription drug or medical device, 
the value of the drug or device to patients where suf-
ficient data is available to determine such value, the 
total Federal investment in the development of the 
drug or device, the size of the patient population re-
ceiving the drug or device, and other factors deter-
minative as to the true cost of production; and 
(5) whether the price of the prescription drug 
or medical device increased during any annual quar-
ter by a percentage that is more than 2 percent 
greater than the CPI increase percentage (as defined 
in section 215(i) of the Social Security Act (42 
U.S.C. 415)) for the respective annual quarter. 
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(g) VALUE
OR
COST-EFFECTIVENESS
ASSESS-
MENTS.—The use of Quality-Adjusted Life Years, Dis-
ability-Adjusted Life Years, or other similar mechanisms 
is prohibited for use in value or cost-effectiveness assess-
ments for purposes of this section. 
SEC. 304. ENFORCEMENT PROVISIONS. 
(a) REDUCED PATENT TERM.—If the Board finds 
that the manufacturer of a prescription drug or medical 
device, who is also an owner of a patent for such drug 
or device, charged an excessive price for such drug or de-
vice in violation of section 303(a), the Board may— 
(1) reduce the term, by not more than 5 years, 
of any patent issued under title 35, United States 
Code, relating to such drug or device; or 
(2) if the term of each patent for such drug or 
device has expired, reduce the term, by not more 
than 5 years, of another patent owned by the patent 
owner relating to a prescription drug or medical de-
vice. 
(b) CIVIL PENALTIES.—If the Board determines 
under section 303(c) that a manufacturer of a prescription 
drug or medical device charged an excessive price for a 
prescription drug or medical device in violation of section 
303(a), the Board may impose a civil penalty on the man-
ufacturer of not more than 10 percent of the manufactur-
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er’s gross sales of the drug or device during the period 
beginning on the date on which an excessive price is first 
charged and ending on the date on which the manufac-
turer ceases to charge an excessive price. 
(c) TAX ON EXCESS PRESCRIPTION DRUG AND MED-
ICAL DEVICE PROFITS.— 
(1) DETERMINATION
OF
AMOUNT.—If the 
Board determines under section 303(a) that a man-
ufacturer, producer, or importer of a prescription 
drug or medical device charged an excessive price for 
such prescription drug or medical device during a 
taxable year, the Board may determine under this 
paragraph a reasonable price for such drug or device 
for such taxable year. 
(2) IMPOSITION OF TAX.— 
(A) IN GENERAL.—The Internal Revenue 
Code of 1986 is amended by inserting after sec-
tion 4191 the following new section: 
‘‘SEC. 4192. EXCESSIVE PRESCRIPTION DRUG AND MEDICAL 
DEVICE PRICE. 
‘‘(a) IN GENERAL.—There is hereby imposed on the 
sale of any prescription drug or medical device by the 
manufacturer, producer, or importer a tax equal to the 
difference between the price at which such drug or device 
is so sold and the reasonable price determined by the Pre-
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scription Drug and Medical Device Price Review Board 
under section 303(c)(1) of the Medicare for America Act 
for such drug or device for the taxable year for sales after 
the determination. 
‘‘(b) PRESCRIPTION DRUG OR MEDICAL DEVICE.— 
For purposes of this section, the term ‘prescription drug 
or medical device’ means any prescription drug (as defined 
in section 9008 of the Patient Protection and Affordable 
Care Act) or device (as defined in section 201(h) of the 
Federal Food, Drug, and Cosmetic Act) intended for hu-
mans.’’. 
(B) CLERICAL AMENDMENT.—The table of 
parts for chapter 32 of such Code is amended— 
(i) in the item relating to subchapter 
E, by striking ‘‘Medical’’ and inserting 
‘‘Drugs and medical’’; and 
(ii) by inserting after the item relating 
to section 4191 the following new item: 
‘‘Sec. 4192. Excessive prescription drug and medical device price.’’. 
