Little Health Law Blog

Our healthcare law firm works with many providers and healthcare practices to assist them in complying with federal, state, and local laws. In particular, our med spa clients often ask to consider whether they can offer stem cell or exosome therapies as part of their practice. Stem cell and exosome therapies are popular treatment items for med spas, but offering these therapies also carries legal risk and compliance issues. This blog covers two considerations that med spas should consider before offering stem cell and exosome treatments to patients for therapeutic purposes. If you need assistance setting up a med spa to offer stem cell and exosome treatments or would like to discuss this blog post, you may contact our healthcare law firm at (404) 685-1662 (Atlanta) or (706) 722-7886 (Augusta), or by email, info@littlehealthlaw.com. You may also learn more about our law firm by visiting www.littlehealthlaw.com.

Background

Stem cells and exosomes are biological products that can be marketed and sold only if a business has a valid biologics license application (BLA) or, if in the development stage, such a product can be distributed for clinical use in humans if the sponsor has an Investigation New Drug (IND) designation. If a sponsor has an IND and wishes to work with another entity to investigate by conducting research, that researching entity Continue reading ›

We previously wrote about concierge medical practices in 2022 but wanted to write an updated post because our clients have had renewed interest in starting concierge medical practices. Concierge medical practices are a subscription-based model where patients pay a membership fee to receive a menu of healthcare services. Concierge medical practices can provide healthcare services under several business models, including providing only non-medical services that are self-pay or providing both non-medical services that are self-pay and medical services that are billed to insurance and Medicare.

Before starting a concierge practice, it is important to be aware of the legal pitfalls that can come with starting a concierge medical practice. This blog covers two considerations that providers should consider before starting a concierge medical practice. If you need assistance setting up a concierge medical practice or would like to discuss this blog post, you may contact our healthcare law firm at (404) 685-1662 (Atlanta) or (706) 722-7886 (Augusta), or by email, info@littlehealthlaw.com. You may also learn more about our law firm by visiting www.littlehealthlaw.com.

First Consideration: It Is Important to State Clearly the Type of Services Your Practice Provides Under Its Membership Fee to Avoid Double-Billing.

A concierge medical practice’s membership contract is a crucial document for the practice. The membership contract outlines the services your concierge medical practice will provide, the membership fees that the patient will pay, and what services are covered under Continue reading ›

Our healthcare law firm works with many residents and other students who are facing discipline in their programs ranging from probation to termination and non-renewal of their residency contracts. A question that comes up is what residents can do when they have been notified of disciplinary measures from their residency programs. This blog covers three considerations that residents should account for when they are notified of disciplinary measures from their programs. If you need assistance responding to a disciplinary action from your residency program or would like to discuss this blog post, you may contact our healthcare law firm at (404) 685-1662 (Atlanta) or (706) 722-7886 (Augusta), or by email, info@littlehealthlaw.com. You may also learn more about our law firm by visiting www.littlehealthlaw.com.

First Consideration: Review Your Residency Handbook and Consider Legal Representation When You Have Been Put on Probation, Not Just When You Have Been Notified That Your Contract Has Been Terminated or Has Not Been Renewed.

Barring the most egregious actions that warrant immediate termination, most residents who are disciplined are put on probation to give themselves an opportunity to improve under supervision. Once you are put on probation, you should review your Continue reading ›

Our healthcare law firm works with many providers who prescribe medications, including medications for use that is considered “off label” by the Food and Drug Administration (“FDA”). One such off-label use is administering ketamine to patients for treatment-resistant depression. Ketamine, and the recently FDA-approved Spravato®, which has esketamine as its active ingredient, has garnered popularity as a potential treatment for treatment-resistant depression, but it has come under scrutiny in recent years. This blog covers three considerations that providers should consider before administering ketamine or Spravato® to patients. If you need assistance setting up a practice to administer ketamine or Spravato® or would like to discuss this blog post, you may contact our healthcare law firm at (404) 685-1662 (Atlanta) or (706) 722-7886 (Augusta), or by email, info@littlehealthlaw.com. You may also learn more about our law firm by visiting www.littlehealthlaw.com.

First Consideration: Ketamine and Spravato® Are Controlled Substances That Are Subject to DEA Regulations

Ketamine and Spravato® are Schedule III controlled substances that are subject to controlled substance laws and regulations under the Drug Enforcement Administration (“DEA”). Providers who administer ketamine or Spravato® should have a DEA registration and may need a DEA registration for Continue reading ›

Our healthcare and business law firm works with many providers who work with compounded medications.  Recently, pharmaceutical manufacturers of weight loss drugs have brought lawsuits against compounding pharmacies and medical businesses who advertise and prescribe compounded weight loss drugs.  As against the medical businesses, the manufacturers bring claims of  false advertising and unfair trade practices for marketing and prescribing compounded semaglutide or compounded tirzepatide for weight loss. This blog covers two considerations that providers should account for when marketing or prescribing compounded semaglutide or tirzepatide for weight loss. If you need assistance responding to a lawsuit by a pharmaceutical manufacturer or would like to discuss this blog post, you may contact our healthcare and business law firm at (404) 685-1662 (Atlanta) or (706) 722-7886 (Augusta), or by email, info@littlehealthlaw.com. You may also learn more about our law firm by visiting www.littlehealthlaw.com.

Background

Semaglutide and tirzepatide are peptides that are in popular drugs, including Ozempic®, Wegovy®, Mounjaro®, and Zepbound®. The Food and Drug Administration (“FDA”) originally approved Ozempic® and Mounjaro® for type-2 diabetes. These drugs gained enormous popularity as a weight-loss drug, so doctors started prescribing Ozempic® off label for weight-loss use. The FDA later approved Wegovy® and Zepbound® for weight loss. Because the popularity of these drugs soared, a drug shortage resulted. Because there was low supply and high demand, providers and pharmacies decided to sell compounded versions of semaglutide and tirzepatide. Compounded versions of drugs are not FDA-approved, so they are not subject to FDA scrutiny before they are sold on the market.

In October 2024, the FDA removed tirzepatide from the drug shortage list, and compound pharmacies filed a lawsuit, seeking to Continue reading ›

Our healthcare and business law firm works with many providers as they undergo investigations, discipline, and/or hearings before state licensing boards. These investigations cover a variety of topics, including whether to report misconduct to a state’s licensing board. Each state’s licensing board has different reporting requirements, so ensuring compliance with the reporting requirements of each state’s licensing board can be challenging. This blog covers examples of reporting requirements in certain states as it relates to inadvertently prescribing a controlled substance to a patient who lives in a state where you are not licensed to practice. If you need assistance determining whether to report an action to a state licensing board or would like to discuss this blog post, you may contact our healthcare and business law firm at (404) 685-1662 (Atlanta) or (706) 722-7886 (Augusta), or by email, info@littlehealthlaw.com. You may also learn more about our law firm by visiting www.littlehealthlaw.com.

Consideration 1: What are the Federal reporting requirements?

The Drug Enforcement Administration (“DEA”) has federal jurisdiction over controlled substances. Once a provider discovers a “suspicious order,” which is defined as an unusually large controlled substance order, unusually frequent controlled substance orders, or controlled substance orders that deviate substantially from a normal pattern, the provider must notify the DEA Administrator and the Special Agent in Charge of the local DEA Division Office. If a provider has had their state license registration suspended, revoked, or denied, or the state licensing board has recommended suspension, revocation, or denial of the provider’s DEA registration, the DEA can Continue reading ›