On December 14, 2020, HRSA established a long overdue Administrative Dispute Resolution (ADR) process that allows covered entities and drug manufacturers to bring claims against each other related to the 340B Drug Pricing...more
The Centers for Medicare and Medicaid Services (CMS) has proposed reducing the Medicare payment rate to hospitals for most separately payable drugs purchased under the 340B program from average sales price (ASP) plus six...more
The Centers for Medicare & Medicaid Services (“CMS”) has released the final version of its much anticipated revisions to the regulations governing Medicaid managed care (the “Final Rule”). First proposed in May 2015, the...more
5/5/2016
/ Beneficiaries ,
Centers for Medicare & Medicaid Services (CMS) ,
Fee-for-Service ,
Final Rules ,
Health Care Providers ,
Managed Care Contracts ,
Medicaid ,
Mental Health ,
Prescription Drug Coverage ,
Quality of Care Standards ,
Reporting Requirements ,
Section 340B ,
State Medicaid Programs ,
Subcontractors ,
Value-Based Purchasing
A federal court vacated the Department of Health and Human Services’ (HHS) Orphan Drug Rule that had allowed certain 340B Drug Pricing Program (340B Program) hospital covered entities to receive discounted prices when...more
10/20/2015
/ Abuse of Discretion ,
Administrative Procedure Act ,
Arbitrary and Capricious ,
Comment Period ,
Covered Entities ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Final Rules ,
Hospitals ,
HRSA ,
Interpretive Rule ,
Omnibus Guidance ,
Orphan Drugs ,
Pharmaceutical Industry ,
PHRMA ,
Section 340B ,
Vacated
The Centers for Medicare and Medicaid Services (“CMS”) released, on May 26, 2015, the a far-ranging proposal for revising the Medicaid managed care regulations (“Proposed Rule”). The number of individuals enrolled in Medicaid...more