Introduction
In 1953, Boston University established the Law-Medicine Research Institute, which remains one of the most influential and important health law programs in the country.Footnote 1 Today, the demand for lawyers with knowledge of the legal issues faced by individuals and entities either delivering health care or supporting the health care industry continues to boom.Footnote 2 In the years since 1953, almost every law school in the United States has added health law courses to its curriculum, and many have developed bona fide health law programs.Footnote 3 One of the factors in the growth of health law may be the expanding oversight role played by the federal government in the delivery and funding of health care.Footnote 4 It is because helping regulated entities comply with these laws is such an important area of practice that the U.S. Supreme Court’s decision in Loper Bright Enterprises v. Raimondo is so significant.Footnote 5 It, along with the Court’s decision in Corner Post, Inc. v. Board of Governors of the Federal Reserve System a few days later,Footnote 6 is, as one DC law firm explained to its clients, “one of a series of decisions in which the Roberts Court has pared back the flexibility and power of administrative agencies.”Footnote 7
Although these cases were not specific to the health care industry, they will have a significant impact on the practice and teaching of healthcare compliance, as they invite stakeholders to “revisi[t] agency positions” the Court had “previously upheld on deference grounds.”Footnote 8 Whatever the result of these legal challenges, the immediate beneficiaries of this increase in litigation will be lawyers.Footnote 9 This is thus an excellent opportunity to look at the current state of what has become of the complex multi-disciplinary industry of healthcare compliance, as well as the programs law schools have been developing to meet the need for knowledge about the federal regulation of health care. In this essay, I will briefly explain how the health care industry is regulated, and why the industry is therefore likely to quickly feel the effects of the new opportunities for parties to bring regulatory challenges. I will then look at the current structure under which the health care industry maintains compliance with federal regulations, with a focus on the role of lawyers.
Having laid that foundation, I will look directly at the development of healthcare compliance programs that support the industry across law schools. In particular, I will look at the development of two kinds of programs: those that create pathways for J.D. students to secure healthcare compliance jobs and those that offer training in healthcare compliance for non-lawyers.
Finally, I will make some observations about the role of law schools in shaping the future of healthcare compliance through subject matter experts and teachers. In so doing, I will suggest that these programs for non-lawyers be more closely aligned with law schools’ main J.D. programs in order to provide broader access to the field for people without previous experience in the industry. I also suggest that, although these programs do not fall within the jurisdiction of the ABA or other entities that monitor the delivery of legal education, law schools take voluntary steps to gather and disseminate information about the career trajectories of their graduates.
How Over-Turning Chevron Will Be of Benefit to Health Lawyers
The U.S. Supreme Court’s decision in Loper Bright to overturn the Chevron Doctrine is being welcomed by some business interests as a positive development, because it will now be easier to challenge burdensome federal regulations.Footnote 10 As one commentator explained in anticipation of the decision, “[m]any businesses would welcome the opportunity to test the boundaries of a newly weakened administrative state.”Footnote 11 Going forward, “[c]hallengers will no longer be constrained to argue that Congress spoke directly to the issue at hand (a relative rarity) or that the agency’s interpretation was outside the bounds of reasonable interpretation.”Footnote 12 Instead, “litigants can prevail in court by arguing that an agency’s interpretation of its authorizing statute is not the best interpretation of the statute.”Footnote 13
Federal Regulation of the Health Care Industry
The extent to which litigants will actually prevail in overturning agencies interpretations is still a topic of debate, but the litigation process these actions entail “will sow some chaos, and when combined with the numerous other Supreme Court decisions weakening agencies, create a sand-in-the-gears of agency action effect.”Footnote 14
This looming increase in challenges to regulation across all industries raises an opportunity to look at the one most likely to be affected: the health care industry.Footnote 15
In 2018, the American Hospital Association (“AHA”), a national organization that purports to “represent[] and serve[] all types of hospitals, health care networks, and their patients and communities,”Footnote 16 issued a report titled Regulatory Overload, in which they documented “a growing regulatory morass that fuels higher health care costs.”Footnote 17 This burden, which they estimated to be “$39 billion per year,” results in “doctors, nurses and caregivers…devoting more time to regulatory compliance, taking them away from patient care.”Footnote 18 It illustrated the point with a graphic purporting to demonstrate that “[f]our federal agencies account for 629 regulatory requirements [with which] health systems, hospitals and post-acute care providers must comply.”Footnote 19 Characterizing these regulations as a whole, the AHA wrote, “[s]ome of these rules do not improve care, and all of them raise costs.”Footnote 20 The concern over regulatory burden is bi-partisan.Footnote 21 Both the left-leaning Center for American ProgressFootnote 22 and the right-leaning Heritage FoundationFootnote 23 have published reports calling for change.
