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CMS Proposes Revised Definition of Medicare Part D Drug “Negotiated Prices”: Rule Could Increase Predictability for Pharmacies and Lower Medicare Enrollee Drug Cost-Sharing but Increase Premiums

On January 6, 2022, the Centers for Medicare & Medicaid Services (“CMS”) issued a proposed rule entitled “Medicare Program; Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs” (the “2022 Proposed Rule”). Of great significance to Medicare Part D plan sponsors, pharmacies, and beneficiaries, the 2022 Proposed Rule includes proposed changes to the way Medicare determines the “negotiated price” (i.e., the price upon which beneficiary cost-sharing is based at the pharmacy counter), and consequently could affect Part D plan sponsors’ reporting of costs to CMS. If finalized in its current form, the 2022 Proposed Rule could enhance predictability of cash flow for pharmacies, reduce out-of-pocket prescription drug costs for Medicare Part D enrollees, and lead Part D plan sponsors to raise premiums, thereby causing increased competition among Part D plan sponsors for beneficiaries. The 2022 Proposed Rule would take effect on January 1, 2023. Comments on the rule are due by March 7, 2022.

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HHS Grants 30-Day Extension on Comment Period for Common Rule Revisions

Time to Read: 1 minutes Practices: Health Care, Life Sciences

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Today, the Department of Health and Human Services (“HHS”) published a Federal Register notice that extends the comment period for the Federal Policy for the Protection of Human Subjects (“Common Rule”) notice of proposed rulemaking (“NPRM”) by 30 days to January 6, 2016. As we noted on September 8, 2015, the NPRM would extensively revise the Common Rule (Title 45 of the Code of Federal Regulations, Part 46), and would mark the first systematic attempt to overhaul the set of regulations that govern research conducted, funded or otherwise subject to regulation by the federal government since its promulgation in 1991. The NPRM has implications for a wide range of stakeholders across the life sciences and health care industries, including drug and device manufacturers, hospitals, academic medical centers, universities and medical schools, institutional review boards (“IRBs”), contract research organizations, laboratories, and tissue banks. 

Of considerable importance to the life sciences and health care industries, the NPRM contains substantive proposals that would (i) significantly alter the regulatory framework for biospecimen research to require informed consent, even for de-identified biospecimen research, and limit the applicability of the waiver of consent mechanism; (ii) impose IRB and data security protection requirements on private entities that receive biospecimens collected during federally funded research; (iii) mandate single IRB review and approval of cooperative research; (iv) require posting of consent forms; (v) grandfather existing biospecimen collections when the research use of the biospecimens occurs after removal of any individually identifiable information associated with the biospecimens; and (vi) require that institutions, researchers, and life sciences companies implement detailed infrastructures to track broad consent and biospecimens. 

To assist life sciences companies in understanding the complexities and implications of the NPRM, please refer to our in-depth Bloomberg BNA article

The NPRM seeks active public engagement on the proposed codified text, on the numerous questions identified for public comment, and on the alternative schemes discussed in the preamble. As the NPRM accurately acknowledges, public trust in the research enterprise is imperative to the success and effectiveness of any changes to the Common Rule. The proposed rule will now be open for public comment until January 6, 2016. If you have any questions about the proposed revisions or how the NPRM may affect your organization, please contact any member of Ropes & Gray’s health care or life sciences practices or your usual Ropes & Gray advisor. 

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