COVID-19 PHE Likely to be Extended Past July 2022

May 2022

The US government will likely extend the COVID-19 PHE past mid-July. The Department of Health and Human Services (HHS) has renewed the PHE every 90 days since its implementation in January 2020, with the latest extension in April 2022. This means the PHE expiration date is now July 15, 2022. The extension of the PHE […]

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SCAI Guidelines for the Management of PFO Closure Address Trial-Excluded Groups

Patent Foramen Ovale (PFO) Closure guidelines released by the Society for Cardiovascular Angiography and Interventions (SCAI) addressed patient groups who were not included in the randomized controlled trials (RCTs). These groups include patients who are advanced in age or who have certain rare conditions (like platypnea-orthodeoxia and systemic thromboembolism) are now included in the guidelines, […]

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OIG Determined Some Medicare Advantage Organizations Denied Prior Authorization and Payment Requests

According to a new report by the Office of Inspector General (OIG), results of case reviews determined Medicare Advantage Organizations (MAOs) sometimes delayed or even denied beneficiaries’ access to services, even though prior authorization requests met Medicare coverage policies. This also included payment request denials. The OIG concluded the MAOs denied prior authorization and payment […]

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Healthcare Providers Required to Return Provider PHE Relief Funds

April 2022

The Department of Health and Human Services (HHS) has requested healthcare providers pay back $100 million collectively in COVID-19 PHE assistance for failing to comply with reporting requirements. Notices were sent to 10,000 non-compliant healthcare practices and providers on March 10, with a 30-day deadline in which to return the funds. Individual fund returns range […]

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COVID-19 PHE Renewed 

On April 12, 2022, Xavier Becerra, Secretary of Health and Human Services (HHS) announced the renewal  of the public health emergency (PHE) declared due to the Coronavirus Disease 2019 (COVID-19). The PHE was originally declared on January 31, 2020. Extensions occurred on April 21, 2020;  July 25, 2020;  October 23, 2020;  January 7, 2021; April 15, 2021; July 19, […]

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CMS Issues CY 2023 Proposed Rule for Inpatient Prospective Payment System

On April 18, 2022, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule that updates Medicare payment policies for hospitals under the Inpatient Prospective Payment System (IPPS) for fiscal year (FY) 2023. Once these polices become final, they will cover inpatient hospital discharges on or after October 1, 2022. Highlights are described […]

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CMS Updated Signature Requirements

March 2022

CMS issued a Medicare Learning Network (MLN) Fact Sheet which provides updated language to documentation signature requirements for physicians and non-physician practitioner, specifically using electronic signatures.   According to MLN905364, electronic signatures must be authenticated, safeguarded against misuse and identifiable as an electronic signature rather than a typed signature. It must also represent the provider […]

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HHS to Revise Independent Dispute Resolution Guidance for No Surprises Act

On February 23, 2022, a federal judge in Texas ruled that the independent dispute resolution process implemented by the U.S. Department of Human and Health Services (HHS) within the No Surprises Act violated the Administrative Procedure Act. The Administrative Procedure Act oversees the process by which federal agencies develop and issue regulations and includes requirements […]

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FDA Advisory Panel Issues Recommendations on Lifelong Surveillance for EVAR

The U.S. Food and Drug Administration (FDA) issued a letter to healthcare providers regarding recommendations for lifelong surveillance of abdominal aortic aneurysm (AAA) patients treated with endovascular repair (EVAR). The recommendations include regular imaging surveillance within 30 days of EVAR and annually thereafter which “may help identify adverse events such as endoleaks, device migration, loss […]

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FDA Issues Guidance on Patient Participation in the Design and Conduct of Device Studies

February 2022

FDA Issues Guidance on Patient Participation in the Design and Conduct of Device Studies The U.S. Food and Drug Administration (FDA) issued two final guidance documents that provide recommendations for utilizing patient perspectives in medical device clinical studies. The first is Patient Engagement in the Design and Conduct of Medical Device Clinical Studies. As outlined […]

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