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Wachler & Associates Health Law Blog

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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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Healthcare Companies Paid 90% of all False Claims Act Settlements in 2021

Healthcare companies were once again the leading source of the Department of Justice’s (DOJ) False Claims Act (FCA) settlements and judgments last year. According to a DOJ news release, healthcare companies paid almost 90% of fraud settlement proceeds under the FCA in 2021. The Justice Department obtained more than $5.6…

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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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More Than One Medicare Audit? Better Check for Overlap.

A phenomenon in Medicare audits that is gaining increased visibility is Medicare contractors “double-dipping” from providers by using overlapping audits. Once viewed as isolated aberrations, it is becoming increasingly common for Medicare contractors to audit and deny the same claims twice in different audits. This practice generally leads to overpayment…

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OIG Opinion Underlines AKS Concerns About Healthcare Joint Ventures

Late last year, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued a significant Advisory Opinion regarding a proposed joint venture (JV) between a therapy services provider and an owner of various long-term care (LTC) facilities. OIG concluded that it viewed the Proposed Arrangement as…

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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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OIG Updates Work Plan for January 2022

The Department of Health and Human Services (HHS) Office of Inspector General (OIG) included several new items in its work plan update in January 2021. The OIG work plan outlines the projects that OIG plans to implement over the foreseeable future. Such projects typically include OIG audits and evaluations. Below…

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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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A Primer on Medicare Statistical Extrapolations

Medicare audits often include a statistical extrapolation to estimate the full extent of an alleged overpayment. Medicare contractors are authorized to review the merits of only a small “sample” of submitted claims and extrapolate the results of that review to a large “universe” of claims to estimate the overpayment amount.…

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CMS Releases Guidance on Hospital Co-Location

Late last year, the Centers for Medicare & Medicaid Services (CMS) released new guidance for hospital co-location. Co-location occurs when two Medicare certified hospitals or a Medicare certified hospital and another healthcare entity are located on the same campus or in the same building and share space, staff, or services.…

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