with respect to an enrollee, in-
forms the enrollee of such notifi-
cation; 
‘‘(ff) shall ensure that the 
application of this subparagraph 
has no effect on the amount paid 
to pharmacies (or the timing of 
such payments) with respect to 
covered part D drugs dispensed 
to the enrollee; and 
‘‘(gg) shall have in place a 
financial reconciliation process to 
correct inaccuracies in payments 
made by an enrollee under this 
subparagraph with respect to 
covered part D drugs during the 
plan year. 
‘‘(III) FAILURE TO PAY AMOUNT 
BILLED
UNDER
MONTHLY
OUT-OF- 
POCKET COST SHARING MAXIMUM OP-
TION.—If an applicable enrollee fails 
to pay the amount billed for a month 
as required under this subparagraph, 
the applicable enrollee’s enrollment in 
the monthly out-of-pocket cost sharing 
VerDate Sep 11 2014 
20:49 Nov 03, 2021
Jkt 029200
PO 00000
Frm 00090
Fmt 6652
Sfmt 6201
E:\BILLS\H5237.IH
H5237
pamtmann on DSKBC07HB2PROD with BILLS
maximum option shall be terminated 
and the enrollee shall pay the cost- 
sharing otherwise applicable for any 
covered part D drugs subsequently 
dispensed to the enrollee up to the an-
nual out-of-pocket threshold specified 
in paragraph (4)(B). 
‘‘(IV) CLARIFICATION
REGARD-
ING PAST DUE AMOUNTS.—Nothing in 
this subparagraph shall be construed 
as prohibiting a PDP sponsor or an 
MA organization from billing an en-
rollee for an amount owed under this 
subparagraph. 
‘‘(V) TREATMENT
OF
UNSET-
TLED BALANCES.—Any unsettled bal-
ances with respect to amounts owed 
under this subparagraph shall be 
treated as plan losses and the Sec-
retary shall not be liable for any such 
balances outside of those assumed as 
losses estimated in plan bids.’’; and 
(2) in paragraph (4)— 
(A) in subparagraph (C), by striking ‘‘and 
subject to subparagraph (F)’’ and inserting 
VerDate Sep 11 2014 
20:49 Nov 03, 2021
Jkt 029200
PO 00000
Frm 00091
Fmt 6652
Sfmt 6201
E:\BILLS\H5237.IH
H5237
pamtmann on DSKBC07HB2PROD with BILLS
‘‘and subject to subparagraphs (F) and (G)’’; 
and 
(B) by adding at the end the following new 
subparagraph: 
‘‘(G) INCLUSION OF COSTS PAID UNDER 
MONTHLY OUT-OF-POCKET COST SHARING MAX-
IMUM OPTION.—In applying subparagraph (A), 
with respect to an applicable enrollee who is en-
rolled in the monthly out-of-pocket cost sharing 
maximum option described in clause (i)(I) of 
paragraph (2)(E), costs shall be treated as in-
curred if such costs are paid by a PDP sponsor 
or an MA organization under the process pro-
vided under such paragraph.’’. 
(b) APPLICATION TO ALTERNATIVE PRESCRIPTION 
DRUG COVERAGE.—Section 1860D–2(c) of the Social Se-
curity Act (42 U.S.C. 1395w–102(c)) is amended by add-
ing at the end the following new paragraph: 
‘‘(4) SAME
MONTHLY
OUT-OF-POCKET
COST 
SHARING MAXIMUM.—For plan years beginning on 
or after January 1, 2024, the monthly out-of-pocket 
cost sharing maximum for applicable enrollees under 
the process provided under subsection (b)(2)(E) 
shall apply to such coverage.’’. 
VerDate Sep 11 2014 
20:49 Nov 03, 2021
Jkt 029200
PO 00000
Frm 00092
Fmt 6652
Sfmt 6201
E:\BILLS\H5237.IH
H5237
pamtmann on DSKBC07HB2PROD with BILLS
SEC. 223. PUBLIC DISCLOSURE OF DRUG DISCOUNTS AND 
OTHER PHARMACY BENEFIT MANAGER (PBM) 
PROVISIONS. 
(a) PUBLIC DISCLOSURE OF DRUG DISCOUNTS.— 
(1) IN GENERAL.—Section 1150A of the Social 
Security Act (42 U.S.C. 1320b–23) is amended— 
(A) in subsection (c), in the matter pre-
ceding paragraph (1), by striking ‘‘this section’’ 
and inserting ‘‘subsection (b)(1)’’; and 
(B) by adding at the end the following new 
subsection: 
‘‘(e) PUBLIC AVAILABILITY OF CERTAIN INFORMA-
TION.— 
‘‘(1) IN GENERAL.—Subject to paragraphs (2) 
and (3), in order to allow patients and employers to 
compare PBMs’ ability to negotiate rebates, dis-
counts, and price concessions and the amount of 
such rebates, discounts, and price concessions that 
are passed through to plan sponsors, not later than 
July 1, 2025, the Secretary shall make available on 
the Internet website of the Department of Health 
and Human Services the information provided to the 
Secretary and described in paragraphs (2) and (3) 
of subsection (b) with respect to each PBM. 
‘‘(2) LAG
IN
DATA.—The information made 
available in a plan year under paragraph (1) shall 
VerDate Sep 11 2014 
20:49 Nov 03, 2021
Jkt 029200
PO 00000
Frm 00093
Fmt 6652
Sfmt 6201
E:\BILLS\H5237.IH
H5237
pamtmann on DSKBC07HB2PROD with BILLS
not include information with respect to such plan 
year or the two preceding plan years. 
‘‘(3) CONFIDENTIALITY.—The Secretary shall 
ensure that such information is displayed in a man-
ner that prevents the disclosure of information on 
rebates, discounts, and price concessions with re-
spect to an individual drug or an individual PDP 
sponsor, MA organization, or qualified health bene-
fits plan.’’. 
(2) EFFECTIVE DATE.—The amendment made 
by paragraph (1)(A) shall take effect on January 1, 
2025. 
(b) PLAN AUDIT OF PHARMACY BENEFIT MANAGER 
DATA.—Section 1860D–2(d)(3) of the Social Security Act 
(42 U.S.C. 1395w–102(d)(3)) is amended— 
(1) by striking ‘‘AUDITS.—To protect’’ and in-
serting the following: ‘‘AUDITS.— 
‘‘(A) AUDITS
OF
PLANS
BY
THE
SEC-
RETARY.—To protect’’; and 
(2) by adding at the end the following new sub-
paragraph: 
‘‘(B) AUDITS
OF
PHARMACY
BENEFIT 
MANAGERS BY PDP SPONSORS AND MA ORGANI-
ZATIONS.— 
VerDate Sep 11 2014 
20:49 Nov 03, 2021
Jkt 029200
PO 00000
Frm 00094
Fmt 6652
Sfmt 6201
E:\BILLS\H5237.IH
H5237
pamtmann on DSKBC07HB2PROD with BILLS
‘‘(i) IN GENERAL.—Beginning Janu-
ary 1, 2025, in order to ensure that— 
‘‘(I) contracting terms between a 
PDP sponsor offering a prescription 
drug plan or an MA organization of-
fering an MA–PD plan and its con-
tracted or owned pharmacy benefit 
manager are met; and 
‘‘(II) the PDP sponsor and MA 
organization can account for the cost 
of each covered part D drug net of all 
direct and indirect remuneration, 
the PDP sponsor or MA organization shall 
conduct financial audits. 
‘‘(ii) INDEPENDENT THIRD PARTY.— 
An audit described in clause (i) shall— 
‘‘(I) be conducted by an inde-
pendent third party; and 
‘‘(II) account and reconcile flows 
of funds that determine the net cost 
of covered part D drugs, including di-
rect and indirect remuneration from 
drug manufacturers and pharmacies 
or provided to pharmacies. 
VerDate Sep 11 2014 
20:49 Nov 03, 2021
Jkt 029200
PO 00000
Frm 00095
Fmt 6652
Sfmt 6201
E:\BILLS\H5237.IH
H5237
pamtmann on DSKBC07HB2PROD with BILLS
‘‘(iii) REBATE AGREEMENTS.—A PDP 
sponsor and an MA organization shall re-
quire pharmacy benefit managers to make 
rebate contracts with drug manufacturers 
made on their behalf available under audits 
described in clause (i). 
‘‘(iv) 
CONFIDENTIALITY
AGREE-
MENTS.—Audits described in clause (i) 
shall be subject to confidentiality agree-
ments to prevent, except as required under 
clause (vii), the redisclosure of data trans-
mitted under the audit. 
‘‘(v) FREQUENCY.—A financial audit 
under clause (i) shall be conducted periodi-
cally (but in no case less frequently than 
once every 2 years). 
‘‘(vi) TIMEFRAME FOR PBM TO PRO-
VIDE INFORMATION.—A PDP sponsor and 
an MA organization shall require that a 
pharmacy benefit manager that is being 
audited under clause (i) provide (as part of 
their contracting agreement) the requested 
information to the independent third party 
conducting the audit within 45 days of the 
date of the request. 
VerDate Sep 11 2014 
20:49 Nov 03, 2021
Jkt 029200
PO 00000
Frm 00096
Fmt 6652
Sfmt 6201
E:\BILLS\H5237.IH
H5237
pamtmann on DSKBC07HB2PROD with BILLS
‘‘(vii) SUBMISSION OF AUDIT REPORTS 
TO THE SECRETARY.— 
‘‘(I) IN GENERAL.—A PDP spon-
sor and an MA organization shall sub-
mit to the Secretary the final report 
on any audit conducted under clause 
(i) within 30 days of the PDP sponsor 
or MA organization receiving the re-
port from the independent third party 
conducting the audit. 
‘‘(II) REVIEW.—The Secretary 
shall review final reports submitted 
under clause (i) to determine the ex-
tent to which the goals specified in 
subclauses (I) and (II) of subpara-
graph (B)(i) are met. 
‘‘(III) CONFIDENTIALITY.—Not-
withstanding any other provision of 
law, information disclosed in a report 
submitted under clause (i) related to 
the net cost of a covered part D drug 
is confidential and shall not be dis-
closed by the Secretary or a Medicare 
contractor. 
VerDate Sep 11 2014 
20:49 Nov 03, 2021
Jkt 029200
PO 00000
Frm 00097
Fmt 6652
Sfmt 6201
E:\BILLS\H5237.IH
H5237
pamtmann on DSKBC07HB2PROD with BILLS
‘‘(viii) 
NOTICE
OF
NONCOMPLI-
ANCE.—A PDP sponsor and an MA orga-
nization shall notify the Secretary if any 
pharmacy benefit manager is not com-
plying with requests for access to informa-
tion required under an audit under clause 
(i). 
‘‘(ix) CIVIL MONETARY PENALTIES.— 
‘‘(I) IN
GENERAL.—Subject to 
subclause (II), if the Secretary deter-
mines that a PDP sponsor or an MA 
organization has failed to conduct an 
audit under clause (i), the Secretary 
may impose a civil monetary penalty 
of not more than $10,000 for each 
day of such noncompliance. 
‘‘(II) PROCEDURE.—The provi-
sions of section 1128A, other than 
subsections (a) and (b) and the first 
sentence of subsection (c)(1) of such 
section, shall apply to civil monetary 
penalties under this clause in the 
same manner as such provisions apply 
to a penalty or proceeding under sec-
tion 1128A.’’. 
