1251
SEC. 5021. BUDGETARY EFFECTS. 
(a) STATUTORY PAYGO SCORECARDS.—The budg-
etary effects of this division and each succeeding division 
shall not be entered on either PAYGO scorecard main-
tained pursuant to section 4(d) of the Statutory Pay-As-
You-Go Act of 2010. 
(b) SENATE PAYGO SCORECARDS.—The budgetary 
effects of this division and each succeeding division shall 
not be entered on any PAYGO scorecard maintained for 
purposes of section 4106 of H. Con. Res. 71 (115th Con-
gress). 
(c) CLASSIFICATION
OF BUDGETARY EFFECTS.—
Notwithstanding Rule 3 of the Budget Scorekeeping 
Guidelines set forth in the joint explanatory statement of 
the committee of conference accompanying Conference Re-
port 105–217 and section 250(c)(8) of the Balanced 
Budget and Emergency Deficit Control Act of 1985, the 
budgetary effects of this division and each succeeding divi-
sion shall not be estimated—
(1) for purposes of section 251 of such Act; 
(2) for purposes of an allocation to the Com-
mittee on Appropriations pursuant to section 302(a) 
of the Congressional Budget Act of 1974; and 
(3) for purposes of paragraph (4)(C) of section 
3 of the Statutory Pay-As-You-Go Act of 2010 as 
being included in an appropriation Act.
1252
DIVISION J—HEALTH CARE 
EXTENDERS 
SEC. 6001. TABLE OF CONTENTS. 
The table of contents of this division is as follows:
DIVISION J—HEALTH CARE EXTENDERS 
Sec. 6001. Table of contents. 
TITLE I—MEDICAID 
Sec. 6101. Streamlined enrollment process for eligible out-of-State providers 
under Medicaid and CHIP. 
Sec. 6102. Removing certain age restrictions on Medicaid eligibility for working 
adults with disabilities. 
Sec. 6103. Medicaid State plan requirement for determining residency and cov-
erage for military families. 
Sec. 6104. State studies and HHS report on costs of providing maternity, 
labor, and delivery services. 
Sec. 6105. Modifying certain disproportionate share hospital allotments. 
Sec. 6106. Modifying certain limitations on disproportionate share hospital pay-
ment adjustments under the Medicaid program. 
TITLE II—MEDICARE 
Sec. 6201. Extension of increased inpatient hospital payment adjustment for 
certain low-volume hospitals. 
Sec. 6202. Extension of the Medicare-dependent hospital (MDH) program. 
Sec. 6203. Extension of add-on payments for ambulance services. 
Sec. 6204. Extending incentive payments for participation in eligible alternative 
payment models. 
Sec. 6205. Extension of funding for quality measure endorsement, input, and 
selection. 
Sec. 6206. Extension of funding outreach and assistance for low-income pro-
grams. 
Sec. 6207. Extension of funding for Medicare hospice surveys. 
Sec. 6208. Extension of the work geographic index floor. 
Sec. 6209. Extension of certain telehealth flexibilities. 
Sec. 6210. Extending acute hospital care at home waiver flexibilities. 
Sec. 6211. In-home cardiopulmonary rehabilitation flexibility. 
Sec. 6212. Enhancing certain program integrity requirements for DME under 
Medicare. 
Sec. 6213. Guidance on furnishing services via telehealth to individuals with 
limited English proficiency. 
Sec. 6214. Inclusion of virtual diabetes prevention program suppliers in MDPP 
Expanded Model. 
Sec. 6215. Medication-induced movement disorder outreach and education. 
Sec. 6216. Report on wearable medical devices. 
Sec. 6217. Extension of temporary inclusion of authorized oral antiviral drugs 
as covered part D drugs. 
Sec. 6218. Extension of adjustment to calculation of hospice cap amount under 
Medicare.
1253
Sec. 6219. Adjustments to Medicare part D cost-sharing reductions for low-in-
come individuals. 
Sec. 6220. Requiring Enhanced and Accurate Lists of (REAL) Health Pro-
viders Act. 
Sec. 6221. Medicare coverage of multi-cancer early detection screening tests. 
Sec. 6222. Medicare coverage of external infusion pumps and non-self-admin-
istrable home infusion drugs. 
Sec. 6223. Assuring pharmacy access and choice for medicare beneficiaries. 
Sec. 6224. Modernizing and ensuring PBM accountability. 
Sec. 6225. Requiring a separate identification number and an attestation for 
each off-campus outpatient department of a provider. 
Sec. 6226. Revising phase-in of medicare clinical laboratory test payment 
changes. 
Sec. 6227. Medicare sequestration. 
Sec. 6228. Medicare Improvement Fund. 
TITLE III—HUMAN SERVICES 
Sec. 6301. Sexual risk avoidance education extension. 
Sec. 6302. Personal responsibility education extension. 
Sec. 6303. Extension of funding for family-to-family health information centers. 
Sec. 6304. Extension of the Temporary Assistance for Needy Families Pro-
gram. 
TITLE IV—PUBLIC HEALTH AND OTHER EXTENDERS 
Subtitle A—Extensions 
Sec. 6401. Extension for community health centers, National Health Service 
Corps, and teaching health centers that operate GME pro-
grams. 
Sec. 6402. Extension of special diabetes programs. 
Sec. 6403. Extension of national health security programs. 
Sec. 6404. No Surprises Act implementation. 
Subtitle B—World Trade Center Health Program 
Sec. 6411. 9/11 responder and survivor health funding corrections. 
TITLE V—PUBLIC HEALTH PROGRAMS 
Sec. 6501. Preventing maternal deaths. 
Sec. 6502. Organ Procurement and Transplantation Network. 
Sec. 6503. Honor our living donors. 
Sec. 6504. Program for pediatric studies of drugs. 
Sec. 6505. Sickle cell disease prevention and treatment. 
Sec. 6506. Lifespan respite care. 
Sec. 6507. PREEMIE. 
Sec. 6508. Dr. Lorna Breen health care provider protection. 
TITLE VI—FOOD AND DRUG ADMINISTRATION 
Subtitle A—Mikaela Naylon Give Kids a Chance Act 
Sec. 6601. Research into pediatric uses of drugs; additional authorities of Food 
and Drug Administration regarding molecularly targeted can-
cer drugs. 
Sec. 6602. Ensuring completion of pediatric study requirements.
1254
Sec. 6603. FDA report on PREA enforcement. 
Sec. 6604. Extension of authority to issue priority review vouchers to encourage 
treatments for rare pediatric diseases. 
Sec. 6605. Limitations on exclusive approval or licensure of orphan drugs. 
Subtitle B—United States-Abraham Accords Cooperation and Security 
Sec. 6611. Establishment of Abraham Accords Office within Food and Drug 
Administration. 
TITLE VII—LOWERING PRESCRIPTION DRUG COSTS 
Sec. 6701. Oversight of pharmacy benefit management services. 
Sec. 6702. Full rebate pass through to plan; exception for innocent plan fidu-
ciaries. 
Sec. 6703. Increasing transparency in generic drug applications.
TITLE I—MEDICAID 
SEC. 6101. STREAMLINED ENROLLMENT PROCESS FOR ELI-
GIBLE 
OUT-OF-STATE 
PROVIDERS 
UNDER 
MEDICAID AND CHIP. 
(a) IN GENERAL.—Section 1902(kk) of the Social Se-
curity Act (42 U.S.C. 1396a(kk)) is amended by adding 
at the end the following new paragraph: 
‘‘(10) STREAMLINED
ENROLLMENT
PROCESS 
FOR ELIGIBLE OUT-OF-STATE PROVIDERS.—
‘‘(A) IN GENERAL.—The State—
‘‘(i) adopts and implements a process 
to allow an eligible out-of-State provider to 
enroll under the State plan (or a waiver of 
such plan) to furnish items and services to, 
or order, prescribe, refer, or certify eligi-
bility for items and services for, qualifying 
individuals without the imposition of 
screening or enrollment requirements by
1255
such State that exceed the minimum nec-
essary for such State to provide payment 
to an eligible out-of-State provider under 
such State plan (or a waiver of such plan), 
such as the provider’s name and National 
Provider Identifier (and such other infor-
mation specified by the Secretary); and 
‘‘(ii) provides that an eligible out-of-
State provider that enrolls as a partici-
pating provider in the State plan (or a 
waiver of such plan) through such process 
shall be so enrolled for a 5-year period, un-
less the provider is terminated or excluded 
from participation during such period. 
‘‘(B) DEFINITIONS.—In this paragraph: 
‘‘(i) ELIGIBLE
OUT-OF-STATE
PRO-
VIDER.—The term ‘eligible out-of-State 
provider’ means, with respect to a State, a 
provider—
‘‘(I) that is located in any other 
State; 
‘‘(II) that—
‘‘(aa) was determined by the 
Secretary to have a limited risk 
of fraud, waste, and abuse for
1256
purposes of determining the level 
of screening to be conducted 
under section 1866(j)(2), has 
been so screened under such sec-
tion 1866(j)(2), and is enrolled in 
the Medicare program under title 
XVIII; or 
‘‘(bb) was determined by the 
State agency administering or su-
pervising the administration of 
the State plan (or a waiver of 
such plan) of such other State to 
have a limited risk of fraud, 
waste, and abuse for purposes of 
determining the level of screening 
to be conducted under paragraph 
(1) of this subsection, has been 
so screened under such para-
graph (1), and is enrolled under 
such State plan (or a waiver of 
such plan); and 
‘‘(III) that has not been—
‘‘(aa) excluded from partici-
pation in any Federal health care
1257
program 
pursuant 
to 
section 
1128 or 1128A; 
‘‘(bb) excluded from partici-
pation in the State plan (or a 
waiver of such plan) pursuant to 
part 1002 of title 42, Code of 
Federal Regulations (or any suc-
cessor regulation), or State law; 
or 
‘‘(cc) terminated from par-
ticipating in a Federal health 
care program or the State plan 
(or a waiver of such plan) for a 
reason described in paragraph 
(8)(A). 
‘‘(ii) QUALIFYING
INDIVIDUAL.—The 
term ‘qualifying individual’ means an indi-
vidual under 21 years of age who is en-
rolled under the State plan (or waiver of 
such plan). 
‘‘(iii) 
STATE.—The 
term 
‘State’ 
means 1 of the 50 States or the District 
of Columbia.’’. 
(b) CONFORMING AMENDMENTS.—
1258
(1) Section 1902(a)(77) of the Social Security 
Act (42 U.S.C. 1396a(a)(77)) is amended by insert-
ing ‘‘enrollment,’’ after ‘‘screening,’’. 
(2) 
The 
subsection 
heading 
for 
section 
1902(kk) of such Act (42 U.S.C. 1396a(kk)) is 
amended by inserting ‘‘enrollment,’’ after ‘‘screen-
ing,’’. 
(3) Section 2107(e)(1)(G) of such Act (42 
U.S.C. 1397gg(e)(1)(G)) is amended by inserting 
‘‘enrollment,’’ after ‘‘screening,’’. 
(c) EFFECTIVE DATE.—The amendments made by 
this section shall take effect on the date that is 3 years 
after the date of enactment of this Act. 
SEC. 6102. REMOVING CERTAIN AGE RESTRICTIONS ON 
MEDICAID 
ELIGIBILITY 
FOR 
WORKING 
ADULTS WITH DISABILITIES. 
(a) MODIFICATION OF OPTIONAL BUY-IN GROUPS.—
(1) IN
GENERAL.—Section 1902(a)(10)(A)(ii) 
of 
the 
Social 
Security 
Act 
(42 
U.S.C. 
1396a(a)(10)(A)(ii)) is amended—
(A) in subclause (XV)—
(i) by striking ‘‘, but less than 65,’’; 
and 
(ii) by inserting ‘‘, including at least 
the 
group 
described 
in 
section
1259
1905(a)(xviii)’’ before the semicolon at the 
end; and 
(B) in subclause (XVI), by inserting ‘‘in-
cluding at least the group described in section 
1905(a)(xii),’’ after ‘‘the State may establish,’’. 
(2) INDIVIDUALS DESCRIBED.—Section 1905(a) 
of the Social Security Act (42 U.S.C. 1396d(a)) is 
amended—
(A) in clause (xvi), by striking ‘‘or’’ at the 
end; 
(B) in clause (xvii), by adding ‘‘or’’ after 
the comma at the end; and 
(C) by adding after clause (xvii) the fol-
lowing new clause: 
‘‘(xviii) individuals who, but for earn-
ings in excess of the limit established 
under subsection (q)(2)(B), would be con-
sidered to be receiving supplemental secu-
rity income, and who are at least 16 years 
of age,’’. 
(3) 
DEFINITION
MODIFICATION.—Section 
1905(v)(1)(A) of the Social Security Act (42 U.S.C. 
1396d(v)(1)(A)) is amended by striking ‘‘, but less 
than 65,’’.
1260
(b) APPLICATION
TO CERTAIN STATES.—A State 
that, as of the date of enactment of this Act, provides for 
making medical assistance available to individuals de-
scribed 
in 
subclause 
(XV) 
or 
(XVI) 
of 
section 
1902(a)(10)(A)(ii) of the Social Security Act (42 U.S.C. 
1396a(a)(10)(A)(ii)) shall not be regarded as failing to 
comply with the requirements of the amendments made 
by subsection (a) before January 1, 2028. 
SEC. 6103. MEDICAID STATE PLAN REQUIREMENT FOR DE-
TERMINING RESIDENCY AND COVERAGE FOR 
MILITARY FAMILIES. 
(a) IN GENERAL.—Section 1902 of the Social Secu-
rity Act (42 U.S.C. 1396a) is amended—
(1) in subsection (a)—
(A) in paragraph (88), by striking ‘‘and’’ 
at the end; 
(B) in paragraph (89), by striking the pe-
riod at the end and inserting ‘‘; and’’; and 
(C) by inserting after paragraph (89), the 
following new paragraph: 
‘‘(90) beginning January 1, 2030, provide, with 
respect to an active duty relocated individual (as de-
fined in subsection (yy)(1))—
‘‘(A) that, for purposes of determining eli-
gibility for medical assistance under the State
1261
plan (or waiver of such plan), such active duty 
relocated individual is treated as a resident of 
the State unless such individual voluntarily 
elects not to be so treated for such purposes; 
‘‘(B) that if, at the time of relocation (as 
described in subsection (yy)(1)), such active 
duty relocated individual is on a home and com-
munity-based services waiting list (as defined in 
subsection (yy)(2)), such individual remains on 
such list until—
‘‘(i) the State completes an assess-
ment and renders a decision with respect 
to the eligibility of such individual to re-
ceive the relevant home and community-
based services at the time a slot for such 
services becomes available and, in the case 
such decision is a denial of such eligibility, 
such individual has exhausted the individ-
ual’s opportunity for a fair hearing; or 
‘‘(ii) such individual elects to be re-
moved from such list; and 
‘‘(C) payment for medical assistance fur-
nished under the State plan (or a waiver of the 
plan) on behalf of such active duty relocated in-
dividual in the military service relocation State
1262
(as referred to in subsection (yy)(1)(B)(i)), to 
the extent that such assistance is available in 
such military service relocation State in accord-
ance with such guidance as the Secretary may 
issue to ensure access to such assistance.’’; and 
(2) by adding at the end the following new sub-
section: 
‘‘(yy) ACTIVE DUTY RELOCATED INDIVIDUAL; HOME 
AND COMMUNITY-BASED SERVICES WAITING LIST.—For 
purposes of subsection (a)(90) and this subsection: 
‘‘(1) ACTIVE DUTY RELOCATED INDIVIDUAL.—
The term ‘active duty relocated individual’ means an 
individual—
‘‘(A) who—
‘‘(i) is enrolled under the State plan 
(or waiver of such plan); or 
‘‘(ii) with respect to an individual de-
scribed in subparagraph (C)(ii), would be 
so 
enrolled 
pursuant 
to 
subsection 
(a)(10)(A)(ii)(VI) if such individual began 
receiving home and community-based serv-
ices; 
‘‘(B) who—
‘‘(i) is a member of the Armed Forces 
engaged in active duty service and is relo-
1263
cated to another State (in this subsection 
referred to as the ‘military service reloca-
tion State’) by reason of such service; 
‘‘(ii) would be described in clause (i) 
except that the individual stopped being 
engaged in active duty service (including 
by reason of retirement from such service) 
and the last day on which the individual 
was engaged in active duty service oc-
curred not more than 12 months ago; or 
‘‘(iii) is a dependent (as defined by 
the Secretary) of a member described in 
clause (i) or (ii) who relocates to the mili-
tary service relocation State with such 
member; and 
‘‘(C) who—
‘‘(i) was receiving home and commu-
nity-based services (as defined in section 
9817(a)(2)(B) of the American Rescue 
Plan Act of 2021) at the time of such relo-
cation; or 
‘‘(ii) if the State maintains a home 
and community-based services waiting list, 
was on such home and community-based
1264
services waiting list at the time of such re-
location. 
‘‘(2) HOME AND COMMUNITY-BASED SERVICES 
WAITING LIST.—The term ‘home and community-
based services waiting list’ means, in the case of a 
State that has a limit on the number of individuals 
who may receive home and community-based services 
under section 1115(a) or section 1915(c), a list 
maintained by such State of individuals who are re-
questing to receive such services under 1 or more 
such sections but for whom the State has not yet 
completed an assessment and rendered a decision 
with respect to the eligibility of such individuals to 
receive the relevant home and community-based 
services at the time a slot for such services becomes 
available due to such limit.’’. 
(b) IMPLEMENTATION FUNDING.—There are appro-
priated, out of any funds in the Treasury not otherwise 
obligated, $1,000,000 for each of fiscal years 2026 
through 2030, to remain available until expended, to the 
Secretary of Health and Human Services for purposes of 
implementing the amendments made by subsection (a).
1265
SEC. 6104. STATE STUDIES AND HHS REPORT ON COSTS OF 
PROVIDING MATERNITY, LABOR, AND DELIV-
ERY SERVICES. 
(a) STATE STUDY.—
(1) IN GENERAL.—Not later than 30 months 
after the date of enactment of this Act, and every 
5 years thereafter, each State (as such term is de-
fined in section 1101(a)(1) of the Social Security 
Act (42 U.S.C. 1301(a)(1)) for purposes of titles 
XIX and XXI of such Act) shall conduct a study on 
the costs of providing maternity, labor, and delivery 
services in applicable hospitals (as defined in para-
graph (3)) and submit the results of such study to 
the Secretary of Health and Human Services (re-
ferred to in this section as the ‘‘Secretary’’) in such 
form and manner as the Secretary requires. 
(2) CONTENT OF STUDY.—A State study re-
quired under paragraph (1) shall include the fol-
lowing information (to the extent practicable and as 
further defined by the Secretary) with respect to 
maternity, labor, and delivery services furnished by 
applicable hospitals located in the State: 
(A) An estimate of the cost of providing 
maternity, labor, and delivery services at appli-
cable hospitals, based on the expenditures a 
representative sample of such hospitals incurred
1266
for providing such services during the 2 most 
recent years for which data is available. 
(B) An estimate of the cost of providing 
maternity, labor, and delivery services at hos-
pitals that would be applicable hospitals (as de-
fined in paragraph (3)) if not for ceasing to 
provide labor and delivery services within the 
past 5 years, based on the expenditures a rep-
resentative sample of such hospitals incurred 
for providing such services during the 2 most 
recent years for which data is available. 
(C) To the extent data allow, an analysis 
of the extent to which geographic location, com-
munity demographics, and local economic fac-
tors (as defined by the Secretary) affect the 
cost of providing maternity, labor, and delivery 
services at applicable hospitals described in sub-
paragraphs (A) and (B), including the cost of 
services that support the provision of maternity, 
labor, and delivery services. 
(D) The amounts applicable hospitals are 
paid for maternity, labor, and delivery services, 
by geographic location and hospital size, 
under—
1267
(i) parts A and B of the Medicare 
program; 
(ii) the State Medicaid program, in-
cluding payment amounts for such services 
under fee-for-service payment arrange-
ments and under managed care (as appli-
cable); 
(iii) the State CHIP plan, including 
payment amounts for such services under 
fee-for-service payment arrangements and 
under managed care (as applicable); and 
(iv) private health insurance. 
(E) A comparative payment rate anal-
ysis—
(i) comparing payment rates for ma-
ternity, labor, and delivery services (inclu-
sive of all payments received by applicable 
hospitals for furnishing maternity, labor, 
and delivery services) under the State 
Medicaid fee-for-service program to such 
payment rates for such services under 
Medicare (including those described in 
paragraphs 
(2) 
and 
(3) 
of 
section 
447.203(b) of title 42, Code of Federal 
Regulations), and, to the extent data is
1268
available, such payment rates for such 
services under Medicaid managed care and 
private health insurers within geographic 
areas of the State; and 
(ii) analyzing different payment meth-
ods for such services, such as the use of 
bundled payments, quality incentives, and 
low-volume adjustments. 
(F) An evaluation, using such methodology 
and parameters established by the Secretary, of 
whether each hospital located in the State that 
furnishes maternity, labor, and delivery services 
is expected to experience in the next 3 years 
significant changes in particular expenditures 
or types of reimbursement for maternity, labor, 
and delivery services. 
(3) APPLICABLE
HOSPITAL
DEFINED.—For 
purposes of this subsection, the term ‘‘applicable 
hospital’’ means any hospital located in a State that 
meets either of the following criteria: 
(A) The hospital provides labor and deliv-
ery services and more than 50 percent of the 
hospital’s births (in the most recent year for 
which such data is available) are financed by 
the Medicaid program or CHIP.
1269
(B) The hospital—
(i) is located in a rural area (as de-
fined by the Federal Office of Rural 
Health Policy for the purpose of rural 
health grant programs administered by 
such Office); 
(ii) based on the most recent 2 years 
of data available (as determined by the 
Secretary), furnished services for less than 
an average of 300 births per year; and 
(iii) provides labor and delivery serv-
ices. 
(4) ASSISTANCE TO SMALL HOSPITALS IN COM-
PILING
COST
INFORMATION.—There are appro-
priated to the Secretary for fiscal year 2026, 
$10,000,000 for the purpose of providing grants and 
technical assistance to a hospital described in para-
graph (3)(B) to enable such hospital to compile de-
tailed information for use in the State studies re-
quired under paragraph (1), to remain available 
until expended. 
(5) HHS REPORT
ON
STATE
STUDIES.—For 
each year in which a State is required to conduct a 
study under paragraph (1), the Secretary shall issue, 
not later than 18 months after the date on which
1270
the State submits to the Secretary the data de-
scribed in such paragraph, a publicly available re-
port that compiles and details the results of such 
study and includes the information described in 
paragraph (2). 
(b) HHS REPORT ON NATIONAL DATA COLLECTION 
FINDINGS.—Not later than 3 years and 6 months after 
the date of enactment of this Act, the Secretary shall sub-
mit to Congress, and make publicly available, a report 
analyzing the first studies conducted by States under sub-
section (a)(1), including recommendations for improving 
data collection on the cost of providing maternity, labor, 
and delivery services. 
(c) IMPLEMENTATION FUNDING.—In addition to the 
amount appropriated under subsection (a)(4), there are 
appropriated, out of any funds in the Treasury not other-
wise obligated, $3,000,000 for fiscal year 2026, to remain 
available until expended, to the Secretary of Health and 
Human Services for purposes of implementing this sec-
tion. 
SEC. 
6105. 
MODIFYING 
CERTAIN 
DISPROPORTIONATE 
SHARE HOSPITAL ALLOTMENTS. 
(a) EXTENDING TENNESSEE DSH ALLOTMENTS.—
Section 1923(f)(6)(A)(vi) of the Social Security Act (42 
U.S.C. 1396r–4(f)(6)(A)(vi)) is amended—
1271
(1) in the heading, by striking ‘‘2025 AND A 
PORTION
OF
FISCAL
YEAR
2026’’ and inserting 
‘‘2027’’; and 
(2) by inserting ‘‘, and the DSH allotment for 
Tennessee for the portion of fiscal year 2026 begin-
ning on January 31, 2026, and ending September 
30, 2026, shall be $35,351,507, which may be 
claimed as fiscal year 2026 uncompensated care 
costs, and the DSH allotment for Tennessee for fis-
cal year 2027, shall be $53,100,000’’ before the pe-
riod. 
(b) ELIMINATING CERTAIN DSH ALLOTMENT RE-
DUCTIONS.—Section 1923(f)(7)(A) of the Social Security 
Act (42 U.S.C. 1396r–4(f)(7)(A)) is amended—
(1) in clause (i)—
(A) in the matter preceding subclause (I), 
by striking ‘‘the period beginning January 31, 
2026, and ending September 30, 2026, and for 
each of fiscal years 2027 and 2028’’ and insert-
ing ‘‘fiscal year 2028’’; 
(B) in subclause (I), by striking ‘‘or pe-
riod’’; and 
(C) in subclause (II), by striking ‘‘or pe-
riod’’ each place it appears; and
1272
(2) in clause (ii), by striking ‘‘the period begin-
ning January 31, 2026, and ending September 30, 
2026, and for each of fiscal years 2027 and 2028’’ 
and inserting ‘‘fiscal year 2028’’. 
SEC. 6106. MODIFYING CERTAIN LIMITATIONS ON DIS-
PROPORTIONATE 
SHARE 
HOSPITAL 
PAY-
MENT ADJUSTMENTS UNDER THE MEDICAID 
PROGRAM. 
