Articles and Blogs

CMS recently issued a Stark Advisory Opinion, which may offer additional flexibility for physician practices in growth mode. CMS-AO-2021-01 concerns a group practice’s proposal to furnish designated health services (“DHS”) through two wholly owned subsidiary entities that do not, themselves, qualify as group practices. CMS concluded the proposed structure did not preclude the group practice…Read More

In The Judge Rotenberg Educational Center, Inc. v. United States Food and Drug Administration, the U.S. Court of Appeals for the D.C. Circuit overturned a 2020 Food and Drug Administration (“FDA”) rule banning the use of electrical stimulation devices to treat patients suffering from severe self-injurious and aggressive behaviors. The court concluded the FDA did…Read More

Earlier this year, the Centers for Medicare and Medicaid Services (“CMS”) finalized a change to the exclusive use requirement of the Stark Law that affects space and equipment leases. The rental of office space exception and the rental of equipment exception now allow a lessee—and any other lessees operating in the same office space or…Read More

In December 2020, the Centers for Medicare & Medicaid Services (“CMS”) issued long-awaited final rules revising the Stark Law regulatory framework and updating the 2021 Medicare Physician Fee Schedule (“MPFS”). Though many health care organizations considered both updated regulatory frameworks when establishing their physician compensation programs for 2021, stakeholders in the industry continue to evaluate…Read More

As the pandemic continues, health care providers, suppliers and managed care organizations are turning to incentive programs in an effort to boost COVID-19 vaccination rates. These programs offer various rewards, such as food and beverages or the chance to win free trips, cruises, groceries, event tickets or large cash prizes, to individuals who receive their…Read More

The story of the rise and fall of the once multi-billion dollar health care company Theranos, Inc. (“Theranos”) and its founder, Elizabeth Holmes, no longer serves merely as a bingeworthy weekend watch but rather yet another cautionary tale for corporations and their counsel. In 2015, Holmes touted a $9-billion dollar valuation of Theranos after she…Read More

On April 15, 2021, Indiana Governor Eric Holcomb signed the Senate Enrolled Act 204 into law (“SEA 204”), creating a new chapter in the Indiana Code, which will provide comprehensive requirements for individuals and health care providers on the issuance and effectiveness of, and exceptions to, health care advance directives. Whether a health care provider…Read More

In State of Wisconsin v. Dawn M. Prado, the Supreme Court of Wisconsin affirmed the earlier 2020 decision of the Wisconsin Court of Appeals (as detailed in a previous Hall Render article), to hold that a provision of Wisconsin’s “implied consent” law (see “Incapacitated driver provision”,  Wis. Stat. § 343.305), which permitted police to obtain…Read More