VerDate Sep 11 2014 
20:49 Nov 03, 2021
Jkt 029200
PO 00000
Frm 00098
Fmt 6652
Sfmt 6201
E:\BILLS\H5237.IH
H5237
pamtmann on DSKBC07HB2PROD with BILLS
(c) DISCLOSURE TO PHARMACY OF POST-POINT-OF- 
SALE PHARMACY PRICE CONCESSIONS AND INCENTIVE 
PAYMENTS.—Section 1860D–2(d)(2) of the Social Secu-
rity Act (42 U.S.C. 1395w–102(d)(2)) is amended— 
(1) by striking ‘‘DISCLOSURE.—A PDP spon-
sor’’ and inserting the following: ‘‘DISCLOSURE.— 
‘‘(A) TO THE SECRETARY.—A PDP spon-
sor’’; and 
(2) by adding at the end the following new sub-
paragraph: 
‘‘(B) TO PHARMACIES.— 
‘‘(i) IN
GENERAL.—For plan year 
2025 and subsequent plan years, a PDP 
sponsor offering a prescription drug plan 
and an MA organization offering an MA– 
PD plan shall report any pharmacy price 
concession or incentive payment that oc-
curs with respect to a pharmacy after pay-
ment for covered part D drugs at the 
point-of-sale, including by an intermediary 
organization with which a PDP sponsor or 
MA organization has contracted, to the 
pharmacy. 
‘‘(ii) TIMING.—The reporting of price 
concessions and incentive payments to a 
VerDate Sep 11 2014 
20:49 Nov 03, 2021
Jkt 029200
PO 00000
Frm 00099
Fmt 6652
Sfmt 6201
E:\BILLS\H5237.IH
H5237
pamtmann on DSKBC07HB2PROD with BILLS
100 
pharmacy under clause (i) shall be made 
on a periodic basis (but in no case less fre-
quently than annually). 
‘‘(iii) CLAIM
LEVEL.—The reporting 
of price concessions and incentive pay-
ments to a pharmacy under clause (i) shall 
be at the claim level or approximated at 
the claim level if the price concession or in-
centive payment was applied at a level 
other than at the claim level.’’. 
(d) DISCLOSURE OF P&T COMMITTEE CONFLICTS OF 
INTEREST.— 
(1) IN
GENERAL.—Section 1860D–4(b)(3)(A) 
of the Social Security Act (42 U.S.C. 1395w– 
104(b)(3)(A)) is amended by adding at the end the 
following new clause: 
‘‘(iii) DISCLOSURE OF CONFLICTS OF 
INTEREST.—With respect to plan year 
2025 and subsequent plan years, a PDP 
sponsor of a prescription drug plan and an 
MA organization offering an MA–PD plan 
shall, as part of its bid submission under 
section 1860D–11(b), provide the Sec-
retary with a completed statement of fi-
nancial conflicts of interest, including with 
VerDate Sep 11 2014 
20:49 Nov 03, 2021
Jkt 029200
PO 00000
Frm 00100
Fmt 6652
Sfmt 6201
E:\BILLS\H5237.IH
H5237
pamtmann on DSKBC07HB2PROD with BILLS
101 
manufacturers, from each member of any 
pharmacy and therapeutic committee used 
by the sponsor or organization pursuant to 
this paragraph.’’. 
(2) 
INCLUSION
IN
BID.—Section 
1860D– 
11(b)(2) of the Social Security Act (42 U.S.C. 
1395w–111(b)(2)) is amended— 
(A) by redesignating subparagraph (F) as 
subparagraph (G); and 
(B) by inserting after subparagraph (E) 
the following new subparagraph: 
‘‘(F) P&T COMMITTEE CONFLICTS OF IN-
TEREST.—The information required to be dis-
closed under section 1860D–4(b)(3)(A)(iii).’’. 
(e) INFORMATION ON DIRECT AND INDIRECT REMU-
NERATION REQUIRED TO BE INCLUDED IN BID.—Section 
1860D–11(b) of the Social Security Act (42 U.S.C. 
1395w–111(b)) is amended— 
(1) in paragraph (1), by adding at the end the 
following new sentence: ‘‘With respect to actual 
amounts of direct and indirect remuneration sub-
mitted pursuant to clause (v) of paragraph (2), such 
amounts shall be consistent with data reported to 
the Secretary in a prior year.’’; and 
(2) in paragraph (2)(C)— 
VerDate Sep 11 2014 
20:49 Nov 03, 2021
Jkt 029200
PO 00000
Frm 00101
Fmt 6652
Sfmt 6201
E:\BILLS\H5237.IH
H5237
pamtmann on DSKBC07HB2PROD with BILLS
102 
(A) in clause (iii), by striking ‘‘and’’ at the 
end; 
(B) in clause (iv), by striking the period at 
the end and inserting the following: ‘‘, and, with 
respect to plan year 2025 and subsequent plan 
years, actual and projected administrative ex-
penses assumed in the bid, categorized by the 
type of such expense, including actual and pro-
jected price concessions retained by a pharmacy 
benefit manager; and’’; and 
(C) by adding at the end the following new 
clause: 
‘‘(v) with respect to plan year 2025 
and subsequent plan years, actual and pro-
jected direct and indirect remuneration, 
categorized as received from each of the 
following: 
‘‘(I) A pharmacy. 
‘‘(II) A manufacturer. 
‘‘(III) A pharmacy benefit man-
ager. 
‘‘(IV) Other entities, as deter-
mined by the Secretary.’’. 
VerDate Sep 11 2014 
20:49 Nov 03, 2021
Jkt 029200
PO 00000
Frm 00102
Fmt 6652
Sfmt 6201
E:\BILLS\H5237.IH
H5237
pamtmann on DSKBC07HB2PROD with BILLS
103 
SEC. 224. PUBLIC DISCLOSURE OF DIRECT AND INDIRECT 
REMUNERATION REVIEW AND AUDIT RE-
SULTS. 
Section 1860D–42 of the Social Security Act (42 
U.S.C. 1395w–152) is amended by adding at the end the 
following new subsection: 
‘‘(e) PUBLIC DISCLOSURE OF DIRECT AND INDIRECT 
REMUNERATION REVIEW
AND FINANCIAL AUDIT RE-
SULTS.— 
‘‘(1) DIR REVIEW RESULTS.— 
‘‘(A) IN GENERAL.—Except as provided in 
subparagraph (B), in 2023 and each subse-
quent year, the Secretary shall make available 
to the public on the Internet website of the 
Centers for Medicare & Medicaid Services infor-
mation on discrepancies related to summary 
and detailed DIR reports submitted by PDP 
sponsors pursuant to section 1860D–15 across 
all prescription drug plans based on the most 
recent data available. Information made avail-
able under this subparagraph shall include the 
following: 
‘‘(i) The number of potential errors 
identified by the Secretary for PDP spon-
sors to review. 
VerDate Sep 11 2014 
20:49 Nov 03, 2021
Jkt 029200
PO 00000
Frm 00103
Fmt 6652
Sfmt 6201
E:\BILLS\H5237.IH
H5237
pamtmann on DSKBC07HB2PROD with BILLS
104 
‘‘(ii) The extent to which PDP spon-
sors resubmitted DIR reports to make 
changes for previous contract years. 
‘‘(iii) The extent to which resubmitted 
DIR reports resulted in an increase or de-
crease in DIR in a previous contract year. 
‘‘(B) EXCLUSION
OF
CERTAIN
SUBMIS-
SIONS IN CALCULATION.—The Secretary shall 
exclude any information in DIR reports sub-
mitted with respect to PACE programs under 
section 1894 (pursuant to section 1860D–21(f)) 
and qualified retiree prescription drug plans (as 
defined in section 1860D–22(a)(2)) from the 
information that is made available to the public 
under subparagraph (A). 
‘‘(2) FINANCIAL AUDIT RESULTS.—In 2023 and 
each subsequent year, the Secretary shall make 
available to the public on the Internet website of the 
Centers for Medicare & Medicaid Services the results 
of DIR audits required under section 1860D– 
12(b)(3)(C). Information made available under this 
paragraph shall include the following: 
‘‘(A) With respect to the year, the number 
of PDP sponsors that received each of the fol-
lowing: 
VerDate Sep 11 2014 
20:49 Nov 03, 2021
Jkt 029200
PO 00000
Frm 00104
Fmt 6652
Sfmt 6201
E:\BILLS\H5237.IH
H5237
pamtmann on DSKBC07HB2PROD with BILLS
105 
‘‘(i) A notice of observations or find-
ings that required the sponsor to make 
DIR report corrections. 
‘‘(ii) An unqualified audit opinion that 
renders the audit closed. 
‘‘(iii) A qualified audit opinion that 
requires the sponsor to submit a corrective 
action plan to the Secretary. 
‘‘(iv) An adverse opinion, with a de-
scription of the types of actions that the 
Secretary takes when issuing an adverse 
opinion. 
‘‘(B) With respect to a preceding year: 
‘‘(i) The number of PDP sponsors 
that reopened a previously closed reconcili-
ation as a result of an audit, including as 
a result of DIR changes. 
‘‘(ii) The extent to which the Sec-
retary recouped an overpayment or made 
an underpayment as a result of a reopen-
ing of a previously closed reconciliation. 
‘‘(3) DEFINITION
OF
DIR.—For purposes of 
this subsection, the term ‘DIR’ means direct and in-
direct remuneration as defined in section 423.308 of 
VerDate Sep 11 2014 
20:49 Nov 03, 2021
Jkt 029200
PO 00000
Frm 00105
Fmt 6652
Sfmt 6201
E:\BILLS\H5237.IH
H5237
pamtmann on DSKBC07HB2PROD with BILLS
106 
title 42, Code of Federal Regulations, or any suc-
cessor regulation.’’. 
SEC. 225. IMPROVEMENTS TO PROVISION OF PARTS A AND 
B CLAIMS DATA TO PRESCRIPTION DRUG 
PLANS. 
(a) DATA USE.— 
(1) IN
GENERAL.—Paragraph (6) of section 
1860D–4(c) of the Social Security Act (42 U.S.C. 
1395w–104(c)), as added by section 50354 of divi-
sion E of the Bipartisan Budget Act of 2018 (Public 
Law 115–123), relating to providing prescription 
drug plans with parts A and B claims data to pro-
mote the appropriate use of medications and im-
prove health outcomes, is amended— 
(A) in subparagraph (B)— 
(i) by redesignating clauses (i), (ii), 
and (iii) as subclauses (I), (II), and (III), 
respectively, and moving such subclauses 2 
ems to the right; 
(ii) by striking ‘‘PURPOSES.—A PDP 
sponsor’’ and inserting ‘‘PURPOSES.— 
‘‘(i) IN GENERAL.—A PDP sponsor.’’; 
and 
(iii) by adding at the end the fol-
lowing new clause: 
VerDate Sep 11 2014 
20:49 Nov 03, 2021
Jkt 029200
PO 00000
Frm 00106
Fmt 6652
Sfmt 6201
E:\BILLS\H5237.IH
H5237
pamtmann on DSKBC07HB2PROD with BILLS
107 
‘‘(ii) CLARIFICATION.—The limitation 
on data use under subparagraph (C)(i) 
shall not apply to the extent that the PDP 
sponsor is using the data provided to carry 
out any of the purposes described in clause 
(i).’’; and 
(B) in subparagraph (C)(i), by striking 
‘‘To inform’’ and inserting ‘‘Subject to subpara-
graph (B)(ii), to inform’’. 
(2) EFFECTIVE DATE.—The amendments made 
by this subsection shall apply to plan years begin-
ning on or after January 1, 2025. 
(b) MANNER OF PROVISION.—Subparagraph (D) of 
such paragraph (6) is amended— 
(1) by striking ‘‘DESCRIBED.—The data de-
scribed in this clause’’ and inserting ‘‘DESCRIBED.— 
‘‘(i) IN
GENERAL.—The data de-
scribed in this subparagraph’’; and 
(2) by adding at the end the following new 
clause: 
‘‘(ii) MANNER OF PROVISION.— 
‘‘(I) IN
GENERAL.—Such data 
may be provided pursuant to this 
paragraph in the same manner as 
data under the Part D Enhanced 
VerDate Sep 11 2014 
20:49 Nov 03, 2021
Jkt 029200
PO 00000
Frm 00107
Fmt 6652
Sfmt 6201
E:\BILLS\H5237.IH
H5237
pamtmann on DSKBC07HB2PROD with BILLS
108 
Medication 
Therapy 
Management 
model tested under section 1115A, 
through 
Application 
Programming 
Interface, or in another manner as de-
termined by the Secretary. 
