H. R. 2617—1429 
vacancies, the number of full-time equivalents funded by 
fees collected pursuant to section 744H, and the number 
of full time equivalents funded by budget authority at 
the Food and Drug Administration by each division within 
the Center for Drug Evaluation and Research, the Center 
for Biologics Evaluation and Research, the Office of Regu-
latory Affairs, and the Office of the Commissioner;’’; 
(B) by amending subparagraph (B) to read as follows: 
‘‘(B) data, analysis, and discussion of the changes in 
the fee revenue amounts and costs for the process for 
the review of biosimilar biological product applications, 
including identifying— 
‘‘(i) drivers of such changes; and 
‘‘(ii) changes in the average total cost per full- 
time equivalent in the biosimilar biological product 
review program;’’; 
(C) in subparagraph (C), by striking the period at 
the end and inserting ‘‘; and’’; and 
(D) by adding at the end the following: 
‘‘(D) data, analysis, and discussion of the changes in 
the average full-time equivalent hours required to complete 
review of each type of biosimilar biological product applica-
tion.’’. 
(2) REAUTHORIZATION.—Section 744I(f) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379j–53(f)) is amended— 
(A) by redesignating paragraphs (2) and (3) as para-
graphs (5) and (6), respectively; 
(B) by inserting after paragraph (1) the following: 
‘‘(2) PRIOR PUBLIC INPUT.—Prior to beginning negotiations 
with the regulated industry on the reauthorization of this part, 
the Secretary shall— 
‘‘(A) publish a notice in the Federal Register requesting 
public input on the reauthorization; 
‘‘(B) hold a public meeting at which the public may 
present its views on the reauthorization; 
‘‘(C) provide a period of 30 days after the public meeting 
to obtain written comments from the public suggesting 
changes to this part; and 
‘‘(D) publish the comments on the Food and Drug 
Administration’s website. 
‘‘(3) PERIODIC
CONSULTATION.—Not less frequently than 
once every month during negotiations with the regulated 
industry, the Secretary shall hold discussions with representa-
tives of patient and consumer advocacy groups to continue 
discussions of their views on the reauthorization and their 
suggestions for changes to this part as expressed under para-
graph (2). 
‘‘(4) UPDATES TO CONGRESS.—The Secretary, in consultation 
with regulated industry, shall provide regular updates on nego-
tiations on the reauthorization of this part to the Committee 
on Health, Education, Labor, and Pensions of the Senate and 
the Committee on Energy and Commerce of the House of Rep-
resentatives.’’; and 
(C) by adding at the end the following: 
‘‘(7) MINUTES OF NEGOTIATION MEETINGS.— 
‘‘(A) PUBLIC AVAILABILITY.—The Secretary shall make 
publicly available, on the public website of the Food and
H. R. 2617—1430 
Drug Administration, minutes of all negotiation meetings 
conducted under this subsection between the Food and 
Drug Administration and the regulated industry, not later 
than 30 days after each such negotiation meeting. 
‘‘(B) CONTENT.—The minutes described under subpara-
graph (A) shall summarize, in sufficient detail, any sub-
stantive proposal made by any party to the negotiations 
as well as significant controversies or differences of opinion 
during the negotiations and their resolution.’’. 
SEC. 3627. IMPROVING INFORMATION TECHNOLOGY SYSTEMS OF THE 
FOOD AND DRUG ADMINISTRATION. 
(a) FDA STRATEGIC INFORMATION TECHNOLOGY PLAN.— 
(1) IN GENERAL.—Not later than September 30, 2023, and 
at least every 4 years thereafter, the Secretary shall develop 
and submit to the appropriate committees of Congress and 
post on the website of the Food and Drug Administration, 
a coordinated information technology strategic plan to mod-
ernize the information technology systems of the Food and 
Drug Administration. Each such report shall be known as the 
‘‘Food and Drug Administration Strategic Information Tech-
nology Plan’’. The first such report may include the Data and 
Technology Modernization Strategy, as set forth in the letters 
described in section 1001(b) of the FDA User Fee Reauthoriza-
tion Act of 2022 (division F of Public Law 117–180). 
(2) CONTENT
OF
STRATEGIC
PLAN.—The Food and Drug 
Administration Strategic Information Technology Plan under 
paragraph (1) shall include— 
(A) agency-wide strategic goals and priorities for mod-
ernizing the information technology systems of the Food 
and Drug Administration to maximize the efficiency and 
effectiveness of such systems for enabling the Food and 
Drug Administration to fulfill its public health mission; 
(B) specific activities and strategies for achieving the 
goals and priorities identified under subparagraph (A), and 
specific milestones, metrics, and performance measures for 
assessing progress against such strategic goals and prior-
ities; 
(C) specific activities and strategies for improving and 
streamlining internal coordination and communication 
within the Food and Drug Administration, including for 
activities and communications related to signals of poten-
tial public health concerns; 
(D) challenges and risks the Food and Drug Adminis-
tration will face in meeting its strategic goals and priorities, 
and the activities the Food and Drug Administration will 
undertake to overcome those challenges and mitigate those 
risks; 
(E) the ways in which the Food and Drug Administra-
tion will use the Plan to guide and coordinate the projects 
and activities of the Food and Drug Administration across 
its offices and centers; and 
(F) a skills inventory, needs assessment, gap analysis, 
and initiatives to address skills gaps as part of a strategic 
approach to information technology human capital plan-
ning.
H. R. 2617—1431 
(3) EVALUATION
OF
PROGRESS.—Each Food and Drug 
Administration Strategic Information Technology Plan issued 
pursuant to this subsection, with the exception of the first 
such Food and Drug Administration Strategic Information Tech-
nology Plan, shall include an evaluation of— 
(A) the progress the Secretary has made, based on 
the metrics, benchmarks, and other milestones that 
measure successful development and implementation of 
information technology systems; and 
(B) whether actions taken in response to the previous 
Plan improved the capacity of the Food and Drug Adminis-
tration to achieve the strategic goals and priorities set 
forth in such previous Plans. 
(b) GAO REPORT.— 
(1) IN GENERAL.—Not later than September 30, 2026, the 
Comptroller General of the United States shall submit to the 
Committee on Health, Education, Labor, and Pensions of the 
Senate and the Committee on Energy and Commerce of the 
House of Representatives a report assessing the implementation 
of the Food and Drug Administration Strategic Information 
Technology Plan adopted pursuant to subsection (a). 
(2) CONTENT OF REPORT.—The report required under para-
graph (1) shall include an assessment of— 
(A) the development and implementation of the Food 
and Drug Administration Strategic Information Technology 
Plan, including the sufficiency of the plan, progress of 
the Food and Drug Administration in meeting the results- 
oriented goals, milestones, and performance measures 
identified in such plan and any gaps in such implementa-
tion; 
(B) the efficiency and effectiveness of the Food and 
Drug Administration’s expenditures on information tech-
nology systems over the preceding 10 fiscal years, including 
the implementation by the Food and Drug Administration 
of the Technology Modernization Action Plan and Data 
Modernization Action Plan; 
(C) challenges posed by the information technology 
systems of the Food and Drug Administration for carrying 
out the Food and Drug Administration’s public health mis-
sion, including on meeting user fee agreement performance 
goals, conducting inspections, responding to identified 
safety concerns, and keeping pace with new scientific and 
medical advances; and 
(D) recommendations for the Food and Drug Adminis-
tration to address the identified challenges, improve its 
implementation of the Food and Drug Administration Stra-
tegic Information Technology Plan, and to otherwise 
improve the Food and Drug Administration’s information 
technology systems. 
SEC. 3628. REPORTING ON MAILROOM AND OFFICE OF THE EXECUTIVE 
SECRETARIAT OF THE FOOD AND DRUG ADMINISTRA-
TION. 
