Introduced in House Passed House Introduced in Senate Passed Senate To President Became Law
02/12/2020          

GENE Therapy Payment Act

Date Version PDF TXT
02/12/2020 Introduced in House Open

            I 

116TH CONGRESS 
2D SESSION H. R. 5882 

To amend title XIX of the Social Security Act to provide States with the 
option under the Medicaid program to pay for covered outpatient drugs 
through risk-sharing value-based agreements, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

FEBRUARY 12, 2020 
Mr. SCHRADER (for himself, Mr. MARSHALL, Mr. CROW, Mr. MULLIN, Mr. 

BERA, Mr. KELLY of Pennsylvania, and Mr. SCHWEIKERT) introduced 
the following bill; which was referred to the Committee on Energy and 
Commerce 

A BILL 
To amend title XIX of the Social Security Act to provide 

States with the option under the Medicaid program to 
pay for covered outpatient drugs through risk-sharing 
value-based agreements, and for other purposes. 

Be it enacted by the Senate and House of Representa-1

tives of the United States of America in Congress assembled, 2

SECTION 1. SHORT TITLE. 3

This Act may be cited as the ‘‘Generating Effective 4

and Novel Evidence for Therapy Payment Act’’ or 5

‘‘GENE Therapy Payment Act’’. 6

VerDate Sep 11 2014 20:55 Feb 21, 2020 Jkt 099200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H5882.IH H5882pa
m

tm
an

n 
on

 D
S

K
B

C
07

H
B

2P
R

O
D

 w
ith

 B
IL

LS



2 

•HR 5882 IH

SEC. 2. RISK-SHARING VALUE-BASED PAYMENT AGREE-1

MENTS FOR COVERED OUTPATIENT DRUGS 2

UNDER MEDICAID. 3

(a) IN GENERAL.—Section 1927 of the Social Secu-4

rity Act (42 U.S.C. 1396r–8) is amended by adding at 5

the end the following new subsection: 6

‘‘(l) STATE OPTION TO PAY FOR COVERED OUT-7

PATIENT DRUGS THROUGH RISK-SHARING VALUE-BASED 8

AGREEMENTS.— 9

‘‘(1) IN GENERAL.—Beginning January 1, 10

2022, a State shall have the option to pay (whether 11

on a fee-for-service or managed care basis) for cov-12

ered outpatient drugs that are potentially curative 13

treatments intended for one-time use that are ad-14

ministered to individuals under this title by entering 15

into a risk-sharing value-based payment agreement 16

with the manufacturer of the drug in accordance 17

with the requirements of this subsection. 18

‘‘(2) SECRETARIAL APPROVAL.— 19

‘‘(A) IN GENERAL.—A State shall submit a 20

request to the Secretary to enter into a risk- 21

sharing value-based payment agreement, and 22

the Secretary shall not approve a proposed risk- 23

sharing value-based payment agreement be-24

tween a State and a manufacturer for payment 25

VerDate Sep 11 2014 20:55 Feb 21, 2020 Jkt 099200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H5882.IH H5882pa
m

tm
an

n 
on

 D
S

K
B

C
07

H
B

2P
R

O
D

 w
ith

 B
IL

LS



3 

•HR 5882 IH

for a covered outpatient drug of the manufac-1

turer unless the following requirements are met: 2

‘‘(i) MANUFACTURER HAS IN EFFECT 3

A REBATE AGREEMENT AND IS IN COMPLI-4

ANCE WITH ALL APPLICABLE REQUIRE-5

MENTS.—The manufacturer has a rebate 6

agreement in effect as required under sub-7

sections (a) and (b) of this section and is 8

in compliance with all applicable require-9

ments under this title. 10

‘‘(ii) NO INCREASE TO PROJECTED 11

NET FEDERAL SPENDING.— 12

‘‘(I) IN GENERAL.—The Chief 13

Actuary certifies that the projected 14

payments for each covered outpatient 15

drug under a proposed risk-sharing 16

value-based payment agreement is not 17

expected to result in greater estimated 18

Federal spending under this title than 19

the net Federal spending that would 20

result in the absence of such agree-21

ment. 22

‘‘(II) NET FEDERAL SPENDING 23

DEFINED.—For purposes of this sub-24

section, the term ‘net Federal spend-25

VerDate Sep 11 2014 20:55 Feb 21, 2020 Jkt 099200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H5882.IH H5882pa
m

tm
an

n 
on

 D
S

K
B

C
07

H
B

2P
R

O
D

 w
ith

 B
IL

LS



4 

•HR 5882 IH

ing’ means the amount of Federal 1

payments the Chief Actuary estimates 2

would be made under this title for ad-3

ministering a covered outpatient drug 4

to an individual eligible for medical 5

assistance under a State plan or a 6

waiver of such plan, reduced by the 7

amount of all rebates the Chief Actu-8

ary estimates would be paid with re-9

spect to the administering of such 10

drug, including all rebates under this 11

title and any supplemental or other 12

additional rebates, in the absence of 13

such an agreement. 14

‘‘(III) INFORMATION.—The Chief 15

Actuary shall make the certifications 16

required under this clause based on 17

the most recently available and reli-18

able drug pricing and product infor-19

mation. The State and manufacturer 20

shall provide the Secretary and the 21

Chief Actuary with all necessary infor-22

mation required to make the estimates 23

needed for such certifications. 24

VerDate Sep 11 2014 20:55 Feb 21, 2020 Jkt 099200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H5882.IH H5882pa
m

tm
an

n 
on

 D
S

K
B

C
07

H
B

2P
R

O
D

 w
ith

 B
IL

LS



5 

•HR 5882 IH

‘‘(iii) LAUNCH AND LIST PRICE JUS-1

TIFICATIONS.—The manufacturer submits 2

all relevant information and supporting 3

documentation necessary for pricing deci-4

sions as deemed appropriate by the Sec-5

retary, which shall be truthful and non- 6

misleading, including manufacturer infor-7

mation and supporting documentation for 8

launch price or list price increases, and 9

any applicable justification required under 10

section 1128L. 11

‘‘(iv) CONFIDENTIALITY OF INFORMA-12

TION; PENALTIES.—The provisions of sub-13

paragraphs (C) and (D) of subsection 14

(b)(3) shall apply to a manufacturer that 15

fails to submit the information and docu-16

mentation required under clauses (ii) and 17

(iii) on a timely basis, or that knowingly 18

provides false or misleading information, in 19

the same manner as such provisions apply 20

to a manufacturer with a rebate agreement 21

under this section. 22

‘‘(B) CONSIDERATION OF STATE REQUEST 23

FOR APPROVAL.— 24

VerDate Sep 11 2014 20:55 Feb 21, 2020 Jkt 099200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H5882.IH H5882pa
m

