federal_register: 2011-12423
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
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| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts | regulation_id_numbers |
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| 2011-12423 | Exclusion of Orphan Drugs for Certain Covered Entities Under 340B Program | Proposed Rule | The "Veterans Health Care Act of 1992," enacted section 340B of the Public Health Service Act (PHSA) "Limitation on Prices of Drugs Purchased by Covered Entities." Section 340B implemented a drug pricing program by which manufacturers who participate in Medicaid are required to sell covered outpatient drugs to particular covered entities listed in the statute and must agree to charge a price that will not exceed the amount determined under a statutory formula. The manufacturer's obligation to sell at no greater than the ceiling price extends only to covered outpatient drugs and does not apply to inpatient drugs. Covered entities are required to ensure that drugs purchased under 340B are used only for outpatients. The Patient Protection and Affordable Care Act expanded the types of covered entities eligible to participate in the 340B Drug Pricing Program (340B Program) under the PHSA to include certain free standing cancer hospitals, rural referral centers, sole community hospitals, critical access hospitals, and children's hospitals. Of these entities, children's hospitals were already eligible to participate in the 340B drug pricing program under the Deficit Reduction Act of 2005. The Health Care and Education Reconciliation Act (HCERA) (the Patient Protection and Affordable Care Act and HCERA collectively hereinafter will be referred to as the "Affordable Care Act"), as amended by the Medicare and Medicaid Extenders Act of 2010, contained a provision that limits the types of drugs that free standing cancer hospitals, rural referral centers, sole community hospitals and critical access hospitals could obtain through the 340B Program. Under the changes made by the Affordable Care Act, orphan drugs, when used for the rare condition or disease for which that orphan drug was designated under the Federal Food, Drug, and Cosmetic Act (FFDCA), are excluded from the definition of covered outpatient drug for the specified newly-eligible covered entity types for purposes of the 340B Program. This regulatory action details how these exclusions will be implemented under the 340B Program. | 2011-05-20 | 2011 | 5 | https://www.federalregister.gov/documents/2011/05/20/2011-12423/exclusion-of-orphan-drugs-for-certain-covered-entities-under-340b-program | https://www.govinfo.gov/content/pkg/FR-2011-05-20/pdf/2011-12423.pdf | Health and Human Services Department | 221 | The "Veterans Health Care Act of 1992," enacted section 340B of the Public Health Service Act (PHSA) "Limitation on Prices of Drugs Purchased by Covered Entities." Section 340B implemented a drug pricing program by which manufacturers who participate... | 0906-AA94 |