Health Law Scan

Legal Insights and Perspectives for the Healthcare Industry

In a stunning move, the Centers for Medicare and Medicaid Services (CMS) has linked reporting and tracking of the incidence and impact of the coronavirus (COVID-19) disease to satisfaction of the Medicare Conditions of Participation (CoPs) for hospitals and critical access hospitals, in spite of the federal about-face that has caused confusion concerning that same reporting since the inception of the pandemic.

CMS’s Interim Final Rule (IFR) applies to a large variety of healthcare and non-healthcare providers that are currently testing for coronavirus. Hospitals, employers, and other entities are struggling to ensure they comply with an ever-changing landscape of local, state, and federal reporting requirements. However, this recent IRF subjects these entities to fairly stout enforcement consequences for failure to stay current, comply, and perform. CMS released its IFR with comment for public display on August 25 with publication in the Federal Register on September 2, 2020. Comments are due 60 days after publication.

The interim final rule was so abruptly issued that several healthcare trade association issued searing critiques, charging that the administration’s “heavy handed” approach threaten to expel hospitals and other providers from the Medicare and Medicaid programs at a time when these very organizations are on the front lines in the fight against COVID-19.

 Updated Regulations

In the more than 220 pages of the IFR, CMS updates regulations regarding supplemental medical insurance benefits, payment for end-stage renal disease (ESRD) services, updates to several Healthcare Common Procedural Coding System (HCPCS) codes, changes to Medicare Advantage calculation of star ratings, requirements for states and long-term care facilities (LTFs), infection control CoPs for hospitals, and condition level deficiency regulations for laboratories and those laboratories that have Clinical Laboratory Improvement Amendments (CLIA) waivers.

CMS makes clear that failure to perform can result in significant civil monetary penalties (CMPs) and, in the most egregious circumstances, violate the Medicare CoPs, which would threaten a facility’s Medicare certification and ability to stay in business.

 Information Reporting

The hospital CoPs for hospitals and specialized entities, such as Critical Access Hospitals (CAHs), were amended to require that during the COVID-19 public health emergency, these entities report information “in accordance with the frequency as specified by the Secretary [of Health and Human Services] on COVID-19 in a standardized format specified by the Secretary.”

The issue of reporting the results of COVID-19 tests appears to change with some frequency, and often can be confusing with states, local health departments, and the federal government all making demands on entities that test. There have been instances reported in which data was submitted by hospitals, but the data had not made it through the “HHS approved” data hub. CMPs would be imposed for failure to report.

With regard to LTFs, the IFR contains equally punitive provisions, which immediately implement a new enforcement regulation requiring weekly facility reporting of suspected and/or confirmed COVID-19 cases, including the requirement that facilities have written standards, policies, and procedures regarding infection control. Nursing homes are required to report COVID-19-related facility data to the CDC’s National Healthcare Safety Network (NHSN). The new CMS reporting requirements do not preclude LTFs from additionally assuring compliance with state and local public health reporting laws.

The IFR also clarifies the need for a physician order for the performance of a COVID-19 test or a test for influenza that would help to rule out COVID-19. This clarification is presumed to resolve several payment and reimbursement issues associated with orders and tests performed relating to COVID-19 for patients.

In further implementation of the CARES Act laboratory reporting requirements, Section 18115, the regulations add condition level requirements that apply to all CLIA certified laboratories performing SARS-CoV-2 testing. Per Section 18115, “Every laboratory that performs or analyzes a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 shall report the results from each test to the Secretary of Health and Human Services in such form and manner, and at such timing and frequency, as the Secretary may prescribe until the end of the Secretary’s Public Health Emergency.”

Concurrent with the issuance of the IFR, CMS issued a memo to State Survey Agency Directors, dated August 26, 2020, which provided instruction to surveyors. The memo specifies that the IFR changes are intended to update the CLIA SARS-CoV-2 test result reporting provisions. This guidance makes clear, in bold print, that “health care facilities using Point of Care COVID-19 testing devices under a CLIA Certificate of Waiver, including nursing homes, pharmacies, or other settings[,] will be required to report test results under this regulation. The regulations add enforcement provisions and CMPs of a minimum of $1,000 for the first day of noncompliance, with an incremental $500 increase for each additional day of noncompliance.

Given the variety of entities performing testing and the significant variations across localities, states, and even changes occurring in reporting at the federal level, the amount of confusion regarding how to comply effectively will be high. The burdens associated with ensuring compliance with the variety of reporting mechanisms should be the subject of industry commentary regarding the need to focus on patient care and the testing of patients, rather than complying with complex and confusing reporting mechanisms.