In August 2022, President Biden signed into law the Inflation Reduction Act. The Act’s key provisions include the ability of the federal government to negotiate certain prescription drug pricing. Specifically, the law created a program that allows the federal government to negotiate prices for a limited number of high-cost single-source drugs (lacking generic and/or biosimilar substitutions). The Secretary of the Department of Health and Human Services (HHS) will have the ability to choose a list of 50 pharmacy drugs and 50 drugs administered at a physician’s office that will be priced in accordance with this new methodology. 

By September 1, 2023, the Centers for Medicare and Medicaid Services (CMS) must publish the highest cost drugs for negotiation. While the effective date for this first round of drugs is not until CY2026, in CY2023 a total of 10 drugs will be selected from the Medicare Part D program.

In this recent article published by Reuters entitled Bristol Myers, Pfizer, AbbVie Drugs Likely to Face U.S. Price Negotiation, the authors discuss some of the drugs anticipated to be on this initial list and the efforts being made by the industry to better understand how this new pricing system will be implemented.

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Photo of John W. Kaveney John W. Kaveney

Partner, Healthcare and Litigation Departments

Mr. Kaveney focuses his practice in the area of healthcare law, representing a range of clients that includes for-profit and non-profit hospitals and health systems, academic medical centers, individual physicians and physician groups, ambulatory surgery centers, ancillary service…

Partner, Healthcare and Litigation Departments

Mr. Kaveney focuses his practice in the area of healthcare law, representing a range of clients that includes for-profit and non-profit hospitals and health systems, academic medical centers, individual physicians and physician groups, ambulatory surgery centers, ancillary service providers, medical billing companies, skilled nursing and rehabilitation facilities, behavioral health centers and pharmacies.

His practice in the healthcare field encompasses advising healthcare clients on corporate compliance matters, including the implementation of new, and the assessment of existing, corporate compliance programs. He also assists healthcare clients with compliance audits and investigations, as well as guiding clients through the self-disclosure and repayment processes. Finally, he provides general legal advice concerning compliance and regulatory matters under state and federal healthcare laws.

In the area of information privacy and data security, Mr. Kaveney advises healthcare clients on issues arising under the Health Insurance Portability and Accountability Act (HIPAA) and the Health Information Technology for Economic and Clinical Health Act (HITECH). This includes the implementation and assessment of privacy and security policies and procedures to ensure the proper protection and utilization of protected health information both by healthcare providers and the business associates with which they contract. In addition, he represents healthcare clients in investigating, reporting, and remediating information breaches and the liability such breaches create under various information privacy and security laws.

Additionally, Mr. Kaveney provides counsel on Medicaid and Medicare reimbursement matters before the Division of Medical Assistance and Health Services and the Provider Reimbursement Review Board, as well as assisting clients in civil litigation and with professional licensing and medical staffing concerns.

Contact information:

jkaveney@greenbaumlaw.com | 973.577.1796 | vCard | LinkedIn

For more information visit the Greenbaum, Rowe, Smith & Davis LLP website.