H. R. 133—1752 
(1) by striking ‘‘December 18, 2020’’ each place it appears 
and inserting ‘‘September 30, 2024’’; and 
(2) in subparagraph (B), by striking ‘‘December 18, 2022’’ 
and inserting ‘‘September 30, 2026’’. 
SEC. 322. CONDITIONS OF USE FOR BIOSIMILAR BIOLOGICAL PROD-
UCTS. 
Section 351(k)(2)(A)(iii) of the Public Health Service Act (42 
U.S.C. 262(k)(2)(A)(iii)) is amended— 
(1) in subclause (I), by striking ‘‘; and’’ and inserting a 
semicolon; 
(2) in subclause (II), by striking the period and inserting 
‘‘; and’’; and 
(3) by adding at the end the following: 
‘‘(III) may include information to show that 
the conditions of use prescribed, recommended, or 
suggested in the labeling proposed for the 
biological product have been previously approved 
for the reference product.’’. 
SEC. 323. ORPHAN DRUG CLARIFICATION. 
Section 527(c) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360cc(c)) is amended by adding at the end the following: 
‘‘(3) APPLICABILITY.—This subsection applies to any drug 
designated under section 526 for which an application was 
approved under section 505 of this Act or licensed under section 
351 of the Public Health Service Act after the date of enactment 
of the FDA Reauthorization Act of 2017, regardless of the 
date on which such drug was designated under section 526.’’. 
SEC. 324. MODERNIZING THE LABELING OF CERTAIN GENERIC DRUGS. 
Chapter V of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 351 et seq.) is amended by inserting after section 503C 
the following: 
‘‘SEC. 503D. PROCESS TO UPDATE LABELING FOR CERTAIN GENERIC 
DRUGS. 
‘‘(a) DEFINITIONS.—For purposes of this section: 
‘‘(1) The term ‘covered drug’ means a drug approved under 
section 505(c)— 
‘‘(A) for which there are no unexpired patents included 
in the list under section 505(j)(7) and no unexpired period 
of exclusivity; 
‘‘(B) for which the approval of the application has been 
withdrawn for reasons other than safety or effectiveness; 
and 
‘‘(C) for which— 
‘‘(i)(I) there is new scientific evidence available 
pertaining to new or existing conditions of use that 
is not reflected in the approved labeling; 
‘‘(II) the approved labeling does not reflect current 
legal and regulatory requirements for content or for-
mat; or 
‘‘(III) there is a relevant accepted use in clinical 
practice that is not reflected in the approved labeling; 
and 
‘‘(ii) updating the approved labeling would benefit 
the public health.
H. R. 133—1753 
‘‘(2) The term ‘period of exclusivity’, with respect to a 
drug approved under section 505(c), means any period of exclu-
sivity under clause (ii), (iii), or (iv) of section 505(c)(3)(E), clause 
(ii), (iii), or (iv) of section 505(j)(5)(F), or section 505A, 505E, 
or 527. 
‘‘(3) The term ‘generic version’ means a drug approved 
under section 505(j) whose reference listed drug is a covered 
drug. 
‘‘(4) The term ‘relevant accepted use’ means a use for 
a drug in clinical practice that is supported by scientific evi-
dence that appears to the Secretary to meet the standards 
for approval under section 505. 
‘‘(5) The term ‘selected drug’ means a covered drug for 
which the Secretary has determined through the process under 
subsection (c) that the labeling should be changed. 
‘‘(b) IDENTIFICATION OF COVERED DRUGS.—The Secretary may 
identify covered drugs for which labeling updates would provide 
a public health benefit. To assist in identifying covered drugs, 
the Secretary may do one or both of the following: 
‘‘(1) Enter into cooperative agreements or contracts with 
public or private entities to review the available scientific evi-
dence concerning such drugs. 
‘‘(2) Seek public input concerning such drugs, including 
input on whether there is a relevant accepted use in clinical 
practice that is not reflected in the approved labeling of such 
drugs or whether new scientific evidence is available regarding 
the conditions of use for such drug, by— 
‘‘(A) holding one or more public meetings; 
‘‘(B) opening a public docket for the submission of 
public comments; or 
‘‘(C) other means, as the Secretary determines appro-
priate. 
‘‘(c) SELECTION
OF DRUGS
FOR UPDATING.—If the Secretary 
determines, with respect to a covered drug, that the available 
scientific evidence meets the standards under section 505 for adding 
or modifying information to the labeling or providing supplemental 
information to the labeling regarding the use of the covered drug, 
the Secretary may initiate the process under subsection (d). 
‘‘(d) INITIATION OF THE PROCESS OF UPDATING.—If the Secretary 
determines that labeling changes are appropriate for a selected 
drug pursuant to subsection (c), the Secretary shall provide notice 
to the holders of approved applications for a generic version of 
such drug that— 
‘‘(1) summarizes the findings supporting the determination 
of the Secretary that the available scientific evidence meets 
the standards under section 505 for adding or modifying 
information or providing supplemental information to the 
labeling of the covered drug pursuant to subsection (c); 
‘‘(2) provides a clear statement regarding the additional, 
modified, or supplemental information for such labeling, 
according to the determination by the Secretary (including, 
as applicable, modifications to add the relevant accepted use 
to the labeling of the drug as an additional indication for 
the drug); and 
‘‘(3) states whether the statement under paragraph (2) 
applies to the selected drug as a class of covered drugs or 
only to a specific drug product.
