The Centers for Medicare & Medicaid Services (CMS) has released on its website an interim final rule with comment (IFC) related to the COVID-19 public health emergency (PHE). The IFC has not yet been released in the Federal Register. The IFC revises requirements for long-term care (LTC) facilities and strengthens CMS enforcement to ensure compliance with COVID-19 reporting as well as other specified policies:

• Requires LTC facilities to test facility residents and staff for COVID-19;
• Requires hospitals to track the incidence and impact of COVID-19;
• Requires all CLIA laboratories to report COVID-19 test results to HHS in such form and manner, and at such timing and frequency, as the Secretary may prescribe;
• Updates the extraordinary circumstances exceptions (ECEs) policy for various quality programs;
• Revises the FY 2022 performance period under the Skilled Nursing Facility (SNF) VBP program;
• Notes they will not enforce certain requirements for four national coverage determinations;
• Revises the May 8th COVID-19 IFC policy by establishing that one single COVID-19 diagnostic test and one of each other applicable related tests without an order is reasonable and necessary; and
• Establishes policy where pharmacists and other practitioners operating within their scope of practice can fulfill the requirements related to orders for covered COVID-19 and related tests.

CMS believes that the urgency of the COVID-19 PHE constitutes good cause to waive the normal notice-and-comment process and the normal 30-day delay in effective date. Thus, these changes take effect immediately upon publication in the Federal Register and are applicable for the duration of the COVID-19 PHE. Any comments are due within 60 days of publication.

Enforcement of Data Reporting for LTC Facilities Now Includes Civil Monetary Penalties

As of publication of this rule, CMS implements a new enforcement regulation to help ensure LTC facilities follow the infection prevention and control reporting requirements that became effective on May 8, 2020 as part of the second COVID-specific rule. In the May 8th rule, CMS added new provisions to require facilities to electronically report information about COVID-19 in a format and frequency specified by the Secretary, but not less than weekly to the CDC National Healthcare Safety Network (NHSN). CMS also developed a process within the software used by State Survey Agencies to determine compliance with the new reporting requirements. With this rule, CMS codifies the following policies that impose civil monetary penalties (CMPs) for each time a facility fails to report required data:

• Minimum $1,000 CMP will be imposed for the first occurrence of noncompliance; and
• For each subsequent occurrence, the amount of the CMP imposed will be increased by $500.

LTC Facilities Required to Test Facility Residents and Staff

CMS believes that it should strengthen the requirements for LTC facilities to better protect residents, who are members of a high-risk population. In this rule, CMS revises the LTC facility infection control regulations to establish a new requirement for LTC facilities to test their facility residents and staff, including individuals providing services under arrangement and volunteers. The Agency believes that these requirements will positively and substantially impact efforts to control the spread of COVID-19.

Though not included in the rule, the accompanying press release noted that CMS is directing surveyors to inspect nursing homes for adherence to the new testing requirements. Facilities that do not comply will be cited for non-compliance and may face enforcement sanctions based on the severity of the noncompliance, such as CMP fines in excess of $400 per day or over $8,000 for an instance. CMS also notes in their press release that they are helping facilities offset the cost of testing through new funding from the Provider Relief Fund. On July 22, 2020, the Administration announced the release of an additional $5 billion to help LTC facilities address critical needs such as staffing, technology, and testing.

New Requirement for Hospitals to Submit COVID-19 Data

Conditions of Participation (CoPs) are the minimum health and safety standards required by Medicare in order to participate in the program. Hospital CoPs currently require that hospitals have active programs, for the surveillance, prevention, and control of healthcare-associated infections (HAIs) and other infectious diseases. In this rule, CMS updates the hospital CoPs to require the reporting of COVID-19 information in accordance with a format and frequency as specified by the Secretary during the PHE.

CLIA Program Reporting Requirements Modified to Include Mandatory Reporting and Civil Monetary Penalties

Section 18115(a) of the CARES Act requires 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 to report the results from each test until the end of the PHE, and directs HHS to determine the format and frequency of such reporting. In guidance issued on June 4, HHS required that all data be reported through existing public health data reporting methods and required that all laboratories (including temporary overflow and remote locations for a laboratory and locations performing point of care or at-home specimen collection) must report results for completed tests, within 24 hours, on a daily basis.

