Buried in the 2,124-page Consolidated Appropriations Act, 2021 (the Act), which was signed by Donald Trump yesterday, was a brief provision requiring the reporting of average sales price (ASP) by manufacturers that do not have a Medicaid Drug Rebate Agreement. ASP is used by CMS …
On September 24, 2020, the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) announced a Final Rule and an FDA Guidance for the importation of certain prescription drugs. (See our coverage of the proposed rule and draft guidance here.) …
CMS Proposed MDRP regulation: In the Federal Register of Friday, June 19, CMS published a proposed rule to implement statutory amendments to the Medicaid Rebate Program statute, and to add CMS’s own policy proposals to encourage value based purchasing arrangements and discourage patient copay assistance. …
From the enactment of the Medicaid Drug Rebate Statute in 1990 until last year, a term appearing in the statute – “original new drug application” – caused controversy and uncertainty. The term was not defined in the statute and the legislative history shone no light …
On February 10, the Court of Appeals for the Federal Circuit ruled that the Department of Veterans Affairs (“VA”) erred in interpreting the Trade Agreements Act of 1979 (“TAA”) and the Federal Acquisition Regulation (“FAR”) to exclude from procurement pharmaceutical products that are manufactured in …
On November 2, 2018, the Health Resources and Services Administration (“HRSA”) released a proposed rule to move up to January 1, 2019 the effective date of implementation and enforcement of the previously delayed final rule implementing the 340B Drug Discount Program (“Final Rule”). The Final …
On July 10, 2018, the Court of Federal Claims found the Department of Veterans Affairs’ (“VA’s”) interpretation of the Trade Agreements clause to be arbitrary and capricious in Acetris Health, LLC v. United States, No. 18-433C (Fed. Cl. July 10, 2018) (the “Decision”). This action …
On October 9, 2017, California Governor Jerry Brown signed into law a bill (SB 17), which imposes new notification and reporting requirements on pharmaceutical companies, health care service plans, and health insurers. Among the many reporting obligations under SB 17, we describe below only those …
To complete our initial summaries (see here, here, and here) of the 21st Century Cures Act (Act), we want to highlight the three health care provisions included in Title IV – Delivery and Title V – Savings that we think are of most relevance to …
As we previously reported, the President signed into the law the 21st Century Cures Act (Act) on December 13, 2016 (find the full text here). This post is part two of a two-part post that summarizes the relevant provisions related to development of drugs and …
The 21st Century Cures Act (Act) was passed by the House on November 30, 2016 and the Senate on December 7, 2016. The President signed it into law on December 13, 2016. The Act contains three primary titles that address acceleration of medical product discovery, …
