Sec. 204. Improving transparency and preventing the use of abusive spread 
pricing and related practices in Medicaid. 
Sec. 205. T–MSIS drug data analytics reports. 
Sec. 206. Risk-sharing value-based payment agreements for covered outpatient 
drugs under Medicaid. 
Sec. 207. Applying Medicaid drug rebate requirement to drugs provided as part 
of outpatient hospital services. 
TITLE III—FOOD AND DRUG ADMINISTRATION 
Subtitle A—Pay-for-Delay 
Sec. 301. Unlawful agreements. 
Sec. 302. Notice and certification of agreements. 
Sec. 303. Forfeiture of 180-day exclusivity period. 
Sec. 304. Commission litigation authority. 
Sec. 305. Statute of limitations. 
Subtitle B—Advancing Education on Biosimilars 
Sec. 321. Education on biological products. 
Subtitle C—Other Provisions 
Sec. 331. Clarifying the meaning of new chemical entity. 
TITLE IV—REVENUE PROVISION 
Sec. 401. Safe harbor for high deductible health plans without deductible for 
insulin. 
TITLE V—MISCELLANEOUS 
Sec. 501. Payment for biosimilar biological products during initial period. 
Sec. 502. GAO study and report on average sales price. 
Sec. 503. Requiring prescription drug plans and MA–PD plans to report poten-
tial fraud, waste, and abuse to the Secretary of HHS. 
Sec. 504. Establishment of pharmacy quality measures under Medicare part D. 
Sec. 505. Improving coordination between the Food and Drug Administration 
and the Centers for Medicare & Medicaid Services. 
Sec. 506. Patient consultation in Medicare national and local coverage deter-
minations in order to mitigate barriers to inclusion of such per-
spectives. 
Sec. 507. MedPAC report on shifting coverage of certain Medicare part B 
drugs to Medicare part D. 
Sec. 508. Requirement that direct-to-consumer advertisements for prescription 
drugs and biological products include truthful and non-mis-
leading pricing information. 
Sec. 509. Chief Pharmaceutical Negotiator at the Office of the United States 
Trade Representative. 
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TITLE I—MEDICARE PARTS B 
AND D 
Subtitle A—Medicare Part B 
Provisions 
SEC. 101. IMPROVEMENTS TO MEDICARE SITE-OF-SERVICE 
TRANSPARENCY. 
Section 1834(t) of the Social Security Act (42 U.S.C. 
1395m(t)) is amended— 
(1) in paragraph (1)— 
(A) in the heading, by striking ‘‘IN GEN-
ERAL’’ and inserting ‘‘SITE PAYMENT’’; 
(B) in the matter preceding subparagraph 
(A)— 
(i) by striking ‘‘or to’’ and inserting ‘‘, 
to’’; 
(ii) by inserting ‘‘, or to a physician 
for services furnished in a physician’s of-
fice’’ after ‘‘surgical center’’; and 
(iii) by inserting ‘‘(or 2022 with re-
spect to a physician for services furnished 
in a physician’s office)’’ after ‘‘2018’’; and 
(C) in subparagraph (A)— 
(i) by striking ‘‘and the’’ and insert-
ing ‘‘, the’’; and 
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(ii) by inserting ‘‘, and the physician 
fee schedule under section 1848 (with re-
spect to the practice expense component of 
such payment amount)’’ after ‘‘such sec-
tion’’; 
(2) by redesignating paragraphs (2) through 
(4) as paragraphs (3) through (5), respectively; and 
(3) by inserting after paragraph (1) the fol-
lowing new paragraph: 
‘‘(2) 
PHYSICIAN
PAYMENT.—Beginning 
in 
2022, the Secretary shall expand the information in-
cluded on the Internet website described in para-
graph (1) to include— 
‘‘(A) the amount paid to a physician under 
section 1848 for an item or service for the set-
tings described in paragraph (1); and 
‘‘(B) the estimated amount of beneficiary 
liability applicable to the item or service.’’. 
