Division F — Health Extenders

119th Congress · Approved Nov 12, 2025 · 139 Stat. 495

DIVISION F Health Extenders

TITLE I Public Health Extenders

SEC. 6101. Extension for Community Health Centers, National Health Service Corps, and Teaching Health Centers That Operate Gme Programs.

(a)

Extension for Community Health Centers.— Section 10503(b)(1) of the Patient Protection and Affordable Care Act (42 U.S.C. 254b–2(b)(1)) is amended—

(1)

in subparagraph (I), by striking “ and” at the end; and

(2)

by adding at the end the following:

“(K) $1,423,890,411 for the period beginning on October 1, 2025, and ending on January 30, 2026; and”

(b)

Extension for the National Health Service Corps.— Section 10503(b)(2) of the Patient Protection and Affordable Care Act (42 U.S.C. 254b–2(b)(2)) is amended—

(1)

in subparagraph (J), by striking “ and” at the end;

(2)

in subparagraph (K), by striking the period at the end and inserting “ ; and”; and

(3)

by adding at the end the following:

“(L) $115,315,068 for the period beginning on October 1, 2025, and ending on January 30, 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—

(1)

in subparagraph (E), by striking “ and” at the end;

(2)

in subparagraph (F), by striking the period at the end and inserting “ ; and”; and

(3)

by adding at the end the following:

“(G) $58,493,151 for the period beginning on October 1, 2025, and ending on January 30, 2026.”

(d)

Application of Provisions.— Amounts appropriated pursuant to the amendments made by this section shall be subject to the requirements contained in Public Law 117–328 for funds for programs authorized under sections 330 through 340 of the Public Health Service Act (42 U.S.C. 254b et seq.).

(e)

Conforming Amendment.— Section 3014(h)(4) of title 18, United States Code, is amended by striking “ and section 2101(d) of division B of the Full-Year Continuing Appropriations and Extensions Act, 2025” and inserting “ section 2101(d) of division B of the Full-Year Continuing Appropriations and Extensions Act, 2025, and section 6101(d) of the Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act, 2026”.

SEC. 6102. Extension of Special Diabetes Programs.

(a)

Extension of Special Diabetes Programs for Type I Diabetes.— Section 330B(b)(2) of the Public Health Service Act (42 U.S.C. 254c–2(b)(2)) is amended—

(1)

in subparagraph (F), by striking “ and” at the end;

(2)

in subparagraph (G), by striking the period at the end and inserting “ ; and”; and

(3)

by adding at the end the following:

“(H) $53,145,205 for the period beginning on October 1, 2025, and ending on January 30, 2026, to remain available until expended.”

(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—

(1)

in subparagraph (F), by striking “ and” at the end;

(2)

in subparagraph (G), by striking the period at the end and inserting “ ; and”; and

(3)

by adding at the end the following:

“(H) $53,145,205 for the period beginning on October 1, 2025, and ending on January 30, 2026, to remain available until expended.”

SEC. 6103. National Health Security Extensions.

(a)

Section 319(e)(8) of the Public Health Service Act (42 U.S.C. 247d(e)(8)) is amended by striking “ September 30, 2025” and inserting “ January 30, 2026”.

(b)

Section 319L(e)(1)(D) of the Public Health Service Act (42 U.S.C. 247d–7e(e)(1)(D)) is amended by striking “ September 30, 2025” and inserting “ January 30, 2026”.

(c)

Section 319L–1(b) of the Public Health Service Act (42 U.S.C. 247d–7f(b)) is amended by striking “ September 30, 2025” and inserting “ January 30, 2026”.

(d)

(1)

Section 2811A(g) of the Public Health Service Act (42 U.S.C. 300hh–10b(g)) is amended by striking “ September 30, 2025” and inserting “ January 30, 2026”.

(2)

Section 2811B(g)(1) of the Public Health Service Act (42 U.S.C. 300hh–10c(g)(1)) is amended by striking “ September 30, 2025” and inserting “ January 30, 2026”.

(3)

Section 2811C(g)(1) of the Public Health Service Act (42 U.S.C. 300hh–10d(g)(1)) is amended by striking “ September 30, 2025” and inserting “ January 30, 2026”.

(e)

Section 2812(c)(4)(B) of the Public Health Service Act (42 U.S.C. 300hh–11(c)(4)(B)) is amended by striking “ September 30, 2025” and inserting “ January 30, 2026”.

TITLE II Medicare

SEC. 6201. Extension of Increased Inpatient Hospital Payment Adjustment for Certain Low-Volume Hospitals.

(a)

In General.— Section 1886(d)(12) of the Social Security Act (42 U.S.C. 1395ww(d)(12)) is amended—

(1)

in subparagraph (B), by striking “ in fiscal year 2026” and inserting “ during the portion of fiscal year 2026 beginning on January 31, 2026, and ending on September 30, 2026, and in fiscal year 2027”;

(2)

in subparagraph (C)(i)—

(A)

in the matter preceding subclause (I)—

(i)

by inserting “ or portion of a fiscal year” after “ for a fiscal year”; and

(ii)

by inserting “ and the portion of fiscal year 2026 beginning on October 1, 2025, and ending on January 30, 2026” after “ through 2025”;

(B)

in subclause (III), by inserting “ and the portion of fiscal year 2026 beginning on October 1, 2025, and ending on January 30, 2026” after “ through 2025”; and

(C)

in subclause (IV), by striking “ fiscal year 2026” and inserting “ the portion of fiscal year 2026 beginning on January 31, 2026, and ending on September 30, 2026, and fiscal year 2027”; and

(3)

in subparagraph (D)—

(A)

in the matter preceding clause (i), by inserting “ or during the portion of fiscal year 2026 beginning on October 1, 2025, and ending on January 30, 2026” after “ through 2025”; and

(B)

in clause (ii), by inserting “ and the portion of fiscal year 2026 beginning on October 1, 2025, and ending on January 30, 2026” after “ through 2025”.