(3) EFFECTIVE DATE.—This subsection and the 
amendments made by this subsection shall apply 
with respect to sales after December 31, 2019. 
SEC. 305. AUTHORITY. 
(a) OBTAINING OFFICIAL DATA.—The chairperson of 
the Board may secure directly from any Federal agency 
information necessary to enable the Board to carry out 
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161 
its duties. Upon request of the chairperson, the head of 
the agency shall furnish such information to the Board 
to the extent such information is not prohibited from dis-
closure by law. 
(b) MAILS.—The Board may use the United States 
mails in the same manner and under the same conditions 
as other Federal agencies. 
(c) ADMINISTRATIVE SUPPORT SERVICES.—Upon the 
request of the chairperson of the Board, the Administrator 
of General Services shall provide to the Board, on a reim-
bursable basis, the administrative support services nec-
essary for the Board to carry out its duties. 
(d) CONTRACT AUTHORITY.—The Board may con-
tract with and compensate government and private agen-
cies or persons for the purpose of conducting research, 
surveys, and other services necessary to enable the Board 
to carry out its duties. 
(e) INVESTIGATIONS.—The Board may make such in-
vestigations as it considers necessary to determine whether 
there is or may be a violation of any regulation promul-
gated under this Act and may require or permit any per-
son to file with it a statement in writing, under oath or 
otherwise as the Board shall determine, as to all the facts 
and circumstances concerning the matter to be inves-
tigated. 
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162 
(f) SUBPOENA POWER.— 
(1) IN GENERAL.—The Board may issue sub-
poenas requiring the attendance and testimony of 
witnesses and the production of any evidence relat-
ing to any matter under investigation by the Board. 
The attendance of witnesses and the production of 
evidence may be required from any place within the 
United States at any designated place of hearing 
within the United States. 
(2) FAILURE TO OBEY A SUBPOENA.—If a per-
son refuses to obey a subpoena issued under para-
graph (1), the Board may apply to a United States 
district court for an order requiring that person to 
appear before the Board to give testimony, produce 
evidence, or both, relating to the matter under inves-
tigation. The application may be made within the ju-
dicial district where the hearing is conducted or 
where that person is found, resides, or transacts 
business. Any failure to obey the order of the court 
may be punished by the court as civil contempt. 
(3) SERVICE OF SUBPOENAS.—The subpoenas 
of the Board shall be served in the manner provided 
for subpoenas issued by a United States district 
court under the Federal Rules of Civil Procedure for 
the United States district courts. 
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(4) SERVICE OF PROCESS.—All process of any 
court to which application is made under paragraph 
(2) may be served in the judicial district in which 
the person required to be served resides or may be 
found. 
(5) NOTICE.—Upon issuing any subpoena 
under this subsection, the Board shall give notice of 
such issuance to the appropriate committees of Con-
gress, including the Committee on Appropriations of 
the House of Representatives and the Committee on 
Appropriations of the Senate. 
(g) CONFIDENTIALITY.—Under this title, the Sec-
retary shall enforce applicable law concerning a trade se-
cret or confidential information subject to section 
552(b)(4) of title 5, United States Code, or section 1905 
of title 18. 
SEC. 306. REGULATIONS. 
(a) IN GENERAL.—Not later than 1 year after the 
date of the initial meeting held under section 302(e), the 
Board shall issue final regulations to carry out this Act. 
(b) NOTICE
AND COMMENT REQUIREMENT.—The 
regulations developed under subsection (a) shall be issued 
in accordance with the notice and comment procedures es-
tablished under section 553 of title 5, United States Code. 
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164 
SEC. 307. REPORT TO FEDERAL AGENCIES. 
Not later than 1 year after the effective date of the 
regulations under section 306 and annually thereafter, the 
Board shall submit to each Federal agency that dispenses 
or makes payments for the dispensing of prescription 
drugs or medical devices a report containing a list of each 
prescription drug and medical device for which an exces-
sive price was charged during the preceding calendar year, 
as determined by the Board under section 303. The Sec-
retary shall make this report publicly available. 