H. R. 133—1754 
‘‘(e) RESPONSE TO NOTIFICATION.—Within 30 days of receipt 
of notification provided by the Secretary pursuant to subsection 
(d), the holder of an approved application for a generic version 
of the selected drug shall— 
‘‘(1) agree to change the approved labeling to reflect the 
additional, modified, or supplemental information the Secretary 
has determined to be appropriate; or 
‘‘(2) notify the Secretary that the holder of the approved 
application does not believe that the requested labeling changes 
are warranted and submit a statement detailing the reasons 
why such changes are not warranted. 
‘‘(f) REVIEW OF APPLICATION HOLDER’S RESPONSE.— 
‘‘(1) IN GENERAL.—Upon receipt of the application holder’s 
response, the Secretary shall promptly review each statement 
received under subsection (e)(2) and determine which labeling 
changes pursuant to the Secretary’s notice under subsection 
(d) are appropriate, if any. If the Secretary disagrees with 
the reasons why such labeling changes are not warranted, 
the Secretary shall provide opportunity for discussions with 
the application holders to reach agreement on whether the 
labeling for the covered drug should be updated to reflect 
available scientific evidence, and if so, the content of such 
labeling changes. 
‘‘(2) 
CHANGES
TO
LABELING.—After 
considering 
all 
responses from the holder of an approved application under 
paragraph (1) or (2) of subsection (e), and any discussion under 
paragraph (1), the Secretary may order such holder to make 
the labeling changes the Secretary determines are appropriate. 
Such holder of an approved application shall— 
‘‘(A) update its paper labeling for the drug at the 
next printing of that labeling; 
‘‘(B) update any electronic labeling for the drug within 
30 days of such order; and 
‘‘(C) submit the revised labeling through the form, 
‘Supplement—Changes Being Effected’. 
‘‘(g) VIOLATION.—If the holder of an approved application for 
the generic version of the selected drug does not comply with 
the requirements of subsection (f)(2), such generic version of the 
selected drug shall be deemed to be misbranded under section 
502. 
‘‘(h) LIMITATIONS; GENERIC DRUGS.— 
‘‘(1) IN
GENERAL.—With respect to any labeling change 
required under this section, the generic version shall be deemed 
to have the same conditions of use and the same labeling 
as its reference listed drug for purposes of clauses (i) and 
(v) of section 505(j)(2)(A). Any labeling change so required shall 
not have any legal effect for the applicant that is different 
than the legal effect that would have resulted if a supplemental 
application had been submitted and approved to conform the 
labeling of the generic version to a change in the labeling 
of the reference drug. 
‘‘(2) SUPPLEMENTAL
APPLICATIONS.—Changes to labeling 
made in accordance with this section shall not be eligible for 
an exclusivity period under this Act. 
‘‘(3) SELECTION OF DRUGS.—The Secretary shall not identify 
a drug as a covered drug or select a drug label for updating 
under subsection (b) or (c) solely based on the availability
H. R. 133—1755 
of new safety information. Upon identification of a drug as 
a covered drug under subsection (b), the Secretary may then 
consider the availability of new safety information (as defined 
in section 505–1(b)) in determining whether the drug is a 
selected drug and in determining what labeling changes are 
appropriate. 
‘‘(i) RULES OF CONSTRUCTION.— 
‘‘(1) APPROVAL STANDARDS.—This section shall not be con-
strued as altering the applicability of the standards for approval 
of an application under section 505. No order shall be issued 
under this subsection unless the scientific evidence supporting 
the changed labeling meets the standards for approval 
applicable to any change to labeling under section 505. 
‘‘(2) REMOVAL OF INFORMATION.—Nothing in this section 
shall be construed to give the Secretary additional authority 
to remove approved indications for drugs, other than the 
authority described in this section. 
‘‘(3) SECRETARY AUTHORITY.—Nothing in this section shall 
be construed to limit the authority of the Secretary to require 
labeling changes under section 505(o). 
‘‘(4) MAINTENANCE OF LABELING.—Nothing in this section 
shall be construed to affect the responsibility of the holder 
of an approved application under section 505(j) to maintain 
its labeling in accordance with existing requirements, including 
subpart B of part 201 and sections 314.70 and 314.97 of title 
21, Code of Federal Regulations (or any successor regulations). 
‘‘(j) REPORTS.—Not later than 4 years after the date of the 
enactment of this section, and every 4 years thereafter, the Sec-
retary shall prepare and submit to the Committee on Energy and 
Commerce of the House of Representatives and the Committee 
on Health, Education, Labor, and Pensions of the Senate, a report 
that— 
‘‘(1) describes the actions of the Secretary under this sec-
tion, including— 
‘‘(A) the number of covered drugs and description of 
the types of drugs the Secretary has selected for labeling 
changes and the rationale for such recommended changes; 
and 
‘‘(B) the number of times the Secretary entered into 
discussions concerning a disagreement with an application 
holder or holders and a summary of the decision regarding 
a labeling change, if any; and 
‘‘(2) includes any recommendations of the Secretary for 
modifying the program under this section.’’. 
