Barbara Straub Williams, principal at Powers, presented at the American Health Lawyers Association Institute on Medicare and Medicaid Payment Issues on March 20 and 21 on the federal 340B drug discount program. Barbara’s presentation included a primer on 340B compliance issues as well as a discussion of recent developments.
Beginning April 1, 2019, after many years of delay, HRSA will provide 340B covered entities access to a database of 340B ceiling prices for the first quarter of 2019 and each quarter thereafter, enabling covered entities to confirm whether they have been overcharged for 340B drugs. But, what process may covered entities use to collect overcharges and will covered entities be able to recoup past manufacturer overcharges? Click here for a memorandum from the 340B attorneys within Powers’ drug pricing practice detailing the current legal and regulatory landscape surrounding 340B overcharges and what steps covered entities can take to recover those overcharges.
After forty-two years practicing law in our nation’s capital, twenty-one of them at Powers, Tom Hylden has retired from the firm.
Tom is a gifted lawyer. His outstanding legal skills, judgment, integrity, and client dedication resulted in sound advice to clients to inform their business decisions and led to consistently superior results for clients in the courtroom, at the negotiating table, and with government agencies and regulators. Those qualities and achievements resulted in loyalty and appreciation from clients, respect from colleagues on both sides of the aisle and the table, and friendships with both.
Tom lives on the Eastern Shore of Maryland and looks forward to remaining in touch with his clients, colleagues, and co-workers. He can be reached at tom.hylden@outlook.com.
On February 6, the HHS Office of Inspector General formally published in the Federal Register its proposed changes to remove PBM rebates from the existing discount safe harbor, and new exceptions for point-of-sale rebates and certain payments from manufacturers to PBMs. These changes have the potential to upend the current PBM rebate framework for prescription drugs.
