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May 01, 2020

Health Law Weekly

COVID-19: Updates and Developments (Week of April 27)

  • May 01, 2020

The Centers for Medicare & Medicaid Services (CMS) issued April 30 another round of blanket waivers to provide additional flexibilities for ramping up diagnostic testing and expanding access to telehealth for Medicare and Medicaid beneficiaries.

“Testing is vital, and CMS’s changes will make getting tested easier and more accessible for Medicare and Medicaid beneficiaries,” CMS Administrator Seema Verma said in statement.

Under the temporary waivers and rule changes, Medicare beneficiaries can be tested for COVID-19 without a physician’s order. Instead, Medicare will cover COVID-19 tests when ordered by any health care professional authorized to do so under state law.

CMS also is allowing pharmacists to perform certain COVID-19 tests if they are enrolled in Medicare as a laboratory. According to CMS, the changes will open the door for more “point-of-care” testing.
Medicare and Medicaid also will cover antibody tests that are authorized by the Food and Drug Administration (FDA).

Beyond its efforts to expand testing, CMS is waiving limits on the types of practitioners who can provide telehealth services and is allowing hospitals to bill Medicare as the originating site for services furnished remotely by hospital-based practitioners to registered outpatients, including when the patient is at home.

Many services for behavioral health and patient education may now be conducted by audio-only telephone between beneficiaries and clinicians, CMS said. The agency also is increasing payments for telephone visits from the current $14-$41 to $46-$110, in line with payments for similar office and outpatient visits. The payments are retroactive to March 1.

CMS will be adding new telehealth services through sub-regulatory guidance during the public health emergency, rather than using notice-and-comment rulemaking, the agency said.

To implement the Coronavirus, Aid, Relief, and Economic Security Act (CARES Act), Medicare will pay for telehealth services provided by rural health clinics and federally qualified health clinics, which previously could not be paid as “distant sites.”

In addition, CMS announced more steps to expand hospital capacity, including allowing providers to increase the number of beds for COVID-19 patients without affecting their Medicare payments; enabling inpatient rehabilitation facilities to accept patients from hospitals experiencing a surge even if the patient doesn’t require rehabilitation care; and paying for outpatient hospital services like wound care, drug administration, and behavioral health services that are delivered in temporary expansion locations.

As mandated by the CARES Act, CMS will now allow nurse practitioners, clinical nurse specialists, and physician assistants to provide home health services.

As urged by providers, CMS also is adjusting its methodology for assessing Accountable Care Organizations’ performance for purposes of the Medicare Shared Savings Program to account for COVID-19 costs. Instead of the annual application cycle for 2021, ACOs will have the option to extend for another year at their current risk level and won't automatically be advanced to the next risk level.

Testing and Further Legislation

In other developments this week, the White House issued April 27 guidelines for ramping up COVID-19 testing nationwide as the administration pivots to focusing on reopening the economy.

The Testing Blueprint is “designed to facilitate State development and implementation of the robust testing plans and rapid response programs” called for in the administration’s reopening guidelines, according to the document.

The blueprint calls for a partnership between federal, state, local, and tribal governments, as well as the private sector. Under the blueprint, the federal government will provide “strategic direction and technical assistance” and serve as “a supplier of last resort.”

Democratic leaders continue to push for another round of major stimulus legislation, though the timing of a follow-on measure to the $2 trillion CARES Act remains unclear. President Trump signed April 24 an $484 billion interim relief measure, which included an additional $75 billion in aid for providers, as well as $320 billion for the popular small business loan program, and $25 billion for COVID-19 testing,

In an interview April 26, House Speaker Nancy Pelosi (D-CA) said the next stimulus measure would include funding for state and local governments, which are facing substantial budget shortfalls because of their COVID-19 response efforts and lost revenues.

Governors have asked Congress for $500 billion in relief. According to published reports, Pelosi plans to seek significantly more than that--$1 trillion—for state and local governments in the next legislative push.

Some Republicans, however, are putting the brakes on the next round of stimulus. “The Senate must focus on concrete steps to strengthen our response to this complex crisis. We cannot get distracted by pre-existing partisan wish-lists or calls to paper over decades of reckless decisions that had nothing to do with COVID-19,” said Senate Majority Leader Mitch McConnell (R-KY)

McConnell also signaled that the Senate, which is expected to reconvene next week, would be considering additional liability protections for health care providers and businesses. “The brave healthcare workers battling this virus and the entrepreneurs who will re-open our economy deserve strong protections from opportunistic lawsuits. Some such protections were included in the bipartisan CARES Act. We will need to expand and strengthen them,” McConnell said.

In an April 28 letter, Senate Democrats called on McConnell to “make COVID-19 related matters and oversight of all COVID-related legislation enacted by Congress the Senate’s focus.”

Senate Minority Leader Chuck Schumer (D-NY), along with other Democratic leadership, requested a series of oversight hearings, including on testing capabilities and capacity and the best ways to protect frontline workers.

Agency Action

Department of Health and Human Services (HHS)

April 30—HHS awarded $20 million to help increase access to telehealth for providers, pregnant women, children, adolescents, and families. The Health Resources and Services Administration’s (HRSA's) Maternal and Child Health Bureau awarded $15 million to four recipients to support pediatric care, maternal health care, state public health systems, and family engagement for children with special health care needs. HRSA’s Federal Office of Rural Health Policy awarded another $5 million to two recipients to assist telehealth clinicians nationally on licensure and credentialing.