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SEC. 102. REQUIRING MANUFACTURERS OF CERTAIN SIN-
GLE-DOSE CONTAINER OR SINGLE-USE PACK-
AGE DRUGS PAYABLE UNDER PART B OF THE 
MEDICARE PROGRAM TO PROVIDE REFUNDS 
WITH RESPECT TO DISCARDED AMOUNTS OF 
SUCH DRUGS. 
Section 1847A of the Social Security Act (42 U.S.C. 
1395w–3a) is amended by adding at the end the following 
new subsection: 
‘‘(i) REFUND
FOR CERTAIN DISCARDED SINGLE- 
DOSE CONTAINER OR SINGLE-USE PACKAGE DRUGS.— 
‘‘(1) SECRETARIAL
PROVISION
OF
INFORMA-
TION.— 
‘‘(A) IN
GENERAL.—For each calendar 
quarter beginning on or after January 1, 2022, 
the Secretary shall, with respect to a refundable 
single-dose container or single-use package drug 
(as defined in paragraph (8)), report to each 
manufacturer 
(as 
defined 
in 
subsection 
(c)(6)(A)) of such refundable single-dose con-
tainer or single-use package drug the following 
for the calendar quarter: 
‘‘(i) Subject to subparagraph (C), in-
formation on the total number of units of 
the billing and payment code of such drug, 
if any, that were discarded during such 
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quarter, as determined using a mechanism 
such as the JW modifier used as of the 
date of enactment of this subsection (or 
any such successor modifier that includes 
such data as determined appropriate by 
the Secretary). 
‘‘(ii) The refund amount that the 
manufacturer is liable for pursuant to 
paragraph (3). 
‘‘(B) 
DETERMINATION
OF
DISCARDED 
AMOUNTS.—For 
purposes 
of 
subparagraph 
(A)(i), with respect to a refundable single-dose 
container or single-use package drug furnished 
during a quarter, the amount of such drug that 
was discarded shall be determined based on the 
amount of such drug that was unused and dis-
carded for each drug on the date of service. 
‘‘(C) EXCLUSION OF UNITS OF PACKAGED 
DRUGS.—The total number of units of the bill-
ing and payment code of a refundable single- 
dose container or single-use package drug of a 
manufacturer furnished during a calendar quar-
ter for purposes of subparagraph (A)(i), and 
the determination of the estimated total allowed 
charges for the drug in the quarter for purposes 
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of paragraph (3)(A)(ii), shall not include such 
units that are packaged into the payment 
amount for an item or service and are not sepa-
rately payable. 
‘‘(2) 
MANUFACTURER
REQUIREMENT.—For 
each calendar quarter beginning on or after January 
1, 2022, the manufacturer of a refundable single- 
dose container or single-use package drug shall, for 
such drug, provide to the Secretary a refund that is 
equal to the amount specified in paragraph (3) for 
such drug for such quarter. 
‘‘(3) REFUND AMOUNT.— 
‘‘(A) IN GENERAL.—The amount of the re-
fund specified in this paragraph is, with respect 
to a refundable single-dose container or single- 
use package drug of a manufacturer assigned to 
a billing and payment code for a calendar quar-
ter beginning on or after January 1, 2022, an 
amount equal to the estimated amount (if any) 
by which— 
‘‘(i) the product of— 
‘‘(I) the total number of units of 
the billing and payment code for such 
drug that were discarded during such 
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quarter (as determined under para-
graph (1)); and 
‘‘(II)(aa) in the case of a refund-
able single-dose container or single- 
use package drug that is a single 
source drug or biological, the amount 
of payment determined for such drug 
or 
biological 
under 
subsection 
(b)(1)(B) for such quarter; or 
‘‘(bb) in the case of a refundable 
single-dose container or single-use 
package drug that is a biosimilar bio-
logical product, the amount of pay-
ment determined for such product 
under subsection (b)(1)(C) for such 
quarter; exceeds 
‘‘(ii) an amount equal to the applica-
ble percentage (as defined in subparagraph 
(B)) of the estimated total allowed charges 
for such drug under this part during the 
quarter. 
