The United States District Court’s 2021 ruling in Milton S. Hershey Medical Center v. Becerra is one example of a successful legal challenge to federal agency action, but a number of more recent cases reaffirm that lower federal courts may not hesitate to overturn agency action deemed outside the bounds of the agency’s legislative authority. This is an important trend for hospitals to note when considering potential challenges of reimbursement determinations made by the Centers for Medicare & Medicaid Services.

In Hershey, a number of teaching hospitals challenged one of the elements that the Secretary of Health and Human Services (HSS) used in fiscal years dating back to 2005 to determine a hospital’s direct Graduate Medical Education (DGME) payment: specifically, each hospital’s weighted number of full-time equivalent (FTE) residents. After students graduate from medical school, they often continue their training in an initial residency period (IRP) which, by statute, is defined to last five years. Some residents additionally complete a fellowship which typically occurs outside the 5-year IRP. Under the Medicare statute, the rules for calculating the weighted average number of FTEs are required to provide a weighing factor of 1.00 for a resident who is in the resident’s IRP, and a weighing factor of .50 for a resident who is not in the resident’s IRP. Thus, the Medicare statute requires that a resident’s time be fully counted but only one-half of a fellow’s time be counted for purposes of the FTE calculation.

In addition, in 1997, Congress amended the Medicare statute to set a limit on how many FTEs a hospital may factor into its count before application of the weighing factors. That limit was capped at the hospital’s 1996 levels.

In 1998, the HHS Secretary amended the agency’s regulation which effectively reduced the weighted number of FTEs a hospital may claim for reimbursement when the hospital’s unweighted FTE count exceeds its 1996 cap. When a hospital exceeds the cap, its weighted FTE count is reduced commensurate with the amount by which the hospital exceeds the cap.  As the Hershey Court explained, assuming a hospital’s cap of 100 which is met by employing 90 residents and 10 fellows, after weighing the fellows at 0.5, the hospital’s post-weighted FTE count is 95. The math is as follows:

100/100   x   95   =   95

 

 

However, if that hospital adds ten more fellows (for a total of 90 residents and 20 fellows), thereby exceeding the cap, its post-regulation weighted FTE count is reduced to 90.91. The math is as follows:

100/110   x   100   =   90.915

 

 

Recognizing, under the rules of statutory construction set forth in Chevron v. Nat’l Resource Defense Council, that it owed no deference to the Secretary’s interpretation of the Medicare statute because the statutory language speaks to the precise issue and is clear, the Court held that the express text of the Medicare statute did not give the Secretary the latitude to decide, when a hospital exceeds its cap or not, to change the weights that Congress assigned to residents and fellows when calculating the FTE residents for each hospital. Consequently, the Hershey Court struck down the agency’s regulation, and thus, the DGME calculation because it violated the express language of the Medicare statute.

Over the past year-and-a-half, we have seen a number of lower federal courts not hesitate to overturn federal agency action when an agency acted outside the bounds of the authority granted to it by Congress in its enabling legislation. The Hershey case is one such example. However, more recently, the United States Supreme Court reinforced this approach in American Hospital Association v. Becerra (Case No. 20-1114 and decided on June 15, 2022), in which the Court limited HHS’s authority to set two separate hospital reimbursement rates under the 340B drug program where Congress spoke clearly in the Medicare statute as to how the rates are to be determined. Further, in West Virginia v. Environmental Protection Agency (Case Nos. 20-1530, 20-1531, 20-1778 and decided June 30, 2022), the Court struck down as not authorized by the Clean Air Act EPA’s sweeping rules to devise carbon emissions caps based on a generation shifting approach away from coal-powered plants, thereby opening the door for more robust challenges to agency action.

The lesson? Aggrieved hospitals are in as good a position as they have ever been to challenge the methodology and calculations made by CMS when determining hospitals’ Medicare rates, DSH and GME payments, or 340B reimbursement.

In an article recently published in the MDAdvisor Journal, Greenbaum attorney John Zen Jackson analyzes the number of times the option to self-administer medication under the Medical Aid in Dying Act (MAID) has been used in New Jersey on an annual basis. Resources in this article include statistics from five demographic categories, a comparison of data available from other jurisdictions with similar laws, and reasons for the relatively low utilization of the Act in New Jersey. The article can be viewed on the website of MDAdvantage, a New Jersey-based leading provider of medical professional liability insurance.

