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Medical-License-Pro-101-What-is-Medical-Licensing-e1644515222485The Centers for Medicare & Medicaid Services (CMS) has proposed a new rule that expands and enhances their authority to (A) deny enrollment, or (B) revoke Medicare billing privileges for healthcare providers and suppliers. The proposed rule would change Medicare enrollment, revocations, and overpayment settlements.

Some key points of the proposed rule include: Continue reading ›

nurses-and-docs-e1681928313827Our healthcare and business law firm often represents medical practices, including primary care practices, specialty practices, and med spas, in the initial set up phase of their practice.  A main question we are asked is: What’s the Corporate Practice of Medicine (CPOMs) Doctrine and does it mean I have to have an MSO?  This is not always an easy question to answer.  The CPOM doctrine essentially encapsulates the following sentiment: We don’t want non-physicians, including corporations, practicing medicine so non-physicians cannot own medical practices.  There is quite a bit of nuance to add to that explanation, but that’s the main idea behind the doctrine.  This post provides 3 initial questions to consider relating to the CPOM doctrine.   If you have medical practice set up or CPOM questions 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.

Question 1: Am I practicing medicine?

This is not always an easy question to answer, even though common sense would say it should be.  Each state’s idea of what constitutes the practice of medicine is drastically different. Continue reading ›

laser-hair-removal-service-e1698438994608Our healthcare and business law firm works with healthcare providers and businesses to open cosmetic medical and wellness spas.  The medical spa entity has grown drastically over the past few years.  Some states and medical boards have developed laws and rules governing medical and wellness spas.  As medical and wellness spas continue to grow, we can anticipate more laws and rules governing medical and wellness spas.  On July 19, 2023, the Alabama Board of Medical Examiners (“Medical Board”) published changes to the rules governing the “Use of Lasers and Other Modalities,” which can be found in Chapter 540-X-11 of the Rules of the Medical Board.  The rule is broken down into many different categories.  This post provides an overview of the rule changes that are potentially applicable to medical spa practitioners.  If you have a question about the Alabama Medical Board’s rules 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.

Rule 540-X-11 “Guidelines for the Use of Lasers and Other Modalities Affecting Living Tissue” has been a rule in Alabama since 2007.  However, on March 16, 2023, the Medical Board passed changes and additions to the Rule, which became effective on July 17, 2023.  The deadline for compliance with the provisions is July 17, 2024.

Although the Medical Board made many changes, an important change to the rules is that these rules apply to many cosmetic lasers including cryotherapy, infrared lasers, radiofrequency micro-needling, Class III lasers that work on heat-based targeting of skin and collagen.  The Medical Board made many changes to Rule 540-X-11.  The Medical Board made many notable changes to the rule that may apply to med spa practitioners, including as follows:

Cooperation-e1683920749306For the better part of the last three years, many healthcare providers either voluntarily or by force have put many of the mandated HIPAA self-assessment audit requirements on the back burner. As has been seen most recently, that is all about to change…significantly.

By way of background, the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH) requires the Department of Health and Human Services to periodically audit covered entities and business associates for their compliance with the requirements of HIPAA.  During these audits, covered entities are often asked to produce policies and procedures as well as evidence that they have been conducting accurate and thorough assessments of the potential risks and vulnerabilities to the confidentiality, integrity, and availability of all electronically-protected health information (PHI) that they create, receive, maintain or transmit.To assist these entities in maintaining compliance, the Office of Civil Rights (OCR) has provided many different self-assessment tools, many of which can be found here.

Since the onset of COVID however, many covered entities have been faced with other significant challenges including strict adherence to vaccine and quarantine requirements as well as significant reductions in workforce and discretionary income often needed to conduct such intensive HIPAA self-assessments. Continue reading ›

nurse-practitioner-vs-primary-care-doctor-002-e1675797754824As a healthcare and business law firm, we have many clients who either are or wish to hire nurse practitioners around the country.  Each state has very specific, and often complicated, laws and rules governing nurse practitioner practices.  In 2020, Florida introduced a new law allowing certain nurse practitioners to practice autonomously, which Florida has sense been expanding on and clarifying.  Herein is an overview of Florida’s autonomous practice law. If you have scope of practice or other practice-related questions 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.

