PlainBillCongress, translated.Legislation. Context. Public interest.Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Congressional Research Service
Version 00 · Introduced in House · Mar 6, 2025
Ensuring Access to Essential Drugs Act
This bill exempts certain brand-name drugs from the Medicare Part D Manufacturer Discount Program. Under the program, drug manufacturers provide discounts to beneficiaries who have incurred costs above the annual deductible under the Medicare prescription drug benefit.
Specifically, the bill exempts from the program orally administered, brand-name drugs that are considered generics for purposes of the Medicaid Drug Rebate Program (per an exception granted by the Centers for Medicare & Medicaid Services).
People & committees
Rep. Garbarino, Andrew R. [R-NY-2] · R–NY
Legislative record
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Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Introduced in House
Introduced in House
Primary sources
Text links open the official source. We also preserved the text version used in the PlainBill explanation below.
No related bills are listed in this snapshot. This does not establish whether the proposal has appeared in earlier Congresses.
Source last updated: Feb 13, 2026. Consult Congress.gov for the current record.
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PlainBill explanation
Based on the full Introduced in House · 2025-03-06 text. This explanation has not received human editorial review. This overview describes the proposal’s major provisions; it does not establish what its real-world effects would be.
This bill would exempt a narrowly defined group of drugs taken by mouth from Medicare Part D’s manufacturer discount program, affecting manufacturers of qualifying drugs. Eligibility would depend on both approval through a new drug application and a special federal exception allowing a different classification under Medicaid’s drug rebate program.
2. Exempting certain drugs from the part D manufacturer discount program under the Medicare program
(C) does not include an orally administered drug— (i) for which a new drug application was approved under section 505 of the Federal Food, Drug, and Cosmetic Act; and (ii) that has been granted a narrow exception permitting reclassification as a noninnovator multiple source drug under the Medicaid drug rebate program by the Centers for Medicare & Medicaid Services.
Section 2 would add an exclusion to section 1860D–14C(g)(2) of the Social Security Act. A drug must be taken by mouth and meet both conditions: approval of a new drug application under section 505 of the Federal Food, Drug, and Cosmetic Act, and an exception already granted by the Centers for Medicare & Medicaid Services permitting reclassification as a “noninnovator multiple source drug”—a classification used in Medicaid’s drug rebate program. The proposal would rely on that classification exception rather than itself grant one.
Section 1860D–14C(g)(2) of the Social Security Act (42 U.S.C. 1395w–114c(g)(2)) is amended—
(3) by adding at the end the following new subparagraph: (C) does not include an orally administered drug— (i) for which a new drug application was approved under section 505 of the Federal Food, Drug, and Cosmetic Act; and (ii) that has been granted a narrow exception permitting reclassification as a noninnovator multiple source drug under the Medicaid drug rebate program by the Centers for Medicare & Medicaid Services.
The supplied official-actions snapshot, updated February 13, 2026, records introduction in the House on March 6, 2025, and referral that day to the Energy and Commerce and Ways and Means committees for consideration of provisions within their respective jurisdictions.
Source snapshot updated 2026-02-13T21:03:05Z.
2025-03-06: Introduced in House
2025-03-06: Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
A closer look
Reviewed version: Introduced in House · 2025-03-06. These findings describe provisions and who may benefit; they are not judgments of waste, corruption, or motive.
This review covers the supplied bill text. “None identified” does not rule out provisions in later versions or accompanying reports and disclosures.
Provisions outside the bill’s main subject, or policy changes attached to appropriations.
None identified in the reviewed text
No unrelated provision or policy change attached to appropriations was identified in the complete supplied introduced text. This conclusion is limited to that version and does not establish absence in other versions or accompanying materials.
Spending directed to particular recipients or places outside ordinary competitive or formula-based allocation.
None identified in the reviewed text
No congressionally directed spending for a particular recipient or place was identified in the complete supplied introduced text. This conclusion is limited to that version and does not establish absence in other versions or accompanying materials.
Narrow exceptions, exemptions, or preferential treatment that warrant a closer look.
Findings to examine
The proposed narrow exemption warrants scrutiny as targeted treatment. This classification does not establish that the exemption is unjustified.
Manufacturers of qualifying orally administered drugs would receive a narrow exemption from the Medicare Part D manufacturer discount program. Eligibility requires both an approved new drug application and a specific federal exception permitting Medicaid rebate reclassification. This preferential treatment is the bill’s central policy.
2. Exempting certain drugs from the part D manufacturer discount program under the Medicare program
(C) does not include an orally administered drug— (i) for which a new drug application was approved under section 505 of the Federal Food, Drug, and Cosmetic Act; and (ii) that has been granted a narrow exception permitting reclassification as a noninnovator multiple source drug under the Medicaid drug rebate program by the Centers for Medicare & Medicaid Services.
Full text preserved for this analysis. Legislative record snapshot: Feb 13, 2026. How PlainBill uses AI