‘‘(II) 
IMPLEMENTATION.—Not-
withstanding any other provision of 
law, the Secretary may implement this 
clause by program instruction or oth-
erwise.’’. 
(c) TECHNICAL CORRECTION.—Such paragraph (6) 
is redesignated as paragraph (7). 
SEC. 226. MEDICARE PART D REBATE BY MANUFACTURERS. 
(a) IN GENERAL.—Part D of title XVIII of the Social 
Security Act is amended by inserting after section 1860D– 
14A (42 U.S.C. 1395w–114a) the following new section: 
‘‘SEC. 1860D–14B. MANUFACTURER REBATE FOR CERTAIN 
DRUGS WITH PRICES INCREASING FASTER 
THAN INFLATION. 
‘‘(a) IN GENERAL.— 
‘‘(1) IN GENERAL.—Subject to the provisions of 
this section, in order for coverage to be available 
under this part for a part D rebatable drug (as de-
fined in subsection (h)(1)) of a manufacturer (as de-
fined in section 1927(k)(5)) dispensed during an ap-
VerDate Sep 11 2014 
20:49 Nov 03, 2021
Jkt 029200
PO 00000
Frm 00108
Fmt 6652
Sfmt 6201
E:\BILLS\H5237.IH
H5237
pamtmann on DSKBC07HB2PROD with BILLS
109 
plicable year, the manufacturer must have entered 
into and have in effect an agreement described in 
subsection (b). 
‘‘(2) AUTHORIZING COVERAGE FOR DRUGS NOT 
COVERED
UNDER
AGREEMENTS.—Paragraph (1) 
shall not apply to the dispensing of a covered part 
D drug if— 
‘‘(A) the Secretary has made a determina-
tion that the availability of the drug is essential 
to the health of beneficiaries under this part; or 
‘‘(B) the Secretary determines that in the 
period beginning on January 1, 2025, and end-
ing on December 31, 2025, there were extenu-
ating circumstances. 
‘‘(3) APPLICABLE YEAR.—For purposes of this 
section the term ‘applicable year’ means a year be-
ginning with 2025. 
‘‘(b) AGREEMENTS.— 
‘‘(1) TERMS OF AGREEMENT.—An agreement 
described in this subsection, with respect to a manu-
facturer of a part D rebatable drug, is an agreement 
under which the following shall apply: 
‘‘(A) SECRETARIAL PROVISION OF INFOR-
MATION.—Not later than 9 months after the 
end of each applicable year with respect to 
VerDate Sep 11 2014 
20:49 Nov 03, 2021
Jkt 029200
PO 00000
Frm 00109
Fmt 6652
Sfmt 6201
E:\BILLS\H5237.IH
H5237
pamtmann on DSKBC07HB2PROD with BILLS
110 
which the agreement is in effect, the Secretary, 
for each part D rebatable drug of the manufac-
turer, shall report to the manufacturer the fol-
lowing for such year: 
‘‘(i) Information on the total number 
of units (as defined in subsection (h)(2)) 
for each dosage form and strength with re-
spect to such part D rebatable drug and 
year. 
‘‘(ii) Information on the amount (if 
any) of the excess average manufacturer 
price increase described in subsection 
(c)(1)(B) for each dosage form and 
strength with respect to such drug and 
year. 
‘‘(iii) The rebate amount specified 
under subsection (c) for each dosage form 
and strength with respect to such drug and 
year. 
‘‘(B) MANUFACTURER
REQUIREMENTS.— 
For each applicable year with respect to which 
the agreement is in effect, the manufacturer of 
the part D rebatable drug, for each dosage 
form and strength with respect to such drug, 
not later than 30 days after the date of receipt 
VerDate Sep 11 2014 
20:49 Nov 03, 2021
Jkt 029200
PO 00000
Frm 00110
Fmt 6652
Sfmt 6201
E:\BILLS\H5237.IH
H5237
pamtmann on DSKBC07HB2PROD with BILLS
111 
from the Secretary of the information described 
in subparagraph (A) for such year, shall pro-
vide to the Secretary a rebate that is equal to 
the amount specified in subsection (c) for such 
dosage form and strength with respect to such 
drug for such year. 
‘‘(2) LENGTH OF AGREEMENT.— 
‘‘(A) IN GENERAL.—An agreement under 
this section, with respect to a part D rebatable 
drug, shall be effective for an initial period of 
not less than one year and shall be automati-
cally renewed for a period of not less than one 
year unless terminated under subparagraph 
(B). 
‘‘(B) TERMINATION.— 
‘‘(i) BY SECRETARY.—The Secretary 
may provide for termination of an agree-
ment under this section for violation of the 
requirements of the agreement or other 
good cause shown. Such termination shall 
not be effective earlier than 30 days after 
the date of notice of such termination. The 
Secretary shall provide, upon request, a 
manufacturer with a hearing concerning 
such a termination, but such hearing shall 
VerDate Sep 11 2014 
20:49 Nov 03, 2021
Jkt 029200
PO 00000
Frm 00111
Fmt 6652
Sfmt 6201
E:\BILLS\H5237.IH
H5237
pamtmann on DSKBC07HB2PROD with BILLS
112 
not delay the effective date of the termi-
nation. 
‘‘(ii) BY A MANUFACTURER.—A man-
ufacturer may terminate an agreement 
under this section for any reason. Any 
such termination shall be effective, with re-
spect to a plan year— 
‘‘(I) if the termination occurs be-
fore January 30 of the plan year, as 
of the day after the end of the plan 
year; and 
‘‘(II) if the termination occurs on 
or after January 30 of the plan year, 
as of the day after the end of the suc-
ceeding plan year. 
‘‘(C) EFFECTIVENESS OF TERMINATION.— 
Any termination under this paragraph shall not 
affect rebates due under the agreement under 
this section before the effective date of its ter-
mination. 
‘‘(D) DELAY
BEFORE
REENTRY.—In the 
case of any agreement under this section with 
a manufacturer that is terminated in a plan 
year, the Secretary may not enter into another 
such agreement with the manufacturer (or a 
VerDate Sep 11 2014 
20:49 Nov 03, 2021
Jkt 029200
PO 00000
Frm 00112
Fmt 6652
Sfmt 6201
E:\BILLS\H5237.IH
H5237
pamtmann on DSKBC07HB2PROD with BILLS
113 
successor manufacturer) before the subsequent 
plan year, unless the Secretary finds good cause 
for an earlier reinstatement of such an agree-
ment. 
‘‘(c) REBATE AMOUNT.— 
‘‘(1) IN GENERAL.—For purposes of this sec-
tion, the amount specified in this subsection for a 
dosage form and strength with respect to a part D 
rebatable drug and applicable year is, subject to sub-
paragraphs (B) and (C) of paragraph (5), the 
amount equal to the product of— 
‘‘(A) the total number of units of such dos-
age form and strength with respect to such part 
D rebatable drug and year; and 
‘‘(B) the amount (if any) by which— 
‘‘(i) the annual manufacturer price 
(as determined in paragraph (2)) paid for 
such dosage form and strength with re-
spect to such part D rebatable drug for the 
year; exceeds 
‘‘(ii) the inflation-adjusted payment 
amount determined under paragraph (3) 
for such dosage form and strength with re-
spect to such part D rebatable drug for the 
year. 
VerDate Sep 11 2014 
20:49 Nov 03, 2021
Jkt 029200
PO 00000
Frm 00113
Fmt 6652
Sfmt 6201
E:\BILLS\H5237.IH
H5237
pamtmann on DSKBC07HB2PROD with BILLS
114 
‘‘(2) DETERMINATION OF ANNUAL MANUFAC-
TURER PRICE.—The annual manufacturer price de-
termined under this paragraph for a dosage form 
and strength, with respect to a part D rebatable 
drug and an applicable year, is the sum of the prod-
ucts of— 
‘‘(A) the average manufacturer price (as 
defined in subsection (h)(6)) of such dosage 
form and strength, as calculated for a unit of 
such drug, with respect to each of the calendar 
quarters of such year; and 
‘‘(B) the ratio of— 
‘‘(i) the total number of units of such 
dosage form and strength dispensed during 
each such calendar quarter of such year; to 
‘‘(ii) the total number of units of such 
dosage form and strength dispensed during 
such year. 
‘‘(3) DETERMINATION OF INFLATION-ADJUSTED 
PAYMENT AMOUNT.—The inflation-adjusted payment 
amount determined under this paragraph for a dos-
age form and strength with respect to a part D 
rebatable drug for an applicable year, subject to sub-
paragraphs (A) and (D) of paragraph (5), is— 
VerDate Sep 11 2014 
20:49 Nov 03, 2021
Jkt 029200
PO 00000
Frm 00114
Fmt 6652
Sfmt 6201
E:\BILLS\H5237.IH
H5237
pamtmann on DSKBC07HB2PROD with BILLS
115 
‘‘(A) the benchmark year manufacturer 
price determined under paragraph (4) for such 
dosage form and strength with respect to such 
drug and an applicable year; increased by 
‘‘(B) the percentage by which the applica-
ble year CPI–U (as defined in subsection 
(h)(5)) for the applicable year exceeds the 
benchmark period CPI–U (as defined in sub-
section (h)(4)). 
‘‘(4) DETERMINATION
OF
BENCHMARK
YEAR 
MANUFACTURER PRICE.—The benchmark year man-
ufacturer price determined under this paragraph for 
a dosage form and strength, with respect to a part 
D rebatable drug and an applicable year, is the sum 
of the products of— 
‘‘(A) the average manufacturer price (as 
defined in subsection (h)(6)) of such dosage 
form and strength, as calculated for a unit of 
such drug, with respect to each of the calendar 
quarters of the payment amount benchmark 
year (as defined in subsection (h)(3)); and 
‘‘(B) the ratio of— 
‘‘(i) the total number of units of such 
dosage form and strength dispensed during 
VerDate Sep 11 2014 
20:49 Nov 03, 2021
Jkt 029200
PO 00000
Frm 00115
Fmt 6652
Sfmt 6201
E:\BILLS\H5237.IH
H5237
pamtmann on DSKBC07HB2PROD with BILLS
116 
each such calendar quarter of such pay-
ment amount benchmark year; to 
‘‘(ii) the total number of units of such 
dosage form and strength dispensed during 
such payment amount benchmark year. 
‘‘(5) SPECIAL TREATMENT OF CERTAIN DRUGS 
AND EXEMPTION.— 
‘‘(A) SUBSEQUENTLY APPROVED DRUGS.— 
In the case of a part D rebatable drug first ap-
proved or licensed by the Food and Drug Ad-
ministration after January 1, 2016, subpara-
graphs (A) and (B) of paragraph (4) shall be 
applied as if the term ‘payment amount bench-
mark year’ were defined under subsection 
(h)(3) as the first calendar year beginning after 
the day on which the drug was first marketed 
by any manufacturer and subparagraph (B) of 
paragraph (3) shall be applied as if the term 
‘benchmark period CPI–U’ were defined under 
subsection (h)(4) as if the reference to ‘January 
2016’ under such subsection were a reference to 
‘January of the first year beginning after the 
date on which the drug was first marketed by 
any manufacturer’. 
VerDate Sep 11 2014 
20:49 Nov 03, 2021
Jkt 029200
PO 00000
Frm 00116
Fmt 6652
Sfmt 6201
E:\BILLS\H5237.IH
H5237
pamtmann on DSKBC07HB2PROD with BILLS
117 
‘‘(B) EXEMPTION FOR SHORTAGES.—The 
Secretary may reduce or waive the rebate under 
paragraph (1) with respect to a part D 
rebatable drug that is described as currently in 
shortage on the shortage list in effect under 
section 506E of the Federal Food, Drug, and 
Cosmetic Act or in the case of other exigent cir-
cumstances, as determined by the Secretary. 
‘‘(C) TREATMENT
OF
NEW
FORMULA-
TIONS.— 
‘‘(i) IN GENERAL.—In the case of a 
part D rebatable drug that is a line exten-
sion of a part D rebatable drug that is an 
oral solid dosage form, the Secretary shall 
establish a formula for determining the 
amount specified in this subsection with 
respect to such part D rebatable drug and 
an applicable year with consideration of 
the original part D rebatable drug. 