SEC. 325. BIOLOGICAL PRODUCT PATENT TRANSPARENCY. 
(a) IN GENERAL.—Section 351(k) of the Public Health Service 
Act (42 U.S.C. 262(k)) is amended by adding at the end the fol-
lowing: 
‘‘(9) PUBLIC LISTING.— 
‘‘(A) IN GENERAL.— 
‘‘(i) INITIAL PUBLICATION.—Not later than 180 days 
after the date of enactment of this paragraph, the 
Secretary shall publish and make available to the 
public in a searchable, electronic format— 
‘‘(I) a list of each biological product, by non-
proprietary name (proper name), for which, as of
H. R. 133—1756 
such date of enactment, a biologics license under 
subsection (a) or this subsection is in effect, or 
that, as of such date of enactment, is deemed 
to be licensed under this section pursuant to sec-
tion 7002(e)(4) of the Biologics Price Competition 
and Innovation Act of 2009; 
‘‘(II) the date of licensure of the marketing 
application and the application number; and 
‘‘(III) with respect to each biological product 
described in subclause (I), the licensure status, 
and, as available, the marketing status. 
‘‘(ii) REVISIONS.—Every 30 days after the publica-
tion of the first list under clause (i), the Secretary 
shall revise the list to include each biological product 
which has been licensed under subsection (a) or this 
subsection during the 30-day period or deemed licensed 
under this section pursuant to section 7002(e)(4) of 
the Biologics Price Competition and Innovation Act 
of 2009. 
‘‘(iii) PATENT
INFORMATION.—Not later than 30 
days after a list of patents under subsection (l)(3)(A), 
or a supplement to such list under subsection (l)(7), 
has been provided by the reference product sponsor 
to the subsection (k) applicant respecting a biological 
product included on the list published under this 
subparagraph, the reference product sponsor shall pro-
vide such list of patents (or supplement thereto) and 
their corresponding expiry dates to the Secretary, and 
the Secretary shall, in revisions made under clause 
(ii), include such information for such biological 
product. Within 30 days of providing any subsequent 
or supplemental list of patents to any subsequent sub-
section (k) applicant under subsection (l)(3)(A) or (l)(7), 
the reference product sponsor shall update the informa-
tion provided to the Secretary under this clause with 
any additional patents from such subsequent or supple-
mental list and their corresponding expiry dates. 
‘‘(iv) 
LISTING
OF
EXCLUSIVITIES.—For 
each 
biological product included on the list published under 
this subparagraph, the Secretary shall specify each 
exclusivity period under paragraph (6) or paragraph 
(7) for which the Secretary has determined such 
biological product to be eligible and that has not con-
cluded. 
‘‘(B) REVOCATION OR SUSPENSION OF LICENSE.—If the 
license of a biological product is determined by the Sec-
retary to have been revoked or suspended for safety, purity, 
or potency reasons, it may not be published in the list 
under subparagraph (A). If such revocation or suspension 
occurred after inclusion of such biological product in the 
list published under subparagraph (A), the reference 
product sponsor shall notify the Secretary that— 
‘‘(i) the biological product shall be immediately 
removed from such list for the same period as the 
revocation or suspension; and 
‘‘(ii) a notice of the removal shall be published 
in the Federal Register.’’.
H. R. 133—1757 
(b) REVIEW AND REPORT ON TYPES OF INFORMATION TO BE 
LISTED.—Not later than 3 years after the date of enactment of 
this Act, the Secretary of Health and Human Services shall— 
(1) solicit public comment regarding the type of information, 
if any, that should be added to or removed from the list required 
by paragraph (9) of section 351(k) of the Public Health Service 
Act (42 U.S.C. 262(k)), as added by subsection (a); and 
(2) transmit to Congress an evaluation of such comments, 
including any recommendations about the types of information 
that should be added to or removed from the list. 
Subtitle D—Technical Corrections 
SEC. 331. TECHNICAL CORRECTIONS. 
(a) EDUCATION AND TRAINING RELATING TO GERIATRICS.—Sec-
tion 753(a)(7)(B) of the Public Health Service Act (42 U.S.C. 
294c(a)(7)(B)) is amended, in the matter preceding clause (i), by 
striking ‘‘Title VII Health Care Workforce Reauthorization Act of 
2019’’ and inserting ‘‘Coronavirus Aid, Relief, and Economic Security 
Act’’. 
(b) NURSING.—Section 851(d)(3) of the Public Health Service 
Act (42 U.S.C. 297t(d)(3)) is amended by striking ‘‘Title VIII Nursing 
Reauthorization Act’’ and inserting ‘‘Coronavirus Aid, Relief, and 
Economic Security Act’’. 
(c) CITATION.—Section 3404(a)(9) of the Coronavirus Aid, Relief, 
and Economic Security Act (Public Law 116–136) is amended by 
striking ‘‘section 846A (42 U.S.C. 247n–1)’’ and inserting ‘‘section 
846A (42 U.S.C. 297n–1)’’. 
(d) EFFECTIVE DATE.—The amendments made by subsections 
(a), (b), and (c) shall take effect as if included in the enactment 
of the Coronavirus Aid, Relief, and Economic Security Act (Public 
Law 116–136). 
