Sec. 203. Protecting seniors from excessive cost-sharing for certain medicines
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Section 1860D–2 of the Social Security Act ( 42 U.S.C. 1395w–102 ) is amended— in subsection (b)— in paragraph (2)(A), in the matter preceding clause (i), by striking and
(9)and inserting , (9), (10), and
(11); and by adding at the end the following new paragraphs: For plan years beginning on or after January 1, 2028, for costs above the annual deductible specified in paragraph
(1)and below the annual out-of-pocket threshold specified in paragraph (4), any coinsurance amount for a discount-eligible drug that is included on the plan's formulary and subject to coinsurance rather than a copayment shall be calculated based on the net price of such discount-eligible drug. For plan years beginning on or after January 1, 2028, a PDP sponsor of a prescription drug plan and an MA organization offering an MA–PD plan shall annually submit to the Secretary, in a form and manner determined appropriate by the Secretary— approximate price concessions and net prices for each discount-eligible drug; and a written explanation of the methodology used to calculate such approximate price concessions and net prices. Approximate price concessions submitted under subparagraph
(B)shall comply with— the drug-specific threshold under clause
(ii)for the applicable plan year; and the aggregate threshold under clause
(iii)for the applicable plan year. For plan years 2028 through 2032— the drug-specific threshold is 20 percent; and the aggregate threshold is 15 percent. For plan years beginning with 2033, the Secretary may, as determined appropriate by the Secretary, adjust the drug-specific and aggregate thresholds under this clause. In making any such adjustments, the Secretary may consider historical variations in expected and actual manufacturer price concessions for covered part D drugs, factors that may result in manufacturer price concession uncertainty or variation in a given plan year, PDP sponsor and MA organization behavioral responses, effects of precise manufacturer price concession disclosures, beneficiary out-of-pocket costs, expenditures under this part, and other factors determined appropriate by the Secretary. In making any such adjustments, the Secretary shall ensure that the aggregate threshold for an applicable plan year is lower than the drug-specific threshold for such applicable plan year. The Secretary shall publish any adjustments to the drug-specific and aggregate thresholds under this clause no later than the first Monday of April of the year before the start of the plan year for which such adjusted thresholds are applicable. Not later than 15 months before the start of each plan year (beginning with plan year 2028), the Secretary shall publish on a publicly available website a list of the discount-eligible drugs that apply with respect to such plan year (as determined by the Secretary under subparagraph (F)(iv)). The Secretary, in consultation with the Office of the Inspector General, shall conduct periodic audits of prescription drug plans and MA–PD plans to monitor compliance with the requirements under this paragraph. All information reported by a PDP sponsor or MA organization under this paragraph may be subject to audit by the Secretary and the Office of the Inspector General. A PDP sponsor or an MA organization that violates the requirements under this paragraph may be subject to civil monetary penalties, consistent with sections 1857(g) and 1860D–12(b)(3)(E), as determined appropriate by the Secretary. The provisions of section 1128A (other than subsections
(a)and (b)) shall apply to a civil monetary penalty under this clause in the same manner as such provisions apply to a penalty or proceeding under section 1128A(a). In this paragraph: The term actual price concessions means, with respect to a covered part D drug, the amount of manufacturer price concessions that the PDP sponsor or MA organization reports for such drug in the Detailed DIR Report (or successor report) for the applicable plan year. The term aggregate threshold means the maximum percentage by which the total approximate price concessions for all discount-eligible drugs may vary from the total actual manufacturer price concessions for all such discount-eligible drugs as reported in the Detailed DIR Report (or successor report) for the applicable plan year. The term approximate price concessions means, with respect to a covered part D drug, the amount of price concessions from manufacturers that the PDP sponsor or MA organization estimates it will receive with respect to an applicable plan year, subject to the thresholds established under subparagraph (C)(ii), and reflected in the net price. The term discount-eligible drug means a covered part D drug (other than a covered part D drug described in paragraph