‘‘(B) 
APPLICABLE
PERCENTAGE
DE-
FINED.— 
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‘‘(i) IN
GENERAL.—For purposes of 
subparagraph (A)(ii), the term ‘applicable 
percentage’ means— 
‘‘(I) subject to subclause (II), 10 
percent; and 
‘‘(II) if applicable, in the case of 
a refundable single-dose container or 
single-use package drug described in 
clause (ii), a percentage specified by 
the Secretary pursuant to such clause. 
‘‘(ii) TREATMENT
OF
DRUGS
THAT 
HAVE
UNIQUE
CIRCUMSTANCES.—In the 
case of a refundable single-dose container 
or single-use package drug that has unique 
circumstances involving similar loss of 
product as that described in paragraph 
(8)(B)(ii), the Secretary, through notice 
and comment rulemaking, may increase 
the applicable percentage otherwise appli-
cable under clause (i)(I) as determined ap-
propriate by the Secretary. 
‘‘(4) FREQUENCY.—Amounts required to be re-
funded pursuant to paragraph (2) shall be paid in 
regular intervals (as determined appropriate by the 
Secretary). 
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‘‘(5) REFUND DEPOSITS.—Amounts paid as re-
funds pursuant to paragraph (2) shall be deposited 
into the Federal Supplementary Medical Insurance 
Trust Fund established under section 1841. 
‘‘(6) ENFORCEMENT.— 
‘‘(A) AUDITS.— 
‘‘(i) MANUFACTURER AUDITS.—Each 
manufacturer of a refundable single-dose 
container or single-use package drug that 
is required to provide a refund under this 
subsection shall be subject to periodic 
audit with respect to such drug and such 
refunds by the Secretary. 
‘‘(ii) PROVIDER
AUDITS.—The Sec-
retary shall conduct periodic audits of 
claims submitted under this part with re-
spect to refundable single-dose container or 
single-use package drugs in accordance 
with the authority under section 1833(e) to 
ensure compliance with the requirements 
applicable under this subsection. 
‘‘(B) CIVIL MONEY PENALTY.— 
‘‘(i) IN
GENERAL.—The Secretary 
shall impose a civil money penalty on a 
manufacturer of a refundable single-dose 
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container or single-use package drug who 
has failed to comply with the requirement 
under paragraph (2) for such drug for a 
calendar quarter in an amount equal to the 
sum of— 
‘‘(I) the amount that the manu-
facturer would have paid under such 
paragraph with respect to such drug 
for such quarter; and 
‘‘(II) 25 percent of such amount. 
‘‘(ii) APPLICATION.—The provisions 
of section 1128A (other than subsections 
(a) and (b)) shall apply to a civil money 
penalty under this subparagraph in the 
same manner as such provisions apply to a 
penalty 
or 
proceeding 
under 
section 
1128A(a). 
‘‘(7) IMPLEMENTATION.—The Secretary shall 
implement this subsection through notice and com-
ment rulemaking. 
‘‘(8) DEFINITION
OF
REFUNDABLE
SINGLE- 
DOSE CONTAINER OR SINGLE-USE PACKAGE DRUG.— 
‘‘(A) IN GENERAL.—Except as provided in 
subparagraph (B), in this subsection, the term 
‘refundable single-dose container or single-use 
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package drug’ means a single source drug or bi-
ological (as defined in section 1847A(c)(6)(D)) 
or a biosimilar biological product (as defined in 
section 1847A(c)(6)(H)) for which payment is 
made under this part and that is furnished 
from a single-dose container or single-use pack-
age. 
‘‘(B) EXCLUSIONS.—The term ‘refundable 
single-dose container or single-use package 
drug’ does not include— 
‘‘(i) a drug or biological that is either 
a radiopharmaceutical or an imaging 
agent; 
‘‘(ii) a drug or biological approved by 
the Food and Drug Administration for 
which dosage and administration instruc-
tions included in the labeling require filtra-
tion during the drug preparation process, 
prior to dilution and administration, and 
require that any unused portion of such 
drug after the filtration process be dis-
carded after the completion of such filtra-
tion process; or 
‘‘(iii) a drug or biological approved by 
the Food and Drug Administration on or 
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after the date of enactment of this sub-
section and with respect to which payment 
has been made under this part for fewer 
than 18 months. 