The majority of these much complained about regulations originate in the Department of Health and Human Services (“HHS”).Footnote 24 While historical accounts differ, HHS traces its origins to the 1839 “appropriation of $1000 to the Commissioner of Patents for the collection of agricultural statistics, and for other agricultural purposes.”Footnote 25 This led to the eventual creation of a separate Department of Agriculture, as well as a division of chemistry within that department formed through the transfer of the Patent Office’s agricultural division.Footnote 26 This chemistry division came to be called the “U.S. Food and Drug Administration” (“FDA”) and was later transferred to the Federal Security Agency, which itself was ultimately “renamed the Department of Health and Human Services in 1979.”Footnote 27 Within HHS, the department’s programs are overseen, and its regulations are enforced by, the Office of Inspector General (“HHSOIG”), which is “the largest civilian inspector general’s office in the Federal Government.”Footnote 28
Among the programs administered directly by HHS are Medicare and Medicaid (1965),Footnote 29 HIPAA (1996),Footnote 30 CHIP (1997),Footnote 31 EMTALA (1986),Footnote 32 and the Affordable Care Act (2010).Footnote 33 Most of these programs have associated anti-fraud provisions, which are also administered by HHS.Footnote 34 In 2023, HHSOIG issued a comprehensive compliance guide describing its office as being at the “forefront of the Nation’s efforts to fight fraud, waste, and abuse and improve the efficiency of Medicare, Medicaid, and more than 100 other HHS programs.”Footnote 35
When violations of these laws infringe on individuals’ fundamental rights of nondiscrimination, conscience, religious freedom, and health information privacy, jurisdiction transfers to the HHS’ Office for Civil Rights (OCR). HHS OCR “enforce[s] federal civil rights laws, conscience and religious freedom laws, the Health Insurance Portability and Accountability Act (HIPAA) Privacy, Security, and Breach Notification Rules, and the Patient Safety Act and Rule.”Footnote 36
Other programs that relate to employment like ERISA (1974),Footnote 37 The ADA (1990),Footnote 38 GINA (2008),Footnote 39 and the Pregnant Worker’s Fairness Act (2023)Footnote 40 are at least partially under the jurisdiction of the Department of Labor, with the exception of the Pregnant Worker’s Fairness Act, which is enforced by the Equal Employment Opportunity Commission.Footnote 41 As if that were insufficient responsibility, HHS also incorporates the FDAFootnote 42 and oversees the regulations protecting human subject research funded or conducted by the federal government as well those participating in clinical drug trials.Footnote 43 In addition to HHS and the Department of Labor, almost every agency from the Department of Agriculture through the rest of the alphabet enforces some portion of a federal regulatory scheme that involves or affects individual or population health.Footnote 44
Previous Constitutional Challenges to Health Care Legislation
The Supreme Court’s watchful oversight of the federal government’s administration of health and safety laws precedes the tenure of the current majority.Footnote 45 It began with taking on the role of assuring that the new federal government did not exceed the “enumerated powers” it was granted in the 1787 Constitution.Footnote 46 Since the Constitution does not specifically give the federal government power over health and safety, the Court has required any law related to these topics be justified by a power granted to the federal government in the Constitution.Footnote 47 This allocation of power between the states and the federal government is called “federalism,” although that word is not used in the Constitution.Footnote 48
The Court’s last comprehensive analysis of the extent of these powers was in 2012, when it reviewed two provisions of the Affordable Care Act in National Federation of Independent Business v. Sebelius. Footnote 49 Writing for the Court, Chief Justice Roberts explained that “[n]othing [in the Constitution] precludes Congress from offering funds under the Affordable Care Act to expand the availability of health care, and requiring that States accepting such funds comply with the conditions on their use.”Footnote 50 However, the Court held, “[w]hat Congress is not free to do is to penalize States that choose not to participate in that new program by taking away their existing Medicaid funding.”Footnote 51 The opinion then turned to the government’s argument that the Affordable Care Act’s requirement that individuals buy insurance was justified by Congress’ power to regulate commerce.Footnote 52 The Supreme Court disagreed, writing that while Congress does have the power to regulate “existing commerce,” it did not have power to require people to engage in commerce.Footnote 53 Footnote 54
From Challenging Congressional Power to Challenging the Decisions of the Federal Agencies
Since NFIB v. Sebelius, the Supreme Court has had very little to say about Congress’ power to regulate under either the Spending or Commerce Clause.Footnote 55 But it has been highly critical of the agencies created by Congress to effectuate and enforce its laws.Footnote 56 As one commentator explains, “[m]uch like the incomplete dinosaur DNA in Jurassic Park, whenever Congress passes legislation, it’s full of holes. Instead of filling these gaps with frog DNA a la everyone’s favorite dinosaur film franchise, the legislative holes get filled by the appropriate government administrative agency.”Footnote 57 The Court’s 1984 decision in Chevron v. Natural Resources Defense Council recognized the importance of this role when it instructed federal courts to defer to agency interpretations of otherwise ambiguous states.Footnote 58 Since Chevron, the Supreme Court has “held that when Congress has not expressly spoken, the courts should defer to administrative interpretation “[i]f this choice represents a reasonable accommodation of conflicting policies that were committed to the agency’s care by the statute.””Footnote 59
Several members of the current Supreme Court had long signaled that they thought this deference unwarranted.Footnote 60 Indeed, three of the current sitting Supreme Court Justices had “opined that specific regulatory agencies were unconstitutional.”Footnote 61
While the Court has not so far declared any specific agency unconstitutional, they have been very active in overturning agency decisions.Footnote 62 In a July 2023 article describing their actions,