DIVISION CC—HEALTH EXTENDERS 
SEC. 1. TABLE OF CONTENTS. 
Sec. 1. Table of contents. 
TITLE I—MEDICARE PROVISIONS 
Subtitle A—Medicare Extenders 
Sec. 101. Extension of the work geographic index floor under the medicare pro-
gram. 
Sec. 102. Extension of funding for quality measure endorsement, input, and selec-
tion. 
Sec. 103. Extension of funding outreach and assistance for low-income programs. 
Sec. 104. Extension of medicare patient IVIG access demonstration project. 
Sec. 105. Extending the independence at home medical practice demonstration pro-
gram under the medicare program. 
Subtitle B—Other Medicare Provisions 
Sec. 111. Improving measurements under the skilled nursing facility value-based 
purchasing program under the Medicare program. 
Sec. 112. Providing the Medicare Payment Advisory Commission and Medicaid and 
CHIP Payment and Access Commission with access to certain drug pay-
ment information, including certain rebate information. 
Sec. 113. Moratorium on payment under the Medicare physician fee schedule of the 
add on code for inherently complex evaluation and management visits.
H. R. 133—1758 
Sec. 114. Temporary freeze of APM payment incentive thresholds. 
Sec. 115. Permitting occupational therapists to conduct the initial assessment visit 
and complete the comprehensive assessment with respect to certain re-
habilitation services for home health agencies under the Medicare pro-
gram. 
Sec. 116. Centers for Medicare & Medicaid Services provider outreach and report-
ing on cognitive assessment and care plan services. 
Sec. 117. Continued coverage of certain temporary transitional home infusion ther-
apy services. 
Sec. 118. Transitional coverage and retroactive Medicare part D coverage for cer-
tain low-income beneficiaries. 
Sec. 119. Increasing the use of real-time benefit tools to lower beneficiary costs. 
Sec. 120. Beneficiary enrollment simplification. 
Sec. 121. Waiving budget neutrality for oxygen under the Medicare program. 
Sec. 122. Waiving medicare coinsurance for certain colorectal cancer screening 
tests. 
Sec. 123. Expanding access to mental health services furnished through telehealth. 
Sec. 124. Public-private partnership for health care waste, fraud, and abuse detec-
tion. 
Sec. 125. Medicare payment for rural emergency hospital services. 
Sec. 126. Distribution of additional residency positions. 
Sec. 127. Promoting Rural Hospital GME Funding Opportunity. 
Sec. 128. Five-year extension of the rural community hospital demonstration pro-
gram. 
Sec. 129. Extension of Frontier Community Health Integration Project Demonstra-
tion. 
Sec. 130. Improving rural health clinic payments. 
Sec. 131. Medicare GME treatment of hospitals establishing new medical residency 
training programs after hosting medical resident rotators for short dura-
tions. 
Sec. 132. Medicare payment for certain Federally qualified health center and rural 
health clinic services furnished to hospice patients. 
Sec. 133. Delay to the implementation of the radiation oncology model under the 
Medicare program. 
Sec. 134. Improving access to skilled nursing facility services for hemophilia pa-
tients. 
TITLE II—MEDICAID EXTENDERS AND OTHER POLICIES 
Sec. 201. Eliminating DSH reductions for fiscal years 2021 through 2023. 
Sec. 202. Supplemental payment reporting requirements. 
Sec. 203. Medicaid shortfall and third party payments. 
Sec. 204. Extension of Money Follows the Person Rebalancing Demonstration. 
Sec. 205. Extension of spousal impoverishment protections. 
Sec. 206. Extension of community mental health services demonstration program. 
Sec. 207. Clarifying authority of State Medicaid fraud and abuse control units to 
investigate and prosecute cases of Medicaid patient abuse and neglect 
in any setting. 
Sec. 208. Medicaid coverage for citizens of Freely Associated States. 
Sec. 209. Medicaid coverage of certain medical transportation. 
Sec. 210. Promoting access to life-saving therapies for Medicaid enrollees by ensur-
ing coverage of routine patient costs for items and services furnished in 
connection with participation in qualifying clinical trials. 
TITLE III—HUMAN SERVICES 
Sec. 301. Extension of TANF, child care entitlement to States, and related pro-
grams. 
Sec. 302. Personal responsibility education extension. 
Sec. 303. Sexual risk avoidance education extension. 
Sec. 304. Extension of support for current health professions opportunity grants. 
Sec. 305. Extension of MaryLee Allen Promoting Safe and Stable Families Program 
and State court support. 
TITLE IV—HEALTH OFFSETS 
Sec. 401. Requiring certain manufacturers to report drug pricing information with 
respect to drugs under the Medicare program. 
Sec. 402. Extended months of coverage of immunosuppressive drugs for kidney 
transplant patients and other renal dialysis provisions. 
Sec. 403. Permitting direct payment to physician assistants under Medicare. 
Sec. 404. Adjusting calculation of hospice cap amount under Medicare. 
Sec. 405. Special rule for determination of ASP in cases of certain noncovered self- 
administered drug products.
H. R. 133—1759 
Sec. 406. Medicaid Improvement Fund. 
Sec. 407. Establishing hospice program survey and enforcement procedures under 
the Medicare program. 
