After years of ongoing discussion at the federal level, we are finally seeing movement regarding pharmacy benefit manager (PBM) reform. In the March 2026 issue of Oncology Practice Management, we discussed some of the recent congressional, legislative, and investigative activities that surrounded movement by the Department of Labor (DOL) to publish proposed PBM regulation language for comment.1 On April 15, 2026, the commenting period on that proposed DOL PBM regulation closed with 564 comments.
July 1, 2026, Impact Looming Soon
The proposed rule included an effective date of just 60 days after publication of the final rule, so the new requirements would apply to plan years beginning on or after July 1, 2026. With the range and depth of the 564 comments, the DOL has a very short time to modify the proposed regulation for any modifications suggested in the comments.
Wide Reactions to the DOL Proposed PBM Rules
It is interesting to review the comments made on the rule. As would be expected, most PBMs and their affiliates objected to the need for the rule at all, citing various concerns about the timing, scope, and legality of the DOL creating PBM regulations, objecting that it was redundant given the PBM reform passed in the Consolidated Appropriations Act of 2026, and in general, citing reasons and objections for the DOL to approve any PBM regulation at all if not to significantly narrow its scope and enforcement options.2
Several individuals shared comments, mostly with concerns or sharing personal adverse experiences with PBMs and supporting the DOL PBM regulations.
A significant number of comments were in full support of the DOL proposed rule, suggesting further enhancements or expansion of the regulations. Many healthcare providers, patient advocacy groups, and plan sponsors, for example, proposed that the scope of the rule should include expansions to capture all entities affiliated or under common ownership with PBMs, apply the requirements of compliance with the rule directly to affiliates, agents, and subcontractors rather than to just the covered service provider, and expanding the definitions of remuneration streams and sources to more accurately encompass many of the relationships that are obscured from employer client fiduciary awareness and monitoring.2
A significant number of comments were in full support of the DOL proposed rule, suggesting further enhancements or expansion of the regulations.
PBMs Abusive Overreach Hurts Patients
I see another direction and expansion of the DOL PBM proposed rule opportunity that has not yet been widely addressed but is of great importance to oncology providers and the vulnerable patients for whom they care. Utilization management and nonmedical decision-making abuse are adding cost and time delays to needed care and have become an abusive overreach of PBMs. Following are some excerpts of the comments that I submitted to DOL on behalf of the National Oncology State Network, a nonprofit action organization established by state leaders collaborating on emerging state issues in order to strengthen cancer care and policy across the country.
We would like to explore several gaps in the proposed regulation, especially ones that may cause ERISA plans to unknowingly impact the health and safety of their most vulnerable health plan participants, while simultaneously putting their own ERISA status at potential risk.
This proposed regulation is much needed on a national scale to address the rampant problems caused for patients and self-insured employers by the operations and policies of contracted pharmacy benefit managers. However, this is a complex issue, and we would like to explore several gaps in the proposed regulation, especially ones that may cause ERISA plans to unknowingly impact the health and safety of their most vulnerable health plan participants, while simultaneously putting their own ERISA status at potential risk.
The PBM industry is built on precepts and strategies that themselves violate the concept of fiduciary responsibility to the patient. The PBM controls, profiteering, steerage, management and drug manipulation processes create an environment that sets up an ERISA self-insured group to fail their fiduciary obligations to their health plan members by blocking timely access to treatments, patient choice, and medical decision-making. The rapid growth and expansion of the PBM industry have led to a blatant violation of patient rights to timely access to medically appropriate treatment and care.
The DOL now has an opportunity to put the patient, physicians, and the ERISA group health plans back in control of quality care, and to block the PBMs and their affiliates, agents, and subcontractors from replacing patient choice, medical decision-making, and prioritization of medical standards of care with nonmedical decision-making and profiteering actions and services that add unnecessary costs to healthcare and prioritize profits over patients.3
Quality and Reasonableness of Care – An Unmet Fiduciary Obligation
Quality of Care – not just Cost of Care – The Consolidated Appropriations Act of 2021 (CAA) addressed Health Care Quality Fiduciary Obligations As Well as Financial – While the proposed DOL regulations appropriately consider many of the adverse impacts that PBMs and their affiliates, agents, and subcontractors may have on the financial interactions with their client ERISA-covered self-insured customers, there is another significant fiduciary obligation NOT addressed in this proposed rule – that of the health plan to provide reasonable access to health care, treatments, and quality of care for its insured employees and their other beneficiaries.
