In a Federal Register notice scheduled to be published on March 20, 2017, the Health Resources and Services Administration (HRSA) announced that it will delay the effective date of the January 5, 2017 final rule (the Final Rule) that provided guidance on the calculation of drug ceiling prices and the imposition of civil monetary penalties on certain drug manufacturers participating
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.
Have you been wondering what OIG has done regarding drug pricing and reimbursement since 2010? Today, OIG has made it easier to find out, posting a Drug Pricing and Reimbursement Web portfolio on its website. According to an OIG announcement, the portfolio “pulls together the HHS OIG’s body of work since 2010 as well as other relevant items that relate to drug pricing and reimbursement in HHS programs.
Last week, FDA issued a draft guidance, Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities – Questions and Answers, describing the Agency’s expectations for drug and device manufacturers’ communication of health care economic information (HCEI) about
The 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties final rule is scheduled to be published in the Federal Register on January 5, 2017. A link to the advance copy of the final rule can be accessed here.
Counsel Lanhee Chen recently authored “The Drug Pricing Conundrum Explained” for RealClear Health. The article describes the recent significant discussions on drug pricing and the reality that employers, pharmacy benefit managers (PBMs), and health plans are working to ensure a competitive marketplace and hold down costs for consumers.
Last week, FDA issued a final version of Guidance for Industry, Contract Manufacturing Arrangements for Drugs: Quality Agreements, which is available here. In this document, FDA sets forth the Agency’s expectations for parties involved in contract drug manufacturing, specifically that they delineate—in written quality agreements—each party’s roles and responsibilities to ensure compliance with FDA’s current good manufacturing practice (CGMP) requirements.
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.
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.
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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.