Sec. 408. Medicare Improvement Fund. 
TITLE V—MISCELLANEOUS 
Sec. 501. Implementation funding. 
TITLE I—MEDICARE PROVISIONS 
Subtitle A—Medicare Extenders 
SEC. 101. EXTENSION OF THE WORK GEOGRAPHIC INDEX FLOOR 
UNDER THE MEDICARE PROGRAM. 
Section 1848(e)(1)(E) of the Social Security Act (42 U.S.C. 
1395w–4(e)(1)(E)), as amended by section 3801 of the CARES Act 
(Public Law 116–136), section 2201 of the Continuing Appropria-
tions Act, 2021 and Other Extensions Act (Public Law 116–159), 
and section 1101 of the Further Continuing Appropriations Act, 
2021, and Other Extensions Act, is amended by striking ‘‘December 
19, 2020’’ and inserting ‘‘January 1, 2024’’. 
SEC. 102. EXTENSION OF FUNDING FOR QUALITY MEASURE ENDORSE-
MENT, INPUT, AND SELECTION. 
(a) EXTENSION.—Section 1890(d)(2) of the Social Security Act 
(42 U.S.C. 1395aaa(d)(2)), as amended by section 1103 of the Fur-
ther Continuing Appropriations Act, 2021, and Other Extensions 
Act, is amended— 
(1) in the first sentence, by striking ‘‘and for the period 
beginning on October 1, 2020, and ending on December 18, 
2020, the amount equal to the pro rata portion of the amount 
appropriated for such period for fiscal year 2020’’ and inserting 
‘‘ $26,000,000 for fiscal year 2021, $20,000,000 for fiscal year 
2022, and $20,000,000 for fiscal year 2023’’; and 
(2) in the third sentence, by striking ‘‘and 2020, and for 
the period beginning on October 1, 2020, and ending on 
December 18, 2020’’ and inserting ‘‘2020, 2021, 2022, and 2023’’. 
(b) ADDITIONAL REPORTING REQUIREMENTS.—Section 1890 of 
the Social Security Act (42 U.S.C. 1395aaa) is amended— 
(1) in subsection (e)— 
(A) by redesignating paragraphs (1) through (6) as 
subparagraphs (A) through (F), respectively; 
(B) by striking ‘‘CONGRESS.—By not later than’’ and 
inserting ‘‘CONGRESS.— 
‘‘(1) IN GENERAL.—By not later than’’; 
(C) in subparagraph (A), as redesignated by this para-
graph, by striking the last sentence; 
(D) in subparagraph (D), as so redesignated, by striking 
‘‘A description’’ and inserting ‘‘Subject to paragraph (2)(B), 
a description’’; 
(E) in subparagraph (E), as so redesignated, by striking 
‘‘The amount’’ and inserting ‘‘Subject to paragraph (2)(B), 
the amount’’; 
(F) in subparagraph (F), as so redesignated, by striking 
‘‘Estimates’’ and inserting ‘‘Subject to paragraph (2)(B), 
estimates’’; and 
(G) by adding at the end the following new paragraph:
H. R. 133—1760 
‘‘(2) ADDITIONAL REQUIREMENTS FOR REPORTS.— 
‘‘(A) ADDRESSING
GAO
REPORT.—Each of the annual 
reports submitted in 2021 and 2022 pursuant to paragraph 
(1) shall also include the following: 
‘‘(i) A comprehensive analysis detailing the ways 
in which the Centers for Medicare & Medicaid Services 
has addressed each of the recommendations set forth 
in the report by the Government Accountability Office 
(GAO–19–628) issued on September 19, 2019, and 
titled ‘Health Care Quality: CMS Could More Effec-
tively Ensure Its Quality Measurement Activities Pro-
mote Its Objectives’. 
‘‘(ii) A detailed description of— 
‘‘(I) any additional steps that the Centers for 
Medicare & Medicaid Services expects to take to 
address the findings and recommendations set 
forth in such report; and 
‘‘(II) the anticipated timing for such steps. 
‘‘(B) ENSURING DETAILED INFORMATION.— 
‘‘(i) IN GENERAL.—In the case of an annual report 
submitted in 2021 or a subsequent year pursuant to 
paragraph (1), the information required under— 
‘‘(I) paragraph (1)(D) shall also include 
detailed information on each of the activities 
described in clause (ii); 
‘‘(II) paragraph (1)(E) shall also include 
detailed information on the specific amounts obli-
gated or expended on each of the activities 
described in clause (ii); and 
‘‘(III) paragraph (1)(F) shall also include 
detailed information on the specific quality 
measurement 
activities 
required 
and 
future 
funding needed for each of the activities described 
in clause (ii). 
‘‘(ii) 
ACTIVITIES
DESCRIBED.—The 
activities 
described in this clause are the following: 
‘‘(I) Measure selection activities. 
‘‘(II) Measure development activities. 
‘‘(III) Public reporting activities. 
‘‘(IV) Education and outreach activities.’’; and 
(2) by adding at the end the following new subsection: 
‘‘(f) ADDITIONAL REPORTING BY THE SECRETARY TO CONGRESS.— 
‘‘(1) IN GENERAL.—By not later than September 30 of each 
year (beginning with 2021), the Secretary shall submit to Con-
gress a report on the amount of unobligated balances for appro-
priations relating to quality measurement. Such report shall 
include detailed plans on how the Secretary expects to expend 
such unobligated balances in the upcoming fiscal years. 