Currently, CMS collects non-waived testing specialty and subspecialty information from CLIA certified laboratories with Certificates of Compliance (CoC), Certificates of Accreditation (CoA), or Certificate of Registration (CoR) to ensure laboratory compliance with CLIA regulations. However, CMS does not have complete information for laboratories performing SARS-CoV-2 testing or which tests are being performed because this type of information is not normally reported. CMS states that it must bridge the gap in understanding the universe of laboratories performing SARS-CoV-2 testing in order to identify quality and accuracy issues with laboratories performing such testing.

CMS is modifying CLIA reporting requirements to require all laboratories, including those with a Certificate of Waiver, performing SARS-CoV-2 testing, report test results within 24 hours of results being determined for the remainder of the PHE. CMS also finalizes that failure to submit test results will result in CMP fines of $1000 for the first day and $500 for each subsequent day of noncompliance with new reporting requirements. Accreditation Organizations and State Licensure Programs that identify a laboratory that fails to report these test results must notify CMS within 10 days of identification.

CMS Limits the Number of Reimbursable COVID-19 Diagnostic Tests Per Beneficiary Without an Order

The May 8 COVID-19 IFC authorized the coverage of multiple COVID-19 diagnostic tests and other related diagnostic tests for a single beneficiary without a physician order. CMS also removed the ordering requirement for coverage of a diagnostic laboratory test for influenza virus and respiratory syncytial virus when these tests are furnished in conjunction with a COVID-19 diagnostic laboratory test as part of establishing or ruling out a COVID-19 diagnosis.

CMS amends the May 8th policy, and beginning effective date of this rule, CMS will only cover one COVID-19 diagnostic test and one of each other related test (including FDA-authorized serology tests) without a physician or other practitioners order. Beneficiaries will be required to obtain an order for coverage of testing beyond one test. Thus far, approximately 1.9 million Medicare beneficiaries have been tested and 83% have been tested only once. However, CMS states that the number of beneficiaries receiving more than one COVID-19 test has been increasing. CMS cites that laboratory testing is a significant source of fraud, waste, and abuse in the Medicare program and states that these revisions in policy are necessary to prevent fraud and address safety issues that arise from beneficiaries being repeatedly testing without proper medical oversight.[1]

CMS Updates Extraordinary Circumstances Exceptions (ECE) Policies for Variety of Programs

On March 22, 2020, CMS provided blanket ECEs to ESRD facilities, hospitals, and SNFs in order to reduce provider burden. The ECEs relieved providers and facilities of reporting obligations for 4Q 2019 through 2Q CY 2020, but CMS stated it would score such data if they were optionally reported. CMS is now concerned that the data are not comparable because of the geographic differences in COVID-19 and thus, it will only score data that was optionally reported for 4Q 2019 and exclude all optionally-reported data for 1Q 2020 and 2Q 2020 from the calculation of performance in the following programs:

• End-Stage Renal Disease Quality Incentive Program (QIP);
• Hospital-Acquired Condition (HAC) Reduction Program;
• Hospital Readmissions Reduction Program (HRRP); and
• Hospital Value-Based Purchasing (HVBP) Program.

CMS states that, for all of the above programs, it may propose to not score hospitals or facilities if it receives such limited data that it cannot reliably measure national performance and therefore would not make associated payment adjustments to facilities or hospitals under these programs for the year.

SNF VBP Program FY 2022 Performance Period Updated

The ECE for the COVID-19 PHE excepts 6 months of claims data from the calculation of the SNF Readmission Measure (SNFRM) during the performance period of the FY 2022 SNF VBP Program. CMS is concerned about using only the remaining 6 months of FY 2020 data for all SNFs nationwide to calculate the SNFRM for the FY 2022 Program, as their internal analysis indicates using 6 months versus one-year of data would decrease the reliability by approximately one-third.  Therefore, CMS is revising the performance period for the FY 2022 SNF VBP program to include data from: April 1, 2019 through December 31, 2019 and July 1, 2020 through September 30, 2020.