SEC. 308. DEFINITIONS. 
In this title: 
(1) AFFILIATE.—The term ‘‘affiliate’’ means, 
with respect to a manufacturer, any entity that con-
trols, is controlled by, or is under common control 
with such manufacturer. 
(2) AVERAGE
MANUFACTURER
PRICE.—The 
term ‘‘average manufacturer price’’ means the aver-
age price charged by the manufacturer of a prescrip-
tion drug or medical device, as applicable, for sales 
of the drug or device by the manufacturer in the 
United States over the respective annual quarter. 
(3) MEDICAL DEVICE.—The term ‘‘medical de-
vice’’ means a device (as defined in section 201 of 
the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 321)). 
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(4) PRESCRIPTION DRUG.—The term ‘‘prescrip-
tion drug’’ means a drug (as defined in section 201 
of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 321)) that is subject to section 503(b)(1) of 
such Act (21 U.S.C. 353(b)(1)). 
(5) MANUFACTURER.—The term ‘‘manufac-
turer’’ means the person— 
(A) that holds the application for a drug 
approved under section 505 of the Federal 
Food, Drug, and Cosmetic Act or the license 
issued under section 351 of the Public Health 
Service Act; or 
(B) who is responsible for setting the price 
for the drug. 
(6) WHOLESALE ACQUISITION COST.—The term 
‘‘wholesale acquisition cost’’ has the meaning given 
that term in section 1847A(c)(6)(B) of the Social 
Security Act (42 U.S.C. 1395w–3a(c)(6)(B)). 
SEC. 309. MORATORIUM ON DIRECT-TO-CONSUMER DRUG 
ADVERTISING. 
The Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 301 et seq.) is amended— 
(1) in section 301 (21 U.S.C. 331), by adding 
at the end the following: 
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‘‘(eee) The conduct of direct-to-consumer advertising 
of a drug in violation of section 506J.’’; and 
(2) in chapter V, by inserting after section 506I 
(21 U.S.C. 356f) the following: 
‘‘SEC. 506J. DIRECT-TO-CONSUMER DRUG ADVERTISING. 
‘‘(a) PROHIBITIONS.— 
‘‘(1) FIRST THREE YEARS.— 
‘‘(A) IN
GENERAL.—Subject to subpara-
graph (B), no person shall conduct direct-to- 
consumer advertising of a drug for which an 
application is submitted under section 505(b) 
before the end of the 3-year period beginning 
on the date of the approval of such application. 
‘‘(B) WAIVER.—The Secretary may waive 
the application of subparagraph (A) to a drug 
during the third year of the 3-year period de-
scribed in such subparagraph if— 
‘‘(i) the sponsor of the drug submits 
an application to the Secretary pursuant to 
subparagraph (C); and 
‘‘(ii) the Secretary, after considering 
the application and any accompanying ma-
terials, determines that direct-to-consumer 
advertising of the drug would have an af-
firmative value to public health. 
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‘‘(C) APPLICATION FOR WAIVER.—To seek 
a waiver under subparagraph (B), the sponsor 
of a drug shall submit an application to the 
Secretary at such time, in such manner, and 
containing such information as the Secretary 
may require. 
‘‘(2) SUBSEQUENT YEARS.—The Secretary may 
prohibit direct-to-consumer advertising of a drug 
during the period beginning at the end of the 3-year 
period described in paragraph (1)(A) if the Sec-
retary determines that the drug has significant ad-
verse health effects based on post-approval studies, 
risk-benefit analyses, adverse event reports, the sci-
entific literature, any clinical or observational stud-
ies, or any other appropriate resource. 
‘‘(b) REGULATIONS.—Not later than 1 year after the 
date of the enactment of this section, the Secretary shall 
revise the regulations promulgated under this Act gov-
erning drug advertisements to the extent necessary to im-
plement this section. 
‘‘(c) RULE OF CONSTRUCTION.—This section shall 
not be construed to diminish the authority of the Secretary 
to prohibit or regulate direct-to-consumer advertising of 
drugs under other provisions of law.’’. 
