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A Unanimous Pennsylvania Supreme Court Decides Leadbitter in Hospital’s Favor

On August 17, 2021, the Pennsylvania Supreme Court issued its long-awaited decision in Leadbitter v. Keystone Anesthesia Consultants, No. 19 WAP 2020, holding that (i) a hospital’s credentials committee qualifies as a “review committee” for purposes of the Peer Review Protection Act (“PRPA”) to the extent it undertakes peer review, and (ii) the federal Health Care Quality and Improvement Act of 1986 (HCQIA) protects from disclosure the responses provided by the National Practitioner Data Bank (NPDB) to queries submitted to it, regardless of any contrary state law. 

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PA COVID-19 Regulatory Waivers Scheduled to Expire on September 30, 2021

On June 10, 2021, the Pennsylvania legislature voted to end Pennsylvania’s COVID-19 emergency disaster declaration, which had been in effect since March 6, 2020.  The vote would have also terminated the hundreds of COVID-19 regulatory waivers authorized under the emergency disaster declaration, but a last minute deal resulted in a bill extending the regulatory waivers until September 30, 2021.  

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HHS Issues “Final Interim Rule” Implementing the No Surprises Act

On July 1, 2021, the Biden administration, through the U.S. Departments of Health and Human Services (HHS), Labor, and Treasury, issued “Requirements Related to Surprise Billing: Part I,” an interim final rule implementing the No Surprises Act. Those provisions relevant to health care providers will be set forth at 45 C.F.R. part 149. They apply to health care providers beginning January 1, 2022. 

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Pennsylvania Department of Health Finalizes “Interim” COVID-19 Vaccination Plan

On November 19, 2020, the Pennsylvania Department of Health (“DOH”) published its long-awaited Interim COVID-19 Vaccination Plan (“Plan”). The publication of DOH’s Plan is welcome news for the Commonwealth, particularly in light of Pfizer’s submission of an application to FDA for emergency use authorization for its vaccine on November 20, 2020, and Moderna’s submission for emergency use authorization on November 30, 2020. Secretary of Health Rachel Levine has said that she anticipates distribution will begin as early as December of 2020.

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HHS Advisory Opinion Reiterates Broad Scope of PREP Act Immunity for “Program Planners” Following Applicable Public Health Guidance

On October 22, 2020, the U.S. Department of Health and Human Services (“HHS”) issued a new Advisory Opinion addressing the availability of immunity for “program planners” following applicable public health guidance under the Public Readiness and Emergency Preparedness (“PREP”) Act, 42 U.S.C. 247d-6d. The Advisory Opinion reflects a striking challenge to interpretation of the PREP Act provided by recent court opinions and should provide strong support for providers and other entities arguing for broader application of the PREP Act going forward. 

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CMS Interoperability Final Rule: Impact on Health Care Providers

The Centers for Medicare and Medicaid (CMS) published a final rule on May 1, 2020 implementing the interoperability requirements of the Cures Act. The CMS Final Rule, along with a companion final rule published by the Office of the National Coordinator for Health IT (ONC), are the latest government efforts to drive the electronic access, exchange, and use of health information across care settings, which despite years of regulatory action pursuant to the HITECH Act, has to date not been achieved due to barriers to information exchange in the U.S. health care system. 

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