Guidance on Free Testing On or about August 4, 2020, the United States Department of Health and Human Services (“HHS”), Office of the Inspector General (“OIG”) issued new guidance in the form of frequently asked questions regarding a clinical laboratory’s ability to offer free COVID-19 antibody testing to federal health care program beneficiaries who receive other medically necessary blood tests. Although the OIG states that providing free laboratory testing to federal health care program beneficiaries may implicate the federal Anti-Kickback Statute as “the clinical laboratory would be providing something of value for free to beneficiaries who could self-refer to the laboratory for items and services reimbursable by a federal health care program," the OIG nevertheless believes that such a public service could outweigh the “sufficiently low risk of fraud and abuse”. To that end, the OIG requires that clinical laboratories seeking to offer free COVID-19 antibody testing to federal health care program beneficiaries follow the below safeguard:
a. the physicians ordering the laboratory tests, including the free COVID-19 antibody tests, would not receive any payments or anything else of value from the clinical laboratory in connection with the free antibody testing program;
b. the patients receiving the laboratory tests would not receive any payments or anything of value, other than the free COVID-19 antibody test, from the clinical laboratory in connection with the free antibody testing program;
c. the tests would be offered only to patients receiving other medically necessary blood tests as part of a medically necessary exam or treatment;
d. no payor, including the patient, a commercial insurance company, or a federal health care program, would be billed for or pay any costs in connection with the COVID-19 antibody tests; and e. the antibody tests are cleared or approved by the U.S. Food and Drug Administration (FDA) or are subject to an FDA-Issued Emergency Use Authorization.
Executive Directive No. 20-026
The New Jersey Department of Health (the “NJDOH”) has issued Executive Directive No. 20-026 (the “Directive”) detailing reopening requirements and phases for long-term care facilities (“LTCFs”). Per the effective date of the Directive, all LTCFs are considered to be in Phase 0, the most restrictive phase. Facilities can advance phases in conjunction with the State’s reopening stages, with a 14‑day delay (i.e., the expected incubation period for COVID-19). All facilities must have an “Outbreak Plan” in place in the event of a rebound in COVID‑19 community transmission. The Outbreak Plan must be posted on each facility’s website no later than October 10, 2020.
The Directive requires that all residents be tested weekly for COVID-19 until no new facility-onset cases are identified among residents and positive cases in staff and at least 14 days have elapsed since the most recent positive result and during this 14-day period at least two weekly tests have been conducted with all individuals having tested negative. Staff also should be tested weekly until the NJDOH recommends otherwise. These testing requirements must be initiated by August 24, 2020.
Even as LTCFs resume normal activities, core infection prevention and control practices must be in place at all times. Facilities should review the Core Infection Prevention and Control Practice for Safe Healthcare Delivery in All Settings – Recommendations of the Healthcare Infection Control Practices Advisory Committee released by the CDC. That guidance, and additional information regarding LTCF reopening practices, is set forth in the Directive.
HHS Announces Allocations of CARES Act Provider Relief Fund for Nursing Homes
HHS recently announced that it would allocate $5 billion to nursing homes through the Provider Relief Fund. An initial $2.5 billion will be distributed to providers this month to help support increased testing, staffing, and PPE needs. There will also be funding available for those establishing COVID-19 isolation facilities. Unlike prior distributions, however, the balance of the $5 billion will be linked to nursing home performance. Almost 40% of all U.S. COVID-19 deaths, totaling tens of thousands of Americans, are nursing-home related, and the intent of the performance-based distribution will be to ensure the federal government is paying for better outcomes. Evaluation of performance will consider the prevalence of the virus in the nursing home’s local geography, and will be based on the nursing home’s ability within this context to minimize COVID spread and COVID-related fatalities among its residents. Information, guidance, and application instructions can be found on the HHS Provider Relief Fund Page for Providers.