tm
an

n 
on

 D
S

K
B

C
07

H
B

2P
R

O
D

 w
ith

 B
IL

LS



6 

•HR 5882 IH

‘‘(i) IN GENERAL.—The Secretary 1

shall treat a State request for approval of 2

a risk-sharing value-based payment agree-3

ment in the same manner that the Sec-4

retary treats a State plan amendment, and 5

subpart B of part 430 of title 42, Code of 6

Federal Regulations, including, subject to 7

clause (ii), the timing requirements of sec-8

tion 430.16 of such title (as in effect on 9

the date of enactment of this subsection), 10

shall apply to a request for approval of a 11

risk-sharing value-based payment agree-12

ment in the same manner as such subpart 13

applies to a State plan amendment. 14

‘‘(ii) TIMING.—The Secretary shall 15

consult with the Commissioner of Food 16

and Drugs as required under subpara-17

graph (C) and make a determination on 18

whether to approve a request from a State 19

for approval of a proposed risk-sharing 20

value-based payment agreement (or request 21

additional information necessary to allow 22

the Secretary to make a determination 23

with respect to such request for approval) 24

within the time period, to the extent prac-25

VerDate Sep 11 2014 20:55 Feb 21, 2020 Jkt 099200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H5882.IH H5882pa
m

tm
an

n 
on

 D
S

K
B

C
07

H
B

2P
R

O
D

 w
ith

 B
IL

LS



7 

•HR 5882 IH

ticable, specified in section 430.16 of title 1

42, Code of Federal Regulations (as in ef-2

fect on the date of enactment of this sub-3

section), but in no case shall the Secretary 4

take more than 180 days after the receipt 5

of such request for approval or response to 6

such request for additional information to 7

make such a determination (or request ad-8

ditional information). 9

‘‘(C) CONSULTATION WITH THE COMMIS-10

SIONER OF FOOD AND DRUGS.—In considering 11

whether to approve a risk-sharing value-based 12

payment agreement, the Secretary, to the ex-13

tent necessary, shall consult with the Commis-14

sioner of Food and Drugs to determine whether 15

the relevant clinical parameters specified in 16

such agreement are appropriate. 17

‘‘(3) INSTALLMENT-BASED PAYMENT STRUC-18

TURE.— 19

‘‘(A) IN GENERAL.—A risk-sharing value- 20

based payment agreement shall provide for a 21

payment structure under which, for every in-22

stallment year of the agreement (subject to sub-23

paragraph (B)), the State shall pay the total in-24

stallment year amount in equal installments to 25

VerDate Sep 11 2014 20:55 Feb 21, 2020 Jkt 099200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H5882.IH H5882pa
m

tm
an

n 
on

 D
S

K
B

C
07

H
B

2P
R

O
D

 w
ith

 B
IL

LS



8 

•HR 5882 IH

be paid at regular intervals over a period of 1

time that shall be specified in the agreement. 2

‘‘(B) REQUIREMENTS FOR INSTALLMENT 3

PAYMENTS.— 4

‘‘(i) TIMING OF FIRST PAYMENT.— 5

The State shall make the first of the in-6

stallment payments described in subpara-7

graph (A) for an installment year not later 8

than 30 days after the end of such year. 9

‘‘(ii) LENGTH OF INSTALLMENT PE-10

RIOD.—The period of time over which the 11

State shall make the installment payments 12

described in subparagraph (A) for an in-13

stallment year shall not be longer than 5 14

years. 15

‘‘(iii) NONPAYMENT OR REDUCED 16

PAYMENT OF INSTALLMENTS FOLLOWING 17

A FAILURE TO MEET CLINICAL PARAM-18

ETER.—If, prior to the payment date (as 19

specified in the agreement) of any install-20

ment payment described in subparagraph 21

(A) or any other alternative date or time 22

frame (as otherwise specified in the agree-23

ment), the covered outpatient drug which 24

is subject to the agreement fails to meet a 25

VerDate Sep 11 2014 20:55 Feb 21, 2020 Jkt 099200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H5882.IH H5882pa
m

tm
an

n 
on

 D
S

K
B

C
07

H
B

2P
R

O
D

 w
ith

 B
IL

LS



9 

•HR 5882 IH

relevant clinical parameter of the agree-1

ment, the agreement shall provide that— 2

‘‘(I) the installment payment 3

shall not be made; or 4

‘‘(II) the installment payment 5

shall be reduced by a percentage spec-6

ified in the agreement that is based 7

on the outcome achieved by the drug 8

relative to the relevant clinical param-9

eter. 10

‘‘(4) NOTICE OF INTENT.— 11

‘‘(A) IN GENERAL.—Subject to subpara-12

graph (B), a manufacturer of a covered out-13

patient drug shall not be eligible to enter into 14

a risk-sharing value-based payment agreement 15

under this subsection with respect to such drug 16

unless the manufacturer notifies the Secretary 17

that the manufacturer is interested in entering 18

into such an agreement with respect to such 19

drug. The decision to submit and timing of a 20

request to enter into a proposed risk-sharing 21

value-based payment agreement shall remain 22

solely within the discretion of the State and 23

shall only be effective upon Secretarial approval 24

as required under this subsection. 25

VerDate Sep 11 2014 20:55 Feb 21, 2020 Jkt 099200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H5882.IH H5882pa
m

tm
an

n 
on

 D
S

K
B

C
07

H
B

2P
R

O
D

 w
ith

 B
IL

LS



10 

•HR 5882 IH

‘‘(B) TREATMENT OF SUBSEQUENTLY AP-1

PROVED DRUGS.— 2

‘‘(i) IN GENERAL.—In the case of a 3

manufacturer of a covered outpatient drug 4

approved under section 505 of the Federal 5

Food, Drug, and Cosmetic Act or licensed 6

under section 351 of the Public Health 7

Service Act after the date of enactment of 8

this subsection, not more than 90 days 9

after meeting with the Food and Drug Ad-10

ministration following phase II clinical 11

trials for such drug (or, in the case of a 12

drug described in clause (ii), not later than 13

March 31, 2022), the manufacturer must 14

notify the Secretary of the manufacturer’s 15

intent to enter into a risk-sharing value- 16

based payment agreement under this sub-17

section with respect to such drug. If no 18

such meeting has occurred, the Secretary 19

may use discretion as to whether a poten-20

tially curative treatment intended for one- 21

time use may qualify for a risk-sharing 22

value-based payment agreement under this 23

section. A manufacturer notification of in-24

terest shall not have any influence on a de-25

VerDate Sep 11 2014 20:55 Feb 21, 2020 Jkt 099200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\H5882.IH H5882pa
m