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SEC. 310. REPORTING ON JUSTIFICATION FOR DRUG PRICE 
INCREASES. 
Title III of the Public Health Service Act (42 U.S.C. 
241 et seq.) is amended by adding at the end the fol-
lowing: 
‘‘PART W—DRUG PRICE REPORTING; DRUG 
VALUE FUND 
‘‘SEC. 399OO. REPORTING ON JUSTIFICATION FOR DRUG 
PRICE INCREASES. 
‘‘(a) DEFINITIONS.—In this section: 
‘‘(1) MANUFACTURER.—The term ‘manufac-
turer’ means the person— 
‘‘(A) that holds the application for a drug 
approved under section 505 of the Federal 
Food, Drug, and Cosmetic Act or the license 
issued under section 351 of the Public Health 
Service Act; or 
‘‘(B) who is responsible for setting the 
price for the drug. 
‘‘(2) QUALIFYING DRUG.—The term ‘qualifying 
drug’ means any drug that is approved under sub-
section (c) or (j) of section 505 of the Federal Food, 
Drug, and Cosmetic Act or licensed under subsection 
(a) or (k) of section 351 of this Act— 
‘‘(A) that has a wholesale acquisition cost 
of $100 or more per month supply or per a 
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course of treatment that lasts less than a 
month and is— 
‘‘(i)(I) subject to section 503(b)(1) of 
the Federal Food, Drug, and Cosmetic 
Act; or 
‘‘(II) commonly administered by hos-
pitals (as determined by the Secretary); 
‘‘(ii) not designated as a drug for a 
rare disease or condition under section 526 
of the Federal Food, Drug, and Cosmetic 
Act; and 
‘‘(iii) not designated by the Secretary 
as a vaccine; and 
‘‘(B) for which, during the previous cal-
endar year, at least 1 dollar of the total amount 
of sales were for individuals enrolled under the 
Medicare program under title XVIII of the So-
cial Security Act (42 U.S.C. 1395 et seq.) or 
under a State Medicaid plan under title XIX of 
such Act (42 U.S.C. 1396 et seq.) or under a 
waiver of such plan. 
‘‘(3) WHOLESALE
ACQUISITION
COST.—The 
term ‘wholesale acquisition cost’ has the meaning 
given that term in section 1847A(c)(6)(B) of the So-
cial Security Act (42 U.S.C. 1395w–3a(c)(6)(B)). 
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‘‘(b) REPORT.— 
‘‘(1) REPORT REQUIRED.—The manufacturer of 
a qualifying drug shall submit a report to the Sec-
retary for each price increase of a qualifying drug 
that will result in an increase in the wholesale acqui-
sition cost of that drug that is equal to— 
‘‘(A) 10 percent or more over a 12-month 
period; or 
‘‘(B) 25 percent or more over a 36-month 
period. 
‘‘(2) REPORT
DEADLINE.—Each report de-
scribed in paragraph (1) shall be submitted to the 
Secretary not later than 30 days prior to the 
planned effective date of such price increase. 
‘‘(c) CONTENTS.—A report under subsection (b) 
shall, at a minimum, include— 
‘‘(1) with respect to the qualifying drug— 
‘‘(A) the percentage by which the manufac-
turer will raise the wholesale acquisition cost of 
the drug on the planned effective date of such 
price increase; 
‘‘(B) a justification for, and description of, 
each manufacturer’s price increase that will 
occur during the 12-month period described in 
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‘‘(J) the total costs associated with mar-
keting and advertising for the qualifying drug; 
‘‘(2) with respect to the manufacturer— 
‘‘(A) the total revenue and the net profit 
of the manufacturer for each of the 12- and 36- 
month periods preceding the submission of the 
report; 
‘‘(B) all stock-based performance metrics 
used by the manufacturer to determine execu-
tive compensation for each of the 12- and 36- 
month periods preceding the submission of the 
report; and 
‘‘(C) any additional information the manu-
facturer chooses to provide related to drug pric-
ing decisions, such as total expenditures on— 
‘‘(i) drug research and development; 
or 
‘‘(ii) clinical trials on drugs that failed 
to receive approval by the Food and Drug 
Administration; and 
‘‘(3) such other related information as the Sec-
retary considers appropriate. 