(a) IN GENERAL.—Section 1923(g) of the Social Se-
curity Act (42 U.S.C. 1396r–4(g)) is amended—
(1) in paragraph (1)—
(A) in subparagraph (A)—
(i) in the matter preceding clause (i), 
by striking ‘‘(other than a hospital de-
scribed in paragraph (2)(B))’’; 
(ii) in clause (i), by inserting ‘‘with 
respect to such hospital and year’’ after 
‘‘described in subparagraph (B)’’; and 
(iii) in clause (ii)—
(I) in subclause (I), by striking 
‘‘and’’ at the end; 
(II) in subclause (II), by striking 
the period and inserting ‘‘; and’’; and 
(III) by adding at the end the 
following new subclause:
1273
‘‘(III) payments made under title 
XVIII or by an applicable plan (as de-
fined in section 1862(b)(8)(F)) for 
such services.’’; and 
(B) in subparagraph (B)—
(i) in the matter preceding clause (i), 
by striking ‘‘in this clause are’’ and insert-
ing ‘‘in this subparagraph are, with respect 
to a hospital and a year,’’; and 
(ii) by adding at the end the following 
new clause: 
‘‘(iii) Individuals who are eligible for 
medical assistance under the State plan or 
under a waiver of such plan and for whom 
the State plan or waiver is a payor for 
such services after application of benefits 
under title XVIII or under an applicable 
plan (as defined in section 1862(b)(8)(F)), 
but only if the hospital has in the aggre-
gate incurred costs exceeding payments 
under such State plan, waiver, title XVIII, 
or applicable plan for such services fur-
nished to such individuals during such 
year.’’; 
(2) by striking paragraph (2);
1274
(3) by redesignating paragraph (3) as para-
graph (2); and 
(4) in paragraph (2), as so redesignated, by 
striking ‘‘Notwithstanding paragraph (2) of this 
subsection (as in effect on October 1, 2021), para-
graph (2)’’ and inserting ‘‘Paragraph (2)’’. 
(b) EFFECTIVE DATE.—
(1) IN GENERAL.—Except as provided in para-
graph (2), the amendments made by this section 
shall apply to payment adjustments made under sec-
tion 1923 of the Social Security Act (42 U.S.C. 
1396r–4) for Medicaid State plan rate years begin-
ning on or after the date of enactment of this Act. 
(2) STATE OPTION TO DISTRIBUTE UNSPENT 
DSH ALLOTMENTS FROM PRIOR YEARS UP TO MODI-
FIED CAP.—
(A) IN
GENERAL.—If, for any Medicaid 
State plan rate year that begins on or after Oc-
tober 1, 2022, and before the date of enactment 
of this Act, a State did not spend the full 
amount of its Federal fiscal year allotment 
under section 1923 of the Social Security Act 
(42 U.S.C. 1396r–4) applicable to that State 
plan rate year, the State may use the unspent 
portion of such allotment to increase the
1275
amount of any payment adjustment made to a 
hospital for such rate year, provided that—
(i) such payment adjustment (as so 
increased) is consistent with subsection (g) 
of such section (as amended by this sec-
tion); and 
(ii) the total amount of all payment 
adjustments for the State plan rate year 
(as so increased) does not exceed the dis-
proportionate share hospital allotment for 
the State and applicable Federal fiscal 
year under subsection (f) of such section. 
(B) NO RECOUPMENT OF PAYMENTS AL-
READY MADE TO HOSPITALS.—A State shall not 
recoup any payment adjustment made by the 
State to a hospital for a Medicaid State plan 
rate year described in subparagraph (A) if such 
payment adjustment is consistent with section 
1923(g) of such Act (42 U.S.C. 1396r–4(g)) as 
in effect on October 1, 2021. 
(C) AUTHORITY TO PERMIT RETROACTIVE 
MODIFICATION OF STATE PLAN AMENDMENTS 
TO ALLOW FOR INCREASES.—
(i) IN
GENERAL.—Subject to clause 
(ii), solely for the purpose of allowing a
1276
State to increase the amount of a payment 
adjustment to a hospital for a Medicaid 
State plan rate year described in subpara-
graph (A) pursuant to this paragraph, a 
State may retroactively modify a provision 
of the Medicaid State plan, a waiver of 
such plan, or a State plan amendment that 
relates to such rate year and the Secretary 
may approve such modification. 
(ii) DEADLINE.—A State may not 
submit a request for approval of a retro-
active modification to a provision of the 
Medicaid State plan, a waiver of such plan, 
or a State plan amendment for a Medicaid 
State plan rate year after the date by 
which the State is required to submit the 
independent certified audit for such State 
plan rate year as required under section 
1923(j)(2) of the Social Security Act (42 
U.S.C. 1396r–4(j)(2)). 
(D) REPORTING.—If a State increases a 
payment adjustment made to a hospital for a 
Medicaid State plan rate year pursuant to this 
paragraph, the State shall include information 
in such form and manner as the Secretary shall
1277
specify on such increased payment adjustment 
as part of the annual report submitted by the 
State under section 1923(j)(1) of the Social Se-
curity Act (42 U.S.C. 1396r–4(j)(1)) for such 
State plan rate year or, if necessary, as deter-
mined by the Secretary, in an amendment to 
such annual report. 
TITLE II—MEDICARE 
SEC. 6201. EXTENSION OF INCREASED INPATIENT HOS-
PITAL 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), by striking ‘‘during 
the portion of fiscal year 2026 beginning on January 
31, 2026, and ending on September 30, 2026, and 
in fiscal year 2027’’ and inserting ‘‘during the por-
tion of fiscal year 2027 beginning on January 1, 
2027, and ending on September 30, 2027, and in 
fiscal year 2028’’; 
(2) in subparagraph (C)(i)—
(A) in the matter preceding subclause (I), 
by striking ‘‘through 2025 and the portion of 
fiscal year 2026 beginning on October 1, 2025, 
and ending on January 30, 2026’’ and inserting
1278
‘‘through 2026 and the portion of fiscal year 
2027 beginning on October 1, 2026, and ending 
on December 31, 2026’’; 
(B) 
in 
subclause 
(III), 
by 
striking 
‘‘through 2025 and the portion of fiscal year 
2026 beginning on October 1, 2025, and ending 
on January 30, 2026’’ and inserting ‘‘through 
2026 and the portion of fiscal year 2027 begin-
ning on October 1, 2026, and ending on De-
cember 31, 2026’’; and 
(C) in subclause (IV), by striking ‘‘the por-
tion of fiscal year 2026 beginning on January 
31, 2026, and ending on September 30, 2026, 
and fiscal year 2027’’ and inserting ‘‘the por-
tion of fiscal year 2027 beginning on January 
1, 2027, and ending on September 30, 2027, 
and fiscal year 2028’’; and 
(3) in subparagraph (D)—
(A) in the matter preceding clause (i), by 
striking ‘‘through 2025 or during the portion of 
fiscal year 2026 beginning on October 1, 2025, 
and ending on January 30, 2026’’ and inserting 
‘‘through 2026 or during the portion of fiscal 
year 2027 beginning on October 1, 2026, and 
ending on December 31, 2026’’; and
1279
(B) in clause (ii), by striking ‘‘through 
2025 and the portion of fiscal year 2026 begin-
ning on October 1, 2025, and ending on Janu-
ary 30, 2026’’ and inserting ‘‘through 2026 and 
the portion of fiscal year 2027 beginning on Oc-
tober 1, 2026, and ending on December 31, 
2026’’. 
(b) IMPLEMENTATION.—Notwithstanding any other 
provision of law, the Secretary of Health and Human 
Services may implement the amendments made by this 
section by program instruction or otherwise. 
SEC. 6202. EXTENSION OF THE MEDICARE-DEPENDENT 
HOSPITAL (MDH) PROGRAM. 
(a) IN GENERAL.—Section 1886(d)(5)(G) of the So-
cial Security Act (42 U.S.C. 1395ww(d)(5)(G)) is amend-
ed—
(1) in clause (i), by striking ‘‘January 31, 
2026’’ and inserting ‘‘January 1, 2027’’; and 
(2) in clause (ii)(II), by striking ‘‘January 31, 
2026’’ and inserting ‘‘January 1, 2027’’. 
(b) CONFORMING AMENDMENTS.—
(1) IN
GENERAL.—Section 1886(b)(3)(D) of 
the 
Social 
Security 
Act 
(42 
U.S.C. 
1395ww(b)(3)(D)) is amended—
1280
(A) in the matter preceding clause (i), by 
striking ‘‘January 31, 2026’’ and inserting 
‘‘January 1, 2027’’; and 
(B) in clause (iv), by striking ‘‘through fis-
cal year 2025 and the portion of fiscal year 
2026 beginning on October 1, 2025, and ending 
on January 30, 2026’’ and inserting ‘‘through 
fiscal year 2026 and the portion of fiscal year 
2027 beginning on October 1, 2026, and ending 
on December 31, 2026’’. 
(2) PERMITTING HOSPITALS TO DECLINE RE-
CLASSIFICATION.—Section 13501(e)(2) of the Omni-
bus Budget Reconciliation Act of 1993 (42 U.S.C. 
1395ww note) is amended by striking ‘‘through fis-
cal year 2025, or the portion of fiscal year 2026 be-
ginning on October 1, 2025, and ending on January 
30, 2026’’ and inserting ‘‘through fiscal year 2026, 
or the portion of fiscal year 2027 beginning on Octo-
ber 1, 2026, and ending on December 31, 2026’’. 
SEC. 6203. EXTENSION OF ADD-ON PAYMENTS FOR AMBU-
LANCE SERVICES. 
Section 1834(l) of the Social Security Act (42 U.S.C. 
1395m(l)) is amended—
(1) in paragraph (12)(A), by striking ‘‘January 
31, 2026’’ and inserting ‘‘January 1, 2028’’; and
1281
(2) in paragraph (13), by striking ‘‘January 31, 
2026’’ each place it appears and inserting ‘‘January 
1, 2028’’ in each such place. 
SEC. 6204. EXTENDING INCENTIVE PAYMENTS FOR PAR-
TICIPATION IN ELIGIBLE ALTERNATIVE PAY-
MENT MODELS. 
(a) IN GENERAL.—Section 1833(z) of the Social Se-
curity Act (42 U.S.C. 1395l(z)) is amended—
(1) in paragraph (1)(A)—
(A) by inserting ‘‘, and during 2028,’’ 
after ‘‘with 2026’’; and 
(B) by inserting ‘‘, or, with respect to 
2028, 3.1 percent’’ after ‘‘1.88 percent’’; 
(2) in paragraph (2)—
(A) in subparagraph (B)—
(i) in the heading, by inserting ‘‘AND 
2028’’ after ‘‘2026’’; and 
(ii) in the matter preceding clause (i), 
by inserting ‘‘and 2028’’ after ‘‘2026’’; 
(B) in subparagraph (C)—
(i) in the heading, by striking ‘‘BE-
GINNING IN 2027’’ and inserting ‘‘2027 AND 
2029 AND SUBSEQUENT YEARS’’; and
1282
(ii) in the matter preceding clause (i), 
by inserting ‘‘and 2029’’ after ‘‘2027’’; 
and 
(C) in subparagraph (D), by striking ‘‘and 
2026’’ and inserting ‘‘2026, and 2028’’; and 
(3) in paragraph (4)(B), by inserting ‘‘, or, 
with respect to 2028, 3.1 percent’’ after ‘‘1.88 per-
cent’’. 
(b) 
CONFORMING
AMENDMENTS.—Section 
1848(q)(1)(C)(iii) of the Social Security Act (42 U.S.C. 
1395w–4(q)(1)(C)(iii)) is amended—
(1) in subclause (II), by inserting ‘‘and 2028’’ 
after ‘‘2026’’; and 
(2) in subclause (III), by inserting ‘‘and 2029’’ 
after ‘‘2027’’. 
SEC. 6205. EXTENSION OF FUNDING FOR QUALITY MEAS-
URE ENDORSEMENT, INPUT, AND SELECTION. 
Section 1890(d)(2) of the Social Security Act (42 
U.S.C. 1395aaa(d)(2)) is amended—
(1) in the first sentence—
(A) by striking ‘‘and $13,300,000’’ and in-
serting ‘‘$13,300,000’’; and 
(B) by inserting the following before the 
period at the end: ‘‘, and $15,100,000 for fiscal 
year 2027’’; and
1283
(2) in the third sentence, by striking ‘‘and 
2026’’ and inserting ‘‘2026, and 2027’’. 
SEC. 6206. EXTENSION OF FUNDING OUTREACH AND AS-
SISTANCE FOR LOW-INCOME PROGRAMS. 
(a) STATE HEALTH INSURANCE ASSISTANCE PRO-
GRAMS.—Subsection (a)(1)(B) of section 119 of the Medi-
care Improvements for Patients and Providers Act of 2008 
(42 U.S.C. 1395b–3 note) is amended—
(1) in clause (xiv), by striking ‘‘and’’ at the 
end; 
(2) in clause (xv), by striking the period at the 
end and inserting ‘‘; and’’; and 
(3) by inserting after clause (xv) the following 
new clause: 
‘‘(xvi) for the period beginning on 
January 31, 2026, and ending on Decem-
ber 31, 2027, $30,000,000.’’. 
(b) 
AREA
AGENCIES
ON
AGING.—Subsection 
(b)(1)(B) of such section 119 is amended—
(1) in clause (xiv), by striking ‘‘and’’ at the 
end; 
(2) in clause (xv), by striking the period at the 
end and inserting ‘‘; and’’; and 
(3) by inserting after clause (xv) the following 
new clause:
1284
‘‘(xvi) for the period beginning on 
January 31, 2026, and ending on Decem-
ber 31, 2027, $30,000,000.’’. 
(c) AGING AND DISABILITY RESOURCE CENTERS.—
Subsection (c)(1)(B) of such section 119 is amended—
(1) in clause (xiv), by striking ‘‘and’’ at the 
end; 
(2) in clause (xv), by striking the period at the 
end and inserting ‘‘; and’’; and 
(3) by inserting after clause (xv) the following 
new clause: 
‘‘(xvi) for the period beginning on 
January 31, 2026, and ending on Decem-
ber 31, 2027, $10,000,000.’’. 
(d) COORDINATION OF EFFORTS TO INFORM OLDER 
AMERICANS ABOUT BENEFITS AVAILABLE UNDER FED-
ERAL AND STATE PROGRAMS.—Subsection (d)(2) of such 
section 119 is amended—
(1) in clause (xiv), by striking ‘‘and’’ at the 
end; 
(2) in clause (xv), by striking the period at the 
end and inserting ‘‘; and’’; and 
(3) by inserting after clause (xv) the following 
new clause:
1287
FURNISHED
THROUGH
TELEHEALTH
AND
TELE-
COMMUNICATIONS TECHNOLOGY.—
(1) DELAY
IN
REQUIREMENTS
FOR
MENTAL 
HEALTH
SERVICES
FURNISHED
THROUGH
TELE-
HEALTH.—Section 1834(m)(7)(B)(i) of the Social 
Security Act (42 U.S.C. 1395m(m)(7)(B)(i)) is 
amended, in the matter preceding subclause (I), by 
striking ‘‘on or after January 31, 2026’’ and insert-
ing ‘‘on or after January 1, 2028’’. 
(2) MENTAL
HEALTH
VISITS
FURNISHED
BY 
RURAL HEALTH CLINICS.—Section 1834(y)(2) of the 
Social Security Act (42 U.S.C. 1395m(y)(2)) is 
amended by striking ‘‘January 31, 2026’’ and in-
serting ‘‘January 1, 2028’’. 
(3) MENTAL
HEALTH
VISITS
FURNISHED
BY 
FEDERALLY QUALIFIED HEALTH CENTERS.—Section 
1834(o)(4)(B) of the Social Security Act (42 U.S.C. 
1395m(o)(4)(B)) is amended by striking ‘‘January 
31, 2026’’ and inserting ‘‘January 1, 2028’’. 
(e) ALLOWING FOR THE FURNISHING OF AUDIO-
ONLY TELEHEALTH SERVICES.—Section 1834(m)(9) of 
the Social Security Act (42 U.S.C. 1395m(m)(9)) is 
amended by striking ‘‘ending on January 30, 2026’’ and 
inserting ‘‘ending on December 31, 2027’’.
1288
(f) EXTENDING USE OF TELEHEALTH TO CONDUCT 
FACE-TO-FACE ENCOUNTER PRIOR TO RECERTIFICATION 
OF ELIGIBILITY FOR HOSPICE CARE.—
(1) IN GENERAL.—Section 1814(a)(7)(D)(i)(II) 
of 
the 
Social 
Security 
Act 
(42 
U.S.C. 
1395f(a)(7)(D)(i)(II)) is amended—
(A) by striking ‘‘ending on January 30, 
2026’’ and inserting ‘‘ending on December 31, 
2027’’; and 
(B) by inserting ‘‘, except that this sub-
clause shall not apply in the case of such an en-
counter with an individual occurring on or after 
January 31, 2026, if such individual is located 
in an area that is subject to a moratorium on 
the enrollment of hospice programs under this 
title pursuant to section 1866(j)(7), if such in-
dividual is receiving hospice care from a pro-
vider that is subject to enhanced oversight 
under this title pursuant to section 1866(j)(3), 
or if such encounter is performed by a hospice 
physician or nurse practitioner who is not en-
rolled under section 1866(j) and is not an opt-
out physician or practitioner (as defined in sec-
tion 1802(b)(6)(D))’’ before the semicolon.
1289
(2) REQUIRING
USE
OF
MODIFIER.—Section 
1814(a)(7)(D)(i)(II) of the Social Security Act (42 
U.S.C. 1395f(a)(7)(D)(i)(II)), as amended by para-
graph (1), is further amended by inserting ‘‘, but 
only if, in the case of such an encounter occurring 
on or after January 1, 2027, any hospice claim in-
cludes 1 or more modifiers or codes (as specified by 
the Secretary) to indicate that such encounter was 
conducted via telehealth’’ after ‘‘as determined ap-
propriate by the Secretary’’. 
(g) REQUIRING MODIFIERS FOR TELEHEALTH SERV-
ICES IN CERTAIN INSTANCES.—Section 1834(m) of the 
Social Security Act (42 U.S.C. 1395m(m)) is amended by 
adding at the end the following new paragraph: 
‘‘(10) REQUIRED USE OF MODIFIERS IN CER-
TAIN INSTANCES.—Not later than January 1, 2027, 
the Secretary shall establish requirements to include 
one or more codes or modifiers, as determined ap-
propriate by the Secretary, in the case of—
‘‘(A) claims for telehealth services under 
this subsection that are furnished through a 
telehealth virtual platform—
‘‘(i) by a physician or practitioner 
that contracts with an entity that owns 
such virtual platform; or
1290
‘‘(ii) for which a physician or practi-
tioner has a payment arrangement with an 
entity for use of such virtual platform; and 
‘‘(B) claims for telehealth services under 
this subsection that are furnished incident to a 
physician’s or practitioner’s professional serv-
ice.’’. 
(h) IMPLEMENTATION.—Notwithstanding any other 
provision of law, the Secretary of Health and Human 
Services may implement the amendments made by this 
section by program instruction or otherwise. 
SEC. 6210. EXTENDING ACUTE HOSPITAL CARE AT HOME 
WAIVER FLEXIBILITIES. 
(a) IN GENERAL.—Section 1866G(a)(1) of the Social 
Security Act (42 U.S.C. 1395cc–7(a)(1)) is amended by 
striking ‘‘January 30, 2026’’ and inserting ‘‘September 
30, 2030’’. 
(b) REQUIRING ADDITIONAL STUDY AND REPORT.—
Section 1866G of the Social Security Act (42 U.S.C. 
1395cc–7) is amended—
(1) in subsection (a)(3)(E)—
(A) in clause (ii), by striking ‘‘the study 
described in subsection (b)’’ and inserting ‘‘the 
studies described in subsections (b) and (c)’’; 
and
1291
(B) by adding at the end the following new 
flush sentence: 
‘‘The Secretary may require that such data and 
information be submitted through a hospital’s 
cost report, through such survey instruments as 
the Secretary may develop, through medical 
record information, or through such other 
means as the Secretary determines appro-
priate.’’; 
(2) in subsection (b)—
(A) in the subsection heading, by striking 
‘‘STUDY’’ and inserting ‘‘INITIAL STUDY’’; and 
(B) in paragraph (3), by striking ‘‘sub-
section’’ and inserting ‘‘section’’; 
(3) by redesignating subsections (c) and (d) as 
subsections (d) and (e), respectively; 
(4) by inserting after subsection (b) the fol-
lowing new subsection: 
‘‘(c) SUBSEQUENT STUDY AND REPORT.—
‘‘(1) IN GENERAL.—Not later than September 
30, 2029, the Secretary shall conduct a study to—
‘‘(A) analyze, to the extent practicable, the 
criteria established by hospitals under the Acute 
Hospital Care at Home initiative to determine
1292
which individuals may be furnished services 
under such initiative; and 
‘‘(B) analyze and compare (both within 
and between hospitals participating in the ini-
tiative, and relative to comparable hospitals 
that do not participate in the initiative, for rel-
evant parameters such as diagnosis-related 
groups)—
‘‘(i) quality of care furnished to indi-
viduals with similar conditions and charac-
teristics in the inpatient setting and 
through the Acute Hospital Care at Home 
initiative, including health outcomes, hos-
pital readmission rates (including readmis-
sions both within and beyond 30 days post-
discharge), hospital mortality rates, length 
of stay, infection rates, composition of care 
team (including the types of labor used, 
such as contracted labor), the ratio of 
nursing staff, transfers from the hospital 
to the home, transfers from the home to 
the hospital (including the timing, fre-
quency, and causes of such transfers), 
transfers and discharges to post-acute care 
settings (including the timing, frequency,
1293
and causes of such transfers and dis-
charges), and patient and caregiver experi-
ence of care; 
‘‘(ii) clinical conditions treated and di-
agnosis-related groups of discharges from 
inpatient settings relative to discharges 
from the Acute Hospital Care at Home ini-
tiative; 
‘‘(iii) costs incurred by the hospital 
for furnishing care in inpatient settings 
relative to costs incurred by the hospital 
for furnishing care through the Acute Hos-
pital Care at Home initiative, including 
costs relating to staffing, equipment, food, 
prescriptions, and other services, as deter-
mined by the Secretary; 
‘‘(iv) the quantity, mix, and intensity 
of services (such as in-person visits and 
virtual contacts with patients and the in-
tensity of such services) furnished in inpa-
tient settings relative to the Acute Hospital 
Care at Home initiative, and, to the extent 
practicable, the nature and extent of family 
or caregiver involvement;
1294
‘‘(v) socioeconomic information on in-
dividuals treated in comparable inpatient 
settings relative to the initiative, including 
racial and ethnic data, income, housing, 
geographic proximity to the brick-and-mor-
tar facility and whether such individuals 
are dually eligible for benefits under this 
title and title XIX; and 
‘‘(vi) the quality of care, outcomes, 
costs, quantity and intensity of services, 
and other relevant metrics between individ-
uals who entered into the Acute Hospital 
Care at Home initiative directly from an 
emergency department compared with indi-
viduals who entered into the Acute Hos-
pital Care at Home initiative directly from 
an existing inpatient stay in a hospital. 
‘‘(2) SELECTION
BIAS.—In conducting the 
study under paragraph (1), the Secretary shall, to 
the extent practicable, analyze and compare individ-
uals who participate and do not participate in the 
initiative controlling for selection bias or other fac-
tors that may impact the reliability of data.
1295
‘‘(3) REPORT.—Not later than September 30, 
2029, the Secretary of Health and Human Services 
shall—
‘‘(A) submit to the Committee on Ways 
and Means of the House of Representatives and 
the Committee on Finance of the Senate a re-
port on the study conducted under paragraph 
(1); and 
‘‘(B) make such report publicly available 
on a website of the Centers for Medicare & 
Medicaid Services. 
‘‘(4) FUNDING.—In addition to amounts other-
wise available, there is appropriated to the Centers 
for Medicare & Medicaid Services Program Manage-
ment Account for fiscal year 2026, out of any 
amounts in the Treasury not otherwise appropriated, 
$2,500,000, to remain available until expended, for 
purposes of carrying out this section.’’; and 
(5) in subsection (e), as redesignated by para-
graph (3), by striking ‘‘and (b)(1)’’ and inserting ‘‘, 
(b)(1), and (c)(1)’’. 
SEC. 6211. IN-HOME CARDIOPULMONARY REHABILITATION 
FLEXIBILITY. 
(a) IN GENERAL.—Section 1861(eee)(2)(A)(ii) of the 
Social Security Act (42 U.S.C. 1395x(eee)(2)(A)(ii)) is
1296
amended by inserting ‘‘(including, with respect to items 
and services furnished through audio and video real-time 
communications technology (excluding audio-only) on or 
after January 31, 2026, and before January 1, 2028, in 
the home of an individual who is an outpatient of the hos-
pital)’’ after ‘‘outpatient basis’’. 
(b) IMPLEMENTATION.—Notwithstanding any other 
provision of law, the Secretary of Health and Human 
Services may implement the amendment made by sub-
section (a) by program instruction or otherwise. 
SEC. 6212. ENHANCING CERTAIN PROGRAM INTEGRITY RE-
QUIREMENTS FOR DME UNDER MEDICARE. 
(a) DURABLE MEDICAL EQUIPMENT.—
(1) IN GENERAL.—Section 1834(a) of the So-
cial Security Act (42 U.S.C. 1395m(a)) is amended 
by adding at the end the following new paragraph: 
‘‘(23) MASTER LIST INCLUSION AND CLAIM RE-
VIEW FOR CERTAIN ITEMS.—
‘‘(A) MASTER
LIST
INCLUSION.—Begin-
ning January 1, 2029, for purposes of the Mas-
ter List described in section 414.234(b) of title 
42, Code of Federal Regulations (or any suc-
cessor regulation), in determining which items 
have aberrant billing patterns (as such term is 
used for purposes of such section), the Sec-
1297
retary shall also treat an item for which pay-
ment may be made under this subsection as 
having such an aberrant billing pattern if the 
Secretary determines that, without explanatory 
contributing factors (such as furnishing emer-
gent care services), a substantial number of 
claims for such items under this subsection are 
for such items ordered by a physician or practi-
tioner who has not previously (during a period 
of not less than 24 months, as established by 
the Secretary) furnished to the individual in-
volved any item or service for which payment 
may be made under this title. 
