42 U.S.C. 1320f-1(a)(4)changedby H.R. 6166 Sec. 101(a)
(4) with respect to the initial price applicability year 205029 or a subsequent year, 2050 negotiation-eligible drugs described in subparagraph (A) or (B) of subsection (d)(1), with respect to such year (or, all (if such number is less than 2050) such negotiation-eligible drugs with respect to such year).
The bill says: Section 1192(a)(4) of the Social Security Act (42 U.S.C. 1320f–1(a)(4)) is amended by striking "20" each place it appears and inserting "50" in each such place.
Bill text · Current law (42 U.S.C. 1320f-1)
42 U.S.C. 1320f(c)(2)(A)changedby H.R. 6166 Sec. 101(b)
…service, or by another dispenser, an individual who is enrolled in a prescription drug plan under part D of subchapter XVIII or an MA–PD plan under part C of such subchapter if coverage is provided under such plan for such selected drug , or a participant, beneficiary, or enrollee who is enrolled under a group health plan or health insurance coverage offered in the group or individual market (as such terms are defined in section 2791 of the Public Health Service Act) with respect to which there is in effect an agreement with the Secretary under section 1197 with respect to such selected drug as so furnished or dispensed; and
The bill says: in subparagraph (A), by inserting ", or a participant, beneficiary, or enrollee who is enrolled under a group health plan or health insurance coverage offered in the group or individual market (as such terms are defined in section 2791 of the Public Health Service Act) with respect to which there is in effect an agreement with the Secretary under section 1197 with respect to such selected drug as so furnished or dispensed" after "such selected drug"; and
Bill text · Current law (42 U.S.C. 1320f)
42 U.S.C. 1320f(c)(2)(B)changedby H.R. 6166 Sec. 101(b)
…of services or supplier, an individual who is enrolled under part B of subchapter XVIII, including an individual who is enrolled in an MA plan under part C of such subchapter, if payment may be made under part B for such selected drug , or a participant, beneficiary, or enrollee who is enrolled under a group health plan or health insurance coverage offered in the group or individual market (as such terms are defined in section 2791 of the Public Health Service Act) with respect to which there is in effect an agreement with the Secretary under section 1197 with respect to such selected drug as so furnished or administered.
The bill says: in subparagraph (B), by inserting ", or a participant, beneficiary, or enrollee who is enrolled under a group health plan or health insurance coverage offered in the group or individual market (as such terms are defined in section 2791 of the Public Health Service Act) with respect to which there is in effect an agreement with the Secretary under section 1197 with respect to such selected drug as so furnished or administered" after "such selected drug".
Bill text · Current law (42 U.S.C. 1320f)
42 U.S.C. 1320f-5(a)(3)(A)changedby H.R. 6166 Sec. 101(c)
(A) maximum fair price eligible individuals who are enrolled in a prescription drug plan under part D of subchapter XVIII or an MA–PD plan under part C of such subchapter; and
The bill says: in subparagraph (A), by striking "and" at the end;
Bill text · Current law (42 U.S.C. 1320f-5)
42 U.S.C. 1320f-5(a)(3)(B)changedby H.R. 6166 Sec. 101(c)
The bill says: in subparagraph (B), by striking the period and inserting "; and"; and
Bill text · Current law (42 U.S.C. 1320f-5)
42 U.S.C. 1320f-5(a)(3)added (C)by H.R. 6166 Sec. 101(c)
(C) maximum fair price eligible individuals not described in subparagraph (A) or (B).
The bill says: by adding at the end the following new subparagraph:
Bill text · Current law (42 U.S.C. 1320f-5)
42 U.S.C. 1320frenumberedby H.R. 6166 Sec. 101(d)
The bill says: by redesignating sections 1197 and 1198 as sections 1198 and 1199, respectively; and
Bill text · Current law (42 U.S.C. 1320f)
42 U.S.C. 1320fadded 1197by H.R. 6166 Sec. 101(d)
1197 Voluntary participation by other health plans.—(a) Agreement To participate under program.—(1) In general.— Subject to paragraph (2), under the program under this part the Secretary shall be treated as having in effect an agreement with a group health plan or health insurance issuer offering group or individual health insurance coverage (as such terms are defined in section 2791 of the Public Health Service Act), with respect to a price applicability period and a selected drug with respect to such period—(A) in the case such selected drug furnished or dispensed at a pharmacy or by mail order service if coverage is provided under such plan or coverage during such period for such selected drug as so furnished or dispensed; and(B) in the case such selected drug furnished or administered by a hospital, physician, or other provider of services or supplier if coverage is provided under such plan or coverage during such period for such selected drug as so furnished or administered.(2) Opting out of agreement.— The Secretary shall not be treated as having in effect an agreement under the program under this part with a group health plan or health insurance issuer offering group or individual health insurance coverage with respect to a price applicability period and a selected drug with respect to such period if such a plan or issuer affirmatively elects, through a process specified by the Secretary, not to participate under the program with respect to such period and drug.(b) Publication of election.— With respect to each price applicability period and each selected drug with respect to such period, the Secretary and the Secretary of Labor and the Secretary of the Treasury, as applicable, shall make public a list of each group health plan and each health insurance issuer offering group or individual health insurance coverage, with respect to which coverage is provided under such plan or coverage for such drug, that has elected under subsection (a) not to participate under the program with respect to such period and drug.
