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Articles Posted in COVID-19

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Providing Cross-State Telehealth Services

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…

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Consolidated Appropriations Act Extends Post-PHE Telehealth Coverage

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…

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CMS Terminating Several COVID-19 Blanket Waivers

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…

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HHS to Allow Late PRF Reporting

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,…

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FDA Outlines Termination Plan for COVID-19 EUAs and Enforcement Policies for Medical Devices and PPE

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…

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EKRA Continues to Cause Confusion for Clinical Labs

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…

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HHS to Audit More Providers That Received COVID-19 Relief Funds

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…

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New Guidance on Insurance Coverage of OTC COVID-19 Tests

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…

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HHS Releases Additional $9 Billion in Provider Relief Funds

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…

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Administration Posed to Expand COVID Testing Insurance Coverage Mandate

The Biden Administration recently announced plans to require commercial insurers to cover over-the-counter and at-home COVID-19 tests. Commercial insurers are currently required to cover in vitro diagnostic (IVD) products that test for COVID-19. Most often, this has taken the form of clinical laboratory testing wherein the lab or other provider…

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