(a) REPORT.—Not later than 90 days after the date of enactment 
of this Act, the Secretary shall report to the Committee on Health, 
Education, Labor, and Pensions of the Senate and the Committee 
on Energy and Commerce of the House of Representatives on—
H. R. 2617—1432 
(1) information related to policies, procedures, and activities 
of the mailroom and the Office of the Executive Secretariat 
of the Food and Drug Administration, including— 
(A) taking receipt, tracking, managing, and prioritizing 
confidential informant complaints; 
(B) taking receipt of common carrier packages to the 
Food and Drug Administration; 
(C) the organizational structure and management of 
the mailroom; 
(D) the organizational structure and management of 
the Office of the Executive Secretariat; 
(E) the total number of employees and contractors 
in the mailroom including those working remotely and 
those working in person; 
(F) the total number of employees and contractors in 
the Office of the Executive Secretariat; 
(G) the number of vacant positions in the mailroom; 
(H) the number of vacant positions in the Office of 
the Executive Secretariat; 
(I) the average number of days for response to cor-
respondence received by the Office of the Secretariat; 
(J) the extent to which there is a backlog of common 
carrier packages received by the mailroom and the number 
of common carrier packages in any backlog; 
(K) the extent to which there is a backlog of correspond-
ence in the Office of the Executive Secretariat that has 
not been appropriately responded to by the Food and Drug 
Administration and the number of correspondence or 
common carrier packages in any backlog; 
(L) a rationale for the failure of the Office of the 
Executive Secretariat to respond to correspondence in any 
backlog and the position of the decision-making official 
who determined not to respond to such correspondence; 
(M) the number of whistleblower correspondence 
received, including within each agency center; 
(N) the amount of resources expended for the mailroom, 
including a breakdown of budget authority and user fee 
dollars; 
(O) the amount of resources expended for the Office 
of the Executive Secretariat and correspondence-related 
activities, including a breakdown of budget authority and 
user fee dollars; and 
(P) the performance of third-party contractors respon-
sible for correspondence-related activities with respect to 
the receipt and tracking of correspondence, and efforts 
by the Food and Drug Administration to improve perform-
ance by such contractors; and 
(2) the development and implementation of new or revised 
policies and procedures of the Food and Drug Administration 
to monitor and ensure— 
(A) the effective receipt, tracking, managing, and 
prioritization of such complaints; and 
(B) the effective receipt of common carrier packages 
to the Food and Drug Administration. 
(b) ANNUAL REPORT.—Not later than the end of each of fiscal 
years 2023 and 2024, the Secretary shall issue a report to the 
Committee on Health, Education, Labor, and Pensions of the Senate
H. R. 2617—1433 
and the Committee on Energy and Commerce of the House of 
Representatives on the implementation of the new or revised poli-
cies of the Food and Drug Administration reported under subsection 
(a)(2), and since such implementation— 
(1) the volume of incoming common carrier packages to 
the mailroom; 
(2) the volume of incoming correspondence to the Office 
of the Executive Secretariat; 
(3) the extent to which new backlogs occur in the processing 
of common carrier packages received by the mailroom; 
(4) the extent to which new backlogs occur in the processing 
of correspondence received by the Office of the Executive Secre-
tariat; 
(5) the length of time required to resolve each such backlog; 
(6) any known issues of unreasonable delays in correspond-
ence being provided to the intended recipient, or in correspond-
ence being lost, and the measures taken to remedy such delays 
or lost items; 
(7) the average number of days it takes to respond to 
correspondence received by the Office of the Executive Secre-
tariat; 
(8) the resources expended by the mailroom, including a 
breakdown of budget authority and user fee dollars; and 
(9) the resources expended by the Office of the Executive 
Secretariat on correspondence-related activities, including a 
breakdown of budget authority and user fee dollars. 
(c) GAO REPORT.—Not later than 18 months after the date 
of enactment of this Act, the Comptroller General of the United 
States shall submit to the Committee on Health, Education, Labor, 
and Pensions of the Senate and the Committee on Energy and 
Commerce of the House of Representatives a report assessing the 
policies and practices of the Division of Executive Operations of 
the Office of the Executive Secretariat of the Food and Drug 
Administration with respect to the receipt, tracking, managing, 
and prioritization of correspondence. 
SEC. 3629. FACILITATING THE USE OF REAL WORLD EVIDENCE. 
(a) GUIDANCE.—Not later than 1 year after the date of enact-
ment of this Act, the Secretary shall issue or revise existing guid-
ance on considerations for the use of real world data and real 
world evidence to support regulatory decision-making, as follows: 
(1) With respect to drugs, such guidance shall address 
the use of such data and evidence to support the approval 
of a drug application under section 505 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355) or a biological product 
application under section 351 of the Public Health Service 
Act (42 U.S.C. 262), and to support an investigational use 
exemption submission under section 505(i) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355(i)) or section 351(a)(3) 
of the Public Health Service Act (42 U.S.C. 262(a)(3)). Such 
guidance shall include considerations for the inclusion, in such 
applications and submissions, of real world data and real world 
evidence obtained as a result of the use of drugs authorized 
for emergency use under section 564 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 360bbb–3), and considerations 
for standards and methodologies for collection and analysis
H. R. 2617—1434 
of real world evidence included in such applications and submis-
sions, as appropriate. 
(2) With respect to devices, such guidance shall address 
the use of such data and evidence to support the approval, 
clearance, or classification of a device pursuant to an application 
or submission submitted under section 510(k), 513(f)(2), or 515 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(k), 
360c(f)(2), 360e), to support an investigational use exemption 
submission under section 520(g) of such Act (21 U.S.C. 360j(g)), 
and to support a determination by the Secretary for purposes 
of section 353 of the Public Health Service Act (42 U.S.C. 
263a) (including the category described under subsection (d)(3) 
of such section). Such guidance shall include considerations 
for the inclusion, in such applications and submissions, of real 
world data and real world evidence obtained as a result of 
the use of devices authorized for emergency use under section 
564 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360bbb–3), including considerations related to a determination 
under section 353(d)(3) of the Public Health Service Act (42 
U.S.C. 263a(d)(3)), and considerations for standards and meth-
odologies for collection and analysis of real world evidence 
included in such applications, submissions, or determinations, 
as appropriate. 
(b) REPORT TO CONGRESS.—Not later than 2 years after the 
end of the public health emergency declared by the Secretary under 
section 319 of the Public Health Service Act (42 U.S.C. 247d) 
on January 31, 2020, with respect to COVID–19, the Secretary 
shall submit a report to the Committee on Health, Education, 
Labor, and Pensions of the Senate and the Committee on Energy 
and Commerce of the House of Representatives on— 
(1) the number of applications, submissions, or requests 
submitted for clearance, approval, or authorization under sec-
tion 505, 510(k), 513(f)(2), or 515 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 355, 360(k), 360c(f)(2), 360e) or 
section 351 of the Public Health Service Act (42 U.S.C. 262), 
for which an authorization under section 564 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–3) was pre-
viously granted; 
(2) of the number of applications so submitted, the number 
of such applications— 
(A) for which real world evidence was submitted and 
used to support a regulatory decision; and 
(B) for which real world evidence was submitted and 
determined to be insufficient to support a regulatory deci-
sion; and 
(3) a summary explanation of why, in the case of applica-
tions described in paragraph (2)(B), real world evidence could 
not be used to support regulatory decisions. 
(c) INFORMATION DISCLOSURE.—Nothing in this section shall 
be construed to authorize the disclosure of information that is 
prohibited from disclosure under section 1905 of title 18, United 
States Code, or subject to withholding under subsection (b)(4) of 
section 552 of title 5, United States Code (commonly referred to 
as the ‘‘Freedom of Information Act’’).
H. R. 2617—1435 
SEC. 3630. FACILITATING EXCHANGE OF PRODUCT INFORMATION 
PRIOR TO APPROVAL. 
