On November 17, FDA announced that it had revised, and finalized in part, Guidance for Industry, Generic Drug User Fee Amendments of 2012: Questions and Answers Related to User Fee Assessments, available here.
Prescription Drug Pricing & Government Price Reporting
Arent Fox is one of only a handful of US firms that can provide sophisticated counsel to the prescription drug industry on the full range of complex pricing issues, including AWP and WAC reporting to the compendia, ASP reporting to Medicare, AMP and Best Price reporting to Medicaid, ceiling and sub-ceiling price reporting to support the Public Health Service 340B program, and non-FAMP and FCP reporting to FA/FSS. We also assist pharmaceutical manufacturers in navigating the Coverage Gap Discount Program under Medicare Part D, NADAC, and the AAC methodologies currently being adopted by state Medicaid programs. Our advice reflects experience gained from supervising government pricing systems audits, handling restatements and voluntary disclosures with CMS, the Office of Pharmacy Affairs at HRSA and the VA, and representing clients facing enforcement actions tied to their price reporting obligations.
On Monday, CMS issued a notice that, in effect, gives drug manufacturers a three-year reprieve to updating their systems to include sales in US territories in the AMP and Best Price. The government’s release about the changes that were published to Medicaid.gov can be found here.
Today, CMS issued a notice announcing changes that would be made to the Medicaid National Drug Rebate Agreement (NDRA). The government’s release about the changes that were published to Medicaid.gov can be found here:
In a ruling that could, if adopted by other courts, expose all pharmaceutical discount and rebate arrangements to anti-kickback liability, on August 23, 2016, Judge Rya Zobel in the United States District Court for the District of Massachusetts denied Omnicare, Inc.’s motion for summary judgment in United States ex rel. Banigan v.
Vermont has published the first list of pharmaceutical products for which manufacturers are required to submit annual price transparency reports. The list is available on the Vermont Office of Attorney General website. Prescribed forms are available for reporting there as well. Reports are due on or before October 1, 2016.
On July 6, CMS issued a set of Frequently Asked Questions to respond to questions raised by the Covered Outpatient Drug Final Rule that was published on February 1, 2016. The FAQs can be accessed here; our January 28 article analyzing the final rule can be accessed here and our analysis of the delayed implementation of the revised 5i AMP methodology and 70/30 test can be found here.
Rising prescription drug costs have been big news this year, and states are beginning to respond. On June 3, 2016, the Governor of Vermont signed into law bill S.216, “An act relating to prescription drug formularies” (the “Law”). The Law is designed to understand the drivers of rising prescription drug costs, and, among other things, will require all health insurers offering plans und
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Arent Fox LLP, founded in 1942, is internationally recognized in core practice areas where business and government intersect. With more than 350 lawyers, the firm provides strategic legal counsel and multidisciplinary solutions to clients that range from Fortune 500 corporations to trade associations. The firm has offices in Los Angeles, New York, San Francisco, and Washington, DC.