tm
an

n 
on

 D
S

K
B

C
07

H
B

2P
R

O
D

 w
ith

 B
IL

LS



11 

•HR 5882 IH

cision for drug approval by the Food and 1

Drug Administration. 2

‘‘(ii) APPLICATION TO CERTAIN SUB-3

SEQUENTLY APPROVED DRUGS.—A drug 4

described in this clause is a covered out-5

patient drug of a manufacturer— 6

‘‘(I) that is approved under sec-7

tion 505 of the Federal Food, Drug, 8

and Cosmetic Act or licensed under 9

section 351 of the Public Health Serv-10

ice Act after the date of enactment of 11

this subsection; and 12

‘‘(II) with respect to which, as of 13

January 1, 2022, more than 90 days 14

have passed after the manufacturer’s 15

meeting with the Food and Drug Ad-16

ministration following phase II clinical 17

trials for such drug. 18

‘‘(iii) PARALLEL APPROVAL.—The 19

Secretary, in coordination with the Admin-20

istrator of the Centers for Medicare & 21

Medicaid Services and the Commissioner of 22

Food and Drugs, shall, to the extent prac-23

ticable, approve a State’s request to enter 24

into a proposed risk-sharing value-based 25

VerDate Sep 11 2014 20:55 Feb 21, 2020 Jkt 099200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\H5882.IH H5882pa
m

tm
an

n 
on

 D
S

K
B

C
07

H
B

2P
R

O
D

 w
ith

 B
IL

LS



12 

•HR 5882 IH

payment agreement that otherwise meets 1

the requirements of this subsection at the 2

time that such a drug is approved by the 3

Food and Drug Administration to help 4

provide that no State that wishes to enter 5

into such an agreement is required to pay 6

for the drug in full at one time if the State 7

is seeking to pay over a period of time as 8

outlined in the proposed agreement. 9

‘‘(iv) RULE OF CONSTRUCTION.— 10

Nothing in this paragraph shall be applied 11

or construed to modify or affect the time-12

frames or factors involved in the Sec-13

retary’s determination of whether to ap-14

prove or license a drug under section 505 15

of the Federal Food, Drug, and Cosmetic 16

Act or section 351 of the Public Health 17

Service Act. 18

‘‘(5) SPECIAL PAYMENT RULES.— 19

‘‘(A) IN GENERAL.—Except as otherwise 20

provided in this paragraph, with respect to an 21

individual who is administered a unit of a cov-22

ered outpatient drug that is reimbursed under 23

a State plan by a State Medicaid agency under 24

a risk-sharing value-based payment agreement 25

VerDate Sep 11 2014 20:55 Feb 21, 2020 Jkt 099200 PO 00000 Frm 00012 Fmt 6652 Sfmt 6201 E:\BILLS\H5882.IH H5882pa
m

tm
an

n 
on

 D
S

K
B

C
07

H
B

2P
R

O
D

 w
ith

 B
IL

LS



13 

•HR 5882 IH

in an installment year, the State shall remain 1

liable to the manufacturer of such drug for pay-2

ment for such unit without regard to whether 3

the individual remains enrolled in the State 4

plan under this title (or a waiver of such plan) 5

for each installment year for which the State is 6

to make installment payments for covered out-7

patient drugs purchased under the agreement 8

in such year. 9

‘‘(B) DEATH.—In the case of an individual 10

described in subparagraph (A) who dies during 11

the period described in such subparagraph, the 12

State plan shall not be liable for any remaining 13

payment for the unit of the covered outpatient 14

drug administered to the individual which is 15

owed under the agreement described in such 16

subparagraph. 17

‘‘(C) WITHDRAWAL OF APPROVAL.—In the 18

case of a covered outpatient drug that is the 19

subject of a risk-sharing value-based payment 20

agreement between a State and a manufacturer 21

under this subsection, including a drug ap-22

proved in accordance with section 506(c) of the 23

Federal Food, Drug, and Cosmetic Act, and 24

such drug is the subject of an application that 25

VerDate Sep 11 2014 20:55 Feb 21, 2020 Jkt 099200 PO 00000 Frm 00013 Fmt 6652 Sfmt 6201 E:\BILLS\H5882.IH H5882pa
m

tm
an

n 
on

 D
S

K
B

C
07

H
B

2P
R

O
D

 w
ith

 B
IL

LS



14 

•HR 5882 IH

has been withdrawn by the Secretary, the State 1

plan shall not be liable for any remaining pay-2

ment that is owed under the agreement. 3

‘‘(D) ALTERNATIVE ARRANGEMENT UNDER 4

AGREEMENT.—Subject to approval by the Sec-5

retary, the terms of a proposed risk-sharing 6

value-based payment agreement submitted for 7

approval by a State may provide that subpara-8

graph (A) shall not apply. 9

‘‘(E) GUIDANCE.—Not later than January 10

1, 2022, the Secretary shall issue guidance to 11

States establishing a process for States to no-12

tify the Secretary when an individual who is ad-13

ministered a unit of a covered outpatient drug 14

that is purchased by a State plan under a risk- 15

sharing value-based payment agreement ceases 16

to be enrolled under the State plan under this 17

title (or a waiver of such plan) or dies before 18

the end of the installment period applicable to 19

such unit under the agreement. 20

‘‘(6) TREATMENT OF PAYMENTS UNDER RISK- 21

SHARING VALUE-BASED AGREEMENTS FOR PUR-22

POSES OF AVERAGE MANUFACTURER PRICE; BEST 23

PRICE.—The Secretary shall treat any payments 24

made to the manufacturer of a covered outpatient 25

VerDate Sep 11 2014 20:55 Feb 21, 2020 Jkt 099200 PO 00000 Frm 00014 Fmt 6652 Sfmt 6201 E:\BILLS\H5882.IH H5882pa
m

