| 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
| November 9, 2016
A top 20 pharma company was facing downward pricing and margin pressures that resulted in: Divergence of gross and net sales Increased rebate spend Confusion in the marketplace If your company is experiencing similar issues, learn how one large pharma manufacturer was able to perform a comprehensive analysis of gross-to-net waterfall, script-level profitability, and identify... Read More
| November 1, 2016
Gross-to-net (GTN) calculations are a growing challenge for life sciences manufacturers navigating increasingly complex supply chains, a changing regulatory environment, and the enhanced negotiating power of consolidated distributor networks. Careful estimation of not only your gross sales, but also your net sales, which are calculated after taking into account the discounts and rebates offered across... Read More
| October 18, 2016
Some life sciences companies, especially those that have gone through a series of mergers and acquisitions, are often saddled with multiple legacy systems that are unable to communicate with one another. This means data is spread throughout the organization, rarely flowing into a central repository where calculations can be automated and analyzed. The result is... Read More
, and | October 7, 2016
In our previous blog on gross-to-net (GTN) leading practices, we considered the challenges manufacturers face in creating a GTN strategy, which provides predictability through enhanced controls and prioritized risk management, as well as profitability through a better understanding of commercial spend and product investments. Now that we’ve identified these leading practices, how are they typically... Read More