The Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC) published a proposed rule on April 14, 2026, titled “Interoperability Standards and Prior Authorization for Drugs” (CMS-0062-P) in the Federal Register (hereafter, the “Proposed Rule”). Among other things, the Proposed Rule would, for the first time, extend electronic prior authorization requirements to prescription drugs. CMS is accepting public comments through June 15, 2026. Public comments on a proposed rulemaking are not merely an opportunity to oppose a rule; they are also a critical avenue for shaping the contours of how the Proposed Rule will operate in practice.
The Proposed Rule introduces significant changes to electronic prior authorization for prescription drugs, with meaningful implications for physicians and other healthcare providers and a key opportunity to provide input before it is finalized.
What the Proposed Rule Would Do
In 2024, CMS finalized a rule requiring insurance companies to use modern electronic systems for prior authorization of medical services like surgeries, imaging, and procedures, but that rule excluded prescription drugs. The new Proposed Rule fills that gap. It would require a wide range of insurance plans, including Medicare Advantage plans, Medicaid and Children’s Health Insurance Program (CHIP) plans, plans sold on the Affordable Care Act (ACA) marketplace exchanges, and, for the first time, small business marketplace plans, to adopt electronic systems for processing prior authorization requests for drugs.
In practical terms, for medications requiring insurance approval, both the requests and the insurer’s decisions would be handled through secure, standardized digital channels rather than through phone calls, fax machines, or web portals. The goal is to make the process faster, more transparent, and less burdensome for everyone involved.
The Proposed Rule includes several other proposed changes:
- Insurance companies would be required to make it easier for physicians to look up, in real time, whether a drug is covered, what the patient’s out-of-pocket cost would be, and whether prior authorization is required, before the prescription is even written.
- Insurance companies would have to publicly report data on how they handle prior authorization for drugs, including how many requests they approve and deny, creating a new layer of accountability.
- CMS is proposing to update the technology standards used across the entire healthcare system for prior authorization transactions, replacing older formats with a modern standard called Fast Healthcare Interoperability Resources (FHIR) that is designed to allow different computer systems to communicate with each other seamlessly.
Most of the proposed requirements would take effect on October 1, 2027.
Notably, CMS is also using the Proposed Rule to request the public’s input on five additional topics it may address in the future: (i) electronic notifications when patients move between care settings; (ii) cybersecurity protections for healthcare data; (iii) oversight of insurance company technology systems; (iv) “step therapy” requirements; and (v) prior authorization burdens for lab tests and medical equipment.
Why the Proposed Rule Matters
Prior authorization for prescription drugs is one of the most significant sources of administrative burdens in healthcare, and the burden is particularly acute for specialists who prescribe high-cost specialty drugs, biologics, and other therapies that are commonly subject to prior authorization under both medical and pharmacy benefits.
The Proposed Rule represents a meaningful opportunity to standardize and automate a process that has historically relied on manual, phone- and fax-based workflows. If implemented effectively, the Proposed Rule’s requirements could reduce the time physicians and their staff spend navigating prior authorization, increase transparency around payor coverage requirements and formulary information, and shorten the timeframes within which payors must render prior authorization decisions. While these are laudable objectives, several aspects of the Proposed Rule present challenges, such as:
- The October 2027 deadline for insurance companies to comply is tight, and the benefits to physicians will only materialize if the electronic health record (EHR) software they use is also updated to work with the new systems.
- The Proposed Rule creates two different technical pathways depending on whether a drug is covered under a patient’s medical insurance or their pharmacy benefit, and the same drug can fall into either category depending on the insurance company, which could create confusion.
- The Proposed Rule only applies to government-regulated insurance programs like Medicare Advantage, Medicaid, and ACA marketplace plans. It does not cover employer-sponsored private insurance, which is how the majority of working Americans under age 65 obtain their coverage, so a large share of patients would not benefit from these changes.
Who Should Consider Submitting a Comment
The federal government is required to consider every substantive comment it receives before finalizing the Proposed Rule.CMS has indicated that it is seeking input from a broad range of healthcare stakeholders. The following types of providers and organizations are particularly well-positioned to submit comments:
- Physician specialty societies and medical associations, including those representing oncology, rheumatology, neurology, psychiatry, cardiology, endocrinology, and other specialties whose members prescribe drugs that are frequently subject to prior authorization
- Primary care physician organizations whose members prescribe across all payor types covered by the rule and bear high aggregate prior authorization volume
- Large physician group practices and independent practice associations that will be directly affected by changes to electronic prior authorization workflows
- Hospital systems and academic medical centers that operate outpatient infusion centers or administer drugs under a medical benefit
- Pharmacies and pharmacy organizations
Submitting a thoughtful public comment ensures that CMS will consider the patient-care concerns and operational realities of the affected providers.
How Frier Levitt Can Help
While anyone can submit a public comment at regulations.gov or by mail, the comments likely to carry the most weight with federal regulators are those that go beyond general opinions and engage directly with the specific language of the Proposed Rule. Frier Levitt’s Advocacy & Government Affairs practice group regularly helps physicians and physician organizations navigate this process, and can assist by: (i) identifying the specific provisions that matter most to your practice, your specialty, or your membership; and (ii) drafting a polished, persuasive comment letter on your behalf that speaks directly to CMS’s questions, cites the relevant regulatory provisions, and includes the kind of supporting evidence and legal reasoning that regulators take seriously.
If your organization has already begun drafting a comment internally, Frier Levitt can review, strengthen, and refine it before submission. We can also help coordinate with other physician groups or allied organizations so that your comment is part of a broader coalition, which may carry more influence in the rulemaking process.
Given the June 15, 2026 comment deadline, we encourage interested providers and organizations to begin the comment development process promptly. For more information, contact Frier Levitt to speak with an attorney.
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