‘‘(2) SEPARATE REPORT.—The annual report required under 
paragraph (1) shall be separate from the annual report required 
under subsection (e).’’. 
(c) INPUT FOR REMOVAL OF MEASURES.—Section 1890(b) of the 
Social Security Act (42 U.S.C. 1395aaa(b)) is amended by inserting 
after paragraph (3) the following new paragraph: 
‘‘(4) REMOVAL OF MEASURES.—The entity may provide input 
to the Secretary on quality and efficiency measures described 
in paragraph (7)(B) that could be considered for removal.’’.
H. R. 133—1761 
(d) 
PRIORITIZATION
OF
MEASURE
ENDORSEMENT.—Section 
1890(b) of the Social Security Act (42 U.S.C. 1395aaa(b)) is amended 
by adding at the end the following new paragraph: 
‘‘(9) PRIORITIZATION OF MEASURE ENDORSEMENT.—The Sec-
retary— 
‘‘(A) during the period beginning on the date of the 
enactment of this paragraph and ending on December 31, 
2023, shall prioritize the endorsement of measures relating 
to maternal morbidity and mortality by the entity with 
a contract under subsection (a) in connection with endorse-
ment of measures described in paragraph (2); and 
‘‘(B) on and after January 1, 2024, may prioritize the 
endorsement of such measures by such entity.’’. 
SEC. 103. EXTENSION OF FUNDING OUTREACH AND ASSISTANCE FOR 
LOW-INCOME PROGRAMS. 
(a) STATE HEALTH INSURANCE PROGRAMS.—Subsection (a)(1)(B) 
of section 119 of the Medicare Improvements for Patients and 
Providers Act of 2008 (42 U.S.C. 1395b–3 note), as amended by 
section 3306 of the Patient Protection and Affordable Care Act 
(Public Law 111–148), section 610 of the American Taxpayer Relief 
Act of 2012 (Public Law 112–240), section 1110 of the Pathway 
for SGR Reform Act of 2013 (Public Law 113–67), section 110 
of the Protecting Access to Medicare Act of 2014 (Public Law 113– 
93), section 208 of the Medicare Access and CHIP Reauthorization 
Act of 2015 (Public Law 114–10), section 50207 of division E of 
the Bipartisan Budget Act of 2018 (Public Law 115–123), section 
1402 of division B of the Continuing Appropriations Act, 2020, 
and Health Extenders Act of 2019 (Public Law 116–59), section 
1402 of division B of the Further Continuing Appropriations Act, 
2020, and Further Health Extenders Act of 2019 (Public Law 116– 
69), section 103 of division N of the Further Consolidated Appropria-
tions Act, 2020 (Public Law 116–94), section 3803 of the CARES 
Act (Public Law 116–136), section 2203 of the Continuing Appropria-
tions Act, 2021 and Other Extensions Act (Public Law 116–159), 
and section 1102 of the Further Continuing Appropriations Act, 
2021, and Other Extensions Act, is amended— 
(1) in clause (x), by striking at the end ‘‘and’’; and 
(2) by striking clause (xi) and inserting the following 
clauses: 
‘‘(xi) for fiscal year 2021, $15,000,000; 
‘‘(xii) for fiscal year 2022, $15,000,000; and 
‘‘(xiii) for fiscal year 2023, $15,000,000.’’. 
(b) AREA AGENCIES ON AGING.—Subsection (b)(1)(B) of such 
section 119, as so amended, is amended— 
(1) in clause (x), by striking at the end ‘‘and’’; and 
(2) by striking clause (xi) and inserting the following 
clauses: 
‘‘(xi) for fiscal year 2021, $15,000,000; 
‘‘(xii) for fiscal year 2022, $15,000,000; and 
‘‘(xiii) for fiscal year 2023, $15,000,000.’’. 
(c) AGING
AND DISABILITY RESOURCE CENTERS.—Subsection 
(c)(1)(B) of such section 119, as so amended, is amended— 
(1) in clause (x), by striking at the end ‘‘and’’; 
(2) by striking clause (xi) and inserting the following 
clauses: 
‘‘(xi) for fiscal year 2021, $5,000,000;
H. R. 133—1762 
‘‘(xii) for fiscal year 2022, $5,000,000; and 
‘‘(xiii) for fiscal year 2023, $5,000,000,’’. 
(d) CONTRACT WITH THE NATIONAL CENTER FOR BENEFITS AND 
OUTREACH ENROLLMENT.—Subsection (d)(2) of such section 119, 
as so amended, is amended— 
(1) in clause (x), by striking at the end ‘‘and’’; 
(2) by striking clause (xi) and inserting the following 
clauses: 
‘‘(xi) for fiscal year 2021, $15,000,000; 
‘‘(xii) for fiscal year 2022, $15,000,000; and 
‘‘(xiii) for fiscal year 2023, $15,000,000.’’. 
SEC. 104. EXTENSION OF MEDICARE PATIENT IVIG ACCESS DEM-
ONSTRATION PROJECT. 
