Little Health Law Blog

Two Considerations When Prescribing Compounded Weight Loss Drugs

July 14, 2025 | Little Health Law

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 ›

Two Considerations If You Mistakenly Prescribe Controlled Substances Where You Are Not Licensed

June 23, 2025 | Little Health Law

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 ›

UPDATE: The Corporate Transparency Act Reporting Rule

June 9, 2025 | Little Health Law

Our healthcare and business law firm advises many medical practices on federal, state, and local compliance matters. One compliance question our clients are curious about is the status of the Corporate Transparency Act’s requirements. Our firm previously posted The Corporate Transparency Act Reporting Rule on August 12, 2024, which gives an overview of the reporting requirements of beneficiary ownership information (“BOI”) under the Corporate Transparency Act (“CTA”). On March 26, 2025, the Financial Crimes Enforcement Network (“FinCEN”) issued an Interim Final Rule exempting U.S. companies from reporting BOI to FinCEN, and this post discusses the Interim Final Rule. If you need assistance with ensuring your healthcare-related business is compliant 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

Before the March 26, 2025 Interim Final Rule, certain U.S. companies were required to report their BOI to FinCEN under the CTA. These reporting requirements were intended to identify certain activities within a company, including tax fraud and money laundering. U.S. companies that were considered “domestic reporting companies” were required to file BOI reports with FinCEN. “Domestic reporting companies” included corporations, limited liability companies, etc. that were created by filing documents with a secretary of state. The CTA had several Continue reading ›

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 ›