2021 was a busy year for Mintz ’s Health Law team, as they helped clients navigate complex health care transactions.

This edition covers return-to-work challenges, insight on patenting AI innovations, FDA guidance on medical devices, transactional and IP activity in the life sciences, and recent Mintz work for life sciences clients.

In this episode of the Health Law Diagnosed podcast, Mintz’s Susan Berson discusses her career trajectory, the benefits of building a diverse and inclusive workplace, why women may be drawn to health law, and the importance of mentorship and sponsorship.

Susan Berson explains why health care technology and artificial intelligence are of particular interest to private equity investors and why these investors are uniquely positioned to invest in technology and bring it to market.

Susan Berson discusses key considerations for private equity firms that are considering investing in the health care sector as well as Congress’ heightened interest in these transactions.

In an unexpected turn of events, the Trump administration has apparently reversed course and has withdrawn the proposed rule that would have amended the discount safe harbor under the Anti-Kickback Statute to eliminate protections for certain drug rebates paid by pharmaceutical manufacturers. “Based on careful analysis and thorough consideration, the president has decided to withdraw the rebate rule. The Trump administration is encouraged by continuing bipartisan conversations about legislation to reduce outrageous drug costs imposed on the American people, and President Trump will consider using any and all tools to ensure that prescription drug costs will continue to decline," White House Deputy Press Secretary Judd Deere said in a statement.

On Friday, after weeks of delay, the President finally delivered his Drug Pricing Speech and released the HHS Blueprint detailing the Trump Administration's plan to lower drug prices and reduce out-of-pocket costs.

As described in last week’s post, Senator Wyden has introduced the C-THRU Act that seeks to require public disclosure of PBM rebate amounts, establish a minimum rebate percentage that PBMs must pass on to Part D and Exchange Plan clients, and intends to change the definition and/or application of “negotiated prices” under the Part D program. 

For several years now, the public outcry over the issue of drug pricing and reimbursement has increased in frequency and fervor. At least one government agency wants you to know that it has been listening and wants to help provide the information necessary to forge a solution.

Just last month the “Improving Transparency and Accuracy in Medicare Part D Spending Act” was introduced in the Senate to amend the Social Security Act. The bill seeks to prohibit Part D plans (and their contracted pharmacy benefit managers (PBMs)) from retroactively reducing payments to pharmacies for clean claims.