Ian Millhiser reported that “[i]n the less than three years since President Joe Biden took office, the Supreme Court has effectively seized control over federal housing policy, decided which workers must be vaccinated against Covid-19, stripped the EPA of much of its power to fight climate change, and rewritten a federal law permitting the secretary of education to modify or forgive student loans.”Footnote 63 These cases were decided under the “major questions doctrine,” which Millhiser explained “as it is understood by the Court’s current majority, [has] emerged almost from thin air.”Footnote 64 The Court used the “major questions doctrine” not to challenge Congress’ authority to regulate or to determine that an agency’s interpretation of a law was correct, but rather to cast doubt on the likelihood that the Congress would have meant for an agency to make a decision on such an important topic.Footnote 65 It has also revitalized another seldom-used doctrine, the “non-delegation doctrine.” Additionally, the Court’s invocation of the Seventh Amendment’s right to a jury trial in SEC v. Jarkesy could also invalidate the ability of other agencies to use internal panels to impose civil penalties.Footnote 66
Given their active anti-regulatory docket, the Court’s decision to hear Loper Bright was quickly interpreted as a sign they were going to overturn Chevron. A regulatory policy associate at the consumer watchdog group Public Citizen explained that “[i]n a post-Chevron world, the decisions of agency experts – scientists, engineers, policy professionals – about how to keep the public safe best would be second-guessed by judges who lack subject-matter expertise and are not accountable to the public.”Footnote 67 In a post after the oral arguments in Loper Bright, Suhasini Ravi of Georgetown’s O’Neill Institute made the case that the “prospect of overruling Chevron is especially concerning in health care policy, where agencies must leverage their expertise to address emergencies, adapt to ever-changing technology, and improve health outcomes.”Footnote 68
Shortly before the Loper Bright opinion was published, two attorneys from the law firm Foley Hoag predicted that the decision would pose a threat to many different programs administered by the Department of Health and Human Services, noting that the “shift in power from HHS to courts will be felt immediately. If the Supreme Court overturns Chevron, it will impact 1) HHS’s consideration of new rules during the notice and comment process, 2) the ability of regulated healthcare entities to challenge new rules, and 3) the permissibility of some long-standing rules, creating short-term uncertainty on the status of numerous regulations.”Footnote 69 A month later, the firm issued a detailed follow-up report specific to the likely effect on regulations administered by the FDA.Footnote 70
Although no one knows for sure which regulations will be challenged or when, observers are already predicting that “agency interpretations” associated with The Inflation Reduction Act, which “authorizes the Centers for Medicare & Medicaid Services (CMS) to directly negotiate prescription drug prices with pharmaceutical companies through the Drug Price Negotiation Program,” could “be subject to increased scrutiny following Loper Bright.”Footnote 71 Whatever happens, the Court did not overturn or even call into question the programs generating the regulations with which the health care industry has to comply. Therefore, the coming years will most likely bring an increase in need for people with knowledge of these laws. In the rest of this essay, I will look at the infrastructure of existing healthcare compliance programs and the role of lawyers in supporting them.
The Evolution of “Healthcare Compliance” Programs
Historians trace the practice of designating specific employees as responsible for compliance with federal law to the 1950s, when the federal government entered into settlements of a “series of antitrust cases brought against electronics manufacturers.”Footnote 72
Pursuant to the Inspector General Act of 1978, each federal agency has their own Office of Inspector General (OIG).Footnote 73 Their purpose is “to prevent and detect waste, fraud, and abuse relating to their agency’s programs and operations, and to promote economy, efficiency, and effectiveness in the agency’s operations and programs.”Footnote 74 Under the terms of the Act, “[a]pproximately half of the 74 federal IGs are appointed by the President subject to Senate confirmation, and approximately half are appointed by the agency head.”Footnote 75 Additionally, “IGs are nonpartisan and are selected without regard to political affiliations.”Footnote 76
For health care companies, formal compliance programs are the result of a recommendation by the HHSOIG “that health care providers of all types establish compliance programs to prevent and mitigate violations of federal healthcare program rules and regulations.”Footnote 77 The HHSOIG’s “mission is to protect the integrity of HHS progams as well as the health and welfare of program beneficiaries.”Footnote 78 In 2010, the HHSOIG’s aforementioned “recommendation” became a mandate for certain providers.Footnote 79
The Patient Protection and Affordable Care Act (“ACA”), “amended the US Social Security Act to give the Secretary of Health and Human Services (“Secretary”) the authority to require Medicare and Medicaid providers, as a condition for enrollment, to establish compliance programs.”Footnote 80 The Secretary of HHS was also required by statute to establish criteria for “a compliance and ethics program” for nursing facilities and skilled nursing facilities to assist them in establishing a compliance program “effective in preventing and detecting criminal, civil, and administrative violations.”Footnote 81 There are “seven core elements” which every healthcare compliance program should typically include, which elements were originally “derived, in part, from the seven elements of an effective compliance and ethics program” in “Chapter 8 of the US Federal Sentencing Guidelines.”Footnote 82 In its most recent recommendation, HHSOIG describes these seven “core elements” as:
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1. Implement written policies, procedures, and standards of conduct.
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2. Designate a compliance officer and a compliance committee.
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3. Conduct effective training and education.
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4. Develop effective lines of communication.
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5. Conduct internal monitoring and auditing.
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6. Enforce standards through well-publicized disciplinary guidelines.
