Little Health Law Blog

Two Considerations Before Dispensing Dangerous Drugs to Patients in Georgia

March 7, 2025 | Little Health Law

Our healthcare and business law firm advises many medical practices on compliance matters. One question our clients often ask us is how a medical practice can properly dispense medications to its patients. Dispensing is distinct from administering medication. To administer, the practitioner gives the dose of the drug to the patient. To dispense, the practice issues the drug to the patient for the patient to administer at a later time. There are state and federal considerations before dispensing drugs to patients, which may differ if the practice dispenses controlled substances. This post discusses some considerations before dispensing dangerous drugs (non-controlled substances) in Georgia. If you would like to discuss compliance considerations for your medical practice, 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: How Can a Physician Properly Dispense Drugs to Patients in Georgia?

Businesses that store and dispense drugs need to comply with the Pharmacy board’s storage, record keeping, and dispensing rules. The Board of Pharmacy permits practitioners to dispense drugs to their patients under Ga. R. & Regs. § 480-28. Each practitioner who intends to dispense drugs must notify his/her licensing boards of his/her desire to dispense, and the licensing board will inform the pharmacy board. The licensing board’s notice to the pharmacy board will include:

(a) The name and address of the practitioner;

(b) The state professional license number of the practitioner;

(c) The practitioner’s Drug Enforcement Administration license number; and

(d) The complete name and address of the office or facility from which drugs shall be dispensed and the complete address where all records pertaining to such drugs shall be maintained.

Appealing a CMS Preclusion List Decision

March 5, 2025 | Little Health Law

Our healthcare and business law firm represents healthcare practitioners, including physicians, mid-level providers, and chiropractors, who are faced with adverse actions from the Centers for Medicare and Medicaid Services (“CMS”) or the relevant Medicare Administrative Contractor (“MAC”). Once such adverse action is placing an individual or entity on the CMS Preclusion List, which is a list of individuals and entities who are not allowed to receive payment for services provided to Medicare beneficiaries enrolled in Medicare Advantage plans, as well as for Part D prescription drugs prescribed. This is distinct from CMS’s Exclusion List. CMS can place individuals and entities on the CMS preclusion list for many reasons specified in 42 C.F.R. 422.2, and, for individual suppliers, 42 C.F.R. § 423.100. If you would like to discuss appealing an adverse CMS decision, including a decision to add an individual or entity to the Preclusion List, 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.

Who Can Be Added to the CMS Preclusion List?

Under 42 C.F.R. § 422.2, CMS may add an individual or entity to the Preclusion List if they are “currently revoked from Medicare for a reason other than [a felony under 42 C.F.R. § 424.535(a)(3)],” “under a reenrollment bar,” and “CMS determines that the underlying conduct that led to the revocation is detrimental to the best interests of the Medicare program.” The regulations include factors that CMS may consider to determine whether it is detrimental to the best interests of the Medicare program. Those factors are:

(A) The seriousness of the conduct involved;

(B) The degree to which the individual’s or entity’s conduct could affect the integrity of the Medicare program; and

(C) Any other evidence that CMS deems relevant to its determination[.]

Two Considerations Before Offering Discounts to Patients

February 5, 2025 | Little Health Law

Our healthcare and business law firm represents healthcare practitioners, including physicians and chiropractors, and their medical and chiropractic practice with compliance matters. A question we are often asked by our clients is, “Can I offer discounts to patients?” There are state and federal considerations before offering discounts, and this post discusses some of those considerations. If you would like to discuss compliance considerations for your medical practice, 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: Federal Statutes

The first consideration we’ll discuss falls under the Anti-Kickback Statute (“AKS”) and the Federal Beneficiary Inducements Civil Monetary Penalty Statute (“CMP”). The AKS generally makes it a felony to give or offer anything of value, including free or otherwise discounted services or the routine waiver of coinsurance/deductibles, to induce (or in return for) the purchase or order of any good or service that is reimbursable by a Federal or state health care program (such as Medicare, Medicaid, TRICARE, CHIP, etc.). Similarly, the CMP allows for the imposition of fines against Continue reading ›

CPOM Corner: Are Members of a Management Service Organization Providing Non-Clinical Services to a Medical Practice “Beneficial Owners” Under the Corporate Transparency Act?

