Hospitals, Labs, LTCs Face Big Fines for Failing to Meet New CMS COVID-19 Test Daily Reporting Rules

Nursing and other long-term care (LTC) facilities have been a hotspot for COVID-19 infection since the public health emergency began. On Aug. 27, CMS issued a new Interim rule requiring LTC facilities to take step up their infection control efforts via COVID-19 testing of staff and residents and daily reporting of test results data. Those that fail to comply with the onerous new requirements face the risk of hefty fines and even exclusion from Medicare and Medicaid. Here are what lab managers and compliance directors need to know about the new rule to keep their own facilities out of trouble. Who Must Be Tested All LTC facility residents and staff must be tested for COVID-19. “Staff” is defined as including “any individuals employed by the facility, any individuals that have arrangements to provide services for the facility, and any individuals volunteering at the facility.” That may extend to individuals providing services to the facility “under arrangement,” e.g., a hospice with an agreement to provide care for LTC facility residents. How Testing Must Be Carried Out Testing must be conducted in a manner consistent with professional standards of practices. CMS doesn’t specifically define those standards but says it plans to issue mandatory guidelines on frequency, result response timing, symptoms identification and other testing parameters. How Testing Records Must Be Kept All test results must be appropriately documented in a resident’s medical records or a staff member’s personnel files, depending on who the test subject is. What Testing Policies Are Required LTCs must implement policies and procedures addressing, among other things, situations where residents or staff refuse or can’t be tested, acquisition of and access to testing supplies and emergency staffing strategies. The Labs & Hospital Reporting Requirements The rules also require all labs that are conducting COVID-19 testing and reporting patient-specific results to submit daily test results reports to the HHS Secretary. In addition, hospitals and critical access hospitals must make daily reports of COVID-19 test results done by in-house labs, as well as other data, including, but not limited to:

• The number of confirmed or suspected COVID-19 positive patients;
• ICU beds occupied; and
• Availability of essential supplies and equipment such as ventilators and PPE.

Takeaway The hospital and lab industries are less than thrilled with the new rule. It’s not just that the requirements are so burdensome and the penalties for violations so high—civil monetary penalties of $1,000 per day for the first day and $500 per subsequent day the violation continues and potential Medicare exclusion. Equally upsetting is that CMS put the rule into effect so suddenly and without morning. Thus, the reporting obligations officially took effect on Sept. 2, just one day after they were published. The only consolation was that labs got a one-time, three-week grace period to begin reporting the required test data. The statement from American Hospital Association President and CEO Rick Pollack expresses the frustration and angst perfectly. While supporting the effort to get the government the public data it needs to control the pandemic, Pollack describes the new rule as “heavy-handed.” “This disturbing move, announced in final form without consultation, or the opportunity to provide feedback through appropriate administrative procedures prior to it becoming effective, could jeopardize access to care and leave patients and communities without vital health services from their local hospital during a pandemic.”