‘‘(ii) LINE EXTENSION DEFINED.—In 
this subparagraph, the term ‘line exten-
sion’ means, with respect to a part D 
rebatable drug, a new formulation of the 
drug (as determined by the Secretary), 
such as an extended release formulation, 
VerDate Sep 11 2014 
20:49 Nov 03, 2021
Jkt 029200
PO 00000
Frm 00117
Fmt 6652
Sfmt 6201
E:\BILLS\H5237.IH
H5237
pamtmann on DSKBC07HB2PROD with BILLS
118 
but does not include an abuse-deterrent 
formulation of the drug (as determined by 
the Secretary), regardless of whether such 
abuse-deterrent formulation is an extended 
release formulation. 
‘‘(D) SELECTED DRUGS.—In the case of a 
part D rebatable drug that is a selected drug 
(as defined in section 1192(c)) for a price appli-
cability 
period 
(as 
defined 
in 
section 
1191(b)(2))— 
‘‘(i) for plan years during such period 
for which a maximum fair price (as defined 
in section 1191(c)(2)) for such drug has 
been determined and is applied under part 
E of title XI, the rebate under subsection 
(b)(1)(B) shall be waived; and 
‘‘(ii) in the case such drug is deter-
mined (pursuant to such section 1192(c)) 
to no longer be a selected drug, for each 
applicable year beginning after the price 
applicability period with respect to such 
drug, subparagraphs (A) and (B) of para-
graph (4) shall be applied as if the term 
‘payment amount benchmark year’ were 
defined under subsection (h)(3) as the last 
VerDate Sep 11 2014 
20:49 Nov 03, 2021
Jkt 029200
PO 00000
Frm 00118
Fmt 6652
Sfmt 6201
E:\BILLS\H5237.IH
H5237
pamtmann on DSKBC07HB2PROD with BILLS
119 
year beginning during such price applica-
bility period with respect to such selected 
drug and subparagraph (B) of paragraph 
(3) shall be applied as if the term ‘bench-
mark period CPI–U’ were defined under 
subsection (h)(4) as if the reference to 
‘January 2016’ under such subsection were 
a reference to January of the last year be-
ginning during such price applicability pe-
riod with respect to such drug. 
‘‘(d) REBATE DEPOSITS.—Amounts paid as rebates 
under subsection (c) shall be deposited into the Medicare 
Prescription Drug Account in the Federal Supplementary 
Medical Insurance Trust Fund established under section 
1841. 
‘‘(e) INFORMATION.—For purposes of carrying out 
this section, the Secretary shall use information submitted 
by manufacturers under section 1927(b)(3). 
‘‘(f) CIVIL MONEY PENALTY.—In the case of a man-
ufacturer of a part D rebatable drug with an agreement 
in effect under this section who has failed to comply with 
the terms of the agreement under subsection (b)(1)(B) 
with respect to such drug for an applicable year, the Sec-
retary may impose a civil money penalty on such manufac-
turer in an amount equal to 125 percent of the amount 
VerDate Sep 11 2014 
20:49 Nov 03, 2021
Jkt 029200
PO 00000
Frm 00119
Fmt 6652
Sfmt 6201
E:\BILLS\H5237.IH
H5237
pamtmann on DSKBC07HB2PROD with BILLS
120 
specified in subsection (c) for such drug for such year. 
The provisions of section 1128A (other than subsections 
(a) (with respect to amounts of penalties or additional as-
sessments) and (b)) shall apply to a civil money penalty 
under this subsection in the same manner as such provi-
sions apply to a penalty or proceeding under section 
1128A(a). 
‘‘(g) JUDICIAL REVIEW.—There shall be no judicial 
review of the following: 
‘‘(1) The determination of units under this sec-
tion. 
‘‘(2) The determination of whether a drug is a 
part D rebatable drug under this section. 
‘‘(3) The calculation of the rebate amount 
under this section. 
‘‘(h) DEFINITIONS.—In this section: 
‘‘(1) PART D REBATABLE DRUG DEFINED.— 
‘‘(A) IN
GENERAL.—The term ‘part D 
rebatable drug’ means a drug or biological that 
would (without application of this section) be a 
covered part D drug, except such term shall, 
with respect to an applicable year, not include 
such a drug or biological if the average annual 
total cost under this part for such year per in-
dividual who uses such a drug or biological, as 
VerDate Sep 11 2014 
20:49 Nov 03, 2021
Jkt 029200
PO 00000
Frm 00120
Fmt 6652
Sfmt 6201
E:\BILLS\H5237.IH
H5237
pamtmann on DSKBC07HB2PROD with BILLS
121 
determined by the Secretary, is less than, sub-
ject to subparagraph (B), $100, as determined 
by the Secretary using the most recent data 
available or, if data is not available, as esti-
mated by the Secretary. 
‘‘(B) INCREASE.—The dollar amount ap-
plied under subparagraph (A)— 
‘‘(i) for 2026, shall be the dollar 
amount specified under such subparagraph 
for 2025, increased by the percentage in-
crease in the consumer price index for all 
urban consumers (United States city aver-
age) for the 12-month period beginning 
with January of 2025; and 
‘‘(ii) for a subsequent year, shall be 
the dollar amount specified in this sub-
paragraph for the previous year, increased 
by the percentage increase in the consumer 
price index for all urban consumers 
(United States city average) for the 12- 
month period beginning with January of 
the previous year. 
Any dollar amount specified under this sub-
paragraph that is not a multiple of $10 shall be 
rounded to the nearest multiple of $10. 
VerDate Sep 11 2014 
20:49 Nov 03, 2021
Jkt 029200
PO 00000
Frm 00121
Fmt 6652
Sfmt 6201
E:\BILLS\H5237.IH
H5237
pamtmann on DSKBC07HB2PROD with BILLS
122 
‘‘(2) UNIT DEFINED.—The term ‘unit’ means, 
with respect to a part D rebatable drug, the lowest 
identifiable quantity (such as a capsule or tablet, 
milligram of molecules, or grams) of the part D 
rebatable drug that is dispensed to individuals under 
this part. 
‘‘(3) PAYMENT AMOUNT BENCHMARK YEAR.— 
The term ‘payment amount benchmark year’ means 
the year beginning January 1, 2016. 
‘‘(4) BENCHMARK
PERIOD
CPI–U.—The term 
‘benchmark period CPI–U’ means the consumer 
price index for all urban consumers (United States 
city average) for January 2016. 
‘‘(5) APPLICABLE YEAR CPI–U.—The term ‘ap-
plicable year CPI–U’ means, with respect to an ap-
plicable year, the consumer price index for all urban 
consumers (United States city average) for January 
of such year. 
‘‘(6) AVERAGE
MANUFACTURER
PRICE.—The 
term ‘average manufacturer price’ has the meaning, 
with respect to a part D rebatable drug of a manu-
facturer, given such term in section 1927(k)(1), with 
respect to a covered outpatient drug of a manufac-
turer for a rebate period under section 1927.’’. 
(b) CONFORMING AMENDMENTS.— 
VerDate Sep 11 2014 
20:49 Nov 03, 2021
Jkt 029200
PO 00000
Frm 00122
Fmt 6652
Sfmt 6201
E:\BILLS\H5237.IH
H5237
pamtmann on DSKBC07HB2PROD with BILLS
123 
(1) TO
PART
B
ASP
CALCULATION.—Section 
1847A(c)(3) of the Social Security Act (42 U.S.C. 
1395w–3a(c)(3)), as amended by section 201(c)(1), 
is further amended by striking ‘‘section 1927 or sec-
tion 1834(x)’’ and inserting ‘‘section 1927, section 
1834(x), or section 1860D–14B’’. 
(2) EXCLUDING PART D DRUG INFLATION RE-
BATE
FROM
BEST
PRICE.—Section 
1927(c)(1)(C)(ii)(I) of the Social Security Act (42 
U.S.C. 1396r–8(c)(1)(C)(ii)(I)), as amended by sec-
tion 201(c)(2), is further amended by striking ‘‘or 
section 1834(x)’’ and inserting ‘‘, section 1834(x), or 
section 1860D–14B’’. 
(3) COORDINATION WITH MEDICAID REBATE IN-
FORMATION DISCLOSURE.—Section 1927(b)(3)(D)(i) 
of the Social Security Act (42 U.S.C. 1396r– 
8(b)(3)(D)(i)), as amended by section 201(c)(3), is 
further amended by striking ‘‘or section 1834(x)’’ 
and inserting ‘‘, section 1834(x), or section 1860D– 
14B’’. 
SEC. 227. PROHIBITING BRANDING ON PART D BENEFIT 
CARDS. 
(a) IN GENERAL.—Section 1851(j)(2)(B) of the So-
cial Security Act (42 U.S.C. 1395w–21(j)(2)(B)) is 
amended by striking ‘‘co-branded network provider’’ and 
VerDate Sep 11 2014 
20:49 Nov 03, 2021
Jkt 029200
PO 00000
Frm 00123
Fmt 6652
Sfmt 6201
E:\BILLS\H5237.IH
H5237
pamtmann on DSKBC07HB2PROD with BILLS
124 
inserting ‘‘co-branded, co-owned, or affiliated network pro-
vider, pharmacy, or pharmacy benefit manager’’. 
(b) EFFECTIVE DATE.—The amendment made by 
subsection (a) shall apply to plan years beginning on or 
after January 1, 2025. 
SEC. 228. REQUIRING PRESCRIPTION DRUG PLANS AND 
MA–PD 
PLANS 
TO 
REPORT 
POTENTIAL 
FRAUD, WASTE, AND ABUSE TO THE SEC-
RETARY OF HHS. 
Section 1860D–4 of the Social Security Act (42 
U.S.C. 1395w–104), as amended by section 225, is 
amended by adding at the end the following new sub-
section: 
‘‘(p) REPORTING POTENTIAL FRAUD, WASTE, AND 
ABUSE.—Beginning January 1, 2024, the PDP sponsor 
of a prescription drug plan shall report to the Secretary, 
as specified by the Secretary— 
‘‘(1) any substantiated or suspicious activities 
(as defined by the Secretary) with respect to the 
program under this part as it relates to fraud, 
waste, and abuse; and 
‘‘(2) any steps made by the PDP sponsor after 
identifying such activities to take corrective ac-
tions.’’. 
VerDate Sep 11 2014 
20:49 Nov 03, 2021
Jkt 029200
PO 00000
Frm 00124
Fmt 6652
Sfmt 6201
E:\BILLS\H5237.IH
H5237
pamtmann on DSKBC07HB2PROD with BILLS
125 
SEC. 229. ESTABLISHMENT OF PHARMACY QUALITY MEAS-
URES UNDER MEDICARE PART D. 
Section 1860D–4(c) of the Social Security Act (42 
U.S.C. 1395w–104(c)), as amended by section 226, is 
amended by adding at the end the following new para-
graph: 
‘‘(8) APPLICATION
OF
PHARMACY
QUALITY 
MEASURES.— 
‘‘(A) IN GENERAL.—A PDP sponsor that 
implements incentive payments to a pharmacy 
or price concessions paid by a pharmacy based 
on quality measures shall use measures estab-
lished or approved by the Secretary under sub-
paragraph (B) with respect to payment for cov-
ered part D drugs dispensed by such pharmacy. 
‘‘(B) 
STANDARD
PHARMACY
QUALITY 
MEASURES.—The Secretary shall establish or 
approve standard quality measures from a con-
sensus and evidence-based organization for pay-
ments described in subparagraph (A). Such 
measures shall focus on patient health outcomes 
and be based on proven criteria measuring 
pharmacy performance. 