‘‘(B) CLAIM
REVIEW.—With respect to 
items furnished on or after January 1, 2029, 
that are included on the Master List pursuant 
to subparagraph (A), if such an item is not sub-
ject to a determination of coverage in advance 
pursuant to paragraph (15)(C), the Secretary 
may conduct prepayment review of claims for 
payment for such item.’’. 
(2) CONFORMING
AMENDMENT
FOR
PROS-
THETIC DEVICES, ORTHOTICS, AND PROSTHETICS.—
Section 1834(h)(3) of the Social Security Act (42 
U.S.C. 1395m(h)(3)) is amended by inserting ‘‘, and
1298
paragraph (23) of subsection (a) shall apply to pros-
thetic devices, orthotics, and prosthetics in the same 
manner as such provision applies to items for which 
payment may be made under such subsection’’ be-
fore the period at the end. 
(b) REPORT ON IDENTIFYING CLINICAL DIAGNOSTIC 
LABORATORY TESTS AT HIGH RISK FOR FRAUD AND EF-
FECTIVE MITIGATION MEASURES.—Not later than Janu-
ary 1, 2028, the Inspector General of the Department of 
Health and Human Services shall submit to Congress a 
report assessing fraud risks relating to clinical diagnostic 
laboratory tests for which payment may be made under 
section 1834A of the Social Security Act (42 U.S.C. 
1395m–1) and effective tools for reducing such fraudulent 
claims. The report may include, at the Inspector General’s 
discretion—
(1) which, if any, clinical diagnostic laboratory 
tests are identified as being at high risk of fraudu-
lent claims, and an analysis of the factors that con-
tribute to such risk; 
(2) with respect to a clinical diagnostic labora-
tory test identified under paragraph (1) as being at 
high risk of fraudulent claims—
(A) the amount payable under such section 
1834A with respect to such test;
1299
(B) the number of such tests furnished to 
individuals enrolled under part B of title XVIII 
of the Social Security Act (42 U.S.C. 1395j et 
seq.); 
(C) whether an order for such a test was 
more likely to come from a provider with whom 
the individual involved did not have a prior re-
lationship, as determined on the basis of prior 
payment experience; and 
(D) the frequency with which a claim for 
payment under such section 1834A included the 
payment modifier identified by code 59 or 91; 
and 
(3) suggested strategies for reducing the num-
ber of fraudulent claims made with respect to tests 
so identified as being at high risk, including—
(A) an analysis of whether the Centers for 
Medicare & Medicaid Services can detect aber-
rant billing patterns with respect to such tests 
in a timely manner; 
(B) any strategies for identifying and mon-
itoring the providers who are outliers with re-
spect to the number of such tests that such pro-
viders order; and
1300
(C) targeted education efforts to mitigate 
improper billing for such tests; and 
(4) such other information as the Inspector 
General determines appropriate. 
(c) FUNDING.—In addition to amounts otherwise 
available, there is appropriated to the Inspector General 
of the Department of Health and Human Services, out 
of any money in the Treasury not otherwise appropriated, 
$1,200,000 for fiscal year 2026, to remain available until 
expended, to carry out this section. 
SEC. 6213. GUIDANCE ON FURNISHING SERVICES VIA TELE-
HEALTH TO INDIVIDUALS WITH LIMITED 
ENGLISH PROFICIENCY. 
(a) IN GENERAL.—Not later than 1 year after the 
date of enactment of this section, the Secretary of Health 
and Human Services, in consultation with 1 or more enti-
ties from each of the categories described in paragraphs 
(1) through (7) of subsection (b), shall issue and dissemi-
nate, or update and revise as applicable, guidance for the 
entities described in such subsection on the following: 
(1) Best practices on facilitating and inte-
grating use of interpreters during a telemedicine ap-
pointment. 
(2) Best practices on providing accessible in-
structions on how to access telecommunications sys-
1301
tems (as such term is used for purposes of section 
1834(m) of the Social Security Act (42 U.S.C. 
1395m(m)) for individuals with limited English pro-
ficiency. 
(3) Best practices on improving access to dig-
ital patient portals for individuals with limited 
English proficiency. 
(4) Best practices on integrating the use of 
video platforms that enable multi-person video calls 
furnished via a telecommunications system for pur-
poses of providing interpretation during a telemedi-
cine appointment for an individual with limited 
English proficiency. 
(5) Best practices for providing patient mate-
rials, communications, and instructions in multiple 
languages, including text message appointment re-
minders and prescription information. 
(b) ENTITIES DESCRIBED.—For purposes of sub-
section (a), an entity described in this subsection is an 
entity in 1 or more of the following categories: 
(1) Health information technology service pro-
viders, including—
(A) electronic medical record companies; 
(B) remote patient monitoring companies; 
and
1302
(C) telehealth or mobile health vendors and 
companies. 
(2) Health care providers, including—
(A) physicians; and 
(B) hospitals. 
(3) Health insurers. 
(4) Language service companies. 
(5) Interpreter or translator professional asso-
ciations. 
(6) Health and language services quality certifi-
cation organizations. 
(7) Patient and consumer advocates, including 
such advocates that work with individuals with lim-
ited English proficiency. 
SEC. 6214. INCLUSION OF VIRTUAL DIABETES PREVENTION 
PROGRAM SUPPLIERS IN MDPP EXPANDED 
MODEL. 
(a) IN GENERAL.—For the period beginning on Jan-
uary 1, 2026, and ending on December 31, 2029—
(1) an entity may participate in the MDPP by 
offering only MDPP services via distance learning or 
online delivery modalities if such entity meets the 
conditions for enrollment as an MDPP supplier; 
(2) if an entity participates in the MDPP in the 
manner described in paragraph (1), in the case of
1303
online MDPP services furnished by such entity to an 
MDPP beneficiary who was not located in the same 
State as the entity at the time such services were 
furnished, the entity shall not be prohibited from 
submitting a claim for payment for such services 
solely by reason of the location of such beneficiary 
at such time; and 
(3) no limit is applied on the number of times 
an individual may enroll in the MDPP. 
(b) DEFINITIONS.—In this section: 
(1) MDPP.—The term ‘‘MDPP’’ means the 
Medicare Diabetes Prevention Program (as such 
term is defined in section 410.79(b) of title 42, Code 
of Federal Regulations). 
(2) REGULATORY TERMS.—The terms ‘‘distance 
learning’’, ‘‘MDPP beneficiary’’, ‘‘MDPP services’’, 
‘‘MDPP supplier’’, and ‘‘online’’ have the meanings 
given such terms in section 410.79(b) of title 42, 
Code of Federal Regulations. 
(3) SECRETARY.—The term ‘‘Secretary’’ means 
the Secretary of Health and Human Services. 
(c) IMPLEMENTATION.—Notwithstanding any other 
provision of law, the Secretary may implement this section 
by program instruction or otherwise.
1304
SEC. 6215. MEDICATION-INDUCED MOVEMENT DISORDER 
OUTREACH AND EDUCATION. 
Not later than January 1, 2028, the Secretary of 
Health and Human Services shall use existing communica-
tions mechanisms to provide education and outreach to 
physicians and appropriate non-physician practitioners 
participating under the Medicare program under title 
XVIII of the Social Security Act (42 U.S.C. 1395 et seq.) 
with respect to periodic screening for medication-induced 
movement disorders that are associated with the treat-
ment of mental health disorders in at-risk patients, as well 
as resources related to clinical guidelines and best prac-
tices for furnishing such screening services through tele-
health. Such education and outreach shall include infor-
mation on how to account for such screening services in 
evaluation and management code selection. The Secretary 
shall, to the extent practicable, seek input from relevant 
stakeholders to inform such education and outreach. Such 
education and outreach may also address other relevant 
screening services furnished through telehealth, as the 
Secretary determines appropriate. 
SEC. 6216. REPORT ON WEARABLE MEDICAL DEVICES. 
Not later than 18 months after the date of the enact-
ment of this Act, the Comptroller General of the United 
States shall conduct a technology assessment of, and sub-
mit to Congress a report on, the capabilities and limita-
1305
tions of wearable medical devices used to support clinical 
decision-making. Such report shall include a description 
of—
(1) the potential for such devices to accurately 
prescribe treatments; 
(2) an examination of the benefits and chal-
lenges of artificial intelligence to augment such ca-
pabilities; and 
(3) policy options to enhance the benefits and 
mitigate potential challenges of developing or using 
such devices. 
SEC. 6217. EXTENSION OF TEMPORARY INCLUSION OF AU-
THORIZED ORAL ANTIVIRAL DRUGS AS COV-
ERED PART D DRUGS. 
Section 1860D–2(e)(1)(C) of the Social Security Act 
(42 U.S.C. 1395w–102(e)(1)(C)) is amended by striking 
‘‘January 30, 2026’’ and inserting ‘‘December 31, 2026’’. 
SEC. 6218. EXTENSION OF ADJUSTMENT TO CALCULATION 
OF HOSPICE CAP AMOUNT UNDER MEDI-
CARE. 
Section 1814(i)(2)(B) of the Social Security Act (42 
U.S.C. 1395f(i)(2)(B)) is amended—
(1) in clause (ii), by striking ‘‘2033’’ and in-
serting ‘‘2035’’; and
1306
(2) in clause (iii), by striking ‘‘2033’’ and in-
serting ‘‘2035’’. 
SEC. 6219. ADJUSTMENTS TO MEDICARE PART D COST-
SHARING REDUCTIONS FOR LOW-INCOME IN-
DIVIDUALS. 
Section 1860D–14(a) of the Social Security Act (42 
U.S.C. 1395w–114(a)) is amended—
(1) in paragraph (1)(D)(ii), by striking ‘‘that 
does not exceed $1 for’’ and all that follows through 
the period at the end and inserting ″that does not 
exceed— ‘‘
‘‘(I) for a plan year before 
2028—
‘‘(aa) for a generic drug or a 
preferred drug that is a multiple 
source drug (as defined in section 
1927(k)(7)(A)(i)), $1 or, if less, 
the copayment amount applicable 
to an individual under clause 
(iii); and 
‘‘(bb) for any other drug, $3 
or, if less, the copayment amount 
applicable to an individual under 
clause (iii); and
1307
‘‘(II) for plan year 2028 and 
each subsequent plan year—
‘‘(aa) for a generic drug, $0; 
‘‘(bb) for a preferred drug 
that is a multiple source drug (as 
defined 
in 
section 
1927(k)(7)(A)(i)), 
the 
dollar 
amount applied under this clause 
for such a drug for the preceding 
plan year, increased by the an-
nual percentage increase in the 
consumer price index (all items; 
U.S. city average) as of Sep-
tember of such preceding year, 
or, if less, the copayment amount 
applicable to an individual under 
clause (iii); and 
‘‘(cc) for a drug not de-
scribed in either item (aa) or 
(bb), the dollar amount applied 
under this clause for such a drug 
for the preceding plan year, in-
creased in the manner specified 
in item (bb), or, if less, the co-
1308
payment amount applicable to an 
individual under clause (iii). 
Any amount established under item (bb) or 
(cc) of subclause (II), that is based on an 
increase of $1 or $3, that is not a multiple 
of 5 cents or 10 cents, respectively, shall 
be rounded to the nearest multiple of 5 
cents or 10 cents, respectively.’’; and 
(2) in paragraph (4)(A)(ii), by inserting ‘‘(be-
fore 2028)’’ after ‘‘a subsequent year’’. 
SEC. 6220. REQUIRING ENHANCED AND ACCURATE LISTS 
OF (REAL) HEALTH PROVIDERS ACT. 
(a) IN GENERAL.—Section 1852(c) of the Social Se-
curity Act (42 U.S.C. 1395w–22(c)) is amended—
(1) in paragraph (1)(C)—
(A) by striking ‘‘plan, and any’’ and insert-
ing ‘‘plan, any’’; and 
(B) by inserting the following before the 
period: ‘‘, and, in the case of a specified MA 
plan (as defined in paragraph (3)(C)), for plan 
year 2028 and subsequent plan years, the infor-
mation described in paragraph (3)(B)’’; and 
(2) by adding at the end the following new 
paragraph: 
‘‘(3) PROVIDER DIRECTORY ACCURACY.—
1309
‘‘(A) IN GENERAL.—For plan year 2028 
and subsequent plan years, each MA organiza-
tion offering a specified MA plan (as defined in 
subparagraph (C)) shall, for each such plan of-
fered by the organization—
‘‘(i) maintain, on a publicly available 
internet website, an accurate provider di-
rectory that includes the information de-
scribed in subparagraph (B); 
‘‘(ii) not less frequently than once 
every 90 days (or, in the case of a hospital 
or any other facility determined appro-
priate by the Secretary, at a lesser fre-
quency specified by the Secretary but in no 
case less frequently than once every 12 
months), verify the provider directory in-
formation of each provider listed in such 
directory and, if applicable, update such 
information; 
‘‘(iii) if the organization is unable to 
verify such information with respect to a 
provider, include in such directory an indi-
cation that the information of such pro-
vider may not be up to date; and
1310
‘‘(iv) remove a provider from such di-
rectory within 5 business days if the orga-
nization determines that the provider is no 
longer a provider participating in the net-
work of such plan. 
‘‘(B) PROVIDER
DIRECTORY
INFORMA-
TION.—The information described in this sub-
paragraph is information enrollees may need to 
access covered benefits from a provider with 
which such organization offering such plan has 
an agreement for furnishing items and services 
covered under such plan, such as name, spe-
cialty, contact information, primary office or fa-
cility addresses where items or services are fur-
nished, whether the provider is accepting new 
patients, accommodations for people with dis-
abilities, cultural and linguistic capabilities, and 
telehealth capabilities. 
‘‘(C) SPECIFIED MA PLAN.—In this para-
graph, the term ‘specified MA plan’ means—
‘‘(i) a network-based plan (as defined 
in subsection (d)(5)(C)); or 
‘‘(ii) a Medicare Advantage private 
fee-for-service plan (as defined in section 
1859(b)(2)) that meets the access stand-
1311
ards under subsection (d)(4), in whole or 
in part, through entering into contracts or 
agreements as provided for under subpara-
graph (B) of such subsection.’’. 
(b) ACCOUNTABILITY
FOR PROVIDER DIRECTORY 
ACCURACY.—
(1) COST SHARING FOR SERVICES FURNISHED 
BASED ON RELIANCE ON INCORRECT PROVIDER DI-
RECTORY
INFORMATION.—Section 1852(d) of the 
Social Security Act (42 U.S.C. 1395w–22(d)) is 
amended—
(A) in paragraph (1)(C)—
(i) in clause (ii), by striking ‘‘or’’ at 
the end; 
(ii) in clause (iii), by striking the 
semicolon at the end and inserting ‘‘, or’’; 
and 
(iii) by adding at the end the fol-
lowing new clause: 
‘‘(iv) for plan year 2028 and subse-
quent plan years, in the case of a specified 
MA 
plan 
(as 
defined 
in 
subsection 
(c)(3)(C)), the services were furnished by a 
provider that was not participating in the 
network of such plan but was listed in the
1312
provider directory of such plan on the date 
on which the appointment was made, as 
described in paragraph (7)(A);’’; and 
(B) by adding at the end the following new 
paragraph: 
‘‘(7) COST SHARING FOR SERVICES FURNISHED 
BASED ON RELIANCE ON INCORRECT PROVIDER DI-
RECTORY INFORMATION.—
‘‘(A) IN GENERAL.—For plan year 2028 
and subsequent plan years, if an enrollee in a 
specified MA plan (as defined in subsection 
(c)(3)(C)) is furnished an item or service by a 
provider that is not participating in the network 
of such plan but is listed in the provider direc-
tory of such plan (as required to be provided to 
an enrollee pursuant to subsection (c)(1)(C)) on 
the date on which the appointment is made, 
and if such item or service would otherwise be 
covered under such plan if furnished by a pro-
vider that is participating in the network of 
such plan, the MA organization offering such 
plan shall ensure that the enrollee is only re-
sponsible for the lesser of—
1313
‘‘(i) the amount of cost sharing that 
would apply if such provider had been par-
ticipating in the network of such plan; or 
‘‘(ii) the amount of cost sharing that 
would otherwise apply (without regard to 
this subparagraph). 
‘‘(B) NOTIFICATION REQUIREMENT.—For 
plan year 2028 and subsequent plan years, each 
MA organization that offers a specified MA 
plan shall—
‘‘(i) notify enrollees of their cost-shar-
ing protections under this paragraph and 
make such notifications, to the extent 
practicable, by not later than the first day 
of an annual, coordinated election period 
under section 1851(e)(3) with respect to a 
year; 
‘‘(ii) include information regarding 
such cost-sharing protections in the pro-
vider directory of each specified MA plan 
offered by the MA organization.; and 
‘‘(iii) notify enrollees of their cost-
sharing protections under this paragraph 
in the first explanation of benefits issued 
in a plan year.’’.
1314
(2) REQUIRED
PROVIDER
DIRECTORY
ACCU-
RACY ANALYSIS AND REPORTS.—
(A) IN GENERAL.—Section 1857(e) of the 
Social Security Act (42 U.S.C. 1395w–27(e)) is 
amended by adding at the end the following 
new paragraph: 
‘‘(6) PROVIDER
DIRECTORY
ACCURACY
ANAL-
YSIS AND REPORTS.—
‘‘(A) IN GENERAL.—Beginning with plan 
years beginning on or after January 1, 2028, 
subject to subparagraph (C), a contract under 
this section with an MA organization shall re-
quire the organization, for each specified MA 
plan (as defined in section 1852(c)(3)(C)) of-
fered by the organization, to annually do the 
following: 
‘‘(i) Conduct an analysis estimating 
the accuracy of the provider directory in-
formation of such plan using a random 
sample of providers included in such pro-
vider directory as follows: 
‘‘(I) Such a random sample shall 
include a random sample of each spe-
cialty of providers with a high inaccu-
racy rate of provider directory infor-
1315
mation relative to other specialties of 
providers, as determined by the Sec-
retary. 
‘‘(II) For purposes of subclause 
(I), one type of specialty may be pro-
viders specializing in mental health or 
substance use disorder treatment. 
‘‘(ii) Submit to the Secretary a report 
containing the results of the analysis con-
ducted under clause (i), including an accu-
racy score for such provider directory in-
formation (as determined using a plan 
verification method specified by the Sec-
retary under subparagraph (B)(i)). 
‘‘(B) 
DETERMINATION
OF
ACCURACY 
SCORE.—
‘‘(i) IN
GENERAL.—The Secretary 
shall specify plan verification methods, 
such as using telephonic verification or 
other approaches using data sources main-
tained by an MA organization or using 
publicly available data sets, that MA orga-
nizations may use for estimating accuracy 
scores of the provider directory information
1316
of specified MA plans offered by such or-
ganizations. 
‘‘(ii) 
ACCURACY
SCORE
METHOD-
OLOGY.—With respect to each such meth-
od specified by the Secretary as described 
in clause (i), the Secretary shall specify a 
methodology for MA organizations to use 
in estimating such accuracy scores. Each 
such methodology shall take into account 
the administrative burden on plans and 
providers and the relative importance of 
certain provider directory information on 
enrollee ability to access care. 
‘‘(C) EXCEPTION.—The Secretary may 
waive the requirements of this paragraph in the 
case of a specified MA plan with low enrollment 
(as defined by the Secretary). 
‘‘(D) 
TRANSPARENCY.—Beginning 
with 
plan years beginning on or after January 1, 
2029, the Secretary shall post accuracy scores 
(as reported under subparagraph (A)(ii)), in a 
machine readable file, on an internet website 
maintained by the Centers for Medicare & Med-
icaid Services.’’.
1317
(B) PROVISION
OF
INFORMATION
TO 
BENEFICIARIES.—Section 1851(d)(4) of the So-
cial Security Act (42 U.S.C. 1395w–21(d)(4)) 
is amended by adding at the end the following 
new subparagraph: 
‘‘(F) PROVIDER
DIRECTORY.—Beginning 
with plan years beginning on or after January 
1, 2029, in the case of a specified MA plan (as 
defined in section 1852(c)(3)(C)), the accuracy 
score of the plan’s provider directory (as re-
ported under section 1857(e)(6)(A)(ii)) listed 
prominently on the plan’s provider directory.’’. 
(C) FUNDING.—In addition to amounts 
otherwise available, there is appropriated to the 
Centers for Medicare & Medicaid Services Pro-
gram Management Account, out of any money 
in the Treasury not otherwise appropriated, 
$4,000,000 for fiscal year 2026, to remain 
available until expended, to carry out the 
amendments made by this paragraph. 
(3) GAO STUDY AND REPORT.—
(A) ANALYSIS.—The Comptroller General 
of the United States (in this paragraph referred 
to as the ‘‘Comptroller General’’) shall conduct 
a study of the implementation of the amend-
1318
ments made by paragraphs (1) and (2). To the 
extent data are available and reliable, such 
study shall include an analysis of—
(i) the use of cost-sharing protections 
required under section 1852(d)(7)(A) of 
the Social Security Act, as added by para-
graph (1); 
(ii) the trends in provider directory in-
formation accuracy scores submitted to the 
Secretary of Health and Human Services 
under section 1857(e)(6)(A)(ii) of the So-
cial Security Act (as added by paragraph 
(2)(A)), both overall and among providers 
specializing in mental health or substance 
use disorder treatment; 
(iii) provider response rates by plan 
verification methods; 
(iv) administrative costs to providers 
and Medicare Advantage organizations; 
and 
(v) other items determined appro-
priate by the Comptroller General. 
(B) REPORT.—Not later than January 15, 
2033, the Comptroller General shall submit to 
Congress a report containing the results of the
1319
study conducted under subparagraph (A), to-
gether with recommendations for such legisla-
tion and administrative action as the Comp-
troller General determines appropriate. 
(c) GUIDANCE
ON MAINTAINING ACCURATE PRO-
VIDER DIRECTORIES.—
(1) STAKEHOLDER MEETING.—
(A) IN
GENERAL.—Not later than 6 
months after the date of enactment of this Act, 
the Secretary of Health and Human Services 
(referred to in this subsection as the ‘‘Sec-
retary’’) shall hold a public meeting to receive 
input on approaches for maintaining accurate 
provider directories for Medicare Advantage 
plans under part C of title XVIII of the Social 
Security Act (42 U.S.C. 1395w–21 et seq.), in-
cluding input on approaches for reducing ad-
ministrative burden, such as data standardiza-
tion, and best practices to maintain accurate 
provider directory information. 
(B) PARTICIPANTS.—Participants of the 
meeting under subparagraph (A) shall include 
representatives from the Centers for Medicare & 
Medicaid Services and the Assistant Secretary 
for Technology Policy and Office of the Na-
1320
tional Coordinator for Health Information 
Technology. Such meeting shall be open to the 
public. To the extent practicable, the Secretary 
shall include health care providers, companies 
that specialize in relevant technologies, health 
insurers, and patient advocates. 
(2) GUIDANCE TO MEDICARE ADVANTAGE OR-
GANIZATIONS.—Not later than 18 months after the 
date of enactment of this Act, the Secretary shall 
issue guidance to Medicare Advantage organizations 
offering Medicare Advantage plans under part C of 
title XVIII of the Social Security Act (42 U.S.C. 
1395w–21 et seq.) on maintaining accurate provider 
directories for such plans, taking into consideration 
input received during the stakeholder meeting under 
paragraph (1). Such guidance may include the fol-
lowing, as determined appropriate by the Secretary: 
(A) Best practices for Medicare Advantage 
organizations on how to work with providers to 
maintain the accuracy of provider directories 
and reduce provider and Medicare Advantage 
organization burden with respect to maintaining 
the accuracy of provider directories. 
(B) Information on data sets and data 
sources with information that could be used by
1321
Medicare Advantage organizations to maintain 
accurate provider directories. 
(C) Approaches for utilizing data sources 
maintained by Medicare Advantage organiza-
tions and publicly available data sets to main-
tain accurate provider directories. 
(D) Information that may be useful to in-
clude in provider directories for Medicare bene-
ficiaries to use in assessing plan networks when 
selecting a plan and accessing providers partici-
pating in plan networks during the plan year. 
(3) GUIDANCE
TO
PART
B
PROVIDERS.—Not 
later than 12 months after the date of enactment of 
this Act, the Secretary shall issue guidance to pro-
viders of services and suppliers who furnish items or 
services for which benefits are available under part 
B of title XVIII of the Social Security Act (42 
U.S.C. 1395j et seq.) on when to update the Na-
tional Plan and Provider Enumeration System (or a 
successor system) for information changes. 
SEC. 6221. MEDICARE COVERAGE OF MULTI-CANCER EARLY 
DETECTION SCREENING TESTS. 
(a) COVERAGE.—Section 1861 of the Social Security 
Act (42 U.S.C. 1395x) is amended—
(1) in subsection (s)(2)—
1322
(A) by striking the semicolon at the end of 
subparagraph (JJ) and inserting ‘‘; and’’; and 
(B) by adding at the end the following new 
subparagraph: 
‘‘(KK) multi-cancer early detection screening 
tests (as defined in subsection (nnn));’’; and 
(2) by adding at the end the following new sub-
section: 
‘‘(nnn) MULTI-CANCER EARLY DETECTION SCREEN-
ING TESTS.—
‘‘(1) IN
GENERAL.—The term ‘multi-cancer 
early detection screening test’ means a test fur-
nished to an individual for the concurrent detection 
of multiple cancer types across multiple organ sites 
on or after January 1, 2029, that—
‘‘(A) is cleared under section 510(k), clas-
sified under section 513(f)(2), or approved 
under section 515 of the Federal Food, Drug, 
and Cosmetic Act; 
‘‘(B) is—
‘‘(i) a genomic sequencing blood or 
blood product test that includes the anal-
ysis of cell-free nucleic acids; or 
‘‘(ii) a test based on samples of bio-
logical material that provide results com-
1323
parable to those obtained with a test de-
scribed in clause (i), as determined by the 
Secretary; and 
‘‘(C) the Secretary determines is—
‘‘(i) reasonable and necessary for the 
prevention or early detection of an illness 
or disability; and 
‘‘(ii) appropriate for individuals enti-
tled to benefits under part A or enrolled 
under part B. 
