For the past several years, physicians and compounding pharmacies have stepped in to address critical patient access gaps during U.S. Food and Drug Administration (FDA) shortage declarations for semaglutide (Ozempic, Wegovy)...more
6/23/2025
/ Compliance ,
Drug Compounding ,
Drug Pricing ,
Enforcement Actions ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Health Care Providers ,
Patent Infringement ,
Pharmaceutical Industry ,
Pharmacies ,
Physicians ,
Prescription Drugs ,
Supply Shortages ,
Telehealth
Texas House Bill 3749 (HB 3749), known as "Jenifer's Law," has undergone dramatic revisions since its introduction. What began as a bill that could have shuttered many IV hydration clinics has transformed into legislation...more
5/30/2025
/ Government Agencies ,
Governor Abbott ,
Health Care Providers ,
Health Clinics ,
Healthcare ,
Healthcare Facilities ,
Medical Centers ,
Medical Devices ,
New Legislation ,
Nurses ,
Physicians ,
Regulatory Reform ,
Regulatory Requirements ,
Texas ,
Training
Weight loss clinics, telehealth companies, physicians, and pharmacies that have been prescribing or dispensing compounded GLP-1 medications must prepare for significant changes following the Food and Drug Administration’s...more
3/24/2025
/ Drug Compounding ,
Enforcement Actions ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Pharmaceutical Industry ,
Pharmacies ,
Physicians ,
Popular ,
Prescription Drugs ,
Regulatory Requirements ,
Supply Shortages ,
Telehealth ,
Weight-Loss Products
On January 9, 2025, the Texas Medical Board (TMB) implemented comprehensive changes to its rules, marking a significant shift in how medical spas, IV hydration clinics, and other healthcare facilities operate in Texas....more
1/24/2025
/ Alternative Medicine ,
Compliance ,
Disclosure Requirements ,
Final Rules ,
Health Care Providers ,
Healthcare Facilities ,
Licensing Rules ,
Marketing ,
New Regulations ,
Physicians ,
Prescription Drugs ,
Regulatory Requirements ,
State Medical Board ,
Telehealth ,
Telemedicine ,
Texas ,
Transparency
Cryotherapy has long been an at-home remedy for minor injuries and conditions. In recent years, the use of whole-body cryotherapy has gained popularity among athletes, fitness enthusiasts, and other individuals seeking...more
The Federal Trade Commission (FTC) has broad authority over marketing and advertising, including for medical spas and other healthcare businesses. While there aren't specific regulations tailored solely to med spas or...more
9/23/2024
/ Advertising ,
Disclosure ,
Efficacy Claims ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Clinics ,
Healthcare Facilities ,
Medical Devices ,
Misleading Statements ,
Professional Services Companies ,
State Medical Board
On Monday, the Department of Justice (DOJ) announced a record $15 million settlement to resolve claims that Baylor St. Lukes Medical Center, Baylor College of Medicine, and Surgical Associates of Texas were billing Medicare...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
5/20/2024
/ Breach Notification Rule ,
CARES Act ,
Code of Federal Regulations (CFR) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HIPAA Privacy Rule ,
Medical Records ,
Mental Health ,
Patient Privacy Rights ,
Popular ,
Substance Abuse
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
Patient-administered nitrous oxide (N2O) delivery systems are quickly becoming a sought-after service for clinicians in various medical fields, from dentists to med spas. Nitrous oxide has effects of both analgesia (pain...more
Retail medicine has directly challenged the role of physicians as gatekeepers to prescription medications and medical procedures, and as fiduciaries to their patients.
Some providers in the current IV hydration market are...more
In June 2022, the U.S. Department of Health and Human Services (HHS) issued new guidance on the use of remote communication technologies to deliver audio-only telemedicine in compliance with the Health Insurance Portability...more
9/5/2023
/ Business Associates Agreement (BAA) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
HIPAA Privacy Rule ,
HIPAA Security Rule ,
Telehealth ,
Telemedicine ,
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
Despite some regulatory flexibilities granted to clinical laboratories during the COVID-19 crisis, there are two separate federal anti-kickback laws labs must strictly adhere to throughout this public health emergency and...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
10/24/2022
/ CARES Act ,
Compliance ,
Custody ,
DEA ,
Drug Treatment ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare Facilities ,
Medicaid ,
Medicare ,
Mental Health ,
Patient Privacy Rights ,
Substance Abuse
An appeal brought before the Texas Supreme Court could unleash a wave of legal action by out-of-network ER physicians pursuing insurers for underpayment of claims. Unlike in-network providers who negotiate reimbursement...more
9/19/2022
/ Arbitration ,
Dispute Resolution ,
Employee Retirement Income Security Act (ERISA) ,
Employer Group Health Plans ,
Essential Functions ,
Health Care Providers ,
Insurance Code ,
Medicaid ,
Medicare ,
Out of Network Provider ,
Physicians ,
Reimbursements ,
TX Supreme Court ,
Underpayment ,
United Healthcare Insurance Co.
EKRA stands for the Eliminating Kickbacks in Recovery Act, and it has become a prominent enforcement tool against fraud in the healthcare and medical testing industries. Although the law was developed in 2018 to help combat...more
4/27/2022
/ Clinical Laboratories ,
Clinical Laboratory Testing ,
Compensation Agreements ,
Criminal Liability ,
Eliminating Kickbacks in Recovery Act of 2018 (EKRA) ,
Health Care Providers ,
Healthcare ,
Kickbacks ,
Opioid ,
Patient Referrals ,
Popular ,
Regulatory Standards