‘‘(9) REPORT TO CONGRESS.—Not later than 3 
years after the date of enactment of this subsection, 
the Office of the Inspector General, after consulta-
tion with the Centers for Medicare & Medicaid Serv-
ices and the Food and Drug Administration, shall 
submit to the Committee on Energy and Commerce 
and the Committee on Ways and Means of the 
House of Representatives and the Committee on Fi-
nance in the Senate, a report on any impact this 
section is reported to have on the licensure, market 
entry, market retention, or marketing of biosimilar 
biological products. Such report shall be updated pe-
riodically at the direction of the Committee on En-
ergy and Commerce and the Committee on Ways 
and Means of the House of Representatives and the 
Committee on Finance in the Senate.’’. 
SEC. 103. PROVIDING FOR VARIATION IN PAYMENT FOR 
CERTAIN DRUGS COVERED UNDER PART B 
OF THE MEDICARE PROGRAM. 
(a) IN GENERAL.—Section 1847A(b) of the Social 
Security Act (42 U.S.C. 1395w–3a(b)) is amended— 
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ject to clause (iii), in the case of a drug or 
biological furnished for which the amount 
of payment is determined under subpara-
graph (A) or (B) of paragraph (1) and not 
under subsection (c)(4), for calendar quar-
ters during a period in which data are not 
sufficiently available to compute a per ben-
eficiary allowed charges for the drug or bi-
ological, the applicable percent is 106 per-
cent. 
‘‘(B) DETERMINATION
OF
PERCENTILE 
RANK OF PER BENEFICIARY ALLOWED CHARGES 
OF DRUGS.— 
‘‘(i) IN GENERAL.—With respect to a 
calendar quarter beginning on or after 
January 1, 2022, for drugs and biologicals 
for which the amount of payment is deter-
mined under subparagraph (A) or (B) of 
paragraph 
(1), 
except 
for 
drugs 
or 
biologicals for which data are not suffi-
ciently available, the Secretary shall— 
‘‘(I) compute the per beneficiary 
allowed charges (as defined in sub-
paragraph (C)) for each such drug or 
biological; 
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‘‘(II) adjust such per beneficiary 
allowed charges for the quarter, to the 
extent provided under subparagraph 
(D); and 
‘‘(III) array such adjusted per 
beneficiary allowed charges for all 
such drugs or biologicals from high to 
low and rank such drugs or biologicals 
by percentile of such arrayed per ben-
eficiary allowed charges. 
‘‘(ii) 
FREQUENCY.—The 
Secretary 
shall make the computations under clause 
(i)(I) every 6 months (or, if necessary, as 
determined by the Secretary, every 9 or 12 
months) and such computations shall apply 
to succeeding calendar quarters until a 
new computation has been made. 
‘‘(iii) APPLICABLE
DATA
PERIOD.— 
For purposes of this paragraph, the term 
‘applicable data period’ means the most re-
cent period for which the data necessary 
for making the computations under clause 
(i) are available, as determined by the Sec-
retary. 
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‘‘(C) 
PER
BENEFICIARY
ALLOWED 
CHARGES
DEFINED.—In this paragraph, the 
term ‘per beneficiary allowed charges’ means, 
with respect to a drug or biological for which 
the amount of payment is determined under 
subparagraph (A) or (B) of paragraph (1)— 
‘‘(i) the allowed charges for the drug 
or biological for which payment is so made 
for the applicable data period, as estimated 
by the Secretary; divided by 
‘‘(ii) the number of individuals for 
whom any payment for the drug or biologi-
cal was made under paragraph (1) for the 
applicable data period, as estimated by the 
Secretary. 
‘‘(D) ADJUSTMENT TO REFLECT CHANGES 
IN
AVERAGE
SALES
PRICE.—In applying this 
paragraph for a particular calendar quarter, the 
Secretary shall adjust the per beneficiary al-
lowed charges for a drug or biological by multi-
plying such per beneficiary allowed charges 
under subparagraph (C) for the applicable data 
period by the ratio of— 
‘‘(i) the average sales price for the 
drug or biological for the most recent cal-
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endar quarter used under subsection 
(c)(5)(B); to 
‘‘(ii) the average sales price for the 
drug or biological for the calendar quarter 
(or the weighted average for the quarters 
involved) included in the applicable data 
period.’’. 