‘‘(2) NCD PROCESS.—In making determina-
tions under paragraph (1)(C) regarding the coverage 
of a new test, the Secretary shall use the process for 
making national coverage determinations (as defined 
in section 1869(f)(1)(B)) under this title.’’. 
(b) PAYMENT AND STANDARDS FOR MULTI-CANCER 
EARLY DETECTION SCREENING TESTS.—
(1) IN GENERAL.—Section 1834 of the Social 
Security Act (42 U.S.C. 1395m) is amended by add-
ing at the end the following new subsection: 
‘‘(aa) PAYMENT AND STANDARDS FOR MULTI-CAN-
CER EARLY DETECTION SCREENING TESTS.—
‘‘(1) 
PAYMENT
AMOUNT.—The 
payment 
amount for a multi-cancer early detection screening 
test (as defined in section 1861(nnn)) is—
1324
‘‘(A) with respect to such a test furnished 
before January 1, 2031, equal to the payment 
amount in effect on the date of the enactment 
of this subsection for a multi-target stool 
screening DNA test covered pursuant to section 
1861(pp)(1)(D); and 
‘‘(B) with respect to such a test furnished 
on or after January 1, 2031, equal to the lesser 
of—
‘‘(i) the amount described in subpara-
graph (A); or 
‘‘(ii) the payment amount determined 
for such test under section 1834A. 
‘‘(2) LIMITATIONS.—
‘‘(A) IN GENERAL.—No payment may be 
made under this part for a multi-cancer early 
detection screening test furnished during a year 
to an individual if—
‘‘(i) such individual—
‘‘(I) is under 50 years of age; or 
‘‘(II) as of January 1 of such 
year, has attained the age specified in 
subparagraph (B) for such year; or 
‘‘(ii) such a test was furnished to the 
individual during the previous 11 months.
1325
‘‘(B) AGE
SPECIFIED.—For purposes of 
subparagraph (A)(i)(II), the age specified in 
this subparagraph is—
‘‘(i) for 2029, 65 years of age; and 
‘‘(ii) for a succeeding year, the age 
specified in this subparagraph for the pre-
ceding year, increased by 1 year. 
‘‘(C) STANDARDS
FOLLOWING
USPSTF 
RATING OF A OR B.—In the case of a multi-can-
cer early detection screening test that is rec-
ommended with a grade of A or B by the 
United States Preventive Services Task Force, 
beginning on the date on which coverage for 
such test is provided pursuant to section 
1861(ddd)(1), the preceding provisions of this 
paragraph shall not apply.’’. 
(2) CONFORMING AMENDMENTS.—
(A) Section 1833 of the Social Security 
Act (42 U.S.C. 1395l) is amended—
(i) in subsection (a)—
(I) in paragraph (1)(D)(i)(I), by 
striking ‘‘section 1834(d)(1)’’ and in-
serting ‘‘subsection (d)(1) or (aa) of 
section 1834’’; and
1326
(II) in paragraph (2)(D)(i)(I), by 
striking ‘‘section 1834(d)(1)’’ and in-
serting ‘‘subsection (d)(1) or (aa) of 
section 1834’’; and 
(ii) in subsection (h)(1)(A), by strik-
ing ‘‘section 1834(d)(1)’’ and inserting 
‘‘subsections (d)(1) and (aa) of section 
1834’’. 
(B) Section 1862(a)(1)(A) of the Social 
Security Act (42 U.S.C. 1395y(a)(1)(A)) is 
amended—
(i) by striking ‘‘or additional preven-
tive services’’ and inserting ‘‘, additional 
preventive services’’; and 
(ii) by inserting ‘‘, or multi-cancer 
early detection screening tests (as defined 
in section 1861(nnn))’’ after ‘‘(as de-
scribed in section 1861(ddd)(1))’’. 
(c) RULE OF CONSTRUCTION RELATING TO OTHER 
CANCER SCREENING TESTS.—Nothing in this section, in-
cluding the amendments made by this section, shall be 
construed—
(1) in the case of an individual who undergoes 
a multi-cancer early detection screening test, to af-
fect coverage under part B of title XVIII of the So-
1327
cial Security Act for other cancer screening tests 
covered under such title, such as screening tests for 
breast, cervical, colorectal, lung, or prostate cancer; 
or 
(2) in the case of an individual who undergoes 
another cancer screening test, to affect coverage 
under such part for a multi-cancer early detection 
screening test or the use of such a test as a diag-
nostic or confirmatory test for a result of the other 
cancer screening test. 
(d) FUNDING.—In addition to amounts otherwise 
available, there is appropriated to the Centers for Medi-
care & Medicaid Services Program Management Account, 
out of any money in the Treasury not otherwise appro-
priated, $2,000,000 for fiscal year 2026, to remain avail-
able until expended, to carry out this section. 
SEC. 6222. MEDICARE COVERAGE OF EXTERNAL INFUSION 
PUMPS 
AND 
NON-SELF-ADMINISTRABLE 
HOME INFUSION DRUGS. 
(a) IN GENERAL.—Section 1861(n) of the Social Se-
curity Act (42 U.S.C. 1395x(n)) is amended by adding 
at the end the following new sentence: ‘‘Beginning with 
the first calendar quarter beginning on or after the date 
that is 1 year after the date of the enactment of this sen-
tence, an external infusion pump and associated home in-
1328
fusion drug (as defined in subsection (iii)(3)(C)) or other 
associated supplies that do not meet the appropriate for 
use in the home requirement applied to the definition of 
durable medical equipment under section 414.202 of title 
42, Code of Federal Regulations (or any successor to such 
regulation) shall be treated as meeting such requirement 
if each of the following criteria is satisfied: 
‘‘(1) The prescribing information approved by 
the Food and Drug Administration for the home in-
fusion drug associated with the pump instructs that 
the drug should be administered by or under the su-
pervision of a health care professional. 
‘‘(2) A qualified home infusion therapy supplier 
(as defined in subsection (iii)(3)(D)) administers or 
supervises the administration of the drug or biologi-
cal in a safe and effective manner in the patient’s 
home (as defined in subsection (iii)(3)(B)). 
‘‘(3) The prescribing information described in 
paragraph (1) instructs that the drug should be in-
fused at least 12 times per year—
‘‘(A) intravenously or subcutaneously; or 
‘‘(B) at infusion rates that the Secretary 
determines would require the use of an external 
infusion pump.’’.
1329
(b) COST SHARING NOTIFICATION.—The Secretary 
of Health and Human Services shall ensure that patients 
are notified of the cost sharing for electing home infusion 
therapy compared to other applicable settings of care for 
the furnishing of infusion drugs under the Medicare pro-
gram. 
SEC. 6223. ASSURING PHARMACY ACCESS AND CHOICE FOR 
MEDICARE BENEFICIARIES. 
(a) IN GENERAL.—Section 1860D–4(b)(1) of the So-
cial Security Act (42 U.S.C. 1395w–104(b)(1)) is amend-
ed by striking subparagraph (A) and inserting the fol-
lowing: 
‘‘(A) IN GENERAL.—
‘‘(i) PARTICIPATION OF ANY WILLING 
PHARMACY.—A PDP sponsor offering a 
prescription drug plan shall permit any 
pharmacy that meets the standard contract 
terms and conditions under such plan to 
participate as a network pharmacy of such 
plan. 
‘‘(ii) CONTRACT TERMS AND CONDI-
TIONS.—
‘‘(I) 
IN
GENERAL.—Notwith-
standing any other provision of law, 
for plan years beginning on or after
1330
January 1, 2029, in accordance with 
clause (i), contract terms and condi-
tions offered by such PDP sponsor 
shall be reasonable and relevant ac-
cording to standards established by 
the Secretary under subclause (II). 
‘‘(II) 
STANDARDS.—Not 
later 
than the first Monday in April of 
2028, the Secretary shall establish 
standards for reasonable and relevant 
contract terms and conditions for pur-
poses of this clause. 
‘‘(III) REQUEST
FOR
INFORMA-
TION.—Not later than April 1, 2027, 
for purposes of establishing the stand-
ards under subclause (II), the Sec-
retary shall issue a request for infor-
mation to seek input on trends in pre-
scription drug plan and network phar-
macy contract terms and conditions, 
current prescription drug plan and 
network pharmacy contracting prac-
tices, whether pharmacy reimburse-
ment and dispensing fees paid by 
PDP sponsors to network pharmacies
1331
sufficiently cover the ingredient and 
operational costs of such pharmacies, 
the use and application of pharmacy 
quality measures by PDP sponsors for 
network pharmacies, PDP sponsor re-
strictions or limitations on the dis-
pensing of covered part D drugs by 
network pharmacies (or any subsets of 
such pharmacies), PDP sponsor au-
diting practices for network phar-
macies, areas in current regulations or 
program guidance related to con-
tracting between prescription drug 
plans and network pharmacies requir-
ing clarification or additional speci-
ficity, factors for consideration in de-
termining the reasonableness and rel-
evance of contract terms and condi-
tions between prescription drug plans 
and network pharmacies, and other 
issues as determined appropriate by 
the Secretary.’’. 
(b) 
ESSENTIAL
RETAIL
PHARMACIES.—Section 
1860D–42 of the Social Security Act (42 U.S.C. 1395w–
1332
152) is amended by adding at the end the following new 
subsection: 
‘‘(e) ESSENTIAL RETAIL PHARMACIES.—
‘‘(1) IN GENERAL.—With respect to plan years 
beginning on or after January 1, 2028, the Sec-
retary shall publish reports, at least once every 2 
years until 2034, and periodically thereafter, that 
provide information, to the extent feasible, on—
‘‘(A) trends in ingredient cost reimburse-
ment, dispensing fees, incentive payments and 
other fees paid by PDP sponsors offering pre-
scription drug plans and MA organizations of-
fering MA–PD plans under this part to essen-
tial retail pharmacies (as defined in paragraph 
(2)) with respect to the dispensing of covered 
part D drugs, including a comparison of such 
trends between essential retail pharmacies and 
pharmacies that are not essential retail phar-
macies; 
‘‘(B) trends in amounts paid to PDP spon-
sors offering prescription drug plans and MA 
organizations offering MA–PD plans under this 
part by essential retail pharmacies with respect 
to the dispensing of covered part D drugs, in-
cluding a comparison of such trends between
1333
essential retail pharmacies and pharmacies that 
are not essential retail pharmacies; 
‘‘(C) trends in essential retail pharmacy 
participation in pharmacy networks and pre-
ferred pharmacy networks for prescription drug 
plans offered by PDP sponsors and MA–PD 
plans offered by MA organizations under this 
part, including a comparison of such trends be-
tween essential retail pharmacies and phar-
macies that are not essential retail pharmacies; 
‘‘(D) trends in the number of essential re-
tail pharmacies, including variation in such 
trends by geographic region or other factors; 
‘‘(E) a comparison of cost-sharing for cov-
ered part D drugs dispensed by essential retail 
pharmacies that are network pharmacies for 
prescription drug plans offered by PDP spon-
sors and MA–PD plans offered by MA organi-
zations under this part and cost-sharing for 
covered part D drugs dispensed by other net-
work pharmacies for such plans located in simi-
lar geographic areas that are not essential retail 
pharmacies; 
‘‘(F) a comparison of the volume of cov-
ered part D drugs dispensed by essential retail
1334
pharmacies that are network pharmacies for 
prescription drug plans offered by PDP spon-
sors and MA–PD plans offered by MA organi-
zations under this part and such volume of dis-
pensing by network pharmacies for such plans 
located in similar geographic areas that are not 
essential retail pharmacies, including informa-
tion on any patterns or trends in such compari-
son specific to certain types of covered part D 
drugs, such as generic drugs or drugs specified 
as specialty drugs by a PDP sponsor under a 
prescription drug plan or an MA organization 
under an MA–PD plan; and 
‘‘(G) a comparison of the information de-
scribed in subparagraphs (A) through (F) be-
tween essential retail pharmacies that are net-
work pharmacies for prescription drug plans of-
fered by PDP sponsors under this part and es-
sential retail pharmacies that are network phar-
macies for MA–PD plans offered by MA organi-
zations under this part. 
‘‘(2) DEFINITION OF ESSENTIAL RETAIL PHAR-
MACY.—In this subsection, the term ‘essential retail 
pharmacy’ means, with respect to a plan year, a re-
tail pharmacy that—
1335
‘‘(A) is not a pharmacy that is an affiliate 
as defined in paragraph (4); and 
‘‘(B) is located in—
‘‘(i) a rural area in which there is no 
other retail pharmacy within 10 miles, as 
determined by the Secretary; 
‘‘(ii) a suburban area in which there 
is no other retail pharmacy within 2 miles, 
as determined by the Secretary; or 
‘‘(iii) an urban area in which there is 
no other retail pharmacy within 1 mile, as 
determined by the Secretary. 
‘‘(3) LIST
OF
ESSENTIAL
RETAIL
PHAR-
MACIES.—
‘‘(A) PUBLICATION OF LIST OF ESSENTIAL 
RETAIL PHARMACIES.—For each plan year (be-
ginning with plan year 2028), the Secretary 
shall publish, on a publicly available internet 
website of the Centers for Medicare & Medicaid 
Services, a list of retail pharmacies that meet 
the criteria described in subparagraphs (A) and 
(B) of paragraph (2) to be considered an essen-
tial retail pharmacy. 
‘‘(B) REQUIRED SUBMISSIONS FROM PDP 
SPONSORS.—For each plan year (beginning
1336
with plan year 2028), each PDP sponsor offer-
ing a prescription drug plan and each MA orga-
nization offering an MA–PD plan shall submit 
to the Secretary, for the purposes of deter-
mining retail pharmacies that meet the criterion 
specified in subparagraph (A) of paragraph (2), 
a list of retail pharmacies that are affiliates of 
such sponsor or organization, or are affiliates of 
a pharmacy benefit manager acting on behalf of 
such sponsor or organization, at a time, and in 
a form and manner, specified by the Secretary. 
‘‘(C) REPORTING BY PDP SPONSORS AND 
MA ORGANIZATIONS.—For each plan year be-
ginning with plan year 2027, each PDP sponsor 
offering a prescription drug plan and each MA 
organization offering an MA–PD plan under 
this part shall submit to the Secretary informa-
tion on incentive payments and other fees paid 
by such sponsor or organization to pharmacies, 
insofar as any such payments or fees are not 
otherwise reported, at a time, and in a form 
and manner, specified by the Secretary. 
‘‘(D) IMPLEMENTATION.—Notwithstanding 
any other provision of law, the Secretary may
1337
implement this paragraph by program instruc-
tion or otherwise. 
‘‘(E) NONAPPLICATION
OF
PAPERWORK 
REDUCTION
ACT.—Chapter 35 of title 44, 
United States Code, shall not apply to the im-
plementation of this paragraph. 
‘‘(4) DEFINITION
OF
AFFILIATE; PHARMACY 
BENEFIT MANAGER.—In this subsection, the terms 
‘affiliate’ and ‘pharmacy benefit manager’ have the 
meaning given those terms in section 1860D–
12(h)(7).’’. 
(c) ENFORCEMENT.—
(1) IN
GENERAL.—Section 1860D–4(b)(1) of 
the Social Security Act (42 U.S.C. 1395w–
104(b)(1)) is amended by adding at the end the fol-
lowing new subparagraph: 
‘‘(F) ENFORCEMENT OF STANDARDS FOR 
REASONABLE AND RELEVANT CONTRACT TERMS 
AND CONDITIONS.—
‘‘(i) ALLEGATION SUBMISSION PROC-
ESS.—
‘‘(I) IN
GENERAL.—Not later 
than January 1, 2029, the Secretary 
shall establish a process through 
which a pharmacy may submit to the
1339
tions by a pharmacy with respect 
to such contract and plan year, 
the allegation submission process 
under this clause shall allow such 
pharmacy to submit an additional 
allegation related to those modi-
fications with respect to such 
contract and plan year. 
‘‘(III) ACCESS
TO
RELEVANT 
DOCUMENTS
AND
MATERIALS.—A 
PDP sponsor subject to an allegation 
under this clause—
‘‘(aa) shall provide docu-
ments or materials, as specified 
by the Secretary, including con-
tract offers made by such spon-
sor to such pharmacy or cor-
respondence related to such of-
fers, to the Secretary at a time, 
and in a form and manner, speci-
fied by the Secretary; and 
‘‘(bb) shall not prohibit or 
otherwise limit the ability of a 
pharmacy to submit such docu-
ments or materials to the Sec-
1340
retary for the purpose of submit-
ting an allegation or providing 
evidence for such an allegation 
under this clause. 
‘‘(IV) 
STANDARDIZED
TEM-
PLATE.—The Secretary shall establish 
a standardized template for phar-
macies to use for the submission of al-
legations described in subclause (I). 
Such template shall require that the 
submission include a certification by 
the pharmacy that the information in-
cluded is accurate, complete, and true 
to the best of the knowledge, informa-
tion, and belief of such pharmacy. 
‘‘(V) PREVENTING
FRIVOLOUS 
ALLEGATIONS.—In the case where the 
Secretary determines that a pharmacy 
has submitted frivolous allegations 
under this clause on a routine basis, 
the Secretary may temporarily pro-
hibit such pharmacy from using the 
allegation submission process under 
this clause, as determined appropriate 
by the Secretary.
1341
‘‘(VI) EXEMPTION
FROM
FREE-
DOM OF INFORMATION ACT.—Allega-
tions submitted under this clause shall 
be exempt from disclosure under sec-
tion 552 of title 5, United States 
Code. 
‘‘(VII) 
RULE
OF
CONSTRUC-
TION.—Nothing in this clause shall be 
construed as limiting the ability of a 
pharmacy to pursue other legal ac-
tions or remedies, consistent with ap-
plicable Federal or State law, with re-
spect to a potential violation of a re-
quirement described in this subpara-
graph. 
‘‘(VIII) ANTI-RETALIATION
AND 
ANTI-COERCION.—Consistent with ap-
plicable Federal or State law, a PDP 
sponsor shall not—
‘‘(aa) retaliate against a 
pharmacy for submitting any al-
legations under this clause; or 
‘‘(bb) 
coerce, 
intimidate, 
threaten, or interfere with the
1342
ability of a pharmacy to submit 
any such allegations. 
‘‘(ii) INVESTIGATION.—The Secretary 
shall investigate, as determined appro-
priate by the Secretary, allegations sub-
mitted pursuant to clause (i). 
‘‘(iii) ENFORCEMENT.—
‘‘(I) IN GENERAL.—In the case 
where the Secretary determines that a 
PDP sponsor offering a prescription 
drug plan has violated the standards 
for reasonable and relevant contract 
terms and conditions under subpara-
graph (A)(ii) or the provisions of 
clause (i)(VIII) of this subparagraph, 
the Secretary may use authorities 
under sections 1857(g) and 1860D–
12(b)(3)(E) to impose civil monetary 
penalties or other intermediate sanc-
tions. 
‘‘(II) 
APPLICATION
OF
CIVIL 
MONETARY
PENALTIES.—The provi-
sions of section 1128A (other than 
subsections (a) and (b)) shall apply to 
a civil monetary penalty under this
1343
clause in the same manner as such 
provisions apply to a penalty or pro-
ceeding under section 1128A(a).’’. 
(2) 
CONFORMING
AMENDMENT.—Section 
1857(g)(1) of the Social Security Act (42 U.S.C. 
1395w–27(g)(1)) is amended—
(A) in subparagraph (J), by striking ‘‘or’’ 
after the semicolon; 
(B) by redesignating subparagraph (K) as 
subparagraph (L); 
(C) by inserting after subparagraph (J), 
the following new subparagraph: 
‘‘(K) fails to comply with the standards for 
reasonable and relevant contract terms and con-
ditions under subparagraph (A)(ii) of section 
1860D–4(b)(1) or violates the provisions of 
subparagraph (F)(i)(VIII) of such section; or’’; 
(D) in subparagraph (L), as redesignated 
by subparagraph (B), by striking ‘‘through (J)’’ 
and inserting ‘‘through (K)’’; and 
(E) in the flush matter following subpara-
graph (L), as so redesignated, by striking ‘‘sub-
paragraphs (A) through (K)’’ and inserting 
‘‘subparagraphs (A) through (L)’’.
1344
(d) ACCOUNTABILITY OF PHARMACY BENEFIT MAN-
AGERS FOR VIOLATIONS OF REASONABLE AND RELEVANT 
CONTRACT TERMS AND CONDITIONS.—
(1) IN GENERAL.—Section 1860D–12(b) of the 
Social Security Act (42 U.S.C. 1395w–112) is 
amended by adding at the end the following new 
paragraph: 
‘‘(9) ACCOUNTABILITY OF PHARMACY BENEFIT 
MANAGERS FOR VIOLATIONS OF REASONABLE AND 
RELEVANT
CONTRACT
TERMS
AND
CONDITIONS.—
For plan years beginning on or after January 1, 
2029, each contract entered into with a PDP spon-
sor under this part with respect to a prescription 
drug plan offered by such sponsor shall provide that 
any pharmacy benefit manager acting on behalf of 
such sponsor has a written agreement with the PDP 
sponsor under which the pharmacy benefit manager 
agrees to reimburse the PDP sponsor for any 
amounts paid by such sponsor under section 1860D–
4(b)(1)(F)(iii)(I) to the Secretary as a result of a 
violation described in such section if such violation 
is related to a responsibility delegated to the phar-
macy benefit manager by such PDP sponsor.’’. 
(2) MA–PD PLANS.—Section 1857(f)(3) of the 
Social Security Act (42 U.S.C. 1395w–27(f)(3)) is
1345
amended by adding at the end the following new 
subparagraph: 
‘‘(F) 
ACCOUNTABILITY
OF
PHARMACY 
BENEFIT MANAGERS FOR VIOLATIONS OF REA-
SONABLE AND RELEVANT CONTRACT TERMS.—
For plan years beginning on or after January 
1, 2029, section 1860D–12(b)(9).’’. 
(e) BIENNIAL
REPORT
ON
ENFORCEMENT
AND 
OVERSIGHT OF PHARMACY ACCESS REQUIREMENTS.—
Section 1860D–42 of the Social Security Act (42 U.S.C. 
1395w–152), as amended by subsection (b), is amended 
by adding at the end the following new subsection: 
‘‘(f) BIENNIAL REPORT
ON ENFORCEMENT
AND 
OVERSIGHT OF PHARMACY ACCESS REQUIREMENTS.—
‘‘(1) IN
GENERAL.—Not later than 2 years 
after the date of enactment of this subsection, and 
at least once every 2 years thereafter, the Secretary 
shall publish a report on enforcement and oversight 
actions and activities undertaken by the Secretary 
with respect to the requirements under section 
1860D–4(b)(1). 
‘‘(2) LIMITATION.—A report under paragraph 
(1) shall not disclose—
1346
‘‘(A) identifiable information about individ-
uals or entities unless such information is oth-
erwise publicly available; or 
‘‘(B) trade secrets with respect to any enti-
ties.’’. 
(f) FUNDING.—In addition to amounts otherwise 
available, there is appropriated to the Centers for Medi-
care & Medicaid Services Program Management Account, 
out of any money in the Treasury not otherwise appro-
priated, $188,000,000 for fiscal year 2026, to remain 
available until expended, to carry out this section. 
SEC. 6224. MODERNIZING AND ENSURING PBM ACCOUNT-
ABILITY. 
(a) IN GENERAL.—
(1) 
PRESCRIPTION
DRUG
PLANS.—Section 
1860D–12 of the Social Security Act (42 U.S.C. 
1395w–112) is amended by adding at the end the 
following new subsection: 
‘‘(h) REQUIREMENTS RELATING TO PHARMACY BEN-
EFIT MANAGERS.—For plan years beginning on or after 
January 1, 2028: 
‘‘(1) AGREEMENTS WITH PHARMACY BENEFIT 
MANAGERS.—Each contract entered into with a 
PDP sponsor under this part with respect to a pre-
scription drug plan offered by such sponsor shall
1347
provide that any pharmacy benefit manager acting 
on behalf of such sponsor has a written agreement 
with the PDP sponsor under which the pharmacy 
benefit manager, and any affiliates of such phar-
macy benefit manager, as applicable, agree to meet 
the following requirements: 
‘‘(A) NO INCOME OTHER THAN BONA FIDE 
SERVICE FEES.—
‘‘(i) IN
GENERAL.—The pharmacy 
benefit manager and any affiliate of such 
pharmacy benefit manager shall not derive 
any remuneration with respect to any serv-
ices provided on behalf of any entity or in-
dividual, in connection with the utilization 
of covered part D drugs, from any such en-
tity or individual other than bona fide serv-
ice fees, subject to clauses (ii) and (iii). 
‘‘(ii) INCENTIVE PAYMENTS.—For the 
purposes of this subsection, an incentive 
payment (as determined by the Secretary) 
paid by a PDP sponsor to a pharmacy 
benefit manager or an affiliate of a phar-
macy benefit manager that is performing 
services on behalf of such sponsor shall be 
deemed a ‘bona fide service fee’ (even if
1348
such payment does not otherwise meet the 
definition of such term under paragraph 
(7)(B)) if such payment is a flat dollar 
amount, is consistent with fair market 
value (as specified by the Secretary), is re-
lated to services actually performed by the 
pharmacy benefit manager or affiliate of 
such pharmacy benefit manager, on behalf 
of the PDP sponsor making such payment, 
in connection with the utilization of cov-
ered part D drugs, and meets additional 
requirements, if any, as determined appro-
priate by the Secretary. 