(a) IN GENERAL.—Section 502 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 352) is amended— 
(1) in paragraph (a)— 
(A) by striking ‘‘drugs for coverage’’ and inserting 
‘‘drugs or devices for coverage’’; and 
(B) by striking ‘‘drug’’ each place it appears and 
inserting ‘‘drug or device’’, respectively; 
(2) in paragraphs (a)(1) and (a)(2)(B), by striking ‘‘under 
section 505 or under section 351 of the Public Health Service 
Act’’ and inserting ‘‘under section 505, 510(k), 513(f)(2), or 515 
of this Act or section 351 of the Public Health Service Act’’; 
(3) in paragraph (a)(1)— 
(A) by striking ‘‘under section 505 or under section 
351(a) of the Public Health Service Act’’ and inserting 
‘‘under section 505, 510(k), 513(f)(2), or 515 of this Act 
or section 351 of the Public Health Service Act’’; and 
(B) by striking ‘‘in section 505(a) or in subsections 
(a) and (k) of section 351 of the Public Health Service 
Act’’ and inserting ‘‘in section 505, 510(k), 513(f)(2), or 
515 of this Act or section 351 of the Public Health Service 
Act’’; and 
(4) by adding at the end the following: 
‘‘(gg)(1) Unless its labeling bears adequate directions for use 
in accordance with paragraph (f), except that (in addition to drugs 
or devices that conform with exemptions pursuant to such para-
graph) no drug or device shall be deemed to be misbranded under 
such paragraph through the provision of truthful and not misleading 
product information to a payor, formulary committee, or other 
similar entity with knowledge and expertise in the area of health 
care economic analysis carrying out its responsibilities for the selec-
tion of drugs or devices for coverage or reimbursement if the product 
information relates to an investigational drug or device or investiga-
tional use of a drug or device that is approved, cleared, granted 
marketing authorization, or licensed under section 505, 510(k), 
513(f)(2), or 515 of this Act or section 351 of the Public Health 
Service Act (as applicable), provided— 
‘‘(A) the product information includes— 
‘‘(i) a clear statement that the investigational drug 
or device or investigational use of a drug or device has 
not been approved, cleared, granted marketing authoriza-
tion, or licensed under section 505, 510(k), 513(f)(2), or 
515 of this Act or section 351 of the Public Health Service 
Act (as applicable) and that the safety and effectiveness 
of such drug or device for such use has not been established; 
‘‘(ii) information related to the stage of development 
of the drug or device involved, such as— 
‘‘(I) the status of any study or studies in which 
the investigational drug or device or investigational 
use is being investigated; 
‘‘(II) how the study or studies relate to the overall 
plan for the development of the drug or device; and 
‘‘(III) whether an application, premarket notifica-
tion, or request for classification for the investigational
H. R. 2617—1436 
drug or device or investigational use has been sub-
mitted to the Secretary and when such a submission 
is planned; 
‘‘(iii) in the case of information that includes factual 
presentations of results from studies, which shall not be 
selectively presented, a description of— 
‘‘(I) all material aspects of study design, method-
ology, and results; and 
‘‘(II) all material limitations related to the study 
design, methodology, and results; 
‘‘(iv) where applicable, a prominent statement dis-
closing the indication or indications for which the Secretary 
has approved, granted marketing authorization, cleared, 
or licensed the product pursuant to section 505, 510(k), 
513(f)(2), or 515 of this Act or section 351 of the Public 
Health Service Act, and a copy of the most current required 
labeling; and 
‘‘(v) updated information, if previously communicated 
information becomes materially outdated as a result of 
significant changes or as a result of new information 
regarding the product or its review status; and 
‘‘(B) the product information does not include— 
‘‘(i) information that represents that an unapproved 
product— 
‘‘(I) has been approved, cleared, granted marketing 
authorization, or licensed under section 505, 510(k), 
513(f)(2), or 515 of this Act or section 351 of the Public 
Health Service Act (as applicable); or 
‘‘(II) has otherwise been determined to be safe 
or effective for the purpose or purposes for which the 
drug or device is being studied; or 
‘‘(ii) information that represents that an unapproved 
use of a drug or device that has been so approved, granted 
marketing authorization, cleared, or licensed— 
‘‘(I) is so approved, granted marketing authoriza-
tion, cleared, or licensed; or 
‘‘(II) that the product is safe or effective for the 
use or uses for which the drug or device is being 
studied. 
‘‘(2) For purposes of this paragraph, the term ‘product informa-
tion’ includes— 
‘‘(A) information describing the drug or device (such as 
drug class, device description, and features); 
‘‘(B) information about the indication or indications being 
investigated; 
‘‘(C) the anticipated timeline for a possible approval, clear-
ance, marketing authorization, or licensure pursuant to section 
505, 510(k), 513, or 515 of this Act or section 351 of the 
Public Health Service Act; 
‘‘(D) drug or device pricing information; 
‘‘(E) patient utilization projections; 
‘‘(F) product-related programs or services; and 
‘‘(G) factual presentations of results from studies that do 
not characterize or make conclusions regarding safety or effi-
cacy.’’. 
(b) GAO STUDY
AND REPORT.—Beginning on the date that 
is 5 years and 6 months after the date of enactment of this Act,
H. R. 2617—1437 
the Comptroller General of the United States shall conduct a study 
on the provision and use of information pursuant to section 502(gg) 
of the Federal Food, Drug, and Cosmetic Act, as added by this 
subsection (a), between manufacturers of drugs and devices (as 
defined in section 201 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 321)) and entities described in such section 502(gg). 
Such study shall include an analysis of the following: 
(1) The types of information communicated between such 
manufacturers and payors. 
(2) The manner of communication between such manufac-
turers and payors. 
(3)(A) Whether such manufacturers file an application for 
approval, marketing authorization, clearance, or licensing of 
a new drug or device or the new use of a drug or device 
that is the subject of communication between such manufactur-
ers and payors under section 502(gg) of the Federal Food, 
Drug, and Cosmetic Act, as added by subsection (a). 
(B) How frequently the Food and Drug Administration 
approves, grants marketing authorization, clears, or licenses 
the new drug or device or new use. 
(C) The timeframe between the initial communications per-
mitted under section 502(gg) of the Federal Food, Drug, and 
Cosmetic Act, as added by subsection (a), regarding an inves-
tigational drug or device or investigational use, and the initial 
marketing of such drug or device. 
SEC. 3631. STREAMLINING BLOOD DONOR INPUT. 
Chapter 35 of title 44, United States Code, shall not apply 
to the collection of information to which a response is voluntary 
and that is initiated by the Secretary to solicit information from 
blood donors or potential blood donors to support the development 
of recommendations by the Secretary, acting through the Commis-
sioner of Food and Drugs, concerning blood donation. 
TITLE IV—MEDICARE PROVISIONS 
Subtitle A—Medicare Extenders 
SEC. 4101. EXTENSION OF INCREASED INPATIENT HOSPITAL PAYMENT 
ADJUSTMENT FOR CERTAIN LOW-VOLUME HOSPITALS. 
(a) IN GENERAL.—Section 1886(d)(12) of the Social Security 
Act (42 U.S.C. 1395ww(d)(12)) is amended— 
(1) in subparagraph (B), in the matter preceding clause 
(i), by striking ‘‘during the portion of fiscal year 2023 beginning 
on December 24, 2022, and ending on September 30, 2023, 
and in fiscal year 2024’’ and inserting ‘‘in fiscal year 2025’’; 
(2) in subparagraph (C)(i)— 
(A) in the matter preceding subclause (I)— 
(i) by striking ‘‘or portion of a fiscal year’’; and 
(ii) by striking ‘‘through 2022 and the portion of 
fiscal year 2023 beginning on October 1, 2022, and 
ending on December 23, 2022’ ’’ and inserting ‘‘through 
2024’’; 
(B) in subclause (III), by striking ‘‘through 2022 and 
the portion of fiscal year 2023 beginning on October 1,
H. R. 2617—1438 
2022, and ending on December 23, 2022’ ’’ and inserting 
‘‘through 2024’’; and 
(C) in subclause (IV), by striking ‘‘the portion of fiscal 
year 2023 beginning on December 24, 2022, and ending 
on September 30, 2023, and fiscal year 2024’’ and inserting 
‘‘fiscal year 2025’’; and 
(3) in subparagraph (D)— 
(A) in the matter preceding clause (i), by striking 
‘‘through 2022 or during the portion of fiscal year 2023 
beginning on October 1, 2022, and ending on December 
23, 2022’ ’’ and inserting ‘‘through 2024’’; and 
(B) in clause (ii), by striking ‘‘through 2022 and the 
portion of fiscal year 2023 beginning on October 1, 2022, 
and ending on December 23, 2022’ ’’ and inserting ‘‘through 
2024’’. 
(b) IMPLEMENTATION.—Notwithstanding any other provision of 
law, the Secretary of Health and Human Services may implement 
the provisions of, including the amendments made by, this section 
by program instruction or otherwise. 
SEC. 4102. EXTENSION OF THE MEDICARE-DEPENDENT HOSPITAL PRO-
GRAM. 
(a) IN GENERAL.—Section 1886(d)(5)(G) of the Social Security 
Act (42 U.S.C. 1395ww(d)(5)(G)) is amended— 
(1) in clause (i), by striking ‘‘December 24, 2022’’ and 
inserting ‘‘October 1, 2024’’; and 
(2) in clause (ii)(II), by striking ‘‘December 24, 2022’’ and 
inserting ‘‘October 1, 2024’’. 
(b) CONFORMING AMENDMENTS.— 
(1) EXTENSION OF TARGET AMOUNTS.—Section 1886(b)(3)(D) 
of the Social Security Act (42 U.S.C. 1395ww(b)(3)(D)) is 
amended— 
(A) in the matter preceding clause (i), by striking 
‘‘December 24, 2022’’ and inserting ‘‘October 1, 2024’’; and 
(B) in clause (iv), by striking ‘‘fiscal year 2022 and 
the portion of fiscal year 2023 beginning on October 1, 
2022, and ending on December 23, 2022,’’ and inserting 
‘‘fiscal year 2024’’. 
