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The Centers for Medicare & Medicaid Services on May 3, 2024, released its draft guidance on administration of the Medicare Drug Price Negotiation Program for initial price applicability year 2027. The program—established by...more
The Internal Revenue Service (IRS) has issued guidance on the pharmaceutical excise tax that may apply to certain drug manufacturers, producers, and importers that fail to negotiate a drug-pricing agreement with the US...more
While only slightly past the midway point of 2023, it has already been a busy year for developments in drug pricing. Notably, CMS released its final guidance in preparation for price negotiations and the first 10 drugs...more
In recent months, six different lawsuits have been filed challenging the Inflation Reduction Act (IRA)’s Drug Price Negotiation Program (the “Program”), with a flurry of activity likely in the coming months before the...more
On December 20, 2019, the President signed into law a bill to fund the federal government through September 30, 2020. The bill included several important health care provisions but left some longstanding policy challenges...more
Senate Democrats recently introduced the Stop Price Gouging Act (S. 378), which seeks to place an excise tax on pharmaceutical companies in proportion to price spikes on prescription drugs. The bill generally requires a...more
Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more
Following a final vote in the U.S. House of Representatives on Wednesday morning, Dec. 20, 2017, Congress sent the Tax Cuts and Jobs Act (H.R. 1) to President Donald Trump's desk. In addition to extensive revisions to the tax...more
Last week, the IRS and the Treasury Department published final regulations regarding the medical device excise tax under § 4191 of the Internal Revenue Code (IRC). IRC § 4191, which was enacted by the Health Care and...more