The bill says: by inserting after section 1196 the following new section:
Bill text · Current law (42 U.S.C. 1320f)
42 U.S.C. 300gg-111added 2799A–11by H.R. 6166 Sec. 101(e)
2799A–11. Drug Price Negotiation Program and application of maximum fair prices.—(a) In general.— In the case of a group health plan or health insurance issuer offering group or individual health insurance coverage that is treated under section 1197 of the Social Security Act as having in effect an agreement with the Secretary under the Drug Price Negotiation Program under part E of title XI of such Act, with respect to a price applicability period (as defined in section 1191(b) of such Act) and a selected drug (as defined in section 1192(c) of such Act) with respect to such period for which coverage is provided under such plan or coverage—(1) the provisions of such part shall apply—(A) in the case the drug is furnished or dispensed at a pharmacy or by a mail order service, to such plan or coverage, and to the participants, beneficiaries, and enrollees enrolled under such plan or coverage, during such period, with respect to such selected drug, in the same manner as such provisions apply to prescription drug plans and MA–PD plans, and to participants, beneficiaries, and enrollees enrolled under such prescription drug plans and MA–PD plans during such period; and(B) in the case the drug is furnished or administered by a hospital, physician, or other provider of services or supplier, to such plan or coverage, and to the participants, beneficiaries, and enrollees enrolled under such plan or coverage, and to hospitals, physicians, and other providers of services and suppliers during such period, with respect to such drug in the same manner as such provisions apply to the Secretary, to participants, beneficiaries, and enrollees entitled to benefits under part A of title XVIII or enrolled under part B of such title, and to hospitals, physicians, and other providers and suppliers participating under title XVIII during such period;(2) the plan or issuer shall apply any cost-sharing responsibilities under such plan or coverage, with respect to such selected drug, by substituting an amount not more than the maximum fair price negotiated under such part E of title XI for such drug in lieu of the drug price upon which the cost-sharing would have otherwise applied, and such cost-sharing responsibilities with respect to such selected drug may not exceed such maximum fair price; and(3) the Secretary shall apply the provisions of such part E to such plan, issuer, and coverage, such participants, beneficiaries, and enrollees so enrolled in such plans and coverage, and such hospitals, physicians, and other providers and suppliers participating in such plans and coverage.(b) Notification regarding nonparticipation in Drug Price Negotiation Program.— A group health plan or a health insurance issuer offering group or individual health insurance coverage shall publicly disclose, in a manner and in accordance with a process specified by the Secretary, any election made under section 1197 of the Social Security Act by such plan or issuer to not participate in the Drug Price Negotiation Program under part E of title XI of such Act with respect to a selected drug (as defined in section 1192(c) of such Act) for which coverage is provided under such plan or coverage before the beginning of the plan year for which such election was made.
The bill says: Part D of title XXVII of the Public Health Service Act (42 U.S.C. 300gg–111 et seq.) is amended by adding at the end the following new section:
Bill text · Current law (42 U.S.C. 300gg-111)
29 U.S.C. 1185added 726by H.R. 6166 Sec. 101(e)
726 Drug Price Negotiation Program and application of maximum fair prices.—(a) In general.— In the case of a group health plan or health insurance issuer offering group health insurance coverage that is treated under section 1197 of the Social Security Act as having in effect an agreement with the Secretary of Health and Human Services under the Drug Price Negotiation Program under part E of title XI of such Act, with respect to a price applicability period (as defined in section 1191(b) of such Act) and a selected drug (as defined in section 1192(c) of such Act) with respect to such period for which coverage is provided under such plan or coverage—(1) the provisions of such part shall apply, as applicable—(A) in the case the drug is furnished or dispensed at a pharmacy or by a mail order service, to such plan or coverage, and to the participants and beneficiaries enrolled under such plan or coverage, during such period, with respect to such selected drug, in the same manner as such provisions apply to prescription drug plans and MA–PD plans, and to participants and beneficiaries enrolled under such prescription drug plans and MA–PD plans during such period; and(B) in the case the drug is furnished or administered by a hospital, physician, or other provider of services or supplier, to the group health plan or coverage offered by an issuer, to the participants and beneficiaries enrolled under such plans or coverage, and to hospitals, physicians, and other providers of services and suppliers during such period, with respect to such drug in the same manner as such provisions apply to the Secretary of Health and Human Services, to participants and beneficiaries entitled to benefits under part A of title XVIII or enrolled under part B of such title, and to hospitals, physicians, and other providers and suppliers participating under title XVIII during such period;(2) the plan or issuer shall apply any cost-sharing responsibilities under such plan or coverage, with respect to such selected drug, by substituting an amount not more than the maximum fair price negotiated under such part E of title XI for such drug in lieu of the drug price upon which the cost-sharing would have otherwise applied, and such cost-sharing responsibilities with respect to such selected drug may not exceed such maximum fair price; and(3) the Secretary shall apply the provisions of such part E to such plan, issuer, and coverage, and such participants and beneficiaries so enrolled in such plans.(b) Notification regarding nonparticipation in Drug Price Negotiation Program.— A group health plan or a health insurance issuer offering group health insurance coverage shall publicly disclose in a manner and in accordance with a process specified by the Secretary any election made under section 1197 of the Social Security Act by the plan or issuer to not participate in the Drug Price Negotiation Program under part E of title XI of such Act with respect to a selected drug (as defined in section 1192(c) of such Act) for which coverage is provided under such plan or coverage before the beginning of the plan year for which such election was made.