(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 Social Security Act (42 U.S.C. 1395ww(d)(5)(G)) is amended—

(1)

in clause (i), by striking “ October 1, 2025” and inserting “ January 31, 2026”; and

(2)

in clause (ii)(II), by striking “ October 1, 2025” and inserting “ January 31, 2026”.

(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—

(A)

in the matter preceding clause (i), by striking “ October 1, 2025” and inserting “ January 31, 2026”; and

(B)

in clause (iv), by inserting “ and the portion of fiscal year 2026 beginning on October 1, 2025, and ending on January 30, 2026” after “ through fiscal year 2025”.

(2)

Permitting hospitals to decline reclassification.— Section 13501(e)(2) of the Omnibus Budget Reconciliation Act of 1993 (42 U.S.C. 1395ww note) is amended by inserting “ , or the portion of fiscal year 2026 beginning on October 1, 2025, and ending on January 30, 2026” after “ through fiscal year 2025”.

SEC. 6203. Extension of Funding for Quality Measure 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 $14,030,000” and inserting “ $14,030,000”; and

(B)

by inserting the following before the period at the end: “ , and $13,300,000 for fiscal year 2026”; and

(2)

in the third sentence, by striking “ and 2024 and the period beginning on October 1, 2024, and ending on September 30, 2025,” and inserting “ 2024, 2025, and 2026”.

SEC. 6204. Extending Acute Hospital Care at Home Waiver Authorities.

Section 1866G(a)(1) of the Social Security Act (42 U.S.C. 1395cc–7(a)(1)) is amended by striking “ September 30, 2025” and inserting “ January 30, 2026”.

SEC. 6205. Extension of Funding for Medicare Hospice Surveys.

Section 3(a)(2) of the IMPACT Act of 2014 (Public Law 113–185) is amended—

(1)

in subparagraph (A), by striking “ and” at the end;

(2)

in subparagraph (B), by striking the period at the end and inserting “ ; and”; and

(3)

by adding at the end the following new subparagraph:

“(C) $2,000,000 for the period beginning on October 1, 2025, and ending on January 30, 2026.”

SEC. 6206. Extension of Add-On Payments for Ambulance Services.

Section 1834(l) of the Social Security Act (42 U.S.C. 1395m(l)) is amended—

(1)

in paragraph (12)(A), by striking “ October 1, 2025” and inserting “ January 31, 2026”; and

(2)

in paragraph (13), by striking “ October 1, 2025” each place it appears and inserting “ January 31, 2026” in each such place.

SEC. 6207. Extension of the Work Geographic Index Floor.

Section 1848(e)(1)(E) of the Social Security Act (42 U.S.C. 1395w–4(e)(1)(E)) is amended by striking “ October 1, 2025” and inserting “ January 31, 2026”.

SEC. 6208. Extension of Certain Telehealth Flexibilities.

(a)

Removing Geographic Requirements and Expanding Originating Sites for Telehealth Services.— Section 1834(m) of the Social Security Act (42 U.S.C. 1395m(m)) is amended—

(1)

in paragraph (2)(B)(iii), by striking “ ending September 30, 2025” and inserting “ ending January 30, 2026”; and

(2)

in paragraph (4)(C)(iii), by striking “ ending on September 30, 2025” and inserting “ ending on January 30, 2026”.

(b)

Expanding Practitioners Eligible To Furnish Telehealth Services.— Section 1834(m)(4)(E) of the Social Security Act (42 U.S.C. 1395m(m)(4)(E)) is amended by striking “ ending on September 30, 2025” and inserting “ ending on January 30, 2026”.

(c)

Extending Telehealth Services for Federally Qualified Health Centers and Rural Health Clinics.— Section 1834(m)(8)(A) of the Social Security Act (42 U.S.C. 1395m(m)(8)(A)) is amended by striking “ ending on September 30, 2025” and inserting “ ending on January 30, 2026”.

(d)

Delaying the In-Person Requirements Under Medicare for Mental Health Services Furnished Through Telehealth and Telecommunications Technology.—

(1)

Delay in requirements for mental health services furnished through telehealth.— 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 October 1, 2025” and inserting “ on or after January 31, 2026”.

(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 “ October 1, 2025” and inserting “ January 31, 2026”.

(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 “ October 1, 2025” and inserting “ January 31, 2026”.

(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 September 30, 2025” and inserting “ ending on January 30, 2026”.

(f)

Extending Use of Telehealth To Conduct Face-to-Face Encounter Prior to Recertification of Eligibility for Hospice Care.— Section 1814(a)(7)(D)(i)(II) of the Social Security Act (42 U.S.C. 1395f(a)(7)(D)(i)(II)) is amended by striking “ ending on September 30, 2025” and inserting “ ending on January 30, 2026”.

(g)

Program Instruction Authority.— The Secretary of Health and Human Services may implement the amendments made by this section through program instruction or otherwise.

SEC. 6209. Revising Phase-In of Medicare Clinical Laboratory Test Payment Changes.

(a)

Revised Phase-in of Reductions From Private Payor Rate Implementation.— Section 1834A(b)(3)(B) of the Social Security Act (42 U.S.C. 1395m–1(b)(3)(B)) is amended—

(1)

in clause (ii), by inserting “ and for the period beginning on January 1, 2026, and ending on January 30, 2026” after “ 2025”; and

(2)

in clause (iii), by striking “ for each of 2026 through 2028” and inserting “ for the period beginning on January 31, 2026, and ending on December 31, 2026, and for each of 2027 and 2028”.

