FDA Law Blog

SEPTEMBER 20, 2021

Below we provide an overview of some of the goals letter’s most notable contents such as new initiatives as well as some large-scale enhancements to programs that have already been in the works. Pandemic influences aside, the FY 2023-2027 goals letter contained many notable new initiatives, announcements, and commitments.

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FDA Law Blog

DECEMBER 3, 2023

As part of this change, the Coverage Gap Discount Program (CGDP), a program that has existed since 2011, will sunset on December 31, 2024, and be replaced by the Medicare Part D Manufacturer Discount Program (the “Discount Program”). CMS will send the final manufacturer invoice for discount liabilities accrued by then on April 30, 2028.

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FDA Law Blog

JULY 7, 2024

Laboratories struggling to understand the myriad implications of being regulated as device “manufacturers” were hopeful that additional guidance would shed light on how to apply FDA’s existing medical device regulatory framework to their operations. 803), Reporting of Corrections and Removals (21 C.F.R. § 806) and Complaint Files (21 C.F.R.

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Alabama Academy of Family Physicians

FEBRUARY 19, 2025

What Happened: Passed out of the House of Representatives HB 46 – Rural Physicians Tax Credit What’s in the Bill: HB 46 terminates the existing Rural Physician Tax Credit program in Alabama, which provided tax credits to physicians practicing in rural areas, effective December 31, 2025.

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FDA Law Blog

JUNE 14, 2023

He highlighted the following key features of TAP: An Innovative Approach To provide proactive support and guidance to medical device manufacturers, FDA has introduced a new CDRH position known as the “TAP Advisor.” up to 225 total products enrolled through FY 2026 and up to 325 total products enrolled through FY 2027).

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FDA Law Blog

OCTOBER 20, 2022

The eye-catching 56% increase for a 510(k) submission could be burdensome to many device manufacturers given that the 510(k) premarket notification is the most frequently used regulatory pathway for medical devices. FY 2026, device manufacturers should take advantage of reduced fees if they qualify as a small business.

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FDA Law Blog

NOVEMBER 22, 2022

In an effort to correct some of the bottlenecks in traceability efforts, the final rule imposes additional recordkeeping requirements on domestic and foreign firms who manufacture, process, pack, or hold foods on the Food Traceability List (FTL) for U.S. 7, 2022 at 1 p.m. EST. Attendees can register here or watch the livestream here.

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FDA Law Blog

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.,

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FDA Law Blog

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. that price controls distort markets and reduce competition.

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FDA Law Blog

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. We previously explained the rebate rule and its likely impact on patients and payors here.

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FDA Law Blog

SEPTEMBER 14, 2021

The MFP would be established through negotiations between HHS and the manufacturer and would incorporate foreign pricing benchmarks, as further described below. In order to permit MFPs to be negotiated under Part D, the current prohibition on Medicare negotiating with manufacturers would be repealed.

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FDA Law Blog

FEBRUARY 20, 2025

That, of course, is not unique to labs with LDTs; kit manufacturers also need to obtain those insights well before they begin studies.) FDA had been scheduled to hold a webinar on the Stage 2 (May 2026) requirements related to the investigational device requirements for LDTs later this month.

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FDA Law Blog

SEPTEMBER 13, 2021

A final OIG rule to change the structure of manufacturer rebates to Medicare Part D and Medicaid Managed Care plans and their PBMs is enmeshed in litigation and is likely to be at least postponed until 2026 (see our post ), and perhaps prevented from implementation altogether, by Congressional mandate.

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