The bill says: Subpart B of part 7 of subtitle B of title I of the Employee Retirement Income Security Act of 1974 (29 U.S.C. 1185 et seq.) is amended by adding at the end the following new section:
Bill text · Current law (29 U.S.C. 1185)
29 U.S.C. 1191a(a)changedby H.R. 6166 Sec. 101(e)
The bill says: Section 732(a) of the Employee Retirement Income Security Act of 1974 (29 U.S.C. 1191a(a)) is amended by striking "section 711" and inserting "sections 711 and 726".
Bill text · Current law (29 U.S.C. 1191a)
26 U.S.C. 9831(a)(2)changedby H.R. 6166 Sec. 101(e)
(2) other than with respect to section 9826, any group health plan for any plan year if, on the first day of such plan year, such plan has less than 2 participants who are current employees.
The bill says: Section 9831(a)(2) of the Internal Revenue Code of 1986 is amended by inserting "other than with respect to section 9826," before "any group health plan".
Bill text · Current law (26 U.S.C. 9831)
42 U.S.C. 1320f-3(e)added (3)by H.R. 6166 Sec. 102(a)
(3) Average international market price.—(A) In general.— The average price (which shall be the net average price, if practicable, and volume-weighted, if practicable) for a unit (as defined in subparagraph (C)) of such drug for sales of such drug (calculated across different dosage forms and strengths of the drug and not based on the specific formulation or package size or package type), as computed (as of the date of publication of such drug as a selected drug under section 1192(a)) in all countries described in clause (ii) of subparagraph (B) that are applicable countries (as described in clause (i) of such subparagraph) with respect to such drug.(B) Applicable countries.—(i) In general.— For purposes of subparagraph (A), a country described in clause (ii) is an applicable country described in this clause with respect to a drug if there is available an average price for any unit for the drug for sales of such drug in such country.(ii) Countries described.— For purposes of this paragraph, the following are countries described in this clause:(I) Australia.(II) Canada.(III) France.(IV) Germany.(V) Japan.(VI) The United Kingdom.(C) Unit defined.— For purposes of this paragraph, term unit means, with respect to a drug, the lowest identifiable quantity (such as a capsule or tablet, milligram of molecules, or grams) of the drug that is dispensed.
The bill says: Section 1194(e) of the Social Security Act (42 U.S.C. 1320f–3(e)) is amended by adding at the end the following new paragraph:
Bill text · Current law (42 U.S.C. 1320f-3)
Public Law 119-21repealedby H.R. 6166 Sec. 103
The bill says: Section 71203 of the Act titled "An Act to provide for reconciliation pursuant to title II of H. Con. Res. 14" (Public Law 119–21) is repealed, and the provisions of law amended by such section are hereby restored as if such section had not been enacted into law.
Bill text
42 U.S.C. 1395w-114b(b)(1)(A)(i)changedby H.R. 6166 Sec. 201(b)
The bill says: in subparagraph (A)(i), by striking "the total number of units" and all that follows through the semicolon and inserting the following: "the total number of units that are used to calculate the average manufacturer price of such dosage form and strength with respect to such part D rebatable drug, as reported by the manufacturer of such drug under section 1927 for each month, with respect to such period;"; and
Bill text · Current law (42 U.S.C. 1395w-114b)
42 U.S.C. 1395w-114b(b)(1)changedby H.R. 6166 Sec. 201(b)
(B) Excluded units.— For purposes of subparagraph (A)(i), the Secretary shall exclude from the total number of units for a dosage form and strength with respect to a part D rebatable drug, with respect to an applicable period, the following:(i) Units of each dosage form and strength of such part D rebatable drug for which payment was made under a State plan under title XIX (or waiver of such plan), as reported by States under section 1927(b)(2)(A).(ii) Units of each dosage form and strength of such part D rebatable drug for which a rebate is paid under section 1847A(i).(iii) Beginning with plan year 2026, units of each dosage form and strength of such part D rebatable drug for which the manufacturer provides a discount under the program under section 340B of the Public Health Service Act.
