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June 19, 2020

Health Law Weekly

COVID-19 Updates and Developments (Week of June 15)

  • June 19, 2020

As the reliance on telehealth services has continued to grow during the COVID-19 pandemic, lawmakers are calling for the expansion to be permanent after the public health emergency is over.

In a June 15 letter to Senate leaders, a bipartisan group of 30 lawmakers said provisions in earlier-passed coronavirus aid packages “have resulted in an important expansion of access to telehealth services for Medicare beneficiaries during the pandemic.”

The Coronavirus Preparedness and Response Supplemental Appropriations Act and the Coronavirus Aid Relief and Economic Security Act included provisions from the Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act, which was first introduced in 2016 as comprehensive telehealth legislation. The provisions will expire, however, after the public health emergency ends.

According to the letter, available data show the number of Medicare beneficiaries using telehealth services increased dramatically during the pandemic. “Expanded Medicare coverage of telehealth services on a permanent basis—where clinically appropriate and with appropriate guardrails and beneficiary protections in place—would ensure that telehealth continues to be an option for all Medicare beneficiaries after the pandemic ends,” the lawmakers said.

The letter to Senate Majority Leader Mitch McConnell (R-KY) and Minority Leader Charles Schumer (D-NY) said extending the changes also will “assure patients that their care will not be interrupted when the pandemic ends” and help encourage health care providers to invest in telehealth for the long term.

The lawmakers also said the federal government should collect and analyze data on the impact of telehealth on utilization and the quality of care, information that could be used to craft future policies.

At a hearing on the issue this week, Senate Health, Education, Labor, and Pensions Committee Chairman Lamar Alexander (R-TN) said he supported making at least two temporary changes permanent: allowing physicians to be reimbursed for a telehealth visit regardless of the patient’s location and maintaining the policy that nearly doubled the telehealth services that Medicare covers. He added other changes also could be on the table in discussions of what temporary federal policies to extend on a permanent basis.

Joseph C. Kvedar, the President of the American Telemedicine Association (ATA) and a Harvard Medical School professor, told the panel that reimbursement challenges are the “most critical barrier at the federal level to the provision of telehealth in a post-pandemic world.” He added that “technology and telehealth infrastructure remain a critical need.”

In the House, Representatives Glenn Thompson (R-PA) and G.K. Butterfield (NC) introduced last week the bipartisan Helping Ensure Access to Local Telehealth (HEALTH Act) to codify Medicare reimbursement for community health centers and rural health clinics for telehealth services.

"The HEALTH Act will cut red tape and provide community health centers and rural health clinics the ability to offer these vital services to their patients on a more permanent basis,” Thompson said.

Agency Action

Health and Human Services (HHS)

June 16—HHS is aiming to have 300 million doses of a COVID-19 vaccine available by January 2021, according to a fact sheet posted by the agency. The push to speed the availability of vaccines and treatments for COVID-19 is part of a multi-agency initiative the administration has dubbed Operation Warp Speed.

Centers for Medicare & Medicaid Services (CMS)

June 12—CMS is extending the deadline for health insurers to report their medical loss ratio (MLR) for 2019 and is giving them additional flexibility to prepay enrollee rebates to support continued coverage for those who may struggle to pay premiums during the COVID-19 pandemic, according to an informational bulletin. The Affordable Care Act and implementing regulations require health insurance companies in the individual and small group markets to spend at least 80% of premium dollars (85% in the large group market) they collect on medical care or activities to improve health care quality. Issuers that fall short of the MLR standard must pay rebates to make up the difference. Insurers must submit an Annual MLR Reporting Form to CMS by July 31 and generally must pay rebates no later than September 30 (or apply premium credits to the first month’s premium due on or after September 30). As a result of updates to the 2019 Benefit Year Risk Adjustment time line, CMS acknowledged that issuers may need additional time to complete and submit their 2019 MLR Annual Reporting Form and extended the deadline until August 17. CMS also said it would not take enforcement action against issuers that elect to pay a portion or all of their estimated 2019 MLR rebates prior to September 30 in advance of submitting their 2019 MLR Annual Reporting Form.

Food and Drug Administration (FDA)

June 18—FDA announced a public-private partnership to advance the development of COVID-19 diagnostics. The project, called the COVID-19 Diagnostics Evidence Accelerator, is organized by the Reagan-Udall Foundation for the FDA in collaboration with Friends of Cancer Research. FDA Principal Deputy Commissioner Amy Abernethy, MD, PhD, said the Diagnostics Evidence Accelerator “will allow the community to analyze both diagnostic and clinical data in real time, which has the potential to contribute to the scientific evaluation of diagnostic tools and medical interventions for COVID-19.”

June 16—FDA revoked the emergency use authorization (EUA) of the Chembio Diagnostic System, Inc. antibody test for COVID-19 citing performance concerns with the accuracy of the test. The Chembio antibody test was one of the first authorized by the FDA. According to the agency, the company’s data as well as an independent review of the test showed “a higher than expected rate of false results.”

June 15—FDA also pulled the EUA for hydroxychloroquine and chloroquine to treat certain patients hospitalized with COVID-19. The agency revoked the EUA, which was granted in March, after concluding that the two drugs, which are commonly used to treat malaria and autoimmune conditions, are unlikely to be effective in treating COVID-19 and that the potential risks, including serious cardiac side effects, outweighed any potential benefits. According to the agency, recent data indicated that the hydroxychloroquine showed no benefit on mortality or in speeding recovery.

