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.
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.
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.
PA SB 425, a bill amending the MCARE Act, 40 P.S. § 1303.504 (“MCARE”), has been signed into law by Governor Wolf, providing much-needed clarity for Pennsylvania’s health care providers by expanding the types of practitioners that can obtain informed consent.
On December 16, 2020, the Pennsylvania Supreme Court issued an order holding its decision on the Petition for Review filed in Ungurian v. Beyzman, pending the release of its decision in Leadbitter v. Keystone Anesthesia Consultants.
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.
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.
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.
The Office of the National Coordinator for Health IT (ONC) published a final rule on May 1, 2020 implementing the interoperability and information blocking requirements of the 21st Century Cures Act. The ONC Final Rule will significantly impact healthcare providers by prohibiting “information blocking” and by requiring health care providers to provide third party smartphone applications with access to their patients’ health information upon the patients’ request.
Health care providers and their Business Associates have faced constantly shifting regulatory requirements and operational changes over the last few months. These developments include COVID-19 related enforcement by the federal government, increased use of telehealth, and the publication of new federal regulations related to interoperability. Given these developments, it is an opportune time for providers to revisit and amend their Business Associate Agreements (BAA).
PA Superior Court Decision in Ungurian Reflects Ongoing Judicial Assault on Privilege in Medical Malpractice Litigation
The Pennsylvania Superior Court decision in Ungurian v. Beyzman is the latest in the trend of appellate cases systematically stripping away privilege protection for robust and candid, self-critical evaluation, and safety analysis by medical professionals and hospitals. This privilege protection, guaranteed by federal and state law, is essential to promoting patient safety and quality of care in our nation's hospitals.
Through the CARES Act and a series of Section 1135 Blanket Waivers and policy statements, the federal government has authorized expansive use of telehealth during the COVID-19 Public Health Emergency, creating an opportunity for the use of telehealth/telemedicine in providing healthcare services on the front lines of the COVID-19 pandemic. The CARES Act allocates $200 million to help the healthcare industry develop greater telehealth capabilities, and directs HHS to both expand reimbursement under the Medicare program and take steps to relax regulatory barriers that have inhibited telehealth expansion. But, to take full advantage, providers need to stay on top of a number of issues that will enable them to provide services that are both legally compliant and reimbursable under federal, state, and/or commercial insurance programs.