The Centers for Medicare & Medicaid Services (CMS) has issued an interim final rule with comment period (IFC). The rule is effective upon publication in the Federal Register. CMS will accept comments for 60 days after it is published. The interim final rule’s major provisions include:

  • Mandatory COVID-19 data reporting for hospitals and critical access hospitals (CAHs) as a Condition of Participation (CoP)
  • Mandatory COVID-19 data reporting for nursing homes and laboratories, with penalties for noncompliance
  • Require nursing homes to test residents and staff for COVID-19 based on parameters set by the Department of Health and Human Services (HHS)
  • Excluding data reported for first and second quarter 2020 (Q1 and Q2 2020) from End-Stage Renal Disease Quality Incentive Program (ESRD QIP), Hospital-Acquired Condition (HAC) Reduction Program, Hospital Readmissions Reduction Program (HRRP), and Hospital Value-Based Purchasing (VBP) Program
  • Limit Medicare payment to one COVID-19 test and one of each related test, such as tests for similarly presenting viruses, for a single beneficiary without a physician or practitioner order

GNYHA is concerned with the implications of mandatory reporting for hospitals and CAHs tied to the CoPs given HHS’s constant changes to reporting requirements. The need for timely and accurate data is stymied by HHS’s changes in reporting portals, weekly changes in data elements, and lack of clarity in data specifications. We continue to monitor CMS’s activities and plan to submit comments during the IFC comment period.

Please see below for details on each provision.

Mandatory COVID-19 Reporting Requirements

Hospitals and CAHs

The IFC makes the administration’s previous request for COVID-19 data reporting a CoP for Medicare and Medicaid for hospitals and CAHs. Facilities must report COVID-19 data as specified by the HHS Secretary during the public health emergency. The current list of data elements can be found here. Daily reporting includes data related to capacity and utilization, remdesivir use and supplies, and critical staffing shortages and reporting on personal protective equipment supplies on Mondays, Wednesdays, and Fridays. Under the IFC, failure to report the required data can result in a finding of non-compliance with the CoPs and termination from the Medicare program if corrective action is not taken. To fulfill the HHS reporting requirement, hospitals must submit data to the TeleTracking COVID-19 portal. For the most recent changes and updates to the TeleTracking portal, please see the August 13 bulletin. Hospital laboratories are also subject to the reporting requirements and penalties described below.

Nursing Homes

The IFC mandates that nursing homes report weekly COVID-19 facility data to the Centers for Disease Control and Prevention’s National Healthcare Safety Network. Facilities that fail to meet reporting requirements will receive a civil monetary penalty (CMP) of $1,000 with the penalty increasing by $500 for each additional missed reporting period, with penalties not to exceed $6,500 per occurrence of noncompliance. That means, for the first reporting period a facility fails to meet requirements, they will receive a CMP of $1,000, $1,500 for the second, $2,000 for the third, and so on. A CMP places a facility back into compliance and a plan of correction is not required. Facilities have the opportunity for Independent Informal Dispute Resolution if specific difficulties prevented timely reporting. These changes are effective at the date of publication and will remain in effect for up to one year beyond the end of the public health emergency.

Laboratories

A June 4 guidance detailed required laboratory reporting from the CARES Act allowing laboratories to report results from COVID-19 testing through existing reporting channels such as state or local health departments. This rule replaces the existing guidance establishing new Clinical Laboratory Improvement Amendments (CLIA) certification requirements for laboratories to submit COVID-19 test results daily to HHS. Failure to meet this requirement will result in a condition level violation of CLIA regulations for which CMPs or other penalties may be applied. Penalties for noncompliance are $1,000 for the first day of noncompliance and an additional $500 for each subsequent day, with penalties not exceeding $10,000 for each day of substantial noncompliance.