(b) APPLICATION
OF JUDICIAL REVIEW PROVI-
SIONS.—Section 1847A(g) of the Social Security Act is 
amended— 
(1) by striking ‘‘and’’ at the end of paragraph 
(4); 
(2) by striking the period at the end of para-
graph (5) and inserting ‘‘; and’’; and 
(3) by adding at the end the following new 
paragraph: 
‘‘(6) the determination of per beneficiary al-
lowed charges of drugs or biologicals and ranking of 
such charges under subsection (b)(9).’’. 
SEC. 104. ESTABLISHMENT OF MAXIMUM ADD-ON PAYMENT 
FOR DRUGS AND BIOLOGICALS. 
(a) IN GENERAL.—Section 1847A of the Social Secu-
rity Act (42 U.S.C. 1395w–3a), as amended by section 
103, is further amended— 
(1) in subsection (b)— 
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(A) in paragraph (1), in the matter pre-
ceding subparagraph (A), by striking ‘‘para-
graph (7)’’ and inserting ‘‘paragraphs (7) and 
(10)’’; and 
(B) by adding at the end the following new 
paragraph: 
‘‘(10) MAXIMUM ADD-ON PAYMENT AMOUNT.— 
‘‘(A) IN
GENERAL.—In determining the 
payment amount under the provisions of sub-
paragraph (A), (B), or (C) of paragraph (1) of 
this subsection, subsection (c)(4)(A)(ii), or sub-
section (d)(3)(C) for a drug or biological fur-
nished on or after January 1, 2022, if the ap-
plicable add-on payment (as defined in subpara-
graph (B)) for each drug or biological on a 
claim for a date of service exceeds the max-
imum add-on payment amount specified under 
subparagraph (C) for the drug or biological, 
then the payment amount otherwise determined 
for the drug or biological under those provi-
sions, as applicable, shall be reduced by the 
amount of such excess. 
‘‘(B) APPLICABLE ADD-ON PAYMENT DE-
FINED.—In this paragraph, the term ‘applicable 
add-on payment’ means the following amounts, 
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determined without regard to the application of 
subparagraph (A): 
‘‘(i) In the case of a multiple source 
drug, an amount equal to the difference 
between— 
‘‘(I) the amount that would oth-
erwise be applied under paragraph 
(1)(A); and 
‘‘(II) the amount that would be 
applied under such paragraph if ‘100 
percent’ were substituted for the ap-
plicable percent (as defined in para-
graph (9)) for such drug. 
‘‘(ii) In the case of a single source 
drug or biological, an amount equal to the 
difference between— 
‘‘(I) the amount that would oth-
erwise be applied under paragraph 
(1)(B); and 
‘‘(II) the amount that would be 
applied under such paragraph if ‘100 
percent’ were substituted for the ap-
plicable percent (as defined in para-
graph (9)) for such drug or biological. 
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‘‘(iii) In the case of a biosimilar bio-
logical product, the amount otherwise de-
termined under paragraph (8)(B). 
‘‘(iv) In the case of a drug or biologi-
cal during the initial period described in 
subsection (c)(4)(A), an amount equal to 
the difference between— 
‘‘(I) the amount that would oth-
erwise be applied under subsection 
(c)(4)(A)(ii); and 
‘‘(II) the amount that would be 
applied under such subsection if ‘100 
percent’ were substituted, as applica-
ble, for— 
‘‘(aa) ‘103 percent’ in sub-
clause (I) of such subsection; or 
‘‘(bb) any percent in excess 
of 100 percent applied under 
subclause (II) of such subsection. 
‘‘(v) In the case of a drug or biologi-
cal to which subsection (d)(3)(C) applies, 
an amount equal to the difference be-
tween— 
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‘‘(I) the amount that would oth-
erwise be applied under such sub-
section; and 
‘‘(II) the amount that would be 
applied under such subsection if ‘100 
percent’ were substituted, as applica-
ble, for— 
‘‘(aa) any percent in excess 
of 100 percent applied under 
clause (i) of such subsection; or 
‘‘(bb) ‘103 percent’ in clause 
(ii) of such subsection. 