Office for Civil Rights (OCR)

June 12—The Health Insurance Portability and Accountability Act (HIPAA) allows health care providers to use protected health information (PHI) to identify and contact recovered COVID-19 patients about potentially donating their blood and plasma that may help treat other patients with the virus, according to recent guidance that OCR released. HIPAA doesn’t require patient authorizations for population-based activities for improving health, case management, and care coordination, which the guidance notes falls under “health care operations.” The guidance emphasizes that the outreach must not constitute marketing (unless the activity meets an exception to the definition of marketing) and should adhere to the “minimum necessary” standard. A hospital also may not disclose PHI about recovered patients to third parties, like blood and plasma donation centers, without an individual authorization.

Occupational Safety and Health Administration (OSHA)

June 18—OSHA issued guidance for non-essential businesses as they begin reopening their workplaces. The Guidance on Returning to Work recommends a three-phase reopening approach, as well as reliance on public health recommendations from the CDC and other federal guidelines. In the first phase, OSHA recommends that businesses continue to allow telework when possible and limit the number of employees in the workplace. Businesses in the second phase can start easing workplace restrictions but should continue to maintain social distancing practices. In phase three, businesses could resume normal operations.

Equal Employment Opportunity Commission (EEOC)

June 17—The Americans with Disabilities Act (ADA) doesn’t allow employers to require antibody testing before allowing employees to return to the workplace, the EEOC warned in an updated guidance document. EEOC previously said employers could require employees to undergo a diagnostic test for COVID-19 before entering the workplace without running afoul of the ADA.

National Institutes of Health (NIH)

June 15—NIH is launching a centralized platform for medical record data from patients diagnosed with coronavirus across the country. The new platform will collect and aggregate clinical, laboratory, and diagnostic data nationwide into a standard format that will be made available to researchers and health care providers working to improve clinical care. The effort is part of the National COVID Cohort Collaborative (N3C), an initiative focused on analyzing patient data to better understand and treat COVID-19.

Internal Revenue Service (IRS)

June 17—High deductible health plans (HDHPs) may temporarily cover telehealth and other remote care services without a deductible, or with a deductible below the minimum annual deductible otherwise required by law, the IRS said. The temporary rules were put in place under the Coronavirus Aid, Relief, and Economic Security Act. In addition, the IRS said “an otherwise eligible individual with coverage under an HDHP may still contribute to an HSA despite receiving coverage for telehealth and other remote care services before satisfying the HDHP deductible, or despite receiving coverage for these services outside the HDHP.” The temporary rules apply as of January 1, 2020.

Other Action

June 17 & 16—House Energy and Commerce Chairman Frank Pallone, Jr. (D-NJ) is pressing CMS to release Medicare demographic claims data for COVID-19 based on race, ethnicity, and gender. In a June 16 letter to CMS Administrator Seema Verma, Pallone said he requested access to the data nine weeks ago, but the agency has yet to make the information publicly available. Although more data is available on COVID-19 outcomes generally, Pallone said Medicare claims data, which includes specific coding, would provide a trove of information for improving care health outcomes. “It is critical that CMS release this data immediately in order to effectively respond to and address clear demographic disparities in care that have become apparent as a result of the COVID-19 pandemic but have long persisted in our health care system,” Pallone wrote. Pallone cited multiple reports and data from the Centers for Disease Control and Prevention (CDC) that individuals of color are dying from COVID-19 at disproportionately higher rates. The Energy and Commerce Subcommittee on Health held a hearing June 17 on racial and ethnic disparities in COVID-19 and the health system. In his opening remarks, Pallone noted that Verma publicly committed in April to releasing the data. Earlier this month, HHS required COVID-19 test labs to report demographic data. But Subcommittee Chair Anne Eshoo (D-CA) said the move came two months after Congress enacted legislation requiring the agency to analyze racial disparities for COVID-19 and pointed out that the new requirements don’t go into effect until August 1.

June 16—The House Select Subcommittee on the Coronavirus Crisis is launching a sweeping probe of the nursing home industry in light of the COVID-19 pandemic. Nursing homes, with their vulnerable populations, have been at the epicenter of the crisis. Representative James Clyburn (D-SC), who chairs the panel, sent letters to five industry executives asking for documents and information on COVID-19-related deaths in their companies’ nursing homes, potential contributing factors, and steps taken to safeguard residents and workers from future outbreaks. The letters were sent to the CEOs of Genesis HealthCare, Life Care Centers of America, Ensign Group, Consulate Health Care, SavaSeniorCareSava and asked for a response by June 30. The panel also sent a letter to CMS Administrator Seema Verma requesting information on the agency’s efforts to protect nursing home residents. The panel cited concerns that “lax oversight by [CMS] and the federal government’s failure to provide testing supplies and personal protective equipment to nursing homes and long-term care facilities may have contributed to the spread of the coronavirus and the deaths of more than 40,000 Americans in these facilities.”

June 15—The American Hospital Association issued a fact sheet detailing the regulatory and legislative action that would be needed to make current telehealth flexibilities permanent after the COVID-19 public health emergency ends.