‘‘(C) EFFECTIVE DATE.—The requirement 
under subparagraph (A) shall take effect for 
plan years beginning on or after January 1, 
VerDate Sep 11 2014 
20:49 Nov 03, 2021
Jkt 029200
PO 00000
Frm 00125
Fmt 6652
Sfmt 6201
E:\BILLS\H5237.IH
H5237
pamtmann on DSKBC07HB2PROD with BILLS
126 
2026, or such earlier date specified by the Sec-
retary if the Secretary determines there are suf-
ficient measures established or approved under 
subparagraph (B) to meet the requirement 
under subparagraph (A).’’. 
SEC. 230. ADDITION OF NEW MEASURES BASED ON ACCESS 
TO BIOSIMILAR BIOLOGICAL PRODUCTS TO 
THE 5-STAR RATING SYSTEM UNDER MEDI-
CARE ADVANTAGE. 
(a) IN GENERAL.—Section 1853(o)(4) of the Social 
Security Act (42 U.S.C. 1395w–23(o)(4)) is amended by 
adding at the end the following new subparagraph: 
‘‘(E) ADDITION OF NEW MEASURES BASED 
ON ACCESS TO BIOSIMILAR BIOLOGICAL PROD-
UCTS.— 
‘‘(i) IN
GENERAL.—For 2028 and 
subsequent years, the Secretary shall add a 
new set of measures to the 5-star rating 
system based on access to biosimilar bio-
logical products covered under part B and, 
in the case of MA–PD plans, such prod-
ucts that are covered part D drugs. Such 
measures shall assess the impact a plan’s 
benefit structure may have on enrollees’ 
utilization of or ability to access biosimilar 
VerDate Sep 11 2014 
20:49 Nov 03, 2021
Jkt 029200
PO 00000
Frm 00126
Fmt 6652
Sfmt 6201
E:\BILLS\H5237.IH
H5237
pamtmann on DSKBC07HB2PROD with BILLS
127 
biological products, including in compari-
son to the reference biological product, and 
shall include measures, as applicable, with 
respect to the following: 
‘‘(I) 
COVERAGE.—Assessing 
whether a biosimilar biological prod-
uct is on the plan formulary in lieu of 
or in addition to the reference biologi-
cal product. 
‘‘(II) 
PREFERENCING.—Assess-
ing tier placement or cost-sharing for 
a biosimilar biological product relative 
to the reference biological product. 
‘‘(III) 
UTILIZATION
MANAGE-
MENT TOOLS.—Assessing whether and 
how utilization management tools are 
used with respect to a biosimilar bio-
logical product relative to the ref-
erence biological product. 
‘‘(IV) 
UTILIZATION.—Assessing 
the percentage of enrollees prescribed 
the biosimilar biological product and 
the percentage of enrollees prescribed 
the reference biological product when 
VerDate Sep 11 2014 
20:49 Nov 03, 2021
Jkt 029200
PO 00000
Frm 00127
Fmt 6652
Sfmt 6201
E:\BILLS\H5237.IH
H5237
pamtmann on DSKBC07HB2PROD with BILLS
128 
the reference biological product is also 
on the plan formulary. 
‘‘(ii) DEFINITIONS.—In this subpara-
graph, the terms ‘biosimilar biological 
product’ and ‘reference biological product’ 
have the meaning given those terms in sec-
tion 1847A(c)(6). 
‘‘(iii) PROTECTING
PATIENT
INTER-
ESTS.—In developing such measures, the 
Secretary shall ensure that each measure 
developed 
to 
address 
coverage, 
preferencing, or utilization management is 
constructed such that patients retain ac-
cess to appropriate therapeutic options 
without undue administrative burden.’’. 
(b) CLARIFICATION REGARDING APPLICATION
TO 
PRESCRIPTION DRUG PLANS.—To the extent the Sec-
retary of Health and Human Services applies the 5-star 
rating system under section 1853(o)(4) of the Social Secu-
rity Act (42 U.S.C. 1395w–23(o)(4)), or a similar system, 
to prescription drug plans under part D of title XVIII of 
such Act, the provisions of subparagraph (E) of such sec-
tion, as added by subsection (a) of this section, shall apply 
under the system with respect to such plans in the same 
VerDate Sep 11 2014 
20:49 Nov 03, 2021
Jkt 029200
PO 00000
Frm 00128
Fmt 6652
Sfmt 6201
E:\BILLS\H5237.IH
H5237
pamtmann on DSKBC07HB2PROD with BILLS
129 
manner as such provisions apply to the 5-star rating sys-
tem under such section 1853(o)(4). 
SEC. 231. HHS STUDY AND REPORT ON THE INFLUENCE OF 
PHARMACEUTICAL MANUFACTURER THIRD- 
PARTY REIMBURSEMENT HUBS ON HEALTH 
CARE PROVIDERS WHO PRESCRIBE THEIR 
DRUGS AND BIOLOGICALS. 
(a) STUDY.— 
(1) IN GENERAL.—The Secretary of Health and 
Human Services (in this section referred to as the 
‘‘Secretary’’) shall conduct a study on the influence 
of pharmaceutical manufacturer distribution models 
that provide third-party reimbursement hub services 
on health care providers who prescribe the manufac-
turer’s drugs and biologicals, including for Medicare 
part D beneficiaries. 
(2) REQUIREMENTS.—The study under para-
graph (1) shall include an analysis of the following: 
(A) The influence of pharmaceutical manu-
facturer distribution models that provide third- 
party reimbursement hub services to health care 
providers who prescribe the manufacturer’s 
drugs and biologicals, including— 
(i) the operations of pharmaceutical 
manufacturer distribution models that pro-
VerDate Sep 11 2014 
20:49 Nov 03, 2021
Jkt 029200
PO 00000
Frm 00129
Fmt 6652
Sfmt 6201
E:\BILLS\H5237.IH
H5237
pamtmann on DSKBC07HB2PROD with BILLS
130 
vide reimbursement hub services for health 
care providers who prescribe the manufac-
turer’s products; 
(ii) Federal laws affecting these phar-
maceutical manufacturer distribution mod-
els; and 
(iii) whether hub services could im-
properly incentivize health care providers 
to deem a drug or biological as medically 
necessary under section 423.578 of title 
42, Code of Federal Regulations. 
(B) Other areas determined appropriate by 
the Secretary. 
(b) REPORT.—Not later than January 1, 2024, the 
Secretary shall submit to Congress a report on the study 
conducted under subsection (a), together with rec-
ommendations for such legislation and administrative ac-
tion as the Secretary determines appropriate. 
(c) CONSULTATION.—In conducting the study under 
subsection (a) and preparing the report under subsection 
(b), the Secretary shall consult with the Attorney General. 
VerDate Sep 11 2014 
20:49 Nov 03, 2021
Jkt 029200
PO 00000
Frm 00130
Fmt 6652
Sfmt 6201
E:\BILLS\H5237.IH
H5237
pamtmann on DSKBC07HB2PROD with BILLS
131 
SEC. 232. DEFINITION OF STRENGTH FOR THE PURPOSES 
OF DETERMINING INTERCHANGEABILITY OF 
BIOLOGICAL AND BIOSIMILAR PRODUCTS. 
(a) Section 351(i) of the Public Health Service Act 
is amended by inserting the following after paragraph (4): 
‘‘(5) The term ‘strength’, in reference to a bio-
logical product intended for administration by injec-
tion, means the total content of drug substance in 
the dosage form without regard to the concentration 
of drug substance or total volume of the biological 
product.’’. 
(b) Section 351(k)(7)(C)(ii)(I) of the Public Health 
Service Act is amended by inserting ‘‘concentration,’’ after 
‘‘delivery device,’’. 
Subtitle C—Miscellaneous 
SEC. 233. DRUG MANUFACTURER PRICE TRANSPARENCY. 
Title XI of the Social Security Act (42 U.S.C. 1301 
et seq.) is amended by inserting after section 1128K the 
following new section: 
‘‘SEC. 
1128L. 
DRUG 
MANUFACTURER 
PRICE 
TRANS-
PARENCY. 
‘‘(a) IN GENERAL.— 
‘‘(1) DETERMINATIONS.—Beginning July 1, 
2025, the Secretary shall make determinations as to 
whether a drug is an applicable drug as described in 
subsection (b). 
VerDate Sep 11 2014 
20:49 Nov 03, 2021
Jkt 029200
PO 00000
Frm 00131
Fmt 6652
Sfmt 6201
E:\BILLS\H5237.IH
H5237
pamtmann on DSKBC07HB2PROD with BILLS
132 
‘‘(2) REQUIRED
JUSTIFICATION.—If the Sec-
retary determines under paragraph (1) that an ap-
plicable drug is described in subsection (b), the man-
ufacturer of the applicable drug shall submit to the 
Secretary the justification described in subsection (c) 
in accordance with the timing described in sub-
section (d). 
‘‘(b) APPLICABLE DRUG DESCRIBED.— 
‘‘(1) IN GENERAL.—An applicable drug is de-
scribed in this subsection if it meets any of the fol-
lowing at the time of the determination: 
‘‘(A) LARGE
INCREASE.—The drug (per 
dose)— 
‘‘(i) has a wholesale acquisition cost of 
at least $10; and 
‘‘(ii) had an increase in the wholesale 
acquisition cost, with respect to determina-
tions made— 
‘‘(I) during 2023, of at least 100 
percent since the date of the enact-
ment of this section; 
‘‘(II) during 2024, of at least 
100 percent in the preceding 12 
months or of at least 150 percent in 
the preceding 24 months; 
VerDate Sep 11 2014 
20:49 Nov 03, 2021
Jkt 029200
PO 00000
Frm 00132
Fmt 6652
Sfmt 6201
E:\BILLS\H5237.IH
H5237
pamtmann on DSKBC07HB2PROD with BILLS
133 
‘‘(III) during 2025, of at least 
100 percent in the preceding 12 
months or of at least 200 percent in 
the preceding 36 months; 
‘‘(IV) during 2026, of at least 
100 percent in the preceding 12 
months or of at least 250 percent in 
the preceding 48 months; or 
‘‘(V) on or after January 1, 
2027, of at least 100 percent in the 
preceding 12 months or of at least 
300 percent in the preceding 60 
months. 
‘‘(B) HIGH SPENDING WITH INCREASE.— 
The drug— 
‘‘(i) was in the top 50th percentile of 
net spending under title XVIII or XIX (to 
the extent data is available) during any 12- 
month period in the preceding 60 months; 
and 
‘‘(ii) per dose, had an increase in the 
wholesale acquisition cost, with respect to 
determinations made— 
VerDate Sep 11 2014 
20:49 Nov 03, 2021
Jkt 029200
PO 00000
Frm 00133
Fmt 6652
Sfmt 6201
E:\BILLS\H5237.IH
H5237
pamtmann on DSKBC07HB2PROD with BILLS
134 
‘‘(I) during 2023, of at least 15 
percent since the date of the enact-
ment of this section; 
‘‘(II) during 2024, of at least 15 
percent in the preceding 12 months or 
of at least 20 percent in the preceding 
24 months; 
‘‘(III) during 2025, of at least 15 
percent in the preceding 12 months or 
of at least 30 percent in the preceding 
36 months; 
‘‘(IV) during 2026, of at least 15 
percent in the preceding 12 months or 
of at least 40 percent in the preceding 
48 months; or 
‘‘(V) on or after January 1, 
2027, of at least 15 percent in the 
preceding 12 months or of at least 50 
percent in the preceding 60 months. 
‘‘(C) HIGH
LAUNCH
PRICE
FOR
NEW 
DRUGS.—In the case of a drug that is marketed 
for the first time on or after January 1, 2023, 
and for which the manufacturer has established 
the first wholesale acquisition cost on or after 
such date, such wholesale acquisition cost for a 
VerDate Sep 11 2014 
20:49 Nov 03, 2021
Jkt 029200
PO 00000
Frm 00134
Fmt 6652
Sfmt 6201
E:\BILLS\H5237.IH
H5237
pamtmann on DSKBC07HB2PROD with BILLS
135 
year’s supply or a course of treatment for such 
drug exceeds the gross spending for covered 
part D drugs at which the annual out-of-pocket 
threshold 
under 
section 
1860D–2(b)(4)(B) 
would be met for the year. 