‘‘(iii) CLARIFICATION
ON
REBATES 
AND DISCOUNTS USED TO LOWER COSTS 
FOR COVERED PART D DRUGS.—Rebates, 
discounts, and other price concessions re-
ceived by a pharmacy benefit manager or 
an affiliate of a pharmacy benefit manager 
from manufacturers, even if such price 
concessions are calculated as a percentage 
of a drug’s price, shall not be considered a 
violation of the requirements of clause (i) 
if they are fully passed through to a PDP 
sponsor and are compliant with all regu-
1349
latory and subregulatory requirements re-
lated to direct and indirect remuneration 
for manufacturer rebates, discounts, and 
other price concessions under this part, in-
cluding in cases where a PDP sponsor is 
acting as a pharmacy benefit manager on 
behalf of a prescription drug plan offered 
by such PDP sponsor. 
‘‘(iv) EVALUATION OF REMUNERATION 
ARRANGEMENTS.—Components of subsets 
of remuneration arrangements (such as 
fees or other forms of compensation paid 
to or retained by the pharmacy benefit 
manager or affiliate of such pharmacy ben-
efit manager), as determined appropriate 
by the Secretary, between pharmacy ben-
efit managers or affiliates of such phar-
macy benefit managers, as applicable, and 
other entities involved in the dispensing or 
utilization of covered part D drugs (includ-
ing PDP sponsors, manufacturers, phar-
macies, and other entities as determined 
appropriate by the Secretary) shall be sub-
ject to review by the Secretary, in con-
sultation with the Office of the Inspector
1350
General of the Department of Health and 
Human Services, as determined appro-
priate by the Secretary. The Secretary, in 
consultation with the Office of the Inspec-
tor General, shall review whether remu-
neration under such arrangements is con-
sistent with fair market value (as specified 
by the Secretary) through reviews and as-
sessments of such remuneration, as deter-
mined appropriate. 
‘‘(v) DISGORGEMENT.—The pharmacy 
benefit manager shall disgorge any remu-
neration paid to such pharmacy benefit 
manager or an affiliate of such pharmacy 
benefit manager in violation of this sub-
paragraph to the PDP sponsor. 
‘‘(vi) ADDITIONAL REQUIREMENTS.—
The pharmacy benefit manager shall—
‘‘(I) enter into a written agree-
ment with any affiliate of such phar-
macy benefit manager, under which 
the affiliate shall identify and disgorge 
any remuneration described in clause 
(v) to the pharmacy benefit manager; 
and
1351
‘‘(II) attest, subject to any re-
quirements determined appropriate by 
the Secretary, that the pharmacy ben-
efit manager has entered into a writ-
ten agreement described in subclause 
(I) with any affiliate of the pharmacy 
benefit manager. 
‘‘(B) TRANSPARENCY REGARDING GUARAN-
TEES
AND
COST
PERFORMANCE
EVALUA-
TIONS.—The pharmacy benefit manager shall—
‘‘(i) define, interpret, and apply, in a 
fully transparent and consistent manner 
for purposes of calculating or otherwise 
evaluating pharmacy benefit manager per-
formance against pricing guarantees or 
similar cost performance measurements re-
lated to rebates, discounts, price conces-
sions, or net costs, terms such as—
‘‘(I) ‘generic drug’, in a manner 
consistent with the definition of the 
term under section 423.4 of title 42, 
Code of Federal Regulations, or a suc-
cessor regulation; 
‘‘(II) ‘brand name drug’, in a 
manner consistent with the definition
1352
of the term under section 423.4 of 
title 42, Code of Federal Regulations, 
or a successor regulation; 
‘‘(III) ‘specialty drug’; 
‘‘(IV) ‘rebate’; and 
‘‘(V) ‘discount’; 
‘‘(ii) identify any drugs, claims, or 
price concessions excluded from any pric-
ing guarantee or other cost performance 
measure in a clear and consistent manner; 
and 
‘‘(iii) where a pricing guarantee or 
other cost performance measure is based 
on a pricing benchmark other than the 
wholesale acquisition cost (as defined in 
section 1847A(c)(6)(B)) of a drug, cal-
culate and provide a wholesale acquisition 
cost-based equivalent to the pricing guar-
antee or other cost performance measure. 
‘‘(C) PROVISION OF INFORMATION.—
‘‘(i) IN
GENERAL.—Not later than 
July 1 of each year, beginning in 2028, the 
pharmacy benefit manager shall submit to 
the PDP sponsor, and to the Secretary, a 
report, in accordance with this subpara-
1353
graph, and shall make such report avail-
able to such sponsor at no cost to such 
sponsor in a format specified by the Sec-
retary under paragraph (5). Each such re-
port shall include, with respect to such 
PDP sponsor and each plan offered by 
such sponsor, the following information 
with respect to the previous plan year: 
‘‘(I) A list of all drugs covered by 
the plan that were dispensed includ-
ing, with respect to each such drug—
‘‘(aa) the brand name, ge-
neric or non-proprietary name, 
and National Drug Code; 
‘‘(bb) the number of plan 
enrollees for whom the drug was 
dispensed, the total number of 
prescription claims for the drug 
(including original prescriptions 
and refills, counted as separate 
claims), and the total number of 
dosage units of the drug dis-
pensed; 
‘‘(cc) the number of pre-
scription claims described in item
1354
(bb) by each type of dispensing 
channel through which the drug 
was dispensed, including retail, 
mail order, specialty pharmacy, 
long term care pharmacy, home 
infusion pharmacy, or other types 
of pharmacies or dispensers; 
‘‘(dd) the average wholesale 
acquisition cost, listed as cost per 
day’s supply, cost per dosage 
unit, and cost per typical course 
of treatment (as applicable); 
‘‘(ee) the average wholesale 
price for the drug, listed as price 
per day’s supply, price per dos-
age unit, and price per typical 
course of treatment (as applica-
ble); 
‘‘(ff) the total out-of-pocket 
spending by plan enrollees on 
such drug after application of 
any benefits under the plan, in-
cluding plan enrollee spending 
through copayments, coinsurance, 
and deductibles;
1355
‘‘(gg) total rebates paid by 
the manufacturer on the drug as 
reported under the Detailed DIR 
Report (or any successor report) 
submitted by such sponsor to the 
Centers for Medicare & Medicaid 
Services; 
‘‘(hh) all other direct or in-
direct remuneration on the drug 
as reported under the Detailed 
DIR Report (or any successor re-
port) submitted by such sponsor 
to the Centers for Medicare & 
Medicaid Services; 
‘‘(ii) the average pharmacy 
reimbursement amount paid by 
the plan for the drug in the ag-
gregate and disaggregated by dis-
pensing channel identified in item 
(cc); 
‘‘(jj) the average National 
Average Drug Acquisition Cost 
(NADAC); and 
‘‘(kk) total manufacturer-de-
rived revenue, inclusive of bona
1356
fide service fees, attributable to 
the drug and retained by the 
pharmacy benefit manager and 
any affiliate of such pharmacy 
benefit manager. 
‘‘(II) In the case of a pharmacy 
benefit manager that has an affiliate 
that is a retail, mail order, or spe-
cialty pharmacy, with respect to drugs 
covered by such plan that were dis-
pensed, the following information: 
‘‘(aa) The percentage of 
total prescriptions that were dis-
pensed by pharmacies that are an 
affiliate of the pharmacy benefit 
manager for each drug. 
‘‘(bb) 
The 
interquartile 
range of the total combined costs 
paid by the plan and plan enroll-
ees, per dosage unit, per course 
of treatment, per 30-day supply, 
and per 90-day supply for each 
drug dispensed by pharmacies 
that are not an affiliate of the 
pharmacy benefit manager and
1357
that are included in the phar-
macy network of such plan. 
‘‘(cc) 
The 
interquartile 
range of the total combined costs 
paid by the plan and plan enroll-
ees, per dosage unit, per course 
of treatment, per 30-day supply, 
and per 90-day supply for each 
drug dispensed by pharmacies 
that are an affiliate of the phar-
macy benefit manager and that 
are included in the pharmacy 
network of such plan. 
‘‘(dd) The lowest total com-
bined cost paid by the plan and 
plan enrollees, per dosage unit, 
per course of treatment, per 30-
day supply, and per 90-day sup-
ply, for each drug that is avail-
able from any pharmacy included 
in the pharmacy network of such 
plan. 
‘‘(ee) The difference between 
the average acquisition cost of 
the affiliate, such as a pharmacy
1358
or other entity that acquires pre-
scription drugs, that initially ac-
quires the drug and the amount 
reported under subclause (I)(jj) 
for each drug. 
‘‘(ff) A list inclusive of the 
brand name, generic or non-pro-
prietary 
name, 
and 
National 
Drug Code of covered part D 
drugs subject to an agreement 
with a covered entity under sec-
tion 340B of the Public Health 
Service Act for which the phar-
macy benefit manager or an affil-
iate of the pharmacy benefit 
manager had a contract or other 
arrangement with such a covered 
entity in the service area of such 
plan. 
‘‘(III) Where a drug approved 
under section 505(c) of the Federal 
Food, Drug, and Cosmetic Act (re-
ferred to in this subclause as the ‘list-
ed drug’) is covered by the plan, the 
following information:
1359
‘‘(aa) A list of currently 
marketed generic drugs approved 
under section 505(j) of the Fed-
eral Food, Drug, and Cosmetic 
Act pursuant to an application 
that references such listed drug 
that are not covered by the plan, 
are covered on the same for-
mulary tier or a formulary tier 
typically associated with higher 
cost-sharing than the listed drug, 
or are subject to utilization man-
agement that the listed drug is 
not subject to. 
‘‘(bb) The estimated average 
beneficiary 
cost-sharing 
under 
the plan for a 30-day supply of 
the listed drug. 
‘‘(cc) Where a generic drug 
listed under item (aa) is on a for-
mulary tier typically associated 
with higher cost-sharing than the 
listed drug, the estimated aver-
age cost-sharing that a bene-
ficiary would have paid for a 30-
1360
day supply of each of the generic 
drugs described in item (aa), had 
the plan provided coverage for 
such drugs on the same for-
mulary tier as the listed drug. 
‘‘(dd) A written justification 
for providing more favorable cov-
erage of the listed drug than the 
generic drugs described in item 
(aa). 
‘‘(ee) The number of cur-
rently marketed generic drugs 
approved under section 505(j) of 
the Federal Food, Drug, and 
Cosmetic Act pursuant to an ap-
plication that references such 
listed drug. 
‘‘(IV) Where a reference product 
(as defined in section 351(i) of the 
Public Health Service Act) is covered 
by the plan, the following information: 
‘‘(aa) A list of currently 
marketed 
biosimilar 
biological 
products licensed under section 
351(k) of the Public Health
1361
Service Act pursuant to an appli-
cation that refers to such ref-
erence product that are not cov-
ered by the plan, are covered on 
the same formulary tier or a for-
mulary tier typically associated 
with higher cost-sharing than the 
reference product, or are subject 
to utilization management that 
the reference product is not sub-
ject to. 
‘‘(bb) The estimated average 
beneficiary 
cost-sharing 
under 
the plan for a 30-day supply of 
the reference product. 
‘‘(cc) Where a biosimilar bi-
ological product listed under item 
(aa) is on a formulary tier typi-
cally associated with higher cost-
sharing than the reference prod-
uct, the estimated average cost-
sharing that a beneficiary would 
have paid for a 30-day supply of 
each of the biosimilar biological 
products described in item (aa),
1362
had the plan provided coverage 
for such products on the same 
formulary tier as the reference 
product. 
‘‘(dd) A written justification 
for providing more favorable cov-
erage of the reference product 
than the biosimilar biological 
products described in item (aa). 
‘‘(ee) The number of cur-
rently marketed biosimilar bio-
logical products licensed under 
section 351(k) of the Public 
Health Service Act, pursuant to 
an application that refers to such 
reference product. 
‘‘(V) Total gross spending on 
covered part D drugs by the plan, not 
net of rebates, fees, discounts, or 
other direct or indirect remuneration. 
‘‘(VI) The total amount retained 
by the pharmacy benefit manager or 
an affiliate of such pharmacy benefit 
manager in revenue related to utiliza-
tion of covered part D drugs under
1363
that plan, inclusive of bona fide serv-
ice fees. 
‘‘(VII) The total spending on cov-
ered part D drugs net of rebates, fees, 
discounts, or other direct and indirect 
remuneration by the plan. 
‘‘(VIII) An explanation of any 
benefit design parameters under such 
plan that encourage plan enrollees to 
fill prescriptions at pharmacies that 
are an affiliate of such pharmacy ben-
efit manager, such as mail and spe-
cialty home delivery programs, and re-
tail and mail auto-refill programs. 
‘‘(IX) The following information: 
‘‘(aa) A list of all brokers, 
consultants, advisors, and audi-
tors that receive compensation 
from the pharmacy benefit man-
ager or an affiliate of such phar-
macy benefit manager for refer-
rals, 
consulting, 
auditing, 
or 
other services offered to PDP 
sponsors related to pharmacy 
benefit management services.
1364
‘‘(bb) The amount of com-
pensation provided by such phar-
macy benefit manager or affiliate 
to each such broker, consultant, 
advisor, and auditor. 
‘‘(cc) The methodology for 
calculating the amount of com-
pensation provided by such phar-
macy benefit manager or affil-
iate, for each such broker, con-
sultant, advisor, and auditor. 
‘‘(X) A list of all affiliates of the 
pharmacy benefit manager. 
‘‘(XI) A summary document sub-
mitted in a standardized template de-
veloped by the Secretary that includes 
such information described in sub-
clauses (I) through (X). 
‘‘(ii) WRITTEN EXPLANATION OF CON-
TRACTS OR AGREEMENTS WITH MANUFAC-
TURERS.—
‘‘(I) IN
GENERAL.—The phar-
macy benefit manager shall, not later 
than 30 days after the finalization of 
any contract or agreement between
1365
such pharmacy benefit manager or an 
affiliate of such pharmacy benefit 
manager and a manufacturer (or sub-
sidiary, agent, or entity affiliated with 
such manufacturer) that makes re-
bates, discounts, payments, or other 
financial incentives related to one or 
more covered part D drugs or other 
prescription drugs, as applicable, of 
the manufacturer directly or indirectly 
contingent upon coverage, formulary 
placement, or utilization management 
conditions on any other covered part 
D drugs or other prescription drugs, 
as applicable, submit to the PDP 
sponsor a written explanation of such 
contract or agreement. 
‘‘(II) REQUIREMENTS.—A writ-
ten explanation under subclause (I) 
shall—
‘‘(aa) include the manufac-
turer subject to the contract or 
agreement, all covered part D 
drugs 
and 
other 
prescription 
drugs, as applicable, subject to
1366
the contract or agreement and 
the manufacturers of such drugs, 
and a high-level description of 
the terms of such contract or 
agreement and how such terms 
apply to such drugs; and 
‘‘(bb) be certified by the 
Chief Executive Officer, Chief Fi-
nancial Officer, or General Coun-
sel of such pharmacy benefit 
manager, or affiliate of such 
pharmacy benefit manager, as 
applicable, or an individual dele-
gated with the authority to sign 
on behalf of one of these officers, 
who reports directly to the offi-
cer. 
‘‘(III) DEFINITION
OF
OTHER 
PRESCRIPTION DRUGS.—For purposes 
of this clause, the term ‘other pre-
scription drugs’ means prescription 
drugs covered as supplemental bene-
fits under this part or prescription 
drugs paid outside of this part. 
‘‘(D) AUDIT RIGHTS.—
1367
‘‘(i) IN GENERAL.—Not less than once 
a year, at the request of the PDP sponsor, 
the pharmacy benefit manager shall allow 
for an audit of the pharmacy benefit man-
ager to ensure compliance with all terms 
and conditions under the written agree-
ment described in this paragraph and the 
accuracy of information reported under 
subparagraph (C). 
‘‘(ii) AUDITOR.—The PDP sponsor 
shall have the right to select an auditor. 
The pharmacy benefit manager shall not 
impose any limitations on the selection of 
such auditor. 
‘‘(iii) PROVISION OF INFORMATION.—
The pharmacy benefit manager shall make 
available to such auditor all records, data, 
contracts, and other information necessary 
to confirm the accuracy of information re-
ported under subparagraph (C), subject to 
reasonable restrictions on how such infor-
mation must be reported to prevent re-
disclosure of such information. 
‘‘(iv) TIMING.—The pharmacy benefit 
manager must provide information under
1368
clause (iii) and other information, data, 
and records relevant to the audit to such 
auditor within 6 months of the initiation of 
the audit and respond to requests for addi-
tional information from such auditor with-
in 30 days after the request for additional 
information. 
‘‘(v) INFORMATION
FROM
AFFILI-
ATES.—The pharmacy benefit manager 
shall be responsible for providing to such 
auditor information required to be reported 
under subparagraph (C) or under clause 
(iii) of this subparagraph that is owned or 
held by an affiliate of such pharmacy ben-
efit manager. 
‘‘(2) ENFORCEMENT.—
‘‘(A) IN
GENERAL.—Each PDP sponsor 
shall—
‘‘(i) disgorge to the Secretary any 
amounts disgorged to the PDP sponsor by 
a pharmacy benefit manager under para-
graph (1)(A)(v); 
‘‘(ii) require, in a written agreement 
with any pharmacy benefit manager acting 
on behalf of such sponsor or affiliate of
1369
such pharmacy benefit manager, that such 
pharmacy benefit manager or affiliate re-
imburse the PDP sponsor for any civil 
money penalty imposed on the PDP spon-
sor as a result of the failure of the phar-
macy benefit manager or affiliate to meet 
the requirements of paragraph (1) that are 
applicable to the pharmacy benefit man-
ager or affiliate under the agreement; and 
‘‘(iii) require, in a written agreement 
with any such pharmacy benefit manager 
acting on behalf of such sponsor or affil-
iate of such pharmacy benefit manager, 
that such pharmacy benefit manager or af-
filiate be subject to punitive remedies for 
breach of contract for failure to comply 
with the requirements applicable under 
paragraph (1). 
‘‘(B) REPORTING
OF
ALLEGED
VIOLA-
TIONS.—The Secretary shall make available and 
maintain a mechanism for manufacturers, PDP 
sponsors, pharmacies, and other entities that 
have contractual relationships with pharmacy 
benefit managers or affiliates of such pharmacy 
benefit managers to report, on a confidential
1370
basis, alleged violations of paragraph (1)(A) or 
subparagraph (C). 
‘‘(C) ANTI-RETALIATION AND ANTI-COER-
CION.—Consistent with applicable Federal or 
State law, a PDP sponsor shall not—
‘‘(i) retaliate against an individual or 
entity for reporting an alleged violation 
under subparagraph (B); or 
‘‘(ii) coerce, intimidate, threaten, or 
interfere with the ability of an individual 
or entity to report any such alleged viola-
tions. 
‘‘(3) CERTIFICATION OF COMPLIANCE.—
‘‘(A) IN
GENERAL.—Each PDP sponsor 
shall furnish to the Secretary (at a time and in 
a manner specified by the Secretary) an annual 
certification of compliance with this subsection, 
as well as such information as the Secretary de-
termines necessary to carry out this subsection. 
‘‘(B) IMPLEMENTATION.—Notwithstanding 
any other provision of law, the Secretary may 
implement this paragraph by program instruc-
tion or otherwise. 
‘‘(4) RULE
OF
CONSTRUCTION.—Nothing in 
this subsection shall be construed as—
1371
‘‘(A) prohibiting flat dispensing fees or re-
imbursement or payment for ingredient costs 
(including customary, industry-standard dis-
counts directly related to drug acquisition that 
are retained by pharmacies or wholesalers) to 
entities that acquire or dispense prescription 
drugs; or 
‘‘(B) modifying regulatory requirements or 
sub-regulatory program instruction or guidance 
related to pharmacy payment, reimbursement, 
or dispensing fees. 
‘‘(5) STANDARD FORMATS.—
‘‘(A) IN GENERAL.—Not later than June 
1, 2027, the Secretary shall specify standard, 
machine-readable formats for pharmacy benefit 
managers to submit annual reports required 
under paragraph (1)(C)(i). 
‘‘(B) IMPLEMENTATION.—Notwithstanding 
any other provision of law, the Secretary may 
implement this paragraph by program instruc-
tion or otherwise. 
‘‘(6) CONFIDENTIALITY.—
‘‘(A) IN GENERAL.—Information disclosed 
by a pharmacy benefit manager, an affiliate of 
a pharmacy benefit manager, a PDP sponsor,
1372
or a pharmacy under this subsection that is not 
otherwise publicly available or available for pur-
chase shall not be disclosed by the Secretary or 
a PDP sponsor receiving the information, ex-
cept that the Secretary may disclose the infor-
mation for the following purposes: 
‘‘(i) As the Secretary determines nec-
essary to carry out this part. 
‘‘(ii) To permit the Comptroller Gen-
eral to review the information provided. 
‘‘(iii) To permit the Director of the 
Congressional Budget Office to review the 
information provided. 
‘‘(iv) To permit the Executive Direc-
tor of the Medicare Payment Advisory 
Commission to review the information pro-
vided. 
‘‘(v) To the Attorney General for the 
purposes of conducting oversight and en-
forcement under this title. 
‘‘(vi) To the Inspector General of the 
Department of Health and Human Serv-
ices in accordance with its authorities 
under the Inspector General Act of 1978
1373
(section 406 of title 5, United States 
Code), and other applicable statutes. 
‘‘(B) RESTRICTION ON USE OF INFORMA-
TION.—The Secretary, the Comptroller General, 
the Director of the Congressional Budget Of-
fice, and the Executive Director of the Medicare 
Payment Advisory Commission shall not report 
on or disclose information disclosed pursuant to 
subparagraph (A) to the public in a manner 
that would identify—
‘‘(i) a specific pharmacy benefit man-
ager, affiliate, pharmacy, manufacturer, 
wholesaler, PDP sponsor, or plan; or 
‘‘(ii) contract prices, rebates, dis-
counts, or other remuneration for specific 
drugs in a manner that may allow the 
identification of specific contracting parties 
or of such specific drugs. 
‘‘(7) DEFINITIONS.—For purposes of this sub-
section: 
‘‘(A) AFFILIATE.—The term ‘affiliate’ 
means, with respect to any pharmacy benefit 
manager or PDP sponsor, any entity that, di-
rectly or indirectly—
1374
‘‘(i) owns or is owned by, controls or 
is controlled by, or is otherwise related in 
any ownership structure to such pharmacy 
benefit manager or PDP sponsor; or 
‘‘(ii) acts as a contractor, principal, or 
agent to such pharmacy benefit manager 
or PDP sponsor, insofar as such con-
tractor, principal, or agent performs any of 
the functions described under subpara-
graph (C). 
‘‘(B) BONA FIDE SERVICE FEE.—The term 
‘bona fide service fee’ means a fee that is reflec-
tive of the fair market value (as specified by the 
Secretary, through notice and comment rule-
making) for a bona fide, itemized service actu-
ally performed on behalf of an entity, that the 
entity would otherwise perform (or contract for) 
in the absence of the service arrangement and 
that is not passed on in whole or in part to a 
client or customer, whether or not the entity 
takes title to the drug. Such fee must be a flat 
dollar amount and shall not be directly or indi-
rectly based on, or contingent upon—
1375
‘‘(i) drug price, such as wholesale ac-
quisition cost or drug benchmark price 
(such as average wholesale price); 
‘‘(ii) the amount of discounts, rebates, 
fees, or other direct or indirect remunera-
tion with respect to covered part D drugs 
dispensed to enrollees in a prescription 
drug plan, except as permitted pursuant to 
paragraph (1)(A)(ii); 
‘‘(iii) coverage or formulary placement 
decisions or the volume or value of any re-
ferrals or business generated between the 
parties to the arrangement; or 
‘‘(iv) any other amounts or meth-
odologies prohibited by the Secretary. 
‘‘(C) PHARMACY BENEFIT MANAGER.—The 
term ‘pharmacy benefit manager’ means any 
person or entity that, either directly or through 
an intermediary, acts as a price negotiator or 
group purchaser on behalf of a PDP sponsor or 
prescription drug plan, or manages the pre-
scription drug benefits provided by such spon-
sor or plan, including the processing and pay-
ment of claims for prescription drugs, the per-
formance of drug utilization review, the proc-
1376
essing of drug prior authorization requests, the 
adjudication of appeals or grievances related to 
the prescription drug benefit, contracting with 
network pharmacies, controlling the cost of cov-
ered part D drugs, or the provision of related 
services. Such term includes any person or enti-
ty that carries out one or more of the activities 
described in the preceding sentence, irrespective 
of whether such person or entity calls itself a 
‘pharmacy benefit manager’.’’. 
(2) MA–PD PLANS.—Section 1857(f)(3) of the 
Social Security Act (42 U.S.C. 1395w–27(f)(3)), as 
amended by section 6223(d)(2), is amended by add-
ing at the end the following new subparagraph: 
‘‘(G) REQUIREMENTS RELATING TO PHAR-
MACY BENEFIT MANAGERS.—For plan years be-
ginning on or after January 1, 2028, section 
1860D–12(h).’’. 
(3) NONAPPLICATION OF PAPERWORK REDUC-
TION ACT.—Chapter 35 of title 44, United States 
Code, shall not apply to the implementation of this 
subsection. 