The bill says: by striking subparagraph (B) and inserting the following:
Bill text · Current law (42 U.S.C. 1395w-114b)
42 U.S.C. 1395w-114b(b)(6)changedby H.R. 6166 Sec. 201(b)
(6) Reconciliation in case of revised informationAMP reports.—The Secretary shall provide for a method and process under which, in the case of a manufacturer of a part D rebatable drug that submits revisions to information submitted under section 1927 by the manufacturer with respect to such drug. The Secretary shall provide for a method and process under which, in the case where a PDP sponsor of a prescription drug plan or an MA organization offering an MA–PD plan submits revisions to the number of units of a rebatable covered…
The bill says: in paragraph (6), by striking "information" and all that follows through "rebatable covered part D drug dispensed" and inserting the following: "AMP reports.—The Secretary shall provide for a method and process under which, in the case of a manufacturer of a part D rebatable drug that submits revisions to information submitted under section 1927 by the manufacturer with respect to such drug"; and
Bill text · Current law (42 U.S.C. 1395w-114b)
42 U.S.C. 1395w-114bchangedby H.R. 6166 Sec. 201(b)
The bill says: by striking subsection (d) and inserting the following:
Bill text · Current law (42 U.S.C. 1395w-114b)
Public Law 111-148(a)(2)changedby H.R. 6166 Sec. 301(d)
The bill says: in subsection (a)(2), by inserting "with respect to plan years beginning before January 1, 2027," before "limits cost-sharing"; and
Bill text
Public Law 111-148(e)(1)(B)(i)changedby H.R. 6166 Sec. 301(d)
The bill says: by inserting "(or, with respect to plan years beginning on or after January 1, 2027, in effect under section 2799A–12(b)(1)(A)) of the Public Health Service Act)" after "subsection (c)(1)"; and
Bill text
Public Law 111-148(e)(1)(B)(i)changedby H.R. 6166 Sec. 301(d)
The bill says: by inserting "and except, with respect to plan years beginning on or after January 1, 2027, in the case of an individual who has incurred cost-sharing expenses with respect to prescription drugs in an amount equal to the annual limitation in effect under section 2799A–12(b)(1)(B) of such Act, for benefits consisting of prescription drugs" after "section 2713"; and
Bill text
Public Law 111-148changedby H.R. 6166 Sec. 301(d)
The bill says: in section 1402(c)(1)(A), by inserting "(or, with respect to plan years beginning on or after January 1, 2027, the applicable out-of-pocket limit under section 2799A–12(b)(1)(A) of the Public Health Service Act)" after "section 1302(c)(1)".
Bill text
42 U.S.C. 18022(d)(2)added (D)by H.R. 6166 Sec. 302(d)
(D) Special rule relating to insulin coverage.— The exemption of coverage of selected insulin products (as defined in section 2799A–13(b) of the Public Health Service Act) from the application of any deductible pursuant to section 2799A–13(a)(1) of such Act, section 728(a)(1) of the Employee Retirement Income Security Act of 1974, or section 9828(a)(1) of the Internal Revenue Code of 1986 shall not be considered when determining the actuarial value of a qualified health plan under this subsection.
The bill says: Section 1302(d)(2) of the Patient Protection and Affordable Care Act (42 U.S.C. 18022(d)(2)) is amended by adding at the end the following new subparagraph:
Bill text · Current law (42 U.S.C. 18022)
42 U.S.C. 18022(e)added (4)by H.R. 6166 Sec. 302(e)
(4) Coverage of certain insulin products.—(A) In general.— Notwithstanding paragraph (1)(B)(i), a health plan described in paragraph (1) shall provide coverage of selected insulin products, in accordance with section 2799A–13 of the Public Health Service Act, for a plan year before an enrolled individual has incurred cost-sharing expenses in an amount equal to the annual limitation in effect under subsection (c)(1) for the plan year.(B) Terminology.— For purposes of subparagraph (A)—(i) the term selected insulin products has the meaning given such term in section 2799A–13(b) of the Public Health Service Act; and(ii) the requirements of section 2799A–13 of such Act shall be applied by deeming each reference in such section to "individual health insurance coverage" to be a reference to a plan described in paragraph (1).
The bill says: Section 1302(e) of the Patient Protection and Affordable Care Act (42 U.S.C. 18022(e)) is amended by adding at the end the following new paragraph:
Bill text · Current law (42 U.S.C. 18022)