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health-medical-e1680627379406-300x188Our healthcare law firm works with many providers to help set up medical practices, including direct primary care practices. We have previously written about direct primary care practices in 2022 and 2023 but are writing an updated post because our clients have had renewed interest in starting direct primary care practices. Direct primary care practices provide an alternative method to the traditional insurance model to provide more targeted, individualized care for patients, but direct primary care also carries legal and compliance risks. This blog covers two considerations that providers should consider before starting a direct primary care practice. If you need assistance setting up a direct primary care practice 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.

First Consideration: Direct Primary Care Is Not Insurance, and Direct Primary Care Agreements Need to State Clearly That These Agreements Are Not Health Insurance

Under Georgia’s Direct Primary Care Act, direct primary care is not considered insurance, meaning direct primary care practices cannot bill their claims to insurance. Because direct primary care practices cannot bill their claims to insurance, issues arise when direct primary care physicians provide Continue reading ›

young-woman-medspa-300x200Our 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 ›

HealthcareImage_062618-700x525-1-e1682709849274-300x189Our healthcare law firm works with many residents and other students who are facing discipline in their programs ranging from probation to termination and non-renewal of their residency contracts. A question that comes up is what residents can do when they have been notified of disciplinary measures from their residency programs. This blog covers three considerations that residents should account for when they are notified of disciplinary measures from their programs. If you need assistance responding to a disciplinary action from your residency program 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.

First Consideration: Review Your Residency Handbook and Consider Legal Representation When You Have Been Put on Probation, Not Just When You Have Been Notified That Your Contract Has Been Terminated or Has Not Been Renewed.

Barring the most egregious actions that warrant immediate termination, most residents who are disciplined are put on probation to give themselves an opportunity to improve under supervision. Once you are put on probation, you should review your Continue reading ›

iStock-1069859094-min-510x340-1-300x200Our healthcare law firm works with many providers who prescribe medications, including medications for use that is considered “off label” by the Food and Drug Administration (“FDA”). One such off-label use is administering ketamine to patients for treatment-resistant depression. Ketamine, and the recently FDA-approved Spravato®, which has esketamine as its active ingredient, has garnered popularity as a potential treatment for treatment-resistant depression, but it has come under scrutiny in recent years. This blog covers three considerations that providers should consider before administering ketamine or Spravato® to patients. If you need assistance setting up a practice to administer ketamine or Spravato® 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.

First Consideration: Ketamine and Spravato® Are Controlled Substances That Are Subject to DEA Regulations

Ketamine and Spravato® are Schedule III controlled substances that are subject to controlled substance laws and regulations under the Drug Enforcement Administration (“DEA”). Providers who administer ketamine or Spravato® should have a DEA registration and may need a DEA registration for Continue reading ›

opioid-painkillers-crisis-and-drug-abuse-concept-o-49X49YX-e1676319930781-300x169Our healthcare law firm works with many providers who prescribe medications, including controlled substances. A question that comes up is what a provider’s reporting obligations to the Drug Enforcement Administration (“DEA”) are when they discover that controlled substances have been stolen from their office or that prescriptions for controlled substances have been fraudulently submitted to patients under their names. This blog covers two considerations that providers should account for when they are notified of theft or fraudulent prescriptions. Please note that this blog post covers reporting obligations to the DEA, not any reporting obligations to state agencies. If you need assistance reporting theft or fraudulent prescriptions to the appropriate sources 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.

First Consideration: The DEA Requires Providers to Report Theft of Controlled Substances and Fraudulent Prescriptions to the DEA Within One Business Day of Discovery of the Theft or Fraudulent Prescriptions

Under the DEA regulations, a provider must notify the local DEA Field Diversion Office in writing of any theft or significant loss of any controlled substances within one business day Continue reading ›

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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 ›

What-is-an-Opioid-e1687291586956-300x200Our 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 ›

med-mal-featured-1-e1685565240921-300x200Our 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 ›

pills-2-300x225Our 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.

Continue reading ›

nurses-and-docs-300x240Our 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[.]

Continue reading ›

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