Blog

| May 23, 2017
On Friday, May 19, 2017, the Health Resources and Services Administration (HRSA) posted an update that further delayed the effective date of the final rule published in the Federal Register (82 FR 1210, (January 5, 2017))  titled ‘340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation’, from May 22, 2017 to the... Read More
and | May 17, 2017
In today’s fast-evolving and complex pharmaceutical ecosystem, measuring and managing Fair Market Value (FMV) has become progressively challenging. With the intense scrutiny on transparency and pricing and ongoing government inquiries and litigation, drug and device manufacturers, distributors, pharmacies, Group Purchasing Organizations (GPOs), Pharmacy Benefit Managers (PBMs), and other supply chain intermediaries should continue to pay... Read More
| May 11, 2017
On Tuesday, May 2, 2017, Centers for Medicaid and Medicare Services (CMS) issued Manufacturer Release #104 (the Release) providing clarification on Medicaid reimbursement and rebates for drugs purchased through the Federal Supply Schedule (FSS) for Indian Health Services (IHS) Facilities. The Manufacturer Release explains that “there is no statutory or regulatory provision that precludes drugs... Read More
| April 27, 2017
States are beginning to take action to try to limit large price increases of Medicaid drugs.  On April 20, 2017, New York became the first state to pass a law that would increase the Medicaid rebate liabilities of pharmaceutical manufacturers for drugs having a price increase exceeding a specified level.  Also the Maryland legislature approved... Read More
| March 21, 2017
On Friday, March 17, 2017, the Health Resources and Services Administration (HRSA) posted an Interim Final Rule that extends the effective date of the final rule titled ‘340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation’, from March 21, 2017 to the new effective date of May 22, 2017 (Interim Rule). As... Read More
| March 17, 2017
The Annual Branded Prescription Drug Fee imposes an annual fee on each covered entity engaged in the business of manufacturing or importing branded prescription drugs.  Manufacturers and Importers are required to pay such fee on each covered entity with aggregated branded prescription drug sales of over $5 million to specific programs.  The IRS distributes to... Read More
| March 13, 2017
On February 16, 2017 the Centers for Medicare and Medicaid Services (CMS) sent an email entitled Operational Guidance on Generic Inflation Penalty (login required) to currently registered technical contacts. This document is intended to provide clarity regarding the way CMS intends to operationalize the non-innovator multiple source (N) drug additional rebate requirements and provide operational... Read More
and | January 20, 2017
Editor’s note: This article was written in regards to the January 5 rule posting. Please reference the March 21 follow-up for most current timelines. The U.S. Department of Health and Human Services (“HHS”) Health Resources and Services Administration (“HRSA”) issued a Final Rule1 on January 5, 2017 to set forth regulations on calculation of 340B Ceiling... Read More
| November 29, 2016
Dear Manufacturer: As part of its oversight of the 340B Drug Pricing Program (340B Program), the Health Resources and Services Administration (HRSA), Office of Pharmacy Affairs (OPA), is requiring each participating manufacturer to sign and submit a Pharmaceutical Pricing Agreement (PPA) Addendum. The PPA Addendum will help to confirm that the requirements of the statute are... Read More
| November 29, 2016
In early November 2016, the Health Resources & Services Administration (HRSA) sent email notices to drug manufacturers who participate in the 340B Drug Pricing Program and have an active Pharmaceutical Pricing Agreement (PPA) in place with HRSA. HRSA asked manufacturers to have a corporate officer, such as the CEO, sign and submit the PPA Addendum by... Read More