Articles Posted in Healthcare Information

MSO-Helathcare-Image-11-25-24-e1732566156791-300x191Our healthcare and business law firm works with medical practices to ensure compliance with state and federal laws, rules, and regulations.  The Corporate Transparency Act (“CTA”) aims to combat illicit activity including tax fraud and money laundering.  The reporting rule under the CTA requires certain entities to file beneficial ownership information (“BOI”) reports.  This has raised an important question for healthcare practices structured to comply with the Corporate Practice of Medicine (CPOM) doctrine: Are members of a Management Service Organization (“MSO”) providing non-clinical services to a medical practice “beneficial owners” under the CTA?  This blog post dives into that question.  If you need assistance understanding how the reporting rule applies to your business 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.

Understanding Beneficial Ownership Under the CTA

A “beneficial owner” is defined by the CTA as any individual who:

  1. Directly or indirectly owns 25% or more of an entity; or
  2. Exercises “substantial control” over the entity.

For most MSOs, the focus is on the “substantial control” standard.  According to the CTA, substantial control includes: Continue reading ›

Medical-License-Pro-101-What-is-Medical-Licensing-300x200Our healthcare and business law firm works with many providers and medical practices to assist them in structuring medical practices that comply with state and federal laws, rules, and regulations.  Over the last few years, physicians and other healthcare providers desire to create non-traditional medical practices.  Traditional medical practices are those that accept commercial and government payors and bill insurance for medical care provided.  Although many traditional practices offer great medical care, there are systemic issues with these practices, including long wait times, low reimbursement rates, high deductibles causing patients to pay out of pocket, restricted face-time with providers, limited practitioner availability, etc.  Non-traditional medical practices aim to reduce some of these issues.  Two major non-traditional practices are direct primary care (or DPC) practices and concierge practices.  Although these terms are often used interchangeably, they stand for unique models.  This blog post discusses the differences between DPC and concierge practices.  If you need assistance structuring your medical practice 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.

Before identifying the major differences, it’s important to first understand these two models.

Direct Primary Care Practices: Continue reading ›

https://www.littlehealthlawblog.com/files/2022/10/shutterstock_588164834.1-300x200.jpgOur 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).

QuackbustersandtheShockTroopsofMedicalMcCarthyism-e1664472813118-300x181Our 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 ›

HIPAA-Breaches-Healthcare-Students-e1615468812558-300x199Our healthcare and business law firm works with many medical spas to ensure compliance with state and federal laws, rules, and regulations.  Recently in Georgia, the Georgia Board of Nursing published two long-awaited position statements; one on “Cosmetic/Aesthetic Procedures,” and the other on “IV Hydration.”  This blog post discusses the Nursing Board’s position statement on Cosmetic/Aesthetic Procedures.  Even if your practice is not in Georgia, it is helpful to consider the perspective of different states because state licensing boards will often consider other published positions when developing policies and positions.  If you need assistance understanding how either position statement impacts your practice 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@hamillittle.com. You may also learn more about our law firm by visiting www.hamillittle.com.

Prior to discussing the substance of Nursing Board’s position, here are some important points: Continue reading ›

shutterstock_1440454943-scaled-1-300x200Our 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.  A hot topic and sometimes controversial category of drug right now is weight loss drugs (also called weight management drugs).  A provider should generally prescribe a drug or treatment pursuant to a patient-provider relationship when the drug is medically necessary and appropriate, but some states have laws and rules specifically governing prescribing weight loss drugs.  If your state has rules or guidance on prescribing weight loss drugs, it’s important, of course, to follow that guidance.  Unlike our firm’s look into Florida’s weight loss statute, blog post available here, this blog post examines what to consider when a state does not have specific weight loss rules by using Georgia as an example.  If you need assistance understanding your state’s guidance on weight loss treatments 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@hamillittle.com. You may also learn more about our law firm by visiting www.hamillittle.com.

If your state has no specific weight loss statute, such as the statute we previously examined in Florida, where do you turn?  Below is an idea of where to start:

  1. Are There Relevant Statutes or Rules?

Continue reading ›

opioid-painkillers-crisis-and-drug-abuse-concept-o-49X49YX-e1676319930781-300x169Our 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.  A hot topic and sometimes controversial category of drug right now is weight loss drugs (also called weight management drugs).  A provider should generally prescribe a drug or treatment pursuant to a patient-provider relationship when the drug is medically necessary and appropriate, but some states have laws and rules specifically governing prescribing weight loss drugs.  If your state has rules or guidance on prescribing weight loss drugs, it’s important, of course, to follow that guidance.  This blog post outlines potential state guidance using Florida’s weight loss statute as an example.  If you need assistance understanding your state’s guidance on weight loss treatments 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.

Some states have not taken any public stance on weight loss drugs.  But if the state in which you practice has published such guidance, then it is important to follow it.  Furthermore, even if your state has not taken any public stance, it may be useful to review guidance from other states to create “best practices.”  Let’s examine the Florida statute governing weight loss treatment. Continue reading ›

nurses-and-docs-e1681928313827Our 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 ›

health-medical-e1680627379406Our healthcare and business law firm works with healthcare providers and businesses like  IV hydration therapy practices.  The IV hydration therapy industry has grown drastically over the past few years.  Some states and medical boards have developed laws and rules governing IV Hydration Therapy practices.  On August 15, 2023, the South Carolina Board of Medical Examiners, Pharmacy, and Nursing published a joint opinion on Retail IV Therapy Businesses.  The language used and sanctions referenced reveal that the South Carolina Boards are critically reviewing IV therapy businesses.  At one place in the 10-page opinion, the Pharmacy Board compared the “patient-drive menu” in many IV therapy practices “to a fast-food restaurant.”  Reading between the lines of the advisory opinion, it is likely each board will begin cracking down on IV therapy practices.  A full version of the Advisory Opinion is available here. We recommend you read the entire opinion if you have or are starting an IV therapy business in South Carolina.  This blog post starts our review of the Advisory Opinion and outlines whether IV therapy is the practice of medicine.   Forthcoming blog posts will dive deeper into different aspects of the opinion.  If you have a question about South Carolina’s rules 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.

  • What lead to this opinion?

After reviewing the opinion, it is clear that each South Carolina board believed this opinion necessary for four main reasons: Continue reading ›

HealthcareImage_062618-700x525-1-e1682709849274Our healthcare and business law firm works with healthcare businesses to assist in compliance matters, including the Health Insurance Portability and Accountability Act (“HIPAA”) and the Health Information Technology for Economic and Clinical Health (HITECH) Act.  The HITECH Act was designed to strengthen HIPAA in many ways.  A question our healthcare business-owning clients often have is whether patients with insurance can choose to pay cash instead of billing to insurance.  This post focuses on what the HITECH Act states on this subject.  If you have a question about the HITECH Act 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.

  • Summary of Self-Pay Rule

Congress passed the HITECH Act in 2009. It provides in part that health care providers must honor a patient’s request—even an insured patient’s request—to pay out-of-pocket for services, and thus not have their Protected Health Information (“PHI”) shared with third parties like billers or insurers—if the patient requests it. The patient, however, must pay in full 42 U.S.C. 17935(a). Continue reading ›

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