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.
On July 2, 2019, New Jersey Governor Phil Murphy signed the Jake Honig Compassionate Use Medical Cannabis Act into law, enacting sweeping reforms to New Jersey's Medical Marijuana Program, which, until 2018, had only 15,000 patients. The law became effective upon signing.
New Excess Compensation Tax for Exempt Organizations Creates New Burdens for Nonprofit Health Systems with Highly-Compensated Physician Leaders
The Tax Cuts and Jobs Act added a new tax for exempt organizations in section 4960 of the Internal Revenue Code that will have implications for tax-exempt health systems, particularly with respect to their physician leaders. The entities subject to the tax include organizations that are tax-exempt under section 501(c)(3) of the Code. To the extent that its covered employees" receive "remuneration" in excess of 1,000,000 dollars, a tax-exempt organization will pay a tax of twenty-one percent on that excess.
New legislation requiring notification to patients about test results will take effect on December 23, 2018. Titled the Patient Test Result Information Act ("Act 112"), the law requires any entity that performs an outpatient diagnostic imaging service in which a significant abnormality may exist to directly notify the patient or their designee within 20 days.
A recent Illinois decision on the tax-exempt status of nonprofit hospitals provides a reminder of the uncertainty that surrounds the standards governing exemptions for hospitals and other nonprofits at the state and local level. The ruling in September that hospitals seeking a property tax exemption must still satisfy the requirement under the state constitution that their property is â€œused exclusivelyâ€ for charitable purposes, notwithstanding recent legislation intended to make the process of qualifying for an exemption more predictable.