(4) FUNDING.—
(A) SECRETARY.—In addition to amounts 
otherwise available, there is appropriated to the
1377
Centers for Medicare & Medicaid Services Pro-
gram Management Account, out of any money 
in the Treasury not otherwise appropriated, 
$113,000,000 for fiscal year 2026, to remain 
available until expended, to carry out this sub-
section. 
(B) OIG.—In addition to amounts other-
wise available, there is appropriated to the In-
spector General of the Department of Health 
and Human Services, out of any money in the 
Treasury 
not 
otherwise 
appropriated, 
$20,000,000 for fiscal year 2026, to remain 
available until expended, to carry out this sub-
section. 
(b) GAO STUDY AND REPORT ON PRICE-RELATED 
COMPENSATION ACROSS THE SUPPLY CHAIN.—
(1) STUDY.—The Comptroller General of the 
United States (in this subsection referred to as the 
‘‘Comptroller General’’) shall conduct a study de-
scribing the use of compensation and payment struc-
tures related to a prescription drug’s price within 
the retail prescription drug supply chain in part D 
of title XVIII of the Social Security Act (42 U.S.C. 
1395w–101 et seq.). Such study shall summarize in-
formation from Federal agencies and industry ex-
1378
perts, to the extent available, with respect to the fol-
lowing: 
(A) The type, magnitude, other features 
(such as the pricing benchmarks used), and 
prevalence of compensation and payment struc-
tures related to a prescription drug’s price, 
such as calculating fee amounts as a percentage 
of a prescription drug’s price, between inter-
mediaries in the prescription drug supply chain, 
including—
(i) pharmacy benefit managers; 
(ii) PDP sponsors offering prescrip-
tion drug plans and Medicare Advantage 
organizations offering MA–PD plans; 
(iii) drug wholesalers; 
(iv) pharmacies; 
(v) manufacturers; 
(vi) pharmacy services administrative 
organizations; 
(vii) brokers, auditors, consultants, 
and other entities that—
(I) advise PDP sponsors offering 
prescription drug plans and Medicare 
Advantage organizations offering MA–
1379
PD plans regarding pharmacy bene-
fits; or 
(II) review PDP sponsor and 
Medicare Advantage organization con-
tracts with pharmacy benefit man-
agers; and 
(viii) other service providers that con-
tract with any of the entities described in 
clauses (i) through (vii) that may use 
price-related compensation and payment 
structures, such as rebate aggregators (or 
other entities that negotiate or process 
price concessions on behalf of pharmacy 
benefit managers, plan sponsors, or phar-
macies). 
(B) The primary business models and com-
pensation structures for each category of inter-
mediary described in subparagraph (A). 
(C) Variation in price-related compensation 
structures between affiliated entities (such as 
entities with common ownership, either full or 
partial, and subsidiary relationships) and unaf-
filiated entities. 
(D) Potential conflicts of interest among 
contracting entities related to the use of pre-
1380
scription drug price-related compensation struc-
tures, such as the potential for fees or other 
payments set as a percentage of a prescription 
drug’s price to advantage formulary selection, 
distribution, or purchasing of prescription drugs 
with higher prices. 
(E) Notable differences, if any, in the use 
and level of price-based compensation struc-
tures over time and between different market 
segments, such as under part D of title XVIII 
of the Social Security Act (42 U.S.C. 1395w–
101 et seq.) and the Medicaid program under 
title XIX of such Act (42 U.S.C. 1396 et seq.). 
(F) The effects of drug price-related com-
pensation structures and alternative compensa-
tion structures on Federal health care programs 
and program beneficiaries, including with re-
spect to cost-sharing, premiums, Federal out-
lays, biosimilar and generic drug adoption and 
utilization, drug shortage risks, and the poten-
tial for fees set as a percentage of a drug’s 
price to advantage the formulary selection, dis-
tribution, or purchasing of drugs with higher 
prices.
1381
(G) Other issues determined to be relevant 
and appropriate by the Comptroller General. 
(2) REPORT.—Not later than 2 years after the 
date of enactment of this section, the Comptroller 
General shall submit to Congress a report containing 
the results of the study conducted under paragraph 
(1), together with recommendations for such legisla-
tion and administrative action as the Comptroller 
General determines appropriate. 
(c) MEDPAC
REPORTS
ON
AGREEMENTS
WITH 
PHARMACY BENEFIT MANAGERS WITH RESPECT TO PRE-
SCRIPTION DRUG PLANS AND MA-PD PLANS.—
(1) IN GENERAL.—The Medicare Payment Ad-
visory Commission shall submit to Congress the fol-
lowing reports: 
(A) INITIAL REPORT.—Not later than the 
first March 15 occurring after the date that is 
2 years after the date on which the Secretary 
makes the data available to the Commission, a 
report regarding agreements with pharmacy 
benefit managers with respect to prescription 
drug plans and MA–PD plans. Such report 
shall include, to the extent practicable—
(i) a description of trends and pat-
terns, including relevant averages, totals,
1382
and other figures for the types of informa-
tion submitted; 
(ii) an analysis of any differences in 
agreements and their effects on plan en-
rollee out-of-pocket spending and average 
pharmacy reimbursement, and other im-
pacts; and 
(iii) any recommendations the Com-
mission determines appropriate. 
(B) FINAL
REPORT.—Not later than 2 
years after the date on which the Commission 
submits the initial report under subparagraph 
(A), a report describing any changes with re-
spect to the information described in subpara-
graph (A) over time, together with any rec-
ommendations the Commission determines ap-
propriate. 
(2) FUNDING.—In addition to amounts other-
wise available, there is appropriated to the Medicare 
Payment Advisory Commission, out of any money in 
the 
Treasury 
not 
otherwise 
appropriated, 
$1,000,000 for fiscal year 2026, to remain available 
until expended, to carry out this subsection.
1383
SEC. 6225. REQUIRING A SEPARATE IDENTIFICATION NUM-
BER AND AN ATTESTATION FOR EACH OFF-
CAMPUS OUTPATIENT DEPARTMENT OF A 
PROVIDER. 
(a) IN GENERAL.—Section 1833(t) of the Social Se-
curity Act (42 U.S.C. 1395l(t)) is amended by adding at 
the end the following new paragraph: 
‘‘(23) USE OF UNIQUE HEALTH IDENTIFIERS; 
ATTESTATION.—
‘‘(A) IN GENERAL.—No payment may be 
made under this subsection (or under an appli-
cable payment system pursuant to paragraph 
(21)) for items and services furnished on or 
after January 1, 2028, by an off-campus out-
patient department of a provider (as defined in 
subparagraph (C)) unless—
‘‘(i) such department has obtained, 
and such items and services are billed 
under, a National Provider Identifier that 
is separate from such identifier for such 
provider; 
‘‘(ii) such provider has submitted to 
the Secretary, during the 2-year period 
ending on the date such items and services 
are so furnished, an initial provider-based 
status attestation that such department is
1384
compliant with the requirements described 
in section 413.65 of title 42, Code of Fed-
eral Regulations (or a successor regula-
tion), which, until the Secretary establishes 
the process described in subparagraph (B), 
may include an attestation submitted in 
accordance with paragraph (b)(3) of such 
section (as in effect on the date of enact-
ment of this paragraph); and 
‘‘(iii) after such provider has sub-
mitted an attestation under clause (ii), 
such provider has submitted a subsequent 
attestation within the timeframe specified 
by the Secretary. 
‘‘(B) PROCESS FOR SUBMISSION AND RE-
VIEW.—
‘‘(i) IN
GENERAL.—The Secretary 
shall, through notice and comment rule-
making, establish a process for each pro-
vider with an off-campus outpatient de-
partment of a provider to submit an initial 
and subsequent attestation pursuant to 
clauses (ii) and (iii), respectively, of sub-
paragraph (A), and for the Secretary to re-
view each such attestation and determine,
1385
through site visits, remote audits, or other 
means (as determined appropriate by the 
Secretary), whether such department is 
compliant with the requirements described 
in such subparagraph. 
‘‘(ii) 
FUNDING.—In 
addition 
to 
amounts otherwise available, there is ap-
propriated to the Centers for Medicare & 
Medicaid Services Program Management 
Account for fiscal year 2026, out of any 
amounts in the Treasury not otherwise ap-
propriated, $20,000,000, to remain avail-
able until expended, for purposes of car-
rying out this subparagraph. 
‘‘(C) OFF-CAMPUS
OUTPATIENT
DEPART-
MENT OF A PROVIDER DEFINED.—For purposes 
of this paragraph, the term ‘off-campus out-
patient department of a provider’ means a de-
partment of a provider (as defined in section 
413.65 of title 42, Code of Federal Regulations, 
or any successor regulation) that is not lo-
cated—
‘‘(i) on the campus (as defined in such 
section) of such provider; or
1386
‘‘(ii) within the distance (described in 
such definition of campus) from a remote 
location of a hospital facility (as defined in 
such section).’’. 
(b) HHS OIG ANALYSIS.—Not later than January 
1, 2030, the Inspector General of the Department of 
Health and Human Services shall submit to Congress—
(1) an analysis of the process established by the 
Secretary of Health and Human Services to conduct 
the reviews and determinations described in section 
1833(t)(23)(B) of the Social Security Act, as added 
by subsection (a) of this section; and 
(2) recommendations based on such analysis, as 
the Inspector General determines appropriate. 
SEC. 6226. REVISING PHASE-IN OF MEDICARE CLINICAL 
LABORATORY TEST PAYMENT CHANGES. 
(a) REVISED PHASE-IN OF REDUCTIONS FROM PRI-
VATE
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 ‘‘2028’’ 
and inserting ‘‘2029’’; and 
(2) in subparagraph (B)—
(A) in clause (ii), by striking ‘‘2025 and 
for the period beginning on January 1, 2026,
1387
and ending on January 30, 2026’’ and inserting 
‘‘2026’’; and 
(B) in clause (iii), by striking ‘‘the period 
beginning on January 31, 2026, and ending on 
December 31, 2026, and for each of 2027 and 
2028’’ and inserting ‘‘each of 2027 through 
2029’’. 
(b) REVISED DATA COLLECTION PERIOD FOR RE-
PORTING OF PRIVATE SECTOR PAYMENT RATES FOR ES-
TABLISHMENT OF MEDICARE PAYMENT RATES.—Section 
1834A(a)(4)(B) of the Social Security Act (42 U.S.C. 
1395m–1(a)(4)(B)) is amended by striking ‘‘2019’’ each 
place it appears and inserting ‘‘2025’’ in each such place. 
(c) REVISED REPORTING PERIOD FOR REPORTING 
OF PRIVATE SECTOR PAYMENT RATES FOR ESTABLISH-
MENT
OF
MEDICARE
PAYMENT
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 ‘‘January 31’’ and 
inserting ‘‘April 30’’; and 
(2) in clause (ii), by striking ‘‘February 1, 
2026, and ending April 30, 2026’’ and inserting 
‘‘May 1, 2026, and ending July 31, 2026’’. 
(d) IMPLEMENTATION.—Notwithstanding any other 
provision of law, the Secretary of Health and Human
1388
Services may implement the amendments made by this 
section by program instruction or otherwise. 
SEC. 6227. MEDICARE SEQUESTRATION. 
Section 251A(6) of the Balanced Budget and Emer-
gency Deficit Control Act of 1985 (2 U.S.C. 901a(6)) is 
amended—
(1) in subparagraph (D), by striking ‘‘such 
that,’’ and all that follows and inserting ‘‘such that 
the payment reduction shall be 2.0 percent for such 
fiscal year.’’; and 
(2) by adding at the end the following: 
‘‘(F) On the date on which the President sub-
mits the budget under section 1105 of title 31, 
United States Code, for fiscal year 2033, the Presi-
dent shall order a sequestration of payments for the 
Medicare programs specified in section 256(d), effec-
tive upon issuance, such that, notwithstanding the 2 
percent limit specified in subparagraph (A) for such 
payments—
‘‘(i) with respect to the first 5 months in 
which such order is effective for such fiscal 
year, the payment reduction shall be 2.0 per-
cent; and 
‘‘(ii) with respect to the last 7 months in 
which such order is effective for such fiscal
1389
year, the payment reduction shall be 0 per-
cent.’’. 
SEC. 6228. MEDICARE IMPROVEMENT FUND. 
Section 1898(b)(1) of the Social Security Act (42 
U.S.C. 
1395iii(b)(1)) 
is 
amended 
by 
striking 
‘‘$1,403,000,000’’ and inserting ‘‘$2,062,000,000’’. 
TITLE III—HUMAN SERVICES 
SEC. 6301. SEXUAL RISK AVOIDANCE EDUCATION EXTEN-
SION. 
Section 510 of the Social Security Act (42 U.S.C. 
710) is amended—
(1) in subsection (a)—
(A) in paragraph (1)—
(i) by striking ‘‘2025, and for the pe-
riod beginning on October 1, 2025, and 
ending on January 30, 2026’’ and insert-
ing ‘‘2026, and for the period beginning on 
October 1, 2026, and ending on December 
31, 2026’’; and 
(ii) by striking ‘‘fiscal year 2026’’ and 
inserting ‘‘fiscal year 2027’’; and 
(B) in paragraph (2)—
(i) in subparagraph (A)—
(I) by striking ‘‘through 2025’’ 
and inserting ‘‘through 2026’’; and
1390
(II) by striking ‘‘fiscal year 
2026’’ each place it appears and in-
serting ‘‘fiscal year 2027’’; and 
(ii) in subparagraph (B)(i), by strik-
ing ‘‘2026’’ and inserting ‘‘2027’’; and 
(2) in subsection (f)(1) by striking ‘‘2025, and 
for the period beginning on October 1, 2025, and 
ending on January 30, 2026, an amount equal to 
the pro rata portion of the amount appropriated for 
the corresponding period for fiscal year 2025’’ and 
inserting ‘‘2026, and for the period beginning on Oc-
tober 1, 2026, and ending on December 31, 2026, 
an amount equal to the pro rata portion of the 
amount appropriated for the corresponding period 
for fiscal year 2026’’. 
SEC. 6302. PERSONAL RESPONSIBILITY EDUCATION EXTEN-
SION. 
Section 513 of the Social Security Act (42 U.S.C. 
713) is amended—
(1) in subsection (a)(1)—
(A) in subparagraph (A), in the matter 
preceding clause (i), by striking ‘‘2025, and for 
the period beginning on October 1, 2025, and 
ending on January 30, 2026’’ and inserting 
‘‘2026, and for the period beginning on October
1391
1, 2026, and ending on December 31, 2026’’; 
and 
(B) in subparagraph (B)(i), by striking 
‘‘fiscal years 2024 and 2025, and for the period 
beginning on October 1, 2025, and ending on 
January 30, 2026’’ and inserting ‘‘fiscal years 
2025 and 2026, and for the period beginning 
on October 1, 2026, and ending on December 
31, 2026’’; 
(2) in subsection (c)(3), by striking ‘‘2026’’ and 
inserting ‘‘2027’’; and 
(3) in subsection (f), by striking ‘‘2025, and for 
the period beginning on October 1, 2025, and ending 
on January 30, 2026, an amount equal to the pro 
rata portion of the amount appropriated for the cor-
responding period for fiscal year 2025’’ and insert-
ing ‘‘2026, and for the period beginning on October 
1, 2026, and ending on December 31, 2026, an 
amount equal to the pro rata portion of the amount 
appropriated for the corresponding period for fiscal 
year 2026’’. 
SEC. 6303. EXTENSION OF FUNDING FOR FAMILY-TO-FAM-
ILY HEALTH INFORMATION CENTERS. 
Section 501(c)(1)(A) of the Social Security Act (42 
U.S.C. 701(c)(1)(A)) is amended—
1392
(1) in clause (viii), by striking ‘‘for fiscal year 
2025’’ and inserting ‘‘for each of fiscal years 2025 
and 2026’’; and 
(2) in clause (ix), by striking ‘‘October 1, 2025, 
and ending on January 30, 2026, an amount equal 
to the pro rata portion of the amount appropriated 
for fiscal year 2025’’ and inserting ‘‘October 1, 
2026, and ending on December 31, 2026, an amount 
equal to the pro rata portion of the amount appro-
priated for fiscal year 2026’’. 
SEC. 6304. EXTENSION OF THE TEMPORARY ASSISTANCE 
FOR NEEDY FAMILIES PROGRAM. 
Activities authorized by part A of title IV of the So-
cial Security Act (other than under section 403(c) or 418 
of such Act) and section 1108(b) of the Social Security 
Act shall continue through December 31, 2026, in the 
manner authorized for fiscal year 2025, and out of any 
money in the Treasury of the United States not otherwise 
appropriated, there are hereby appropriated such sums as 
may be necessary for such purpose.
1393
TITLE IV—PUBLIC HEALTH AND 
OTHER EXTENDERS 
Subtitle A—Extensions 
SEC. 6401. EXTENSION FOR COMMUNITY HEALTH CENTERS, 
NATIONAL HEALTH SERVICE CORPS, AND 
TEACHING HEALTH CENTERS THAT OPERATE 
GME PROGRAMS. 
(a) EXTENSION
FOR COMMUNITY HEALTH CEN-
TERS.—Section 10503(b)(1) of the Patient Protection and 
Affordable Care Act (42 U.S.C. 254b–2(b)(1)) is amended 
by striking subparagraphs (H), (I), (J), and (K) and in-
serting the following: 
‘‘(H) $4,236,712,328 for fiscal year 2024; 
‘‘(I) $4,295,287,671 for fiscal year 2025; 
‘‘(J) $4,600,000,000 for fiscal year 2026; 
and 
‘‘(K) $1,159,452,055 for the period begin-
ning on October 1, 2026, and ending on De-
cember 31, 2026; and’’. 
(b) EXTENSION FOR THE NATIONAL HEALTH SERV-
ICE CORPS.—Section 10503(b)(2) of the Patient Protec-
tion and Affordable Care Act (42 U.S.C. 254b–2(b)(2)) 
is amended by striking subparagraphs (I), (J), (K), and 
(L) and inserting the following: 
‘‘(I) $341,208,605 for fiscal year 2024;
1394
‘‘(J) $349,736,600 for fiscal year 2025; 
‘‘(K) $350,000,000 for fiscal year 2026; 
and 
‘‘(L) $88,219,178 for the period beginning 
on October 1, 2026, and ending on December 
31, 2026.’’. 
(c) TEACHING HEALTH CENTERS THAT OPERATE 
GRADUATE MEDICAL EDUCATION PROGRAMS.—Section 
340H(g)(1) of the Public Health Service Act (42 U.S.C. 
256h(g)(1)) is amended by striking subparagraphs (D), 
(E), (F), and (G) and inserting the following: ‘‘
‘‘(D) $168,915,878 for fiscal year 2024; 
‘‘(E) $181,563,574 for fiscal year 2025; 
‘‘(F) $225,000,000 for fiscal year 2026; 
‘‘(G) $250,000,000 for fiscal year 2027; 
‘‘(H) $275,000,000 for fiscal year 2028; 
and 
‘‘(I) $300,000,000 for fiscal year 2029.’’. 
(d) APPLICATION OF PROVISIONS.—Amounts appro-
priated pursuant to the amendments made by this section 
shall be subject to the requirements contained in Public 
Law 118–47 for funds for programs authorized under sec-
tions 330 through 340 of the Public Health Service Act 
(42 U.S.C. 254b et seq.).
1395
(e) 
CONFORMING
AMENDMENTS.—Section 
3014(h)(4) of title 18, United States Code, is amended 
by striking ‘‘and section 6101(d) of the Continuing Appro-
priations, Agriculture, Legislative Branch, Military Con-
struction and Veterans Affairs, and Extensions Act, 
2026’’ and inserting ‘‘section 6101(d) of the Continuing 
Appropriations, Agriculture, Legislative Branch, Military 
Construction and Veterans Affairs, and Extensions Act, 
2026, and section 6401(d) of the Consolidated Appropria-
tions Act, 2026’’. 
SEC. 6402. EXTENSION OF SPECIAL DIABETES PROGRAMS. 
(a) EXTENSION OF SPECIAL DIABETES PROGRAMS 
FOR TYPE I DIABETES.—Section 330B(b)(2) of the Pub-
lic Health Service Act (42 U.S.C. 254c–2(b)(2)) is amend-
ed by striking subparagraphs (E), (F), (G), and (H) and 
inserting the following: 
‘‘(E) $155,619,196 for fiscal year 2024, to 
remain available until expended; 
‘‘(F) $159,228,188 for fiscal year 2025, to 
remain available until expended; 
‘‘(G) $200,000,000 for fiscal year 2026, to 
remain available until expended; and 
‘‘(H) $50,410,959 for the period beginning 
on October 1, 2026, and ending on December 
31, 2026, to remain available until expended.’’.
1396
(b) EXTENDING FUNDING FOR SPECIAL DIABETES 
PROGRAMS
FOR INDIANS.—Section 330C(c)(2) of the 
Public Health Service Act (42 U.S.C. 254c–3(c)(2)) is 
amended by striking subparagraphs (E), (F), (G), and 
(H) and inserting the following: 
‘‘(E) $155,619,196 for fiscal year 2024, to 
remain available until expended; 
‘‘(F) $159,228,188 for fiscal year 2025, to 
remain available until expended; 
‘‘(G) $200,000,000 for fiscal year 2026, to 
remain available until expended; and 
‘‘(H) $50,410,959 for the period beginning 
on October 1, 2026, and ending on December 
31, 2026, to remain available until expended.’’. 
SEC. 6403. EXTENSION OF NATIONAL HEALTH SECURITY 
PROGRAMS. 
(a) Section 319(e)(8) of the Public Health Service 
Act (42 U.S.C. 247d(e)(8)) is amended by striking ‘‘Janu-
ary 30, 2026’’ and inserting ‘‘December 31, 2026’’. 
(b) Section 319L(e)(1)(D) of the Public Health Serv-
ice Act (42 U.S.C. 247d–7e(e)(1)(D)) is amended by strik-
ing ‘‘January 30, 2026’’ and inserting ‘‘December 31, 
2026’’.
1397
(c) Section 319L–1(b) of the Public Health Service 
Act (42 U.S.C. 247d–7f(b)) is amended by striking ‘‘Jan-
uary 30, 2026’’ and inserting ‘‘December 31, 2026’’. 
(d) Section 2811A(g) of the Public Health Service 
Act (42 U.S.C. 300hh–10b(g)) is amended by striking 
‘‘January 30, 2026’’ and inserting ‘‘December 31, 2026’’. 
(e) Section 2811B(g)(1) of the Public Health Service 
Act (42 U.S.C. 300hh–10c(g)(1)) is amended by striking 
‘‘January 30, 2026’’ and inserting ‘‘December 31, 2026’’. 
(f) Section 2811C(g)(1) of the Public Health Service 
Act (42 U.S.C. 300hh–10d(g)(1)) is amended by striking 
‘‘January 30, 2026’’ and inserting ‘‘December 31, 2026’’. 
(g) Section 2812(c)(4)(B) of the Public Health Serv-
ice Act (42 U.S.C. 300hh–11(c)(4)(B)) is amended by 
striking ‘‘January 30, 2026’’ and inserting ‘‘December 31, 
2026’’. 
SEC. 6404. NO SURPRISES ACT IMPLEMENTATION. 
Section 118(a) of division BB of the Consolidated 
Appropriations Act, 2021 (Public Law 116–260) is 
amended—
(1) in paragraph (1), by striking ‘‘January 30, 
2026’’ and inserting ‘‘December 31, 2026’’; and 
(2) in paragraph (2)—
(A) by striking ‘‘$14,000,000’’ and insert-
ing ‘‘$42,100,000’’; and
1398
(B) by striking ‘‘January 30, 2026’’ and 
inserting ‘‘December 31, 2026’’. 
Subtitle B—World Trade Center 
Health Program 
SEC. 6411. 9/11 RESPONDER AND SURVIVOR HEALTH FUND-
ING CORRECTIONS. 
(a) IN GENERAL.—Section 3351(a)(2)(A) of the 
Public 
Health 
Service 
Act 
(42 
U.S.C. 
300mm–
61(a)(2)(A)) is amended—
(1) in clause (x), by striking ‘‘; and’’ and insert-
ing a semicolon; 
(2) by redesignating clause (xi) as clause (xii); 
and 
(3) by inserting after clause (x), the following: 
‘‘(xi) for each of fiscal years 2026 
through 2040—
‘‘(I) 
the 
amount 
determined 
under this subparagraph for the pre-
vious fiscal year multiplied by 1.07; 
multiplied by 
‘‘(II) the ratio of—
‘‘(aa) the total number of 
individuals enrolled in the WTC 
Program on July 1 of such pre-
vious fiscal year; to
1399
‘‘(bb) the total number of 
individuals so enrolled on July 1 
of the fiscal year prior to such 
previous fiscal year; and’’. 
(b) REPORT TO CONGRESS.—
(1) IN GENERAL.—Not later than 3 years after 
the date of enactment of this Act, the Secretary of 
Health and Human Services (referred to in this sub-
section as the ‘‘Secretary’’) shall conduct an assess-
ment of anticipated budget authority and outlays of 
the World Trade Center Health Program (referred 
to in this subsection as the ‘‘Program’’) through the 
duration of the Program and submit a report sum-
marizing such assessment to—
(A) the Speaker and minority leader of the 
House of Representatives; 
(B) the majority and minority leaders of 
the Senate; 
(C) the Committee on Health, Education, 
Labor, and Pensions and the Committee on the 
Budget of the Senate; and 
(D) the Committee on Energy and Com-
merce and the Committee on the Budget of the 
House of Representatives.
1400
(2) INCLUSIONS.—The report required under 
paragraph (1) shall include—
(A) a projection of Program budgetary 
needs on a per-fiscal year basis through fiscal 
year 2090; 
(B) a review of Program modeling for each 
of fiscal years 2017 through the fiscal year 
prior to the fiscal year in which the report is 
issued to assess how anticipated budgetary 
needs compared to actual expenditures; 
(C) an assessment of the projected budget 
authority and expenditures of the Program 
through fiscal year 2090 by comparing—
(i) such projected authority and ex-
penditures resulting from application of 
section 3351(a)(2)(A) of the Public Health 
Service 
Act 
(42 
U.S.C. 