(2) PERMITTING HOSPITALS TO DECLINE RECLASSIFICATION.— 
Section 13501(e)(2) of the Omnibus Budget Reconciliation Act 
of 1993 (42 U.S.C. 1395ww note) is amended by striking ‘‘fiscal 
year 2000 through fiscal year 2022, or the portion of fiscal 
year 2023 beginning on October 1, 2022, and ending on 
December 23, 2022’’ and inserting ‘‘or fiscal year 2000 through 
fiscal year 2024’’. 
SEC. 4103. EXTENSION OF ADD-ON PAYMENTS FOR AMBULANCE SERV-
ICES. 
Section 1834(l) of the Social Security Act (42 U.S.C. 1395m(l)) 
is amended— 
(1) in paragraph (12)(A), by striking ‘‘January 1, 2023’’ 
and inserting ‘‘January 1, 2025’’; and 
(2) in paragraph (13), by striking ‘‘January 1, 2023’’ in 
each place it appears and inserting ‘‘January 1, 2025’’ in each 
such place.
H. R. 2617—1442 
(1) IN GENERAL.— 
(A) STUDY.—The Secretary shall conduct a study using 
medical record review, as described in subparagraph (C), 
on program integrity related to telehealth services under 
part B of title XVIII of the Social Security Act (42 U.S.C. 
1395j et seq.). 
(B) SCOPE OF STUDY.—In conducting the study under 
subparagraph (A), the Secretary shall review and analyze 
information (to the extent that such information is avail-
able) on the duration of telehealth services furnished, the 
types of telehealth services furnished, and, to the extent 
feasible, the impact of the telehealth services furnished 
on future utilization of health care services by Medicare 
beneficiaries, such as the utilization of additional telehealth 
services or in-person services, including hospitalizations 
and emergency department visits. The Secretary may also 
review and analyze information on— 
(i) any geographic differences in utilization of tele-
health services; 
(ii) documentation of the care and methods of 
delivery associated with telehealth services; and 
(iii) other areas, as determined appropriate by the 
Secretary. 
(C) MEDICAL RECORD REVIEW.—In conducting the study 
under subparagraph (A), the Secretary shall conduct med-
ical record review of a sample of claims for telehealth 
services with dates of service during the period beginning 
on January 1, 2022, and ending on December 31, 2024. 
For such claims with a date of service during the emergency 
period described in section 1135(g)(1)(B) of the Social Secu-
rity Act (42 U.S.C. 1320b–5(g)(1)(B)), the Secretary shall 
only conduct medical record review of those claims that 
have undergone standard program integrity review (as 
defined in paragraph (2)(B)), as determined appropriate 
by the Secretary. 
(D) REPORTS.— 
(i) INTERIM
REPORT.—Not later than October 1, 
2024, the Secretary shall submit to the Committee 
on Finance of the Senate and the Committee on Energy 
and Commerce and the Committee on Ways and Means 
of the House of Representatives an interim report on 
the study conducted under subparagraph (A). 
(ii) FINAL REPORT.—Not later than April 1, 2026, 
the Secretary shall submit to the Committee on 
Finance of the Senate and the Committee on Energy 
and Commerce and the Committee on Ways and Means 
of the House of Representatives a final report on the 
study conducted under subparagraph (A). 
(2) DEFINITIONS.—In this subsection: 
(A) SECRETARY.—The term ‘‘Secretary’’ means the Sec-
retary of Health and Human Services. 
(B) STANDARD PROGRAM INTEGRITY REVIEW.—The term 
‘‘standard program integrity review’’ refers to the review 
of any claim that requires a review of the associated med-
ical record by the Secretary to determine the medical neces-
sity of the services furnished or to identify potential fraud.
H. R. 2617—1443 
(C) 
TELEHEALTH
SERVICE.—The 
term 
‘‘telehealth 
service’’ has the meaning given that term in section 
1834(m)(4)(F) of the Social Security Act (42 U.S.C. 
1395(m)(4)(F)). 
(3) FUNDING.—In addition to amounts otherwise available, 
there is appropriated to the Centers for Medicare & Medicaid 
Services Program Management Account for fiscal year 2023, 
out of any amounts in the Treasury not otherwise appropriated, 
$10,000,000, to remain available until expended, for purposes 
of carrying out this subsection. 
(h) PROGRAM INSTRUCTION AUTHORITY.—Notwithstanding any 
other provision of law, the Secretary of Health and Human Services 
may implement the provisions of, including amendments made by, 
this section through program instruction or otherwise. 
SEC. 4114. REVISED PHASE-IN OF MEDICARE CLINICAL LABORATORY 
TEST PAYMENT CHANGES. 
(a) REVISED PHASE-IN OF REDUCTIONS FROM PRIVATE PAYOR 
RATE IMPLEMENTATION.—Section 1834A(b)(3) of the Social Security 
Act (42 U.S.C. 1395m–1(b)(3)) is amended— 
(1) in subparagraph (A), by striking ‘‘through 2025’’ and 
inserting ‘‘through 2026’’; and 
(2) in subparagraph (B)— 
(A) in clause (ii), by striking ‘‘and 2022’’ and inserting 
‘‘through 2023’’; and 
(B) in clause (iii), by striking ‘‘2023 through 2025’’ 
and inserting ‘‘2024 through 2026’’. 
(b) REVISED REPORTING PERIOD FOR REPORTING OF PRIVATE 
SECTOR PAYMENT RATES FOR ESTABLISHMENT OF MEDICARE PAY-
MENT RATES.—Section 1834A(a)(1)(B) of the Social Security Act 
(42 U.S.C. 1395m–1(a)(1)(B)) is amended— 
(1) in clause (i), by striking ‘‘December 31, 2022’’ and 
inserting ‘‘December 31, 2023’’; and 
(2) in clause (ii)— 
(A) by striking ‘‘January 1, 2023’’ and inserting 
‘‘January 1, 2024’’; and 
(B) by striking ‘‘March 31, 2023’’ and inserting ‘‘March 
31, 2024’’. 
Subtitle C—Medicare Mental Health 
Provisions 
SEC. 4121. COVERAGE OF MARRIAGE AND FAMILY THERAPIST SERV-
ICES 
AND 
MENTAL 
HEALTH 
COUNSELOR 
SERVICES 
UNDER PART B OF THE MEDICARE PROGRAM. 
(a) COVERAGE OF SERVICES.— 
(1) IN GENERAL.—Section 1861(s)(2) of the Social Security 
Act (42 U.S.C. 1395x(s)(2)) is amended— 
(A) in subparagraph (GG), by striking ‘‘and’’ after the 
semicolon at the end; 
(B) in subparagraph (HH), by striking the period at 
the end and inserting ‘‘; and’’; and 
(C) by adding at the end the following new subpara-
graph:
H. R. 2617—1444 
‘‘(II) marriage and family therapist services (as defined 
in subsection (lll)(1)) and mental health counselor services (as 
defined in subsection (lll)(3));’’. 
(2) DEFINITIONS.—Section 1861 of the Social Security Act 
(42 U.S.C. 1395x) is amended by adding at the end the following 
new subsection: 
‘‘(lll) MARRIAGE AND FAMILY THERAPIST SERVICES; MARRIAGE 
AND FAMILY THERAPIST; MENTAL HEALTH COUNSELOR SERVICES; 
MENTAL HEALTH COUNSELOR.— 
‘‘(1) MARRIAGE AND FAMILY THERAPIST SERVICES.—The term 
‘marriage and family therapist services’ means services fur-
nished by a marriage and family therapist (as defined in para-
graph (2)) for the diagnosis and treatment of mental illnesses 
(other than services furnished to an inpatient of a hospital), 
which the marriage and family therapist is legally authorized 
to perform under State law (or the State regulatory mechanism 
provided by State law) of the State in which such services 
are furnished, as would otherwise be covered if furnished by 
a physician or as an incident to a physician’s professional 
service. 
‘‘(2) MARRIAGE AND FAMILY THERAPIST.—The term ‘marriage 
and family therapist’ means an individual who— 
‘‘(A) possesses a master’s or doctor’s degree which quali-
fies for licensure or certification as a marriage and family 
therapist pursuant to State law of the State in which 
such individual furnishes the services described in para-
graph (1); 
‘‘(B) is licensed or certified as a marriage and family 
therapist by the State in which such individual furnishes 
such services; 
‘‘(C) after obtaining such degree has performed at least 
2 years of clinical supervised experience in marriage and 
family therapy; and 
‘‘(D) meets such other requirements as specified by 
the Secretary. 
