New Federal Regulation Regarding Mental Health Reporting and Firearms Access

On January 5, 2016, President Obama issued an executive plan (the Plan) designed to reduce gun violence in the United States. Among other things, the Plan focuses on removing legal barriers preventing states from reporting information to the National Instant Criminal Background Check System (NICS). Briefly, current the Federal mental health prohibitor law bars individuals from buying a gun if, due to a mental health issue, they are either a danger to themselves or others or are unable to manage their own affairs. However, many states continue to provide little information about these individuals because of concerns about whether HIPAA prohibits such reporting.1

As part of this Plan, the Department of Health and Human Services (HHS) is finalizing a rule that will update how HIPAA governs covered entities and whether they may report this type of information related to mental health issues.2 Specifically, the rule expressly permits certain HIPAA covered entities to disclose to the NICS the identities of individuals who are subject to the federal mental health prohibitor law disqualifying them from shipping, transporting, possessing, or receiving a firearm.3 The final rule went into effect on February 5, 2016. Under the final rule, only covered entities authorized to make adjudications or commitment decisions that make individuals subject to the federal law, or that serve as repositories of information for NICS reporting purposes are permitted to disclose the relevant information. Moreover, the disclosure is strictly limited to demographic and certain other information needed for NICS purposes. The rule prohibits disclosing diagnostic or clinical information from medical records as well as any mental health information beyond the indication that the individual is subject to the federal law.4

In addition, the Social Security Administration (SSA) has indicated that it also will promulgate a rule to ensure that appropriate information in their records is reported to NICS. This rule will cover the records of approximately 75,000 people who currently receive disability benefits due to a documented mental health issue, and are unable to manage those benefits, or who have been found by state/federal court to be legally incompetent. The SSA’s rule will also provide a process for individuals to seek relief from the federal ban on possessing firearms due to mental health issues.5

Please refer to psych.org for more information about this evolving issue. Should you have any additional questions, contact your local attorney or risk management professional for additional information.


Attention Alabama Psychiatrists: Telemedicine Regulation Change

In January 2014, the Alabama State Board of Medical Examiners (“ALBME”) promulgated regulations, by some accounts among the strictest in the country, regarding the practice of telemedicine.6 These regulations required, among other things, that first-time visits between patients and physicians be in-person, patients be seen face-to-face once per year, and out-of-state physicians obtain a “special-purpose” license to practice telemedicine in Alabama.

In August 2015, the ALBME suspended enforcement of its telehealth regulations in response to the U.S. Supreme Court’s February 2015 ruling in North Carolina Board of Dental Examiners v. FTC, where the Court held, in part, to prevent antitrust violations, that when a controlling number of the decision makers on a state licensing board are active participants in the occupation the board regulates, the board can invoke state-action immunity only if it is subject to active supervision by the state, or if they are acting under a clearly articulated state policy.7,8 The ALBME is now seeking passage of legislation to address the issues raised by the U.S. Supreme Court’s recent decision and its telehealth regulations.

The suspension of the existing regulations elicits practical questions such as:

  • When will the new statute(s) be enacted?
  • What, if any, changes will these statute(s) make to the currently suspended regulations?
  • What should telehealth professionals do in the interim?

Currently, telemedicine practitioners in Alabama are operating without specific regulations – as if the January 2014 regulations never existed. Even so, the ALBME would surely stop short of saying telehealth is a wholly unregulated industry, as all physicians are still held to the same standard of practice as before August 2015’s suspension, the necessity that any out-of-state physician hold a “special-purpose” license to practice in Alabama is statutory and, thus, still necessary, and the ALBME still has the power to review and address any complaints regarding telemedicine practitioners.9 However, it appears the restrictions, requirements, and prohibitions addressed only by the January 2014 regulations are not – for better or worse – impediments to telehealth professionals in Alabama, at least until potential action by the legislature anticipated in early to mid-2016.

The earliest the Alabama Legislature could take up any submitted legislation would be during its February 2 – May 16, 2016 session. Presently, there is no proposed legislation for public review, but the ALBME and other interested parties are currently drafting what will likely become law in 2016. When the time comes, it is expected that the ALBME and legislators will contemplate relaxation of Alabama’s telehealth regulations, dictated by advancements in technology and the general trend toward efficiency within the healthcare industry, e.g., in-person or face-to-face interaction could potentially be replaced with video-conferencing and real-time access to patient records.

As this is a relatively “fluid” time in the life of telehealth regulation (in Alabama and nationwide), telemedicine practitioners should stay acutely aware of developments, regularly check the ALBME’s website for the possibility of new regulations, keep an ear to the ground for proposed legislation, and discuss developments with appropriate associations and/or their risk management professionals.

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About the Author

Carter H. Dukes is the managing shareholder of Scott Dukes & Geisler, PC in Birmingham, AL.  Mr. Dukes’ practice is focused on the defense of employment and professional liability matters with an emphasis on the representation of mental health providers. Mr. Dukes is admitted to the Alabama and Georgia bars. He graduated from the Emory University School of Law in 1990.