300mm–
61(a)(2)(A)), as amended by subsection 
(a); and 
(ii) such projected authority and ex-
penditures that would result if such section 
were amended so that the formula under 
clause (xi) of such section, as amended by 
subsection (a), were to be extended 
through fiscal year 2090; and
1401
(D) any recommendations of the Secretary 
to make changes to the formula under such sec-
tion 3351(a)(2)(A), as so amended, to fully off-
set anticipated Program expenditures through 
fiscal year 2090. 
(c) TECHNICAL AMENDMENTS.—Title XXXIII of the 
Public Health Service Act (42 U.S.C. 300mm et seq.) is 
amended—
(1) in section 3352(d) (42 U.S.C. 300mm–
62(d)), by striking ‘‘Any amounts’’ and inserting 
‘‘Any unobligated amounts’’; 
(2) in section 3353(d) (42 U.S.C. 300mm–
63(d)), by striking ‘‘Any amounts’’ and inserting 
‘‘Any unobligated amounts’’; and 
(3) in section 3354(d) (42 U.S.C. 300mm–
64(d)), by striking ‘‘Any amounts’’ and inserting 
‘‘Any unobligated amounts’’. 
TITLE V—PUBLIC HEALTH 
PROGRAMS 
SEC. 6501. PREVENTING MATERNAL DEATHS. 
(a) MATERNAL MORTALITY REVIEW COMMITTEES.—
Section 317K(d) of the Public Health Service Act (42 
U.S.C. 247b–12(d)) is amended—
1402
(1) in paragraph (1)(A), by inserting ‘‘(includ-
ing obstetricians and gynecologists)’’ after ‘‘clinical 
specialties’’; and 
(2) in paragraph (3)(A)(i)—
(A) in subclause (I), by striking ‘‘as appli-
cable’’ and inserting ‘‘if available’’; and 
(B) in subclause (III), by striking ‘‘, as ap-
propriate’’ and inserting ‘‘and coordinating with 
individuals responsible for certifying deaths to 
improve the collection and quality of death 
record reports, including by amending errors 
and missing or incomplete information to cause-
of-death information on a death certificate, as 
appropriate’’. 
(b) MATERNAL MORTALITY.—Section 317K of the 
Public Health Service Act (42 U.S.C. 247b–12) is amend-
ed—
(1) by redesignating subsections (e) and (f) as 
subsections (f) and (g), respectively; and 
(2) by inserting after subsection (d) the fol-
lowing: 
‘‘(e) BEST PRACTICES RELATING TO THE PREVEN-
TION OF MATERNAL MORTALITY.—
‘‘(1) IN
GENERAL.—The Secretary, acting 
through the Director of the Centers for Disease
1403
Control and Prevention, shall, in consultation with 
the Administrator of the Health Resources and Serv-
ices Administration, identify and disseminate to 
health care providers, relevant professional societies, 
and perinatal quality collaboratives, best practices 
related to preventing maternal morbidity and mor-
tality, taking into consideration any relevant find-
ings from other Federal maternal health programs. 
‘‘(2) 
FREQUENCY.—The 
Secretary, 
acting 
through the Director of the Centers for Disease 
Control and Prevention, shall disseminate the best 
practices referred to in paragraph (1) not less than 
once per fiscal year.’’. 
(c) AUTHORIZATION
OF
APPROPRIATIONS.—Sub-
section (g) of section 317K of the Public Health Service 
Act (42 U.S.C. 247b–12), as redesignated by subsection 
(b)(1), is amended by striking ‘‘$58,000,000 for each of 
fiscal 
years 
2019 
through 
2023’’ 
and 
inserting 
‘‘$100,000,000 for each of fiscal years 2026 through 
2030’’. 
SEC. 6502. ORGAN PROCUREMENT AND TRANSPLANTATION 
NETWORK. 
Section 372 of the Public Health Service Act (42 
U.S.C. 274) is amended—
(1) in subsection (b)(2)—
1404
(A) by moving the margins of subpara-
graphs (M) through (O) 2 ems to the left; 
(B) in subparagraph (A)—
(i) in clause (i), by striking ‘‘, and’’ 
and inserting ‘‘; and’’; and 
(ii) in clause (ii), by striking the 
comma at the end and inserting a semi-
colon; 
(C) in subparagraph (C), by striking 
‘‘twenty-four-hour telephone service’’ and in-
serting ‘‘24-hour telephone or information tech-
nology service’’; 
(D) in each of subparagraphs (B) through 
(M), by striking the comma at the end and in-
serting a semicolon; 
(E) in subparagraph (N), by striking 
‘‘transportation, and’’ and inserting ‘‘transpor-
tation;’’; 
(F) in subparagraph (O), by striking the 
period and inserting a semicolon; and 
(G) by adding at the end the following: 
‘‘(P) encourage the integration of electronic 
health records systems through application program-
ming interfaces (or successor technologies) among 
hospitals, organ procurement organizations, and
1405
transplant centers, including the use of automated 
electronic hospital referrals and the grant of remote, 
electronic access to hospital electronic health records 
of potential donors by organ procurement organiza-
tions, in a manner that complies with the privacy 
regulations promulgated under the Health Insurance 
Portability and Accountability Act of 1996, at part 
160 of title 45, Code of Federal Regulations, and 
subparts A, C, and E of part 164 of such title (or 
any successor regulations); and 
‘‘(Q) consider establishing a dashboard to dis-
play the number of transplants performed, the types 
of transplants performed, the number and types of 
organs that entered the Organ Procurement and 
Transplantation Network system and failed to be 
transplanted, and other appropriate statistics, which 
should be updated more frequently than annually.’’; 
and 
(2) by adding at the end the following: 
‘‘(d) REGISTRATION FEES.—
‘‘(1) IN GENERAL.—The Secretary may collect 
registration fees from any member of the Organ 
Procurement and Transplantation Network for each 
transplant candidate such member places on the list 
described in subsection (b)(2)(A)(i). Such registra-
1406
tion fees shall be collected and distributed only to 
support the operation of the Organ Procurement 
and Transplantation Network. Such registration fees 
are authorized to remain available until expended. 
‘‘(2) COLLECTION.—The Secretary may collect 
the registration fees under paragraph (1) directly or 
through awards made under subsection (b)(1)(A). 
‘‘(3) DISTRIBUTION.—Any amounts collected 
under this subsection shall—
‘‘(A) be credited to the currently applicable 
appropriation, account, or fund of the Depart-
ment of Health and Human Services as discre-
tionary offsetting collections; and 
‘‘(B) be available, only to the extent and in 
the amounts provided in advance in appropria-
tions Acts, to distribute such fees among 
awardees described in subsection (b)(1)(A). 
‘‘(4) TRANSPARENCY.—The Secretary shall—
‘‘(A) promptly post on the website of the 
Organ Procurement and Transplantation Net-
work—
‘‘(i) the amount of registration fees 
collected under this subsection from each 
member of the Organ Procurement and 
Transplantation Network; and
1407
‘‘(ii) a list of activities such fees are 
used to support; and 
‘‘(B) update the information posted pursu-
ant to subparagraph (A), as applicable for each 
calendar quarter for which fees are collected 
under paragraph (1). 
‘‘(5) GAO REVIEW.—Not later than 2 years 
after the date of enactment of this subsection, the 
Comptroller General of the United States shall, to 
the extent data are available—
‘‘(A) conduct a review concerning the ac-
tivities under this subsection; and 
‘‘(B) submit to the Committee on Health, 
Education, Labor, and Pensions and the Com-
mittee on Finance of the Senate and the Com-
mittee on Energy and Commerce of the House 
of Representatives, a report on such review, in-
cluding related recommendations, as applicable. 
‘‘(6) SUNSET.—The authority to collect reg-
istration fees under paragraph (1) shall expire on 
the date that is 3 years after the date of enactment 
of the Consolidated Appropriations Act, 2026.’’.
1408
SEC. 6503. HONOR OUR LIVING DONORS. 
(a) NO CONSIDERATION OF INCOME OF ORGAN RE-
CIPIENT.—Section 377 of the Public Health Service Act 
(42 U.S.C. 274f) is amended—
(1) by redesignating subsections (c) through (f) 
as subsections (d) through (g), respectively; 
(2) by inserting after subsection (b) the fol-
lowing: 
‘‘(c) NO CONSIDERATION OF INCOME OF ORGAN RE-
CIPIENT.—The recipient of a grant under this section, in 
providing reimbursement to a donating individual through 
such grant, shall not give any consideration to the income 
of the organ recipient.’’; and 
(3) in subsection (f), as so redesignated—
(A) in paragraph (1), by striking ‘‘sub-
section 
(c)(1)’’ 
and 
inserting 
‘‘subsection 
(d)(1)’’; and 
(B) in paragraph (2), by striking ‘‘sub-
section 
(c)(2)’’ 
and 
inserting 
‘‘subsection 
(d)(2)’’. 
(b) REMOVAL OF EXPECTATION OF PAYMENTS BY 
ORGAN
RECIPIENTS.—Section 377(e) of the Public 
Health Service Act (42 U.S.C. 274f(e)), as redesignated 
by subsection (a)(1), is amended—
(1) in paragraph (1), by adding ‘‘or’’ at the 
end;
1409
(2) in paragraph (2), by striking ‘‘; or’’ and in-
serting a period; and 
(3) by striking paragraph (3). 
(c) ANNUAL REPORT.—Section 377 of the Public 
Health Service Act (42 U.S.C. 274f), as amended by sub-
sections (a) and (b), is amended by adding at the end the 
following: 
‘‘(h) ANNUAL REPORT.—Not later than December 31 
of each year, beginning in fiscal year 2027, the Secretary 
shall—
‘‘(1) prepare, submit to the Congress, and make 
public a report on whether grants under this section 
provided adequate funding during the preceding fis-
cal year to reimburse all donating individuals par-
ticipating in the grant program under this section 
for all qualifying expenses; and 
‘‘(2) include in each such report—
‘‘(A) the estimated number of all donating 
individuals participating in the grant program 
under this section who did not receive reim-
bursement for all qualifying expenses during 
the preceding fiscal year; and 
‘‘(B) the total amount of funding that is 
estimated to be necessary to fully reimburse all 
donating individuals participating in the grant
1410
program under this section for all qualifying ex-
penses.’’. 
SEC. 6504. PROGRAM FOR PEDIATRIC STUDIES OF DRUGS. 
Section 409I(d)(1) of the Public Health Service Act 
(42 U.S.C. 284m(d)(1)) is amended by striking ‘‘section,’’ 
and all that follows through the period at the end and 
inserting ‘‘section, $25,000,000 for each of fiscal years 
2026 through 2028.’’. 
SEC. 6505. SICKLE CELL DISEASE PREVENTION AND TREAT-
MENT. 
(a) IN GENERAL.—Section 1106(b) of the Public 
Health Service Act (42 U.S.C. 300b–5(b)) is amended—
(1) in paragraph (1)(A)(iii), by striking ‘‘pre-
vention and treatment of sickle cell disease’’ and in-
serting ‘‘treatment of sickle cell disease and the pre-
vention and treatment of complications of sickle cell 
disease’’; 
(2) in paragraph (2)(D), by striking ‘‘preven-
tion and treatment of sickle cell disease’’ and insert-
ing ‘‘treatment of sickle cell disease and the preven-
tion and treatment of complications of sickle cell dis-
ease’’; 
(3) in paragraph (3)—
(A) in subparagraph (A), by striking 
‘‘enter into a contract with’’ and inserting
1411
‘‘make a grant to, or enter into a contract or 
cooperative agreement with,’’; and 
(B) in subparagraph (B), in each of 
clauses (ii) and (iii), by striking ‘‘prevention 
and treatment of sickle cell disease’’ and insert-
ing ‘‘treatment of sickle cell disease and the 
prevention and treatment of complications of 
sickle cell disease’’; and 
(4) in paragraph (6), by striking ‘‘$4,455,000 
for each of fiscal years 2019 through 2023’’ and in-
serting ‘‘$8,205,000 for each of fiscal years 2026 
through 2030’’. 
(b) SENSE OF CONGRESS.—It is the sense of Con-
gress that further research should be undertaken to ex-
pand the understanding of the causes of, and to find cures 
for, heritable blood disorders, including sickle cell disease. 
SEC. 6506. LIFESPAN RESPITE CARE. 
(a) DEFINITION OF FAMILY CAREGIVER.—Section 
2901(5) of the Public Health Service Act (42 U.S.C. 
300ii(5)) is amended by striking ‘‘unpaid adult’’ and in-
serting ‘‘unpaid individual’’. 
(b) FUNDING.—Section 2905 of the Public Health 
Service Act (42 U.S.C. 300ii–4) is amended by striking 
‘‘fiscal years 2020 through fiscal year 2024’’ and inserting 
‘‘fiscal years 2026 through 2030’’.
1412
SEC. 6507. PREEMIE. 
(a) RESEARCH RELATING TO PRETERM LABOR AND 
DELIVERY AND THE CARE, TREATMENT, AND OUTCOMES 
OF PRETERM AND LOW BIRTHWEIGHT INFANTS.—
(1) IN
GENERAL.—Section 3(e) of the Pre-
maturity Research Expansion and Education for 
Mothers who deliver Infants Early Act (42 U.S.C. 
247b–4f(e)) is amended by striking ‘‘fiscal years 
2019 through 2023’’ and inserting ‘‘fiscal years 
2026 through 2030’’. 
(2) TECHNICAL CORRECTION.—Effective as if 
included in the enactment of the PREEMIE Reau-
thorization Act of 2018 (Public Law 115–328), sec-
tion 2 of such Act is amended, in the matter pre-
ceding paragraph (1), by striking ‘‘Section 2’’ and 
inserting ‘‘Section 3’’. 
(b) INTERAGENCY WORKING GROUP.—Section 5(a) 
of the PREEMIE Reauthorization Act of 2018 (Public 
Law 115–328) is amended by striking ‘‘The Secretary of 
Health and Human Services, in collaboration with other 
departments, as appropriate, may establish’’ and inserting 
‘‘Not later than 18 months after the date of the enactment 
of the Consolidated Appropriations Act, 2026, the Sec-
retary of Health and Human Services, in collaboration 
with other departments, as appropriate, shall establish’’. 
(c) STUDY ON PRETERM BIRTHS.—
1413
(1) IN GENERAL.—The Secretary of Health and 
Human Services shall enter into appropriate ar-
rangements 
with 
the 
National 
Academies 
of 
Sciences, Engineering, and Medicine under which 
the National Academies shall—
(A) not later than 30 days after the date 
of enactment of this Act, convene a committee 
of experts in maternal health to study pre-
mature births in the United States; and 
(B) upon completion of the study under 
subparagraph (A)—
(i) approve by consensus a report on 
the results of such study; 
(ii) include in such report—
(I) an assessment of each of the 
topics listed in paragraph (2); 
(II) the analysis required by 
paragraph (3); and 
(III) the raw data used to de-
velop such report; and 
(iii) not later than 24 months after 
the date of enactment of this Act, transmit 
such report to—
(I) the Secretary of Health and 
Human Services;
1414
(II) the Committee on Energy 
and Commerce of the House of Rep-
resentatives; and 
(III) the Committee on Finance 
and the Committee on Health, Edu-
cation, Labor, and Pensions of the 
Senate. 
(2) ASSESSMENT TOPICS.—The topics listed in 
this subsection are each of the following: 
(A) The financial costs of premature birth 
to society, including—
(i) an analysis of stays in neonatal in-
tensive care units and the cost of such 
stays; 
(ii) long-term costs of stays in such 
units to society and the family involved 
post-discharge; and 
(iii) health care costs for families 
post-discharge from such units (such as 
medications, therapeutic services, co-pay-
ments for visits, and specialty equipment). 
(B) The factors that impact preterm birth 
rates. 
(C) Opportunities for earlier detection of 
premature birth risk factors, including—
1415
(i) opportunities to improve maternal 
and infant health; and 
(ii) opportunities for public health 
programs to provide support and resources 
for parents in-hospital, in non-hospital set-
tings, and post-discharge. 
(3) ANALYSIS.—The analysis required by this 
subsection is an analysis of—
(A) targeted research strategies to develop 
effective drugs, treatments, or interventions to 
bring at-risk pregnancies to term; 
(B) State and other programs’ best prac-
tices with respect to reducing premature birth 
rates; and 
(C) precision medicine and preventative 
care approaches starting early in the life course 
(including during pregnancy) with a focus on 
behavioral and biological influences on pre-
mature birth, child health, and the trajectory of 
such approaches into adulthood. 
SEC. 6508. DR. LORNA BREEN HEALTH CARE PROVIDER 
PROTECTION. 
(a) DISSEMINATION OF BEST PRACTICES.—Section 
2 of the Dr. Lorna Breen Health Care Provider Protection
1416
Act (Public Law 117–105) is amended by striking ‘‘2 
years’’ and inserting ‘‘5 years’’. 
(b) EDUCATION AND AWARENESS INITIATIVE EN-
COURAGING USE OF MENTAL HEALTH AND SUBSTANCE 
USE DISORDER SERVICES BY HEALTH CARE PROFES-
SIONALS.—Section 3 of the Dr. Lorna Breen Health Care 
Provider Protection Act (Public Law 117–105) is amend-
ed—
(1) in subsection (b), by inserting ‘‘and annu-
ally thereafter,’’ after ‘‘of this Act,’’; and 
(2) in subsection (c), by striking ‘‘2022 through 
2024’’ and inserting ‘‘2026 through 2030’’. 
(c) PROGRAMS
TO
PROMOTE
MENTAL
HEALTH 
AMONG THE HEALTH PROFESSIONAL WORKFORCE.—The 
second section 764 of the Public Health Service Act (42 
U.S.C. 294t), as added by section 4 of the Dr. Lorna 
Breen Health Care Provider Protection Act (Public Law 
117–105), is amended—
(1) by redesignating such section 764 as section 
764A; 
(2) in subsection (a)(3)—
(A) by striking ‘‘to eligible entities in’’ and 
inserting ‘‘to eligible entities that—
‘‘(A) are in’’;
1417
(B) by striking the period and inserting ‘‘; 
or’’; and 
(C) by adding at the end the following: 
‘‘(B) have a focus on the reduction of ad-
ministrative burden on health care workers.’’; 
(3) in subsection (c), by inserting ‘‘not less 
than’’ after ‘‘period of’’; and 
(4) in subsection (f), by striking ‘‘2022 through 
2024’’ and inserting ‘‘2026 through 2030’’. 
TITLE VI—FOOD AND DRUG 
ADMINISTRATION 
Subtitle A—Mikaela Naylon Give 
Kids a Chance Act 
SEC. 6601. RESEARCH INTO PEDIATRIC USES OF DRUGS; 
ADDITIONAL AUTHORITIES OF FOOD AND 
DRUG ADMINISTRATION REGARDING MOLEC-
ULARLY TARGETED CANCER DRUGS. 
(a) IN GENERAL.—
(1) ADDITIONAL ACTIVE INGREDIENT FOR AP-
PLICATION DRUG; LIMITATION REGARDING NOVEL-
COMBINATION
APPLICATION
DRUG.—Section 
505B(a)(3) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 355c(a)(3)) is amended—
1418
(A) by redesignating subparagraphs (B) 
and (C) as subparagraphs (C) and (D), respec-
tively; and 
(B) by striking subparagraph (A) and in-
serting the following: 
‘‘(A) IN GENERAL.—For purposes of para-
graph (1)(B), the investigation described in this 
paragraph is a molecularly targeted pediatric 
cancer investigation of—
‘‘(i) the drug or biological product for 
which the application referred to in such 
paragraph is submitted; or 
‘‘(ii) such drug or biological product 
used in combination with—
‘‘(I) an active ingredient of a 
drug or biological product—
‘‘(aa) for which an approved 
application under section 505(j) 
under this Act or under section 
351(k) of the Public Health 
Service Act is in effect; and 
‘‘(bb) that is determined by 
the Secretary, after consultation 
with the applicant, to be part of
1419
the standard of care for treating 
a pediatric cancer; or 
‘‘(II) an active ingredient of a 
drug or biological product—
‘‘(aa) for which an approved 
application under section 505(b) 
of this Act or section 351(a) of 
the Public Health Service Act to 
treat an adult cancer is in effect 
and is held by the same person 
submitting the application under 
paragraph (1)(B); and 
‘‘(bb) that is directed at a 
molecular target that the Sec-
retary determines to be substan-
tially relevant to the growth or 
progression of a pediatric cancer. 
‘‘(B) ADDITIONAL REQUIREMENTS.—
‘‘(i) DESIGN
OF
INVESTIGATION.—A 
molecularly targeted pediatric cancer inves-
tigation referred to in subparagraph (A) 
shall be designed to yield clinically mean-
ingful pediatric study data that is gathered 
using appropriate formulations for each 
age group for which the study is required,
1420
regarding dosing, safety, and preliminary 
efficacy to inform potential pediatric label-
ing. 
‘‘(ii) LIMITATION.—An investigation 
described in subparagraph (A)(ii) may be 
required only if the drug or biological 
product for which the application referred 
to in paragraph (1)(B) contains either—
‘‘(I) a single new active ingre-
dient; or 
‘‘(II) more than one active ingre-
dient, if an application for the com-
bination of active ingredients has not 
previously been approved but each ac-
tive ingredient is in a drug product 
that has been previously approved to 
treat an adult cancer. 
‘‘(iii) RESULTS
OF
ALREADY-COM-
PLETED PRECLINICAL STUDIES OF APPLI-
CATION DRUG.—With respect to an inves-
tigation required pursuant to paragraph 
(1)(B), the Secretary may require the re-
sults of any completed preclinical studies 
relevant to the initial pediatric study plan 
be submitted to the Secretary at the same
1421
time that the initial pediatric study plan 
required under subsection (e)(1) is sub-
mitted. 
‘‘(iv) RULE
OF
CONSTRUCTION
RE-
GARDING
INACTIVE
INGREDIENTS.—With 
respect to a combination of active ingredi-
ents referred to in subparagraph (A)(ii), 
such subparagraph shall not be construed 
as addressing the use of inactive ingredi-
ents with such combination.’’. 
(2) DETERMINATION OF APPLICABLE REQUIRE-
MENTS.—Section 505B(e)(1) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355c(e)(1)) is 
amended by adding at the end the following: ‘‘The 
Secretary shall determine whether subparagraph (A) 
or (B) of subsection (a)(1) applies with respect to an 
application before the date on which the applicant is 
required to submit the initial pediatric study plan 
under paragraph (2)(A).’’. 
(3) 
CLARIFYING
APPLICABILITY.—Section 
505B(a)(1) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 355c(a)(1)) is amended by 
adding at the end the following: 
‘‘(C) RULE OF CONSTRUCTION.—No appli-
cation that is subject to the requirements of
1422
subparagraph (B) shall be subject to the re-
quirements of subparagraph (A), and no appli-
cation (or supplement to an application) that is 
subject to the requirements of subparagraph 
(A) shall be subject to the requirements of sub-
paragraph (B).’’. 
(4) 
CONFORMING
AMENDMENTS.—Section 
505B(a) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 355c(a)) is amended—
(A) in paragraph (3)(C), as redesignated 
by paragraph (1)(A) of this subsection, by 
striking ‘‘investigations described in this para-
graph’’ and inserting ‘‘investigations referred to 
in subparagraph (A)’’; and 
(B) in paragraph (3)(D), as redesignated 
by paragraph (1)(A) of this subsection, by 
striking ‘‘the assessments under paragraph 
(2)(B)’’ and inserting ‘‘the assessments re-
quired under paragraph (1)(A)’’. 
(b) GUIDANCE.—The Secretary of Health and 
Human Services, acting through the Commissioner of 
Food and Drugs, shall—
(1) not later than 12 months after the date of 
enactment of this Act, issue draft guidance on the
1423
implementation of the amendments made by sub-
section (a); and 
(2) not later than 12 months after closing the 
comment period on such draft guidance, finalize 
such guidance. 
(c) APPLICABILITY.—The amendments made by this 
section apply with respect to any application under section 
505(b) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355(b)) and any application under section 351(a) 
of the Public Health Service Act (42 U.S.C. 262(a)), that 
is submitted on or after the date that is 3 years after the 
date of enactment of this Act. 
(d) REPORTS TO CONGRESS.—
(1) SECRETARY OF HEALTH AND HUMAN SERV-
ICES.—Not later than 6 years after the date of en-
actment of this Act, the Secretary of Health and 
Human Services shall submit to the Committee on 
Energy and Commerce of the House of Representa-
tives and the Committee on Health, Education, 
Labor, and Pensions of the Senate a report on the 
Secretary’s efforts, in coordination with industry, to 
ensure implementation of the amendments made by 
subsection (a). 
(2) GAO STUDY AND REPORT.—
1424
(A) STUDY.—Not later than 8 years after 
the date of enactment of this Act, the Comp-
troller General of the United States shall con-
duct a study of the effectiveness of requiring 
assessments and investigations described in sec-
tion 505B of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C.355c), as amended by sub-
section (a), in the development of drugs and bi-
ological products for pediatric cancer indica-
tions, including consideration of any benefits to, 
or burdens on, pediatric cancer drug develop-
ment. 
(B) FINDINGS.—Not later than 10 years 
after the date of enactment of this Act, the 
Comptroller General shall submit to the Com-
mittee on Energy and Commerce of the House 
of Representatives and the Committee on 
Health, Education, Labor, and Pensions of the 
Senate a report containing the findings of the 
study conducted under subparagraph (A). 
SEC. 6602. ENSURING COMPLETION OF PEDIATRIC STUDY 
REQUIREMENTS. 
