CMS Releases Final 2027 IRA Negotiation Guidance Health Highlights October 10, 2024 Subscribe Erin Estey Hertzog Manatt Health Ross Margulies Manatt Health Patrick Brennan Manatt Health This overview is excerpted from Manatt on Health, Manatt’s subscription service that provides in-depth insights and analysis focused on the legal, policy and market developments. For more information on how to subscribe and to activate a complimentary one week trial to Manatt on Health, please reach out to Barret Jefferds. On October 2, the Centers for Medicare & Medicaid Services (CMS) released final guidance outlining how the agency will implement the Inflation Reduction Act’s (IRA) Medicare Drug Price Negotiation Program (the “Program”) for initial price applicability year (IPAY) 2027, the second year for which CMS-negotiated prices will apply. The final guidance also provides more clarity on how manufacturers of drugs selected for both IPAY 2026 and 2027 will make their drugs available to Medicare beneficiaries and dispensing entities at the negotiated maximum fair price (MFP), including through two separate functions provided by a Medicare Transaction Facilitator (MTF). For IPAY 2027, CMS will select an additional 15 Part D drugs for negotiation by February 1, 2025, and begin negotiating their MFPs with manufacturers in the summer of 2025. As in the draft guidance, the final guidance made no major changes to the CMS policies for drug selection, including that multiple products with the same active ingredient/moiety are considered the same “drug,” or that CMS will require a branded drug to have “bona fide” generic or biosimilar competition in order to avoid selection under the Program. For more information on how to subscribe and to activate a complimentary one week trial to Manatt on Health, please reach out to Barret Jefferds. × Newsletters Subscription Country * United States Canada Afghanistan Albania Algeria American Samoa Andorra Angola Anguilla Antarctica Antigua and Barbuda Argentina Armenia Aruba Australia Austria Azerbaijan Bahamas Bahrain Bangladesh Barbados Belarus Belgium Belize Benin Bermuda Bhutan Bolivia Bosnia and Herzegovina Botswana Brazil British Indian Ocean Territory British Virgin Islands Brunei Bulgaria Burkina Faso Burundi Cambodia Cameroon Cape Verde Cayman Islands Central African Republic Chad Chile China Christmas Island Cocos (Keeling) Islands Colombia Comoros Congo Cook Islands Costa Rica Croatia Cuba Curaçao Cyprus Czech Republic Côte d’Ivoire Democratic Republic of the Congo Denmark Djibouti Dominica Dominican Republic Ecuador Egypt El Salvador Equatorial Guinea Eritrea Estonia Ethiopia Falkland Islands Faroe Islands Fiji Finland France French Guiana French Polynesia French Southern Territories Gabon Gambia Georgia Germany Ghana Gibraltar Greece Greenland Grenada Guadeloupe Guam Guatemala Guernsey Guinea Guinea-Bissau Guyana Haiti Honduras Hong Kong S.A.R., China Hungary Iceland India Indonesia Iran Iraq Ireland Isle of Man Israel Italy Jamaica Japan Jersey Jordan Kazakhstan Kenya Kiribati Kuwait Kyrgyzstan Laos Latvia Lebanon Lesotho Liberia Libya Liechtenstein Lithuania Luxembourg Macao S.A.R., China Macedonia Madagascar Malawi Malaysia Maldives Mali Malta Marshall Islands Martinique Mauritania Mauritius Mayotte Mexico Micronesia Moldova Monaco Mongolia Montenegro Montserrat Morocco Mozambique Myanmar Namibia Nauru Nepal Netherlands New Caledonia New Zealand Nicaragua Niger Nigeria Niue Norfolk Island North Korea Northern Mariana Islands Norway Oman Pakistan Palau Palestinian Territory Panama Papua New Guinea Paraguay Peru Philippines Pitcairn Poland Portugal Puerto Rico Qatar Romania Russia Rwanda Réunion Saint Barthélemy Saint Helena Saint Kitts and Nevis Saint Lucia Saint Pierre and Miquelon Saint Vincent and the Grenadines Samoa San Marino Sao Tome and Principe Saudi Arabia Senegal Serbia Seychelles Sierra Leone Singapore Slovakia Slovenia Solomon Islands Somalia South Africa South Korea South Sudan Spain Sri Lanka Sudan Suriname Svalbard and Jan Mayen Swaziland Sweden Switzerland Syria Taiwan Tajikistan Tanzania Thailand Timor-Leste Togo Tokelau Tonga Trinidad and Tobago Tunisia Turkey Turkmenistan Turks and Caicos Islands Tuvalu U.S. Virgin Islands Uganda Ukraine United Arab Emirates United Kingdom United States Minor Outlying Islands Uruguay Uzbekistan Vanuatu Vatican Venezuela Viet Nam Wallis and Futuna Western Sahara Yemen Zambia Zimbabwe Subscribe
