CMS Turns to “Reopening” Movement with New Set of Regulatory Changes

The federal agency has been churning out waivers and adjustments on a rolling basis during recent weeks.

Another day, another set of Centers for Medicare & Medicaid Services (CMS) regulatory adjustments amid the continuing COVID-19 viral pandemic.

But this one is a little different.

The federal agency unveiled yet another round of changes on Thursday, this time with the aim of taking “action to ensure states and localities have the flexibilities they need to ramp up diagnostic testing and access to medical care, key precursors to ensuring a phased, safe, and gradual reopening of America,” in their own words.

A little more than half of U.S. states have announced mostly cautious first steps toward reopening public facilities and lifting lockdown requirements, although questions and concerns abound in light of a glaring lack of any cohesive or comprehensive federal plan for testing and contact tracing, two elements public health officials have said need to be part and parcel of any viable strategy to avoid a resurgence of infection.

The virus has infected more than 1 million and killed 60,000 Americans, by far the highest such totals of any nation, and 30 million residents across the country have filed for unemployment benefits since early March, sparking a budding financial crisis of historic proportions.

“Today’s actions are informed by requests from healthcare providers, as well as by the Coronavirus Aid, Relief, and Economic Security Act, or CARES Act,” CMS’s 2,600-word press release announcing the new regulatory changes read. “CMS’s goals during the pandemic are to 1) expand the healthcare workforce by removing barriers for physicians, nurses, and other clinicians to be readily hired from the local community or other states; 2) ensure that local hospitals and health systems have the capacity to handle COVID-19 patients through temporary expansion sites (also known as the CMS Hospital Without Walls initiative); 3) increase access to telehealth for Medicare patients so they can get care from their physicians and other clinicians while staying safely at home; 4) expand at-home and community-based testing to minimize transmission of COVID-19 among Medicare and Medicaid beneficiaries; and 5) put patients over paperwork by giving providers, healthcare facilities, Medicare Advantage and Part D plans, and states temporary relief from many reporting and audit requirements so they can focus on patient care.”

“I’m very encouraged that the sacrifices of the American people during the pandemic are working. The war is far from over, but in various areas of the country, the tide is turning in our favor,” CMS Administrator Seema Verma said in a statement. “Building on what was already extraordinary, unprecedented relief for the American healthcare system, CMS is seeking to capitalize on our gains by helping to safely reopen the American healthcare system in accord with President Trump’s guidelines.”

The new changes are anticipated to apply for the duration of the current federal Public Health Emergency declaration. Providers and states don’t need to apply for the blanket waivers.

Some of the highlights of the regulatory changes included the following:

• CMS is now requiring nursing homes to inform residents, their families, and representatives of any COVID-19 outbreaks in their facilities.
• Medicare will no longer require an order from a treating physician or other practitioner for beneficiaries to undergo COVID-19 testing and certain laboratory tests required as part of a COVID-19 diagnosis.
• Pharmacists will now be permitted to work with a physician or other practitioner to provide assessment and specimen collection services, and the physician or other practitioner can bill Medicare for the services. Pharmacists also can perform certain COVID-19 tests if they are enrolled in Medicare as a laboratory, in accordance with a pharmacist’s scope of practice, meaning that beneficiaries can get tested at “parking-lot” style test sites operated by pharmacies and other entities, consistent with state requirements.
• CMS will pay hospitals and practitioners to assess beneficiaries and collect laboratory samples for COVID-19 testing, and make separate payment when that is the only service the patient receives. This builds on previous action to pay laboratories for technicians to collect samples for COVID-19 testing from homebound beneficiaries and those in certain non-hospital settings.

“To help facilitate expanded testing and reopen the country, CMS is announcing that Medicare and Medicaid are (also) covering certain serology (antibody) tests, which may aid in determining whether a person may have developed an immune response and may not be at immediate risk for COVID-19 reinfection,” the press release read. “Medicare and Medicaid will cover laboratory processing of certain FDA-authorized tests that beneficiaries self-collect at home.”

For additional background information on the new waivers and rule changes, further detailing steps taken to advance each of the aforementioned numbered agency goals, go online to https://www.cms.gov/newsroom/fact-sheets/additional-backgroundsweeping-regulatory-changes-help-us-healthcare-system-address-covid-19-patient.

For more information on the COVID-19 waivers and guidance, and the Interim Final Rule, please go to the CMS COVID-19 flexibilities web page: https://www.cms.gov/about-cms/emergency-preparedness-response-operations/current-emergencies/coronavirus-waivers.