2023 Government Manufacturing Provider 
FDA Law Blog
MARCH 24, 2024
By Faraz Siddiqui — As drug manufacturers battle the Health Resources and Services Administration (“HRSA”) in federal courts over the role of 340B contract pharmacies, an Eighth Circuit decision to uphold a 2021 Arkansas law may render those cases inconsequential in that state. Code Ann. § 23-92-604(c)(1), (2) (Act 1103).
FDA Law Blog
DECEMBER 7, 2023
In his conference keynote address , Arun Rao—the Deputy Assistant Attorney General for DOJ’s Consumer Protection Branch—provided an overview of DOJ’s year in FDA enforcement. DOJ has provided few bright lines about when conversations and disclosures to FDA may also satisfy its own VSD requirements.
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FDA Law Blog
NOVEMBER 7, 2022
Refunds will still be owed for quarters beginning with 1Q 2023, and CMS will still send annual reports to manufacturers containing the number of discarded units and the refunds owed for four quarters. The requirement to use a JZ modifier where there were no discarded amounts has been delayed for six months until July 1, 2023.
FDA Law Blog
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. The drug was indeed selected on August 29, 2023. Order at 24.
FDA Law Blog
JANUARY 18, 2023
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. They are: Terms and conditions of the manufacturer agreement, including each party’s responsibilities. Content of an explanation for the maximum fair price (MFP).
FDA Law Blog
JULY 17, 2022
Currently, a health care provider identifies any discarded quantity from such a vial in the claim using a JW modifier, and Medicare Part B pays for both the utilized and the discarded amount. On July 8, as part of its annual physician fee schedule update for 2023, CMS issued a proposed regulation to implement the new refund.
FDA Law Blog
MARCH 1, 2023
Brevig, Senior Regulatory Device and Biologics Expert — In January 2023, FDA published a paper summarizing its lessons learned from two pilot Quality Management Maturity (QMM) Pilot Programs, such as best practices for conducting QMM assessments and developing the QMM scoring system. By Holly N.
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