On August 25, 2020 the Centers for Medicare & Medicaid Services (CMS) issued interim final regulations known as CMS-3401-IFC that become effective immediately upon publication in the Federal Register, scheduled for September 2, 2020. Citing the COVID-19 Public Health Emergency (PHE), CMS has used authority under federal law to waive requirements for a proposed rule and a 30-day delay in the effective date, but is accepting comments for a 60-day period. The new regulations remain operative for the duration of the PHE, except as noted in this article.
Here is a brief summary of the regulatory changes:
New CoP Requires Hospitals To Report COVID-19 Data. The Medicare Condition of Participation for Hospitals and Critical Access Hospitals (CAHs) for infection prevention and control is amended to include mandatory COVID-19 reporting in a format and frequency specified by the Department of Health and Human Services (HHS). CMS provides examples of data elements that may have to be reported, including number of staffed and occupied beds, information about supplies and number of inpatients with laboratory-confirmed COVID-19. CMS states that if a hospital or CAH fails to consistently report test results during the PHE, the hospital/CAH will be considered non-compliant with CoPs and subject to penalties under existing law, including termination of its Medicare provider agreement. We note that CMS rarely terminates a provider agreement for non-compliance with a CoP (and only after notice and hearing rights).
Long-Term Care Facilities Subject to CMPs for Failing to Report COVID-19 Data. In a May 8, 2020 rule, CMS mandated that Medicare skilled nursing facilities and Medicaid nursing facilities (collectively, long-term care or LTC facilities) report COVID-19 related facility data on a weekly basis to the CDC. Now under the new rule, CMS is enforcing compliance by providing for civil monetary penalties if a LTC facility fails to submit weekly reporting. CMS may impose a minimum $1,000 the first time a LTC facility fails to submit a timely report; for each subsequent time, CMS will increase the CMP by $500. CMPs may be imposed up to one year after the PHE ends.
Laboratories Subject to CMPs for Failing to Report SARS-CoV-2 Test Results. The Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations are amended to require all laboratories (including labs holding a Certificate of Waiver) to directly report SARS-CoV-2 test results to HHS in the form and manner, and at such timing and frequency, as HHS prescribes. Failure to report test results is a condition level deficiency under CLIA to which CMPs and other sanctions apply.
LTC Facilities Must Test All Residents and Staff for COVID-19. The infection control requirements for LTC facilities to participate in Medicare are amended to require a LTC facility to test all of its residents and facility staff for COVID-19, document the testing and results, and take action to prevent transmission. Facility staff includes employees, contractors and volunteers providing services on-site at the facility. CMS has issued policy guidance on testing of staff and residents, including an updated focused survey tool.
Medicare Coverage of COVID-19 Testing Without Physician Order Now Limited. Effective as of the date of publication of CMS-3401-IFC (scheduled for September 2, 2020), Medicare will, on a going forward basis, pay for one COVID-19 diagnostic test and one of each other related tests that are obtained by a Medicare beneficiary without an order from a physician or other practitioner. This reverses CMS’s prior policy and regulatory change announced on May 8, 2020, which allowed for broad coverage of multiple instances of COVID-19 testing for a Medicare beneficiary without a physician or other practitioner order. The change to “only one COVID-19 test without an order” applies beginning on the effective date of this new rule (expected this week); any tests furnished previously will not be considered for purposes of this limit on tests without a physician or other practitioner order.
CMS justified this change in policy on the basis of concerns for potential fraud, waste and abuse related to repeated testing without an order and public health and safety issues that could arise from individuals having multiple tests without medical attention or oversight. As a conciliatory measure, CMS announced a new policy potentially expanding health professionals who can order a COVID-19 diagnostic test. CMS states that COVID-19 and related tests are covered by Medicare when ordered by a pharmacist or other health professional authorized to do so under his/her state license. However, we note that under Medicare, a pharmacist or other health professionals not enrolled in Medicare to furnish services, may only provide services “incident to” a physician (or other practitioner) and under the supervision of the physician or practitioner. Thus it is unclear whether this CMS policy change will actually expand a beneficiary’s ability to obtain an order for a COVID-19 test.
Other Data Reporting Changes. CMS-3401-IFC sets forth a number of changes in data reporting as a result of the COVID-19 PHE, including the following: CPT code additions under Merit Based Incentive Payment System (MIPS) to include communications technology-based services and the telephone E/M services in the definition of primary care services; non-enforcement of certain procedural volume requirements for facilities and practitioners to maintain Medicare coverage under specific national coverage determinations (NCDs); updates in extraordinary circumstances exceptions (ECEs) granted on March 22, 2020, for the End Stage Renal Disease (ESRD) Quality Incentive Program (QIP), Hospital Acquired Condition (HAC) Reduction Program, HRRP, and Hospital Value-Based Purchasing (VBP) Program; revision of FY 2022 performance period under the Skilled Nursing Facility Value-Based Purchasing Program (SNF VBP); and application of the extreme and uncontrollable circumstances policy for calculation of the 2022 Medicare Advantage Plans (Part C) and Prescription Drug Plans (Part D) Star Ratings for assessing quality of health and drug services received by beneficiaries.
If you have questions about these new regulations, please contact your McAfee & Taft Healthcare Attorney.