CMS Announces Testing Rule, Details About Provider Relief, Antigen Testing and PPE on Wide-Ranging Stakeholder Call

Regulation | August 25, 2020 | by Ruth Katz, Allison Ciborowski

CMS held a wide-ranging stakeholder call today to discuss a number of hot topics related to nursing homes.

HHS took the opportunity of the release of the CMS interim final rule on nursing home testing and CLIA reporting (article here) to update on several related activities. The CMS Stakeholder Update Call was announced at 2:30 today and held at 4:30.

Administrator Seema Verma started with a top line summary of the new rule, “a dramatic ramp up to control spread of COVID-19,” including that it:

  • Requires testing of nursing home staff and requires offering testing to residents.
  • Requires increased and regular test result reporting by CLIA labs, including nursing homes with CLIA waivers and antigen testing machines. If a lab or test provider does not report, CMS will impose a CMP ranging from $400 to $8,000 and potentially deny payment for new admissions. Labs will have a 3-week grace period to learn the new reporting system.
  • Revises previous policies that allowed repeat COVID-19 testing without a physician’s order. Revised policy that after the first test, Medicare will cover additional tests with an order from a physician. This will prevent fraud and ensure individuals are getting appropriate medical care.
  • CMS also announced a new infection control training program. CMS Targeted COVID-19 Training for Frontline Nursing Home Staff and Management”. Read the announcement here. This training is designed for both front-line staff and nursing home management, with separate training modules for each (5 for front-line staff, 10 for management). This self-paced training is available immediately on the CMS Quality, Safety & Education portal and certificates of completion will be available for each course completed. (In a separate call with Katie Sloan, Seema Verma encouraged all types of providers to use the training program, as appropriate.)

Administrator Verma asked Rear Admiral John Polowczyk, Supply Chain Task Force Lead, HHS Office of the Assistant Secretary for Preparedness and Response to provide an update on PPE distribution. He offered the following:

  • N95 distribution: Because of increased production of N95s, will be shipping 1.5 million n95s to nursing homes who need them (based on those who indicated need through NHSN reporting). Shipments will start this Thursday through next week.
  • Additionally, 14 million masks will be deferred from the national stockpile, and sent to targeted markets. Will be sent to the commercial market place, hospitals, nursing homes, first responders, trying to provide additional commercial volume for those facilities to purchase.
  • It was noted that “We are fundamentally in a different place than we were back in March or April.” The country now has 120,000 ventilators ready to deploy. States now have 30-60 day supply on hand of PPE.

Finally, she turned to Admiral Brett Giroir, MD, HHS Assistant Secretary for Health, and Testing Lead for the White House Coronavirus Task Force, for an update on distribution of antigen testing machines and materials. He reported that 5,593 nursing homes had already received antigen testing machines. By the end of September all nursing homes with CLIA waivers (about 14,800) will have the machines. He added that over two million test kits had also been shipped, enough to test each staff members at least twice and that nursing homes would be able to order additional tests (no details provided on that).

Administrator Verma added that FDA had released an FAQ yesterday, clarifying that if highly sensitive tests are not available, health care providers should screen asymptomatic people with a less sensitive, point of care test. She clarified that negative antigen tests on asymptomatic people do not have to be repeated, per the new FAQ.

Finally, she reported that $2.5 billion of the $5 billion in Provider Relief Funds that were announced in July will likely be available to nursing home providers this week, for testing and related costs.