Blog

and | January 20, 2017
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 Price and imposition of Civil Monetary Penalties (“CMP”) on manufacturers that overcharge 340B Covered Entities.  The Final Rule is effective March 6, 2017,... 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
, and | September 29, 2016
Establishing an effective and reliable gross-to-net (GTN) strategy is challenging. There are external factors such as evolving product portfolios and contracting strategies, and internal complications such as siloed business departments and non-integrated data and systems that are slow and cumbersome. To combat these challenges, leading practices for life sciences manufacturers include an integrated, enterprise-wide GTN... Read More
and | September 20, 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. Manufacturers are required to report not only their gross sales, but also their net sales, which are calculated after taking into account the discounts and rebates... Read More
| July 15, 2016
On July 6, 2016, the Centers for Medicare and Medicaid Services (CMS) published “Covered Outpatient Drug Final Rule with Comment (CMS-2345-FC) Frequently Asked Questions.”  This document is intended to respond to questions raised by various stakeholders regarding the AMP Final Rule that was published in the Federal Register on February 1, 2016, as well as... Read More