Articles Posted in Physician Practices

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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.

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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[.]

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nurse-practitioner-vs-primary-care-doctor-002-e1675797661360-300x141Our 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 ›

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HIPAA-Breaches-Healthcare-Students-e1615468812558-300x199Our 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 ›

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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 ›

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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).

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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 ›

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GettyImages-1296010644-e1689271225783-300x193Our 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 ›

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istockphoto-168325387-612x612-1-e1723492642359-300x200

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 beneficiary ownership information (“BOI”) reports.  This blog post provides an overview of the reporting requirements.  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.

The Report

The report must contain information about the entity and two categories of individuals: beneficial owners and company applicants.  A beneficial owner is any individual who, directly or indirectly, exercises substantial control over a reporting company and anyone who owns or controls at least 25 percent of the ownership interests of a reporting company.  Ownership includes equity, stock, voting rights, capital or profit interests, and convertible interests.  As to company applicants, there are two categories.  Continue reading ›

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understanding-physician-employment-contracts-e1677703586595-300x197Our healthcare and business law firm works with many providers and medical practices to ensure compliance with state and federal laws, rules, and regulations.  Mid-level providers, such as physician assistants (“PAs”) and nurse practitioners, are widely used, and they help expand the provision of medical care and services. States differ on the amount of oversight that is required for PAs to practice.  This blog post outlines possible requirements that may be present in your state for PAs to practice under physician supervision, using Georgia as an example.  If you need assistance understanding your state’s guidance on mid-level supervision and delegation requirements 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.

In Georgia, the rules governing PAs and their supervising physician include the following:

First, the Supervisory Relationship Must be Established:

Under Georgia Rule 360-5-.03, in order to supervise a PA, a supervising physician must submit an application to the Board that must be approved by the Board before delegating tasks. On the flip side, upon termination of the supervisory relationship, the PA and physician must give notice and date of termination. Continue reading ›

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