‘‘(d) CIVIL PENALTY.—Any manufacturer of a quali-
fying drug that fails to submit a report for the drug as 
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required by this section shall be subject to a civil penalty 
of $100,000 for each day on which the violation continues. 
‘‘(e) PUBLIC POSTING.— 
‘‘(1) IN GENERAL.—Subject to paragraph (3), 
not later than 30 days after the submission of a re-
port under subsection (b), the Secretary shall post 
the report on the public website of the Department 
of Health and Human Services. 
‘‘(2) FORMAT.—In developing the format of 
such report for public posting, the Secretary shall 
consult stakeholders, including beneficiary groups, 
and shall seek feedback on the content and format 
from consumer advocates and readability experts to 
ensure such public reports are user-friendly to the 
public and are written in plain language that con-
sumers can readily understand. 
‘‘(3) TRADE SECRETS AND CONFIDENTIAL IN-
FORMATION.—In carrying out this section, the Sec-
retary shall enforce applicable law concerning the 
protection of confidential commercial information 
and trade secrets. 
‘‘SEC. 399OO–1. USE OF CIVIL PENALTY AMOUNTS. 
‘‘The Secretary shall, without further appropriation, 
collect civil penalties under section 399OO and use the 
funds derived from such civil penalties, in addition to any 
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other amounts available to the Secretary, to carry out ac-
tivities described in this part and to improve consumer and 
provider information about drug value and drug price 
transparency. 
‘‘SEC. 399OO–2. ANNUAL REPORT TO CONGRESS. 
‘‘(a) IN GENERAL.—Subject to subsection (b), the 
Secretary shall submit to Congress, and post on the public 
website of the Department of Health and Human Services 
in a way that is easy to use and understand, an annual 
report— 
‘‘(1) summarizing the information reported pur-
suant to section 399OO; and 
‘‘(2) including copies of the reports and sup-
porting detailed economic analyses submitted pursu-
ant to such section. 
‘‘(b) TRADE SECRETS AND CONFIDENTIAL INFORMA-
TION.—In carrying out this section, the Secretary shall 
enforce applicable law concerning the protection of con-
fidential commercial information and trade secrets.’’. 
TITLE IV—OUTCOMES AND 
REPORTING 
SEC. 401. SENSE OF CONGRESS. 
It is the sense of Congress that Medicare for America 
will have a significant impact on the health and well-being 
of the United States population and the social deter-
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minants of the health of beneficiaries of Medicare for 
America. 
SEC. 402. EVALUATION OF BILL’S OUTCOME. 
(a) IN GENERAL.—To assess the impact of this Act 
on the health of the population, not later than 2 years 
after the date of the enactment of this Act, the Secretary 
of Health and Human Services shall allow for analysis of 
administrative records that have removed all personally 
identifiable information from the Center for Health Care 
to existing population surveys conducted by the Federal 
Government and federally supported surveys. 
(b) CDC AND NIH.—The Directors of the Centers 
for Disease Control and Prevention and the National In-
stitutes of Health shall solicit a comprehensive, longitu-
dinal study to evaluate any differential individual impact 
on coverage expansion based on— 
(1) race and ethnicity; 
(2) socioeconomic status; or 
(3) health status. 
(c) REPORT.—Ten years after the date of the enact-
ment of this Act and every ten years thereafter, the Sec-
retary shall submit a report to the House Committee on 
Energy and Commerce and the Senate Committee on 
Health, Education, Labor, and Pensions regarding impact 
of this Act on the health of the United States population 
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based on the results of subsection (b) contributions from 
all other relevant agencies. 
Æ 
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