PBMs and their affiliates, agents, and subcontractors engage in nonmedical decision-making solely for profit while exercising their self-appropriated authority over drug formularies, utilization management, and control of sourcing of specialty pharmacy drugs for ERISA health plan clients.
With no direct knowledge of the patient, the PBMs and their affiliates, agents, and subcontractors interfere directly with the choice of medication the physician has subscribed for a patient given that patient’s unique health care needs and status, by denying the prior authorization request, requiring use of less appropriate drugs through step edits or nonmedical switching, denying the pharmaceutical claim, manipulating the physician or patient away from the prescribed drug to another on the PBMs preferred formulary, or by outright denying any coverage at all for the drug and mandating the patient turn to an alternative funding vendor where the patient is subjected to further delays and access restrictions, or even illegal imported foreign drugs.
This proposed rule fails to address the fiduciary obligation of the ERISA self-insured group health plan to provide reasonable access to medical evidence-based standards of care in a timely manner – not just an obligation to obtain low costs at the expense of quality medical care that the employee has a right to expect for their health benefit premiums.
The DOL, which enforces ERISA, stated in 1998 that quality of service is a factor in selecting and monitoring a health plan service provider and that “a plan fiduciary’s failure to take quality of services into account in the selection process would constitute a breach of the fiduciary’s duty under ERISA.” According to DOL, a responsible health plan fiduciary “must engage in an objective process designed to elicit information necessary to assess the qualifications of the provider, the quality of services offered, and the reasonableness of the fees charged in light of the services provided.” This process includes an evaluation of (a) the qualifications of those who will be providing medical services; (b) ease of access to medical providers and information about the health care provider’s operations; (c) the procedures in place to timely consider and resolve patient questions and complaints; (d) the procedures for patient record confidentiality; and (e) enrollee satisfaction statistics.3
What Can Practices Do?
When PBM vendors try to convince the public, potential self-insured employer clients, providers, legislators, policy makers, and the affected employee patients that they have the authority to exercise nonmedical decision-making against reasonable and appropriate healthcare for vulnerable patients, the medical community needs to speak up. When PBM vendors and their affiliates or subcontractors exercise that nonmedical decision-making in a manner that is not reasonable, is contrary to accepted medical standards of care, or not in the best interest of the vulnerable patient, the medical community needs to speak up. If PBM vendors sponsor or support similar misleading legislation in our states, we need to raise our voices to call out misrepresentation or obfuscation of the real impact of abusive nonmedical decision-making and utilization management on the health and safety of vulnerable patients and even legal/fiduciary status of their self-insured employer clients.
Next Steps for Cancer Practices
- Monitor PBM trends and patterns in your market and state
- Review and understand the implications of proposed PBM legislation and regulation, whether through the DOL or in your own states
- Collaborate, inform, and join forces with others facing similar challenges—local, state, and federal leadership
- Comment on and address federal and state legislation and policy that may have a positive or adverse impact on the impact of patient care, coverage, and policies
Share your thoughts and experiences with me at
References
- Holcombe D. Major PBM reform in play? Shell games require action. Oncology Practice Management. 2026;16:6-9.
- Carnagie TC, Shaikh H, Callander G, Trautz S. DOL’s Proposed PBM Fee Disclosure Rule: Key Themes from the Public Comments. Mintz Insights. May 11, 2026. www.mintz.com/insights-center/viewpoints/2146/2026-05-11-dols-proposed-pbm-fee-disclosure-rule-key-themes-public
- Holcombe D. 1210-AB37 Comment 0143 National Oncology State Network 04152026, Improving Transparency into Pharmacy Benefit Manager Fee Disclosure. Posted by the Employee Benefits Security Administration on Jan 30, 2026. Regulations.gov. Accessed May 28, 2026, www.regulations.gov/document/EBSA-2026-0001-0001/comment?filter=national%20oncology%20state%20network