J&J Sues HRSA Over Agency’s Challenge of its Rebate Model Health Highlights November 20, 2024 Subscribe Ross Margulies Manatt Health Haider David Andazola 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 November 12, Johnson & Johnson (J&J) filed suit against the Health Resources and Services Administration (HRSA) in D.C. federal district court, arguing that the 340B statute explicitly provides flexibility for manufacturers to decide how to offer 340B pricing, either through upfront discounts or post-purchase rebates, and that HSRA has not prohibited such an arrangement through its agreement with manufacturers (known as the Pharmaceutical Pricing Agreement (PPA)). This comes after HRSA challenged through a series of letters J&J’s proposed rebate model announced in September, on the grounds that “[J&J’s] proposal to implement a 340B rebate model is inconsistent with 340B statute, which requires Secretarial approval of any such proposal,” and that “the Secretary has not approved J&J’s rebate model. As a result, J&J paused implementing the model. In its complaint, J&J states that the 340B statute mentions that manufacturers must ensure the 340B price does not exceed the ceiling price, “taking into account any rebate or discount, as provided by the Secretary,” which J&J interprets as a clear allowance for using rebates. Further, J&J points out that neither the statute nor the PPA specifies or mandates a particular mechanism for pricing, reinforcing that manufacturers retain discretion in how they comply with the ceiling price. 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