Although the Hospital Price Transparency Rule – which requires hospitals to make public a comprehensive list of charges for items and services – has been in effect for almost two years, the Congressional House Committee on Energy and Commerce advises that hundreds of warning letters and requests for civil monetary penalties to hospitals that are still not fully compliant have been issued by CMS. In this Client Alert, our partner John W. Kaveney reports that the House Committee recently asked the Government Accountability Office (GAO) to take action to address this lack of compliance, and suggests that now is the time for hospitals to review their compliance and consult with legal counsel and other advisors to ensure that the legal requirements of the rule have been fully met in order to avoid significant financial ramifications.

In fiscal year 2020, Medicare paid over $16 billion to hospitals throughout the United States in the form of Graduate Medical Education (GME) payments. This Client Alert by Greenbaum attorneys James A. Robertson, John W. Kaveney and Paul L. Croce is an overview of the basic details of those Medicare GME payments.

The Affidavit of Merit Statute was originally enacted in 1995. Over the ensuing twenty-five years, it has been the focus of numerous opinions from the New Jersey Supreme Court and the Appellate Division examining numerous facets of the statute. In the 2003 decision in Knorr v. Smeal, the Supreme Court observed that “[o]n repeated occasions, we have addressed the obligation of plaintiffs who file malpractice actions to conform to the procedural requirements of the Affidavit of Merit statute.” Some degree of frustration was subsequently expressed in the 2016 decision in Meehan v. Antonellis with the statement: “In this appeal, we return to the vexing and recurring issue of whether an affidavit of merit submitted by a plaintiff in an action alleging negligence by a licensed professional satisfies the requirements of the Affidavit of Merit statute.”

Most recently, in a November 9, 2022 decision in Gilligan v. Junod approved for publication, the Appellate Division again addressed “a question of first impression.” The straightforward issue in Gilligan was whether a licensed practical nurse (LPN) was a “licensed person” for whom an affidavit of merit was required in a malpractice lawsuit involving the LPN’s liability. The Appellate Division panel noted that “licensed person” was a defined term in the statute. As originally enacted, in addition to a healthcare facility, the statute set forth a list of nine professions that were within the term and to whom the affidavit requirement applied. Five more professions were added with an amendment in 2001, another in 2010, and still one more in 2019. None of these referred to or added licensed practical nurses.

In Gilligan, the court followed the same analysis that had been used in Saunders by Saunders v. Capital Health System, a case involving a licensed midwife. Notwithstanding that the tort reform effort leading to enactment of the original affidavit of merit statute had its foundations in the healthcare field, the court rejected the contention that the statutory requirement applied to any healthcare professional. It examined the specific language of the statutory text. The legislature had initially included only ten categories of licensed professionals. When it amended the statute six years later, it added five additional professions. The court reasoned that “[t]he absence of midwives as ‘licensed persons’ strongly suggests that the list contained in N.J.S.A. 2A:53A-26 is an exclusive one and implies that the omission of other licensed health providers ‘was intentional, not an oversight.’” It noted that the legislature could have used the common phrasing of “including but not limited to” if it had intended a more expansive approach. In response to the Saunders decision, the legislature passed an amendment in 2010 to specifically add “a certified midwife, certified professional midwife, or certified nurse midwife” but still without the broader “including but not limited to” language.

The court examined the Nursing Act which provides for separate licensure of both professional registered nurses (RNs) and licensed practical nurses (LPNs). Moreover, the Nursing Act states that scope of practice for an LPN is to work under the direction of “a registered nurse or licensed or otherwise authorized physician or dentist.”

Further support for the Appellate Division’s approach was found in the more recent Supreme Court decision of Haviland v. Lourdes Medical Ctr. of Burlington Cty. decided in April 2022. The court held that an affidavit of merit was not required when the conduct of an unlicensed person employed by a “licensed person” such as a healthcare facility that gave rise to the employer’s potential vicarious liability. The factual context involved the actions of a radiology technician, an unlicensed position, during an imaging study of the plaintiff’s shoulder. The court concluded that the statute “explicitly limits the term ‘licensed person’” to the listed professions.

Although the court in Gilligan held that no affidavit of merit was required, that is only a preliminary procedural requirement. Expert testimony as to the standard of care to be followed by an LPN would still be necessary to prevail at trial.