‘‘(2) SPECIAL RULES.— 
‘‘(A) AUTHORITY OF SECRETARY TO SUB-
STITUTE PERCENTAGES WITHIN A DE MINIMIS 
RANGE.—For purposes of applying paragraph 
(1), the Secretary may substitute for each per-
centage described in subparagraph (A) or (B) 
of such paragraph (other than the percentile de-
scribed subparagraph (B)(i) of such paragraph) 
a percentage within a de minimis range speci-
fied by the Secretary below the percentage so 
described. 
‘‘(B) DRUGS WITH HIGH LAUNCH PRICES 
ANNUALLY
REPORT
UNTIL
A
THERAPEUTIC 
EQUIVALENT IS AVAILABLE.—In the case of a 
drug that the Secretary determines is an appli-
cable drug described in subparagraph (C) of 
paragraph (1), such drug shall remain de-
scribed in such subparagraph (C) (and the 
manufacturer of such drug shall annually re-
port the justification under subsection (c)(2)) 
VerDate Sep 11 2014 
20:49 Nov 03, 2021
Jkt 029200
PO 00000
Frm 00135
Fmt 6652
Sfmt 6201
E:\BILLS\H5237.IH
H5237
pamtmann on DSKBC07HB2PROD with BILLS
136 
until the Secretary determines that there is a 
therapeutic equivalent (as defined in section 
314.3 of title 21, Code of Federal Regulations, 
or any successor regulation) for such drug. 
‘‘(3) DOSE.—For purposes of applying para-
graph (1), the Secretary shall establish a definition 
of the term ‘dose’. 
‘‘(c) JUSTIFICATION DESCRIBED.— 
‘‘(1) INCREASE IN WAC.—In the case of a drug 
that the Secretary determines is an applicable drug 
described in subparagraph (A) or (B) of subsection 
(b)(1), the justification described in this subsection 
is all relevant, truthful, and nonmisleading informa-
tion and supporting documentation necessary to jus-
tify the increase in the wholesale acquisition cost of 
the applicable drug of the manufacturer, as deter-
mined appropriate by the Secretary and which may 
include the following: 
‘‘(A) The individual factors that have con-
tributed to the increase in the wholesale acqui-
sition cost. 
‘‘(B) An explanation of the role of each 
factor in contributing to such increase. 
‘‘(C) Total expenditures of the manufac-
turer on— 
VerDate Sep 11 2014 
20:49 Nov 03, 2021
Jkt 029200
PO 00000
Frm 00136
Fmt 6652
Sfmt 6201
E:\BILLS\H5237.IH
H5237
pamtmann on DSKBC07HB2PROD with BILLS
137 
‘‘(i) materials and manufacturing for 
such drug; 
‘‘(ii) acquiring patents and licensing 
for each drug of the manufacturer; and 
‘‘(iii) costs to purchase or acquire the 
drug from another company, if applicable. 
‘‘(D) The percentage of total expenditures 
of the manufacturer on research and develop-
ment for such drug that was derived from Fed-
eral funds. 
‘‘(E) The total expenditures of the manu-
facturer on research and development for such 
drug. 
‘‘(F) The total revenue and net profit gen-
erated from the applicable drug for each cal-
endar year since drug approval. 
‘‘(G) The total expenditures of the manu-
facturer that are associated with marketing and 
advertising for the applicable drug. 
‘‘(H) Additional information specific to the 
manufacturer of the applicable drug, such as— 
‘‘(i) the total revenue and net profit of 
the manufacturer for the period of such in-
crease, as determined by the Secretary; 
VerDate Sep 11 2014 
20:49 Nov 03, 2021
Jkt 029200
PO 00000
Frm 00137
Fmt 6652
Sfmt 6201
E:\BILLS\H5237.IH
H5237
pamtmann on DSKBC07HB2PROD with BILLS
138 
‘‘(ii) metrics used to determine execu-
tive compensation; and 
‘‘(iii) any additional information re-
lated to drug pricing decisions of the man-
ufacturer, such as total expenditures on— 
‘‘(I) drug research and develop-
ment; or 
‘‘(II) clinical trials on drugs that 
failed to receive approval by the Food 
and Drug Administration. 
‘‘(2) HIGH LAUNCH PRICE.—In the case of a 
drug that the Secretary determines is an applicable 
drug described in subparagraph (C) of subsection 
(b)(1), the justification described in this subsection 
is all relevant, truthful, and nonmisleading informa-
tion and supporting documentation necessary to jus-
tify the wholesale acquisition cost of the applicable 
drug of the manufacturer, as determined by the Sec-
retary and which may include the items described in 
subparagraph (C) through (H) of paragraph (1). 
‘‘(d) TIMING.— 
‘‘(1) NOTIFICATION.—Not later than 60 days 
after the date on which the Secretary makes the de-
termination that a drug is an applicable drug under 
subsection (b), the Secretary shall notify the manu-
VerDate Sep 11 2014 
20:49 Nov 03, 2021
Jkt 029200
PO 00000
Frm 00138
Fmt 6652
Sfmt 6201
E:\BILLS\H5237.IH
H5237
pamtmann on DSKBC07HB2PROD with BILLS
139 
facturer of the applicable drug of such determina-
tion. 
‘‘(2) SUBMISSION
OF
JUSTIFICATION.—Not 
later than 180 days after the date on which a manu-
facturer receives a notification under paragraph (1), 
the manufacturer shall submit to the Secretary the 
justification required under subsection (a). 
‘‘(3) POSTING ON INTERNET WEBSITE.— 
‘‘(A) IN
GENERAL.—Subject to subpara-
graph (B), not later than 30 days after receiv-
ing the justification under paragraph (2), the 
Secretary shall post on the Internet website of 
the Centers for Medicare & Medicaid Services 
the justification, together with a summary of 
such justification that is written and formatted 
using language that is easily understandable by 
beneficiaries under titles XVIII and XIX. 
‘‘(B) EXCLUSION OF PROPRIETARY INFOR-
MATION.—The Secretary shall exclude propri-
etary information, such as trade secrets and in-
tellectual property, submitted by the manufac-
turer in the justification under paragraph (2) 
from the posting described in subparagraph 
(A). 
VerDate Sep 11 2014 
20:49 Nov 03, 2021
Jkt 029200
PO 00000
Frm 00139
Fmt 6652
Sfmt 6201
E:\BILLS\H5237.IH
H5237
pamtmann on DSKBC07HB2PROD with BILLS
140 
‘‘(e) EXCEPTION
TO REQUIREMENT
FOR SUBMIS-
SION.—In the case of a drug that the Secretary deter-
mines is an applicable drug described in subparagraph (A) 
or (B) of subsection (b)(1), the requirement to submit a 
justification under subsection (a) shall not apply where the 
manufacturer, after receiving the notification under sub-
section (d)(1) with respect to the applicable drug of the 
manufacturer, reduces the wholesale acquisition cost of a 
drug so that it no longer is described in such subpara-
graph (A) or (B) for at least a 4-month period, as deter-
mined by the Secretary. 
‘‘(f) PENALTIES.— 
‘‘(1) FAILURE TO SUBMIT TIMELY JUSTIFICA-
TION.—If the Secretary determines that a manufac-
turer has failed to submit a justification as required 
under this section, including in accordance with the 
timing and form required, with respect to an appli-
cable drug, the Secretary shall apply a civil mone-
tary penalty in an amount of $10,000 for each day 
the manufacturer has failed to submit such justifica-
tion as so required. 
‘‘(2) FALSE INFORMATION.—Any manufacturer 
that submits a justification under this section and 
knowingly provides false information in such jus-
tification is subject to a civil monetary penalty in an 
VerDate Sep 11 2014 
20:49 Nov 03, 2021
Jkt 029200
PO 00000
Frm 00140
Fmt 6652
Sfmt 6201
E:\BILLS\H5237.IH
H5237
pamtmann on DSKBC07HB2PROD with BILLS
141 
amount not to exceed $100,000 for each item of 
false information. 
‘‘(3) APPLICATION OF PROCEDURES.—The pro-
visions of section 1128A (other than subsections (a) 
and (b)) shall apply to a civil monetary penalty 
under this subsection in the same manner as such 
provisions apply to a penalty or proceeding under 
section 1128A(a). Civil monetary penalties imposed 
under this subsection are in addition to other pen-
alties as may be prescribed by law. 
‘‘(g) DEFINITIONS.—In this section: 
‘‘(1) DRUG.—The term ‘drug’ means a drug, as 
defined in section 201(g) of the Federal Food, Drug, 
and Cosmetic Act, that is intended for human use 
and subject to section 503(b)(1) of such Act, includ-
ing a product licensed under section 351 of the Pub-
lic Health Service Act. 
‘‘(2) MANUFACTURER.—The term ‘manufac-
turer’ has the meaning given that term in section 
1847A(c)(6)(A). 
‘‘(3) WHOLESALE
ACQUISITION
COST.—The 
term ‘wholesale acquisition cost’ has the meaning 
given that term in section 1847A(c)(6)(B).’’. 
VerDate Sep 11 2014 
20:49 Nov 03, 2021
Jkt 029200
PO 00000
Frm 00141
Fmt 6652
Sfmt 6201
E:\BILLS\H5237.IH
H5237
pamtmann on DSKBC07HB2PROD with BILLS
142 
SEC. 234. STRENGTHENING AND EXPANDING PHARMACY 
BENEFIT 
MANAGERS 
TRANSPARENCY 
RE-
QUIREMENTS. 
Section 1150A of the Social Security Act (42 U.S.C. 
1320b–23), as amended by section 223, is amended— 
(1) in subsection (a)— 
(A) in paragraph (1), by striking ‘‘or’’ at 
then end; 
(B) in paragraph (2), by striking the 
comma at the end and inserting ‘‘; or’’; and 
(C) by inserting after paragraph (2) the 
following new paragraph: 
‘‘(3) a State plan under title XIX, including a 
managed 
care 
entity 
(as 
defined 
in 
section 
1932(a)(1)(B)),’’; 
(2) in subsection (b)— 
(A) in paragraph (2)— 
(i) by striking ‘‘(excluding bona fide’’ 
and all that follows through ‘‘patient edu-
cation programs))’’; and 
(ii) by striking ‘‘aggregate amount of’’ 
and inserting ‘‘aggregate amount and per-
centage of’’; 
(B) in paragraph (3), by striking ‘‘aggre-
gate amount of’’ and inserting ‘‘aggregate 
VerDate Sep 11 2014 
20:49 Nov 03, 2021
Jkt 029200
PO 00000
Frm 00142
Fmt 6652
Sfmt 6201
E:\BILLS\H5237.IH
H5237
pamtmann on DSKBC07HB2PROD with BILLS
143 
amount and percentage (defined as a share of 
gross drug costs) of’’; and 
(C) by adding at the end the following new 
paragraph: 
‘‘(4) The aggregate amount of bona fide service 
fees (which include distribution service fees, inven-
tory management fees, product stocking allowances, 
and fees associated with administrative services 
agreements and patient care programs (such as 
medication compliance programs and patient edu-
cation programs)) the PBM received from— 
‘‘(A) PDP sponsors; 
‘‘(B) qualified health benefit plans; 
‘‘(C) managed care entities (as defined in 
section 1932(a)(1)(b)); and 
‘‘(D) drug manufacturers.’’; 
(3) in subsection (c), by adding at the end the 
following new paragraphs: 
‘‘(5) To States to carry out their administration 
and oversight of the State plan under title XIX. 
‘‘(6) To the Federal Trade Commission to carry 
out section 5(a) of the Federal Trade Commission 
Act (15 U.S.C. 45a) and any other relevant con-
sumer protection or antitrust authorities enforced by 
VerDate Sep 11 2014 
20:49 Nov 03, 2021
Jkt 029200
PO 00000
Frm 00143
Fmt 6652
Sfmt 6201
E:\BILLS\H5237.IH
H5237
pamtmann on DSKBC07HB2PROD with BILLS
144 
such Commission, including reviewing proposed 
mergers in the prescription drug sector. 
