The COVID-19 pandemic has brought seismic changes to the clinical lab industry. High demand for COVID-19 testing services, tremendous amounts of funding, and rapidly changing government regulations have created opportunity for clinical labs, but also new compliance and audit challenges. As the dust settles and government entities and commercial insurers…
As telemedicine becomes an increasingly popular method for connecting patients with healthcare providers, many providers are becoming interested in expanding the reach of their telehealth practices across state lines. Although technological advancements have helped providers communicate with patients remotely, state and federal regulations add additional considerations for practicing across multiple…
On March 15, 2022, President Biden signed into law the Consolidated Appropriations Act, otherwise known as the “Omnibus Bill.” Included in the many provisions introduced by the Omnibus Bill is an extension of Medicare coverage of professional consultations, office visits, and office psychiatry services conducted via telemedicine for 151 days…
On April 7, 2022, the Centers for Medicare and Medicaid Services (CMS) issued a memorandum stating that several COVID-19 blanket waivers for certain healthcare services will be ending soon. Specifically, CMS will terminate blanket waivers of regulatory requirements that apply to skilled nursing facilities (SNFs), inpatient hospices, intermediate care facilities…
Healthcare providers who missed a Provider Relief Fund (PRF) reporting deadline may get a second chance. In response to overwhelming industry outcry over its attempts to clawback PRF payments, the Department of Health and Human Services (HHS), through the Health Resources and Services Administration (HRSA), which currently administers the PRF,…
On February 22, 2022, the US Food and Drug Administration (FDA) hosted a webinar detailing its current transition plans for medical devices marketed pursuant to either Emergency Use Authorization (EUA) or Enforcement Policies during the COVID-19 public health emergency (PHE). The primary purposes of the webinar were to help prepare…
The Eliminating Kickbacks in Recovery Act (“EKRA”) is an incredibly broad and incredibly vague criminal statute that continues to create compliance issues for clinical laboratories. Many arrangements between clinical laboratories and other entities that were previously compliant, or which are currently authorized under other federal statutes, may be unlawful under…
The Department of Health and Human Services (HHS) recently announced additional audits of certain healthcare providers that received funding from the Provider Relief Fund (PRF). These audits will focus on whether hospitals that received PRF payments have complied with the surprise billing provisions of the PRF terms and conditions. HHS…
On January 10, 2022, the Departments of Labor (DOL), Health and Human Services (HHS), and the Treasury (DOT) (collectively, the Departments) jointly issued FAQs regarding the implementation of required insurance coverage for at-home COVID-19 tests under the Families First Coronavirus Response Act (FFCRA). Pursuant to the new guidance, insurance plans…
On December 14, 2021, the Department of Health and Human Services (HHS), through the Health Resources and Services Administration (HRSA), announced the release of an approximately $9 billion distribution in Provider Relief Fund (PRF) Phase 4 payments to healthcare providers who have experienced lost revenues and expenses due to the…