Little Health Law Blog
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.
- 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).
The Centers for Medicare & Medicaid Services (CMS) has proposed a new rule that expands and enhances their authority to (A) deny enrollment, or (B) revoke Medicare billing privileges for healthcare providers and suppliers. The proposed rule would change Medicare enrollment, revocations, and overpayment settlements.
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, 
Our healthcare and business law firm often represents medical practices, including primary care practices, specialty practices, med spas, and IV hydration clinics, in the initial set up phase of the business. Related to