(b)

Revised Reporting Period for Reporting of Private Sector Payment Rates for Establishment 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 “ December 31, 2025” and inserting “ January 31, 2026”; and

(2)

in clause (ii), by striking “ January 1, 2026, and ending March 31, 2026” and inserting “ February 1, 2026, and ending April 30, 2026”.

SEC. 6210. Extension of Funding Outreach and Assistance for Low-Income Programs.

(a)

State Health Insurance Assistance Programs.— Subsection (a)(1)(B) of section 119 of the Medicare Improvements for Patients and Providers Act of 2008 (42 U.S.C. 1395b–3 note) is amended—

(1)

in clause (xiii), by striking “ and” at the end;

(2)

in clause (xiv), by striking the period at the end and inserting “ ; and”; and

(3)

by inserting after clause (xiv) the following new clause:

“(xv) for the period beginning on October 1, 2025, and ending on January 30, 2026, $5,013,699.”

(b)

Area Agencies on Aging.— Subsection (b)(1)(B) of such section 119 is amended—

(1)

in clause (xiii), by striking “ and” at the end;

(2)

in clause (xiv), by striking the period at the end and inserting “ ; and”; and

(3)

by inserting after clause (xiv) the following new clause:

“(xv) for the period beginning on October 1, 2025, and ending on January 30, 2026, $5,013,699.”

(c)

Aging and Disability Resource Centers.— Subsection (c)(1)(B) of such section 119 is amended—

(1)

in clause (xiii), by striking “ and” at the end;

(2)

in clause (xiv), by striking the period at the end and inserting “ ; and”; and

(3)

by inserting after clause (xiv) the following new clause:

“(xv) for the period beginning on October 1, 2025, and ending on January 30, 2026, $1,671,233.”

(d)

Coordination of Efforts to Inform Older Americans About Benefits Available Under Federal and State Programs.— Subsection (d)(2) of such section 119 is amended—

(1)

in clause (xiii), by striking “ and” at the end;

(2)

in clause (xiv), by striking the period at the end and inserting “ ; and”; and

(3)

by inserting after clause (xiv) the following new clause:

“(xv) for the period beginning on October 1, 2025, and ending on January 30, 2026, $5,013,699.”

SEC. 6211. Extension of Temporary Inclusion of Authorized Oral Antiviral Drugs as Covered 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 “ September 30, 2025” and inserting “ January 30, 2026”.

SEC. 6212. Medicare Improvement Fund.

Section 1898(b)(1) of the Social Security Act (42 U.S.C. 1395iii(b)(1)) is amended—

(1)

by striking “ fiscal year 2026” and inserting “ fiscal year 2027”; and

(2)

by striking “ $1,804,000,000” and inserting “ $1,403,000,000”.

SEC. 6213. Medicare Sequestration.

Section 251A(6)(D) of the Balanced Budget and Emergency Deficit Control Act of 1985 (2 U.S.C. 901a(6)(D)) is amended—

(1)

in clause (i), by striking “ 10 months” and inserting “ 11 months”; and

(2)

in clause (ii), by striking “ 2 months” and inserting “ 1 month”.

TITLE III Human Services

SEC. 6301. Sexual Risk Avoidance Education Extension.

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 “ 2023, for the period beginning on October 1, 2023, and ending on November 17, 2023, for the period beginning on November 18, 2023, and ending on January 19, 2024, for the period beginning on January 20, 2024, and ending on March 8, 2024, for the period beginning on March 9, 2024, and ending on September 30, 2024, and for fiscal year 2025” and inserting “ 2025, and for the period beginning on October 1, 2025, and ending on January 30, 2026”; and

(ii)

by striking “ fiscal year 2024” and inserting “ fiscal year 2026”; and

(B)

in paragraph (2)—

(i)

in subparagraph (A)—

(I)

by striking “ through 2023” and inserting “ through 2025”;

(II)

by striking “ fiscal year 2024 or 2025” and inserting “ fiscal year 2026”; and

(III)

by inserting “ (or, with respect to the applicable period, for fiscal year 2026)” after “ an application for the fiscal year”; and

(ii)

in subparagraph (B)(i), by striking “ 2024 or 2025” and inserting “ 2026”; and

(2)

in subsection (f)(1) by striking “ 2023, for the period beginning on October 1, 2023, and ending on November 17, 2023, an amount equal to the pro rata portion of the amount appropriated for the corresponding period for fiscal year 2023, for the period beginning on November 18, 2023, and ending on January 19, 2024, an amount equal to the pro rata portion of the amount appropriated for the corresponding period for fiscal year 2023, for the period beginning on January 20, 2024, and ending on March 8, 2024, an amount equal to the pro rata portion of the amount appropriated for the period at the end of the corresponding sentence for fiscal year 2023, for the period beginning on March 9, 2024, and ending on September 30, 2024, an amount equal to the pro rata portion of the amount appropriated for the corresponding period for fiscal year 2023, and for for fiscal year 2025, an amount equal to the amount appropriated for fiscal year 2024” and inserting “ 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”.

SEC. 6302. Personal Responsibility Education Extension.

