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On May 17, 2021, the Biden Administration took its first major action impacting the 340B Drug Discount Program. In a forceful statement, the Administration made plain its views on a major controversy that has pitted drug manufacturers against 340B covered entities for the past year - proclaiming that drug manufacturers are violating the 340B statute by restricting covered entity access to 340B discounts for drugs dispensed through 340B contract pharmacies.
Background
As regular readers of our blog know, for a number of years the 340B Program has been at a crossroads. The 340B Program, overseen by the Health Resources and Services Administration (HRSA), was intended to provide a safety net pipeline for individuals in need of access to out-patient drugs. However, the 340B Program grew by leaps and bounds over the last fifteen years and, for many larger hospital systems, it transformed into a major source of revenue s
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On April 22, 2021, Reps. G.K. Butterfield (D-NC) and David McKinley (R-WV), along with 22 co-sponsors from both major parties, introduced H.R. 2759, “A Bill to amend title XVIII of the Social Security Act to provide for coverage under the Medicare program of pharmacist services.” The bill which marks Congress’s fourth attempt to enact the Pharmacy and Medically Underserved Areas Enhancement Act (PMUAEA) would allow Medicare to directly reimburse pharmacists for delivering certain Medicare Part B services to Medicare beneficiaries living in medically underserved areas, or MUAs. In other words, by guaranteeing Medicare reimbursement to pharmacists who administer select primary care services to Medicare beneficiaries in regions with limited access to primary medical care, the PMUAEA aims to expand pharmacy services to seniors, providing them with easily accessible and consistent primary care services, and, in turn, mo
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On April 28, the Massachusetts Public Health Council (“PHC”) approved final proposed amendments to the clinic licensure regulations. The initial revisions presented by the Department of Public Health (the “Department”) in 2016 focused on making the regulations more readable, updating definitions as necessary, and aligning the clinics’ reporting requirements with other state and federal requirements. Following the initial public comment period, the Department collaborated with MassHealth, the Department of Mental Health (“DMH”), and the Bureau of Substance Addiction Services (“BSAS”) to better integrate mental health services and treatment of substance use disorder in clinic settings. Additional revisions reflecting the collaboration with MassHealth, DMH, and BSAS were presented to the PHC in January 2020. Following that presentation, the Department held a second public comment period and made addi
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On April 28, 2021, President Biden gave his first address to Congress and announced the American Families Plan (AFP or the Act). The AFP follows the 1.9 trillion-dollar stimulus, the American Rescue Plan Act, signed into law on March 11, 2021. The AFP seeks to invest approximately 1.8 trillion dollars in various issues facing families, including childcare, pre-school, paid family leave, Affordable Care Act (ACA) premium tax cuts, nutrition support, and free community college. According to the White House’s Fact Sheet on the AFP (Fact Sheet), the AFP “is an investment in our children and our families helping families cover the basic expenses that so many struggle with now, lowering health insurance premiums, and continuing the American Rescue Plan’s historic reductions in child poverty.” This blog post discusses the health-related portions of the AFP and provides an overview of the Lower Drug Costs Now Act, which
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The Food and Drug Administration (FDA) and the National Institutes of Health (NIH) have the authority to regulate clinical trial reporting requirements. Despite this authority, FDA and NIH have scantly enforced this area since the requirements were created by Congress in 2007, hindering the clinical trial transparency promised to the public. However, there may be a shift in the lackadaisical enforcement over such reporting. On April 28, 2021, Acting FDA Commissioner Janet Woodcock, M.D., announced that that the agency had sent more than 40 pre-notices to sponsors of clinical trials for failing to submit required clinical trial results to ClinicalTrials.gov. Notably, a Notice of Noncompliance was issued for the first time.