‘‘(3) MENTAL
HEALTH
COUNSELOR
SERVICES.—The term 
‘mental health counselor services’ means services furnished 
by a mental health counselor (as defined in paragraph (4)) 
for the diagnosis and treatment of mental illnesses (other than 
services furnished to an inpatient of a hospital), which the 
mental health counselor is legally authorized to perform under 
State law (or the State regulatory mechanism provided by 
the State law) of the State in which such services are furnished, 
as would otherwise be covered if furnished by a physician 
or as incident to a physician’s professional service. 
‘‘(4) MENTAL HEALTH COUNSELOR.—The term ‘mental health 
counselor’ means an individual who— 
‘‘(A) possesses a master’s or doctor’s degree which quali-
fies for licensure or certification as a mental health coun-
selor, clinical professional counselor, or professional coun-
selor under the State law of the State in which such indi-
vidual furnishes the services described in paragraph (3); 
‘‘(B) is licensed or certified as a mental health coun-
selor, clinical professional counselor, or professional coun-
selor by the State in which the services are furnished;
H. R. 2617—1445 
‘‘(C) after obtaining such a degree has performed at 
least 2 years of clinical supervised experience in mental 
health counseling; and 
‘‘(D) meets such other requirements as specified by 
the Secretary.’’. 
(3) AMOUNT OF PAYMENT.—Section 1833(a)(1) of the Social 
Security Act (42 U.S.C. 1395l(a)(1)), as amended by section 
11101(b) of Public Law 117–169, is further amended— 
(A) by striking ‘‘, and (EE)’’ and inserting ‘‘(EE)’’; and 
(B) by inserting before the semicolon at the end the 
following: ‘‘and (FF) with respect to marriage and family 
therapist services and mental health counselor services 
under section 1861(s)(2)(II), the amounts paid shall be 80 
percent of the lesser of the actual charge for the services 
or 75 percent of the amount determined for payment of 
a psychologist under subparagraph (L)’’. 
(4) EXCLUSION OF MARRIAGE AND FAMILY THERAPIST SERV-
ICES AND MENTAL HEALTH COUNSELOR SERVICES FROM SKILLED 
NURSING
FACILITY
PROSPECTIVE
PAYMENT
SYSTEM.—Section 
1888(e)(2)(A)(ii) of the Social Security Act (42 U.S.C. 
1395yy(e)(2)(A)(ii)) is amended by inserting ‘‘marriage and 
family therapist services (as defined in section 1861(lll)(1)), 
mental health counselor services (as defined in section 
1861(lll)(3)),’’ after ‘‘qualified psychologist services,’’. 
(5) INCLUSION OF MARRIAGE AND FAMILY THERAPISTS AND 
MENTAL HEALTH COUNSELORS AS PRACTITIONERS FOR ASSIGN-
MENT OF CLAIMS.—Section 1842(b)(18)(C) of the Social Security 
Act (42 U.S.C. 1395u(b)(18)(C)) is amended by adding at the 
end the following new clauses: 
‘‘(vii) A marriage and family therapist (as defined in section 
1861(lll)(2)). 
‘‘(viii) A mental health counselor (as defined in section 
1861(lll)(4)).’’. 
(b) COVERAGE OF CERTAIN MENTAL HEALTH SERVICES PROVIDED 
IN CERTAIN SETTINGS.— 
(1) RURAL
HEALTH
CLINICS
AND
FEDERALLY
QUALIFIED 
HEALTH CENTERS.—Section 1861(aa)(1)(B) of the Social Security 
Act (42 U.S.C. 1395x(aa)(1)(B)) is amended by striking ‘‘or 
by a clinical social worker (as defined in subsection (hh)(1))’’ 
and inserting ‘‘, by a clinical social worker (as defined in sub-
section (hh)(1)), by a marriage and family therapist (as defined 
in subsection (lll)(2)), or by a mental health counselor (as 
defined in subsection (lll)(4))’’. 
(2) HOSPICE
PROGRAMS.—Section 1861(dd)(2)(B)(i)(III) of 
the Social Security Act (42 U.S.C. 1395x(dd)(2)(B)(i)(III)) is 
amended by inserting ‘‘, marriage and family therapist, or 
mental health counselor’’ after ‘‘social worker’’. 
(c) EFFECTIVE DATE.—The amendments made by this section 
shall apply with respect to services furnished on or after January 
1, 2024. 
SEC. 4122. ADDITIONAL RESIDENCY POSITIONS. 
(a) IN GENERAL.—Section 1886(h) of the Social Security Act 
(42 U.S.C. 1395ww(h)) is amended— 
(1) in paragraph (4)(F)(i), by striking ‘‘and (9)’’ and inserting 
‘‘(9), and (10)’’;
H. R. 2617—1446 
(2) in paragraph (4)(H)(i), by striking ‘‘and (9)’’ and 
inserting ‘‘(9), and (10)’’; and 
(3) by adding at the end the following new paragraph: 
‘‘(10) DISTRIBUTION OF ADDITIONAL RESIDENCY POSITIONS 
IN PSYCHIATRY AND PSYCHIATRY SUBSPECIALTIES.— 
‘‘(A) ADDITIONAL RESIDENCY POSITIONS.— 
‘‘(i) IN GENERAL.—For fiscal year 2026, the Sec-
retary shall, subject to the succeeding provisions of 
this paragraph, increase the otherwise applicable resi-
dent limit for each qualifying hospital (as defined in 
subparagraph (F)) that submits a timely application 
under this subparagraph by such number as the Sec-
retary may approve effective beginning July 1 of the 
fiscal year of the increase. 
‘‘(ii) NUMBER AVAILABLE FOR DISTRIBUTION.—The 
aggregate number of such positions made available 
under this paragraph shall be equal to 200. 
‘‘(iii) DISTRIBUTION FOR PSYCHIATRY OR PSYCHIATRY 
SUBSPECIALTY RESIDENCIES.—At least 100 of the posi-
tions made available under this paragraph shall be 
distributed for a psychiatry or psychiatry subspecialty 
residency (as defined in subparagraph (F)). 
‘‘(iv) TIMING.—The Secretary shall notify hospitals 
of the number of positions distributed to the hospital 
under this paragraph as a result of an increase in 
the otherwise applicable resident limit by January 31 
of the fiscal year of the increase. Such increase shall 
be effective beginning July 1 of such fiscal year. 
‘‘(B) DISTRIBUTION.—For purposes of providing an 
increase in the otherwise applicable resident limit under 
subparagraph (A), the following shall apply: 
‘‘(i) CONSIDERATIONS IN DISTRIBUTION.—In deter-
mining for which qualifying hospitals such an increase 
is provided under subparagraph (A), the Secretary 
shall take into account the demonstrated likelihood 
of the hospital filling the positions made available 
under this paragraph within the first 5 training years 
beginning after the date the increase would be effec-
tive, as determined by the Secretary. 
‘‘(ii) MINIMUM
DISTRIBUTION
FOR
CERTAIN
CAT-
EGORIES OF HOSPITALS.—With respect to the aggregate 
number of such positions available for distribution 
under this paragraph, the Secretary shall distribute 
not less than 10 percent of such aggregate number 
to each of the following categories of hospitals: 
‘‘(I) Hospitals that are located in a rural area 
(as defined in section 1886(d)(2)(D)) or are treated 
as being located in a rural area pursuant to section 
1886(d)(8)(E). 
‘‘(II) Hospitals in which the reference resident 
level of the hospital (as specified in subparagraph 
(F)(iii)) is greater than the otherwise applicable 
resident limit. 
‘‘(III) Hospitals in States with— 
‘‘(aa) new medical schools that received 
‘Candidate School’ status from the Liaison 
Committee on Medical Education or that
H. R. 2617—1448 
under this paragraph, the approved FTE per resident 
amounts are deemed to be equal to the hospital per resident 
amounts for nonprimary care computed under paragraph 
(2)(D) for that hospital. 
‘‘(E) PERMITTING
FACILITIES
TO
APPLY
AGGREGATION 
RULES.—The Secretary shall permit hospitals receiving 
additional residency positions attributable to the increase 
provided under this paragraph to, beginning in the fifth 
year after the effective date of such increase, apply such 
positions to the limitation amount under paragraph (4)(F) 
that may be aggregated pursuant to paragraph (4)(H) 
among members of the same affiliated group. 
‘‘(F) DEFINITIONS.—In this paragraph: 
‘‘(i) OTHERWISE APPLICABLE RESIDENT LIMIT.—The 
term ‘otherwise applicable resident limit’ means, with 
respect to a hospital, the limit otherwise applicable 
under subparagraphs (F)(i) and (H) of paragraph (4) 
on the resident level for the hospital determined with-
out regard to this paragraph but taking into account 
paragraphs (7)(A), (7)(B), (8)(A), (8)(B), and (9)(A). 