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7. Respond promptly to detected offenses and undertake corrective action.Footnote 83
In addition to compliance programs mandated by HHS, some health care entities also have compliance obligations stemming from other federal regulations, such as those associated with publicly traded companies.Footnote 84
The Price of Non-Compliance
A 2018 article in the Harvard Business Review titled Why Compliance Programs Fail—and How to Fix Them reported that “[m]any executives are rightly frustrated about paying immense and growing compliance costs without seeing clear benefits.”Footnote 85 It concluded, however, that companies “continue to invest—not because they think it’s necessarily productive but because they fear exposing their organizations to greater liability should they fail to spend enough.”Footnote 86
The extent of this potential liability, civil and criminal, is enormous. On June 27, 2024, the Department of Justice reported that it had brought “criminal charges against 193 defendants, including 76 doctors, nurse practitioners, and other licensed medical …. for their alleged participation in various health care fraud schemes involving approximately $2.75 billion in intended losses and $1.6 billion in actual losses.”Footnote 87 A few days later it followed up with the warning that “[c]ombating health care fraud is a critical priority for the Justice Department.”Footnote 88 Earlier the same year, on February 22, 2024, the Department announced that in the past fiscal year it had “collected over $2.68 billion” from civil “settlements and judgments under the False Claims Act.”Footnote 89 The “leading source” of these settlements and recoveries involved “health care fraud.”Footnote 90 The volume of HIPAA enforcement actions is lower, but, in what an industry website described as a “a banner year for healthcare fines and breaches,” the HHS’ Office of Civil Rights collected “$4,176,500” from “eight covered entities and four business associates” in 2023.Footnote 91
To provide covered entities further incentive to maintain robust compliance programs, the programs are structured to reward self-disclosure.Footnote 92 As one law firm advises its potential clients, “[w]hen a healthcare provider realizes the entity may have violated federal healthcare laws or requirements, it is often the best course of action to report the violation instead of waiting for the Government to potentially investigate the violation and bring criminal and/or civil action.”Footnote 93
Lawyers’ Role in Regulatory Compliance
Law Firms
The market for lawyers with knowledge of how the federal government regulates the health care industry is strong.Footnote 94 As discussed earlier, this is because the federal government’s mandate that certain health care entities have compliance programs, the penalties associated with violating the law, and the benefits associated with self-reporting all create a need for health care entities to hire lawyers.Footnote 95 The 12,000-member-strong American Health Law Association (AHLA) describes these lawyers as practicing “health law” which they define as “the body of federal, state, and local laws, rules, regulations and cases that governs the health care industry, including the delivery of all health-related services to patients by all of its individual and institutional participants.”Footnote 96 These lawyers are distinctive in that they have an “in-depth knowledge and experience working in this regulatory framework, and provide advice to hospitals, physician organizations, long term care facilities, home health agencies, health insurance companies, pharmaceutical companies, as well as to physicians and other individual health care providers on how to comply with these rules.”Footnote 97
Many of these lawyers with specific knowledge of health care regulation work directly in departments of large U.S. law firms.Footnote 98 One example is Latham and Watkins, which reports on its website that its:
[H]ealthcare and life sciences regulatory team draws on market-leading experience and deep industry knowledge to advise healthcare and life sciences companies, digital health and technology providers, private equity, investment banks, venture capital firms, and other industry stakeholders. We advise on regulatory counseling, fraud and abuse compliance, reimbursement and related matters, data, privacy, and security, licensure, accreditation, quality management, controlled substances regulation, as well as on the regulatory aspects of mergers and acquisitions and other corporate transactions in the sector.”Footnote 99
This description is followed by links and biographies for 17 Partners, 15 Associates, and 4 Counsel.Footnote 100
In-House Counsel
In addition to retaining outside law firms, most companies subject to health regulations have their own internal legal departments.Footnote 101 These departments are often staffed by lawyers who started their careers at law firms.Footnote 102 In 2023, a large legal recruiting firm reported that that there were currently “around 130,000 in-house lawyers in the U.S… . In fact, the number of lawyers who are in-house is almost equal to the number of lawyers across the nation’s top 500 law firms.”Footnote 103 Looking more specifically at health care companies, another recruiter described a “fiercely competitive landscape” with a “median total compensation at private healthcare companies [of] $325,000, compared to $400,000 at public companies. Total compensation at private life sciences companies is $431,000 versus $478,000 at public companies.”Footnote 104
Because these in-house jobs involve providing legal advice to clients, the states where the lawyers work require that they have an active license to practice law.Footnote 105 Violations of these rules can lead to a criminal charge for the “unauthorized practice of law.”Footnote 106 They can also result in a disciplinary referral to the state where they are licensed or serve as a barrier to future licensure.Footnote 107 Advertisements for in-house lawyers, like this one from Vault Health, indicate this requirement directly: “[m]ust have a J.D. degree from an ABA-approved law school and be an active member of the Bar in good standing”Footnote 108
J.D. Preferred, Licensure not Required