Clozapine Risk Evaluation and Mitigation Strategy (REMS)

On November 19, 2015, the FDA announced that due to continued implementation challenges with the new Clozapine Risk Evaluation and Mitigation Strategy Program (REMS), it is extending the November 23, 2015 prescriber certification deadline and the December 14, 2015 pharmacy certification deadline to help ensure that health care professionals have sufficient time to complete this process and that patient access to clozapine is maintained. Once a new timeline is established, a new prescriber certification deadline will be communicated.10 Additional information about the deadline extension can be found at: https://www.clozapinerems.com. Previously, the FDA announced that beginning on October 12, 2015, all Clozapine prescribers are required to be certified in a Clozapine REMS program.11

According to the FDA’s announcement, “healthcare providers should prioritize the medical needs of their patients and, as appropriate, continue prescribing and dispensing clozapine to patients with an absolute neutrophil count (ANC) within the acceptable ranges while the issues are being resolved by the Clozapine REMS program administrators. Prescribers and pharmacies should continue to work with the Clozapine REMS Program administrators to resolve any issues and continue their efforts to complete certification and update patient information to meet the requirements of the program.”12

The Clozapine REMS is designed to manage known risks of neutropenia associated with Clozapine use, and to ensure that the benefits of the drug outweigh the known risks. The Clozapine REMS Program replaces the six current individual Clozapine patient registries.13 All prescribers of Clozapine products must certify in the Clozapine REMS Program. Certification requires prescribers to:

  • Enroll: Complete the Enrollment form (name, address, NPI, DEA)
  • Educate: Review Clozapine and the Risk of Neutropenia: A Guide for Healthcare Providers
  • Assess: Successfully complete the Knowledge Assessment

To read more about the issues around Clozapine, see the Psychiatric News article, “Why Won’t Clinicians Use Clozapine Despite Proven Superiority?


American Bar Association Files Amicus Brief Challenging Florida’s Firearm Owners Privacy Act

The American Bar Association (ABA) is opposing the Florida Firearm Owner’s Privacy Act (“The Act”) and has filed an amicus brief in the case of Wollschlaeger, et al, v. The Governor of the State of Florida.14 The Act prevents physicians from asking patients about gun ownership or the presence of guns in their patients’ homes, or to document such information in the medical record, unless it is relevant to the patient’s medical care or safety. Physicians who violate this rule may be subject to disciplinary action.15

The ABA’s brief in Wollschlaeger reviews the data and guidelines of various medical organizations that recommend gun safety counseling in homes with children and/or other at-risk individuals. Additionally, the ABA notes the importance of healthcare and argues that the Florida law violates the First Amendment rights of healthcare practitioners and their patients. Specifically, the ABA stated that the previous decision by the United States Court of Appeals for the Eleventh Circuit (Eleventh Circuit) decision incorrectly upheld a restriction on “truthful speech by regulated professionals, under the guise of regulating the medical profession.”16 The ABA further argues that the current law is not necessary to protect the medical privacy rights of patients as those rights are already protected by HIPAA and state privacy laws.17

In 2014, a panel of the Eleventh Circuit upheld the constitutionality of the law. The ABA now requests that the full court re-hear this case.18


New Federal Regulation Regarding Mental Health Reporting and Firearms Access

  1. The White House, Office of the Press Secretary, “FACT SHEET: New Executive Actions to Reduce Gun Violence and Make Our Communities Safer,” (1/4/16).
  2.  Id.
  3. Office for Civil Rights, Department of Health and Human Services, “Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule and the National Instant Criminal Background Check System (NICS),” 45 CFR Part 164.
  4.  Id.
  5. White House, FACT SHEET.

ATTENTION Alabama Psychiatrists: Telemedicine Regulation Change

  1. Latoya Thomas & Gary Capistrant, State Telemedicine Gaps Analysis; Physician Practice; Standards & Licensure, May 2015, http://www.americantelemed.org/docs/default-source/policy/50-state-telemedicine-gaps-analysis–physician-practice-standards-licensure.pdf?sfvrsn=14.
  2. Alabama State Board of Medical Licensure, Certificate of Emergency Rules Filed with Legislative Reference Service, August 19, 2015, http://www.albme.org/Documents/Rules/Temp/540-X-15ER%20repealed.pdf.
  3. N. Carolina State Bd. of Dental Examiners v. F.T.C., 135 S.Ct. 1101, 1106 (2015).
  4. Ala. Code §§ 34-24-502 to 34-24-503.

Clozapine Risk Evaluation and Mitigation Strategy (REMS)

  1. United States Food and Drug Administration, “FDA working with manufacturers to resolve challenges with the Clozapine REMS Program,” (11/19/15). (http://www.fda.gov/Drugs/DrugSafety/ucm467560.htm) (Last accessed 11/23/15).
  2. American Psychiatric Association, Psychiatric News Alert, “APA Takes Action on Problems with Clozapine REMS,” (10/26/15).
  3. United States Food and Drug Administration, “FDA working with manufacturers to resolve challenges with the Clozapine REMS Program,” (11/19/15).
  4. Federal Drug Administration, Drug Safety Communication: “FDA modifies monitoring for neutropenia associated with schizophrenia medicine clozapine; approves new shared REMS program for all clozapine medicines,” (9/15/15).

American Bar Association Files Amicus Brief Challenging Florida’s Firearm Owners Privacy Act

  1. An amicus brief is filed in court by a person (or agency/company) with an interest or view on a subject matter but is not a party.  Amicus briefs are often filed in appeals when there are matters of a broad public interest and the person may want to educate and raise awareness to the court on the issue before them.
  2. Terry, K., Medscape Medical News, “American Bar Association Challenges Florida ‘Gun-Gag” Ruling,” (September 14, 2015).
  3. American Bar Association, Motion For Leave To File Brief As Amicus Curiae In Support Of Petition For Rehearing En Banc Of Petitioners-Appellees, Dr. Bernd Wollschlaeger, Et Al. (8/28/15).
  4. Medscape.
  5. Id.
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