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With Passage of the Inflation Reduction Act in 2022, Speculation Begins Regarding Which Drugs Will Face U.S. Price Negotiation This Fall

By John W. Kaveney on March 20, 2023
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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.

Photo of John W. Kaveney John W. Kaveney

Partner, Healthcare and Litigation

John provides legal guidance to healthcare sector clients on a broad variety of topics, including Medicare/Medicaid reimbursement issues, corporate compliance, data privacy and cybersecurity concerns, healthcare provider licensure and medical staffing concerns, involuntary commitment laws, and general healthcare regulatory…

Partner, Healthcare and Litigation

John provides legal guidance to healthcare sector clients on a broad variety of topics, including Medicare/Medicaid reimbursement issues, corporate compliance, data privacy and cybersecurity concerns, healthcare provider licensure and medical staffing concerns, involuntary commitment laws, and general healthcare regulatory support. He represents a diverse roster of healthcare entities, including for-profit and nonprofit 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.

John advises on Medicaid reimbursement matters before the New Jersey Division of Medical Assistance and Health Services (DMAHS), which administers the state’s Medicaid programs, and handles Medicare reimbursement disputes, both in New Jersey and in numerous other states, before the federal Provider Reimbursement Review Board (PRRB).

In the area of corporate compliance, John supports clients on matters including the implementation of new, and the assessment and improvement of existing, compliance programs. He assists healthcare clients in navigating compliance audits, internal investigations, and governmental investigations related to compliance issues, including potential violations of the federal Stark Law, Anti-Kickback Statute (AKS), and Civil Monetary Penalties law (CMP). He further provides general guidance concerning compliance and regulatory matters under state and federal healthcare laws.

On issues related to information privacy and cybersecurity at the intersection of healthcare law, John assists providers with 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 (PHI) 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.

John also counsels healthcare providers with professional licensure issues and advises hospitals and health systems regarding their medical staff bylaws and corresponding policies and procedures, as well as assisting with internal investigations of medical staff members and the corresponding disciplinary process. He further provides legal guidance related to New Jersey’s involuntary commitment laws, and provides representation in civil litigation.

John serves as Editor-In-Chief of Healthcare Perspectives, Greenbaum’s blog covering issues of interest to the healthcare industry.

Results may vary depending on your particular facts and legal circumstances.

Contact information:

jkaveney@greenbaumlaw.com | 973.577.1796 | vCard | LinkedIn

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

Read more about John W. KaveneyEmail
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  • Posted in:
    Health Care and Life Sciences
  • Blog:
    Healthcare Perspectives
  • Organization:
    Greenbaum, Rowe, Smith & Davis LLP
  • Article: View Original Source

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