While “in-house counsel” as a term refers to lawyers who are, according to the rules of the state where they work, actively practicing law, there is a much larger and less defined category of jobs for people knowledgeable about regulation, but not requiring active law degrees or licensure. The National Association for Law Placement calls these “JD Advantage Jobs.”Footnote 109 These are jobs that for “which the employer is seeking an individual who has a J.D., but the position itself does not require admission to the bar or a law license. These are law related positions in which knowledge of the law is part of the job, but the job itself does not require bar admission.”Footnote 110 These jobs are also called “JD preferred” because neither a law degree nor admission to the bar is among the “require[d]” criteria for hiring.Footnote 111 For example, a job posted in July 2024 by UF Health’s Shands Hospital (Jacksonville, FL) advertised for a compliance specialist “[t]o ensure compliance with applicable legal and regulatory requirements, and to promote ethics within the hospital” identifies the “educational qualifications” as “Bachelor’s Degree Required; Preferred Education: Master’s or J.D., MD, PhD, HIM, RN.”Footnote 112
There is no single source of information to track J.D. Advantage jobs, whether in general or specific to health care. There are anecdotal reports that the market for recent law school graduates in compliance jobs that do not require law degrees is not as strong as had been hoped. A 2022 report by the NALP using 2020 data showed that while “the percentage of jobs taken by law school graduates which are JD Advantage” went “from 8.8% of all jobs in 2006 to 16.9% of jobs in 2016,” that trend is now going in the other direction.Footnote 113 Only 11.8% of the Class of 2020 enrolled in J.D. Advantage jobs, a drop of “more than 5 percentage points.”Footnote 114 There is no explanation offered for why this dropped happened or whether some industries were more affected than others.Footnote 115
No J.D. Needed or Preferred
The final category of jobs related to compliance neither require nor necessarily prefer a person with a law degree.Footnote 116 As one consulting firm explains, the difference in roles between “Compliance Officers” and “lawyers” is that “Compliance officers are more involved in the day-to-day operations and implementation of compliance programs, focusing on prevention and education,” while “compliance lawyers are typically consulted for legal advice, and representation, and to address compliance issues after they have arisen.”Footnote 117 These “no JD degree required” jobs may be positions in compliance, or they could be executive positions that require knowledge of regulatory issues.Footnote 118 Even clinicians need knowledge of the regulations governing their work.Footnote 119 Given the variety in job responsibilities, what these jobs are called and what the people holding them do varies considerably. One category, as outlined by guidance from the U.S. Sentencing Commission Guidelines, consists of people who are designated to have “day-to-day operational responsibility for the compliance and ethics program.”Footnote 120 Such a role is “not merely a recommendation but a requirement,” practically speaking.Footnote 121 But the need for knowledge of healthcare compliance requirements can extend beyond those administrators with direct responsibility for operating compliance programs.Footnote 122
Health Law Instruction in American Law Schools
Having reported on the likelihood that the Supreme Court’s recent anti-regulatory decisions will increase demand for those with legal training and described the development of the healthcare compliance industry, I now turn to the role of U.S. law schools in meeting this demand.
“Health Law” as a field of instruction or study is relatively new.Footnote 123 Professor Mark Hall noted, in 2006, that law schools had been offering classes in “health law” or “law and medicine…for decades,” and that health law “as a legal academic field” began with “William Curran’s 1960 publication of the first casebook.”Footnote 124 Three years later, in 2009, Professor Wendy Mariner took on the “challenge” of describing “the health law field as a whole” and “as separate from other fields of law.Footnote 125 In so doing, she identified “two major challenges: (1) the range of legal issues the field covers; and (2) the fact that many doctrines formerly unique to medicine have given way to more general principles from other legal domains.”Footnote 126 After careful review of these issues and doctrines, she concluded that “[h]ealth law is an eclectic and integrated translegal field, drawing on multiple domains of law to create an identifiable applied field of law. It applies and adapts existing law to protect health within the constraints of justice and human rights.”Footnote 127
From Health Law to Healthcare Compliance
In 2017, Professor Peter L. Lindseth, director of UConn’s Professional Certificate Program in Corporate and Regulatory Compliance, then described “[t]he proliferation of compliance programs in US law schools over the last several years” as a “[r]espon[se] to a fundamental shift in the market for law graduates.”Footnote 128 Looking backwards, he explained that “[t]he last two decades have seen a dramatic increase in the number of jobs for in-house lawyers, far outpacing the growth in government or law firm positions over the same period.”Footnote 129 Attributing this to “[t]he expanding compliance demands on businesses,” he concluded that “[a]lthough today some argue that the growth may have peaked, there is no denying that law schools have needed to respond to the new reality.”Footnote 130 It is evident that many law schools have done so by developing health law programs and offering certificates in healthcare compliance.Footnote 131
For the rest of this article, I will describe and discuss what law schools in the United States offer students interested in the field of healthcare compliance. Primarily, these offerings are in the form of programs for law students enrolled in their J.D. programs and for healthcare compliance professionals who are seeking master’s degrees or certificates in healthcare compliance law, but not a law degree.
The Role of External, CCB Accreditation in Law School Healthcare Compliance Programs
It is common for both J.D.-required and J.D.-preferred jobs in healthcare compliance to list “Certification in Healthcare Compliance” as an additional credential.Footnote 132 This credential usually refers to certificates offered through a collaboration between the Society of Corporate Compliance and Ethics® (“SCCE”)Footnote 133 and the Healthcare Compliance Association® (“HCCA”).Footnote 134
In recognition of the value of this credential to healthcare compliance professionals, fourteen U.S. law schools have become “accredited”Footnote 135 by the Compliance Certification Board (“CCB”) to offer their students a “Certificate in Healthcare Compliance,” which creates an expedited pathway for their students to take the exam which leads to them being certified in “Healthcare Compliance.”Footnote 136 The terminology is unintentionally confusing, because while both of these credentials are called “certificates,” one is awarded by a specific law school and the other by an external credential entity.
