Texas Senate Bill 378, often referred to as the "Botox Party Bill", is currently making its way through the Texas legislative process. Initiated by State Sen. Charles Schwertner, the bill aims to restrict who can perform...more
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
Novo Nordisk, the manufacturer of Ozempic and Wegovy, has petitioned the Food and Drug Administration (FDA) to add semaglutide, the active ingredient in Wegovy and Ozempic, to the "Demonstrable Difficulties for Compounding"...more
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
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
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
A DSO, or a dental support organization, is an entity that contracts with dental practices to provide administrative, marketing, and/or other business management services for the practice. DSOs do not perform any clinical...more
Meta description: With the federal public health emergency (PHE) ending in May, changes to telehealth prescription rules are set to change. Read on to learn about proposed permanent changes.
DEA Proposes Rules for...more
3/22/2023
/ Controlled Substances ,
Controlled Substances Act ,
Coronavirus/COVID-19 ,
DEA ,
Department of Health and Human Services (HHS) ,
Medical Evaluation Reports ,
Medical Examinations ,
Prescription Drugs ,
Proposed Rules ,
Public Health Emergency ,
Secretary of HHS ,
Telehealth ,
Telemedicine
IV hydration clinics engage in sterile compounding activities (combining or mixing ingredients to create a custom drug/medicine for an individual patient), such as creating IV vitamin therapies, etc. This act of drug...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
Telemedicine is being used in innovative ways in freestanding emergency centers (a.k.a. FECs or FSEDs) around the country. Still, providers must stay compliant with Texas law and federal telemedicine regulations. ...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.
Investment in ambulatory surgery centers (ASCs) is soaring. Physicians, hospitals, and health systems are attracted by the high margins, significant growth potential, payer influence, and efficient patient care. Beyond...more
8/11/2022
/ Ambulatory Surgery Centers ,
Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Due Diligence ,
Investors ,
IRS ,
Medicaid ,
Ownership Interest ,
Physician Ownership ,
Physicians ,
Safe Harbors ,
Stark Law ,
Texas
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