On May 8, 2020, the Centers for Medicare & Medicaid Services (CMS) published an interim final rule with comment period (the “Interim Rule”) in the Federal Register, setting forth additional regulatory waivers and other changes to healthcare regulations and policies in response to the COVID-19 public health emergency (PHE). At a high level, the Interim Rule encompasses topics including expansion of telehealth, support for and expansion of COVID-19 testing, allowing certain licensed professionals to practice at the top of their licenses, Medicare payments for teaching hospitals, changes to the Medicare Shared Savings Program regarding financial methodologies, and application and risk assumption deadlines for accountable care organizations, among other changes. CMS has also updated provider-specific fact sheets on recent waivers and flexibilities, available here. Below are highlights from the Interim Rule.  Providers are encouraged to read all applicable sections of the Interim Rule in their entirety here. Comments may be submitted to CMS within 60 days of the date of publication in the Federal Register.
Continue Reading CMS Interim Rule Makes Sweeping Changes in Response to COVID-19 Public Health Emergency

On February 15, 2018, the Centers for Medicare & Medicaid Services (CMS) issued a Decision Memo outlining revisions to its 2005 National Coverage Determination (NCD) for Implantable Automatic Defibrillators (ICDs) . The updated NCD  includes changes to the covered indications for ICDs, new patient criteria and exceptions to waiting periods for symptomatic patients with certain

On October 24, 2016, the Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) published a joint announcement of their plan to continue the Program for Parallel Review of Medical Devices.

The Program is a collaborative effort that is intended to reduce the time between FDA marketing approval and Medicare