CMS Eliminates Procedural Volume Requirements for Four NCDs Through the End of the PHE

As a result of COVID-19, hospitals and practitioners were forced to postpone non-essential services and procedures. As a result of this delay, hospitals and practitioners may be unable to meet the procedural volume requirements for Medicare coverage of certain services under a national coverage determination (NCD). To ensure minimal disruption in patient care, CMS will not enforce these requirements through the end of the PHE for hospitals and practitioners that met the volume requirements prior to the commencement of the PHE for the following NCDs:

• NCD 20.34 Percutaneous Left Atrial Appendage Closures (LAAC);
• NCD 20.32 Transcatheter aortic valve replacement (TAVR);
• NCD 20.33 Transcatheter mitral valve repair (TMVR); and
• NCD 20.9.1 Ventricular Assist devices (VADs).

CMS Eliminates 60% Rule for Part C & Part D 2022 Star Ratings

CMS will eliminate use of the 60 percent rule in the current extreme and uncontrollable circumstances policy for the Part C and Part D 2022 Star Ratings. The 2022 Star Ratings are based on performance in 2020. The 60 percent rule removes contracts with 60 percent or more of their enrollees living in a FEMA-designated Individual Assistance area from certain calculations made in the Star Ratings. CMS notes that applying the 60 percent rule for the 2022 ratings would remove close to 98 percent of contracts, resulting in too few contracts for reliable calculations. CMS adopted Star Ratings-related policies in the previous COVID-19 IFCs, including updates to data reporting and usage.

Merit-Based Incentive Payment System (MIPS) Updates

CMS to Include Telehealth Codes in Definition of Primary Care

In the March 31st COVID-19 IFC, CMS established flexibilities and separate payment for certain virtual services that are not considered Medicare telehealth services such as virtual check-ins and e-visits.  CMS also established separate payment for telephone E/M and other services codes during the COVID-19 PHE. These services are not currently included in the definition of primary care services used for the purpose of MIPS beneficiary assignment methodology for the CMS Web Interface and CAHPS for MIPS survey. CMS is proposing to include the following services in the definition of primary care to ensure the expanded use of technology during COVID-19 is accurately reflected.

Previously finalized codes considered primary care but not codified:

• CPT codes: 99201 through 99215 (office or other outpatient visit for the E/M of a patient);
• CPT codes: 99304 through 99318 (professional services furnished in nursing facility, excluding SNF);
• CPT codes: 99319 through 99340 (patient domiciliary, rest home, or custodial care visit);
• CPT codes: 99341 through 99350 (E/M services furnished in a patients’ home);
• CPT codes: 99487, 99489, and 99490 (chronic care management);
• CPT codes: 99495 and 99496 (transitional care management);
• HCPCS codes: G0402 (Welcome to Medicare visit); and
• HCPCS codes: G0438 and G0439 (annual wellness visits).

CMS is proposing the additional codes for inclusion in the definition of primary care:

• CPT codes: 99421, 99422, and 99423 (online digital E/M service or e-visit);
• CPT codes: 99441, 99442, and 99443 (telephone E/M services); and
• HCPCS codes: G2010 (remote evaluation of patient video/images) and G2012 (virtual check-in).

These codes will be included in the definition of primary care services for the 2020 MIPS performance year and any subsequent performance year that starts during the PHE for COVID-19.

CMS Expands COVID-19 Clinical Trials Improvement Activity

In the March 31st IFC for COVID-19, CMS added an improvement activity for the MIPS CY 2020 performance period, “COVID-19 Clinical Trials,” which promotes clinician participation in a COVID-19 clinical trial utilizing a drug or biological product to treat a patient with COVID-19. CMS is adding a second improvement activity criteria (2 below) to qualify for meeting this requirement:

1. Participate in a COVID-19 clinical trial utilizing a drug or biological product to treat a patient with a COVID-19 infection and report their findings through a clinical data repository or clinical data registry for the duration of their study; or
2. Participate in the care of patients diagnosed with COVID-19 and simultaneously submit relevant clinical data to a clinical data registry for ongoing or future COVID-19 research.

Participating clinical data registries must declare that they are ready to accept data via a public online posting and actively use the data to improve population health outcomes. CMS is also extending this COVID-19 Clinical Data Reporting with or without Clinical Trial improvement activity through the CY 2021 performance period.

 

[1] The HHS Office of Inspector General is currently conducting analysis of fraud and abuse with COVID-19 add-on testing https://oig.hhs.gov/reports-and-publications/workplan/summary/wp-summary-0000489.asp.