In response to the COVID-19 pandemic, pharmaceutical companies like Pfizer worked diligently to develop safe and effective vaccines. Following the FDA’s approval of these vaccines, many state governments and private employers—including those in the educational and medical fields—implemented policies requiring
Healthcare Law Insights
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Ketamine Clinics: Five Legal Considerations for Psychedelic-Assisted Psychotherapists
Amid the growing interest in psychedelic-assisted psychotherapy, especially with substances like MDMA, psilocybin, and ketamine, it becomes imperative to navigate the intricate landscape of legal considerations associated with this burgeoning field. While the therapeutic benefits are promising, each substance brings…
Gift Card Giveaway Does Not Violate Anti-Kickback Statute, HHS Says
The plan of a healthcare consulting firm (the “Firm”) to give gift cards to physicians in exchange for referrals to new customers does not violate the Federal Anti-Kickback Statute (the “AKS”), according to an Advisory Opinion from the U.S. Department…
Federal Judge Acquits Physician Following Criminal E/M Fraud Conviction at Trial
As previously reported in this post, criminal trials premised on upcoding evaluation and management (E/M) service codes are extremely rare. The Justice Department took that rare step in Maryland in connection with a practice in which Dr. Ron Elfenbein,…
IPSE DIXIT: Because My Patient Said So – How to Challenge Medical Experts Who Base an Opinion of Injury Causation Solely on a Patient’s Self-Report
Plaintiffs often disclose medical experts to opine not only as to the diagnosis or prognosis of an injury or medical condition, but also as to whether the defendant’s actions caused plaintiff’s alleged injury/condition. In the usual course of treatment, physicians…
Should Healthcare Providers Give Law Enforcement Protected Health Information When Informally Requested? Congress Says No.
For years, law enforcement has bypassed traditional means of securing evidence by informal requests for documents from witnesses of crimes. At some point, that practice bled over into informal requests for healthcare providers’ documents, including documents reflecting protected health information…
California Health Care Transaction Reporting Regulations Update
On November 28, 2023, the California Office of Health Care Affordability (“OHCA”) submitted proposed emergency regulations (the “Regulations”) on the reporting of certain transactions involving health care entities for review by the California Office of Administrative Law, the final step…
The First Leap to Receive Approval for a Novel Approach to PTSD Treatment
On December 12, 2023, the Multidisciplinary Association for Psychedelic Studies Public Benefit Corporation (“MAPS PBC”) announced it has submitted a new drug application (“NDA”) to the FDA for the use of 3,4-Methylenedioxymethamphetamine (“MDMA”) for the treatment of post-traumatic stress disorder…
A Higher Power: Physician obligations to report another physician’s conduct under Wyoming law
Wyoming physicians are sometimes confronted with the awkward and difficult choice of whether to bring a colleague’s potentially unprofessional, unethical, or harmful conduct to light by making a report to a hospital’s peer review committee, or even the Wyoming Board…
Developing a Regulatory Compliance Checklist for Ketamine-Assisted Therapy
The Rise of Ketamine Clinics and Ketamine-Assisted Therapy
Ketamine clinics have been on the rise in the U.S. in recent years. As a byproduct of the common practice of prescribing drugs “off-label,” these clinics are not necessarily new in their…