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 “ 2023, for the period beginning on October 1, 2023, and ending on November 17, 2023, for the period beginning on November 18, 2023, and ending on January 19, 2024, for the period beginning on January 20, 2024, and ending on March 8, 2024, for the period beginning on March 9, 2024, and ending on September 30, 2024, and for fiscal year 2025” and inserting “ 2025, and for the period beginning on October 1, 2025, and ending on January 30, 2026”; and

(B)

in subparagraph (B)(i), by striking “ the period beginning on October 1, 2023, and ending on November 17, 2023, for the period beginning on November 18, 2023, and ending on January 19, 2024, for the period beginning on January 20, 2024, and ending on March 8, 2024, for the period beginning on March 9, 2024, and ending on September 30, 2024, and for fiscal year 2025” and inserting “ fiscal years 2024 and 2025, and for the period beginning on October 1, 2025, and ending on January 30, 2026”;

(2)

in subsection (c)(3), by striking “ 2024 or 2025” and inserting “ 2026”; and

(3)

in subsection (f), by striking “ 2023, for the period beginning on October 1, 2023, and ending on November 17, 2023, an amount equal to the pro rata portion of the amount appropriated for the corresponding period for fiscal year 2023, for the period beginning on November 18, 2023, and ending on January 19, 2024, an amount equal to the pro rata portion of the amount appropriated for the corresponding period for fiscal year 2023, for the period beginning on January 20, 2024, and ending on March 8, 2024, an amount equal to the pro rata portion of the amount appropriated for the corresponding period for fiscal year 2023, for the period beginning on March 9, 2024, and ending on September 30, 2024, an amount equal to the pro rata portion of the amount appropriated for the corresponding period for fiscal year 2023, and for fiscal year 2025, an amount equal to the amount appropriated for fiscal year 2024 for fiscal year 2024” and inserting “ 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”.

SEC. 6303. Extension of Funding for Family-To-Family Health Information Centers.

Section 501(c)(1)(A) of the Social Security Act (42 U.S.C. 701(c)(1)(A)) is amended—

(1)

in clause (vii), by striking “ and” at the end;

(2)

in clause (viii), by adding “ ; and” at the end; and

(3)

by adding at the end the following new clause:

“(ix) 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 fiscal year 2025.”

TITLE IV Medicaid

SEC. 6401. 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—

(1)

in the heading, by inserting “ and a portion of fiscal year 2026” after “ 2025”; and

(2)

by inserting “ , and the DSH allotment for Tennessee for the portion of fiscal year 2026 beginning October 1, 2025, and ending January 30, 2026, shall be $17,748,493, which may be claimed as fiscal year 2026 uncompensated care costs” before the period.

(b)

Delaying DSH Allotment Reductions.— Section 1923(f) of the Social Security Act (42 U.S.C. 1396r–4(f)) is amended—

(1)

in paragraph (7)(A)—

(A)

in clause (i)—

(i)

in the matter preceding subclause (I), by striking “ For each of fiscal years 2026 through 2028” and inserting “ For the period beginning January 31, 2026, and ending September 30, 2026, and for each of fiscal years 2027 and 2028”;

(ii)

in subclause (I), by inserting “ or period” after “ the fiscal year”; and

(iii)

in subclause (II), by inserting “ or period” after “ in the fiscal year”; and

(B)

in clause (ii), by striking “ for each of fiscal years 2026 through 2028” and inserting “ for the period beginning January 31, 2026, and ending September 30, 2026, and for each of fiscal years 2027 and 2028”; and

(2)

in paragraph (8), by striking “ 2027” and inserting “ 2028”.

TITLE V Food and Drug Administration

SEC. 6501. Short Title.

This title may be cited as the “Over-the-Counter Monograph Drug User Fee Amendments”.

SEC. 6502. Finding.

Congress finds that the fees authorized by the amendments made in this title will be dedicated to over-the-counter (OTC) monograph drug activities, as set forth in the goals identified for purposes of part 10 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–71 et seq.), in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Energy and Commerce of the House of Representatives and the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate, as set forth in the Congressional Record.

SEC. 6503. Definitions.

Section 744L(9)(A) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–71(9)(A)) is amended—

(1)

in clause (v), by striking “ ; or” and inserting a semicolon;

(2)

in clause (vi)—

(A)

by striking “ addition” and inserting “ the addition”; and

(B)

by striking the period and inserting “ ; or”; and

(3)

by adding at the end the following:

“(vii) the addition or modification of a testing procedure applicable to one or more OTC monograph drugs, provided that such additional or modified testing procedure reflects a voluntary consensus standard with respect to pharmaceutical quality that is—

“(I) established by a national or international standards development organization; and

“(II) recognized by the Secretary through a process described in guidance for industry, initially published in July 2023, or any successor guidance, publicly available on the website of the Food and Drug Administration, which addresses voluntary consensus standards for pharmaceutical quality.”

SEC. 6504. Authority to Assess and Use Otc Monograph Fees.

(a)

Types of Fees.— Section 744M(a)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–72(a)(1)) is amended—

(1)

in subparagraph (A)—

(A)

by striking “ on December 31 of the fiscal year or at any time during the preceding 12-month period” and inserting “ at any time during the applicable period specified in clause (ii) for a fiscal year”;

(B)

by striking “ Each person” and inserting the following:

“(i) Assessment of fees.—Each person”

; and

(C)

by adding at the end the following:

“(ii) Applicable period.—For purposes of clause (i), the applicable period is—

“(I) for fiscal year 2026, the 12-month period ending on December 31, 2025;

“(II) for fiscal year 2027, the 9-month period ending on September 30, 2026; and

“(III) for fiscal year 2028 and each subsequent fiscal year, the 12-month period ending on September 30 of the preceding fiscal year.”