tm
an

n 
on

 D
S

K
B

C
07

H
B

2P
R

O
D

 w
ith

 B
IL

LS



15 

•HR 5882 IH

drug under a risk-sharing value-based payment 1

agreement under this subsection during a rebate pe-2

riod in the same manner that the Secretary treats 3

payments made under a State supplemental rebate 4

agreement under sections 447.504(c)(19) and 5

447.505(c)(7) of title 42, Code of Federal Regula-6

tions (or any successor regulations) for purposes of 7

determining average manufacturer price and best 8

price under this section with respect to the covered 9

outpatient drug and a rebate period and for pur-10

poses of offsets required under subsection (b)(1)(B). 11

‘‘(7) ASSESSMENTS AND REPORT TO CON-12

GRESS.— 13

‘‘(A) ASSESSMENTS.— 14

‘‘(i) IN GENERAL.—Not later than 15

180 days after the end of each assessment 16

period of any risk-sharing value-based pay-17

ment agreement for a State approved 18

under this subsection, the Secretary shall 19

conduct an evaluation of such agreement 20

which shall include an evaluation by the 21

Chief Actuary to determine whether pro-22

gram spending under the risk-sharing 23

value-based payment agreement aligned 24

with the projections for the agreement 25

VerDate Sep 11 2014 20:55 Feb 21, 2020 Jkt 099200 PO 00000 Frm 00015 Fmt 6652 Sfmt 6201 E:\BILLS\H5882.IH H5882pa
m

tm
an

n 
on

 D
S

K
B

C
07

H
B

2P
R

O
D

 w
ith

 B
IL

LS



16 

•HR 5882 IH

made under paragraph (2)(A)(ii), including 1

an assessment of whether actual Federal 2

spending under this title under the agree-3

ment was less or more than net Federal 4

spending would have been in the absence 5

of the agreement. 6

‘‘(ii) ASSESSMENT PERIOD.—For pur-7

poses of clause (i)— 8

‘‘(I) the first assessment period 9

for a risk-sharing value-based pay-10

ment agreement shall be the period of 11

time over which payments are sched-12

uled to be made under the agreement 13

for the first 10 individuals who are 14

administered covered outpatient drugs 15

under the agreement except that such 16

period shall not exceed the 5-year pe-17

riod after the date on which the Sec-18

retary approves the agreement; and 19

‘‘(II) each subsequent assessment 20

period for a risk-sharing value-based 21

payment agreement shall be the 5- 22

year period following the end of the 23

previous assessment period. 24

‘‘(B) RESULTS OF ASSESSMENTS.— 25

VerDate Sep 11 2014 20:55 Feb 21, 2020 Jkt 099200 PO 00000 Frm 00016 Fmt 6652 Sfmt 6201 E:\BILLS\H5882.IH H5882pa
m

tm
an

n 
on

 D
S

K
B

C
07

H
B

2P
R

O
D

 w
ith

 B
IL

LS



17 

•HR 5882 IH

‘‘(i) TERMINATION OPTION.—If the 1

Secretary determines as a result of the as-2

sessment by the Chief Actuary under sub-3

paragraph (A) that the actual Federal 4

spending under this title for any covered 5

outpatient drug that was the subject of the 6

State’s risk-sharing value-based payment 7

agreement was greater than the net Fed-8

eral spending that would have resulted in 9

the absence of the agreement, the Sec-10

retary may terminate approval of such 11

agreement and shall immediately conduct 12

an assessment under this paragraph of any 13

other ongoing risk-sharing value-based 14

payment agreement to which the same 15

manufacturer is a party. 16

‘‘(ii) REPAYMENT REQUIRED.— 17

‘‘(I) IN GENERAL.—If the Sec-18

retary determines as a result of the 19

assessment by the Chief Actuary 20

under subparagraph (A) that the Fed-21

eral spending under the risk-sharing 22

value-based agreement for a covered 23

outpatient drug that was subject to 24

such agreement was greater than the 25

VerDate Sep 11 2014 20:55 Feb 21, 2020 Jkt 099200 PO 00000 Frm 00017 Fmt 6652 Sfmt 6201 E:\BILLS\H5882.IH H5882pa
m

tm
an

n 
on

 D
S

K
B

C
07

H
B

2P
R

O
D

 w
ith

 B
IL

LS



18 

•HR 5882 IH

net Federal spending that would have 1

resulted in the absence of the agree-2

ment, the manufacturer shall repay 3

the difference to the State and Fed-4

eral Governments in a timely manner 5

as determined by the Secretary. 6

‘‘(II) TERMINATION FOR FAIL-7

URE TO PAY.—The failure of a manu-8

facturer to make repayments required 9

under subclause (I) in a timely man-10

ner shall result in immediate termi-11

nation of all risk-sharing value-based 12

agreements to which the manufacturer 13

is a party. 14

‘‘(III) ADDITIONAL PEN-15

ALTIES.—In the case of a manufac-16

turer that fails to make repayments 17

required under subclause (I), the Sec-18

retary may treat such manufacturer 19

in the same manner as a manufac-20

turer that fails to pay required re-21

bates under this section, and the Sec-22

retary may— 23

VerDate Sep 11 2014 20:55 Feb 21, 2020 Jkt 099200 PO 00000 Frm 00018 Fmt 6652 Sfmt 6201 E:\BILLS\H5882.IH H5882pa
m

tm
an

n 
on

 D
S

K
B

C
07

H
B

2P
R

O
D

 w
ith

 B
IL

LS



19 

•HR 5882 IH

‘‘(aa) suspend or terminate 1

the manufacturer’s rebate agree-2

ment under this section; and 3

‘‘(bb) pursue any other rem-4

edy that would be available if the 5

manufacturer had failed to pay 6

required rebates under this sec-7

tion. 8

‘‘(C) REPORT TO CONGRESS.—Not later 9

than 5 years after the first risk-sharing value- 10

based payment agreement is approved under 11

this subsection, the Secretary shall submit to 12

Congress and make available to the public a re-13

port that includes— 14

‘‘(i) an assessment of the impact of 15

risk-sharing value-based payment agree-16

ments on access for individuals who are eli-17

gible for benefits under a State plan or 18

waiver under this title to medically nec-19

essary covered outpatient drugs and re-20

lated treatments; 21

‘‘(ii) an analysis of the impact of such 22

agreements on overall State and Federal 23

spending under this title; 24

VerDate Sep 11 2014 20:55 Feb 21, 2020 Jkt 099200 PO 00000 Frm 00019 Fmt 6652 Sfmt 6201 E:\BILLS\H5882.IH H5882pa
m

