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Medicare Expands Coverage of “Breakthrough” Medical Devices and Codifies “Reasonable and Necessary” Standard

On January 14, 2021, the Centers for Medicare and Medicaid Services (“CMS”) published a final rule that significantly alters the Medicare reimbursement landscape for medical devices approved under the Food and Drug Administration’s (“FDA”) “Breakthrough Devices Program.” The rule, which represents the culmination of years of advocacy by the medical device industry and patient and provider interest groups, finalizes a September 1, 2020 proposed rule that aimed to address the substantial time lag between FDA authorization of medical devices and Medicare coverage of the same. Specifically, the rule establishes a Medicare Coverage of Innovative Technology (“MCIT”) pathway for Medicare coverage of Breakthrough Devices and related medical procedures during a four-year period that begins immediately upon FDA marketing authorization. The final rule also codifies the definition of the “reasonable and necessary” standard that is used to determine when other items and services (and MCIT devices after the four-year period) may be covered by the Medicare program. The new rule becomes effective March 15, 2021.

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Federal Government Releases Resource Package for Hospitals Facing COVID-19 Surge


Time to Read: 1 minutes Practices: Health Care

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Coronavirus Landing Site

On April 17, 2020, the Federal Healthcare Resilience Task Force released a COVID-19 Resource Package (the “Resource Package”), which gathers guidance documents to assist hospitals that are preparing for and responding to the COVID-19 pandemic. The Resource Package is available from the U.S. Department of Health and Human Services Assistant Secretary for Preparedness and Response.

Hospital Surge

The Resource Package includes recent guidance from CMS regarding how Medicare and Medicaid providers can ensure compliance with the Emergency Medical Treatment and Labor Act (EMTALA) while screening and treating patients suspected of having COVID-19. It also collects guidance related to increasing existing resources, such as space and equipment, including how to create temporary treatment sites and how to supplement full-featured ventilators with other ventilatory strategies.

Crisis Standards of Care

The Resource Package consolidates federal and non-federal guidance regarding how hospitals can plan for and implement crisis standards of care. These documents articulate guiding principles and goals underlying crisis standards and provide a framework for crisis planning by hospitals. Guidance from the National Academy of Medicine lists topics for an institution to consider when developing a crisis plan, including how triage decisions will be made if necessary, how staffing shortages will be addressed, and how incident command will be organized. Guidance from HHS’s Office for Civil Rights addresses compliance with civil rights laws that prohibit discrimination on the basis of race, disability, and age.

Workforce Protection

The Resource Package contains a substantial number of resources related to managing a staffing surge and ensuring adequate workforce protection. This includes guidance from the American College of Chest Physicians outlining how to identify additional internal and external staffing resources, and guidance from entities including the National Institute for Occupational Safety and Health regarding the correct use of personal protective equipment (PPE).

The Resource Package provides useful insight for institutions that are planning for a potential surge of patients requiring medical care. For state-specific guidance regarding developing an emergency triage policy, please visit Rope & Gray’s Alerts page.

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