(2)

in subparagraph (B)(i), by amending subclause (I) to read as follows:

“(I) has ceased all activities related to OTC monograph drugs prior to—

“(aa) for purposes of fiscal year 2026, January 1, 2025;

“(bb) for purposes of fiscal year 2027, January 1, 2026; and

“(cc) for purposes of fiscal year 2028 and each subsequent fiscal year, October 1 of the preceding fiscal year; and”

; and

(3)

by amending subparagraph (D) to read as follows:

“(D) Due date.—

“(i) Fiscal year 2026.—For fiscal year 2026, the facility fees required under subparagraph (A) shall be due on the later of—

“(I) the first business day of June of such year; or

“(II) the first business day after the enactment of an appropriations Act providing for the collection and obligation of fees under this section for such year.

“(ii) Fiscal year 2027.—For fiscal year 2027, the facility fees required under subparagraph (A) shall be due—

“(I) in a first installment representing 50 percent of such fee, on the later of—

“(aa) October 1, 2026; or

“(bb) the first business day after the enactment of an appropriations Act providing for the collection and obligation of fees under this section for such year; and

“(II) in a second installment representing the remaining 50 percent of such fee, on—

“(aa) February 1, 2027; or

“(bb) if an appropriations Act described in subclause (I)(bb) is not in effect on February 1, 2027, the first business day after enactment of such an appropriations Act.

“(iii) Subsequent fiscal years.—For fiscal year 2028 and each subsequent fiscal year, the facility fees required under subparagraph (A) shall be due on the later of—

“(I) the first business day on or after October 1 of the fiscal year; or

“(II) the first business day after the date of enactment of an appropriations Act providing for the collection and obligation of fees under this section for the fiscal year.”

(b)

Fee Revenue Amounts.— Section 744M(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–72(b)) is amended to read as follows:

“(b) Fee Revenue Amounts.—

“(1) In general.—For each of the fiscal years 2026 through 2030, fees under subsection (a)(1) shall be established to generate a total facility fee revenue amount equal to the sum of—

“(A) the annual base revenue for the fiscal year (as determined under paragraph (2));

“(B) the dollar amount equal to the inflation adjustment for the fiscal year (as determined under subsection (c)(1));

“(C) the dollar amount equal to the operating reserve adjustment for the fiscal year, if applicable (as determined under subsection (c)(2));

“(D) additional direct cost adjustments (as determined under subsection (c)(3));

“(E) an additional dollar amount equal to—

“(i) $2,373,000 for fiscal year 2026;

“(ii) $1,233,000 for fiscal year 2027; and

“(iii) $854,000 for fiscal year 2028; and

“(F) in the case of a fiscal year for which the Secretary applies the one-time facility fee workload adjustment under subsection (c)(4), the dollar amount equal to such adjustment.

“(2) Annual base revenue.—For purposes of paragraph (1), the dollar amount of the annual base revenue for a fiscal year shall be—

“(A) for fiscal year 2026, the dollar amount of the total revenue amount established for fiscal year 2025 under this subsection as in effect on the day before the date of enactment of the Over-the-Counter Monograph Drug User Fee Amendments, not including any adjustments made for such fiscal year 2025 under subsection (c)(2), as so in effect; and

“(B) for fiscal years 2027 through 2030, the dollar amount of the total revenue amount established under this subsection for the previous fiscal year, not including any adjustments made for such previous fiscal year under subsection (c)(2) or (c)(3).”

(c)

Adjustments; Annual Fee Setting.— Section 744M(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–72(c)) is amended—

(1)

in paragraph (1)—

(A)

in subparagraph (A), in the matter preceding clause (i)—

(i)

by striking “ subsection (b)(2)(B)” and inserting “ subsection (b)(1)(B)”; and

(ii)

by striking “ fiscal year 2022 and each subsequent fiscal year” and inserting “ each fiscal year”;

(B)

in subparagraph (B), by striking “ fiscal year 2022” and all that follows through the period at the end and inserting the following:

“(i) for fiscal year 2026—

“(I) the fee for fiscal year 2025 under subsection (a)(2); and

“(II) the inflation adjustment percentage under subparagraph (C); and

“(ii) for each of fiscal years 2027 through 2030—

“(I) the applicable fee under subsection (a)(2) for the preceding fiscal year; and

“(II) the inflation adjustment percentage under subparagraph (C).”

; and

(C)

in subparagraph (C)—

(i)

in the matter preceding clause (i), by inserting “ the sum of” after “ is equal to”;

(ii)

by striking clause (i);

(iii)

by redesignating subclauses (I) and (II) of clause (ii) as clauses (i) and (ii), respectively, and adjusting the margins accordingly;

(iv)

by striking “ (ii) for each of fiscal years 2024 and 2025, the sum of—”; and

(v)

in clause (ii), as so redesignated, by striking “ Washington-Baltimore, DC–MD–VA–WV” and inserting “ Washington–Arlington–Alexandria–DC–VA–MD–WV”;

(2)

in paragraph (2)—

(A)

in subparagraph (A)—

(i)

by striking “ fiscal year 2021 and subsequent fiscal years” and inserting “ each fiscal year”;

(ii)

by striking “ subsections (b)(1)(B) and (b)(2)(C)” and inserting “ subsection (b)(1)(C)”; and

(iii)

by striking “ the number of weeks specified in subparagraph (B)” and inserting “ 10 weeks”;

(B)

by striking subparagraph (B);

(C)

by redesignating subparagraphs (C) and (D) as subparagraphs (B) and (C), respectively; and

(D)

in subparagraph (C), as so redesignated, by striking “ paragraph (4) establishing” and inserting “ paragraph (5) publishing”;

(3)

in paragraph (3)—

(A)

in the matter preceding subparagraph (A), by striking “ subsection (b)(2)(D)” and inserting “ subsection (b)(1)(D)”; and

(B)

by striking subparagraphs (A) through (E) and inserting the following:

“(A) $135,000 for fiscal year 2026;

“(B) $300,000 for fiscal year 2027;

“(C) $55,000 for fiscal year 2028;

“(D) $30,000 for fiscal year 2029; and

“(E) $0 for fiscal year 2030.”