tm
an

n 
on

 D
S

K
B

C
07

H
B

2P
R

O
D

 w
ith

 B
IL

LS



20 

•HR 5882 IH

‘‘(iii) an assessment of the impact of 1

such agreements on drug prices, including 2

launch price and price increases; and 3

‘‘(iv) such recommendations to Con-4

gress as the Secretary deems appropriate. 5

‘‘(8) GUIDANCE AND REGULATIONS.— 6

‘‘(A) IN GENERAL.—Not later than Janu-7

ary 1, 2022, the Secretary shall issue guidance 8

to States seeking to enter into risk-sharing 9

value-based payment agreements under this 10

subsection that includes a model template for 11

such agreements. The Secretary may issue any 12

additional guidance or promulgate regulations 13

as necessary to implement and enforce the pro-14

visions of this subsection. 15

‘‘(B) MODEL AGREEMENTS.— 16

‘‘(i) IN GENERAL.—If a State ex-17

presses an interest in pursuing a risk-shar-18

ing value-based payment agreement under 19

this subsection with a manufacturer for 20

the purchase of a covered outpatient drug, 21

the Secretary may share with such State 22

any risk-sharing value-based agreement be-23

tween a State and the manufacturer for 24

the purchase of such drug that has been 25

VerDate Sep 11 2014 20:55 Feb 21, 2020 Jkt 099200 PO 00000 Frm 00020 Fmt 6652 Sfmt 6201 E:\BILLS\H5882.IH H5882pa
m

tm
an

n 
on

 D
S

K
B

C
07

H
B

2P
R

O
D

 w
ith

 B
IL

LS



21 

•HR 5882 IH

approved under this subsection. While such 1

shared agreement may serve as a template 2

for a State that wishes to propose, the use 3

of a previously approved agreement shall 4

not affect the submission and approval 5

process for approval of a proposed risk- 6

sharing value-based payment agreement 7

under this subsection, including the re-8

quirements under paragraph (2)(A). 9

‘‘(ii) CONFIDENTIALITY.—In the case 10

of a risk-sharing value-based payment 11

agreement that is disclosed to a State by 12

the Secretary under this subparagraph and 13

that is only in effect with respect to a sin-14

gle State, the confidentiality of information 15

provisions described in subsection 16

(b)(3)(D) shall apply to such information. 17

‘‘(C) OIG CONSULTATION.— 18

‘‘(i) IN GENERAL.—The Secretary 19

shall consult with the Office of the Inspec-20

tor General of the Department of Health 21

and Human Services to determine whether 22

there are potential program integrity con-23

cerns (including issues related to compli-24

ance with sections 1128B and 1877) with 25

VerDate Sep 11 2014 20:55 Feb 21, 2020 Jkt 099200 PO 00000 Frm 00021 Fmt 6652 Sfmt 6201 E:\BILLS\H5882.IH H5882pa
m

tm
an

n 
on

 D
S

K
B

C
07

H
B

2P
R

O
D

 w
ith

 B
IL

LS



22 

•HR 5882 IH

agreement approvals or templates and ad-1

dress accordingly. 2

‘‘(ii) OIG POLICY UPDATES AS NEC-3

ESSARY.—The Inspector General of the 4

Department of Health and Human Serv-5

ices shall review and update, as necessary, 6

any policies or guidelines of the Office of 7

the Inspector General of the Department 8

of Health and Human Services (including 9

policies related to the enforcement of sec-10

tion 1128B) to accommodate the use of 11

risk-sharing value-based payment agree-12

ments in accordance with this section. 13

‘‘(9) RULES OF CONSTRUCTION.— 14

‘‘(A) MODIFICATIONS.—Nothing in this 15

subsection or any regulations promulgated 16

under this subsection shall prohibit a State 17

from requesting a modification from the Sec-18

retary to the terms of a risk-sharing value- 19

based payment agreement. A modification that 20

is expected to result in any increase to pro-21

jected net State or Federal spending under the 22

agreement shall be subject to recertification by 23

the Chief Actuary as described in paragraph 24

VerDate Sep 11 2014 20:55 Feb 21, 2020 Jkt 099200 PO 00000 Frm 00022 Fmt 6652 Sfmt 6201 E:\BILLS\H5882.IH H5882pa
m

tm
an

n 
on

 D
S

K
B

C
07

H
B

2P
R

O
D

 w
ith

 B
IL

LS



23 

•HR 5882 IH

(2)(A)(ii) before the modification may be ap-1

proved. 2

‘‘(B) REBATE AGREEMENTS.—Nothing in 3

this subsection shall be construed as requiring 4

a State to enter into a risk-sharing value-based 5

payment agreement or as limiting or super-6

seding the ability of a State to enter into a sup-7

plemental rebate agreement for a covered out-8

patient drug. 9

‘‘(C) FFP FOR PAYMENTS UNDER RISK- 10

SHARING VALUE-BASED PAYMENT AGREE-11

MENTS.—Federal financial participation shall 12

be available under this title for any payment 13

made by a State to a manufacturer for a cov-14

ered outpatient drug under a risk-sharing 15

value-based payment agreement in accordance 16

with this subsection, except that no Federal fi-17

nancial participation shall be available for any 18

payment made by a State to a manufacturer 19

under such an agreement on and after the ef-20

fective date of a disapproval of such agreement 21

by the Secretary. 22

‘‘(D) CONTINUED APPLICATION OF OTHER 23

PROVISIONS.—Except as expressly provided in 24

this subsection, nothing in this subsection or in 25

VerDate Sep 11 2014 20:55 Feb 21, 2020 Jkt 099200 PO 00000 Frm 00023 Fmt 6652 Sfmt 6201 E:\BILLS\H5882.IH H5882pa
m

