On March 22, 2020 Texas Governor Greg Abbott issued an executive order prohibiting all surgeries and procedures that are “not immediately medically necessary to correct a serious medical condition of, or to preserve the life of, a patient” who would be at risk for serious adverse medical consequences or death without the immediate performance of the surgery or procedure. The determination is to be made by the patient’s physician. Procedures that would not deplete hospital capacity or supplies of personal protective equipment are allowed.
The nation’s healthcare system is preparing to reach record capacity in the coming weeks. Much focus has been on the limited capacities of the nation’s acute care hospitals. As a result of the COVID-19 public health emergency, the Health and Human Services (“HHS”) Secretary is authorized to make temporary waivers under the Social Security Act (known as “Section 1135 Waivers”). In turn, the Center for Medicare and Medicaid Services (“CMS”) COVID-19 Emergency Declarations have expanded the ability to move patients from acute care setting to skilled nursing settings in an expedited manner to reserve hospital beds for the most severely ill patients.
In an unprecedented announcement (and on the heels of other directives on healthcare privacy matters), the Office for Civil Rights (OCR) of the U.S. Department of Health & Human Services (HHS) issued a statement on March 17, 2020, that it will not impose penalties against covered entity healthcare providers in connection with their “good faith provision of telehealth services” as long as the Public Health Emergency related to COVID-19 is in place. OCR is the federal agency responsible for the regulation and enforcement of the Health Insurance Portability and Accountability Act of 1996 and its Privacy and Security Rules (together, HIPAA).
HIPAA and COVID-19: Privacy Protections Still Control in Case of Pandemic
As noted in our recent alert listed below, the HIPAA Privacy Rule is not suspended during a public health or other emergency. However, the Secretary of Health & Human Services may waive certain portions of the Privacy Rule during an emergency. Effective as of March 15, 2020 (and retroactive to March 1, 2020), HHS Secretary Alex Azar issued a limited waiver of HIPAA sanctions and penalties. Even with this limited waiver in place, HHS continues to stress the importance of appropriately sharing healthcare information and maintaining healthcare privacy protections during the COVID-19 pandemic situation.
Startup? Organized in Delaware? Then you likely received a notice from the Secretary of State of Delaware saying you owe thousands (maybe even tens of thousands) in franchise taxes and have to file an Annual Report by March 1, 2020. DON’T PANIC!! There are two ways to calculate franchise taxes, and Delaware defaults to the one that is usually less favorable to startups.
In a long-anticipated move, the United States Food and Drug Administration (FDA), on September 26, 2019, published six guidance documents clarifying its scope of authority and enforcement discretion policies with regards to Digital Health Content in light of the questions raised by the 21st Century Cures Act (Cures Act).
In this article, we take a look at the FDA’s draft guidance that proposes a framework of regulating Clinical Decision Support (CDS) Software, including software containing machine-learning algorithms (ML). Continue Reading FDA Guidance Clarifies Clinical Decision Support, Machine-Learning, and Other Digital Health Content
It is common practice for a hospital to require a physician to sign a non-compete agreement whenever the hospital employs the physician or acquires the physician’s medical practice. In certain respects, that is to be expected. Non-compete agreements are a common feature in employment agreements and business acquisition documents across all industries and therefore it makes sense that they would be prevalent in the healthcare industry, too. However, the healthcare industry is different; uniquely so. Among other things, the healthcare industry is subject to state and federal laws and regulations that prohibit physicians from referring patients in exchange for compensation (collectively, the “anti-kickback and physician self-referral laws”). The focus of this article is on the interplay between those anti-kickback and physician self-referral laws and hospital-physician non-compete agreements. Specifically, this article explores whether there really is a rightful place for non-compete agreements in hospital-physician employment and practice acquisition agreements given the regulatory constraints imposed by the anti-kickback and physician self-referral laws.