‘‘(7) To assist the Department of Justice to 
carry out its antitrust authorities, including review-
ing proposed mergers in the prescription drug sec-
tor.’’; and 
(4) by adding at the end the following new sub-
section: 
‘‘(f) ANNUAL OIG EVALUATION AND REPORT.— 
‘‘(1) ANALYSIS.—The Inspector General of the 
Department of Health and Human Services shall 
conduct an annual evaluation of the information pro-
vided to the Secretary under this section. Such eval-
uation shall include an analysis of— 
‘‘(A) PBM rebates; 
‘‘(B) administrative fees; 
‘‘(C) the difference between what plans pay 
PBMs and what PBMs pay pharmacies; 
‘‘(D) generic dispensing rates; and 
‘‘(E) other areas determined appropriate 
by the Inspector General. 
‘‘(2) REPORT.—Not later than July 1, 2023, 
and annually thereafter, the Inspector General of the 
Department of Health and Human Services shall 
submit to Congress a report containing the results 
VerDate Sep 11 2014 
20:49 Nov 03, 2021
Jkt 029200
PO 00000
Frm 00144
Fmt 6652
Sfmt 6201
E:\BILLS\H5237.IH
H5237
pamtmann on DSKBC07HB2PROD with BILLS
145 
of the evaluation conducted under paragraph (1), to-
gether with recommendations for such legislation 
and administrative action as the Inspector General 
determines appropriate. Such report shall not dis-
close the identity of a specific PBM, plan, or price 
charged for a drug.’’. 
SEC. 235. PRESCRIPTION DRUG PRICING DASHBOARDS. 
Part A of title XI of the Social Security Act is 
amended by adding at the end the following new section: 
‘‘SEC. 1150C. PRESCRIPTION DRUG PRICING DASHBOARDS. 
‘‘(a) IN GENERAL.—Beginning not later than Janu-
ary 1, 2023, the Secretary shall establish, and annually 
update, internet website-based dashboards, through which 
beneficiaries, clinicians, researchers, and the public can re-
view information on spending for, and utilization of, pre-
scription drugs and biologicals (and related supplies and 
mechanisms of delivery) covered under each of parts B 
and D of title XVIII and under a State program under 
title XIX, including information on trends of such spend-
ing and utilization over time. 
‘‘(b) MEDICARE PART B DRUG AND BIOLOGICAL 
DASHBOARD.— 
‘‘(1) IN GENERAL.—The dashboard established 
under subsection (a) for part B of title XVIII shall 
provide the information described in paragraph (2). 
VerDate Sep 11 2014 
20:49 Nov 03, 2021
Jkt 029200
PO 00000
Frm 00145
Fmt 6652
Sfmt 6201
E:\BILLS\H5237.IH
H5237
pamtmann on DSKBC07HB2PROD with BILLS
146 
‘‘(2) INFORMATION DESCRIBED.—The informa-
tion described in this paragraph is the following in-
formation with respect to drug or biologicals covered 
under such part B: 
‘‘(A) The brand name and, if applicable, 
the generic names of the drug or biological. 
‘‘(B) Consumer-friendly information on the 
uses and clinical indications of the drug or bio-
logical. 
‘‘(C) The manufacturer or labeler of the 
drug or biological. 
‘‘(D) To the extent feasible, the following 
information: 
‘‘(i) Average total spending per dos-
age unit of the drug or biological in the 
most recent 2 calendar years for which 
data is available. 
‘‘(ii) The percentage change in aver-
age spending on the drug or biological per 
dosage unit between the most recent cal-
endar year for which data is available 
and— 
‘‘(I) the preceding calendar year; 
and 
VerDate Sep 11 2014 
20:49 Nov 03, 2021
Jkt 029200
PO 00000
Frm 00146
Fmt 6652
Sfmt 6201
E:\BILLS\H5237.IH
H5237
pamtmann on DSKBC07HB2PROD with BILLS
147 
‘‘(II) the preceding 5 and 10 cal-
endar years. 
‘‘(iii) The annual growth rate in aver-
age spending per dosage unit of the drug 
or biological in the most recent 5 or 10 
calendar years for which data is available. 
‘‘(iv) Total spending for the drug or 
biological for the most recent calendar year 
for which data is available. 
‘‘(v) The number of beneficiaries re-
ceiving the drug or biological in the most 
recent calendar year for which data is 
available. 
‘‘(vi) Average spending on the drug 
per beneficiary for the most recent cal-
endar year for which data is available. 
‘‘(E) The average sales price of the drug 
or biological (as determined under section 
1847A) for the most recent quarter. 
‘‘(F) Consumer-friendly information about 
the coinsurance amount for the drug or biologi-
cal for beneficiaries for the most recent quarter. 
Such information shall not include coinsurance 
amounts for qualified medicare beneficiaries (as 
defined in section 1905(p)(1)). 
VerDate Sep 11 2014 
20:49 Nov 03, 2021
Jkt 029200
PO 00000
Frm 00147
Fmt 6652
Sfmt 6201
E:\BILLS\H5237.IH
H5237
pamtmann on DSKBC07HB2PROD with BILLS
148 
‘‘(G) For the most recent calendar year for 
which data is available— 
‘‘(i) the 15 drugs and biologicals with 
the highest total spending under such part; 
and 
‘‘(ii) any drug or biological for which 
the average annual per beneficiary spend-
ing exceeds the gross spending for covered 
part D drugs at which the annual out-of- 
pocket threshold under section 1860D– 
2(b)(4)(B) would be met for the year. 
‘‘(H) Other information (not otherwise 
prohibited in law from being disclosed) that the 
Secretary determines would provide bene-
ficiaries, clinicians, researchers, and the public 
with helpful information about drug and bio-
logical spending and utilization (including 
trends of such spending and utilization). 
‘‘(c) MEDICARE COVERED PART D DRUG DASH-
BOARD.— 
‘‘(1) IN GENERAL.—The dashboard established 
under subsection (a) for part D of title XVIII shall 
provide the information described in paragraph (2). 
‘‘(2) INFORMATION DESCRIBED.—The informa-
tion described in this paragraph is the following in-
VerDate Sep 11 2014 
20:49 Nov 03, 2021
Jkt 029200
PO 00000
Frm 00148
Fmt 6652
Sfmt 6201
E:\BILLS\H5237.IH
H5237
pamtmann on DSKBC07HB2PROD with BILLS
149 
formation with respect to covered part D drugs 
under such part D: 
‘‘(A) The information described in sub-
paragraphs (A) through (D) of subsection 
(b)(2). 
‘‘(B) Information on average annual bene-
ficiary out-of-pocket costs below and above the 
annual out-of-pocket threshold under section 
1860D–2(b)(4)(B) for the current plan year. 
Such information shall not include out-of-pocket 
costs for subsidy eligible individuals under sec-
tion 1860D–14. 
‘‘(C) Information on how to access re-
sources as described in sections 1860D–1(c) 
and 1851(d). 
‘‘(D) For the most recent calendar year for 
which data is available— 
‘‘(i) the 15 covered part D drugs with 
the highest total spending under such part; 
and 
‘‘(ii) any covered part D drug for 
which the average annual per beneficiary 
spending exceeds the gross spending for 
covered part D drugs at which the annual 
out-of-pocket 
threshold 
under 
section 
VerDate Sep 11 2014 
20:49 Nov 03, 2021
Jkt 029200
PO 00000
Frm 00149
Fmt 6652
Sfmt 6201
E:\BILLS\H5237.IH
H5237
pamtmann on DSKBC07HB2PROD with BILLS
150 
1860D–2(b)(4)(B) would be met for the 
year. 
‘‘(E) Other information (not otherwise pro-
hibited in law from being disclosed) that the 
Secretary determines would provide bene-
ficiaries, clinicians, researchers, and the public 
with helpful information about covered part D 
drug spending and utilization (including trends 
of such spending and utilization). 
‘‘(d) MEDICAID COVERED OUTPATIENT DRUG DASH-
BOARD.— 
‘‘(1) IN GENERAL.—The dashboard established 
under subsection (a) for title XIX shall provide the 
information described in paragraph (2). 
‘‘(2) INFORMATION DESCRIBED.—The informa-
tion described in this paragraph is the following in-
formation with respect to covered outpatient drugs 
under such title: 
‘‘(A) The information described in sub-
paragraphs (A) through (D) of subsection 
(b)(2). 
‘‘(B) For the most recent calendar year for 
which data is available, the 15 covered out-
patient drugs with the highest total spending 
under such title. 
VerDate Sep 11 2014 
20:49 Nov 03, 2021
Jkt 029200
PO 00000
Frm 00150
Fmt 6652
Sfmt 6201
E:\BILLS\H5237.IH
H5237
pamtmann on DSKBC07HB2PROD with BILLS
151 
‘‘(C) Other information (not otherwise pro-
hibited in law from being disclosed) that the 
Secretary determines would provide bene-
ficiaries, clinicians, researchers, and the public 
with helpful information about covered out-
patient drug spending and utilization (including 
trends of such spending and utilization). 
‘‘(e) DATA FILES.—The Secretary shall make avail-
able the underlying data for each dashboard established 
under subsection (a) in a machine-readable format.’’. 
SEC. 236. IMPROVING COORDINATION BETWEEN THE FOOD 
AND DRUG ADMINISTRATION AND THE CEN-
TERS FOR MEDICARE & MEDICAID SERVICES. 
(a) IN GENERAL.— 
(1) PUBLIC MEETING.— 
(A) IN
GENERAL.—Not later than 12 
months after the date of the enactment of this 
Act, the Secretary of Health and Human Serv-
ices (referred to in this section as the ‘‘Sec-
retary’’) shall convene a public meeting for the 
purposes of discussing and providing input on 
improvements to coordination between the Food 
and Drug Administration and the Centers for 
Medicare & Medicaid Services in preparing for 
the availability of novel medical products de-
VerDate Sep 11 2014 
20:49 Nov 03, 2021
Jkt 029200
PO 00000
Frm 00151
Fmt 6652
Sfmt 6201
E:\BILLS\H5237.IH
H5237
pamtmann on DSKBC07HB2PROD with BILLS
152 
scribed in subsection (c) on the market in the 
United States. 
(B) ATTENDEES.—The public meeting 
shall include— 
(i) representatives of relevant Federal 
agencies, including representatives from 
each of the medical product centers within 
the Food and Drug Administration and 
representatives from the coding, coverage, 
and payment offices within the Centers for 
Medicare & Medicaid Services; 
(ii) stakeholders with expertise in the 
research and development of novel medical 
products, including manufacturers of such 
products; 
(iii) representatives of commercial 
health insurance payers; 
(iv) stakeholders with expertise in the 
administration and use of novel medical 
products, including physicians; and 
(v) stakeholders representing patients 
and with expertise in the utilization of pa-
tient experience data in medical product 
development. 
VerDate Sep 11 2014 
20:49 Nov 03, 2021
Jkt 029200
PO 00000
Frm 00152
Fmt 6652
Sfmt 6201
E:\BILLS\H5237.IH
H5237
pamtmann on DSKBC07HB2PROD with BILLS
153 
(C) TOPICS.—The public meeting shall in-
clude a discussion of— 
(i) the status of the drug and medical 
device development pipeline related to the 
availability of novel medical products; 
(ii) the anticipated expertise necessary 
to review the safety and effectiveness of 
such products at the Food and Drug Ad-
ministration and current gaps in such ex-
pertise, if any; 
(iii) the expertise necessary to make 
coding, coverage, and payment decisions 
with respect to such products within the 
Centers for Medicare & Medicaid Services, 
and current gaps in such expertise, if any; 
(iv) trends in the differences in the 
data necessary to determine the safety and 
effectiveness of a novel medical product 
and the data necessary to determine 
whether a novel medical product meets the 
reasonable and necessary requirements for 
coverage and payment under title XVIII of 
the Social Security Act pursuant to section 
1862(a)(1)(A) of such Act (42 U.S.C. 