There is as yet no published decision involving the Affidavit of Merit Statute and a nurse practitioner. It remains to be seen how that category of increasingly utilized healthcare professional is assessed. The statute does not include any reference to nurse practitioners. There is no separate licensure for a nurse practitioner (also referred to as an advanced practice nurse) but there is an additional certification as well as educational and experience requirements. However, one cannot become a nurse practitioner without having first achieved the status of a registered professional nurse. Thus, at least an affidavit of merit from an RN will have to be submitted which will satisfy another section of the Affidavit of Merit Statute requiring “particular expertise in the general area or specialty involved in the action.”

A recent holding by the Eighth Circuit Court of Appeals in United States ex rel. Cairns v. D.S. Med., LLC took a stance on the causation standard for False Claims Act (FCA) cases premised on violations of the Anti-Kickback Statute (AKS) and may provide defendants in those cases with the ability to raise a valid new defense. In this Client Alert, Greenbaum attorneys Christopher D. Adams, Rachel A. Frost and Robert B. Hille analyze the reasoning behind – and significance of – the Court’s decision. They further note that in conflicting with a previous Third Circuit holding, it is not far-fetched to imagine that such a circuit split could eventually bring this issue before the U.S. Supreme Court.

On November 1, 2022, the Centers for Medicare & Medicaid Services (CMS) issued two important final rules: one that included updates and policy changes for Medicare payments under the Physician Fee Schedule (PFS) and aspects of Medicare Part B, and the other that finalized Medicare payment rates for hospital outpatient and ambulatory surgical center (ASC) services.

Hospital Outpatient Prospective Payment System (OPPS) and ASC Payment System Final Rule

CMS has indicated that in addition to setting payment rates, the final rule is intended to “align with several key goals of the Administration, including addressing the health equity gap, fighting the COVID-19 Public Health Emergency (PHE), encouraging transparency in the health system and promoting safe, effective, and patient-centered care.”

Although not fully inclusive, the following is a brief summary of some significant items addressed in the final rule:

  • Rate Increases – CMS has implemented a 3.8% increase to Medicare hospital OPPS rates for hospitals that meet applicable quality reporting requirements. This is a significant increase from the 2.7% increase included in the proposed rule.
  • 340B Program – CMS has established reimbursement for drugs and biologicals acquired through the 340B program at the average sale price plus 6%. This decision is consistent with the Supreme Court’s recent decision in American Hospital Association v. Becerra. CMS did not address the remedy for 340B drug payments for the years 2018-2022, which were the focus of the Becerra decision, but indicated it will do so in future rulemaking prior to the CY 2024 OPPS/ASC proposed rule.
  • Rural Emergency Hospitals – CMS has established a new provider type known as the Rural Emergency Hospital (REH). Qualifying critical access hospitals and small rural hospitals will be able to convert to REHs and Medicare payments beginning January 1, 2023. REHs will be eligible for additional facility payments in the amount of $272,866 monthly.
  • Exemption to Site-Neutral Clinic Visit Cuts – In 2019, CMS instituted a policy to pay for hospital outpatient clinic services furnished at grandfathered off-campus provider-based departments at a rate of 40% of the OPPS. For 2023, CMS has exempted rural small community hospitals from its earlier policy of site-neutral clinic visit cuts. For these facilities, CMS will pay the full OPPS payment rate.
  • Telehealth Services – During the COVID-19 PHE, CMS allowed hospitals to provide and bill for remote telehealth behavioral health services. The new rule allows these remote services to continue to be provided beyond the expiration of the PHE. In a change from the proposed rule, CMS will allow these remote services to be provided without the physician’s physical presence in the hospital. CMS will also allow these services to be provided by way of audio-only communications. The rule provides additional requirements for intermittent in-person services. However, those requirements can be waived if the patient and physician agree, and document in the chart, that the risks of in-person services outweigh its benefits, and the patient has a regular source of general medical care.

CMS has published a Fact Sheet on its website providing additional details regarding the above items and many of the other changes found in the Medicare Hospital OPPS and ASC Final Rule.

Physician Fee Schedule Final Rule

CMS has identified the goal of its 2023 PFS final rule as reflecting “a broader Administration-wide strategy to create a more equitable health care system that results in better accessibility, quality, affordability, and innovation.”