(a) EXTENSION OF DEMONSTRATION PROJECT.—Section 101(b) 
of the Medicare IVIG Access and Strengthening Medicare and 
Repaying Taxpayers Act of 2012 (42 U.S.C. 13951 note) is 
amended— 
(1) by striking paragraph (1) and inserting the following: 
‘‘(1) DURATION.—Beginning not later than one year after 
the date of enactment of this Act, the Secretary shall conduct 
the demonstration project for a period of 3 years and, subject 
to the availability of funds under subsection (g), the period 
beginning on October 1, 2017, and ending on December 31, 
2023.’’; and 
(2) in paragraph (2)— 
(A) by amending the first sentence to read as follows: 
‘‘The Secretary shall enroll for participation in the dem-
onstration project for the period beginning on October 1, 
2014, and ending on September 30, 2020, not more than 
4,000 Medicare beneficiaries who have been diagnosed with 
primary immunodeficiency disease and for the period begin-
ning on October 1, 2014, and ending on December 31, 
2023, not more than 6,500 Medicare beneficiaries who have 
been so diagnosed.’’; and 
(B) by striking ‘‘December 31, 2020’’ and inserting 
‘‘December 31, 2023’’. 
(b) UPDATED
EVALUATION
AND
REPORT.—Section 101(f) is 
amended— 
(1) by redesignating paragraph (2) as paragraph (3); and 
(2) by inserting after paragraph (1) the following new para-
graph: 
‘‘(2) UPDATED EVALUATION AND REPORT.—Not later than 
2 years after the date of the enactment of Consolidated Appro-
priations Act, 2021, the Secretary shall submit to Congress 
an updated report that contains the following: 
‘‘(A) The total number of beneficiaries enrolled in the 
demonstration project during the updated report period. 
‘‘(B) The total number of claims submitted for services 
during the updated report period, disaggregated by month. 
‘‘(C) An analysis of the impact of the demonstration 
on beneficiary access to the in-home administration of 
intravenous immune globin, including the impact on bene-
ficiary health. 
‘‘(D) An analysis of the impact of in-home administra-
tion of intravenous immune globin on overall costs to Medi-
care, including the cost differential between in-home
H. R. 133—1763 
administration of intravenous immune globin and adminis-
tration of intravenous immune globin in a healthcare 
facility. 
‘‘(E) To the extent practicable, a survey of providers 
and enrolled beneficiaries that participated in the dem-
onstration project that identifies barriers to accessing serv-
ices, including reimbursement for items and services. 
‘‘(F) Recommendations to Congress on the appropriate-
ness of establishing a permanent bundled services payment 
for the in-home administration of intravenous immune 
globin for Medicare beneficiaries.’’. 
(c) DEFINITION OF UPDATED REPORT PERIOD.—Section 101(h) 
is amended by adding at the end the following new paragraph: 
‘‘(4) UPDATED REPORT PERIOD.—The term ‘updated report 
period’ means the period beginning on October 1, 2014, and 
ending on September 30, 2020.’’. 
SEC. 105. EXTENDING THE INDEPENDENCE AT HOME MEDICAL PRAC-
TICE DEMONSTRATION PROGRAM UNDER THE MEDI-
CARE PROGRAM. 
(a) IN GENERAL.—Section 1866E of the Social Security Act 
(42 U.S.C. 1395cc–5) is amended— 
(1) in subsection (e)— 
(A) in paragraph (1), by striking ‘‘7-year’’ and inserting 
‘‘10-year’’; and 
(B) in paragraph (5)— 
(i) in the first sentence, by striking ‘‘15,000’’ and 
inserting ‘‘20,000’’; 
(ii) in the second sentence, by striking ‘‘sixth and 
seventh’’ and inserting ‘‘sixth through tenth’’; and 
(iii) by adding at the end the following new sen-
tence: ‘‘An applicable beneficiary that participates in 
the demonstration program by reason of the increase 
from 15,000 to 20,000 in the first sentence of this 
paragraph pursuant to the amendment made by section 
105 of division CC of the Consolidated Appropriations 
Act, 2021 shall be considered in the spending target 
estimates under paragraph (1) of subsection (c) and 
the incentive payment calculations under paragraph 
(2) of such subsection for the eighth through tenth 
years of such program.’’; and 
(2) in subsection (h), by inserting ‘‘and $9,000,000 for fiscal 
year 2021’’ after ‘‘2015’’. 
(b) EFFECTIVE DATE.—The amendments made by subsection 
(a) shall take effect as if included in the enactment of Public 
Law 111–148. 
Subtitle B—Other Medicare Provisions 
SEC. 111. IMPROVING MEASUREMENTS UNDER THE SKILLED NURSING 
FACILITY VALUE-BASED PURCHASING PROGRAM UNDER 
THE MEDICARE PROGRAM. 
