On July 10, the Centers for Medicare & Medicaid Services (CMS) released the Medicare Physician Fee Schedule Proposed Rule (Proposed Rule) for the calendar year 2025. The Proposed Rule would implement certain provisions of the...more
The Department of Justice announced one if its most aggressive and wide-ranging enforcement actions to date, a coordinated two-week operation spanning 32 federal districts. The orchestrated effort involved the FBI, HHS-OIG,...more
Cosmetic injections, such as Botox and dermal fillers, and weight-loss injections, such as Wegovy® and Ozempic®, are popular offerings at med spas, weight-loss clinics, and dermatology practices. But are they considered the...more
It’s widely known but seldom said that many of the biggest challenges in our healthcare system stem from how its laws and regulations were written by many hands working decades apart. Inevitably, as revisions and overlapping...more
F. Scott Fitzgerald famously declared that “Too much of anything is bad, but too much champagne is just right.” That may be true, but it now appears that it may have been “Special K” that proved the undoing of beloved actor...more
In October, the Texas Medical Board addressed the emergence of medical business models that may violate Texas regulations. Specifically, TMB President Dr. Sherif Zaafran, M.D., FASA, cited facilities offering intravenous (IV)...more
On October 27, 2023, the Ninth Circuit Court of Appeals, in Aggarwal v. DEA, held that the U.S. Drug Enforcement Agency (DEA) must reconsider its denial of a petition to transfer psilocybin, the active ingredient in “magic...more
The October 6 decision in RSK v. DLK is non-precedential but still important because of the subject. The parties are parents of four children and have been divorced for a decade. One of those children KK was born as female...more
On August 30, 2023, the federal government formally acknowledged the medical use and low potential of abuse for cannabis, with the US Department of Health and Human Services (HHS) recommending that cannabis be rescheduled to...more
On July 13, 2023, the Centers for Medicare & Medicaid Services (CMS) announced a proposal to significantly expand behavioral health coverage provided under Medicare. The proposal, presented as a part of the calendar year 2024...more
In April, the Centers for Medicare & Medicaid Services (CMS) finalized new regulations that will make critical healthcare services more accessible and affordable for Americans while expanding opportunities for physicians and...more
North Carolina is poised to enact significant certificate of need (CON) reforms that are expected to eliminate the need to secure CON approvals for the development of new psychiatric and chemical dependency treatment...more
On March 23, 2023, the North Carolina General Assembly passed legislation that would expand Medicaid for an estimated 600,000 North Carolinians who currently lack health care coverage but do not actively qualify for Medicaid....more
As Matt Zorn discussed here and in this opinion piece with Chris Koddermann, Australia’s Therapeutic Goods Administration (TGA) recently approved a request to reschedule psilocybin and MDMA under that country’s drug...more
The Biden administration announced on January 30, 2023, that it plans to terminate the COVID-19 public health emergency declaration (the “PHE declaration”) on May 11, 2023. COVID-19 EUA medical products and policies- As FDA...more
Speakers From AbbVie, National Institutes of Health, National Organization for Rare Disorders, NYU Grossman School of Medicine and Verily Share Insights on How Medical Innovation Is Disrupting Policy—and What Needs to Come...more
Florida Doctor Receives 20-Year Prison Sentence for Substance Abuse Treatment Fraud - Following a guilty plea to conspiracy to commit health care and wire fraud, a Florida doctor was sentenced to 20 years in prison for...more
Ketamine has been used as an anesthetic in medical settings for decades, but in recent years, there has been increasing interest in the use of low-dose ketamine as a treatment for PTSD, depression, and anxiety. This interest...more
The U.S. Department of Health and Human Services (“HHS”) has announced proposed changes (the “Proposed Rule”) to 42 C.F.R. Part 2 (“Part 2”). While the Health Insurance Portability and Accountability Act (“HIPAA”) governs the...more
Starting January 1, 2023, Medicare will cover telehealth-based treatment services delivered by federally-accredited opioid treatment programs (OTPs), commonly referred to as “methadone clinics.” This new reimbursement is...more
To protect patients seeking addiction treatment, the federal government passed strict regulations limiting the disclosure of substance abuse patient records. Substance abuse treatment programs must not only comply with the...more
On June 6, 2022, the U.S. Department of Health and Human Services (HHS), Office of Inspector General (OIG), released its spring 2022 semiannual report to Congress. The semiannual report covers the period of October 1, 2021 to...more
This November, Colorado could see some big changes in the area of psychedelics as activists believe they have enough signatures to place a measure on the state’s ballot that would legalize possession of psilocybin and create...more
On March 2, 2022, the Department of Health and Human Services (“HHS”) Office of the Inspector General (the “OIG”) issued a new advisory opinion (“AO 22-04”) related to a program through which the Requestor would provide...more
In December 2021, the U.S. Food and Drug Administration announced that it would make permanent its COVID-19-era enforcement policy, which allows for the delivery of the abortion pill (MIFEPREX (mifepristone)) by mail and...more