Prior to the autonomous practice law, nurse practitioners could practice in Florida pursuant to a collaborative/supervisory protocol as defined by Florida Statute 464.012Florida Statute 464.0123 allows the Florida Board of Nursing to register an individual as an advanced practice registered nurse or as an autonomous advanced practice registered nurse if the nurse practitioner meets the following criteria: Continue reading ›

As a healthcare and business law firm, we work with many employers and employees to navigate complex employment matters, oftentimes with an eye towards federal employment regulations. 021721125026-300x188 The COVID-19 pandemic has impacted employment in the United States.  Now that the Country is reopening and people are returning to work, a question on everyone’s mind is: “Can my employer require me to get the vaccine”?  The Equal Employment Opportunity Commission (“EEOC”) recently released guidance answering that question.  This post intends to outline the EEOC’s position; it does not address the potential impact of state and local rules on this topic.  If you have questions regarding this blog post, employment matters, or EEOC rules and regulations, you may contact us 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 EEOC Hearing

To assist in developing its guidance, on April 28, 2021, the EEOC held a hearing to discuss the impact of the pandemic on workplace civil rights.  During the hearing, the EEOC heard from experts in economics, policy, disability rights, and many more.  The hearing transcript and audio is available here.  It may be important going forward to consider that the EEOC hearing was held before the CDC issued new guidance on May 13th pertaining to fully vaccinated individuals.

As a healthcare and business law firm, we work with many healthcare employers and employees to resolve employment disputes.  When disputes involve the civil rights of the employee, the Equal eeoc-gavel-new-300x250-1Employment Opportunity Commission’s (“EEOC”) administrative process may be triggered.  For instance, if an employee alleges discrimination based on sex or race under Title VII, the employee is required to file a Notice of Charge with the EEOC and allow the EEOC to review the charge for at least 180 days.  After 180 days passes, the EEOC may issue the complainant-employee a Notice of Right to Sue, and then, the employee may file a federal lawsuit.  Sometimes, however, the employee fears continued discrimination or retaliation from initiating the EEOC action.  Can the employee bring an injunction in federal court enjoining the employer from discriminating or retaliating? This post intends to outline the Eleventh Circuit’s stance on this question.  If you have questions regarding this blog post or employment matters, including unlawful discrimination in the workplace, you may contact us at (404) 685-1662 (Atlanta) or (706) 722-7886 (Augusta), or by email, info@littlehealthlaw.com.

At the outset, anti-discrimination laws generally provide equitable relief as a remedy.  See, e.g., 42 U.S.C. § 2000e-5(g)(1).  Further, the EEOC may move a federal court for an injunction pending the EEOC’s investigation.  As recognized by federal courts, the EEOC taking such an intervening step requires many moving parts.  In Drew v. Liberty Mut. Ins. Co., the Fifth Circuit painted a picture that that the complainant “would have to be fortunate enough for her complaint with EEOC so to divert the attention of the staff from its overwhelming burden of cases to distinguish it as one which demanded immediate attention, resulting in the preparation and filing of a suit by staff attorneys pending the usual course of processing the complaint before she would ever be able to act on her own to seek an end to the irreparable damage she was suffering.  480 F.2d 69, 74 (5th Cir. 1973).  This begs the question—can the private employee move for an injunction pending the EEOC action?

Circuit courts are split on this issue.  See David Tecson, Federal Remedies in Employment Discrimination Actions, at 6-7 (2007).  The Eleventh Circuit precedent comes from the Fifth Circuit case in Drew, which is binding on the Eleventh Circuit because it was decided prior to 1981.  In Drew, the court stated: “We conclude that in the limited class of cases, such as the present, in which irreparable injury is shown and likelihood of ultimate success has been established, . . . the individual employee may bring her own suit to maintain the status quo pending the action of the [EEOC]. . . .”  Although circuits and even district courts within the Eleventh Circuit have disagreed with this stance, the present rule is that in limited circumstances, the employee may move for an injunction pending the EEOC action.  As an example of disagreement, in McGee v. Puralator Courier Corp., 430 F. Supp. 1285, 1286-88 (N.D. Ala. 1977), the Northern District of Alabama disagreed with Drew in part because the EEOC requirement was a jurisdiction bar to bringing suit at that time.  In 2019, the Supreme Court resolved the jurisdictional split on that issue and found exhausting the EEOC process was not a jurisdictional bar.  Fort Bend Cnty., Texas v. Davis, 139 S.Ct. 1843 (2019).  In 1984, the Eleventh Circuit, after splitting with the Fifth Circuit, summarily affirmed a Northern District of Georgia case applying Drew to a case involving a federal employee.  Goza v. Bolger, 538 F. Supp. 1012, 1017 (N.D. Ga. 1982), aff’d, 741 F.2d 1383 (Table) (11th Cir. 1984).  Although there is disagreement over the ability of an individual to bring a suit for injunctive relief pending an EEOC charge, it seems that it is available in limited circumstances in the Eleventh Circuit.

