The US District Court for the District of Columbia recently held that the Centers for Medicare and Medicaid Services (CMS) exceeded its authority by reducing Medicare payment rates for 340B drugs, but, because of the budget-neutral nature of the cuts, the court left implementation details of its order temporarily unresolved to avoid disrupting administration of the Medicare Hospital Outpatient Prospective Payment System. It remains to be seen what remedies the court will ultimately order and whether CMS will appeal the decision.
Court Issues Permanent Injunction Blocking Medicare 340B Payment Cuts
By Drew Elizabeth McCormick, Emily J. Cook, Eric Zimmerman and Steven J. Schnelle on January 22, 2019
Posted In Employee Benefits, Health and Welfare Plans
Tags: 2018 Final Rule, 340B, 340B drugs, AHA, America’s Essential Hospitals, American Hospital Association, CMS, federal 340B drug discount program, International Pricing Index, Medicare and Medicaid Services, Medicare Hospital Outpatient Prospective Payment System, OPPS, Section 603 of the Bipartisan Budget Act, US District Court for the District of Columbia

Drew Elizabeth McCormick maintains a general health industry and regulatory practice. Drew advises health care clients on a wide variety of health care regulatory issues, including Medicare and Medicaid regulations, the Federal Anti-Kickback Statute, Ethics in Patient Referral Law, False Claims Act and Health Insurance Portability and Accountability Act (HIPAA), as well as state fraud and abuse laws, privacy laws, licensure regulation, research regulation, and health care compliance matters. Drew also has experience counseling clients who are undergoing government audits and investigations. Read Drew Elizabeth McCormicks' full bio.

In today’s complex and fast-changing healthcare regulatory environment, Emily Jane Cook helps healthcare organizations thrive. Innovative start-ups and established market leaders alike turn to Emily for broad-spectrum strategies to fuel new business initiatives and solve their most pressing compliance, transactional, reimbursement and litigation challenges. Emily is a practice area leader for the Healthcare Regulatory & Compliance practice. In addition to Emily’s role as a national authority on the 340B drug pricing program, Emily helps clients navigate the full suite of federal and state regulations that are essential to healthcare operations. She partners with a wide range of organizations, including non-traditional service providers and new market entrants to identify, protect and expand revenue opportunities, including via private-equity-backed ventures. Her comprehensive counsel encompasses evolving issues such as No Surprises Act (NSA) implementation, development of new provider types, Medicare provider-based and co-location rules, and trends in qui tam litigation and government investigations. She works closely with colleagues in McDermott’s transactional, litigation and private equity practices to deliver fully realized solutions for her clients. Read Emily Cook's full bio.

Eric Zimmerman is a recognized Medicare law and policy authority and registered lobbyist who represents clients before Congress and administrative agencies, and helps clients navigate federal legislative and regulatory processes related to Medicare coverage, coding, reimbursement and compliance. Eric is partner-in-charge of the Firm's Washington, DC Health Industry Advisory Practice Group. He also serves as a principal of McDermott+Consulting LLC. Read Eric Zimmerman's full bio.

Steven Schnelle focuses his practice on regulatory and transactional matters involving health care providers and suppliers, pharmacies, pharmaceutical firms, device manufacturers, and market innovators. Read Steven Schnelle's full bio.
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