August 26, 2020

CMS Releases Interim Rule that ties COVID-19 Data Reporting to Hospital Conditions of Participation

Holland & Knight Healthcare Blog
Miranda A. Franco
Healthcare Blog

On Aug. 25, the Centers for Medicare and Medicaid Services (CMS) issued an interim final rule (IFR) as an emergency regulation under the public health emergency (PHE). Under the IFR, CMS will require all hospitals to which the requirements of 42 CFR part 482 apply — including short-term acute care hospitals, long-term care (LTC) hospitals, rehabilitation hospitals, psychiatric hospitals, cancer hospitals, children's hospitals and critical access hospitals (CAHs) — to provide the U.S. Department of Health and Human Services (HHS) with daily updates on specific data related to the coronavirus as a condition of participation (CoP) in Medicare and Medicaid.

The data will include, but is not limited to, statistics on a hospital's number of suspected or confirmed patients with COVID-19, the disease caused by the coronavirus; the number of occupied intensive care unit (ICU) beds; and supplies of equipment essential for treating patients infected with the coronavirus, such as personal protective equipment (PPE) and ventilators.

CMS notes that the items mentioned above are not exhaustive of the data items the agency may require hospitals to submit. CMS directs readers of the IFR to July guidance for the current list of specified data items. The new standards will require hospitals and CAHs to report information on COVID-19 in a standardized format and at a frequency and manner specified by the secretary of HHS.

Notably, CMS states that it lacks the statutory authority to impose civil monetary penalties (CMPs) against hospitals and CAHs; however, intermediate penalties such as CMPs have been an extremely useful tool in enforcing reporting requirements for nursing homes, helping to achieve 98 percent compliance. Therefore, CMS will continue to utilize all enforcement and payment authorities available to incentivize and promote compliance with all health and safety requirements as allowed by statute and regulation.

CMS is also changing lab reporting requirements through Clinical Laboratory Improvement Amendments (CLIA). CMS will implement the Coronavirus Aid, Relief, and Economic Security (CARES) Act requirements that laboratories report COVID-19 test results daily to HHS, and all labs — including those in hospitals, nursing homes and other facilities — will be required to comply. If a lab doesn't report, CMS will impose a civil monetary penalty of $1,000 for the first day and $500 for each following day. CMS notes that labs will have a one-time, three-week grace period to begin reporting the required data.

The IFR also will limit Medicare coverage for repeated coronavirus testing for beneficiaries to only one test unless repeat testing is ordered by a physician or practitioner; suspend enforcement of national coverage decision volume requirements regarding Medicare payments for certain cardiac procedures; establish new weekly COVID-19 reporting requirements for nursing homes and update CMS's extraordinary circumstances exceptions policies for several Medicare quality programs.

Related Insights