(a) IN GENERAL.—Section 1888(h) of the Social Security Act 
(42 U.S.C. 1395yy(h)) is amended— 
(1) in paragraph (1), by adding at the end the following 
new subparagraph:
H. R. 133—1764 
‘‘(C) EXCLUSIONS.—With respect to payments for serv-
ices furnished on or after October 1, 2022, this subsection 
shall not apply to a facility for which there are not a 
minimum number (as determined by the Secretary) of— 
‘‘(i) cases for the measures that apply to the facility 
for the performance period for the applicable fiscal 
year; or 
‘‘(ii) measures that apply to the facility for the 
performance period for the applicable fiscal year.’’; 
(2) in paragraph (2)(A)— 
(A) by striking ‘‘The Secretary shall apply’’ and 
inserting ‘‘The Secretary— 
‘‘(i) shall apply’’; 
(B) by striking the period at the end and inserting 
‘‘; and’’; and 
(C) by adding at the end the following: 
‘‘(ii) may, with respect to payments for services 
furnished on or after October 1, 2023, apply additional 
measures determined appropriate by the Secretary, 
which may include measures of functional status, 
patient safety, care coordination, or patient experience. 
Subject to the succeeding sentence, in the case that the 
Secretary applies additional measures under clause (ii), 
the Secretary shall consider and apply, as appropriate, 
quality measures specified under section 1899B(c)(1). In 
no case may the Secretary apply more than 10 measures 
under this subparagraph.’’; 
(3) in subparagraph (A) of each of paragraphs (3) and 
(4), by striking ‘‘measure’’ and inserting ‘‘measures’’; and 
(4) by adding at the end the following new paragraph: 
‘‘(12) VALIDATION.— 
‘‘(A) IN GENERAL.—The Secretary shall apply to the 
measures applied under this subsection and the data sub-
mitted under subsection (e)(6) a process to validate such 
measures and data, as appropriate, which may be similar 
to the process specified in section 1886(b)(3)(B)(viii)(XI) 
for validating inpatient hospital measures. 
‘‘(B) FUNDING.—For purposes of carrying out this para-
graph, the Secretary shall provide for the transfer, from 
the Federal Hospital Insurance Trust Fund established 
under section 1817, of $5,000,000 to the Centers for Medi-
care & Medicaid Services Program Management Account 
for each of fiscal years 2023 through 2025, to remain avail-
able until expended.’’. 
(b) REPORT BY MEDPAC.—Not later than March 15, 2022, the 
Medicare Payment Advisory Commission shall submit to Congress 
a report on establishing a prototype value-based payment program 
under a unified prospective payment system for post-acute care 
services under the Medicare program under title XVIII of the Social 
Security Act (42 U.S.C. 1395 et seq.). Such report— 
(1) shall— 
(A) consider design elements such as— 
(i) measures that are important to the Medicare 
program and to beneficiaries under such program; 
(ii) methodologies for scoring provider performance 
and effects on payment; and
H. R. 133—1765 
(iii) other elements determined appropriate by the 
Commission; and 
(B) analyze the effects of implementing such prototype 
program; and 
(2) may— 
(A) discuss the possible effects, with respect to the 
Medicare program, on program spending, post-acute care 
providers, patient outcomes, and other effects determined 
appropriate by the Commission; and 
(B) include recommendations with respect to such 
prototype program, as determined appropriate by the 
Commission, to Congress and the Secretary of Health and 
Human Services. 
SEC. 112. PROVIDING THE MEDICARE PAYMENT ADVISORY COMMIS-
SION AND MEDICAID AND CHIP PAYMENT AND ACCESS 
COMMISSION WITH ACCESS TO CERTAIN DRUG PAYMENT 
INFORMATION, INCLUDING CERTAIN REBATE INFORMA-
TION. 
(a) ACCESS
TO CERTAIN PART D PAYMENT DATA.—Section 
1860D–15(f) of the Social Security Act (42 U.S.C. 1395w–115(f)) 
is amended— 
(1) in paragraph (2)— 
(A) in subparagraph (A)(ii), by striking ‘‘and’’ at the 
end; 
(B) in subparagraph (B), by striking the period at 
the end and inserting ‘‘; and’’; and 
(C) by inserting at the end the following new subpara-
graph: 
‘‘(C) by the Executive Director of the Medicare Payment 
Advisory Commission for purposes of monitoring, making 
recommendations for, and analysis of the program under 
this title and by the Executive Director of the Medicaid 
and CHIP Payment and Access Commission for purposes 
of monitoring, making recommendations for, and analysis 
of the Medicaid program established under title XIX and 
the Children’s Health Insurance Program under title XXI.’’; 
and 
(2) by adding at the end the following new paragraph: 
‘‘(3) ADDITIONAL RESTRICTIONS ON DISCLOSURE OF INFORMA-
TION.— 
‘‘(A) IN GENERAL.—The Executive Directors described 
in paragraph (2)(C) shall not disclose any of the following 
information disclosed to such Executive Directors or 
obtained by such Executive Directors pursuant to such 
paragraph, with respect to a prescription drug plan offered 
by a PDP sponsor or an MA–PD plan offered by an MA 
organization: 
‘‘(i) The specific amounts or the identity of the 
source of any rebates, discounts, price concessions, or 
other forms of direct or indirect remuneration under 
such prescription drug plan or such MA–PD plan. 
‘‘(ii) Information submitted with the bid submitted 
under section 1860D–11(b) by such PDP sponsor or 
under section 1854(a) by such MA organization. 
‘‘(iii) In the case of such information from prescrip-
tion drug event records, information in a form that