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HIPAA-Breaches-Healthcare-Students-e1615468812558-300x199Our healthcare and business law firm advises many medical practices, including telemedicine and cash-only practices, on regulatory compliance.  A question we frequently receive is whether the No Surprises Act applies to a practice that does not participate in any insurance network.  The answer is not always straightforward—the No Surprises Act has several distinct components, and whether a particular requirement applies depends on what type of entity or provider is involved.  This post explains the structure of the Act, discusses the Good Faith Estimate (“GFE”) requirement and which providers it reaches, and outlines practical compliance steps.  If you would like to discuss No Surprises Act compliance for your 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.

(1) The No Surprises Act Has Multiple Components

The No Surprises Act was enacted as part of the Consolidated Appropriations Act of 2021 and created a suite of consumer protections against unexpected medical bills.  It is important to understand that not all of those protections apply to the same entities.  Some provisions—particularly those addressing surprise billing for emergency services and certain non-emergency services—are tied specifically to “health care facilities,” a defined term that encompasses hospitals, hospital outpatient departments, critical access hospitals, and ambulatory surgical centers.  Those facility-specific provisions are primarily designed for the insured-patient context, where a patient receives care at an in-network facility but is Continue reading ›

If your practice has not yet updated its HIPAA Notice of Privacy Practices (NPP), action is overdue. Effective February 16, 2026, all HIPAA-covered health care providers are required to revise their NPP to reflect new federal rules governing the confidentiality of substance use disorder (SUD) treatment records under 42 C.F.R. Part 2 (“Part 2”). These changes stem from the CARES Act and a 2024 HHS final rule that aligned Part 2 more closely with HIPAA while preserving heightened protections for SUD patient records.

Importantly, this obligation is not limited to practices that specialize in SUD treatment. The updated NPP requirements apply to any HIPAA-covered health care provider that creates or maintains Part 2 records — including providers who receive SUD treatment records from other sources in the course of treating a patient, such as through care coordination, referrals, or integrated care arrangements. In other words, if your practice could receive records identifying a patient as having received SUD diagnosis, treatment, or a referral for treatment at a federally assisted program, your NPP must address Part 2’s requirements.

The changes require NPPs to include the following:

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 ›

iStock-1014086596-1000x500-2-e1661804634296-300x182Many of our healthcare and business law firm’s clients have an interest in offering more flexibility to patients.  Common flexibilities we see include offering alternative pay structures and virtual visits.  Since COVID-19, the use of telemedicine visits has increased and remains higher than pre-pandemic levels.  Complying with telemedicine rules requires analyzing federal, state, and payor requirements.  Under the federal Ryan Haight Act of 2008, a prescribing provider may prescribe controlled substances only after an in-person evaluation.  An exception to that rule is when the Secretary of the U.S. Department of Health and Human Services (“HHS”) declares a public health emergency (“PHE”).  21 C.F.R. § 1300.04(i)(4).  During the COVID-19 PHE, the in-person requirement was waived.  Although the PHE is over, the tele-prescribing flexibility for controlled substances remain.  This post discusses the reasons why the DEA continues to allow the COVID-era flexibilities and what the Third Temporary Extension (issued November 19, 2024) does.  If you have questions about tele-prescribing rules that may apply to your 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 https://www.littlehealthlaw.com/.

At the outset, here is a summary of the COVID-Era Flexibilities from the DEA’s March 20, 2020 press release, which our firm discussed in a previous blog post.  DEA-registered practitioners may issue prescriptions for all schedule II-V controlled substances to patients for whom they have not conducted an in-person medical evaluation, if all the following conditions are met:

  • The prescription is issued for a legitimate medical purpose by a practitioner acting in the usual course of his/her professional practice;

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.

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