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.
FDA Law Blog
JULY 17, 2022
Under the new law, Part B will continue to pay for discarded amounts from single-dose containers, but the manufacturer must pay a rebate (called a “refund”) to Medicare for discarded amounts above a specified threshold. The manufacturer responsible for paying the refunds will be the company whose NDC is on the label.
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FDA Law Blog
SEPTEMBER 14, 2021
Beginning in 2025, payment for certain “Selected” single source drugs under Parts B and D, and under commercial plans that do not opt out of the program, would be limited to a Maximum Fair Price (MFP). In order to permit MFPs to be negotiated under Part D, the current prohibition on Medicare negotiating with manufacturers would be repealed.
ClimateChange-ClimateLaw
MARCH 13, 2023
In 2022, Texas, along with several other states and industry groups representing fuel manufacturers (together, Petitioners), challenged EPA’s new emissions standards in court. These standards required each automobile manufacturer to reduce the average emissions from its vehicle fleet by approximately 5% per year between 2012 and 2025.
FDA Law Blog
OCTOBER 4, 2021
In yet another decision based on statutory interpretation, an appellate court has decided that FDA’s interpretation of the Federal Food, Drug, and Cosmetic Act (FDCA) is contrary to the plain text of the statute. Earlier this year, the D.C. And just last year , the D.C. 6 to less than 17 years of age).
ClimateChange-ClimateLaw
APRIL 9, 2021
In Minnesota, the district court granted the State of Minnesota’s motion to remand its case, which asserts state law claims under common law and consumer protection statutes. s consumer protection statute. On March 26, 2021, the court denied Exxon’s emergency motion for a temporary stay of the remand order.
ClimateChange-ClimateLaw
FEBRUARY 10, 2020
In a separate order, the court granted the motions of states and American Fuel & Petrochemical Manufacturers to intervene in support of the respondents. The district court scheduled a hearing for April 16, 2020 to consider the defendants’ motion to dismiss or transfer those cases. Union of Concerned Scientists v. 19-1230 et al.
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