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Provide for reconciliation pursuant to title II of H. Con. Res. 14 › Section 71203

Expanding and Clarifying the Exclusion for Orphan Drugs under the Drug Price Negotiation Program

Section 71203 · Sec. 71203 ·

What this chapter is about

This part widens a carve-out for rare disease drugs in price talks. A drug may now cover more than one rare disease. It also sets a new clock for a drug that stops being an orphan drug. It applies from price years starting January 1, 2028.

2 proposals indexed from this chapter.

The carve-out reaches a drug for more than one rare disease

The document says “is amended”Who acts: CongressHow: statuteSec. 71203 in the PDF
What the document says

“by striking "only one rare disease or condition" and inserting "one or more rare diseases or conditions"; and”

To provide for reconciliation pursuant to title II of H. Con. Res. 14, Sec. 71203

The section amends section 1192(e)(3)(A) of the Social Security Act (42 U.S.C. 1320f-1(e)) by replacing only one rare disease or condition with one or more rare diseases or conditions, and by tying the term to the meaning in section 526(a)(2) of the Federal Food, Drug, and Cosmetic Act.

What the document actually says

“by striking "only one rare disease or condition" and inserting "one or more rare diseases or conditions"; and”

To provide for reconciliation pursuant to title II of H. Con. Res. 14, Sec. 71203
That sentence, in plain words

Words limiting the rule to one rare disease are taken out. Words covering one or more are put in.

What this is about

So a drug for several rare diseases now counts. The meaning of the term comes from a food and drug law. That law is not indexed here.

No action is recorded against this proposal. That is not evidence that none has been taken, and nobody has yet read it against the record. See what the tracker does not yet cover.

A drug that stops being an orphan drug starts a new clock

The document says “shall apply”Who acts: Secretary of Health and Human ServicesHow: statuteSec. 71203 in the PDF
What the document says

“In the case of a drug or biological product that, as of the date of the approval or licensure of such drug or biological product, is a drug or biological product described in paragraph (3)(A)”

To provide for reconciliation pursuant to title II of H. Con. Res. 14, Sec. 71203

The section adds a new paragraph (4) to section 1192(e) of the Social Security Act so that for a drug or biological product that was an orphan drug when approved or licensed, the date used in the negotiation timing rules is the first day after approval or licensure on which it is no longer such a drug. The amendments apply to initial price applicability years beginning on or after January 1, 2028.

What the document actually says

“In the case of a drug or biological product that, as of the date of the approval or licensure of such drug or biological product, is a drug or biological product described in paragraph (3)(A)”

To provide for reconciliation pursuant to title II of H. Con. Res. 14, Sec. 71203
That sentence, in plain words

A drug may count as an orphan drug when first approved. The rule that follows covers such a drug.

What this is about

Its clock starts later than usual. It starts the day it stops being an orphan drug. That pushes back when price talks may reach it.

No action is recorded against this proposal. That is not evidence that none has been taken, and nobody has yet read it against the record. See what the tracker does not yet cover.

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What This Page Covers, and What It Leaves Out

Each distinct thing the section does: widen the carve-out to drugs for more than one rare disease, set the new rule for former orphan drugs, and fix when it applies.

The cross reference edit in paragraph (1).

The section works by amending section 1192(e) of the Social Security Act and points to section 526(a)(2) of the Federal Food, Drug, and Cosmetic Act, neither of which is indexed here.