Access to Innovative Treatments Act of 2022
The bill mandates that the Centers for Medicare & Medicaid Services (CMS) must review denied drug coverage requests within 30 days. It prevents applying prior coverage decisions that contradict a drug's FDA approval.
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HR 9358 — Access to Innovative Treatments Act of 2022
Last action — Referred to the Subcommittee on Health.
No card. One bill, free forever — alerts when it moves.
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✓Introduced
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2In Committee
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3Passed House
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4Passed Senate
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5To Executive
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6Enacted
This bill died with 117th Congress. It reached “In Committee” and never advanced before the session ended, so it can no longer move — a new version would have to be reintroduced in the current session.
This bill is no longer active — its legislative session has ended, so there is no live prognosis. It would have to be reintroduced in the current session to move again.
In plain language
The bill requires timely reviews of Medicare drug coverage denials.
The bill mandates that the Centers for Medicare & Medicaid Services (CMS) must review denied drug coverage requests within 30 days. It prevents applying prior coverage decisions that contradict a drug's FDA approval.
What this means for you
- Healthcare: This means potential changes in drug coverage under Medicare based on new FDA approvals.
Summary
Access to Innovative Treatments Act of 2022 This bill requires the Centers for Medicare & Medicaid Services (CMS) to review adverse national coverage determinations of drugs under Medicare within 30 days of receiving a request to do so. (Under the bill, adverse national coverage determinations are denials or limitations of coverage that are inconsistent with the drug's approval by the Food and Drug Administration.) The bill's requirements do not apply if the CMS already conducted such a review within a two-year period. The bill also prohibits the CMS from applying prior coverage determinations that were made for drugs before they were approved by the FDA if such determinations are inconsistent with the drug's approval.
Bill Text
- Introduced Introduced in House Current html November 29, 2022
Compared against current U.S. Code AI-generated reading aid — verify against the official bill.
The bill establishes a process for reviewing national coverage determinations related to drug coverage under the Medicare program.
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42 U.S.C. 1395y(l)
(5) Review of national coverage determinations for drugs and biologicals.-- (A) In general.--Subject to subparagraph (D), not later than 30 days after receiving a request for a review of a specified national coverage determination (as defined in subparagraph (E)), the Secretary shall initiate such a review in accordance with the provisions of this paragraph. (B) Public comment period.--Beginning on the date of the initiation of a review of a specified national coverage determination under subparagraph (A), the Secretary shall provide for a 30-day public comment period as to whether such determination should be affirmed, reversed, or otherwise modified. (C) Final decision.--Not later than 30 days after the conclusion of the 30-day period described in subparagraph (B) with respect to a specified national coverage determination, the Secretary shall-- (i) make a final decision as to whether such determination should be affirmed, reversed, or otherwise modified; (ii) include in such final decision summaries of the public comments received and responses to such comments; (iii) make available to the public the clinical evidence and other data used in making such decision when such decision differs from the recommendations of the Medicare Coverage Advisory Committee; and (iv) in the case of a final decision under clause (i) to reverse or modify such determination, the Secretary shall assign a temporary or permanent code (whether existing or unclassified) and implement the coding change as applicable. (D) Limitation on successive reviews.--Subparagraph (A) shall not apply with respect to a request for a review of a specified national coverage determination if the Secretary has made a final decision with respect to a previous review of such determination under this paragraph during the 2-year period ending on the date of the receipt of such request. Nothing in the preceding sentence shall be construed to limit the authority of the Secretary to review or reconsider a national coverage determination if determined appropriate by the Secretary. (E) Specified national coverage determination defined.--In this paragraph, the term `specified national coverage determination' means a national coverage determination made with respect to a drug or biological approved under section 505(c) of the Federal Food, Drug, and Cosmetic Act or licensed under section 351 of the Public Health Service Act under which coverage of such drug or biological under this title was denied or otherwise limited in a manner inconsistent with such approval or licensure.
This addition creates a structured review process for national coverage determinations affecting drug coverage.
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42 U.S.C. 1395w-102(e)(3)
In determining whether payment would not be made with respect to a covered part D drug if section 1862(a) applied to this part, a prescription drug plan or MA-PD plan may not base such determination on a national coverage determination made with respect to such drug if such determination is a specified national coverage determination (as defined in section 1862(l)(5)).
This provision prevents certain national coverage determinations from being used to deny payment for new drugs under Part D.
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42 U.S.C. 1395y(l)
paragraphs (5) and (6)→ paragraphs (7) and (8)This change renumbers the existing paragraphs in the section to accommodate the insertion of new provisions.
Action History
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Referred to the Subcommittee on Health.
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Introduced in House
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Introduced in House
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Referred to the Committee on Ways and Means, and in addition to the Committee on Energy and Commerce, 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.
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Referred to the Committee on Ways and Means, and in addition to the Committee on Energy and Commerce, 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.
Sponsors
- John Joyce · Cosponsor
- Nanette Diaz Barragán · Primary
Sponsorship breakdown
Export CSV (upgrade) →1 sponsors · 1 co-sponsors · 545 not signed on
Sponsors (1)
- Barragán, Nanette Diaz Democratic
Co-sponsors (1)
- Joyce, John Republican
Not signed on (545)
545 members have not signed on to this bill.
Show all 545 →"Not signed on" means a member has not sponsored or co-sponsored this bill — it does not imply opposition. Members flagged Voted No have a recorded No vote on this bill.
Subjects
Frequently asked questions
- What does HR 9358 do?
- Access to Innovative Treatments Act of 2022 This bill requires the Centers for Medicare & Medicaid Services (CMS) to review adverse national coverage determinations of drugs under Medicare within 30 days of receiving a request to do so. (Under the bill, adverse national coverage determinations are denials or limitations of coverage that are inconsistent with the drug's approval by the Food and Drug Administration.) The bill's requirements do not apply if the CMS already conducted such a review within a two-year period. The bill also prohibits the CMS from applying prior coverage determinations that were made for drugs before they were approved by the FDA if such determinations are inconsistent with the drug's approval.
- Who sponsors HR 9358?
- HR 9358 is sponsored by Joyce, John (Republican) and Barragán, Nanette Diaz (Democratic).
- What is the current status of HR 9358?
- This bill died with 117th Congress. It reached “In Committee” and never advanced before the session ended, so it can no longer move — a new version would have to be reintroduced in the current session.
- Where can I track HR 9358?
- Track HR 9358 free on One Click Politics — get push/email alerts when it moves.
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