2026 Government Manufacturing Provider 
FDA Law
JANUARY 18, 2023
The memorandum outlines CMS’s priorities and timeline for the Initial Price Applicability Year 2026. Upcoming CMS Guidance CMS provides a list of topics on which it plans to issue guidance. The Agency has promised it will provide comment periods for each guidance. The memorandum also introduced the Program’s spanking new logo.
FDA Law
NOVEMBER 16, 2021
5376 that has garnered the greatest amount of attention (at least in the food and drug law world) is TITLE XIII, Subtitle J (Drug Pricing), Part 1 (Lowering Prices Through Fair Drug Price Negotiation), Section 139001 (Providing for Lower Prices for Certain High-Priced Single Source Drugs). One of the new programs included in the H.R.
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FDA Law
OCTOBER 4, 2023
According to the court, the Constitution guarantees no right to conduct business with the government, so the consequences of that participation can be “conditioned by regulation” without being considered unconstitutional. Standing The Defendants questioned, and the court reviewed, Plaintiffs’ standing. Order at 24.
FDA Law
FEBRUARY 13, 2025
Modifications to previously authorized PCCPs can be submitted via a Special 510(k), and eSTAR recommends that the manufacturer submit a clean copy and redline of the PCCP as an attachment. Manufacturers should develop the Modification Protocol consistent with their quality system and should follow their risk management processes.
FDA Law
NOVEMBER 16, 2021
The Act now extends that delay until January 1, 2026. In addition, section 90004 of the Act requires manufactures of drugs sold in single-dose containers to pay refunds to Medicare for discarded Part B drugs. The new refund requirement applies to drugs that are (1) separately paid under Medicare Part B; (2) single source drugs (i.e.,
FDA Law
AUGUST 14, 2022
The number will begin in 2026 with 10 drug covered under Medicare Part D and will increase annually to 20 Part B and 20 Part D drugs by 2029 and thereafter, with the selected drugs accumulating from year to year.
FDA Law
AUGUST 3, 2021
Department of Health and Human Services in December 2020 to prevent Medicare Part D and Medicaid Managed Care plans from receiving rebates from manufacturers unless the rebates are passed through to pharmacies to reduce patient out-of-pocket expenses. The rule was estimated to cost the federal government around $196 billion over ten years.
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