tm
an

n 
on

 D
S

K
B

C
07

H
B

2P
R

O
D

 w
ith

 B
IL

LS



24 

•HR 5882 IH

any regulations promulgated under this sub-1

section shall affect the application of any other 2

provision of this Act. 3

‘‘(10) APPROPRIATIONS.—For fiscal year 2020 4

and each fiscal year thereafter, there are appro-5

priated to the Secretary $5,000,000 for the purpose 6

of carrying out this subsection. 7

‘‘(11) DEFINITIONS.—In this subsection: 8

‘‘(A) CHIEF ACTUARY.—The term ‘Chief 9

Actuary’ means the Chief Actuary of the Cen-10

ters for Medicare & Medicaid Services. 11

‘‘(B) INSTALLMENT YEAR.—The term ‘in-12

stallment year’ means, with respect to a risk- 13

sharing value-based payment agreement, a 12- 14

month period during which a covered outpatient 15

drug is administered under the agreement. 16

‘‘(C) POTENTIALLY CURATIVE TREATMENT 17

INTENDED FOR ONE-TIME USE.—The term ‘po-18

tentially curative treatment intended for one- 19

time use’ means a treatment that consists of 20

the administration of a covered outpatient drug 21

that— 22

‘‘(i) is a form of gene therapy for a 23

rare disease, as defined by the Commis-24

sioner of Food and Drugs, designated 25

VerDate Sep 11 2014 20:55 Feb 21, 2020 Jkt 099200 PO 00000 Frm 00024 Fmt 6652 Sfmt 6201 E:\BILLS\H5882.IH H5882pa
m

tm
an

n 
on

 D
S

K
B

C
07

H
B

2P
R

O
D

 w
ith

 B
IL

LS



25 

•HR 5882 IH

under section 526 of the Federal Food, 1

Drug, and Cosmetic Act, and approved 2

under section 505 of such Act or licensed 3

under subsection (a) or (k) of section 351 4

of the Public Health Service Act to treat 5

a serious or life-threatening disease or con-6

dition; 7

‘‘(ii) if administered in accordance 8

with the labeling of such drug, is expected 9

to result in either— 10

‘‘(I) the cure of such disease or 11

condition; or 12

‘‘(II) a reduction in the symp-13

toms of such disease or condition to 14

the extent that such disease or condi-15

tion is not expected to lead to early 16

mortality; and 17

‘‘(iii) is expected to achieve a result 18

described in clause (ii), which may be 19

achieved over an extended period of time, 20

after not more than 3 administrations. 21

‘‘(D) RELEVANT CLINICAL PARAMETER.— 22

The term ‘relevant clinical parameter’ means, 23

with respect to a covered outpatient drug that 24

VerDate Sep 11 2014 20:55 Feb 21, 2020 Jkt 099200 PO 00000 Frm 00025 Fmt 6652 Sfmt 6201 E:\BILLS\H5882.IH H5882pa
m

tm
an

n 
on

 D
S

K
B

C
07

H
B

2P
R

O
D

 w
ith

 B
IL

LS



26 

•HR 5882 IH

is the subject of a risk-sharing value-based pay-1

ment agreement— 2

‘‘(i) a clinical endpoint specified in the 3

drug’s labeling or supported by one or 4

more of the compendia described in section 5

1861(t)(2)(B)(ii)(I) that— 6

‘‘(I) is able to be measured or 7

evaluated on an annual basis for each 8

year of the agreement on an inde-9

pendent basis by a provider or other 10

entity; and 11

‘‘(II) is required to be achieved 12

(based on observed metrics in patient 13

populations) under the terms of the 14

agreement; or 15

‘‘(ii) a surrogate endpoint (as defined 16

in section 507(e)(9) of the Federal Food, 17

Drug, and Cosmetic Act), including those 18

developed by patient-focused drug develop-19

ment tools, that— 20

‘‘(I) is able to be measured or 21

evaluated on an annual basis for each 22

year of the agreement on an inde-23

pendent basis by a provider or other 24

entity; and 25

VerDate Sep 11 2014 20:55 Feb 21, 2020 Jkt 099200 PO 00000 Frm 00026 Fmt 6652 Sfmt 6201 E:\BILLS\H5882.IH H5882pa
m

tm
an

n 
on

 D
S

K
B

C
07

H
B

2P
R

O
D

 w
ith

 B
IL

LS



27 

•HR 5882 IH

‘‘(II) has been qualified by the 1

Food and Drug Administration. 2

‘‘(E) RISK-SHARING VALUE-BASED PAY-3

MENT AGREEMENT.—The term ‘risk-sharing 4

value-based payment agreement’ means an 5

agreement between a State plan and a manu-6

facturer— 7

‘‘(i) for the purchase of a covered out-8

patient drug of the manufacturer that is a 9

potentially curative treatment intended for 10

one-time use; 11

‘‘(ii) under which payment for such 12

drug shall be made pursuant to an install-13

ment-based payment structure that meets 14

the requirements of paragraph (3); 15

‘‘(iii) which conditions payment on the 16

achievement of at least 2 relevant clinical 17

parameters (as defined in subparagraph 18

(C)); 19

‘‘(iv) which provides that— 20

‘‘(I) the State plan will directly 21

reimburse the manufacturer for the 22

drug; or 23

VerDate Sep 11 2014 20:55 Feb 21, 2020 Jkt 099200 PO 00000 Frm 00027 Fmt 6652 Sfmt 6201 E:\BILLS\H5882.IH H5882pa
m

tm
an

n 
on

 D
S

K
B

C
07

H
B

2P
R

O
D

 w
ith

 B
IL

LS



28 

•HR 5882 IH

‘‘(II) a third party will reimburse 1

the manufacture in a manner ap-2

proved by the Secretary; and 3

‘‘(v) is approved by the Secretary in 4

accordance with paragraph (2). 5

‘‘(F) TOTAL INSTALLMENT YEAR 6

AMOUNT.—The term ‘total installment year 7

amount’ means, with respect to a risk-sharing 8

value-based payment agreement for the pur-9

chase of a covered outpatient drug and an in-10

stallment year, an amount equal to the product 11

of— 12

‘‘(i) the unit price of the drug charged 13

under the agreement; and 14

‘‘(ii) the number of units of such drug 15

administered under the agreement during 16

such installment year.’’. 17

(b) CONFORMING AMENDMENTS.— 18

(1) Section 1903(i)(10)(A) of the Social Secu-19

rity Act (42 U.S.C. 1396b(i)(10)(A)) is amended by 20

striking ‘‘or unless section 1927(a)(3) applies’’ and 21

inserting ‘‘, section 1927(a)(3) applies with respect 22

to such drugs, or such drugs are the subject of a 23

risk-sharing value-based payment agreement under 24

section 1927(l)’’. 25

VerDate Sep 11 2014 20:55 Feb 21, 2020 Jkt 099200 PO 00000 Frm 00028 Fmt 6652 Sfmt 6201 E:\BILLS\H5882.IH H5882pa
m

