MOST RECENT MANUFACTURER NOTICES & ACTION PLAN
Peggy Tighe, Principal, Powers Law Firm, joined us for a second time to address the most recent drug manufacturer notices and look at the responses and congressional action that has followed. The goal of the webinar was to highlight these recent updates related to the 340B industry.
Recent Manufacturer Actions
In the past three months, Merck, Lilly, Astrazeneca, Novartis, and Sanofi-Aventis have presented new ways they would like to focus on duplicate discounts. This new notice limits contract pharmacy participation in the 340B Program and would allow manufacturers to regulate the 340B Program without HRSA’s review. Most of these actions from manufacturers have taken the form of letters to Covered Entities, leaving the Covered Entities to figure out how to respond to the unprecedented letters.
Covered Entity and TPA Responses
Some common themes of the letters and responses focus on how the actions violate the intent and spirit of Statute and contracts with TPA’s, limit access to pharmaceuticals, and come at a questionable time amid COVID-19 and pre-election. Other themes express concern for HIPAA violations and harm to grantees.
In the midst of the pandemic, organizations are left wondering, “why now?”. NACHC has announced this week that they are preparing for a lawsuit. 340B Health has enlisted 1100 hospitals to sign a letter to Secretary Azar stating that providers have no legal obligation to share the data and their actions threaten to cut off access of discounts to contract pharmacies.
Powers Law Firm recommend seeking legal counsel prior to responding and has put together a chart will help organizations make sense of these letters. The chart can be found here: https://www.rwc340b.org/
HRSA’s response has not come in the form of a letter, message or notice on their website, but rather, they have responded directly to the press. 340B Report was the first to report on HRSA’s statement on September 2, 2020 and can be found here: https://340breport.substack.com/p/breaking-hrsa-is-investigating-whether
Congress, despite the hurdle of the current pandemic, is working to stop manufacturers from these their recent actions. The Majority Chairs of the Energy and Commerce committee, Pallone, Eshoo, and DeGette, wrote a letter that addressed their “strong concerns” about the actions that “threaten to undermine the 340B Program.” For more details on this two-page letter, please view the webinar presentation slides.
Over 100 members of Congress have already signed a bipartisan letter including Reps DeGette (D-CO) and McKinley (R-WV), joined by Gianforte (R-MT), Johnson (R-SD), Welch (D-VT), and Matsui (D-CA). The letter calls for Secretary Azar “to address these troubling actions”, to “take immediate action to stop these companies from either denying or limiting access to 340B pricing” and “comply with the law”. Senator Blumenthal (D-CT) wrote a letter directly to PhRMA criticizing the recent spate of 340B actions.
Election Implications for 340B
There is currently potential for significant change in the balance of power with the upcoming election. The House is very likely to stay in the Majority held by the Democrats, while the Senate could stay in the Majority held by Republicans but has a better chance to flip. Any changes to the 340B Program, whether in its favor or not, have been stymied by the power held by Congress and could ultimately determine future changes depending how this election turns out.
Peggy Tighe states that while the majority is in favor of the 340B Program, it is the Democrats that are warry of any changes. There has been a vocal minority of Republicans who have come out with legislation that could potentially undermine the 340B Program. Peggy’s predictions for the program under another four years of a Trump Administration would be further changes through Executive Orders/Actions.
Under a Biden Administration, Peggy suggests a few potential scenarios. One scenario being overt protection of the 340B Program or no Congressional Action, putting its focus on HRSA. Other scenarios include removal of Trump Executive Orders, stricter regulations, or expansion of the program.
There are current litigation, advocacy, and congressional work all in play against these manufacturer notices and we are dedicated to continuing to provide insight and advice on the matter. We hope the information displayed has helped your organization capture and organize more of the recent issues and notices.
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