As a healthcare and business law firm, we work with may healthcare providers and employers who wish to integrate telehealth into their business models and, understandably, have questions.  4-300x169What is telehealth versus telemedicine?  What laws and rules govern the practice of telemedicine?  Has COVID-19 impacted telemedicine?  Etc.  This post intends to outline some of the rules and laws relevant to practitioners, including the impact of HB 307 on telehealth in Georgia.  If you have questions regarding this blog post or telehealth, you may contact us at (404) 685-1662 (Atlanta) or (706) 722-7886 (Augusta), or by email, info@littlehealthlaw.com.

As an initial matter, telehealth and telemedicine are distinct terms.  Telemedicine is a subset of telehealth.  The definitions of both are found within Georgia’s insurance code.   Telehealth is defined as “the use of information and communications technologies, including, but not limited to, telephones, remote patient monitoring devices or other electronic means which support clinical health care, provider consultation, patient and professional health related education, public health, and health administration.”  O.C.G.A. § 33-24-56.4(b)(6).  “Telemedicine” is defined as:

[A] form of telehealth which is the delivery of clinical health care services by means of real time two-way audio, visual, or other telecommunications or electronic communications, including the application of secure video conferencing or store and forward transfer technology to provide or support health care delivery, which facilitate the assessment, diagnosis, consultation, treatment, education, care management, and self-management of a patient’s health care by a health care provider practicing within his or her scope of practice as would be practiced in-person with a patient, and legally allowed to practice in this state, while such patient is at an originating site and the health care provider is at a distant site.

As a healthcare and business law firm, we work with many employers and employees to prevent, resolve, and, if required, litigate employment matters. When the underlying issue alleged is iStock-928775258-300x200discrimination in the workplace, the law grants the employee a required process for investigating the matter through the Equal Employment Opportunity Commission (“EEOC”). The federal laws enforced by the EEOC apply to employers with 15 or more employees (20 in age discrimination cases) and make it unlawful to discriminate against a person based on race, color, religion, national origin, sex, pregnancy, age, disability, or genetic information. The laws also generally make it unlawful for an employer to retaliate against an individual for reporting discrimination or participating in the EEOC process. If an employee believes her employer has unlawfully discriminated and the parties are unable to resolve the matter among themselves, the employee may wish to file a lawsuit against the employer. Before doing so, however, the employee must exhaust her administrative remedies by initiating an action with the EEOC.1

Initiating EEOC Action

  1. Charge of Discrimination

On May 1, 2020, the Centers for Medicare and Medicaid Services (“CMS”) published final rule CMS-9115-F known as the Interoperability and Patient Access final rule.  “This final rule is the first ehrsiner_770-300x200phase of policies centrally focused on advancing interoperability and patient access to health information.”  85 Fed. Reg. 25511.  CMS states that this rule “puts patients first by giving them access to their health information when they need it most, and in a way they can best use it.”  Policies and Technology for Interoperability and Burden Reduction, CMS.gov.  The rule requires coordinated communication between patients, providers, and payers.  These changes largely require the use of improved and updated technology, and CMS provides implementation support here.  Although many of the requirements under the final rule went into effect on January 1, 2021, because of the hardships posed by COVID-19, “CMS will not enforce these requirements until July 1, 2021.”  Id.

Payors carry the brunt of this regulatory change.  Without detailing all requirements under the rule, a few are as follows.  CMS-regulated payors must maintain a secure, standards-based application programming interface (API) that will support the exchange of patient electronic health information (“EHI”).  These payers must also maintain a patient-facing API allowing patients to access their EHI, including information about claims and costs, and make provider directory information publicly available through an API.  Further, payors are required to implement a process for exchanging data, which is not required until January 1, 2022.

Governed hospitals will soon have a duty to send event notifications of a patient’s hospital “admission, discharge, and/or transfer to another healthcare facility or to another community provider or practitioner” to “improve care coordination.”  Interoperability and Patient Access Fact Sheet, CMS.gov (Mar. 9, 2020).  CMS-regulated providers are encouraged to register all interoperability digital contact information through the National Plan and Provider Enumeration System (NPPES).  A list of providers who fail to do so will be publicly available as a way to incentivize compliance.  Landi, H., CMS’ New Interoperability Rule Requires Major Changes for Payers, Hospitals.  Here are 6 Key Elements, Fierce Healthcare (Mar. 9, 2020).

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