(a) EQUAL ACCOUNTABILITY FOR PEDIATRIC STUDY 
REQUIREMENTS.—Section 505B(d) of the Federal Food,
1425
Drug, and Cosmetic Act (21 U.S.C. 355c(d)) is amend-
ed—
(1) in paragraph (1), by striking ‘‘Beginning 
270’’ and inserting ‘‘NONCOMPLIANCE
LETTER.—
Beginning 270’’; 
(2) in paragraph (2)—
(A) by striking ‘‘The drug or’’ and insert-
ing ‘‘EFFECT OF NONCOMPLIANCE.—The drug 
or’’; and 
(B) by striking ‘‘(except that the drug or 
biological product shall not be subject to action 
under section 303)’’ and inserting ‘‘(except that 
the drug or biological product shall be subject 
to action under section 303 only if such person 
demonstrated a lack of due diligence in satis-
fying the applicable requirement)’’; and 
(3) by adding at the end the following: 
‘‘(3) LIMITATION.—The Secretary shall not 
issue enforcement actions under section 303 for fail-
ures under this subsection in the case of a drug or 
biological product that is no longer marketed.’’. 
(b) DUE DILIGENCE.—Section 505B(d) of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 355c(d)), 
as amended by subsection (a), is further amended by add-
ing at the end the following:
1426
‘‘(4) DUE
DILIGENCE.—Before the Secretary 
may conclude that a person failed to submit or oth-
erwise meet a requirement as described in the mat-
ter preceding paragraph (1), the Secretary shall—
‘‘(A) issue a noncompliance letter pursuant 
to paragraph (1); 
‘‘(B) provide such person with a 45-day 
period beginning on the date of receipt of such 
noncompliance letter to respond in writing as 
set forth in such paragraph; and 
‘‘(C) after reviewing such written response, 
determine whether the person demonstrated a 
lack of due diligence in satisfying such require-
ment.’’. 
(c) 
CONFORMING
AMENDMENTS.—Section 
303(f)(4)(A) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 333(f)(4)(A)) is amended by striking ‘‘or 505–
1’’ and inserting ‘‘505–1, or 505B’’. 
(d) TRANSITION RULE.—The Secretary of Health 
and Human Services may take enforcement action under 
section 303 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 333) only for failures described in section 
505B(d) of such Act (21 U.S.C. 355c(d)) that occur on 
or after the date that is 180 days after the date of enact-
ment of this Act.
1427
SEC. 6603. FDA REPORT ON PREA ENFORCEMENT. 
Section 508(b) of the Food and Drug Administration 
Safety and Innovation Act (21 U.S.C. 355c–1(b)) is 
amended—
(1) in paragraph (11), by striking the semicolon 
at the end and inserting ‘‘, including an evaluation 
of compliance with deadlines provided for in defer-
rals and deferral extensions;’’; 
(2) in paragraph (15), by striking ‘‘and’’ at the 
end; 
(3) in paragraph (16), by striking the period at 
the end and inserting ‘‘; and’’; and 
(4) by adding at the end the following: 
‘‘(17) a listing of penalties, settlements, or pay-
ments under section 303 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 353) for failure to 
comply with requirements under such section 505B, 
including, for each penalty, settlement, or payment, 
the name of the drug, the sponsor thereof, and the 
amount of the penalty, settlement, or payment im-
posed.’’. 
SEC. 6604. EXTENSION OF AUTHORITY TO ISSUE PRIORITY 
REVIEW VOUCHERS TO ENCOURAGE TREAT-
MENTS FOR RARE PEDIATRIC DISEASES. 
(a) EXTENSION.—Paragraph (5) of section 529(b) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
1428
360ff(b)) is amended by striking ‘‘December 20, 2024, un-
less’’ and all that follows through the period at the end 
and inserting ‘‘September 30, 2029.’’. 
(b) USER FEE PAYMENT.—Section 529(c)(4) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360ff(c)(4)) is amended by striking subparagraph (A) and 
inserting the following: 
‘‘(A) IN
GENERAL.—The priority review 
user fee required by this subsection shall be due 
upon the submission of a human drug applica-
tion under section 505(b)(1) or section 351(a) 
of the Public Health Service Act for which the 
priority review voucher is used. All other user 
fees associated with the human drug application 
shall be due as required by the Secretary or 
under applicable law.’’. 
(c) GAO REPORT ON EFFECTIVENESS OF RARE PE-
DIATRIC
DISEASE
PRIORITY
VOUCHER
AWARDS
IN 
INCENTIVIZING RARE PEDIATRIC DISEASE DRUG DEVEL-
OPMENT.—
(1) GAO STUDY.—
(A) STUDY.—The Comptroller General of 
the United States shall conduct a study of the 
effectiveness of awarding rare pediatric disease 
priority vouchers under section 529 of the Fed-
1429
eral Food, Drug, and Cosmetic Act (21 U.S.C. 
360ff), as amended by subsection (a), in the de-
velopment of human drug products that treat or 
prevent rare pediatric diseases (as defined in 
such section 529). 
(B) CONTENTS OF STUDY.—In conducting 
the study under subparagraph (A), the Comp-
troller General shall examine the following: 
(i) The indications for each drug or 
biological product that—
(I) is the subject of a rare pedi-
atric disease product application (as 
defined in section 529 of the Federal 
Food, Drug, and Cosmetic Act (21 
U.S.C. 360ff)) for which a priority re-
view voucher was awarded; and 
(II) was approved under section 
505 of the Federal Food, Drug, and 
Cosmetic Act (42 U.S.C. 355) or li-
censed under section 351 of the Pub-
lic Health Service Act (42 U.S.C. 
262). 
(ii) Whether, and to what extent, an 
unmet need related to the treatment or 
prevention of a rare pediatric disease was
1430
met through the approval or licensure of 
such a drug or biological product. 
(iii) The size of the company to which 
a priority review voucher was awarded 
under section 529 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360ff) 
for such a drug or biological product. 
(iv) The value of such priority review 
voucher if transferred. 
(v) Identification of each drug for 
which a priority review voucher awarded 
under such section 529 was used. 
(vi) The size of the company using 
each priority review voucher awarded 
under such section 529. 
(vii) The length of the period of time 
between the date on which a priority re-
view voucher was awarded under such sec-
tion 529 and the date on which it was 
used. 
(viii) Whether, and to what extent, an 
unmet need related to the treatment or 
prevention of a rare pediatric disease was 
met through the approval under section 
505 of the Federal Food, Drug, and Cos-
1431
metic Act (42 U.S.C. 355) or licensure 
under section 351 of the Public Health 
Service Act (42 U.S.C. 262) of a drug for 
which a priority review voucher was used. 
(ix) Whether, and to what extent, 
companies were motivated by the avail-
ability of priority review vouchers under 
section 529 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 360ff) to at-
tempt to develop a drug for a rare pedi-
atric disease. 
(x) Whether, and to what extent, pedi-
atric review vouchers awarded under such 
section were successful in stimulating de-
velopment and expedited patient access to 
drug products for treatment or prevention 
of a rare pediatric disease that wouldn’t 
otherwise take place without the incentive 
provided by such vouchers. 
(xi) The impact of such priority re-
view vouchers on the workload, review 
process, and public health prioritization ef-
forts of the Food and Drug Administra-
tion.
1432
(xii) Any other incentives in Federal 
law that exist for companies developing 
drugs or biological products described in 
clause (i). 
(2) REPORT ON FINDINGS.—Not later than 5 
years after the date of the enactment of this Act, the 
Comptroller General of the United States shall sub-
mit to the Committee on Energy and Commerce of 
the House of Representatives and the Committee on 
Health, Education, Labor, and Pensions of the Sen-
ate a report containing the findings of the study 
conducted under paragraph (1). 
SEC. 6605. LIMITATIONS ON EXCLUSIVE APPROVAL OR LI-
CENSURE OF ORPHAN DRUGS. 
(a) IN GENERAL.—Section 527 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360cc) is amended—
(1) in subsection (a), in the matter following 
paragraph (2), by striking ‘‘same disease or condi-
tion’’ and inserting ‘‘same approved use or indica-
tion within such rare disease or condition’’; 
(2) in subsection (b)—
(A) in the matter preceding paragraph (1), 
by striking ‘‘same rare disease or condition’’ 
and inserting ‘‘same approved use or indication
1433
for which such 7-year period applies to such al-
ready approved or licensed drug’’; and 
(B) in paragraph (1), by inserting ‘‘, relat-
ing to the approved use or indication,’’ after 
‘‘the needs’’; 
(3) in subsection (c)(1), by striking ‘‘same rare 
disease or condition as the already approved drug’’ 
and inserting ‘‘same use or indication for which the 
already approved or licensed drug was approved or 
licensed’’; and 
(4) by adding at the end the following: 
‘‘(f) APPROVED USE OR INDICATION DEFINED.—In 
this section, the term ‘approved use or indication’ means 
the use or indication approved under section 505 of this 
Act or licensed under section 351 of the Public Health 
Service Act for a drug designated under section 526 for 
a rare disease or condition.’’. 
(b) APPLICATION OF AMENDMENTS.—The amend-
ments made by subsection (a) shall apply with respect to 
any drug designated under section 526 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360bb), regard-
less of the date on which the drug was so designated, and 
regardless of the date on which the drug was approved 
under section 505 of such Act (21 U.S.C. 355) or licensed
1434
under section 351 of the Public Health Service Act (42 
U.S.C. 262). 
Subtitle B—United States-Abraham 
Accords Cooperation and Security 
SEC. 6611. ESTABLISHMENT OF ABRAHAM ACCORDS OF-
FICE WITHIN FOOD AND DRUG ADMINISTRA-
TION. 
(a) IN GENERAL.—Chapter X of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 391 et seq.) is amend-
ed by adding at the end the following: 
‘‘SEC. 1015. ABRAHAM ACCORDS OFFICE. 
‘‘(a) IN GENERAL.—The Secretary, acting through 
the Commissioner of Food and Drugs, shall establish with-
in the Food and Drug Administration an office, to be 
known as the Abraham Accords Office, to be headed by 
a director. 
‘‘(b) OFFICE.—Not later than 2 years after the date 
of enactment of this section, the Secretary shall—
‘‘(1) in consultation with the governments of 
Abraham Accords countries, as well as appropriate 
United States Government diplomatic and security 
personnel—
‘‘(A) select the location of the Abraham 
Accords Office in an Abraham Accords country; 
and
1435
‘‘(B) establish such office; and 
‘‘(2) assign to such office such personnel of the 
Food and Drug Administration as the Secretary de-
termines necessary to carry out the functions of 
such office. 
‘‘(c) DUTIES.—The Secretary, acting through the Di-
rector of the Abraham Accords Office, shall—
‘‘(1) after the Abraham Accords Office is estab-
lished—
‘‘(A) as part of the Food and Drug Admin-
istration’s work to strengthen the international 
oversight of regulated commodities, provide 
technical assistance to regulatory partners in 
Abraham Accords countries on strengthening 
regulatory oversight and converging regulatory 
requirements for the oversight of regulated 
products, including good manufacturing prac-
tices and other issues relevant to manufacturing 
medical products that are regulated by the 
Food and Drug Administration; and 
‘‘(B) facilitate interactions between the 
Food and Drug Administration and interested 
parties in Abraham Accords countries, including 
by sharing relevant information regarding 
United States regulatory pathways with such
1436
parties, and facilitate feedback on the research, 
development, and manufacturing of products 
regulated in accordance with this Act; and 
‘‘(2) carry out other functions and activities as 
the Secretary determines to be necessary to carry 
out this section. 
‘‘(d) ABRAHAM ACCORDS COUNTRY DEFINED.—In 
this section, the term ‘Abraham Accords country’ means 
a country identified by the Department of State as having 
signed the Abraham Accords Declaration. 
‘‘(e) NATIONAL SECURITY.—Nothing in this section 
shall be construed to require any action inconsistent with 
a national security recommendation provided by the Fed-
eral Government.’’. 
(b) REPORT TO CONGRESS.—
(1) IN GENERAL.—Not later than 3 years after 
the date of enactment of this Act, the Secretary of 
Health and Human Services shall submit to the 
Congress a report on the Abraham Accords Office, 
including—
(A) an evaluation of how the Office has ad-
vanced progress toward conformance with Food 
and Drug Administration regulatory require-
ments by manufacturers in the Abraham Ac-
cords countries;
1437
(B) a numerical count of parties that the 
Office has helped facilitate interactions or feed-
back pursuant to section 1015(c)(1)(B) of the 
Federal Food, Drug, and Cosmetic Act (as 
added by subsection (a)); 
(C) a summary of technical assistance pro-
vided to regulatory partners in Abraham Ac-
cords countries pursuant to subparagraph (A) 
of such section 1015(c)(1); and 
(D) recommendations for increasing and 
improving coordination between the Food and 
Drug Administration and entities in Abraham 
Accords countries. 
(2) ABRAHAM ACCORDS COUNTRY DEFINED.—
In this subsection, the term ‘‘Abraham Accords 
country’’ has the meaning given such term in section 
1015(d) of the Federal Food, Drug, and Cosmetic 
Act (as added by subsection (a)). 
TITLE VII—LOWERING 
PRESCRIPTION DRUG COSTS 
SEC. 6701. OVERSIGHT OF PHARMACY BENEFIT MANAGE-
MENT SERVICES. 
(a) PUBLIC HEALTH SERVICE ACT.—Title XXVII of 
the Public Health Service Act (42 U.S.C. 300gg et seq.) 
is amended—
1438
(1) in part D (42 U.S.C. 300gg–111 et seq.), 
by adding at the end the following new section: 
‘‘SEC. 2799A–11. OVERSIGHT OF ENTITIES THAT PROVIDE 
PHARMACY BENEFIT MANAGEMENT SERV-
ICES. 
‘‘(a) IN GENERAL.—For plan years beginning on or 
after the date that is 30 months after the date of enact-
ment of this section (referred to in this subsection and 
subsection (b) as the ‘effective date’), a group health plan 
or a health insurance issuer offering group health insur-
ance coverage, or an entity providing pharmacy benefit 
management services on behalf of such a plan or issuer, 
shall not enter into a contract, including an extension or 
renewal of a contract, entered into on or after the effective 
date, with an applicable entity unless such applicable enti-
ty agrees to—
‘‘(1) not limit or delay the disclosure of infor-
mation to the group health plan (including such a 
plan offered through a health insurance issuer) in 
such a manner that prevents an entity providing 
pharmacy benefit management services on behalf of 
a group health plan or health insurance issuer offer-
ing group health insurance coverage from making 
the reports described in subsection (b); and
1439
‘‘(2) provide the entity providing pharmacy ben-
efit management services on behalf of a group health 
plan or health insurance issuer relevant information 
necessary to make the reports described in sub-
section (b). 
‘‘(b) REPORTS.—
‘‘(1) IN GENERAL.—For plan years beginning 
on or after the effective date, in the case of any con-
tract between a group health plan or a health insur-
ance issuer offering group health insurance coverage 
offered in connection with such a plan and an entity 
providing pharmacy benefit management services on 
behalf of such plan or issuer, including an extension 
or renewal of such a contract, entered into on or 
after the effective date, the entity providing phar-
macy benefit management services on behalf of such 
a group health plan or health insurance issuer, not 
less frequently than every 6 months (or, at the re-
quest of a group health plan, not less frequently 
than quarterly, and under the same conditions, 
terms, and cost of the semiannual report under this 
subsection), shall submit to the group health plan a 
report in accordance with this section. Each such re-
port shall be made available to such group health 
plan in plain language, in a machine-readable for-
1440
mat, and as the Secretary may determine, other for-
mats. Each such report shall include the information 
described in paragraph (2). 
‘‘(2) INFORMATION DESCRIBED.—For purposes 
of paragraph (1), the information described in this 
paragraph is, with respect to drugs covered by a 
group health plan or group health insurance cov-
erage offered by a health insurance issuer in connec-
tion with a group health plan during each reporting 
period—
‘‘(A) in the case of a group health plan 
that is offered by a specified large employer or 
that is a specified large plan, and is not offered 
as health insurance coverage, or in the case of 
health insurance coverage for which the election 
under paragraph (3) is made for the applicable 
reporting period—
‘‘(i) a list of drugs for which a claim 
was filed and, with respect to each such 
drug on such list—
‘‘(I) the contracted compensation 
paid by the group health plan or 
health insurance issuer for each cov-
ered drug (identified by the National 
Drug Code) to the entity providing
1441
pharmacy benefit management serv-
ices or other applicable entity on be-
half of the group health plan or health 
insurance issuer; 
‘‘(II) the contracted compensa-
tion paid to the pharmacy, by any en-
tity providing pharmacy benefit man-
agement services or other applicable 
entity on behalf of the group health 
plan or health insurance issuer, for 
each covered drug (identified by the 
National Drug Code); 
‘‘(III) for each such claim, the 
difference between the amount paid 
under subclause (I) and the amount 
paid under subclause (II); 
‘‘(IV) the proprietary name, es-
tablished name or proper name, and 
the National Drug Code; 
‘‘(V) for each claim for the drug 
(including original prescriptions and 
refills) and for each dosage unit of the 
drug for which a claim was filed, the 
type of dispensing channel used to
1442
furnish the drug, including retail, mail 
order, or specialty pharmacy; 
‘‘(VI) with respect to each drug 
dispensed, for each type of dispensing 
channel (including retail, mail order, 
or specialty pharmacy)—
‘‘(aa) whether such drug is a 
brand name drug or a generic 
drug, and—
‘‘(AA) in the case of a 
brand name drug, the whole-
sale acquisition cost, listed 
as cost per days supply and 
cost per dosage unit, on the 
date such drug was dis-
pensed; and 
‘‘(BB) in the case of a 
generic drug, the average 
wholesale price, listed as 
cost per days supply and 
cost per dosage unit, on the 
date such drug was dis-
pensed; and 
‘‘(bb) the total number of—
1443
‘‘(AA) 
prescription 
claims 
(including 
original 
prescriptions and refills); 
‘‘(BB) participants and 
beneficiaries for whom a 
claim for such drug was 
filed through the applicable 
dispensing channel; 
‘‘(CC) dosage units and 
dosage units per fill of such 
drug; and 
‘‘(DD) days supply of 
such drug per fill; 
‘‘(VII) the net price per course of 
treatment or single fill, such as a 30-
day supply or 90-day supply to the 
plan or coverage after rebates, fees, 
alternative discounts, or other remu-
neration received from applicable enti-
ties; 
‘‘(VIII) the total amount of out-
of-pocket spending by participants 
and beneficiaries on such drug, in-
cluding spending through copayments, 
coinsurance, and deductibles, but not
1444
including any amounts spent by par-
ticipants and beneficiaries on drugs 
not covered under the plan or cov-
erage, or for which no claim is sub-
mitted under the plan or coverage; 
‘‘(IX) the total net spending on 
the drug; 
‘‘(X) the total amount received, 
or expected to be received, by the plan 
or issuer from any applicable entity in 
rebates, fees, alternative discounts, or 
other remuneration; 
‘‘(XI) the total amount received, 
or expected to be received, by the enti-
ty providing pharmacy benefit man-
agement services, from applicable en-
tities, in rebates, fees, alternative dis-
counts, or other remuneration from 
such entities—
‘‘(aa) for claims incurred 
during the reporting period; and 
‘‘(bb) that is related to utili-
zation of such drug or spending 
on such drug; and
1445
‘‘(XII) to the extent feasible, in-
formation on the total amount of re-
muneration for such drug, including 
copayment assistance dollars paid, co-
payment cards applied, or other dis-
counts provided by each drug manu-
facturer (or entity administering co-
payment assistance on behalf of such 
drug manufacturer), to the partici-
pants and beneficiaries enrolled in 
such plan or coverage; 
‘‘(ii) a list of each therapeutic class 
(as defined by the Secretary) for which a 
claim was filed under the group health 
plan or health insurance coverage during 
the reporting period, and, with respect to 
each such therapeutic class—
‘‘(I) the total gross spending on 
drugs in such class before rebates, 
price 
concessions, 
alternative 
dis-
counts, or other remuneration from 
applicable entities; 
‘‘(II) the net spending in such 
class after such rebates, price conces-
1446
sions, alternative discounts, or other 
remuneration from applicable entities; 
‘‘(III) the total amount received, 
or expected to be received, by the enti-
ty providing pharmacy benefit man-
agement services, from applicable en-
tities, in rebates, fees, alternative dis-
counts, or other remuneration from 
such entities—
‘‘(aa) for claims incurred 
during the reporting period; and 
‘‘(bb) that is related to utili-
zation of drugs or drug spending; 
‘‘(IV) the average net spending 
per 30-day supply and per 90-day 
supply by the plan or by the issuer 
with respect to such coverage and its 
participants and beneficiaries, among 
all drugs within the therapeutic class 
for which a claim was filed during the 
reporting period; 
‘‘(V) the number of participants 
and beneficiaries who filled a prescrip-
tion for a drug in such class, includ-
1447
ing the National Drug Code for each 
such drug; 
‘‘(VI) if applicable, a description 
of the formulary tiers and utilization 
mechanisms (such as prior authoriza-
tion or step therapy) employed for 
drugs in that class; and 
‘‘(VII) the total out-of-pocket 
spending under the plan or coverage 
by participants and beneficiaries, in-
cluding spending through copayments, 
coinsurance, and deductibles, but not 
including any amounts spent by par-
ticipants and beneficiaries on drugs 
not covered under the plan or cov-
erage or for which no claim is sub-
mitted under the plan or coverage; 
‘‘(iii) with respect to any drug for 
which gross spending under the group 
health plan or health insurance coverage 
exceeded $10,000 during the reporting pe-
riod or, in the case that gross spending 
under the group health plan or coverage 
exceeded $10,000 during the reporting pe-
riod with respect to fewer than 50 drugs,
1448
with respect to the 50 prescription drugs 
with the highest spending during the re-
porting period—
‘‘(I) a list of all other drugs in 
the same therapeutic class as such 
drug; 
‘‘(II) if applicable, the rationale 
for the formulary placement of such 
drug in that therapeutic category or 
class, selected from a list of standard 
rationales established by the Sec-
retary, in consultation with stake-
holders; and 
‘‘(III) any change in formulary 
placement compared to the prior plan 
year; and 
‘‘(iv) in the case that such plan or 
issuer (or an entity providing pharmacy 
benefit management services on behalf of 
such plan or issuer) has an affiliated phar-
macy or pharmacy under common owner-
ship, including mandatory mail and spe-
cialty home delivery programs, retail and 
mail auto-refill programs, and cost sharing
1449
assistance incentives funded by an entity 
providing pharmacy benefit services—
‘‘(I) an explanation of any ben-
efit design parameters that encourage 
or require participants and bene-
ficiaries in the plan or coverage to fill 
prescriptions at mail order, specialty, 
or retail pharmacies; 
‘‘(II) the percentage of total pre-
scriptions dispensed by such phar-
macies to participants or beneficiaries 
in such plan or coverage; and 
‘‘(III) a list of all drugs dis-
pensed by such pharmacies to partici-
pants or beneficiaries enrolled in such 
plan or coverage, and, with respect to 
each drug dispensed—
‘‘(aa) the amount charged, 
per dosage unit, per 30-day sup-
ply, or per 90-day supply (as ap-
plicable) to the plan or issuer, 
and to participants and bene-
ficiaries; 
‘‘(bb) the median amount 
charged to such plan or issuer,
1450
and the interquartile range of the 
costs, per dosage unit, per 30-
day supply, and per 90-day sup-
ply, including amounts paid by 
the 
participants 
and 
bene-
ficiaries, when the same drug is 
dispensed by other pharmacies 
that are not affiliated with or 
under common ownership with 
the entity and that are included 
in the pharmacy network of such 
plan or coverage; 
‘‘(cc) the lowest cost per 
dosage unit, per 30-day supply 
and per 90-day supply, for each 
such drug, including amounts 
charged to the plan or coverage 
and to participants and bene-
ficiaries, that is available from 
any pharmacy included in the 
network of such plan or coverage; 
and 
‘‘(dd) the net acquisition 
cost per dosage unit, per 30-day 
supply, and per 90-day supply, if
1451
such drug is subject to a max-
imum price discount; and 
‘‘(B) with respect to any group health 
plan, including group health insurance coverage 
offered in connection with such a plan, regard-
less of whether the plan or coverage is offered 
by a specified large employer or whether it is a 
specified large plan—
‘‘(i) a summary document for the 
group health plan that includes such infor-
mation described in clauses (i) through (iv) 
of subparagraph (A), as specified by the 
Secretary through guidance, program in-
struction, or otherwise (with no require-
ment of notice and comment rulemaking), 
that the Secretary determines useful to 
group health plans for purposes of select-
ing pharmacy benefit management serv-
ices, such as an estimated net price to 
group health plan and participant or bene-
ficiary, a cost per claim, the fee structure 
or reimbursement model, and estimated 
cost per participant or beneficiary; 
‘‘(ii) a summary document for plans 
and issuers to provide to participants and
1452
beneficiaries, which shall be made available 
to participants or beneficiaries upon re-
quest to their group health plan (including 
in the case of group health insurance cov-
erage offered in connection with such a 
plan), that—
‘‘(I) contains such information 
described in clauses (iii), (iv), (v), and 
(vi), as applicable, as specified by the 
Secretary through guidance, program 
instruction, or otherwise (with no re-
quirement of notice and comment 
rulemaking) that the Secretary deter-
mines useful to participants or bene-
ficiaries in better understanding the 
plan or coverage or benefits under 
such plan or coverage; 
‘‘(II) contains only aggregate in-
formation; and 
‘‘(III) states that participants 
and beneficiaries may request specific, 
claims-level information required to be 
furnished under subsection (c) from 
the group health plan or health insur-
ance issuer; and