; and

(4)

by striking paragraph (4) and inserting the following:

“(4) One-time facility fee workload adjustment.—

“(A) In general.—In addition to the adjustments under paragraphs (1), (2), and (3), the Secretary may further increase the fee revenues and fees through a one-time adjustment made for fiscal year 2028, 2029, or 2030, in accordance with this paragraph.

“(B) Adjustment described.—

“(i) Conditions for adjustment.—An adjustment under this paragraph may be made for a fiscal year only if—

“(I) an adjustment under this paragraph had not been made for any prior fiscal year;

“(II) the average number of OTC monograph drug facilities subject to a facility fee under subsection (a)(1) over the period of the preceding 3 fiscal years exceeds 1,625; and

“(III) with respect to facilities described in subclause (II), the average number of such facilities (expressed as a percentage) that appeared on the arrears lists pursuant to subsection (e)(1)(A)(i) over the period of the preceding 3 fiscal years is less than 30 percent.

“(ii) Amount of adjustment.—An adjustment under this paragraph for a fiscal year shall equal the product of—

“(I) the total facility revenue amount determined under subsection (b) for the fiscal year, exclusive of the adjustment under this paragraph for such fiscal year; and

“(II) the excess facility percentage described in clause (iii).

“(iii) Excess facility percentage.—The excess facility percentage described in this clause is—

“(I) the amount by which the average number of OTC monograph drug facilities subject to a facility fee under subsection (a)(1) over the preceding 3 fiscal years exceeds 1,625; divided by

“(II) 1,625.

“(5) Annual fee setting.—The Secretary shall, not later than 60 days before the first day of each fiscal year—

“(A) establish for such fiscal year, based on the revenue amounts under subsection (b) and the adjustments provided under this subsection—

“(i) OTC monograph drug facility fees under subsection (a)(1); and

“(ii) OTC monograph order request fees under subsection (a)(2); and

“(B) publish such fee revenue amounts, facility fees, and OTC monograph order request fees in the Federal Register.”

(d)

Crediting and Availability of Fees.— Section 744M(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–72(f)) is amended—

(1)

in paragraph (2)(D)—

(A)

in the subparagraph heading, by striking “ in subsequent years”; and

(B)

by striking “ (after fiscal year 2021)”; and

(2)

in paragraph (3), by striking “ 2021 through 2025” and inserting “ 2026 through 2030”.

SEC. 6505. Reauthorization; Reporting Requirements.

(a)

Performance Report.— Section 744N of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–73) is amended—

(1)

in subsection (a)—

(A)

by striking “ Beginning with fiscal year 2021, and not later than 120 calendar days after the end of each fiscal year thereafter” and inserting the following:

“(1) In general.—Not later than 120 calendar days after the end of each fiscal year”

(B)

by striking “ section 3861(b) of the CARES Act” and inserting “ section 6502 of the Over-the-Counter Monograph Drug User Fee Amendments”; and

(C)

by adding at the end the following:

“(2) Additional information.—Beginning with fiscal year 2026, the annual report under this subsection shall include—

“(A) the progress of the Food and Drug Administration in achieving the goals, and future plans for meeting the goals, including—

“(i) the number of Tier 1 OTC monograph order requests for which a proposed order was issued, and the number of such requests for which a final order was issued, in the previous fiscal year;

“(ii) the number of Tier 2 OTC monograph order requests for which a proposed order was issued, and the number of such requests for which a final order was issued, in the previous fiscal year;

“(iii) the number of specified safety OTC monograph order requests for which a proposed order was issued, and the number of such requests for which a final order was issued, in the previous fiscal year;

“(iv) the number of generally recognized as safe and effective finalization OTC monograph order requests for which a proposed order was issued, and the number of such requests for which a final order was issued, in the previous fiscal year;

“(v) the average timeline for processing OTC monograph order requests, in the aggregate and by submission type, in the previous fiscal year; and

“(vi) postmarket safety activities with respect to OTC monograph drugs, including—

“(I) collecting, developing, and reviewing safety information on OTC monograph drugs, including adverse event reports;

“(II) developing and using improved analytical tools, adverse event data-collection systems, including information technology systems, to assess potential safety problems, including access to external databases; and

“(III) activities under section 760;

“(B) information regarding registration of OTC monograph drug facilities and contract manufacturing organization facilities and payment of registration fees by such facilities, including—

“(i) the OTC monograph drug facilities and contract manufacturing organization facilities that were first registered under section 510(c) or 510(i) in the fiscal year; and

“(ii) for each OTC monograph drug facility and contract manufacturing organization facility that was assessed a facility fee under section 744M(a) in the fiscal year, whether the facility paid such fee;

“(C) the status of implementation of evidence and testing standards under section 505G(r) for nonprescription drugs intended for topical administration, including—

“(i) the application of evidence or testing standards; and

“(ii) the number of active ingredient requests for nonprescription drugs intended for topical administration reviewed using the standards under section 505G(b); and

“(D) the progress of the Food and Drug Administration in allowing nonclinical testing alternatives to animal testing for the consideration of sunscreen active ingredients.