While the final rule covers an expansive list of topics, the following is a list of some highlights:

  • CY 2023 Conversion Factor – With the expiration of the 3% supplemental increase to PFS payments for CY 2022, and the budget neutrality requirements for Medicare spending, the CY 2023 PFS conversion factor will be $33.06, a decrease of $1.55 from the CY 2022 PFS conversion factor of $34.61.
  • Evaluation and Management (E/M) Visits – CMS adopted most of the AMA CPT Editorial Panel changes to E/M visit codes and guidelines, effective January 1, 2023, which are intended to reduce administrative burden.
  • Split (or Shared) E/M Visits – CMS finalized its policy for addressing how to bill for a shared visit by defining the “substantive portion” of the service as more than half of the total time dedicated to one or more of the following elements: (1) history; (2) performing a physical exam; (3) medical decision making; (4) spending time (more than half of the total time). This choice will be permitted until CY 2024.
  • Telehealth Services – CMS has extended the temporarily available telehealth services permitted because of the PHE at least through CY 2023, in order to allow additional time for the collection of data. Several other updates were also implemented for telehealth services for CY2023.
  • Behavioral Health Services – A new exception was added to the direct supervision requirement for “incident to” allowing behavioral health services to be provided under general supervision of a physician or non-physician practitioner when such services are provided by auxiliary personnel.

CMS has published a Fact Sheet on its website providing additional details regarding the above items and many of the other changes found in the Medicare PFS Final Rule.

In recognition of National Cybersecurity Awareness Month, the Office of Civil Rights (OCR) issued its October 2022 Cybersecurity Newsletter addressing best practices and tips for compliance with HIPAA’s Security Rule. The Newsletter discussed the ever-increasing need for members of the healthcare industry to be vigilant in their practices, as research shows a 42% increase in cyber-attacks in the first half of 2022 compared to 2021, and a 69% increase in cyber-attacks targeting the healthcare sector alone. Moreover, OCR reported that in 2021, 74% of the reported breaches involved hacking/IT incidents. As a result, OCR has identified hacking as the greatest threat to the privacy and security of protected health information (PHI) in the healthcare sector.

These statistics underscore the importance of providers ensuring that their HIPAA programs are in full compliance with the law. OCR notes the significance of entities ensuring they have sufficient plans in place to: (1) identify security incidents; (2) respond to security incidents; (3) mitigate harmful effects of security incidents; and (4) document security incidents and their outcomes in compliance with the HIPAA Security Rules. The Newsletter provides helpful summaries of key items to keep in mind when planning to address each of these key tasks.

Moreover, the OCR underscores the importance of forming a security incident response team prior to the identification of a potential cybersecurity incident or breach. Having a trained and organized team is critical to ensure that when an incident does occur, as is almost certain in any organization, the team is prepared to take action with an appropriate and timely response.

When forming a security incident response team, factors that should be considered in identifying a well-rounded group include sufficient expertise, those with sufficient lines of communication to key individuals, ensuring key internal groups are represented (i.e., management, IT, legal, public affairs, etc.), and identifying key services that the team will need to provide as part of their duties.

The value of a well-prepared security incident response protocol is best summed up in the Newsletter’s conclusion, which states, “The policies and procedures regulated entities create to prepare for and respond to security incidents can pay dividends in the long run with faster recovery times and reduced compromises of ePHI. A well thought-out, well-tested security incident response plan is integral to ensuring the confidentiality, integrity, and availability of a regulated entity’s ePHI.”

With the pandemic, the struggling economy, and so many other issues impacting providers and consuming their daily attention, it is easy to become complacent and/or overlook the constant threats that cyber-attacks pose to the healthcare sector. The OCR’s Newsletter serves as a key reminder of that threat and provides a helpful overview of key areas for providers to review in assessing the sufficiency of their respective HIPAA programs.

In today’s post-Roe world, women living in states where abortion is illegal have begun to search for alternative options when seeking abortion services. Regulatory policies and state laws, which have not previously had to account for these alternatives, are now impacted by the unprecedented means being used to increase access.

At present, more than half of the abortions in the United States are performed using mifepristone and misoprostol (“the abortion pill”) since the Federal and Drug Administration (FDA) approved its use for women taking the pills up to ten weeks following their last menstrual period. When taken together, the pills are 98% effective. Despite their known safety and effectiveness, the FDA’s drug and safety programs, also known as the Risk and Evaluation Mitigation Strategy (REMS) protocols, impose the same dispensing and distributing restrictions typically associated with high-risk drugs.