April 27—HHS launched a new COVID-19 Uninsured Program Portal for providers to submit claims for reimbursement of COVID-19 testing or treatment rendered to uninsured individuals on or after February 4. Health care providers can request reimbursement electronically through the portal for testing and treating uninsured patients for COVID-19. Reimbursement generally will be at Medicare rates, HHS said. As previously announced by the agency, HHS will use a portion of the $100 billion of funding set aside in the CARES Act for health care providers to pay for testing and treatment of the uninsured.

Centers for Medicare & Medicaid Services

April 30—CMS announced a new independent Commission to assess the nursing home response to the COVID-19 pandemic. CMS Administrator Seema Verma said the Commission will make recommendations “to further enhance efforts at the federal, state and local level, and help strengthen the Nation’s response to Coronavirus and keeping residents safe in nursing homes,” which have seen large clusters of cases during the the COVID-19 pandemic. The Commission, expected to convene in late May, will include industry experts, family members, clinicians, resident/patient advocates, medical ethicists, administrators, academicians, infection control and prevention professionals, state and local authorities, and other selected experts. The recommendations will focus on three areas: ensuring residents are protected from COVID-19 and improving the responsiveness of care delivery; strengthening efforts to enable rapid and effective identification and mitigation of COVID-19 transmission (and other infectious disease) in nursing homes; and enhancing strategies to improve compliance with infection control policies in response to COVID-19. The Commission also will consider potentially innovative approaches to using nursing home data to coordinate federal, state, and local government efforts to address the spread of COVID-19 in nursing homes, CMS said.

April 26—CMS is reevaluating its Accelerated Payment Program and suspending its Advance Payment Program (APP) to Part B suppliers effective immediately. CMS said it has distributed $100 billion to health care provider and suppliers through the programs. The agency in late March expanded the programs to help providers and suppliers facing cash flow problems because of significant disruptions in claims submission or claims processing as a result of the COVID-19 pandemic. According to CMS, it has approved more than 21,000 applications totaling $59.6 billion in payments to Part A providers and 24,000 applications totaling $40.4 billion in payments to Part B suppliers. The payments are loans that suppliers must pay back. Starting April 26, CMS will no longer accept new applications for the APP and will reevaluate all pending and new applications for Accelerated Payments in light of the $175 billion Provider Relief Fund made available under the CARES Act and the interim relief measure enacted last week. The $175 billion is distributed as grants that do not need to be repaid. In an April 26 letter to CMS Administrator Seema Verma, the American Medical Group Association (AMGA) urged the agency to reverse its decision to suspend the APP and “instruct the Medicare Administrative Contractors to continue processing loan requests for both Part A and Part B providers.” The group argued that the Provider Relief Fund and the APP “serve two very distinct purposes,” with the former intended to offset lost revenue and expenses associated with COVID-19 and the latter aimed at minimizing disruption in providers’ cash flow. “CMS may believe the Provider Relief Fund represents sufficient financial support, but, unfortunately, this is not the case. Healthcare providers are in desperate need of more support, not less,” AMGA said.

National Institutes of Health (NIH)

April 29—NIH is looking to jump start innovation for COVID-19 testing technologies with a $1.5 billion investment from federal stimulus funds in the newly launched Rapid Acceleration of Diagnostics (RADx) initiative. As part of the initiative, NIH is urging scientists and investors to compete in a $500 million national challenge to identify the best candidates for at-home or point-of-care tests for COVID-19. “We need all innovators, from the basement to the boardroom, to come together to advance diagnostic technologies, no matter where they are in development,” said NIH Director Francis S. Collins, M.D., Ph.D. NIH said the initiative is aimed at making millions of tests per week available to all Americans by the end of the summer, and even more by flu season.

Substance Abuse and Mental Health Services Administration (SAMHSA)

April 27—SAMHSA expanded awards to community-based behavioral health clinics  with $250 million in emergency COVID-19 funding. The funding is an addition to $200 million in annual appropriations for clinics that provide community mental and substance use disorder treatment services.

Other Developments

April 29—The long term care industry is urging federal and state governments to expand funding for testing and protective equipment for frontline staff in the nation’s nursing homes, which have been at the epicenter of the COVID-19 outbreak. The American Health Care Association and National Center for Assisted Living (AHCA/NCAL) said despite recent data showing the disproportionate impact of the novel coronavirus on long term care residents, nursing homes and assisted living communities have not been prioritized for supplies, testing, or resources. “Our profession has been sounding the alarm for weeks and weeks, but we have largely been forgotten by the public health sector. If we are not made a top priority, this situation will get worse with the most vulnerable in our society being lost,” said AHCA/NCAL President and CEO Mark Parkinson. Parkinson said the federal government should provide an emergency response fund for long term care facilities like it did for hospitals.

April 28—Provider, insurance, and business groups are urging Congress to take action to protect and expand affordable health care coverage in the wake of the COVID-19 pandemic, including unemployment insurance and Medicaid. In a letter to House and Senate leaders, groups including the American Hospital Association, Blue Cross Blue Shield Association, and the U.S. Chamber of Commerce said “millions” will lose health coverage without further legislative action. Congress, in the next round of stimulus legislation, should, among other things, provide employers with temporary subsidies to preserve health benefits; cover the cost of COBRA coverage; expand use of health savings accounts; open a special enrollment period for the Affordable Care Act marketplaces; and increase eligibility for federal subsidies through the marketplaces.