The U.S. Department of Education distinguishes between “Certification” and an “Educational Certificate.”Footnote 137 The first is “[a] credential awarded by a certification body based on an individual demonstrating through an examination process that he or she has acquired the designated knowledge, skills, and abilities to perform a specific job.”Footnote 138 The second, an “Educational Certificate,” is “[a] credential awarded by an educational institution based on completion of all requirements for a program of study, including coursework and test or other performance evaluations. Certificates are typically awarded for life (like a degree).”Footnote 139 CCB certification, then, would fall under the first definition while a certificate offered by a law school itself is the second.Footnote 140
The SCEE and HCCA work with the CCB “to develop criteria for the determination of competence in the practice of compliance at a variety of levels, and to recognize individuals meeting these criteria.”Footnote 141 As CCB explains, it offers “[c]ompliance certification by the profession, for the profession and of the profession.”Footnote 142 One of the certifications CCB offers is in “Healthcare Compliance.”Footnote 143 It is, therefore, more like the specialty certificates offered by state bar associations than a measure of minimal competence.Footnote 144
This Certificate is designed to demonstrate competence among people who are already healthcare compliance professionals. CCB defines a “Compliance Professional” as someone with:
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▪ “[A]t least one year in a full-time compliance position or 1,500 hours of direct compliance job duties earned in the two years preceding your application date; and
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▪ “[J]ob duties directly relate to the tasks reflected in the ‘Detailed Content Outline’ on pages 22-24 of the Candidate Handbook.”Footnote 145
But this work criteria is waived for students who complete a Certificate of Healthcare Compliance in a CCB-accredited school.Footnote 146 Seton Hall University’s Law School advertises that it “cooperates with the CCB as well as offering its own extensive array of programs in healthcare compliance.”Footnote 147 MitchellHamline Law School encourages “all qualified program graduates … to take the Compliance Certification Board’s (CCB) Certified in Healthcare Compliance Exam.”Footnote 148 It also offers its students “access to [its own] proprietary CHC Exam Toolkit featuring tips from … alumni.”Footnote 149
The value, then, of getting a Certificate from a CCB-accredited Law School program is twofold. First, for students who are not yet working in healthcare compliance, it is the only path to taking the exam without relevant work experience.Footnote 150 Second, it provides a structured program of study that satisfies at least part of the 20-hour continuing education requirement.Footnote 151
Since 13 of the 21 academic programs accredited by the CCB are law schools,Footnote 152 it seems likely that it is only law students, not former law students working in other disciplines and seeking new areas of practice, who have the greatest interest in taking the exam without the otherwise required work experience. It is therefore reasonable to ask whether being certified without previous work experience enhances the employment opportunities for these law students. One reason to think it does is that while these students may not have had prior careers in Healthcare Compliance, they are able to obtain relevant experience while in law school.
J.D. Programs
The 2024 UNWR law school specialty rankings list 191 of the “nearly 200 [ABA recognized law schools]” self-reporting that they offered a “health care law” program.Footnote 153 While UNWR provides no definition of the word “program,” the large number suggests that almost all U.S. law schools are now offering at least one class falling under the banner of “health law” as part of their J.D. curriculum.Footnote 154 A closer look at this list shows that many schools are doing much more than offering one course and, following BU’s lead, have made a substantial investment in health law.Footnote 155 In looking at the history of the development of health law programs, there is evidence that not many “focus[ed] heavily in the areas of regulatory and transactional health care.”Footnote 156 It is difficult to tell when and to what extent these programs began using the term “healthcare compliance” to describe parts of their curriculum. In 2014, a report by the American Health Law Association which both surveyed practitioners and law schools and provided a model health law curriculum used the word frequently.Footnote 157 The portion of the report reflecting employers’ perspectives noted “that 89.2% of respondents reported that their practice includes Compliance” and commented that “[g]iven the complexity and pervasiveness of regulatory issues, it is not surprising” that this percentage was as high as it was.Footnote 158 A review of the UNWR top health law programs shows that Healthcare Compliance’s place in the curriculum is secure.Footnote 159 At least 13 law schools offer Certificates in Healthcare Compliance.Footnote 160
Law School Programs That Do Not Lead to Law Degrees
In addition to programs leading to legal degrees, many U.S. law schools offer master’s degrees and certificates designed for people who do not have and are not seeking a J.D.Footnote 161 Several law schools offer advanced law degrees specific to health law.Footnote 162 But the focus of this essay is on master’s degree programs in healthcare compliance designed for people who are not seeking a law degree.Footnote 163
Master’s degrees in Healthcare Compliance
The “Standards” set by the Council on Legal Education (the “Council”), a division of the American Bar Association (the “ABA”), only apply to J.D. degrees.Footnote 164 While law schools seeking to offer degrees other than the J.D. are required to inform the Council of their intent to offer additional degrees, the Council’s only role is to “determine[e] whether the proposed degree program will interfere with the ability of the law school to … carry out its program of legal education” in “compliance with the standards” for J.D. programs.Footnote 165 Among these programs, several are specific to healthcare compliance.Footnote 166 These are, as the schools offering them explain, “directed at educating working professionals seeking to enhance their knowledge in Compliance and Risk Management while gaining a comprehensive understanding of how the law intersects with and applies to this field.”Footnote 167 Without the oversight of the Council, law schools’ “non-J.D. degree programs” are “subject to the oversight of the law school’s or its university’s national accreditor.”Footnote 168
If the Council determines that the additional degree program will not interfere with the J.D. program, it “acquiesces” to its being offered.Footnote 169 This is not, however, “approval of the degree itself and, therefore, the law school may not announce that the degree is approved by the Council.”Footnote 170 Therefore, “the content and requirements of those degrees, such as an LL.M., are created by the law school itself and do not reflect any judgment by the ABA accrediting bodies regarding the quality of the program.”Footnote 171
That lack of direct oversight by the ABA allows law schools considerable flexibility in offering programs other than the J.D. It also, however, puts these programs outside of the jurisdiction of organizations that while not regulatory, track and set voluntary standards for ABA-recognized law schools.