‘‘(ii) PSYCHIATRY
OR
PSYCHIATRY
SUBSPECIALTY 
RESIDENCY.—The term ‘psychiatry or psychiatry sub-
specialty residency’ means a residency in psychiatry 
as accredited by the Accreditation Council for Graduate 
Medical Education for the purpose of preventing, diag-
nosing, and treating mental health disorders. 
‘‘(iii) QUALIFYING HOSPITAL.—The term ‘qualifying 
hospital’ means a hospital described in any of sub-
clauses (I) through (IV) of subparagraph (B)(ii). 
‘‘(iv) REFERENCE RESIDENT LEVEL.—The term ‘ref-
erence resident level’ means, with respect to a hospital, 
the resident level for the most recent cost reporting 
period of the hospital ending on or before the date 
of enactment of this paragraph, for which a cost report 
has been settled (or, if not, submitted (subject to 
audit)), as determined by the Secretary. 
‘‘(v) RESIDENT
LEVEL.—The term ‘resident level’ 
has the meaning given such term in paragraph 
(7)(C)(i).’’. 
(b) IME.—Section 1886(d)(5)(B) of the Social Security Act (42 
U.S.C. 1395ww(d)(5)(B)) is amended— 
(1) in clause (v), in the third sentence, by striking ‘‘and 
(h)(9)’’ and inserting ‘‘(h)(9), and (h)(10)’’; 
(2) by moving clause (xii) 4 ems to the left; and 
(3) by adding at the end the following new clause: 
‘‘(xiii) For discharges occurring on or after July 1, 2026, 
insofar as an additional payment amount under this subpara-
graph is attributable to resident positions distributed to a hos-
pital under subsection (h)(10), the indirect teaching adjustment 
factor shall be computed in the same manner as provided 
under clause (ii) with respect to such resident positions.’’. 
(c) PROHIBITION ON JUDICIAL REVIEW.—Section 1886(h)(7)(E) 
of the Social Security Act (42 U.S.C. 1395ww—4(h)(7)(E)) is 
amended by inserting ‘‘paragraph (10),’’ after ‘‘paragraph (8),’’.
H. R. 2617—1449 
SEC. 4123. IMPROVING MOBILE CRISIS CARE IN MEDICARE. 
(a) PAYMENT FOR PSYCHOTHERAPY FOR CRISIS SERVICES FUR-
NISHED IN AN APPLICABLE SITE OF SERVICE.— 
(1) IN GENERAL.—Section 1848(b) of the Social Security 
Act (42 U.S.C. 1395w–4(b)) is amended by adding at the end 
the following new paragraph: 
‘‘(12) PAYMENT FOR PSYCHOTHERAPY FOR CRISIS SERVICES 
FURNISHED IN AN APPLICABLE SITE OF SERVICE.— 
‘‘(A) IN GENERAL.—The Secretary shall establish new 
HCPCS codes under the fee schedule established under 
this subsection for services described in subparagraph (B) 
that are furnished on or after January 1, 2024. 
‘‘(B) SERVICES DESCRIBED.—The services described in 
this subparagraph are psychotherapy for crisis services 
that are a furnished in an applicable site of service. 
‘‘(C) AMOUNT OF PAYMENT.—For services described in 
subparagraph (B) that are furnished to an individual in 
a year (beginning with 2024), in lieu of the fee schedule 
amount that would otherwise be determined under this 
subsection for such year, the fee schedule amount for such 
services for such year shall be equal to 150 percent of 
the fee schedule amount for non-facility sites of service 
for such year determined for services identified, as of 
January 1, 2022, by HCPCS codes 90839 and 90840 (and 
any succeeding codes). 
‘‘(D) DEFINITIONS.—In this paragraph: 
‘‘(i) APPLICABLE
SITE
OF
SERVICE.—The term 
‘applicable site of service’ means a site of service other 
than a site where the facility rate under the fee 
schedule under this subsection applies and other than 
an office setting. 
‘‘(ii) PSYCHOTHERAPY
FOR
CRISIS
SERVICES.—The 
code descriptions for services described in subpara-
graph (B) shall be the same as the code descriptions 
for services identified, as of January 1, 2022, by 
HCPCS codes 90839 and 90840 (and any succeeding 
codes), except that such new codes shall be limited 
to services furnished in an applicable site of service.’’. 
(2) 
WAIVER
OF
BUDGET
NEUTRALITY.—Section 
1848(c)(2)(B)(iv) of such Act (42 U.S.C. 1395w–4(c)(2)(B)(iv)) 
is amended— 
(A) in subclause (IV), by striking ‘‘and’’ at the end; 
(B) in subclause (V), by striking the period at the 
end and inserting ‘‘; and’’ and 
(C) by adding at the end the following new subclause: 
‘‘(VI) subsection (b)(12) shall not be taken into 
account in applying clause (ii)(II) for 2024.’’. 
(b) EDUCATION
AND OUTREACH.—Not later than January 1, 
2024, the Secretary shall use existing communications mechanisms 
to provide education and outreach to stakeholders with respect 
to the ability of health professionals to bill for psychotherapy for 
crisis services under the Medicare physician fee schedule under 
section 1848 of the Social Security Act (42 U.S.C. 1395w–4) when 
such services are furnished in an applicable site of service to a 
Medicare beneficiary who is experiencing a mental or behavioral 
health crisis.
H. R. 2617—1450 
(c) OPEN DOOR FORUM.—Not later than January 1, 2024, the 
Secretary shall convene stakeholders and experts for an open door 
forum or other appropriate mechanism to discuss current Medicare 
program coverage and payment policies for services that can be 
furnished to provide care to a Medicare beneficiary who is experi-
encing a mental or behavioral health crisis. 
(d) EDUCATION AND OUTREACH ON THE USE OF PEER SUPPORT 
SPECIALISTS AND OTHER AUXILIARY PERSONNEL IN FURNISHING OF 
PSYCHOTHERAPY
FOR CRISIS SERVICES
AND BEHAVIORAL HEALTH 
INTEGRATION SERVICES.—Not later than January 1, 2024, the Sec-
retary shall use existing communication mechanisms to provide 
education and outreach to providers of services, physicians, and 
practitioners with respect to the ability of auxiliary personnel, 
including peer support specialists, to participate, consistent with 
applicable requirements for auxiliary personnel, in the furnishing 
of— 
(1) psychotherapy for crisis services billed under the Medi-
care physician fee schedule under section 1848 of the Social 
Security Act (42 U.S.C. 1395w–4), as well as other services 
that can be furnished to a Medicare beneficiary experiencing 
a mental or behavioral health crisis; and 
(2) behavioral health integration services. 
(e) DEFINITIONS.—In this section: 
(1) APPLICABLE
SITE
OF
SERVICE.—The term ‘‘applicable 
site of service’’ has the meaning given that term in section 
1848(b)(12)(D)(i) of the Social Security Act, as added by sub-
section (a). 
(2) BEHAVIORAL HEALTH INTEGRATION SERVICES.—The term 
‘‘behavioral health integration services’’ means services identi-
fied, as of January 1, 2022, by HCPCS codes 99484, 99492, 
99493, 99494, and G2214 (and any successor or similar codes 
as determined appropriate by the Secretary). 
(3) PSYCHOTHERAPY
FOR
CRISIS
SERVICES.—The term 
‘‘psychotherapy for crisis services’’ means services described 
in 1848(b)(12)(D)(ii) of the Social Security Act, as added by 
subsection (a). 
(4) SECRETARY.—The term ‘‘Secretary’’ means the Secretary 
of Health and Human Services. 
SEC. 4124. ENSURING ADEQUATE COVERAGE OF OUTPATIENT MENTAL 
HEALTH SERVICES UNDER THE MEDICARE PROGRAM. 
(a) MODIFICATION OF DEFINITION OF PARTIAL HOSPITALIZATION 
SERVICES.—Section 1861(ff)(1) of the Social Security Act (42 U.S.C. 
1395x(ff)(1)) is amended by inserting ‘‘for an individual determined 
(not less frequently than monthly) by a physician to have a need 
for such services for a minimum of 20 hours per week’’ after ‘‘pre-
scribed by a physician’’. 
(b) COVERAGE OF INTENSIVE OUTPATIENT SERVICES.— 
(1) SCOPE OF BENEFITS.— 
(A) COMMUNITY
MENTAL
HEALTH
CENTERS.—Section 
1832(a)(2)(J) of the Social Security Act (42 U.S.C. 