‘‘(C) MAXIMUM ADD-ON PAYMENT AMOUNT 
SPECIFIED.—For purposes of subparagraph 
(A), the maximum add-on payment amount 
specified in this subparagraph is— 
‘‘(i) with respect to a drug or biologi-
cal 
(other 
than 
autologous 
cellular 
immunotherapy)— 
‘‘(I) for each of 2022 through 
2029, $1,000; and 
‘‘(II) for a subsequent year, the 
amount specified in this subparagraph 
for the preceding year increased by 
the percentage increase in the con-
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sumer price index for all urban con-
sumers (all items; United States city 
average) for the 12-month period end-
ing with June of the previous year; or 
‘‘(ii) with respect to a drug or biologi-
cal 
consisting 
of 
autologous 
cellular 
immunotherapy— 
‘‘(I) for each of 2022 through 
2029, $2,000; and 
‘‘(II) for a subsequent year, the 
amount specified in this subparagraph 
for the preceding year increased by 
the percentage increase in the con-
sumer price index for all urban con-
sumers (all items; United States city 
average) for the 12-month period end-
ing with June of the previous year. 
Any amount determined under this subpara-
graph that is not a multiple of $10 shall be 
rounded to the nearest multiple of $10.’’; and 
(2) in subsection (c)(4)(A)(ii), by striking ‘‘in 
the case’’ and inserting ‘‘subject to subsection 
(b)(10), in the case’’. 
(b) CONFORMING AMENDMENTS RELATING TO SEPA-
RATELY PAYABLE DRUGS.— 
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(1) OPPS.—Section 1833(t)(14) of the Social 
Security Act (42 U.S.C. 1395l(t)(14)) is amended— 
(A) in subparagraph (A)(iii)(II), by insert-
ing ‘‘, subject to subparagraph (I)’’ after ‘‘are 
not available’’; and 
(B) by adding at the end the following new 
subparagraph: 
‘‘(I) APPLICATION
OF
MAXIMUM
ADD-ON 
PAYMENT
FOR
SEPARATELY
PAYABLE
DRUGS 
AND BIOLOGICALS.—In establishing the amount 
of payment under subparagraph (A) for a speci-
fied covered outpatient drug that is furnished 
as part of a covered OPD service (or group of 
services) on or after January 1, 2022, if such 
payment is determined based on the average 
price for the year established under section 
1847A pursuant to clause (iii)(II) of such sub-
paragraph, the provisions of subsection (b)(10) 
of section 1847A shall apply to the amount of 
payment so established in the same manner as 
such provisions apply to the amount of payment 
under section 1847A.’’. 
(2) ASC.—Section 1833(i)(2)(D) of the Social 
Security Act (42 U.S.C. 1395l(i)(2)(D)) is amend-
ed— 
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(A) by moving clause (v) 6 ems to the left; 
(B) by redesignating clause (vi) as clause 
(vii); and 
(C) by inserting after clause (v) the fol-
lowing new clause: 
‘‘(vi) If there is a separate payment 
under the system described in clause (i) for 
a drug or biological furnished on or after 
January 1, 2022, the provisions of sub-
section (t)(14)(I) shall apply to the estab-
lishment of the amount of payment for the 
drug or biological under such system in the 
same manner in which such provisions 
apply to the establishment of the amount 
of payment under subsection (t)(14)(A).’’. 
SEC. 105. TREATMENT OF DRUG ADMINISTRATION SERV-
ICES FURNISHED BY CERTAIN EXCEPTED 
OFF-CAMPUS OUTPATIENT DEPARTMENTS OF 
A PROVIDER. 
Section 1833(t)(16) of the Social Security Act (42 
U.S.C. 1395l(t)(16)) is amended by adding at the end the 
following new subparagraph: 
‘‘(G) SPECIAL PAYMENT RULE FOR DRUG 
ADMINISTRATION SERVICES FURNISHED BY AN 
EXCEPTED DEPARTMENT OF A PROVIDER.— 
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