tm
an

n 
on

 D
S

K
B

C
07

H
B

2P
R

O
D

 w
ith

 B
IL

LS



29 

•HR 5882 IH

(2) Section 1927(b) of the Social Security Act 1

(42 U.S.C. 1396r–8(b)) is amended— 2

(A) in paragraph (1)(A), by inserting ‘‘but 3

excluding any drugs for which payment is made 4

by a State under a risk-sharing value-based 5

payment agreement under subsection (l))’’ after 6

‘‘for coverage of such drugs’’; and 7

(B) in paragraph (3)— 8

(i) in subparagraph (C)(i), by insert-9

ing ‘‘or subsection (l)(2)(A)’’ after ‘‘sub-10

paragraph (A)’’; and 11

(ii) in subparagraph (D), in the mat-12

ter preceding clause (i), by inserting ‘‘, 13

under subsection (l)(2)(A),’’ after ‘‘under 14

this paragraph’’. 15

Æ 

VerDate Sep 11 2014 20:55 Feb 21, 2020 Jkt 099200 PO 00000 Frm 00029 Fmt 6652 Sfmt 6301 E:\BILLS\H5882.IH H5882pa
m

tm
an

n 
on

 D
S

K
B

C
07

H
B

2P
R

O
D

 w
ith

 B
IL

LS


<<
  /ASCII85EncodePages false
  /AllowTransparency false
  /AutoPositionEPSFiles true
  /AutoRotatePages /None
  /Binding /Left
  /CalGrayProfile (Dot Gain 20%)
  /CalRGBProfile (sRGB IEC61966-2.1)
  /CalCMYKProfile (U.S. Web Coated \050SWOP\051 v2)
  /sRGBProfile (sRGB IEC61966-2.1)
  /CannotEmbedFontPolicy /Error
  /CompatibilityLevel 1.4
  /CompressObjects /Off
  /CompressPages true
  /ConvertImagesToIndexed true
  /PassThroughJPEGImages true
  /CreateJobTicket false
  /DefaultRenderingIntent /Default
  /DetectBlends true
  /DetectCurves 0.0000
  /ColorConversionStrategy /LeaveColorUnchanged
  /DoThumbnails false
  /EmbedAllFonts true
  /EmbedOpenType false
  /ParseICCProfilesInComments true
  /EmbedJobOptions true
  /DSCReportingLevel 0
  /EmitDSCWarnings false
  /EndPage -1
  /ImageMemory 1048576
  /LockDistillerParams true
  /MaxSubsetPct 100
  /Optimize false
  /OPM 1
  /ParseDSCComments true
  /ParseDSCCommentsForDocInfo true
  /PreserveCopyPage true
  /PreserveDICMYKValues true
  /PreserveEPSInfo true
  /PreserveFlatness true
  /PreserveHalftoneInfo false
  /PreserveOPIComments true
  /PreserveOverprintSettings true
  /StartPage 1
  /SubsetFonts false
  /TransferFunctionInfo /Preserve
  /UCRandBGInfo /Preserve
  /UsePrologue true
  /ColorSettingsFile ()
  /AlwaysEmbed [ true
  ]
  /NeverEmbed [ true
  ]
  /AntiAliasColorImages false
  /CropColorImages true
  /ColorImageMinResolution 300
  /ColorImageMinResolutionPolicy /OK
  /DownsampleColorImages false
  /ColorImageDownsampleType /Bicubic
  /ColorImageResolution 300
  /ColorImageDepth 8
  /ColorImageMinDownsampleDepth 1
  /ColorImageDownsampleThreshold 1.50000
  /EncodeColorImages true
  /ColorImageFilter /FlateEncode
  /AutoFilterColorImages false
  /ColorImageAutoFilterStrategy /JPEG
  /ColorACSImageDict <<
    /QFactor 0.15
    /HSamples [1 1 1 1] /VSamples [1 1 1 1]
  >>
  /ColorImageDict <<
    /QFactor 0.15
    /HSamples [1 1 1 1] /VSamples [1 1 1 1]
  >>
  /JPEG2000ColorACSImageDict <<
    /TileWidth 256
    /TileHeight 256
    /Quality 30
  >>
  /JPEG2000ColorImageDict <<
    /TileWidth 256
    /TileHeight 256
    /Quality 30
  >>
  /AntiAliasGrayImages false
  /CropGrayImages true
  /GrayImageMinResolution 300
  /GrayImageMinResolutionPolicy /OK
  /DownsampleGrayImages false
  /GrayImageDownsampleType /Bicubic
  /GrayImageResolution 300
  /GrayImageDepth 8
  /GrayImageMinDownsampleDepth 2
  /GrayImageDownsampleThreshold 1.50000
  /EncodeGrayImages true
  /GrayImageFilter /FlateEncode
  /AutoFilterGrayImages false
  /GrayImageAutoFilterStrategy /JPEG
  /GrayACSImageDict <<
    /QFactor 0.15
    /HSamples [1 1 1 1] /VSamples [1 1 1 1]
  >>
  /GrayImageDict <<
    /QFactor 0.15
    /HSamples [1 1 1 1] /VSamples [1 1 1 1]
  >>
  /JPEG2000GrayACSImageDict <<
    /TileWidth 256
    /TileHeight 256
    /Quality 30
  >>
  /JPEG2000GrayImageDict <<
    /TileWidth 256
    /TileHeight 256
    /Quality 30
  >>
  /AntiAliasMonoImages false
  /CropMonoImages true
  /MonoImageMinResolution 1200
  /MonoImageMinResolutionPolicy /OK
  /DownsampleMonoImages false
  /MonoImageDownsampleType /Bicubic
  /MonoImageResolution 1200
  /MonoImageDepth -1
  /MonoImageDownsampleThreshold 1.50000
  /EncodeMonoImages true
  /MonoImageFilter /CCITTFaxEncode
  /MonoImageDict <<
    /K -1
  >>
  /AllowPSXObjects false
  /CheckCompliance [
    /None
  ]
  /PDFX1aCheck true
  /PDFX3Check false
  /PDFXCompliantPDFOnly true
  /PDFXNoTrimBoxError false
  /PDFXTrimBoxToMediaBoxOffset [
    0.00000
    0.00000
    0.00000
    0.00000
  ]
  /PDFXSetBleedBoxToMediaBox true
  /PDFXBleedBoxToTrimBoxOffset [
    0.00000
    0.00000
    0.00000
    0.00000
  ]
  /PDFXOutputIntentProfile (U.S. Web Coated \050SWOP\051 v2)
  /PDFXOutputConditionIdentifier (CGATS TR 001)
  /PDFXOutputCondition ()
  /PDFXRegistryName (http://www.color.org)
  /PDFXTrapped /False