Mandatory Resident and Staff COVID-19 Testing for Long-Term Care (LTC) Facilities

CMS is requiring LTC facilities (classified as skilled nursing facilities [SNF] for Medicare and nursing facilities for Medicaid) to conduct resident and staff testing for COVID-19 based on parameters determined by the HHS Secretary. These parameters may include but are not limited to testing frequency, identification of any facility resident or staff diagnosed with COVID-19 in the facility, identification of any facility resident or staff with symptoms consistent with COVID-19 or with known or suspected exposure to COVID-19, return to work criteria for those presenting with COVID-19 symptoms or who test positive for COVID-19, criteria for conducting testing of asymptomatic individuals, the response time for test results, and other factors specified by the HHS Secretary that help identify and prevent the transmission of COVID-19. Facilities must document that testing was completed and the results of each staff test. Staff includes individuals providing services under arrangement (e.g., hospice) and volunteers. Staff who provide services for a facility from an off-site location are not required to be tested.

Updates to CMS Hospital Pay-for-Performance Programs Extraordinary Circumstance Exception (ECE) and FY 2022 SNF VBP Program

CMS made Q4 2019, Q1 2020, and Q2 2020 reporting optional for CMS quality reporting programs in a blanket waiver announced in March with supplemental guidance. The IFC builds on this blanket waiver and excludes Q1 and Q2 2020 data from ESRD QIP, HAC Reduction Program, HRRP, and Hospital VBP Program. Data that providers opted to report for Q4 2019 will still be used in the respective programs. The blanket reporting waivers have not been extended beyond Q2 2020. CMS is also updating the performance period for the FY 2022 SNF VBP Program to exclude claims from Q1 and Q2 2020, as CMS believes these periods may be affected by COVID-19 and do not reflect the actual SNF quality of care. The new performance period will replace the original period (October 1, 2019–September 30, 2020) with data from April 1, 2019–December 31, 2019 and July 1, 2020–September 30, 2020 to provide sufficient data for evaluation.

CMS also announced that it may propose to not score providers or make the associated payment adjustments for the affected program year if, as a result of a national blanket waiver or the submission of individual ECE requests, there is insufficient data to reliably measure national performance in these programs. In the interest of time and transparency, CMS may provide subregulatory advance notice of intentions to suspend such penalties and adjustments through routine communication channels to providers, vendors, and Quality Improvement Organizations. This is due to concerns that scoring remaining facilities after excluding Q1 and Q2 2020 data may result in only larger facilities meeting case minimums for scoring. GNYHA supports this approach and will continue to advocate for making the remainder of CY 2020 optional for reporting programs.

Limits on COVID-19 and Related Testing without an Order

Revising previous policy that allowed for payment of COVID-19 testing without a physician or other practitioner order, CMS will cover one COVID-19 diagnostic test and one of each related tests (the full list of related tests that do not require a practitioner order during the public health emergency can be found here) for a single beneficiary without an order from a physician or other practitioner. This limitation will apply beginning on the effective date of the IFC and will not affect tests furnished prior to the effective date. Additionally, tests can be covered when ordered by a pharmacist or other health care professional who is authorized to order diagnostic laboratory tests in accordance with state scope of practice and other pertinent laws.

Additional Policies

  • National Coverage Determination Procedural Volume Requirement Exceptions: National coverage determinations are determinations of whether CMS will cover an item or service nationally. Certain determinations include procedural volume requirements that providers must meet as a condition of coverage for that item or service. CMS is waiving the volume requirements for NCD 20.34 Percutaneous Left Atrial Appendage Closure, NCD 20.32 Transcatheter Aortic Valve Replacement, NCD 20.33 Transcatheter Mitral Valve Repair, and NCD 20.9.1 Ventricular Assist Devices.
  • Merit-Based Incentive Payment System (MIPS) Updates: CMS is expanding codes used for beneficiary assignment for the CMS Web Interface and CAHPS for MIPS Survey to include telehealth codes such as virtual check-in, remote evaluations, e-visits, and telephone evaluation and management services.

Please contact Zeynep Sumer King with questions about COVID-19 reporting requirements and Amy Chin with questions about quality reporting and the value-based payment programs. For issues with CoP enforcement, please contact Lorraine Ryan.