Between a rock and a hard place: medical-device stakeholders disappointed by cancelled CMS rulemaking

By Emmie Futrell, Class of 2018; Denise D. Burke, Partner at Waller Another attempt at bridging the gaping lag between FDA approval for medical devices and CMS’s Medicare coverage determinations has been struck down, after a nine-month standstill. CMS’s proposed rulemaking included a promising new program called EXCITE, or expedited coverage of innovative technology. The proposed …

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CMS unveils new bundled payment model

By Chase Doscher, Class of 2018; Elizabeth N. Pitman, Counsel at Waller; Zachary D. Trotter, Associate at Waller Earlier this month, CMS announced the launch of the Bundled Payment for Care Improvement Advanced (BPCI Advanced) payment model. This is the first Advanced Alternative Payment Model (Advanced APM) introduced under the Trump Administration and the start of the …

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Back to the Future: CMS revives Obama-era proposed rule on critical access hospitals

By Emmie Futrell, Class of 2018; Kristen A. Larremore, Partner at Waller; Amber Green Arnold, Associate at Waller Since the 1997 Balanced Budget Act, which created the designation for Critical Access Hospitals (CAH), the requirements for Medicare and Medicaid participation for these rural facilities have largely remained untouched.  But, a recent decision by CMS to revive and …

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Dr. Alexa, MD

By Emmie Futrell, Class of 2018 Picturing Amazon drones dropping pharmaceuticals from the sky, or Amazon’s Alexa becoming Dr. Alexa, MD, may not be so far-fetched as it sounds. Amazon has reportedly obtained approval for wholesale pharmacy licenses in at least 12 states. They include Nevada, Arizona, North Dakota, Louisiana, Alabama, New Jersey, Michigan, Connecticut, Idaho, …

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Veterans Choice Health Care Program Could Run Out of Funding

By William Dodd, Class of 2019 The Veterans’ Access to Care through Choice, Accountability, and Transparency Act of 2014, more commonly known as the Veterans Choice Program, is a U.S. public law that works to expand the number of healthcare options available for eligible veterans. Among many provocations leading up to the creation of the …

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