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Drug Treatment

Foley & Lardner LLP

Substance Use Disorder Treatment Services: 2025 Physician Fee Schedule Proposed Rule Would Expand Access and Medicare Coverage

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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

Lathrop GPM

Nearly 200 Health Care Providers Charged in Aggressive Enforcement Action by DOJ Health Care Fraud Strike Force Alleging Schemes...

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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

Hendershot Cowart P.C.

Do Cosmetic Injections Involve The Practice Of Medicine?

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

Nelson Hardiman, LLP

Decades in the Making: 42 CFR Part 2’s Transformation After 50 Years

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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

Nelson Hardiman, LLP

Too Much Of A Good Thing?

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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

Hendershot Cowart P.C.

Texas Medical Board Cracking Down on IV Hydration

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

Vicente LLP

A Potential Breakthrough for Psychedelic Treatments: Ninth Circuit Court Ruling on Psilocybin Rescheduling

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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

Fox Rothschild LLP

An Appellate Decision on Transgender Care Comes Without Getting to the Substance

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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

Vicente LLP

US Officially Recognizes Medical Use and Safety of Cannabis: The Top 6 Things to Know About Schedule III and the Process Ahead

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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

Venable LLP

CMS Proposes Behavioral Health Program Changes

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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

Benesch

New CMS Standards Pave the Way for Expanded Access to Mental Health, Substance Abuse Services

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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

Williams Mullen

North Carolina CON Update: Psychiatric & Chemical Dependency Treatment Capacities

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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

Parker Poe Adams & Bernstein LLP

Changes to CON Regulations in North Carolina Medicaid Expansion Bill

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

Vicente LLP

A Wake-up Call from Down Under: Australia's Therapeutic Goods Administration Reschedules Psilocybin and MDMA

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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

MoFo Life Sciences

Ending The COVID-19 Public Health Emergency – What Happens Next

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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

Manatt, Phelps & Phillips, LLP

[Webinar] Reimagining Medicine: Can Policy Keep Pace With Scientific Advances? - February 1st, 1:00 pm - 2:00 pm ET

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

ArentFox Schiff

Investigation Newsletter: Florida Doctor Receives 20-Year Prison Sentence for Substance Abuse Treatment Fraud

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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

Hendershot Cowart P.C.

Setting Up a Ketamine Clinic in Texas

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

Sheppard Mullin Richter & Hampton LLP

Proposal to Overhaul Privacy Law Governing Substance Use Disorder Treatment Records

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

Foley & Lardner LLP

Expanded Medicare Telehealth Coverage for Opioid Use Disorder Treatment Services Furnished by Opioid Treatment Programs

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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

Hendershot Cowart P.C.

Stricter than HIPAA: Is Your Substance Abuse or Mental Health Program in Compliance With 42 CFR Part 2?

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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

Venable LLP

HHS 2021 Semiannual Report to Congress Draws Attention to Genetic Testing, Durable Medical Equipment, and Opioid Disorder...

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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

The Rodman Law Group, LLC

Colorado Voters Eye Decriminalization of Psilocybin

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

Sheppard Mullin Richter & Hampton LLP

HHS OIG Signs Off on Substance Use Recovery Incentive Program

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

MoFo Life Sciences

FDA Oks Mail-Order Mifepristone: State Laws May Inhibit Its Use

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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

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