1395y(a)(1)(A)); 
VerDate Sep 11 2014 
20:49 Nov 03, 2021
Jkt 029200
PO 00000
Frm 00153
Fmt 6652
Sfmt 6201
E:\BILLS\H5237.IH
H5237
pamtmann on DSKBC07HB2PROD with BILLS
154 
(v) the availability of information for 
sponsors of such novel medical products to 
meet each of those requirements; and 
(vi) the coordination of information 
related to significant clinical improvement 
over existing therapies for patients between 
the Food and Drug Administration and the 
Centers for Medicare & Medicaid Services 
with respect to novel medical products. 
(D) TRADE SECRETS AND CONFIDENTIAL 
INFORMATION.—No information discussed as a 
part of the public meeting under this paragraph 
shall be construed as authorizing the Secretary 
to disclose any information that is a trade se-
cret or confidential information subject to sec-
tion 552(b)(4) of title 5, United States Code. 
(2) IMPROVING
TRANSPARENCY
OF
CRITERIA 
FOR MEDICARE COVERAGE.— 
(A) DRAFT GUIDANCE.—Not later than 18 
months after the public meeting under para-
graph (1), the Secretary shall update the final 
guidance titled ‘‘National Coverage Determina-
tions with Data Collection as a Condition of 
Coverage: Coverage with Evidence Develop-
ment’’ to address any opportunities to improve 
VerDate Sep 11 2014 
20:49 Nov 03, 2021
Jkt 029200
PO 00000
Frm 00154
Fmt 6652
Sfmt 6201
E:\BILLS\H5237.IH
H5237
pamtmann on DSKBC07HB2PROD with BILLS
155 
the availability and coordination of information 
as described in clauses (iv) through (vi) of para-
graph (1)(C). 
(B) FINAL GUIDANCE.—Not later than 12 
months after issuing draft guidance under sub-
paragraph (A), the Secretary shall finalize the 
updated guidance to address any such opportu-
nities. 
(b) REPORT ON CODING, COVERAGE, AND PAYMENT 
PROCESSES UNDER MEDICARE
FOR NOVEL MEDICAL 
PRODUCTS.—Not later than 12 months after the date of 
the enactment of this Act, the Secretary shall publish a 
report on the Internet website of the Department of 
Health and Human Services regarding processes under 
the Medicare program under title XVIII of the Social Se-
curity Act (42 U.S.C. 1395 et seq.) with respect to the 
coding, coverage, and payment of novel medical products 
described in subsection (c). Such report shall include the 
following: 
(1) A description of challenges in the coding, 
coverage, and payment processes under the Medicare 
program for novel medical products. 
(2) Recommendations to— 
(A) incorporate patient experience data 
(such as the impact of a disease or condition on 
VerDate Sep 11 2014 
20:49 Nov 03, 2021
Jkt 029200
PO 00000
Frm 00155
Fmt 6652
Sfmt 6201
E:\BILLS\H5237.IH
H5237
pamtmann on DSKBC07HB2PROD with BILLS
156 
the lives of patients and patient treatment pref-
erences) into the coverage and payment proc-
esses within the Centers for Medicare & Med-
icaid Services; 
(B) decrease the length of time to make 
national and local coverage determinations 
under the Medicare program (as those terms 
are defined in subparagraph (A) and (B), re-
spectively, of section 1862(l)(6) of the Social 
Security Act (42 U.S.C. 1395y(l)(6))); 
(C) streamline the coverage process under 
the Medicare program and incorporate input 
from relevant stakeholders into such coverage 
determinations; and 
(D) identify potential mechanisms to incor-
porate novel payment designs similar to those 
in development in commercial insurance plans 
and State plans under title XIX of such Act 
(42 U.S.C. 1396 et seq.) into the Medicare pro-
gram. 
(c) NOVEL MEDICAL PRODUCTS DESCRIBED.—For 
purposes of this section, a novel medical product described 
in this subsection is a medical product, including a drug, 
biological (including gene and cell therapy), or medical de-
vice, that has been designated as a breakthrough therapy 
VerDate Sep 11 2014 
20:49 Nov 03, 2021
Jkt 029200
PO 00000
Frm 00156
Fmt 6652
Sfmt 6201
E:\BILLS\H5237.IH
H5237
pamtmann on DSKBC07HB2PROD with BILLS
157 
under section 506(a) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 356(a)), a breakthrough device 
under section 515B of such Act (21 U.S.C. 360e–3), or 
a regenerative advanced therapy under section 506(g) of 
such Act (21 U.S.C. 356(g)). 
SEC. 237. PATIENT CONSULTATION IN MEDICARE NA-
TIONAL AND LOCAL COVERAGE DETERMINA-
TIONS IN ORDER TO MITIGATE BARRIERS TO 
INCLUSION OF SUCH PERSPECTIVES. 
Section 1862(l) of the Social Security Act (42 U.S.C. 
1395y(l)) is amended by adding at the end the following 
new paragraph: 
‘‘(7) PATIENT
CONSULTATION
IN
NATIONAL 
AND LOCAL COVERAGE DETERMINATIONS.—The Sec-
retary may consult with patients and organizations 
representing patients in making national and local 
coverage determinations.’’. 
SEC. 238. GAO STUDY ON INCREASES TO MEDICARE AND 
MEDICAID SPENDING DUE TO COPAYMENT 
COUPONS AND OTHER PATIENT ASSISTANCE 
PROGRAMS. 
(a) STUDY.—The Comptroller General of the United 
States shall conduct a study on the impact of copayment 
coupons and other patient assistance programs on pre-
scription drug pricing and expenditures within the Medi-
VerDate Sep 11 2014 
20:49 Nov 03, 2021
Jkt 029200
PO 00000
Frm 00157
Fmt 6652
Sfmt 6201
E:\BILLS\H5237.IH
H5237
pamtmann on DSKBC07HB2PROD with BILLS
158 
care and Medicaid programs. The study shall assess the 
following: 
(1) The extent to which copayment coupons and 
other patient assistance programs contribute to in-
flated prescription drug prices under such programs. 
(2) The impact copayment coupons and other 
patient assistance programs have in the Medicare 
Part D program established under part D of title 
XVIII of the Social Security Act (42 U.S.C. 1395w– 
101 et seq.) on utilization of higher-cost brand drugs 
and lower utilization of generic drugs in that pro-
gram. 
(3) The extent to which manufacturers report 
or obtain tax benefits, including deductions of busi-
ness expenses and charitable contributions, for any 
of the following: 
(A) Offering copayment coupons or other 
patient assistance programs. 
(B) Sponsoring manufacturer patient as-
sistance programs. 
(C) Paying for sponsorships at outreach 
and advocacy events organized by patient as-
sistance programs. 
(4) The efficacy of oversight conducted to en-
sure that independent charity patient assistance pro-
VerDate Sep 11 2014 
20:49 Nov 03, 2021
Jkt 029200
PO 00000
Frm 00158
Fmt 6652
Sfmt 6201
E:\BILLS\H5237.IH
H5237
pamtmann on DSKBC07HB2PROD with BILLS
159 
grams adhere to guidance from the Office of the In-
spector General of the Department of Health and 
Human Services on avoiding waste, fraud, and 
abuse. 
(b) DEFINITIONS.—In this section: 
(1) INDEPENDENT CHARITY PATIENT ASSIST-
ANCE
PROGRAM.—The term ‘‘independent charity 
patient assistance program’’ means any organization 
described in section 501(c)(3) of the Internal Rev-
enue Code of 1986 and exempt from taxation under 
section 501(a) of such Code and which is not a pri-
vate foundation (as defined in section 509(a) of such 
Code) that offers patient assistance. 
(2) MANUFACTURER.—The term ‘‘manufac-
turer’’ has the meaning given that term in section 
1927(k)(5) of the Social Security Act (42 U.S.C. 
1396r–8(k)(5)). 
(3) MANUFACTURER PATIENT ASSISTANCE PRO-
GRAM.—The term ‘‘manufacturer patient assistance 
program’’ means an organization, including a private 
foundation (as so defined), that is sponsored by, or 
receives funding from, a manufacturer and that of-
fers patient assistance. Such term does not include 
an independent charity patient assistance program. 
VerDate Sep 11 2014 
20:49 Nov 03, 2021
Jkt 029200
PO 00000
Frm 00159
Fmt 6652
Sfmt 6201
E:\BILLS\H5237.IH
H5237
pamtmann on DSKBC07HB2PROD with BILLS
160 
(4) PATIENT ASSISTANCE.—The term ‘‘patient 
assistance’’ means assistance provided to offset the 
cost of drugs for individuals. Such term includes free 
products, coupons, rebates, copay or discount cards, 
and other means of providing assistance to individ-
uals related to drug costs, as determined by the Sec-
retary of Health and Human Services. 
(c) REPORT.—Not later than 24 months after the 
date of the enactment of this Act, the Comptroller General 
of the United States shall submit to Congress a report 
describing the findings of the study required under sub-
section (a). 
SEC. 239. MEDPAC REPORT ON SHIFTING COVERAGE OF 
CERTAIN MEDICARE PART B DRUGS TO MEDI-
CARE PART D. 
(a) STUDY.—The Medicare Payment Advisory Com-
mission (in this section referred to as the ‘‘Commission’’) 
shall conduct a study on shifting coverage of certain drugs 
and biologicals for which payment is currently made under 
part B of title XVIII of the Social Security Act (42 U.S.C. 
1395j et seq.) to part D of such title (42 U.S.C. 1395w– 
21 et seq.). Such study shall include an analysis of— 
(1) differences in program structures and pay-
ment methods for drugs and biologicals covered 
under such parts B and D, including effects of such 
VerDate Sep 11 2014 
20:49 Nov 03, 2021
Jkt 029200
PO 00000
Frm 00160
Fmt 6652
Sfmt 6201
E:\BILLS\H5237.IH
H5237
pamtmann on DSKBC07HB2PROD with BILLS
173 
may affect their independence of 
judgement in board matters; and 
‘‘(III) contains clear processes, 
such as recusal from voting or discus-
sion, for those members who report a 
conflict of interest, along with appro-
priate processes to address any in-
stance where a member fails to report 
a conflict of interest.’’; and 
(2) by adding at the end the following new sub-
paragraph: 
‘‘(E) DUR 
BOARD
MEMBERSHIP
RE-
PORTS.— 
‘‘(i) DUR BOARD
REPORTS.—Each 
State shall require the DUR Board to pre-
pare and submit to the State an annual re-
port on the DUR Board membership. Each 
such report shall include any conflicts of 
interest with respect to members of the 
DUR Board that the DUR Board recorded 
or was aware of during the period that is 
the subject of the report, and the process 
applied to address such conflicts of inter-
est, in addition to any other information 
required by the State. 
VerDate Sep 11 2014 
20:49 Nov 03, 2021
Jkt 029200
PO 00000
Frm 00173
Fmt 6652
Sfmt 6201
E:\BILLS\H5237.IH
H5237
pamtmann on DSKBC07HB2PROD with BILLS
198 
relevant clinical parameter of the agree-
ment, the agreement shall provide that— 
‘‘(I) the installment payment 
shall not be made; or 
‘‘(II) the installment payment 
shall be reduced by a percentage spec-
ified in the agreement that is based 
on the outcome achieved by the drug 
relative to the relevant clinical param-
eter. 
‘‘(4) NOTICE OF INTENT.— 
‘‘(A) IN
GENERAL.—Subject to subpara-
graph (B), a manufacturer of a covered out-
patient drug shall not be eligible to enter into 
a risk-sharing value-based payment agreement 
under this subsection with respect to such drug 
unless the manufacturer notifies the Secretary 
that the manufacturer is interested in entering 
into such an agreement with respect to such 
drug. The decision to submit and timing of a 
request to enter into a proposed risk-sharing 
value-based payment agreement shall remain 
solely within the discretion of the State and 
shall only be effective upon Secretarial approval 
as required under this subsection. 
VerDate Sep 11 2014 
20:49 Nov 03, 2021
Jkt 029200
PO 00000
Frm 00198
Fmt 6652
Sfmt 6201
E:\BILLS\H5237.IH
H5237
pamtmann on DSKBC07HB2PROD with BILLS