This extends not just to the curriculum, but to all the standards for operation that apply to law schools. For example, MLS and Certificate programs can be offered entirely online, even though J.D. degrees (so far) cannot.Footnote 172 Each school can also set its own criteria for admissions without concern about the ABA’s requirements which require law schools to “only admit applicants who appear capable of satisfactorily completing its program of legal education and being admitted to the bar.”Footnote 173 If the law school is granting a master’s degree, it must comply with the general rules of the university with which it is associated.Footnote 174
Although both master’s Degrees and Certificates are largely untethered from ABA regulation, law schools are usually bound by the rules that apply to degree granting programs at their university or in their state. For example, Cleveland State University’s School of Law MSL’s home page states that “MLS students pay graduate tuition rate. Graduate tuition is $616.50 per credit hour for Ohio residents ($1,058.20 for non-residents).Footnote 175 Finally, law schools can, again depending on the rules of their university, choose not to disclose tuition at all.
At least one law school offering MSL degrees specific to healthcare compliance is careful to advise students that while the MSL “does not qualify graduates to take a bar exam or to practice law as an attorney in any jurisdiction,” it is “designed for professionals who desire a comprehensive knowledge of law, policy, and principles in compliance and risk management, but do not require a JD degree to accomplish their goals.”Footnote 176
But even though these statements are clear in making the distinction between a degree that qualifies a student to take the bar exam and become a licensed attorney and one that does not, the fact that Master of Studies in law degrees are offered by ABA-recognized law schools may be confusing to students. For example, edX, a “global online learning platform that exists to help learners everywhere unlock their potential,”Footnote 177 hosts a website that offers a list of “Accredited Master of Legal Studies (MLS) Programs.” Footnote 178 edX explains, correctly, that “[m]any MLS programs and related law degrees are recognized by the American Bar Association (ABA) by way of ‘acquiescence.’”Footnote 179 But it then goes on to incorrectly advise that “ABA-recognition for MLS programs may help prospective students understand that a program is affirmed by rigorous academic and career standards.”Footnote 180 It then correctly notes that “[i]t is important to note that the ABA does not grant accreditation to any non-Juris Doctor (J.D.) or post-J.D. programs.”Footnote 181 The distinction edX seems to be drawing is between MLS programs offered by ABA-recognized law schools and those that are offered by schools not affiliated with a law school.
But the implication that the ABA’s recognition of a law school or even “acquiescence” toward that law school having additional degree or certificate programs is an indication of those programs’ quality is absolutely false. As the ABA explains, although a law school operating an MSL or Certificate Program may be recognized by the ABA for adhering to these Standards,Footnote 182 the Council “does not…accredit or approve non-J.D. degrees or certificates.”Footnote 183 Moreover, a statement of “acquiescence” means only that the ABA has determined that the additional program will not be a drain on the resources of the J.D. program.Footnote 184
Another source of possible confusion is that law schools offering master’s Degrees or Certificates may advertise that they are “accredited” by CBB.Footnote 185 Prospective students may not know that this “accreditation” is limited to that specific program. Moreover, while CBB accreditation is the only way to for a prospective examinee to get a waiver of the work experience requirement, CBB does not require the continuing education credits come from an accredited program.Footnote 186
Educational Certificate Programs for Non-Lawyers
In addition to offering master’s degrees to non-lawyers, many law schools have now developed certificate programs for professionals already working in regulated fields like healthcare.
These programs are designed specifically for “non-lawyers who work in fields where legal knowledge would enhance their occupational success and satisfaction.”Footnote 187 Some schools offer students an opportunity to obtain a certificate in healthcare compliance by taking the same classes as the master’s degree program.Footnote 188
While the majority of programs seem to be entirely online, some offer in-person instruction.Footnote 189 For example, Seton Hall Law School offers a four-day, in-person Healthcare Compliance Certificate program not just at its home campus but also in other locations around the world.Footnote 190Attesting to the value of Program, George Peters, Vice President of Quality Systems and Chief Compliance Officer at Flowonix, said that “[a]s someone new to the world of compliance, this certification program featured a comprehensive syllabus and offered a wealth of knowledge across a broad spectrum of topics.”Footnote 191
Observations and Recommendations
With respect to the Loper Bright ruling, I am optimistic that it is not the end of federal regulation of health law. Limits on deference to ambiguous interpretations of federal law should not mean that any agency decision is ripe for second guessing by any federal judge.Footnote 192 Nor does Loper Bright, or the Court’s other anti-regulatory decisions, mean that Congress can no longer use its enumerated powers to fund programs that provide healthcare services or regulate activity related to healthcare that affects interstate commerce.Footnote 193 That being said, while I doubt I could find support for the statement that these decisions alone interfering with Congress’ efforts to manage the health programs on which so many people rely have played a central role in serious efforts to curb judicial overreach, I predict that their disruptive consequences over the next few years will only add fuel to the fire.Footnote 194
Law schools, and law professors, have a big role to play in shaping what is likely to be a period of considerable post-Loper Bright litigation.Footnote 195 As scholars and advocates for sound public policy, health law professors have consistently advised and guided Congress and agencies by testifying as experts or becoming directly involved in drafting complex legislation.Footnote 196
Since the Supreme Court’s concern over the past several years seems to be on how Congress is using its powers, rather than questioning that power,Footnote 197 it should be within Congress’ own ability clarify its intent. Law professors can help to develop and disseminate proposals for ways Congress can address the Supreme Court’s objections, such as incorporating the agencies into the structure of Congress.
