Health Care Law Today

On July 6, the U.S. Food and Drug Administration (FDA) revised its emergency use authorization (EUA) for the COVID-19 antiviral treatment PaxlovidTM (nirmatrelvir and ritonavir) to allow prescribing by pharmacists for quicker and easier access for patients. Pfizer’s Paxlovid was first granted an EUA in December 2021, meaning that the FDA authorized the product for emergency use, even though it has not been approved for any purpose by the FDA. Paxlovid is used to treat…
On July 20, 2022, HHS-OIG published a new Special Fraud Alert on arrangements with telemedicine companies, setting forth seven characteristics OIG believes could suggest a given arrangement poses a heighted risk of fraud and abuse.  The Alert follows dozens of civil and criminal investigations into fraud schemes involving companies that claimed to provide telehealth, telemedicine, or telemarketing services, but allegedly engaged in kickbacks and substandard medical practices to generate medically unnecessary orders and prescriptions.  Those…
On June 7, 2022, Governor Jared Polis signed into law the Colorado False Claims Act (CFCA) at Colo. Rev. Stat. Ann. § 24-31-101 et seq. The CFCA is largely based on the Federal False Claims Act (FCA), but is not an exact replica. Per Colorado Attorney General Phil Weiser, whose office will be tasked with enforcing the CFCA, the new law provides “increased enforcement mechanisms to provide new and more robust avenues to target…
This article originally appeared in Entrepreneur on May 31, 2022, and is republished here with permission. In what feels like an instant, telemedicine has gone from an emerging niche to a must-have. The pandemic created an opportunity for telemedicine providers to grow — rapidly — giving even more reason for venture capital and private equity firms to accelerate that growth and back many new entrants. With loads of capital supporting expansion, coupled with a material uptick…
In this episode of Health Care Law Today, Foley partner Emily Weber and associate Lauren Carboni talk with Dr. Casey Wolfington of Vail Health Eagle Valley Behavioral Health about behavioral health reform and a people-first approach to behavioral health care that is accessible, affordable and equitable. We encourage you to listen to the podcast in its entirety. Please note that the interview copy below is not verbatim. We do our best to provide you with a…
This article originally appeared in Entrepreneur and is republished here with permission. The promise (and peril) of actionable and monetizable patient data in digital health has never been higher. On the one hand, the overnight acceptance and adoption of telemedicine during the pandemic turned what had been a niche into a juggernaut, and with it transformed millions of valuable patient interactions and disclosures into searchable, actionable intelligence that can be mined. On the other hand,…
One Health Resources and Services Administration program, “COVID-19 Claims Reimbursement to Health Care Providers and Facilities for Testing, Treatment, and Vaccine Administration for the Uninsured,” has been a huge source of funding for COVID-19 services during the public health emergency. The HRSA uninsured program has paid approximately $18 billion in claims, including approximately $11.4 billion for testing, $5.85 billion for treatment and $1.6 billion for vaccines.1 Over the last few weeks, the HRSA stopped accepting…
Florida has taken another step towards expanding telemedicine.  On April 6, 2022, Governor Ron DeSantis signed into law legislation to remove Florida’s prior restrictions on telemedicine prescribing of controlled substances. Previously, Florida had a general prohibition on prescribing controlled substances via telemedicine, with only narrow exceptions. The new law (SB 312) eliminates the ban for all controlled substances except Schedule II. Schedule II drugs can be prescribed via telemedicine, but only if the…
Over the last two years, behavioral health (BH) has been one of the biggest growth areas in the health care ecosystem, fueled by the Public Health Emergency (PHE) but in many ways an ignored, overlooked, understaffed, and underfunded element of care delivery in the United States. Providers, payers, and investors―both public and private―have all taken notice. The coming year will be both an expansion of that growth and to some extent a consolidation of players…
On March 15, 2022, the Senate Health, Education, Labor and Pensions Committee (HELP) held a full committee markup to offer several amendments and vote on S. 3799, the Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act (PREVENT Pandemics Act).  The committee voted to report the bill as amended to the floor by a vote of 20-2, with Sens. Rand Paul (R-KY) and Mike Braun (R-IN) voting against the bill.  The…