  /CreateJDFFile false
  /Description <<
    /ARA 
    /BGR 
    /CHS 
    /CHT 
    /CZE 
    /DAN 
    /DEU 
    /ESP 
    /ETI 
    /FRA 
    /GRE 
    /HEB 
    /HRV 
    /HUN 
    /ITA (Utilizzare queste impostazioni per creare documenti Adobe PDF che devono essere conformi o verificati in base a PDF/X-1a:2001, uno standard ISO per lo scambio di contenuto grafico. Per ulteriori informazioni sulla creazione di documenti PDF compatibili con PDF/X-1a, consultare la Guida dell'utente di Acrobat. I documenti PDF creati possono essere aperti con Acrobat e Adobe Reader 4.0 e versioni successive.)
    /JPN 
    /KOR 
    /LTH 
    /LVI 
    /NLD (Gebruik deze instellingen om Adobe PDF-documenten te maken die moeten worden gecontroleerd of moeten voldoen aan PDF/X-1a:2001, een ISO-standaard voor het uitwisselen van grafische gegevens. Raadpleeg de gebruikershandleiding van Acrobat voor meer informatie over het maken van PDF-documenten die compatibel zijn met PDF/X-1a. De gemaakte PDF-documenten kunnen worden geopend met Acrobat en Adobe Reader 4.0 en hoger.)
    /NOR 
    /POL 
    /PTB 
    /RUM 
    /RUS 
    /SKY 
    /SLV 
    /SUO 
    /SVE 
    /TUR 
    /UKR 
    /ENU (Use these settings to create Adobe PDF documents that are to be checked or must conform to PDF/X-1a:2001, an ISO standard for graphic content exchange.  For more information on creating PDF/X-1a compliant PDF documents, please refer to the Acrobat User Guide.  Created PDF documents can be opened with Acrobat and Adobe Reader 4.0 and later.)
  >>
  /Namespace [
    (Adobe)
    (Common)
    (1.0)
  ]
  /OtherNamespaces [
    <<
      /AsReaderSpreads false
      /CropImagesToFrames true
      /ErrorControl /WarnAndContinue
      /FlattenerIgnoreSpreadOverrides false
      /IncludeGuidesGrids false
      /IncludeNonPrinting false
      /IncludeSlug false
      /Namespace [
        (Adobe)
        (InDesign)
        (4.0)
      ]
      /OmitPlacedBitmaps false
      /OmitPlacedEPS false
      /OmitPlacedPDF false
      /SimulateOverprint /Legacy
    >>
    <<
      /AddBleedMarks false
      /AddColorBars false
      /AddCropMarks false
      /AddPageInfo false
      /AddRegMarks false
      /ConvertColors /ConvertToCMYK
      /DestinationProfileName ()
      /DestinationProfileSelector /DocumentCMYK
      /Downsample16BitImages true
      /FlattenerPreset <<
        /PresetSelector /HighResolution
      >>
      /FormElements false
      /GenerateStructure false
      /IncludeBookmarks false
      /IncludeHyperlinks false
      /IncludeInteractive false
      /IncludeLayers false
      /IncludeProfiles false
      /MultimediaHandling /UseObjectSettings
      /Namespace [
        (Adobe)
        (CreativeSuite)
        (2.0)
      ]
      /PDFXOutputIntentProfileSelector /DocumentCMYK
      /PreserveEditing true
      /UntaggedCMYKHandling /LeaveUntagged
      /UntaggedRGBHandling /UseDocumentProfile
      /UseDocumentBleed false
    >>
  ]
>> setdistillerparams
<<
  /HWResolution [2400 2400]
  /PageSize [612.000 792.000]
>> setpagedevice



		Superintendent of Documents
	2020-02-21T22:44:54-0500
	US GPO, Washington, DC 20401
	Superintendent of Documents
	GPO attests that this document has not been altered since it was disseminated by GPO
        

Picture Name From Date Type
Kurt Schrader D-OR 02/12/2020 Sponsor
David Schweikert R-AZ 02/12/2020 Cosponsor
Markwayne Mullin R-OK 02/12/2020 Cosponsor
Roger Marshall R-KS 02/12/2020 Cosponsor
Mike Kelly R-PA 02/12/2020 Cosponsor
Jason Crow D-CO 02/12/2020 Cosponsor
Ami Bera D-CA 02/12/2020 Cosponsor
Date Branch Action
02/12/2020 President Referred to the House Committee on Energy and Commerce.Action By: House of Representatives
02/12/2020 President Introduced in HouseAction By: House of Representatives
Summary
Congress - Bill Number Major Title
Branch Vote Date Yes No Not Voting
Wiki







Bill TEXT Points.
This Bill has been listed with the following Subjects from Texts:
Appropriations
(10)AppropriationsFor fiscal year 2020 and each fiscal year thereafter, there are appropriated to the Secretary $5,000,000 for the purpose of carrying out this subsection

Commerce
Schweikert) introduced the following bill; which was referred to the Committee on Energy and CommerceA BILLTo amend title XIX of the Social Security Act to provide States with the option under the Medicaid program to pay for covered outpatient drugs through risk-sharing value-based agreements, and for other purposes

Congress
(7)Assessments and report to Congress(A)Assessments(i)In generalNot later than 180 days after the end of each assessment period of any risk-sharing value-based payment agreement for a State approved under this subsection, the Secretary shall conduct an evaluation of such agreement which shall include an evaluation by the Chief Actuary to determine whether program spending under the risk-sharing value-based payment agreement aligned with the projections for the agreement made under paragraph (2)(

Death
(B)DeathIn the case of an individual described in subparagraph (A) who dies during the period described in such subparagraph, the State plan shall not be liable for any remaining payment for the unit of the covered outpatient drug administered to the individual which is owed under the agreement described in such subparagraph


End Bill TEXT Points.
Date Bill Major Title
Committee Name
Subject Type