May 19, 2020
As we wait the enactment of a fourth stimulus package, SNMMI would like to inform its membership of the recent U.S. Department of Health and Human Services (HHS) administrative updates as a result of COVID-19.
Centers for Medicare and Medicaid (CMS)
- A new MLN Matters Special Edition Article SE20008 clarifies CMS’ recognition of interstate license compacts as valid and full licenses for purposes of meeting federal license requirements. An interstate license compact offers a new, voluntary expedited pathway to licensure for qualified physicians and non-physician practitioners who wish to practice in multiple states. CMS has determined that the interstate license compacts, for certain provider types, will be treated as valid, full licenses for the purposes of meeting our federal license requirements.
- CMS updated its Medicare fee-for-service billing guidance. Section 1135 of the Social Security Act authorizes the Secretary of the Department of Health and Human Services to waive or modify certain Medicare, Medicaid, CHIP, and HIPAA requirements.
Food and Drug Administration (FDA)
- The FDA issued an Emergency Use Authorization (EUA) in response to concerns relating to the insufficient supply and availability of infusion pumps and infusion pump accessories for use by healthcare providers (HCPs) to treat conditions caused by COVID-19 with the controlled infusion of medications, total parenteral nutrition (TPN), and/or other fluids.
- The FDA also released final guidance on “Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency.” This guidance describes a policy for laboratories and commercial manufacturers to help accelerate the use of tests they develop in order to achieve more rapid and widespread testing capacity in the United States.
- Additional actions taken by the FDA in response to the COVID-19 pandemic can be found here.
Agency for Healthcare Quality and Research (AHRQ)
- AHRQ has been awarded $5 million for health services research related to COVID-19.AHRQ expects to fund critical research focused on topics such as the effects on quality, safety, and value of the health system response to COVID-19; the role of primary care practices and professionals during the COVID-19 epidemic; understanding how the response to COVID-19 affected socially vulnerable populations and people with multiple chronic conditions; and the integration of digital health in the response to COVID-19, including innovations and challenges encountered in the expansion of telehealth.
- AHRQ is interested in funding critical research focused on evaluating topics such as effects on quality, safety, and value of health system response to COVID-19; the role of primary care practices and professionals during the COVID-19 epidemic; understanding how the response to COVID-19 affected socially vulnerable populations and people with multiple chronic conditions; and digital healthcare, including innovations and challenges encountered in the rapid expansion of telehealth response to COVID-19. The agency announced a new funding opportunity, inviting R01 grant applications for funding to support novel, high-impact studies evaluating the responsiveness of healthcare delivery systems, healthcare professionals, and the overall U.S. healthcare system to the COVID-19 pandemic.
- With funding from the AHRQ Effective Health Care Program, the Pacific Northwest Evidence-based Practice Center (EPC) produced two reports on telehealth: (1) in 2016 an evidence map on the impact of telehealth on patient outcomes and (2) in 2019 a systematic review of the evidence about telehealth for acute- and chronic-care consultations. The EPC then produced a white paper summarizing the evidence on selected topics from these reports that may be relevant in the context of the response to the COVID-19 pandemic.
Centers for Disease Control and Prevention (CDC)
- The CDC released guidelines in separate one-page documents offering decision-making tools for schools, workplaces, camps, child care programs, mass transit systems, bars, and restaurants.
- The CDC also put out a new Request for Information (RFI) Concerning Personnel and the Retention of Next Generation Sequencing Data in Clinical and Public Health Laboratories. The comments will be used by the Clinical Laboratory Improvement Advisory Committee (CLIAC) for deliberation and possible recommendations about future changes to the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations.