New Jersey will fully exit its pandemic-era regulatory framework for certain healthcare providers on February 16, 2026. As outlined in this recent client alert by Greenbaum attorney Sukrti Thonse, impacted providers – including Advanced Practice Nurses, Physician Assistants, hospitals, medical practices, and providers operating under emergency or reciprocity licenses – should take action now to ensure that all collaborative agreements, supervision structures, and prescribing authority are compliant by the February 16th deadline.

Two lessons emerge from the Appellate Division’s December 5, 2025 opinion in Weissman v. Li. The first is a reiteration of the importance of precision of the language used in questioning witnesses. The other is rejection of the reflexive reluctance to question one’s own witness in a pretrial deposition.

This is a medical malpractice case involving a claim that spinal surgery caused the plaintiff’s leg and foot pain. The plaintiff had a Minimally Invasive Lumbar Decompression (MILD) procedure to treat his spinal stenosis. The trial court excluded the plaintiff’s liability expert, a board-certified anesthesiologist and pain management specialist, from opining on medical causation and then granted summary judgment dismissing the complaint for failure to establish a prima facie case because the plaintiff had no expert testimony to support the essential element of causation.

The trial court reached this conclusion for two reasons. The expert stated in his deposition that he would “defer to a neurologist” regarding causation undermining the witness’ expertise to express an opinion. In addition, the trial judge deemed the expert’s report an inadmissible “net opinion” lacking sufficient factual basis. On appeal, in an opinion authored by Judge Jack M. Sabatino, the Appellate Division affirmed but without endorsing the trial judge’s analysis completely. The court invoked the commonly used deferential standard for review of trial court evidentiary rulings from Townsend v. Pierre that admissibility of expert testimony “is committed to the sound discretion of the trial court” but with de novo review of questions of law. The court framed the pivotal legal issue as whether the plaintiff’s expert satisfied the requirement found at N.J.R.E. 702 that the witness has sufficient expertise to offer the intended testimony.

The plaintiff’s theory of liability was that while performing a surgical procedure on the patient’s spine, the defendant caused an injury to the nerve in the spine. The Appellate Division noted that the expert had extensive training and experience in the fields of anesthesia and pain management, was board-certified in the field, and was manifestly familiar with the nervous system and its effect on pain. He was the sole expert on behalf of the plaintiff. Since the defendant was a board-certified pain management physician, the expert satisfied the requirement of the Patients First Act that a witness opining on medical liability issues must have comparable or equivalent credentials to those of the defendant. The defense had two experts: a board-certified anesthesiologist and pain management specialist and a neurologist. The proffered opinions of the defense experts were that there was no deviation from accepted standards of care in the performance of the procedure and that the procedure did not cause the plaintiff’s leg and foot problems.

Defense counsel conducted a pretrial deposition of the plaintiff’s expert in a fashion to limit the scope of his opinions. In response to questions, the witness acknowledged that nerve injury was a known risk of the MILD procedure. The examination then included the following crucial passage:

Q: Would I be correct, Doctor, that you would defer to a neurologist in terms of whether or not Mr. Weissman’s complaints on the bottom of his foot are related to the surgery or not?

A: Yes, I would defer to a neurologist.

Q: I understand those are your opinions and maybe you just didn’t understand my question, because it could short-circuit the deposition is what I’m trying to do. So if I’m understanding, your role in this case is to give us your opinions as a pain management specialist as to deviation from standard of care. Correct?

A: Yes.

 Q: And I’m correct that in terms of what these alleged deviations caused in terms of any possible neurological damage to the patient, you would defer to a neurologist because that’s not your area of specialty. Correct?

A: Yes.

The trial court concluded that this deposition testimony was a concession by the expert that he was unqualified to opine on the causation issues in this case. On appeal, Judge Sabatino identified the effect of the expert’s concession that he would defer to a neurologist in the evaluation of the cause of the nerve injury as “a matter of first impression” in New Jersey. Although finding no germane precedent in New Jersey case law, he cited decisions from other jurisdictions addressing the issue. He referred to cases from the Tenth Circuit Court of Appeals (applying Kansas law) and from Georgia where an expert was disqualified from testifying on the basis of such a deferral to the expertise of another specialty. But decisions from other jurisdictions, including New Hampshire and Texas, reached a contrary conclusion. In final analysis, the court declined to adopt a blanket rule that such a concession precluded an expert from testifying and described the evaluation as “highly contextual.”

No one asked [the deponent] to define the term “defer” or what he understood the word to      mean in this context. The questioner did not define the term either. The plaintiff’s counsel did       not object to the question.

Nor did the plaintiff’s counsel ask any clarifying questions of the expert after defense counsel   had finished her questioning of Dr. Gerges.

Emphasizing the lack of definition or clarification, Judge Sabatino looked to dictionary usage of the word “defer” and found that these connoted a yielding or submitting to the opinions of another person. He noted that one might infer that the witness was acknowledging to his questioner that he is not a neurologist, and that only a neurologist is qualified to render opinions about whether the MILD procedure medically caused the plaintiff’s foot and leg pain. However, it could also be that he was simply expressing professional respect for the views of neurologists and their specialty. A third interpretation was that as a board-certified anesthesiologist and pain management doctor, he was not as qualified as a neurologist to render opinions about the cause(s) of a patient’s pain but notwithstanding that deference, he nonetheless advanced his own contrary opinions on what caused the plaintiff’s condition. In the context of a summary judgment motion given these various inferences and the need to draw all inferences in favor of the party opposing the motion, the court declined to rest the analysis on the supposed concession.

Rather Judge Sabatino proceeded to review the net opinion aspect of the trial court’s ruling. He concluded that the trial judge had correctly applied the doctrine’s requirement that the expert’s testimony must provide the “whys and wherefores” to support the admissibility of the opinion. The plaintiff’s expert report did not explain anatomically the causal mechanism as to how the spinal procedure produced the problem with a nerve root resulting in weakness of the plaintiff’s leg and pain in the foot. “An expert’s explanation of a causal mechanism is important when it is not obvious to a layperson how an action or inaction can cause an injury.” Since nerve injury is a generally recognized risk of this procedure, the expert did not explain how the risk of such harm in the plaintiff’s case was increased by the defendant’s alleged surgical deviations.  The expert’s discussion of causation was brief and largely a temporal analysis, resting upon what he referred to as the “timing component” of the plaintiff’s symptoms and conditions. But Judge Sabatino explained that “the association or coincidence of the timing doesn’t suffice to prove causation” and referenced the Supreme Court’s decision in State v. Olenowski, one of a line of cases holding that correlation, consistency or association does not equal causation. In Olenowski, while temporarily assigned tothe Supreme Court, Judge Sabatino demonstrated the insufficiency of “mere coincidence”:

A simple example illustrates the point: the fact that, between 1908 and 2020, the same political party’s candidate won the presidential election in two-thirds of the years in which a National League team won the World Series does not mean that the World Series outcome caused the presidential election result. The correlation between those events is obviously coincidental. 

The assertion that because a condition follows some event chronologically, it was caused by that event is the false logic of post hoc, ergo propter hoc rejected in several New Jersey decisions dating back at least to 1961 with Schulman v. Male. Temporal analysis may play a role in cases that qualify for the application of the doctrine of res ipsa loquitur; however, that doctrine is narrowly applied under New Jersey law to medical malpractice claims. Moreover, the doctrine has been held inapplicable to an injury which is a known risk of the surgery or procedure.

Judge Sabatino’s analysis of the supposed concession by the plaintiff’s expert that he was unqualified to opine on causation because he would “defer” to a neurologist illustrated the possible interpretations and resulting ambiguities of the testimony. The use of clear, precise language is essential to avoid misunderstandings and ambiguities, and to effectively communicate recollections and observations. Having a medical witness explain and define technical terminology is basic in trial work. The Appellate Division in its opinion in Ruth v. Fenchel recognized that this could be done by opposing counsel or even the judge at trial. This concern typically revolves around scientific or medical information. But one must be alert for not only for “weasel words” to evade answering a question but also for vague and connotative words capable of multiple meanings. Otherwise, there is a risk of setting the stage at trial for an exchange reminiscent of the scene in Through the Looking-Glass in which Humpty Dumpty said to Alice: “When I use a word, it means just what I choose it to mean — neither more nor less.”

That the plaintiff’s case was made vulnerable by the plaintiff expert’s concession regarding “deferring to a neurologist” is apparent in retrospect; however, that could have been recognized at the deposition table. While long-standing traditional wisdom is to not question one’s own witness at a pretrial deposition, that precept should not be rigidly followed in all situations. As Judge Sabatino commented, there was no objection to the form of the question and neither “did the plaintiff’s counsel ask any clarifying questions of the expert after defense counsel had finished her questioning.” The issue that was problematic at the trial level for the plaintiff could have been avoided. And that same issue that became adverse for the defense on appeal could have been eliminated with more precise follow-up phrasing that committed the witness to a definition of this critical term.

On November 12, 2025, President Donald Trump signed, legislation, H.R. 5371, extending key Medicare telehealth flexibilities on a temporary basis through January 1, 2026. Our previous client alert outlined the immediate rollback of pandemic-era telehealth rules following the government shutdown and the resulting disruption. This new legislation temporarily reverses that rollback and restores the pandemic-era telehealth framework.

In addition, the Centers for Medicare and Medicaid (CMS) is expected to issue updated guidance addressing the submission of impacted claims, eligibility for retroactive reimbursement, and the processing of claims that have been held or suspended—consistent with the clarifying bulletins CMS released during the shutdown period. While these extensions preserve many pandemic-era policies, it’s important to note that they do not make those policies permanent.

Providers and their organizations should plan now for potential changes when these flexibilities sunset.

Overview of Key Medicare Telehealth Flexibilities Extended Through January 1, 2026

  1. Home as an originating site: Medicare beneficiaries may continue to receive telehealth services from their homes without geographic or originating-site restrictions.
  1. Audio-only telehealth: Coverage for certain audio-only telehealth services remains in place subject to applicable service and documentation requirements.
  1. Expanded practitioner eligibility: The broadened list of practitioners eligible to furnish and bill Medicare telehealth services (e.g., physical therapists, occupational therapists, speech-language pathologists, and others) continues as permitted by statute and CMS guidance.
  1. Federally qualified health centers (FQHCs) and rural health clinics (RHCs) as distant site providers: FQHCs and RHCs may continue to serve as distant site practitioners for covered telehealth services, using applicable payment methodologies.
  1. In-person visit requirements: Any delayed or modified in‑person visit requirements tied to specific telehealth services remain deferred as provided in the new legislation and subsequent CMS rulemaking.
  1. Hospital and facility considerations: Flexibilities related to hospital outpatient department telehealth arrangements and supervision maintained under the extension continue to the extent preserved by the new legislation and CMS policy.

Note: These flexibilities apply to Medicare fee-for-service and may be incorporated into Medicare Advantage plans subject to plan terms. Commercial payer and Medicaid policies may differ by payer and state.

Implications for New Jersey Providers and Their Organizations

  1. Update policies and consent: Ensure telehealth policies, procedures, and consent forms reflect current federal requirements and New Jersey-specific laws and regulations, including licensure, scope of practice, patient identification, privacy/security, and emergency protocols.
  1. Billing and coding: Align coding, modifiers, and place-of-service indicators with current CMS guidance for telehealth (including audio-only where permitted) and verify payer-specific requirements for Medicare Advantage and commercial plans. Confirm FQHC/RHC billing rules where applicable.
  1. Compliance and documentation: Maintain documentation supporting modality (audio-only vs. audio-video), medical necessity, patient location, practitioner eligibility, and technology used; confirm HIPAA-compliant platforms or applicable enforcement discretion parameters as currently in effect.
  1. Cross-border practice: Confirm New Jersey licensure or applicable compacts/exemptions when treating patients located in New Jersey or out of state; verify payer credentialing and enrollment for telehealth services.
  1. Privacy and security: Review HIPAA and New Jersey privacy/security obligations; ensure Business Associate Agreements, risk analyses, and safeguards reflect telehealth workflows.
  1. Prepare for sunset: Develop contingency plans for services most affected if flexibilities lapse after January 1, 2026, including:
    • Reinstatement of geographic/originating site limits.
    • Narrower practitioner eligibility.
    • Restrictions on audio-only services.
    • Changes to FQHC/RHC distant site status and reimbursement.
    • Potential reimposition of in-person visit prerequisites.
  1. Monitor developments: Track CMS rulemaking and sub-regulatory guidance implementing H.R. 5371, as well as New Jersey legislative or regulatory updates that may affect Medicaid and commercial telehealth coverage.

Our Healthcare team will continue to monitor these issues and will keep you advised accordingly. Please contact the authors of this Alert with questions or to discuss your specific circumstances.

On May 12, 2025, President Donald Trump issued an Executive Order (EO) entitled “Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients” with the goal of ensuring Americans pay no more for prescription drugs than other developed nations.

The EO directed the Secretary of Health and Human Services to communicate most-favored-nation (MFN) price targets to manufacturers, and if significant progress is not made toward such pricing structures, to propose a rulemaking plan to address the issue. The EO further directed the HHS Secretary to facilitate direct-to-consumer purchasing programs for manufacturers selling their products at the MFN prices.

In furtherance of these goals, on July 31, 2025, President Trump sent letters to leading pharmaceutical manufacturers outlining steps they must take to bring down the prices of prescription drugs in the United States to match the lowest price offered in other developed nations.  

As a result, on September 30, 2025, President Trump announced the first agreement with a major pharmaceutical company, Pfizer, to bring American drug prices in line with the lowest price paid by other developed nations.  According to the White House, the agreement with Pfizer will:

  • Provide every state Medicaid program with access to MFN prices on Pfizer products;
  • Ensure “foreign nations can no longer use price controls to freeride on American innovation” by guaranteeing MFN prices on all new medicines brought to the market by Pfizer;
  • Require Pfizer to repatriate increased foreign revenue realized as a result of the administration’s trade policies; and
  • Require Pfizer to offer medications at deep discounts when selling directly to American patients.

Also on September 30, the administration announced it would be rolling out a new direct-to-consumer website called TrumpRx, where individuals can buy prescription medications at discounted prices rather than through insurance. Though few specific details were provided about TrumpRx, the administration announced at least four Pfizer medicines, Eucrisa, Duavee, Zavzpret and Xeljanz, would be available through the website, which is planned for launch in “early 2026.”

The Pfizer deal and the announcement of TrumpRx constitute significant steps towards reaching the administration’s goal of lowering prescription drug prices for American citizens. However, the lack of specifics in the rollout of TrumpRx leaves many questions unanswered. At the top of that list is whether the TrumpRx program, which addresses the cash price of prescription drugs, will have a tangible impact on the prices patients covered by insurance pay for such medications.

California has enacted two bills that will significantly impact private equity firms, management services organizations (MSOs), and physician practices operating in the state.

Assembly Bill 1415 (AB 1415) and Senate Bill 351 (SB 351) build on longstanding concerns about the corporate practice of medicine (CPOM) by expanding regulatory oversight of transactions and strengthening statutory prohibitions on non-physician influence over clinical decision-making. Both measures were signed into law by Governor Gavin Newsom and are set to take effect on January 1, 2026, representing the most comprehensive update to California’s CPOM framework in decades.

AB 1415 focuses on transaction oversight and reporting. The bill broadens the scope of entities subject to the Office of Health Care Affordability (OHCA) review by expressly including MSOs, parent entities, private equity funds, and hedge funds within its notice requirements. Under AB 1415, any “material change” transaction involving a California healthcare entity—including changes of control, mergers, or significant asset transfers—will trigger a mandatory 90-day advance notice to OHCA. While the agency does not have explicit authority to block deals, its expanded jurisdiction means that private equity sponsors and MSOs must now plan for additional disclosure, regulatory scrutiny, and potential delays in closing.

SB 351 directly addresses the CPOM doctrine and explicitly extends its reach to private equity firms and hedge funds investing in medical and dental practices. The bill prohibits investors from exercising control over key aspects of clinical operations, such as hiring or firing physicians, approving diagnostic tests, controlling patient records, or dictating payer contracting terms. It also voids restrictive covenants such as non-compete and non-disparagement clauses in agreements between investors and physician practices. SB 351 grants the California Attorney General the authority to enforce these provisions and seek injunctive relief and attorneys’ fees, raising the stakes for non-compliance.

The key requirements and practice impacts of each bill are summarized on this chart:

BillFocusKey RequirementsPractical Impact
AB 1415Expands OHCA’s authority over health care transactions• Broadens scope to include MSOs, private equity, hedge funds, and parent entities.
• Requires at least 90 days’ advance notice to OHCA for “material change” transactions, including mergers, acquisitions, governance shifts, or significant asset transfers.
• Authorizes OHCA to collect data and impose reporting obligations on MSOs.		• Private equity and MSOs must account for new regulatory timelines in deal planning.
• Transactions that previously escaped notice may now face disclosure and review.
• OHCA scrutiny may delay closings or raise reputational risk.
SB 351Codifies and strengthens CPOM restrictions• Extends CPOM prohibitions to private equity firms and hedge funds.
• Bars investor interference with core clinical decisions (diagnosis, referrals, patient records, payer contracting).
• Renders void restrictive covenants such as non-competes and non-disparagement clauses in physician practice agreements.
• Grants Attorney General enforcement authority, including injunctions and recovery of attorneys’ fees.		• Heightened risk of AG enforcement actions.
• Common MSO/PE contract provisions may need revision.
• Physicians gain greater statutory protection against investor control.
• Potential chilling effect on investment structures in California.

Together, AB 1415 and SB 351 underscore California’s effort to curb perceived overreach by private equity in healthcare and to preserve physician independence. For private equity firms, MSOs, and physician groups, the new laws require proactive contract review, careful structuring of governance rights, and early regulatory engagement in transactions. Given California’s outsized influence, these developments may also set the tone for similar legislative efforts across the country.

As of this writing, New Jersey has not introduced new CPOM legislation comparable to AB 1415 or SB 351. However, there has been significant talk in the healthcare industry and in regulatory circles about ways in which the government can strengthen its oversight and authority over private equity investment in healthcare.

AB 1415 and SB 351 encompass the types of strengthened controls one would expect, and thus, those involved in private equity transactions in New Jersey should not be surprised if similar bills are introduced here in the coming future. Nevertheless, for the time being, New Jersey continues to enforce a long-standing prohibition on the corporate practice of medicine through professional corporation laws and Board of Medical Examiners regulations. While management services arrangements are permitted, New Jersey requires that only licensed physicians control medical practices, and regulators closely scrutinize agreements that grant non-physicians influence over clinical judgment.

For private equity firms and MSOs active across multiple jurisdictions, this means that although California now imposes explicit statutory regulation, New Jersey’s risk remains grounded in its established regulatory framework, and deal structures must be calibrated to comply with both regimes. For more information regarding New Jersey’s CPOM regulations, please see our prior posts on this blog.

Among the many ripples from the current government shutdown is a sudden rollback of telehealth flexibilities under Medicare that will impact both providers and beneficiaries. Greenbaum partner John Kaveney provides an overview of key issues for healthcare entities in this recently published Client Alert.

The U.S. Department of Health and Human Services (HHS) has announced a renewed effort under Secretary Robert F. Kennedy, Jr. to crack down on information blocking practices that limit the ability of patients to access, exchange, or use their electronic health information (EHI). 

What Is Being Targeted

  • Those failing to comply with the legal obligations under the 21st Century Cures Act (2016), including certified health IT developers, providers, health information networks, and health information exchanges.
  • Any efforts that hinder or otherwise unlawfully restrict access, exchange, or use of EHI.

What Laws Empower HHS

  • The 21st Century Cures Act gives ASTP/ONC (the Office of the Assistant Secretary for Technology Policy / Office of the National Coordinator for Health Information Technology) and the HHS Office of Inspector General (OIG) authority to enforce rules against information blocking.  
  • The ONC’s Cures Act Final Rule confirms that patients must have free, easy electronic access to their EHI—including via apps of their choice—and that providers should be able to choose digital tools without being hampered by excessive costs or technical barriers.  

Key Voices

HHS officials emphasized that data transparency is central to transforming healthcare.

In the words of Deputy Secretary Jim O’Neill:

“Unblocking the flow of health information is critical to unleashing health IT innovation and transforming our healthcare ecosystem. . . We will take appropriate action against any health care actors who are found to be blocking health data for patients, caregivers, providers, health innovators, and others.”

This statement underscores the administration’s broader goal of empowering patients in an effort to improve care.

Moreover, such efforts to root out information blocking have already begun.

Tom Keane, MD, Assistant Secretary for Technology Policy and National Coordinator for Health Information Technology has stated:

“We had already begun reviewing reports of information blocking against developers of certified health IT under the ONC Health IT Certificate Program and are providing technical assistance to our colleagues at OIG for investigations.”

Thus, the time for action by providers and others to ensure compliance with the law is now. 

Key Changes & Enforcement Measures

  • HHS is increasing the resources committed to identifying and curbing information blocking.  
  • The ONC and OIG will play leading roles—the ONC reviewing reports of information blocking and offering technical assistance, and the OIG investigating and taking enforcement actions where necessary.
  • Those found violating the law may face:
    • Disincentives under applicable Medicare/Medicaid‑linked programs (for providers)
    • Civil monetary penalties up to $1 million per violation (for health IT developers, health information networks, or exchanges) 
    • Termination of certification or being banned from the ONC Health IT Certification Program for certified health IT developers who fail to comply

Why This Matters

  • For patients: guaranteed legal rights to see, use, and share their EHI, which HHS believes supports more informed decision‑making, error detection, easier coordination of care, and better health outcomes.  
  • For innovators: clearer expectations and enforcement, which HHS believes can reduce uncertainty, encourage development of tools, apps, or platforms that leverage health data more freely.
  • For healthcare providers: greater interoperability, less friction in data exchange, supporting efforts to improve care, reduce waste, and increase efficiency.

What to Do

  • Reporting: Patients, providers, innovators, or anyone who has witnessed or experienced information blocking can report through the ONC’s “Report Information Blocking Portal.”  
  • Compliance: Those subject to the information blocking rules should evaluate their practices now to ensure they are not in violation of the law—especially around how they share EHI, which apps are supported, and cost/technical barriers.

Bottom Line

HHS’s increased focus on enforcement of information blocking rules represents a clear warning to the healthcare industry – patient data must flow freely, legally, and responsibly. For healthcare providers and IT vendors, now is the time to ensure full compliance with federal law or face potential significant consequences.

Compliance programs, in coordination with legal counsel, should be vetting all relevant policies and procedures, and their operational implementations, to ensure consistency with the law.

In recent weeks, vaccine policy has become a flashpoint at the state level. On September 3, 2025, the governors of Oregon, California, and Washington inaugurated a West Coast Health Alliance, a regional partnership aimed at preserving scientific integrity in vaccine policy amid growing skepticism toward federal health leadership. Through this partnership, the three states will start coordinating health guidelines by aligning immunization recommendations informed by respected national medical organizations and scientific evidence-based recommendations from trusted scientists, clinicians, and other public health leaders. While each state will independently pursue strategies shaped by their unique demographics, geographics, and laws, the Alliance’s coordinated plan is intended to ensure consistency and transparency across the West Coast in determining who should receive vaccines and under what circumstances.

In subsequent developments, Hawaii announced it would join the Alliance, expanding the collaboration to four states united behind evidence-driven immunization recommendations, respecting tribal sovereignty, and acknowledging each jurisdiction’s unique regulatory needs.

By contrast, Florida has moved in the opposite direction. Florida surgeon general, Joseph Ladapo, stated on September 3 that the state plans to end all state vaccine mandates, including for students to attend schools. Ladapo said his agency would roll back mandates for a half-dozen or so vaccines under its authority but that the agency will need to work with the Florida legislature on a broader package of reforms. He did not specify which vaccine mandates his agency would do away with.

Currently, all states have vaccine requirements to attend public schools with specific exceptions that vary by state (mainly for medical and religious reasons). This move to reverse the vaccine mandate for school children, and possibly a larger group, shows a significant shift in state-level policy and signals growing divergence nationwide.

What This Means for New Jersey Providers and Health Systems

These developments highlight how states are increasingly asserting authority over vaccine policy, diverging from federal standards. While most states have historically aligned closely with CDC guidance, the current climate suggests we may see greater variability in immunization requirements, school-entry rules, and employer/healthcare provider obligations.

For New Jersey providers, this trend matters for several reasons:

  • Regulatory Drift: If states like California or Florida test new approaches, others may follow, either strengthening or loosening requirements.
  • Compliance Complexity: Multi-state providers, payors, and vendors will need to navigate inconsistent state rules.
  • Future in NJ: New Jersey could face pressure to adopt its own state-specific vaccine policies if public confidence in federal guidance erodes further.

Greenbaum’s Healthcare team is actively monitoring these state-led initiatives. We are prepared to advise physician groups, health systems, and management companies on compliance with evolving immunization requirements, the potential need to adjust policies for multi-state operations, and any state-specific rulemaking that could impact school-based, workplace, and clinical vaccination obligations.

Although much of the public commentary related to the One Big Beautiful Bill Act (OBBBA) has focused on dire predictions that millions will lose coverage, healthcare leaders – including hospital system leaders, compliance teams and finance departments – should pay close attention to the regulatory details of the bill and take proactive steps now to address highly consequential changes to eligibility, provider funding, and state financing mechanisms. Greenbaum healthcare attorneys Jim Robertson and Sukrti Thonse provide an overview of the legislation’s significant impacts in this recently published Client Alert.

