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June 12, 2020

Health Law Weekly

COVID-19 Updates and Developments (Week of June 8)

  • June 12, 2020

The Centers for Medicare & Medicaid Services (CMS) issued recommendations for health care providers to resume non-emergency, in-person care in areas in the second phase of reopening.

Because of the COVID-19 pandemic, many health care providers suspended non-emergency care to mitigate the spread of the virus and to increase capacity for coronavirus patients.

In areas with “lower or declining-without-rebound, levels of COVID-19,” CMS recommends that patients and providers continue to maximize the use of telehealth “when available and appropriate” and for high-risk individuals to continue to avoid in-patient care unless warranted by their health conditions.  

“[W]hile telehealth has proven to be a lifeline, nothing can absolutely replace the gold standard: in-person care,” said CMS Administrator Seema Verma. “Those needing operations, vaccinations, procedures, preventive care, or evaluation for chronic conditions should feel confident seeking in-person care when recommended by their provider.” 

As they resume non-emergency, in-person care, CMS recommends that facilities test patients for the virus 24 hours before a scheduled procedure or operation, including those in labor and delivery areas. If testing is not available, CMS advises that patients self-isolate for 14 days in advance of admission. Hospital staff also should be screened daily for COVID-19, CMS said.

Along with the recommendations to health care providers, CMS also issued a guide for patients on seeking non-emergency, in-person care.

Agency Action

Centers for Medicare & Medicaid Services

June 11—CMS is warning nursing homes that seizing residents’ federal stimulus checks amounts to “misappropriation of resident property” in violation of federal regulations and could result in enforcement action including termination from Medicare and Medicaid. CMS said it hasn’t received any specific complaints but wanted to ensure residents knew their rights and nursing homes understood the consequences. The warning to nursing homes came after lawmakers in the House and Senate wrote the agency expressing “concern regarding reports of some nursing homes and assisted living facilities requiring their residents on Medicaid to sign over their economic impact payments,” according to a June 8 letter from House Ways and Means Committee Chairman Richard Neal (D-MA) and Subcommittee on Health Chairman Frank Pallone, Jr. (D-NJ). The Federal Trade Commission in May issued an alert to consumers about the issue. Senate Finance Committee Chairman Charles Grassley (R-IA) and Ranking Member Ron Wyden (D-OR) also have asked the Department of Health and Human Services (HHS) Office of Inspector General to investigate and issue alerts to raise awareness. 

June 8—CMS issued guidance for non-governmental health plans on the requirement under the Families First Coronavirus Response Act to cover COVID-19 diagnostic testing and certain related items and services without cost-sharing or medical management. The guidance also discusses the temporary relaxed enforcement of certain timeframes related to group market requirements and expanding access to telehealth options and prescription drugs during the pandemic.

Department of Health and Human Services

June 11—HHS awarded $8 million to nonprofit organizations to provide training and technical assistance to health centers for preventing and responding to the COVID-19 pandemic. According to HHS, the awards will go to 73 organizations, including $6 million to Primary Care Associations and $2.5 million to National Training and Technical Assistance Partners. “This funding helps improve and build partnerships so health centers and other local organizations can coordinate their COVID-19 response and efforts to continue delivering care during the pandemic,” HHS Secretary Alex Azar said.

June 9—HHS is distributing $15 billion in provider relief funds under the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) to eligible providers that participate in Medicaid and the Children’s Health Insurance Program and haven’t yet received any payments. HHS also is distributing $10 billion in aid this week to safety net hospitals, which serve a disproportionate number of uninsured and low-income patients. The agency has faced criticism for delays in distributing relief funds to Medicaid providers and safety net hospitals. Last week, a bipartisan group of House and Senate lawmakers questioned the agency about the delays. Congress set aside $175 billion in the Public Health and Social Services Emergency Fund. to help ease the financial strain on health care providers in the wake of the COVID-19 pandemic. While providers participating in Medicare have received distributions from the emergency fund, the same has not been true for providers that rely on Medicaid for the bulk of their payments. HHS also unveiled an enhanced Provider Relief Payment Portal that will allow Medicaid and CHIP providers to report annual patient revenue. Payments to each provider will be at least 2% of reported ross revenue from patient care, with the final amount based on reported data including the number of Medicaid patients, the agency said. According to HHS, 62% of all providers participating in Medicaid and CHIP have received payments from the $50 billion general distributions the agency already has made. The latest distribution will target the remaining 38% that have not received any funding, many of which are safety net providers.

Food and Drug Administration (FDA)

June 10—The FDA issued an emergency use authorization (EUA) for the first COVID-19 diagnostic test utilizing next generation sequencing technology. The EUA was issued to Illumina, Inc. for the qualitative detection of the virus from respiratory specimens of patients suspected to have COVID-19. The test can help determine the virus’ genomic sequence, which is key to monitoring how the virus mutates, said FDA Commissioner Dr. Stephen Hahn, MD.

National Institutes of Health 

June 10—The National Institute on Minority Health and Health Disparities (NIMHHD) is accepting applications through December 15 for research on using existing digital interventions to help consumers and clinicians manage the social, behavioral, and economic effects of COVID-19 among vulnerable populations and those who experience health disparities. Digital interventions may use phone or video delivery, app-based approaches, web-based platforms, wearable devices, and/or new technologies, according to the notice. The research will focus “particularly on NIH-designated health disparity (racial/ethnic minorities, less privileged socioeconomic status, rural residents and sexual and gender minorities) and other populations with medical or social vulnerabilities,” the notice said.

June 10—NIMHHD also is accepting applications through December 15 for supplemental funding of research to examine community interventions to reduce the impact of COVID-19 on populations who experience health disparities and on other vulnerable groups. For example, research topics could include local or state policy interventions to mitigate COVID-19 exposures and their impact on cases, hospitalizations, or deaths among populations who experience health disparities or among other vulnerable groups.

Other Developments

June 10—Diagnostic testing for COVID-19 could cost between $6 billion and $25 billion annually, according to a new study released by America’s Health Insurance Plans (AHIP). The study, prepared by Wakely Consulting Group, also found antibody testing could cost between $5 billion and $19 billion per year. Because of the uncertainty in testing strategies, “the total cost of testing will be less than the combination of the costs of diagnostic and antibody tests,” AHIP noted.