Before the pandemic, REMS protocols required women to have an in-person consultation with their healthcare provider before receiving the pills. Despite FDA approval for the use and method of medication abortion, many state laws prevent access to the abortion pill with specific regulations and exceptions. Fourteen states criminalize prescribing and dispensing the medication; fifteen states have targeted regulation of abortion providers laws (TRAP). Specifically, the TRAP laws require in-person waiting periods, an ultrasound, in-person counseling, or the clinician to be present with the patient during the ingestion of the abortion pill.

In light of the chilling effect requiring in-person visits had on receiving essential healthcare during the pandemic, the FDA temporarily lifted this requirement. In December 2021, the requirement was permanently lifted. As a result, it opened the market for online telemedicine abortions in states where abortion is legal. Telemedicine is the use of digital technologies to access healthcare services outside of traditional, in-person medical settings. Despite the evolution of telemedicine during the pandemic, and the FDA’s lifting of restrictions, states can continue to restrict abortion services through the TRAP laws which have rendered telemedicine abortions futile.

Less than 25% of the states permit telemedicine and abortion. Because telemedicine services are defined and regulated by states, providers must comply with state definitions of telemedicine. Significantly, some states require that patients have an established relationship with practitioners via initial in-person visits before receiving telemedicine services. Although many states waived this requirement during the public health emergency declared in January 2021, women seeking telemedicine abortion could not access care during that time because many did not have an established provider relationship.

As a result, this highlighted another area of concern for providers offering telemedicine abortion across state lines. In general, because providers must be licensed in the state where the patient is located and the laws of that state govern, some state laws require patients to verify, and even authenticate, their location to prevent providers from criminal or civil liability in states that prohibit abortion or have “aiding and abetting” laws.

While telemedicine abortion has been identified as a safe and effective option for women seeking medication abortion, providers are limited in their ability to offer FDA-approved services without adequate legal protections. To continue telemedicine abortion without fear of legal and professional ramifications, state legislatures and attorneys general in states such as Massachusetts, Delaware, New York, New Jersey, and Connecticut have enacted shield laws to protect providers providing abortion care to patients living in states where it is restricted.

It is possible that regulatory policies and laws focusing on increasing access to telemedicine abortion may significantly shape the future of reproductive healthcare.

The facts of In the Matter of Jitan are rather startling, but this opinion by the Superior Court of New Jersey Appellate Division, decided on October 13, 2022, provides a reminder of the exceedingly deferential standard of judicial review of professional disciplinary decisions and the broad discretion permitted to the licensing boards in determining appropriate sanctions. It also provides an unstated punctuation mark in the evolution of grounds for licensure action that were enacted on May 11, 2021.

The Attorney General filed an administrative complaint with the Board of Medical Examiners seeking revocation or suspension of the respondent physician’s license after he had been convicted of a criminal offense in February 2020. The physician, a nuclear cardiologist, was arrested and charged with multiple counts of sexual assault, criminal sexual contact, and invasion of privacy arising out of an approximate five-year practice of obtaining pictures of his daughter without her knowledge or consent using cameras placed in her bedroom and bathroom. These photographs depicted the full nudity of the girl as well as images of her “intimate parts.”  Jitan eventually pled guilty to the invasion of privacy provisions of N.J.S.A. 2C:14-9(b), a crime of the third degree.  He was sentenced to two years of probation and a mental health evaluation.

The Board complaint alleged the commission of “a crime of moral turpitude” in violation of N.J.S.A. 45:1-21(f).  The text of that statutory provision authorizes suspension or revocation of a license where an individual “[h]as been convicted of, or engaged in acts constituting, any crime or offense involving moral turpitude or relating adversely to the activity regulated by the board.” The respondent physician did not contest the factual assertions and admitted liability but offered evidence in mitigation of penalty.  In addition to providing information concerning a 39-year career without any disciplinary actions, letters of support from character witnesses and hospitals, and a mental health evaluation, Jitan attempted to justify his conduct with an explanation that he was concerned that his daughter was smoking marijuana at home, and he wanted to obtain evidence of that behavior with this being “a limited lapse in judgment.” Given the time span and volume of photographic images obtained, the Board rejected this position along with its observation that as a physician he could have used more clinical methods of detecting and monitoring alcohol or drug usage.