As experts in the field, health law professors have a considerable advantage in helping those tasked with healthcare compliance navigate these uncertain times. We can do so, in part, by addressing the coming change on all fronts, working directly with regulators and industry, contributing ideas through scholarship, and developing a curriculum that prepares our students to lead and advise in the face of ongoing and unpredictable change. We will also be supporting lawyers across the spectrum of affected regulated industries, from financial services to transportation to telecommunications.
Law schools have already made substantial investments in developing healthcare compliance programs for lawyers and lay people. Because there is no central source of information about these programs, a helpful first step is to learn more about these programs and what they are offering. Based on my review of information available to the public, these programs are of considerable benefit to students who know of them and can be part of a larger effort to open career pathways to lawyers, both those newly graduated and well into their careers. These programs could be of considerable benefit because they could create pathways into careers in health compliance even for students who had not previously been healthcare compliance professionals. For these students in particular, such a program could introduce them to an industry with which they either might not be familiar or which they might think requires a background in healthcare.
Of course, any change in the law made by the Supreme Court requires changes in the content of individual law school classes. Law schools tend to be siloed, with each professor teaching their own course in sixteen-week blocks. But the coming changes to regulatory practice create an opportunity for planning a curriculum to prepare students for working in regulated industries, whether it be healthcare, airlines, or banking. It also appears, anecdotally, that students who come into law school with a background in the healthcare industry but do not meet the narrow hiring criteria of big law may have job opportunities that would not be available for students without that background.
Recommendations
It would be helpful to have more data about healthcare compliance programs. The lack of mandated consumer information about MSL and Certificate Programs for people who are already healthcare professionals is unfortunate. While these programs are, by definition, offered to sophisticated consumers who are already healthcare compliance professionals and therefore familiar with what they need to do to advance their careers, it would still be helpful to allow them to compare one program to another. Because these programs are largely offered online, potential consumers have little basis for comparison other than the reputation of the school itself.
Information would also be helpful for prospective J.D. students. There is no ABA mandate to track the career paths of alumni. While this might have been an expensive task thirty years ago, it is now very easy to stay in touch. There are several organizations who might partner with us to get this information. For example, in 2018 the “AccessLex Institute commissioned Gallup to conduct a study of law school graduates at various stages of their careers, as well as graduates in other disciplines.”Footnote 198 Additionally, LSAC,Footnote 199 NALP,Footnote 200 and the American Bar FoundationFootnote 201 have all been involved in projects studying law school graduates. Perhaps they could be persuaded to look at graduates of other programs as well.
Without information from reliable sources, we are left with commercial data aggregators and anonymous information from on-line forums where people seek career advice.Footnote 202 For example, the subreddit r/Lawyertalk recently contained a thread responding to a request for advice by “entitledfanman,” who described themselves as three years out of law school doing bankruptcy work in a law firm and wanting to transition to a career in health law compliance.Footnote 203 Specifically, they stated that “the law school near me offers an online Master of Law in Healthcare Compliance, and a shorter certification program as well. They’re not terribly expensive, but not chump change to throw away either” and asked “Would those be helpful at all in jumping over?”Footnote 204
“Snowed_up6152,” who reported that they took “healthcare compliance classes for [their] JD,” advised “entitledfanman” that, “if you can swing it financially, I would recommend pursuing education because healthcare compliance is super niche. Frankly, understanding the business of healthcare is a huge piece of the puzzle that plays into understanding the regulatory piece, so getting a 30,000 ft perspective from the classroom may help. The field also is growing competitive with candidates who have educational credentials.”Footnote 205 User “Unreasonably-Clutch” stated, “I don’t think you need to get a full blown masters of law [sic] if you can get a cheaper alternative certification. Getting the Certified in Health Care Compliance (CHC) credential from the Health Care Compliance Association is a good choice.”Footnote 206 User “mrtoren” also joined the thread to advise that “[i]f you truly want to pursue this, my recommendation would be to shell out for a healthcare compliance certification program. The school or organization may be able to connect you with experiential learning opportunities that will lead to a job.”Footnote 207
While nothing a law school does can, of course, ever be at the detriment of their own students, many law schools have enough connections and resources to facilitate external placements for the benefit of lawyers either transitioning from one field to another or reentering the legal workplace after raising a family or pursuing other interests. Gathering more information about the programs and the experiences of students from different backgrounds would be valuable to lawyers like “entitledfanman” seeking to change careers.
Conclusion
I want to close by thanking the Boston University Health Law Program for its role in creating the academic field of health law and, by extension, creating a career for many health law professors. My research for this essay shows that health law is thriving across the spectrum of law schools, public and private, large and small. I have also been impressed by the success in sharing knowledge about the law with the larger community of professionals who must grapple with it every day without any training.
The early investment law schools like Boston University have been making in health law make our entire community of health law teachers and health lawyers ready to not just navigate these changes, but to use them as an opportunity to support our students. I wish the law school, their faculty who have been so influential to me professionally and personally, and their students past, present, and future much continued success and happiness!
Acknowledgment
This article is dedicated to Professor Fran H. Miller who has been my paradigm of a health law professor could and should be. Many thanks to Neil Taylor, Director, Corporate Law Center, University of Cincinnati College of Law for his helpful comments and suggestions. Many thanks for the research and document preparation assistance of University of Cincinnati College of Law students Madison White '25, and Carrington Calder, Danielle Douglas, Perry Ben Collier '26 and for the research assistance of Laura Dixon-Caldwell, Instructional & Reference Services Librarian, Robert S. Marx Law Library, University of Cincinnati College of Law. Of course, all errors and opinions are my own.