“(3) Confidentiality.—Nothing in paragraph (2) shall be construed to authorize the disclosure of information that is prohibited from disclosure under section 301(j) of this Act or section 1905 of title 18, United States Code, or that is subject to withholding under section 552(b)(4) of title 5, United States Code.”

(2)

in subsection (b), by striking “ fiscal year 2021 and each subsequent fiscal year” and inserting “ each fiscal year”; and

(3)

in subsection (d)—

(A)

by striking “ 2025” each place it appears and inserting “ 2030”; and

(B)

by adding at the end the following:

“(4) Minutes of negotiation meetings.—

“(A) Public availability.—The Secretary shall make publicly available, on the public website of the Food and Drug Administration, robust written minutes of all negotiation meetings conducted under this subsection between the Food and Drug Administration and the regulated industry, not later than 30 days after each such negotiation meeting.

“(B) Content.—The robust written minutes described under subparagraph (A) shall contain, in detail, any substantive proposal made by any party to the negotiations as well as significant controversies or differences of opinion during the negotiations and their resolution.”

(b)

GAO Report.—

(1)

In general.— Not later than September 30, 2027, the Comptroller General of the United States shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report assessing the supply chain of over-the-counter monograph drugs.

(2)

Contents.— The report required under paragraph (1) shall include an assessment of—

(A)

the overall stability of the supply chain of over-the-counter monograph drugs;

(B)

what information is collected by the Food and Drug Administration with respect to the supply chain of over-the-counter monograph drugs;

(C)

how the Food and Drug Administration uses information collected on the supply chain of over-the-counter monograph drugs to inform regulatory decisions;

(D)

how the Food and Drug Administration coordinates with other Federal agencies to monitor and mitigate disruptions to the supply chain of over-the-counter monograph drugs; and

(E)

the unique characteristics of the over-the-counter monograph drug marketplace and what additional authorities or information the Food and Drug Administration may need to ensure the stability of the supply chain of over-the-counter monograph drugs.

SEC. 6506. Treatment of Active Ingredients for Topical Administration.

(a)

In General.— Section 505G of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355h) is amended by adding at the end the following:

“(r) Evidence and Testing Standards for Active Ingredients for Topical Administration.—

“(1) Evidence and testing standards for active ingredients for topical administration.—The Secretary shall—

“(A) in evaluating the generally recognized as safe and effective status of active ingredients used in nonprescription drugs intended for topical administration for purposes of subsection (a), utilize standards that allow for the use of real world evidence (as defined in section 505F(b)), as appropriate, as part of a comprehensive evaluation of scientific evidence to demonstrate the safety and effectiveness of such active ingredients, to supplement evidence from traditional clinical trials, provided that such standards allow the Secretary to evaluate whether the benefits of such active ingredients outweigh the risks; and

“(B) apply subsection (b)(6)(C) to the regulation of active ingredients used in drugs intended for topical administration.

“(2) Non-animal testing methods for topical active ingredients.—

“(A) In general.—The Secretary shall consider the types of nonclinical tests described in paragraphs (1) through (4) of the first subsection (z) of section 505 (as inserted by section 3209(a)(2) of the Health Extenders, Improving Access to Medicare, Medicaid, and CHIP, and Strengthening Public Health Act of 2022 (division FF of Public Law 117–328)), or any other alternative to animal testing that the Secretary determines appropriate, in the consideration of drugs intended for topical administration under this section.

“(B) Guidance.—Not later than 1 year after the date of enactment of this subsection, the Secretary shall issue new draft guidance on how sponsors can use nonclinical testing alternatives to animal testing, as appropriate, to meet safety and efficacy standards under this section for drugs intended for topical administration.

“(3) Clarification.—Nothing in this subsection shall be construed to alter, supersede, or limit the standards for making determinations of whether a drug is generally recognized as safe and effective under section 201(p) or the standards set forth under section 505 for determining the safety and effectiveness of drugs.”

(b)

Sunscreen Final Administrative Order.— A final administrative order on nonprescription sunscreen active ingredients issued under section 3854 of the Coronavirus Aid, Relief, and Economic Security Act (Public Law 116–136; 21 U.S.C. 360fff–3 note) shall—

(1)

account for historical data regarding the safety of sunscreen active ingredients that have previously been accepted for marketing in the United States;

(2)

account for the role of broad spectrum sunscreens with a Sun Protection Factor of 15 or higher in effective skin cancer prevention; and

(3)

incorporate the evidence and testing standards for sunscreen active ingredients detailed in section 505G(r) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355h) (as added by subsection (a)).

SEC. 6507. Increasing the Clarity and Predictability of the Process for Developing Applications for Rx-To-Nonprescription Switches.

(a)

In General.— Section 505(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)) is amended by adding at the end the following:

“(7) Rx-to-nonprescription switches.—

“(A) Meetings.—Any person planning to submit an application for an Rx-to-nonprescription switch may submit to the Secretary a written request for a meeting, for purposes of developing a plan for such application that addresses the potential risks to public health of such switch and the evidence necessary to support such application, including the design of any necessary studies, and the format and content of the planned application. The Secretary may grant such a meeting, as appropriate, consistent with established procedures for granting meetings with, and providing written responses to, applications under this section. Each such meeting shall be documented in meeting minutes.

“(B) Guidance.—

“(i) In general.—Not later than 18 months after the date of enactment of this paragraph, the Secretary shall issue guidance to increase the clarity and predictability of the process and standards for approval of applications for nonprescription drugs under this section, including in the case of applications for an Rx-to-nonprescription switch, especially with respect to prescription drugs with well-established safety profiles for which an applicant may seek approval for nonprescription use.

