Articles Posted in Healthcare Information

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 peptides as part of their practice. Peptides have garnered recent popularity among med spas, but offering peptides also carries legal risk. This blog covers two considerations that med spas should consider before offering peptides to patients for therapeutic purposes. If you need assistance setting up a med spa to offer peptides 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

Peptides are smaller versions of proteins that may provide pro-aging support, anti-inflammatory, or muscle-building properties. Although popular peptides include weight loss drugs such as semaglutide or tirzepatide, certain peptides such as BPC-157 and Sermorelin are currently being used at med spas for therapeutic purposes. Peptides that are used for therapeutic purposes are not FDA-approved, so they are considered off-label use.

First Consideration: The FDA Is Aware of the Risks of Peptides

The FDA has classified certain peptides, such as BPC-157 and Thymosin Beta-4, in Category 2 of bulk drug substances. Category 2 is for substances where the FDA has identified “significant safety risks” associated with compounding, which means pharmacies cannot compound drugs containing Continue reading ›

Our healthcare and business law firm works with many providers and medical practices to ensure compliance with state and federal laws, rules, and regulations for given procedures, treatments, and prescriptions.  As new treatments become popular, common questions circulate around who can and cannot order, prescribe, and/or administer such treatment.  One device that is becoming popular is the SoftWave device.  SoftWave uses ultrasound vibration to penetrate into muscles in an attempt to improve healing.  This blog post outlines three considerations prior to introducing SoftWave or similar treatments to your medical and wellness practices’ offerings.  If you need assistance understanding the full realm of considerations governing SoftWave 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.

1. The Food and Drug Administration Approved it for Prescription Use

The FDA has approved the SoftWave device, specifically OrthoGold 100, as a Class 1 medical device that does not need its own premarket approval because it is substantially similar to a device that’s already FDA approved (the Dermablate Effect).  The FDA only approved it for prescription use (not over the counter use).  K182682-connective-tissue.pdf (softwavetrt.com).

Our healthcare and business law firm guides many medical practices and physicians through employment matters.  At this point, most people are aware that the Federal Trade Commission (“FTC”) published its final non-compete rule (“Non-Compete Rule”) on April 23, 2024.  Our firm previously posted 3 Facts about the Non-Compete Rule, which provides information about the FTC Rule including that it limits non-competes both prospectively and retrospectively, applies to all workers with one limited exception, and that current non-compete disputes may still continue even if the Non-Compete Rule becomes effective. On August 20, 2024, a judge blocked the FTC from enforcing the Non-Compete Rule, and this post discusses that decision.  If you need assistance with employment matters 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.

Legal Challenges

The Non-Compete Rule was set to become effective on September 4, 2024 despite many challenges.  Those challenges were Ryan, LLC v. FTC in the U.S. District Court for the Northern District of Texas, ATS Tree Services, LLC v. FTC in the U.S. District Court for the Eastern District of Pennsylvania, and Properties of the Villages, Inc. v. FTC in the U.S. District Court for the Middle District of Florida.

• Preliminary Court Orders

On July 3, 2024, the Judge in Ryan issued a Continue reading ›

Our healthcare and business law firm often represents medical practices, including primary care practices, specialty practices, and med spas, in the initial set up phase of their practice.  Whether a Management Services Organization (“MSO”) is necessary or advisable for your practice usually requires a detailed review of your business structure and state laws.  If an MSO is advisable for your practice based on the Corporate Practice of Medicine (“CPOM”) doctrine in your state, this post provides 3 key provisions that should be within your Management Services Agreement (“MSA”).  If you have medical practice set up or MSO questions 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.

As discussed in previous blog posts, including 2 Facts About Management Services Organizations (MSOs) and Med Spas, Management Services Organizations can be useful in CPOM states to provide all non-medical functions of the business while contracting with the Physician Entity to provide all medical functions. The MSA that outlines this agreement is typically a lengthy and involved document, but here are three key provisions that should be contained within the agreement: Continue reading ›