On August 25, 2020, the Centers for Medicare & Medicaid Services (“CMS”) released an Interim Final Rule with comment period (“Rule”) with new requirements and enforcement for Medicare and Medicaid Programs, Clinical Laboratory Improvement Amendments (“CLIA”) and Patient Protection and Affordable Care Act, as well as additional policy and regulatory revisions in response to the COVID-19 Public Health Emergency (“PHE”). This Rule imposes additional data reporting requirements for hospitals, critical access hospitals (“CAHs”) and clinical laboratories and provides revised guidance related to order requirements for COVID-19 tests.
Hospitals and Critical Access Hospitals
The Rule revises and amends specific portions of the hospital and CAH conditions of participation (“CoP”) and conditions for coverage (“CfCs”) to establish universal mandatory reporting requirements to improve surveillance of COVID-19 and for use in future prevention of COVID-19 spreading. Hospitals and CAHs will be required to report certain data in accordance with the Secretary’s specified frequency and in a standardized format for the duration of the PHE. Of note, the new reporting requirements do not relieve a hospital or CAH of complying with the CoPs at 42 CFR §§ 482.42(a)(3) and 485.640(a)(3).
CMS’s examples of such data that hospitals and CAHs will be required to report may include information about supplies, the number of staffed beds in a hospital, the number of occupied beds and a count of patients currently hospitalized who have laboratory-confirmed COVID-19. The current list of data items specified can be found here.
Reporting Enforcement and Civil Monetary Penalties
If hospitals and CAHs consistently fail to comply with the new reporting requirements set forth in this Rule, hospitals and CAHs will be found to be non-compliant with the CoPs set forth at 42 CFR §§ 482.42(e) and 485.640(d), which state hospitals and CAHs “must report information in accordance with a frequency as specified by the Secretary on COVID-19 in a standardized format specified by the Secretary.” Non-compliant providers could ultimately be subject to termination as defined at 489.53(a)(3).
CMS does not have the statutory authority to impose Civil Monetary Penalties (“CMPs”) against hospitals and CAHs, but CMS has indicated it will use all statutory and regulatory enforcement and payment authorities that are within its authority to incentivize and promote compliance with these reporting requirements.
Laboratories Conducting COVID-19 Testing and Reporting Patient-Specific Results
Under § 18115(a) of the CARES Act, “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 such 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” PHE. On June 4, 2020, HHS released guidance that required all data to be reported through existing public health reporting methods.
Due to the numerous options currently available for detecting SARS-CoV-2 and diagnosing COVID-19, CMS has indicated there is a gap in reported testing. As such, CMS has made the following amendments and additions to modify CLIA regulations to require reporting of SARS-CoV-2 test results and to finalize requirements for SARS-CoV-2 test results to be reported to the Secretary:
- Certificate of Waiver (“CoW”) laboratories must report SARS-CoV-2 test results to the Secretary for the duration of the PHE.
- CMS-deemed Accreditation Organization (“AOs”), State Licensure Programs and Exempt States must notify CMS within 10 days of identifying a laboratory that fails to comply with the reporting requirements.
- Laboratories performing non-waived SARS-CoV-2 testing must report SARS-CoV-2 test results to the Secretary for the duration of the PHE.
Enforcement and Civil Monetary Penalties
In order to encourage compliance with the PHE reporting requirements, CMS will now impose sanctions for failure to comply with the reporting requirements of COVID-19 and SARS-CoV-2 testing results. The Condition Level Requirements have been amended to include the new reporting requirements in order to allow CMS to enforce these requirements against CoW laboratories through the imposition of CMPs.
CMS has added § 493.1834(d)(2)(iii) to define the potential CMP amounts to be imposed for reporting violations as follows:
- $1,000 for the first day of noncompliance;
- $500 for each subsequent day the laboratory fails to report SARS-CoV-2 test results; and
- CMP amount not to exceed $10,000 for each violation or for each day of substantial noncompliance.
In addition, to the new enforcement regulations above, CMS notes under CLIA regulations, both AOs and Exempt States are required to have equal or more stringent requirements than those required by CLIA. Of note, Exempt States have the authority to impose CMPs, and CMS expects Exempt States will have an equivalent penalty to that outlined above. Violation of these reporting requirements (CLIA and Exempt State) may then result in enforcement penalties by both CMS and Exempt States.
The Rule notes that there will be a one-time, three-week grace period to begin reporting the required data.
Medicare Beneficiary Testing
On May 8, 2020, CMS removed the requirement that a physician order is obtained prior to undergoing COVID-19, influenza virus or similar respiratory condition testing for Medicare beneficiaries. Due to concerns for fraud, waste and abuse, as well as fears that beneficiaries requiring multiple tests were not receiving necessary medical oversight, CMS has again revised the requirements for an order. As of the effective date of this Rule and for the duration of the PHE, an order of a physician or other practitioner is not required for “one otherwise covered diagnostic laboratory test for COVID-19 and for one otherwise covered influenza virus or similar respiratory condition needed to obtain final COVID-19 diagnosis, when performed in conjunction with a COVID-19 diagnostic laboratory test in order to discount influenza virus or related diagnosis.” All such subsequent tests will require the order of a physician, pharmacist or other practitioner authorized by state scope of practice laws.
Practical Takeaways
- Hospitals and CAHs need to adopt policies and procedures for reporting in compliance with this Rule.
- Laboratories need to adopt policies and procedures for reporting COVID-19 and SARS-CoV-2 test results.
- All providers should ensure they have policies and procedures to ensure Medicare beneficiaries obtain the appropriate order for subsequent COVID-19 testing.
- The Rule was published to the Federal Register on September 2, 2020, and comments are due by November 1, 2020.
If you have questions, would like additional information about this topic, or would like to submit comments to CMS, please contact:
- Regan Tankersley at (317) 977-1445 or rtankersley@wp.hallrender.com;
- Lori Wink at (414) 721-0456 or lwink@wp.hallrender.com;
- Megan Culp at (317) 429-3644 or mculp@wp.hallrender.com; or
- Your regular Hall Render attorney.
Hall Render blog posts and articles are intended for informational purposes only. For ethical reasons, Hall Render attorneys cannot—outside of an attorney-client relationship—answer specific questions that would be legal advice.