With its final agency decision, the Board suspended Jitan’s license for eight years. The physician appealed. He argued that because his conduct had only involved a “personal matter,” the eight-year suspension was “shockingly inconsistent with fairness.” The Appellate Division found his contentions to be insufficient to merit extended discussion in a written opinion but nonetheless added comments while affirming the Board’s action.

It started with the usual recitation regarding the limited review of administrative agency determinations. The court declined to second-guess or substitute its judgment for that of the regulators. It emphasized that review of an agency’s choice of sanctions would be modified only when necessary to bring the agency’s action into conformity with its statutory authority. Referring to the Supreme Court precedents of In re Zahl and In re Polk’s License, it recited the oft-repeated refrain that the test was whether the punishment was “so disproportionate to the offense, in light of all the circumstances, as to be shocking to one’s sense of fairness.” Cases meeting this test are as rare as hen’s teeth.

It concluded that the Board’s imposition of the eight-year suspension was warranted by the commission of this “‘egregious’ crime of moral turpitude” with the misconduct raising questions about this physician’s ability to safely interact with patients in the future.

The scope of a crime of moral turpitude has long been a matter of problematic analysis. In connection with an offense of conspiracy to convert pension funds, the Supreme Court of New Jersey observed in In re Fanelli that the legislative history of the statute did not define moral turpitude. It quoted at length from State Bd. of Medical Examiners v. Weiner, where the Appellate Division had stated:

What is ‘moral turpitude’? It has been defined as an ‘act of baseness, vileness, or depravity in the private and social duties which a man owes to his fellow men, to society in general, contrary to the accepted and customary rule of right and duty between man and man,’ … and as, ‘in its legal sense * * * everything done contrary to justice, honesty, modesty, or good morals.’ … The United States Supreme Court, in connection with alien deportation proceedings, has held that, in addition to ‘crimes * * * of the gravest character,’ any crime in which fraud is an ingredient involves moral turpitude. … But the attempt to apply these definitions to specific criminal acts, especially in the context of license revocation proceedings, has demonstrated only the elasticity of the phrase and its necessarily adaptive character, reflective at all times of the common moral sense prevailing throughout the community.

The Supreme Court noted the variety of manifestations of “moral turpitude” reflected in the case law. It held that Fanelli was entitled to a hearing on whether his conduct constituted “moral turpitude” and that the burden of proving the elements of moral turpitude was on the Board. It also addressed the second aspect of the statute providing for discipline where the offense related adversely to the practice of medicine. It concluded that the conduct need not have occurred during the rendering of professional services and that the practice of medicine involves more than patient care but also encompasses record keeping, billing practices, and how physicians treat their employees. It emphasized that Fanelli should have the opportunity to show that his unlawful actions were unrelated to the practice of medicine.

It is no longer necessary to deal with the vagueness and vagaries of what constitutes “moral turpitude” in the context of license revocation or suspension proceedings. The provisions of N.J.S.A. 45:1-21(f) were amended by P.L. 2021, chapter 81. The Appellate Division opinion includes no reference to or recognition of the modification of the statutory grounds for action.

The bill containing the amendments also included a new section codified as N.J.S.A. 45:1-21.5 that deals with rehabilitation of persons who had been convicted of an offense and setting forth notice and hearing requirements. The legislative history explicitly deletes “moral turpitude” as a standard for license denial, suspension or revocation. Amended subsection (f) now reads that disciplinary action may be taken when a person:

[h]as been convicted of, or engaged in acts constituting, any crime or offense that has a direct or substantial relationship to the activity regulated by the board or is of a nature such that certification, registration or licensure of the person would be inconsistent with the public’s health, safety, or welfare, provided that the board shall make this determination in a manner consistent with [N.J.S.A. 45:1-21.5].

The provisions of N.J.S.A. 45:1-21.5 set forth standards for making the new determination:

  • the nature and seriousness of the crime or offense and the passage of time since its commission;
  • the relationship of the crime or offense to the purposes of regulating the profession or occupation regulated by the entity;
  • any evidence of rehabilitation of the person in the period of time following the prior conviction that may be made available to the entity; and
  • the relationship of the crime or offense to the ability, capacity, and fitness required to perform the duties and discharge the responsibilities of the profession or occupation regulated by the entity.

There are no published cases yet on determining a “direct” or “substantial” relationship to the professional practice activity regulated by the licensing board or what would be “inconsistent with the public’s health, safety, or welfare.” Those determinations undoubtedly will continue to be subjected to judicial review on a limited and deferential basis.