HealthcareImage_062618-700x525-1-e1682709849274Our healthcare and business law firm works with healthcare businesses to assist in compliance matters, including the Health Insurance Portability and Accountability Act (“HIPAA”) and the Health Information Technology for Economic and Clinical Health (HITECH) Act.  The HITECH Act was designed to strengthen HIPAA in many ways.  A question our healthcare business-owning clients often have is whether patients with insurance can choose to pay cash instead of billing to insurance.  This post focuses on what the HITECH Act states on this subject.  If you have a question about the HITECH Act 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@hamillittle.com. You may also learn more about our law firm by visiting www.hamillittle.com.

  • Summary of Self-Pay Rule

Congress passed the HITECH Act in 2009. It provides in part that health care providers must honor a patient’s request—even an insured patient’s request—to pay out-of-pocket for services, and thus not have their Protected Health Information (“PHI”) shared with third parties like billers or insurers—if the patient requests it. The patient, however, must pay in full 42 U.S.C. 17935(a). Continue reading ›

IV-Therapy-1-e1699043729176Our healthcare and business law firm works with healthcare providers and businesses to  IV hydration therapy practices.  The IV hydration therapy industry has grown drastically over the past few years.  Some states and medical boards have developed laws and rules governing IV Hydration Therapy practices.  In 2022, the Alabama Board of Medical Examiners (“Medical Board”) conducted an investigation into ten businesses advertising retail IV hydration therapy services.  The investigation revealed that many IV therapy businesses allowed unqualified people to treat patients.  Although IV therapy is relatively safe, there are still risks, such as harm to the patient’s kidney.  Because there were no rules or regulations directly governing IV therapy businesses, the Medical Board issued a declaratory ruling.  This blog post summarizes the Medical Board’s answers to three key questions relating to retail IV Therapy practices in Alabama.  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@hamillittle.com. You may also learn more about our law firm by visiting www.hamillittle.com.

  1. Is IV Hydration Therapy the Practice of Medicine?

Yes, “the diagnosis of the patient’s condition and the recommendation of IV therapy constitutes the practice of medicine.”  It is a Class C felony for a person to practice medicine or osteopathy without a medical license.

  1. Who can evaluate, diagnose, treat, and prescribe IV Therapy?

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@hamillittle.com. You may also learn more about our law firm by visiting www.hamillittle.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:

woman_receiving_skin_resurfacing_treatment_657671370-e1696966883317Our 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.  A previous post provided an overview of the rule changes that are potentially applicable to medical spa practitioners.  This post focuses on important rules that apply to Non-Laser Skin Rejuvenation procedures.  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@hamillittle.com. You may also learn more about our law firm by visiting www.hamillittle.com.

As mentioned in the previous blog post, the use of Lasers/Pulsed Light Devices (“LLBDs”) for cosmetic purposes is considered “the practice of medicine” in Alabama.  Level 1 and Level 2 Delegates can perform certain LLBDs only if allowed by the rules, which go fully into effect on July 17, 2024.  This post focuses on the new rules governing Non-Laser Skin Rejuvenation. Continue reading ›

health-medical-e1680627379406Our healthcare and business law firm consistently works with physicians who are dealing with complications resulting from adverse reporting to the National Practitioner Data Bank (“NPDB”).  A previous blog post outlines the process for disputing an NPDB report.  Although difficult, our law firm has had success in appeals to HHS resulting in void reports. This post provides more information about the process of disputing a report directly with HHS and what occurs with a successful resolution.  If you have a question about the NPDB 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@hamillittle.com. You may also learn more about our law firm by visiting www.hamillittle.com.

Initiating the Dispute with HHS

As mentioned in our previous blog post, Two Steps to Dispute an NPDB Report, after attempting to resolve a dispute with the reporting entity, a provider can elevate the dispute by submitting a dispute to the Secretary of the U.S. Department of Health and Human Resources (“HHS”).  HHS’s jurisdiction to review reports is strictly limited, such that it can only review: (a) “if the report was submitted in accordance with reporting requirements”; (b) “if the reporting organization is eligible to report the information”; and (c) “if the report accurately depicts the action taken by the reporting organization and basis for the action in the organization’s written record.”  It is important to frame the request in a way that allows HHS to agree and exercise its jurisdiction.  For example, in a recent matter our firm worked on, our client resigned from employment while the entity was conducting an investigation into matters relating to our client. Continue reading ›

Legal-cases-and-rulings-lower-courts-FHPAF-scaled-e1695156255815Our healthcare and business law firm consistently works with physicians who are dealing with complications resulting from adverse reporting to the National Practitioner Data Bank (“NPDB”) as well as entities in deciding what reports may be appropriate for certain situations.  Whether you are on the side of the provider or reporting entity, it is important to understand the types of NPDB reports that are permitted.  This post outlines the four types of reports. If you have a question about the NPDB 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@hamillittle.com. You may also learn more about our law firm by visiting www.hamillittle.com.

Each reporting organization has the ability to submit four types of reports: an Initial Report, a Correction Report, a Void Report, and a Revision-to-Action Report.