An article in the August 9, 2025, issue of the New England Journal of Medicine highlights the opportunity, if not the responsibility, of the bar in the private law sector to fill the gaps in healthcare access, quality, and accountability resulting from the Trump administration’s deregulation efforts regarding federal administrative agencies and legislation. Moreover, the termination or redirection of many federal programs and funding will put increased strain on the regulation of healthcare at a state-law level. State-level regulation has commonly encompassed insurance requirements and consumer protection issues. But there are other aspects of healthcare that need attention.

The authors of the NEJM article are professors of law and public health at Boston University and the University of Chicago. They identify the body of law encompassing contracts, torts, and fiduciary duties as the key areas that will respond to the potential vacuum following federal deregulation efforts. They characterize the changes being implemented by the Trump administration as “causing a seismic shift in health care governance.”

Beginning their review with the diminution in the authority and staffing of the Food and Drug Administration, the authors foresee an increased use of contractual provisions to enable private entities such as insurers to require evidence of safety or efficacy to obtain reimbursement for new products and services. They also note that states that purchase healthcare for large numbers of people can build public health goals into their contracts with private payers and healthcare organizations, commenting that the use of market leverage to promote cost containment or quality improvement is not new but is of increased importance with the erosion of public law regulators.

Tort law will likely become “a critical backstop for accountability and quality control in health care” through medical malpractice actions, including informed consent, and product liability claims. The civil justice system including tort liability is widely recognized as advancing objectives of compensation for losses, deterrence of future wrongful conduct, and encouraging safety. The conservative Cato Institute has acknowledged that “[i]n some instances tort liability does serve a potentially risk-reducing role by fostering new safety measures” although it questions whether it makes economic sense to make all products risk-free. 

Corporate governance and fiduciary responsibilities are highlighted by the weakening of governmental regulators. The NEJM authors hypothesize that “[i]f public oversight wanes, courts may face pressure to dial up enforcement of duties of care and loyalty in private-law frameworks.” They also note the hybrid nature of some actions that might be taken in the private law sector springboarding from statutes such as the False Claims Act, antitrust statutes, and civil rights laws. Many, but not all of these provide a private right of action.

The NEJM article concludes with a discussion of several risks in relying on private law. These include the difficulty of developing standards for robust ethical conduct and clear comprehensive contracts. The authors foresee a return to an atmosphere of “caveat emptor” for patients, with a need to be wary of insurance policy provisions and treatment options and to subject them to appropriate scrutiny and evaluation. They also point out the inherent imbalance across the general population that follows from the advantage that well-informed or well-resourced parties have in negotiating and navigating these circumstances. Legal counsel is not automatically available to everyone. Even in the setting of tort actions where representation is commonly provided through a contingency fee agreement, there is delay and unpredictability of result that takes away from the appeal of pursuing tort remedies. The authors conclude: “Regardless of whether the elevation of private law in health care represents a temporary stopgap or a durable shift, the time to reckon with its implications is now.”

Ironically, in the same week that the NEJM article appeared, Heather Cox Richardson, a professor of American history at Boston College, published one of her “Letters from an American” making note of the 90th anniversary of the signing of the Social Security Act by President Franklin Delano Roosevelt on August 14, 1935. The primary focus of her historical review was the role of Frances Perkins as Secretary of Labor and the experiences in her life that led her to be the driving force behind the legislation. The Social Security Act was a move away from the notions of “rugged individualism” toward a basic social safety net of interdependence with the pooling of funds available from tax dollars. The congressional vote on enacting the Social Security Act was 371 to 33 in the House of Representatives and 77 to 6 in the Senate. Perkins is the longest serving Secretary of Labor in the country’s history, serving from 1933 to 1945. In a speech delivered in 1962, Perkins stated: “One thing I know: Social Security is so firmly embedded in the American psychology today that no politician, no political party, no political group could possibly destroy this Act and still maintain our democratic system.”

The juxtaposition of Perkins’ 1962 comments with the observations regarding healthcare deregulation in the 2025 NEJM article is thought-provoking. At least since Justice Brandeis’ 1932 decision in New State Ice Co. v. Liebman, the states have been recognized as “a laboratory [to] try novel social and economic experiments without risk to the rest of the country.”  While there is the potential of returning to the era when “states’ rights” was a code word, the strong tradition of federalism to the contrary was recognized by Justice Brennan in his classic 1977 Harvard Law Review article entitled “State Constitutions and the Protection of Individual Rights.”

The NEJM article identifies several areas of challenge to the bar. Are we ready?