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What Awaits in the First Year of Medicare Drug Price Negotiations? CMS Issues Guidance and Solicits Comment on the 2026 Inflation Reduction Act Part D Negotiation Process

On March 15, 2023, the Centers for Medicare & Medicaid Services (“CMS”) issued an initial guidance memorandum (“Memorandum”) describing how it proposes to implement the Inflation Reduction Act Medicare Drug Price Negotiation Program (“Negotiation Program”) for the Initial Price Applicability Year of 2026 (the “Initial Year”). In the Memorandum, CMS provides further guidance regarding (i) how it intends to select the Medicare Part D drugs and biologics for which it will negotiate a maximum fair price (“MFP”) for the Initial Year (the “Selected Drugs”), (ii) the data and evidence that manufacturers will be required to submit that will inform CMS’s initial price proposals, (iii) the structure of the negotiation process, and (iv) implementation and enforcement of the MFP.

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NIH Publishes Advance Notice of Proposed Rulemaking to Revise PHS Conflict of Interest in Research Regulations

Time to Read: 2 minutes Practices: Health Care Industries: Educational Institutions

The National Institutes of Health (NIH) issued an Advance Notice of Proposed Rulemaking on Friday, May 8, 2009, announcing the first comprehensive re-examination of the Public Health Service (PHS) conflict of interest in research regulations since they were adopted in 1995.

In the notice, the NIH seeks comments from the public on a series of questions regarding possible areas in which the regulations might be changed. The six areas that the NIH plans to re-examine, and some of the key issues that the NIH raised, are:

  • Expanding Scope of the Regulations and Disclosure of Interests 
    • Should investigators be required to disclose all significant financial interests (SFIs) related to their responsibilities, regardless of dollar value and perceived conflict?
  • Revising Definition of “Significant Financial Interest”
    • Is the current list of interests that do not constitute SFIs (e.g., royalties received from an institution) too broad?
  • Adopting New Requirements for Identification and Management of Conflicts by Institutions
    • Should institutions be required to establish independent review committees, develop formal conflict management plans (possibly pursuant to prescribed standards), and file conflict management plans with the PHS?
    • Should all investigators involved in participant selection, the informed consent process, and clinical management be prohibited from having any SFI in any company whose interests could be affected by the research?
  • Enhancing Methods for Assuring Institutional Requirements
    • Should the PHS’s enforcement options be enhanced?
    • Should institutions’ compliance be subject to independent confirmation? If so, how? Should accreditation be required?
  • Requiring Institutions to Provide Additional Information to PHS
    • What information should institutions be required to submit to the PHS? Should it differ by kind of research? How would the PHS use the information?
  • Amending Regulations to Address Institutional Conflicts of Interest
    • Should the regulations address institutional conflicts of interest? If so, how?

The NIH notice comes at a time of continuing attention in this area. Indeed, on April 28, 2009 the Institute of Medicine (IOM) released a report, “Conflict of Interest in Medical Research, Education, and Practice,” in which it made a number of recommendations in areas where the NIH has suggested regulations may change. For example, the IOM recommended eliminating the $10,000 reporting threshold for SFIs; establishing a presumptive bar prohibiting all investigators with SFIs from having substantial responsibility for the design, conduct, or reporting of the findings of clinical studies; and extending the PHS regulations to cover institutional conflicts of interest and to require institutions to report such interests to the NIH. Please see our May 5 alert, IOM Releases Report Addressing Potential Conflicts of Interest Between Industry and the Medical Community, for more information.

Comments to the NIH are due on July 7, 2009. Following the public comment period, the NIH expects to undertake a comprehensive review, and is not expected to issue new proposed regulations for a year or more. Although many in the academic community already have adopted policies that go beyond the 1995 regulations, and likely will have further developed policies by the time any new regulations are adopted, the potential changes are extensive. Institutions should be aware of the evolving requirements, and may want to submit comments to the NIH to supplement those that the American Association of Medical Colleges is expected to file.

If you have any questions regarding the Advance Notice of Proposed Rulemaking or other conflict of interest matters, please contact the attorneys listed above or your regular Ropes & Gray attorney.

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