Articles Posted in Improving Your Practice

Our 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 ›

Our 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 ›

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 ›

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 ›

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 ›

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 ›