1395k(a)(2)(J)) is amended by inserting ‘‘and intensive out-
patient services’’ after ‘‘partial hospitalization services’’. 
(B) INCIDENT-TO
SERVICES.—Section 1861(s)(2)(B) is 
amended by inserting ‘‘or intensive outpatient services’’ 
after ‘‘partial hospitalization services’’.
H. R. 2617—1451 
(2) DEFINITION.—Section 1861(ff) of the Social Security Act 
(42 U.S.C. 1395x(ff)) is amended— 
(A) in the header, by inserting ‘‘; Intensive Outpatient 
Services’’ after ‘‘Partial Hospitalization Services’’; and 
(B) by adding at the end the following new paragraph: 
‘‘(4) The term ‘intensive outpatient services’ has the meaning 
given the term ‘partial hospitalization services’ in paragraph (1), 
except that— 
‘‘(A) section 1835(a)(2)(F)(i) shall not apply; 
‘‘(B) the reference in such paragraph to an individual ‘deter-
mined (not less frequently than monthly) by a physician to 
have a need for such services for a minimum of 20 hours 
per week’ shall be treated as a reference to an individual 
‘determined (not less frequently than once every other month) 
by a physician to have a need for such services for a minimum 
of 9 hours per week’; and 
‘‘(C) the reference to ‘a community mental health center 
(as defined in subparagraph (B))’ in paragraph (3) shall be 
treated as a reference to ‘a community mental health center 
(as defined in subparagraph (B)), a Federally qualified health 
center, or a rural health clinic’.’’. 
(3) EXCLUSION FROM CALCULATION OF CERTAIN TREATMENT 
COSTS.—Section 1833(c)(2) of the Social Security Act (42 U.S.C. 
1395l(c)(2)) is amended by inserting ‘‘or intensive outpatient 
services’’ after ‘‘partial hospitalization services’’. 
(4) CONFORMING AMENDMENTS.— 
(A) INTENSIVE OUTPATIENT SERVICES.—Section 1861(aa) 
of the Social Security Act (42 U.S.C. 1395x(aa)) is 
amended— 
(i) in paragraph (1)— 
(I) in subparagraph (B), by striking ‘‘and’’ at 
the end; 
(II) in subparagraph (C), by adding ‘‘and’’ at 
the end; and 
(III) by inserting after subparagraph (C) the 
following new subparagraph: 
‘‘(D) intensive outpatient services (as defined in section 
1861(ff)(4)),’’; and 
(ii) in paragraph (3), by striking ‘‘through (C)’’ 
and inserting ‘‘through (D)’’. 
(B) PROVIDER OF SERVICES.—Section 1866(e)(2) of the 
Social Security Act (42 U.S.C. 1395cc(e)(2)) is amended 
by inserting ‘‘, or intensive outpatient services (as described 
in section 1861(ff)(4))’’ after ‘‘partial hospitalization services 
(as described in section 1861(ff)(1))’’. 
(c) SPECIAL PAYMENT RULE FOR FQHCS AND RHCS.—Section 
1834 of the Social Security Act (42 U.S.C. 1395m) is amended— 
(1) in subsection (o), by adding at the end the following 
new paragraph: 
‘‘(5) SPECIAL
PAYMENT
RULE
FOR
INTENSIVE
OUTPATIENT 
SERVICES.— 
‘‘(A) IN GENERAL.—In the case of intensive outpatient 
services furnished by a Federally qualified health center, 
the payment amount for such services shall be equal to 
the amount that would have been paid under this title 
for such services had such services been covered OPD serv-
ices furnished by a hospital.
H. R. 2617—1452 
‘‘(B) EXCLUSION.—Costs associated with intensive out-
patient services shall not be used to determine the amount 
of payment for Federally qualified health center services 
under the prospective payment system under this sub-
section.’’; and 
(2) in subsection (y)— 
(A) in the header, by striking ‘‘TO HOSPICE PATIENTS’’; 
and 
(B) by adding at the end the following new paragraph: 
‘‘(3) SPECIAL
PAYMENT
RULE
FOR
INTENSIVE
OUTPATIENT 
SERVICES.— 
‘‘(A) IN GENERAL.—In the case of intensive outpatient 
services furnished by a rural health clinic, the payment 
amount for such services shall be equal to the amount 
that would have been paid under this title for such services 
had such services been covered OPD services furnished 
by a hospital. 
‘‘(B) EXCLUSION.—Costs associated with intensive out-
patient services shall not be used to determine the amount 
of payment for rural health clinic services under the meth-
odology for all-inclusive rates (established by the Secretary) 
under section 1833(a)(3).’’. 
(d) EFFECTIVE DATE.—The amendments made by this section 
shall apply with respect to items and services furnished on or 
after January 1, 2024. 
SEC. 4125. IMPROVEMENTS TO MEDICARE PROSPECTIVE PAYMENT 
SYSTEM FOR PSYCHIATRIC HOSPITALS AND PSYCHIATRIC 
UNITS. 
(a) IMPROVEMENTS THROUGH ADDITIONAL CLAIMS DATA.—Sec-
tion 1886(s) of the Social Security Act (42 U.S.C. 1395ww(s)) is 
amended by adding at the end the following new paragraph: 
‘‘(5) ADDITIONAL DATA AND INFORMATION.— 
‘‘(A) IN GENERAL.—The Secretary shall collect data and 
information as the Secretary determines appropriate to 
revise payments under the system described in paragraph 
(1) for psychiatric hospitals and psychiatric units pursuant 
to subparagraph (D) and for other purposes as determined 
appropriate by the Secretary. The Secretary shall begin 
to collect such data by not later than October 1, 2023. 
‘‘(B) DATA AND INFORMATION.—The data and informa-
tion to be collected under subparagraph (A) may include— 
‘‘(i) charges, including those related to ancillary 
services; 
‘‘(ii) the required intensity of behavioral moni-
toring, such as cognitive deficit, suicide ideations, vio-
lent behavior, and need for physical restraint; and 
‘‘(iii) interventions, such as detoxification services 
for substance abuse, dependence on respirator, total 
parenteral nutritional support, dependence on renal 
dialysis, and burn care. 
‘‘(C) METHOD OF COLLECTION.—The Secretary may col-
lect the additional data and information under subpara-
graph (A) on cost reports, on claims, or otherwise. 
‘‘(D) REVISIONS TO PAYMENT RATES.— 
‘‘(i) IN GENERAL.—Notwithstanding the preceding 
paragraphs of this subsection or section 124 of the
H. R. 2617—1453 
Medicare, Medicaid, and SCHIP Balanced Budget 
Refinement Act of 1999, for rate year 2025 (and for 
any subsequent rate year, if determined appropriate 
by the Secretary), the Secretary shall, by regulation, 
implement revisions to the methodology for deter-
mining the payment rates under the system described 
in paragraph (1) for psychiatric hospitals and psy-
chiatric units, as the Secretary determines to be appro-
priate. Such revisions may be based on a review of 
data and information collected under subparagraph (A). 
‘‘(ii) REVIEW.—The Secretary may make revisions 
to the diagnosis-related group classifications, in accord-
ance with subsection (d)(4)(C), to reflect nursing and 
staff resource use and costs involved in furnishing 
services at such hospitals and units, including consider-
ations for patient complexity and prior admission to 
an inpatient psychiatric facility, which may be based 
on review of data and information collected under 
subparagraph (A), as the Secretary determines to be 
appropriate. 
‘‘(iii) BUDGET NEUTRALITY.—Revisions in payment 
implemented pursuant to clause (i) for a rate year 
shall result in the same estimated amount of aggregate 
expenditures under this title for psychiatric hospitals 
and psychiatric units furnished in the rate year as 
would have been made under this title for such care 
in such rate year if such revisions had not been imple-
mented.’’. 
(b) IMPROVEMENTS THROUGH STANDARDIZED PATIENT ASSESS-
MENT DATA.—Section 1886(s) of the Social Security Act (42 U.S.C. 
1395ww(s)), as amended by subsection (a), is further amended— 
(1) in paragraph (4)— 
(A) in subparagraph (A)(i), by striking ‘‘subparagraph 
(C)’’ and inserting ‘‘subparagraphs (C) and (E)’’; 
(B) by redesignating subparagraph (E) as subpara-
graph (F); 
(C) by inserting after subparagraph (D) the following 
new subparagraph: 
‘‘(E) STANDARDIZED PATIENT ASSESSMENT DATA.— 
‘‘(i) IN GENERAL.—For rate year 2028 and each 
subsequent rate year, in addition to such data on the 
quality measures described in subparagraph (C), each 
psychiatric hospital and psychiatric unit shall submit 
to the Secretary, through the use of a standardized 
assessment instrument implemented under clause (iii), 
the standardized patient assessment data described 
in clause (ii). Such data shall be submitted with respect 
to admission and discharge of an individual (and may 
be submitted more frequently as the Secretary deter-
mines appropriate). 