(8)or (9))— that is in an applicable category or class described in subclause (II); and for which the aggregate manufacturer price concessions received by PDP sponsors and MA organizations (or pharmacy benefit managers acting on behalf of such sponsors or organizations) for such drug are equal to or exceed 50 percent of aggregate gross covered prescription drug costs for such drug in the most recent plan year for which data is available, as determined by the Secretary based on previous submissions of Detailed DIR Reports (or successor reports) or other relevant reporting from PDP sponsors or MA organizations. The applicable categories and classes described in this subclause are the following, as specified by the United States Pharmacopeia: Anti-inflammatories (Inhaled Corticosteroids). Bronchodilators, Anticholinergic. Bronchodilators, Sympathomimetic. Respiratory tract agents. Anticoagulants. Cardiovascular agents. The term drug-specific threshold means the maximum percentage by which approximate price concessions with respect to a discount-eligible drug may vary from the actual manufacturer price concessions for such drug, as reported in the Detailed DIR Report (or successor report) for the applicable plan year. The term net price means, with respect to a covered part D drug, the negotiated price of such drug, net of all approximate price concessions (estimated on an average per-unit basis, as needed) not already reflected in the negotiated price for the applicable plan year. The term manufacturer price concessions means, with respect to a covered part D drug, rebates that the PDP sponsor or MA organization receives from manufacturers. Chapter 35 of title 44, United States Code, shall not apply to any data collection undertaken by the Secretary under this paragraph. For plan years beginning on or after January 1, 2028, the cost-sharing (for costs above the annual deductible specified in paragraph (1)) for a covered part D drug (other than a covered part D drug described in paragraph
(8)or (9)) shall not exceed the negotiated price for such covered part D drug net of all price concessions (as defined in paragraph (10)(F)(v)), as reported in the Detailed DIR Report (or successor report) for the applicable plan year. The Secretary shall monitor compliance with the requirements under subparagraph
(A)on an ongoing basis, including through periodic audits. A PDP sponsor or an MA organization that violates the requirements under subparagraph
(A)may be subject to civil monetary penalties, consistent with sections 1857(g) and 1860D–12(b)(3)(E), as determined appropriate by the Secretary. The Secretary may impose such penalties retroactively upon review of the Detailed DIR Report (or any successor report) with respect to a given plan year. The provisions of section 1128A (other than subsections
(a)and (b)) shall apply to a civil monetary penalty under this clause in the same manner as such provisions apply to a penalty or proceeding under section 1128A(a). The Comptroller General of the United States (in this paragraph referred to as the Comptroller General ) shall conduct a study on certain effects of the implementation of the requirements specified under the provisions of paragraphs
(10)and (11). Once the data and information needed to conduct the study described in subparagraph
(A)has become available and the Comptroller General has had sufficient opportunity to review and analyze such data and information, the Comptroller General shall develop and publish a report on the findings of such study, including with respect to the following: Effects on enrollee cost-sharing, utilization and adherence, formulary coverage and placement, and utilization management with respect to affected covered part D drugs (discount-eligible drugs and covered part D drugs for which, prior to implementation of such provisions, cost-sharing exceeded net price for some beneficiaries). Changes to pharmacy reimbursement methodologies and levels, if any, with respect to discount-eligible drugs. Changes in manufacturer rebating levels (relative to gross costs) for discount-eligible drugs. Other behavioral responses by PDP sponsors, enrollees, manufacturers, pharmacies, or other entities related to the implementation of such provisions. Effects of such provisions on enrollee premiums and Federal outlays. Other issues determined appropriate by the Comptroller General. The Comptroller General may, as determined appropriate, conduct subsequent studies and produce subsequent reports with respect to the ongoing implementation and effects of the provisions of paragraphs
(10)and (11). ; and in subsection (c), by adding at the end the following new paragraphs: The coverage is provided in accordance with subsection (b)(10). The coverage is provided in accordance with subsection (b)(11). .
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- 42 USC 1395w–102
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Sec. 203
Protecting seniors from excessive cost-sharing for certain medicines
Cite42 USC 1395w–102
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