Initial Report

An Initial Report is the first report of a medical malpractice payment, adverse action, or judgment or conviction that is submitted by a reporting entity to the NPDB.  Copies of an initial report are provided to the subject and reporting entity.  Certain reports must also be reported to an appropriate state licensing board.    Continue reading ›

D1432441-e1632924477482Our healthcare and business law firm consistently works with physicians who are dealing with complications resulting from adverse reporting to the National Practitioner Data Bank (“NPDB”).  Certain entities, including medical licensure boards, facilities with a peer review process, and medical malpractice payers, have a duty to report specific actions or events to the NPDB. Any practitioner who has had the misfortune of having an action reported to the NPDB is likely aware of the negative impact such a report can have on his or her ability to practice.  Sometimes, however, the information reported to the NPDB is inaccurate in whole or in part or, even if accurate, inappropriately reported.  Inaccurate or inappropriate reports can have equally serious adverse impacts on a medical provider’s ability to practice as any correctly submitted NPDB report.  This post outlines the process for disputing a report that is inaccurate or inappropriately report. If you have a question about the NPDB 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@hamillittle.com. You may also learn more about our law firm by visiting www.hamillittle.com.

STEP 1: Dispute the Report with the Reporting Entity

The NPDB directs providers to contact the reporting organization before initiating a formal dispute with the NPDB.  Doing this is as simple as it sounds: contact the reporting entity, explain why the report is inaccurate or not reported in accordance with NPDB requirements, and request they correct or void the report.  If the report is accurate, yet a new action should have also been reported, you can also request that the reporting entity file a Revision-to-Action Report.  Although reporting entities have a duty to correctly report to the NPDB, entities can be sanctioned for not reporting.  As such, entities have an incentive to report if there is any question as to whether reporting is required.  Motivating an entity to modify a report to make it more factually accurate is a much easier feat than motivating an entity to void a report.  In our experience, entities have little incentive to void a report; they would rather the provider dispute the report to HHS and have HHS direct them to void the report. Continue reading ›

Amankora-Bhutan-–-Spa-Wellness-Aman-Spa-Paro-Amankora-Holistic-Massage-e1694207101902Our 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@hamillittle.com. You may also learn more about our law firm by visiting www.hamillittle.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. Continue reading ›

hearing-loss-older-adults-inline-e1688417272253Our healthcare and business law firm works with numerous medical practices in compliance and regulatory matters.  Many medical practices are unaware of the requirements of the Americans With Disabilities Act (“ADA”), and in particular the requirements to accommodate individuals with auditory disabilities (including individuals who are deaf or hard of hearing).  The ADA does not just prevent disability discrimination by employers.  Title III of the ADA applies to “public accommodations.”  A public accommodation is a business that is open to the public or provides goods or services to the public and specifically includes a “professional office of a health care provider.”  28 CFR 36.104; Guide to Disability Rights Law, ada.gov.   This post provides an overview of the ADA’s auxiliary aids and services requirements and how they apply to medical Practices.  If you have questions regarding this blog post or would like to speak with counsel regarding your medical practice, you may contact us at (404) 685-1662 (Atlanta) or (706) 722-7886 (Augusta), or by email, info@hamillittle.com. You may also learn more about our law firm by visiting www.hamillittle.com.

  1. Medical Practices Must Take Proactive Steps in Certain Situations

The general auxiliary acts and services rule applicable to medical practices is: “No individual shall be discriminated against on the basis of disability in the full and equal enjoyment of the goods, services, facilities, privileges, advantages, or accommodations of any place of public accommodation by any private entity who owns, leases (or leases to), or operates a place of public accommodation.”  28 C.F.R. 36.201.   As related to auxiliary aids or services, full and equal enjoyment means (a) a patient cannot be refused access because of his/her disability, (b) effective communication modalities (i.e., auxiliary aids or services) are required, and (c) when necessary to accommodate a patient’s needs, the practice must reasonably modify policies, physical space, and procedures.  28 C.F.R. Part 36. Continue reading ›

are-you-taking-too-many-supplements-1440x810-1-e1692129513681Our healthcare and business law firm works with many providers and other allied health professionals who are beginning their journeys of opening a Medical Spa.  Medical Spas have been growing in popularity across the country.  They are unique practices in that they involve many medical and non-medical procedures.  There are many factors to consider in opening a medical spa and/or IV hydration clinic, and this medical spa series focuses on key factors to consider when opening a medical spa in Georgia.  Although our healthcare law firm has assisted numerous clients in establishing a medical spa from the ground up, each client continues to present unique issues requiring our firm to research and analyze the nuances of each client’s intended setup.  This Georgia Medical Spa Series is intended to provide spas.

This post in the Georgia Medical Spa Series focuses on a newer treatment, nicotinamide adenine dinucleotide (“NAD+”), which is a newer treatment our clients have inquired about.  If you have questions regarding this blog post or would like to speak with counsel regarding opening your medical spa practice, you may contact us at (404) 685-1662 (Atlanta) or (706) 722-7886 (Augusta), or by email, info@hamillittle.com. You may also learn more about our law firm by visiting www.hamillittle.com.

  1. NAD+ is a dietary supplement.

NAD+ is currently a dietary supplement (not an “approved drug” by the Food and Drug Administration (“FDA”)).  “The FDA generally does not approve dietary supplement claims or other labeling before use.”  Questions and Answers on Dietary Supplements, FDA.gov.  As such, it is on the manufacturer and distributor to “ensur[e] that the dietary supplements it manufactures or distributes are not adultered, misbranded, or otherwise in violation of federal law.”  Id.

  1. NAD+ does not require a prescription in Georgia.

Continue reading ›

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