November 25, 2024 | Little Health Law

Our 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:

Directly or indirectly owns 25% or more of an entity; or
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 ›

Changes to Mid-Level Provider Practice in Georgia

November 20, 2024 | Little Health Law

Our healthcare and business law firm works with many medical practices to ensure compliance with the use of mid-level providers (such as nurse practitioner and physician assistants). Although certain federal rules are applicable, the scope of practice for mid-level providers is largely provided for in state laws and rules. It is important to remember that these laws and rules may change from time to time, so practices that use mid-level providers should always monitor relevant laws to stay apprised of any changes. Earlier this month, changes to certain Georgia laws impacting mid-level providers went into effect. If you have questions about these changes 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.

House Bill 1046 went into effect on July 1, 2024. A copy of the bill is available here. The bill made changes to, among other sections, Georgia Code Section 31-10-14 relating to death certificates, Georgia Code Section 43-34-23 relating to delegation of authority to nurses or physician assistants, and Georgia Code Sections 43-34-25 and 43-34-103 relating to delegation of certain medical acts to advanced practice registered nurses and physician assistants and construction and limitations of such delegation.

As to Section 31-10-14, the bill authorizes nurse practitioners and physician assistants to sign death certificates. Previously, mid-level providers could only Continue reading ›

Third Temporary Extension of the DEA’s COVID-19 Tele-Prescribing Flexibilities: Why Another Extension and What Does It Do?

November 19, 2024 | Little Health Law

Many of our healthcare and business law firm’s clients have an interest in offering more flexibility to patients. Common flexibilities we see include offering alternative pay structures and virtual visits. Since COVID-19, the use of telemedicine visits has increased and remains higher than pre-pandemic levels. Complying with telemedicine rules requires analyzing federal, state, and payor requirements. Under the federal Ryan Haight Act of 2008, a prescribing provider may prescribe controlled substances only after an in-person evaluation. An exception to that rule is when the Secretary of the U.S. Department of Health and Human Services (“HHS”) declares a public health emergency (“PHE”). 21 C.F.R. § 1300.04(i)(4). During the COVID-19 PHE, the in-person requirement was waived. Although the PHE is over, the tele-prescribing flexibility for controlled substances remain. This post discusses the reasons why the DEA continues to allow the COVID-era flexibilities and what the Third Temporary Extension (issued November 19, 2024) does. If you have questions about tele-prescribing rules that may apply to 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@littlehealthlaw.com. You may also learn more about our law firm by visiting https://www.littlehealthlaw.com/.

At the outset, here is a summary of the COVID-Era Flexibilities from the DEA’s March 20, 2020 press release, which our firm discussed in a previous blog post. DEA-registered practitioners may issue prescriptions for all schedule II-V controlled substances to patients for whom they have not conducted an in-person medical evaluation, if all the following conditions are met:

The prescription is issued for a legitimate medical purpose by a practitioner acting in the usual course of his/her professional practice;

Differences Between Direct Primary Care & Concierge Practices

November 4, 2024 | Little Health Law

Our 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 ›

3 Considerations Before Offering SoftWave at Your Wellness Spa

September 12, 2024 | Little Health Law

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).

UPDATE: FTC Non-Compete Rule Blocked by Federal Judge

August 23, 2024 | Little Health Law

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 ›

3 Steps to Avoid Professional Boundary Violations

August 21, 2024 | Little Health Law

Our healthcare and business law firm works with many providers as they undergo investigations, discipline, and/or hearings before the provider’s licensing board. Over the years, our firm has been able to determine which situations licensing boards find particularly worrisome. Boundary violations are often one of those situations that boards are particularly concerned with. This blog post outlines three steps for avoiding boundary violations. If you need assistance with a licensing board matter 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.

Boundary violations discussed in this blog post include inappropriate relationships between provider and patient, which could involve romantic relationships or providing care to and writing prescriptions for immediate family members. Here three steps to avoid boundary violations.

First, know your licensing board’s rules!

These rules will explain boundaries that you, as a provider, must always maintain. For instance, Continue reading ›