“(ii) Contents.—The guidance under clause (i) shall—

“(I) describe how published reports in medical literature, any previous finding of safety or effectiveness for the drug under this section, the results of significant human experience with the drug, unpublished studies and other data, and other sources of information may be used to support an application for a nonprescription drug, including in the context of an application for an Rx-to-nonprescription switch;

“(II) set forth procedures for sponsors to request meetings described in subparagraph (A) and document the recommendations made in such meetings;

“(III) describe evidentiary expectations to support approval of an application for a nonprescription drug, including in the context of an application for an Rx-to-nonprescription switch, including how sponsors can demonstrate that consumers can appropriately self-select and use the drug and comprehend the nonprescription drug label; and

“(IV) provide recommendations for how mechanisms, in addition to the required Drug Facts Label, such as mobile applications and decisions aids, can be incorporated into the information submitted in support of an application for an Rx-to-nonprescription switch.

“(C) Plan to engage with stakeholders.—Not later than 1 year after the date of enactment of this paragraph, the Secretary shall develop and make publicly available on the website of the Food and Drug Administration a plan to engage stakeholders on steps and factors for application holders and other stakeholders to consider in identifying approved prescription drugs that may be promising candidates for applications for an Rx-to-nonprescription switch.

“(D) Definition.—For purposes of this paragraph, the term ‘Rx-to-nonprescription switch’ means the approval of an application, or supplemental application, as applicable, submitted under this section by the holder of an approved application for a prescription drug seeking approval to market such drug as a nonprescription drug, including for—

“(i) a full Rx-to-nonprescription switch, under which a drug previously approved for prescription use only is—

“(I) approved for nonprescription use under the same conditions as applied to the drug when approved for prescription use; or

“(II) approved for nonprescription use subject to one or more additional conditions for nonprescription use; and

“(ii) a partial Rx-to-nonprescription switch, under which the drug is approved for nonprescription use only under certain conditions described in the approved labeling, while the drug otherwise remains approved for prescription use only.

“(E) Rule of construction.—Nothing in this paragraph shall be construed to—

“(i) supersede or modify the authority of the Secretary under section 505G with respect to the regulation of OTC monograph drugs; or

“(ii) authorize the disclosure by the Secretary of confidential commercial information or trade secrets.”

(b)

GAO Report.—

(1)

In general.— Not later than 1 year after the date of enactment of this Act, the Comptroller General of the United States shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report that evaluates—

(A)

the number of applications for an Rx-to-nonprescription switch approved during the period beginning on October 1, 2022, and ending on the date of the report;

(B)

the number of drugs for which an application for an Rx-to-nonprescription switch was approved during such period subject to an additional condition for nonprescription use;

(C)

among the drugs for which an application for a full or partial Rx-to-nonprescription switch was approved during such period, the average length of time from receipt by the Food and Drug Administration of the application to the approval of such application;

(D)

the number of partial Rx-to-nonprescription switch applications approved during such period, and the number of applications for such a partial switch not approved;

(E)

any barriers to timely and predictable review of applications for an Rx-to-nonprescription switch;

(F)

engagement by the Food and Drug Administration with public stakeholders, including public meetings or additional activities to support review of applications for an Rx-to-nonprescription switch; and

(G)

opportunities for collaboration between the Center for Drug Evaluation and Research and the Centers for Medicare & Medicaid Services for the purpose of analyzing health insurance claims data for commonly prescribed drugs that appear to be suitable for an Rx-to-nonprescription switch.

(2)

Definition.— In this subsection, the term “Rx-to-nonprescription switch” has the meaning given such term in paragraph (7) of section 505(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 244(b)), as added by subsection (a).

SEC. 6508. Regulation of Certain Nonprescription Drugs That Are Marketed Without an Approved Drug Application.

(a)

Development Advice to Sponsors or Requestors.— Section 505G(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355h(h)) is amended by striking “ sponsors or requestors” and inserting “ sponsors, requestors, or organizations nominated by sponsors or requestors to represent their interests in a proceeding”.

(b)

Technical Correction.— Section 505G(b)(2)(A)(iv)(III) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355h(b)(2)(A)(iv)(III)) is amended by striking “ requestors” and inserting “ sponsors or requestors”.

SEC. 6509. Sunset Dates.

(a)

Authorization.— Sections 744L and 744M of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–71; 379j–72) shall cease to be effective October 1, 2030.

(b)

Reporting Requirements.— Section 744N of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–73) shall cease to be effective January 31, 2031.

SEC. 6510. Effective Date.

The amendments made by this title shall take effect on October 1, 2025, or the date of the enactment of this Act, whichever is later, except that fees under part 10 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–71 et seq.) shall be assessed beginning October 1, 2025, regardless of the date of the enactment of this Act.

SEC. 6511. Savings Clause.

Notwithstanding the amendments made by this title, part 10 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–71 et seq.), as in effect on the day before the date of enactment of this Act, shall continue to be in effect with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2026.

TITLE VI No Surprises Act Implementation

SEC. 6601. Extending Availability of Funding for No Surprises Act Implementation.

Section 118(a) of division BB of the Consolidated Appropriations Act, 2021 (Public Law 116–260) is amended—

(1)

by striking “ otherwise appropriated, to the Secretary of Health and Human Services” and inserting the following:

“(1) to the Secretary of Health and Human Services”

(2)

in paragraph (1), as so inserted, by striking “ September 30, 2025.” and inserting “ January 30, 2026; and”; and

(3)

by adding at the end the following new paragraph:

“(2) to the Secretary of Health and Human Services, in addition to amounts otherwise appropriated under paragraph (1), $14,000,000 for the period beginning on October 1, 2025, and ending on January 30, 2026.”