The following is the latest information from federal regulators and others as of 4:00 p.m. on Monday, April 13.
Department of Health and Human Services
- HHS has published its terms and conditions for providers that accept grants from the $100 billion in the CARES Act designated for hospitals and other health care providers.
- The HHS Office of the Inspector General (OIG) has updated its FAQ on administrative enforcement authorities addressing arrangements directly connected to the COVID-19 crisis to include answers to two new questions about providers providing free or reduced-rate services to skilled nursing facilities and hospitals extending free, HIPAA-based telehealth platforms to independent physicians. This site also advises stakeholders how to submit their own questions for OIG consideration.
- HHS’s Agency for Healthcare Research and Quality has announced certain COVID-19-related administrative flexibilities for its grant recipients and applicants.
- HHS’s Office for Human Research Protections has issued guidance on the protection of human research subjects affected by COVID-19-related research.
Centers for Medicare & Medicaid Services
- Late last week CMS updated its FAQ on COVID-19 Medicare fee-for-service billing.
- CMS has issued new guidance on portions of two COVID-19 bills that expand upon coverage for essential diagnostic services among the COVID-19 emergency. The new guidance, building upon the Families First Coronavirus Response Act and the CARES Act, implements the requirement for group health plans and group and individual health insurance to cover both diagnostic testing and certain related items and services provided during a medical visit with no cost sharing. This includes urgent care visits, emergency room visits, and in-person or telehealth visits to the doctor’s office that result in an order for or administration of a COVID-19 test.
Department of Labor
- The Department of Labor has updated its guidance on the pandemic emergency unemployment compensation program with revised operating, financial, and reporting instructions.
- The Department of Labor’s Occupational Safety and Health Administration has issued enforcement guidance reminding compliance safety and health officers that COVID-19 is a reportable illness and that employers are responsible for recording cases of COVID-19 if the case is confirmed and work-related.
Food and Drug Administration
- The FDA has released guidance on its new, temporary policy regarding non-standard personal protective equipment practices during human drug compounding at state-licensed pharmacies or federal facilities not registered with the FDA as outsourcing facilities.
- The FDA has issued an emergency use authorization (EUA) granting permission for the use of selected advanced sterilization products to be use to decontaminate N95 respirators. This EUA is explained in an FDA news release.
- The FDA has announced that it will be publishing a notice in the Federal Register with product-specific guidance to support generic development of chloroquine phosphate and hydroxychloroquine sulfate.
- The FDA has issued a warning to caregivers that humans should not be treated with the version of the anti-parasitic drug ivermectin that is formulated for the treatment of animals.
- The FDA has authorized the emergency use of two commercial blood purification systems to treat COVID-19 patients admitted to hospital ICUs with confirmed or imminent respiratory failure.
Centers for Disease Control and Prevention
- The CDC has published interim clinical guidance for the care and management of patients with confirmed COVID-19.
- The CDC has updated its FAQ on the provision of care to obstetric patients with COVID-19 or at risk of contracting COVID-19.
- The CDC has posted interim guidance for public health personnel evaluating persons under investigation and asymptomatic close contacts of confirmed cases of COVID-19 in their homes or non-home residential settings.
National Institutes of Health
- The NIH has launched a study to quantify undetected cases of COVID-19.
Medicaid and CHIP Payment and Access Commission
MACPAC has written to CMS administrator Seema Verma to express its concern that the manner in which CMS has chosen to distribute $30 billion of the $100 billion designated in the CARES Act for hospitals and health care providers “…does not account for the real and pressing concerns of safety-net providers that are on the frontlines of serving the nation’s poorest and most vulnerable people…” MACPAC also asks Ms. Verma to “…ensure that safety-net providers, including hospitals considered deemed disproportionate share hospitals (DSH) for the purpose of Medicaid payment…children’s hospitals, and other providers serving Medicaid and other low-income patients have access to federal funds made available through the CARES Act without delay.” See the MACPAC letter here.
Federal Funding Opportunities for Hospitals
- The National Alliance of Safety-Net Hospitals has prepared a document that collects and presents in one place the various new federal funding opportunities for hospitals resulting from legislation addressing the COVID-19 public health emergency. Find that document here.