‘‘(ii) STANDARDIZED
PATIENT
ASSESSMENT
DATA 
DESCRIBED.—For purposes of clause (i), the standard-
ized patient assessment data described in this clause, 
with respect to a psychiatric hospital or psychiatric 
unit, is data with respect to the following categories: 
‘‘(I) Functional status, such as mobility and 
self-care at admission to a psychiatric hospital or
H. R. 2617—1454 
unit and before discharge from a psychiatric hos-
pital or unit. 
‘‘(II) Cognitive function, such as ability to 
express ideas and to understand, and mental 
status, such as depression and dementia. 
‘‘(III) Special services, treatments, and inter-
ventions for psychiatric conditions. 
‘‘(IV) Medical conditions and co-morbidities, 
such as diabetes, congestive heart failure, and 
pressure ulcers. 
‘‘(V) Impairments, such as incontinence and 
an impaired ability to hear, see, or swallow. 
‘‘(VI) Other categories as determined appro-
priate by the Secretary. 
‘‘(iii) STANDARDIZED ASSESSMENT INSTRUMENT.— 
‘‘(I) IN GENERAL.—For purposes of clause (i), 
the Secretary shall implement a standardized 
assessment instrument that provides for the 
submission of standardized patient assessment 
data under this title with respect to psychiatric 
hospitals and psychiatric units which enables 
comparison of such assessment data across all such 
hospitals and units to which such data are 
applicable. 
‘‘(II) FUNDING.—The Secretary shall provide 
for the transfer, from the Federal Hospital Insur-
ance Trust Fund under section 1817 to the Centers 
for Medicare & Medicaid Services Program 
Management Account, of $10,000,000 for purposes 
of carrying out subclause (I).’’; and 
(D) in subparagraph (F), as redesignated by subpara-
graph (B) of this paragraph, by striking ‘‘subparagraph 
(C)’’ and inserting ‘‘subparagraphs (C) and (F)’’; and 
(2) by adding at the end the following new paragraph: 
‘‘(6) ADDITIONAL CONSIDERATIONS FOR DIAGNOSIS-RELATED 
GROUP CLASSIFICATIONS.— 
‘‘(A) IN
GENERAL.—Notwithstanding the preceding 
paragraphs of this subsection (other than paragraph (5)) 
or section 124 of the Medicare, Medicaid, and SCHIP Bal-
anced Budget Refinement Act of 1999, beginning not later 
than rate year 2031, in addition to any revisions pursuant 
to paragraph (5), the Secretary shall, by regulation, imple-
ment revisions to the methodology for determining the 
payment rates under the system described in paragraph 
(1) for psychiatric hospitals and psychiatric units, as the 
Secretary determines to be appropriate, to take into account 
the patient assessment data described in paragraph 
(4)(E)(ii). 
‘‘(B) BUDGET
NEUTRALITY.—Revisions in payment 
implemented pursuant to subparagraph (A) for a rate year 
shall result in the same estimated amount of aggregate 
expenditures under this title for psychiatric hospitals and 
psychiatric units furnished in the rate year as would have 
been made under this title for such care in such rate 
year if such revisions had not been implemented.’’.
H. R. 2617—1455 
(c) IMPROVEMENTS THROUGH INCLUSION OF PATIENTS’ PERSPEC-
TIVE ON CARE QUALITY MEASURE.—Section 1886(s)(4) of the Social 
Security Act (42 U.S.C. 1395ww(s)(4)) is amended— 
(1) in subparagraph (D), by adding at the end the following 
new clause: 
‘‘(iv) PATIENTS’ PERSPECTIVE ON CARE.—Not later 
than for rate year 2031, the quality measures specified 
under this subparagraph shall include a quality 
measure of patients’ perspective on care.’’; and 
(2) in subparagraph (E), by inserting ‘‘, including the 
quality measure of patients’ perspective on care described in 
subparagraph (D)(iv),’’ after ‘‘shall report quality measures’’. 
SEC. 4126. EXCEPTION FOR PHYSICIAN WELLNESS PROGRAMS. 
(a) IN GENERAL.—Section 1877(e) of the Social Security Act 
(42 U.S.C. 1395nn(e)) is amended by adding at the end the following: 
‘‘(9) PHYSICIAN WELLNESS PROGRAMS.—A bona fide mental 
health or behavioral health improvement or maintenance pro-
gram offered to a physician by an entity, if— 
‘‘(A) such program— 
‘‘(i) consists of counseling, mental health services, 
a suicide prevention program, or a substance use dis-
order prevention and treatment program; 
‘‘(ii) is made available to a physician for the pri-
mary purpose of preventing suicide, improving mental 
health and resiliency, or providing training in appro-
priate strategies to promote the mental health and 
resiliency of such physician; 
‘‘(iii) is set out in a written policy, approved in 
advance of the operation of the program by the gov-
erning body of the entity providing such program (and 
which shall be updated accordingly in advance to 
substantial changes to the operation of such program), 
that includes— 
‘‘(I) a description of the content and duration 
of the program; 
‘‘(II) a description of the evidence-based sup-
port for the design of the program; 
‘‘(III) the estimated cost of the program; 
‘‘(IV) the personnel (including the qualifica-
tions of such personnel) conducting the program; 
and 
‘‘(V) the method by which such entity will 
evaluate the use and success of the program; 
‘‘(iv) is offered by an entity described in subpara-
graph (B) with a formal medical staff to all physicians 
who practice in the geographic area served by such 
entity, including physicians who hold bona fide 
appointments to the medical staff of such entity or 
otherwise have clinical privileges at such entity; 
‘‘(v) is offered to all such physicians on the same 
terms and conditions and without regard to the volume 
or value of referrals or other business generated by 
a physician for such entity; 
‘‘(vi) is evidence-based and conducted by a qualified 
health professional; and
H. R. 2617—1456 
‘‘(vii) meets such other requirements the Secretary 
may impose by regulation as needed to protect against 
program or patient abuse; 
‘‘(B) such entity is— 
‘‘(i) a hospital; 
‘‘(ii) an ambulatory surgical center; 
‘‘(iii) a community health center; 
‘‘(iv) a rural emergency hospital; 
‘‘(v) a rural health clinic; 
‘‘(vi) a skilled nursing facility; or 
‘‘(vii) a similar entity, as determined by the Sec-
retary; and 
‘‘(C) neither the provision of such program, nor the 
value of such program, are contingent upon the number 
or value of referrals made by a physician to such entity 
or the amount or value of other business generated by 
such physician for the entity.’’. 
(b) EXCEPTION UNDER THE ANTI-KICKBACK STATUTE.—Section 
1128B(b)(3) of the Social Security Act (42 U.S.C. 1320a–7b(b)(3)) 
is amended— 
(1) in subparagraph (J), by striking ‘‘and’’ at the end; 
(2) in subparagraph (K), by striking the period at the 
end and inserting ‘‘; and’’; and 
(3) by adding at the end the following: 
‘‘(L) a bona fide mental health or behavioral health 
improvement or maintenance program, if— 
‘‘(i) such program— 
‘‘(I) consists of counseling, mental health services, 
a suicide prevention program, or a substance use dis-
order prevention and treatment program; 
‘‘(II) is made available to a physician or other 
clinician for the primary purpose of preventing suicide, 
improving mental health and resiliency, or providing 
training in appropriate strategies to promote the 
mental health and resiliency of such physician or other 
clinician; 
‘‘(III) is set out in a written policy, approved in 
advance of the operation of the program by the gov-
erning body of the entity providing such program (and 
which shall be updated accordingly in advance to 
substantial changes to the operation of such program), 
that includes— 
‘‘(aa) a description of the content and duration 
of the program; 
‘‘(bb) a description of the evidence-based sup-
port for the design of the program; 
‘‘(cc) the estimated cost of the program; 
‘‘(dd) the personnel (including the qualifica-
tions of such personnel) implementing the pro-
gram; and 
‘‘(ee) the method by which such entity will 
evaluate the use and success of the program; 
‘‘(IV) is offered by an entity described in clause 
(ii) with a formal medical staff to all physicians and 
other clinicians who practice in the geographic area 
served by such entity, including physicians who hold 
bona fide appointments to the medical staff of such