CMS Interoperability Standards and Prior Authorization Comments

Thank You for the opportunity to provide comments on the proposed rule: Medicare and Medicaid Programs; Patient Protection and Affordable Care Act; Interoperability Standards and Prior Authorization for Drugs for Medicare Advantage Organizations, Medicaid Managed Care Plans, State Medicaid Agencies, Children’s Health Insurance Program (CHIP) Agencies and CHIP Managed Care Entities, and Issuers of Qualified Health Plans on the Federally-Facilitated Exchanges Proposed Rule 

As background, HealthHIV is a national nonprofit that advances effective HIV, viral hepatitis, sexually transmitted infection (STI), mpox and LGBTQ health care through education and training, technical assistance and capacity building, advocacy, communications and health services research and evaluation. HealthHIV supports health care organizations, providers, public programs and community partners working to maintain uninterrupted access to treatment, prevention and related care across chronic, infectious disease and public health needs.

Executive Summary: HealthHIV supports CMS making prior authorization more electronic, transparent and transferable across payers. That includes faster electronic processing, clearer denial reasons and better payer-to-payer exchange when someone changes coverage. But making prior authorization faster or more electronic does not mean prior authorization is appropriate for every drug. For HIV treatment, HIV prevention and other medications where delay can undermine treatment, prevention or continuity of care, the first question should be whether prior authorization should be used at all.

Extended Comments: HealthHIV recognizes that this rule is intended to make prior authorization work better: faster, more electronic, clearer and less opaque. That can reduce harm. But any prior authorization process that results in delay can still mean someone starts treatment late, receives a refill with too little cushion, has prevention or treatment postponed, or needs provider or navigator support to untangle payer rules. The same delay can affect people differently when they depend on uninterrupted medication to stay clinically stable or are managing several conditions and higher clinical risk at once. 

Older people with HIV are a strong example because they have lifelong HIV treatment needs and are often managing comorbidities, multiple prescribers, pharmacies, coverage rules and medications. For them, the problem is not only how prior authorization works. The problem may be that prior authorization is being used at all.

For this population, prior authorization delays and fragmented payer systems can create disproportionate access risks. Many are managing HIV alongside cardiovascular disease, diabetes, renal concerns, behavioral health needs, pain, frailty, cognitive changes or other age-related conditions. Their care often involves multiple specialists, pharmacies, medications and coverage touchpoints. When prior authorization information is not timely, electronic, standardized or visible across care teams, patients, providers and navigators are left to track approvals, denials, missing documentation, pharmacy and medical benefit distinctions and appeal pathways.

And the distinction between drugs covered under someone’s pharmacy benefit or medical benefit genuinely matters in this context because clinically necessary medications and related therapies may move through different benefit channels. That can create confusion about which standard applies, who receives the request, what documentation is needed and how quickly a decision must be made. CMS’ proposal to use National Council for Prescription Drug Programs (NCPDP) standards for pharmacy benefit drugs and Fast Healthcare Interoperability Resources (FHIR)-based Prior Authorization Application Programming Interfaces (APIs) for drugs covered under a medical benefit is an important step toward reducing avoidable delays.

CMS should also consider how these policies affect people with long-term, chronic and complex conditions who experience coverage transitions, including older adults with HIV. And while Medicare Part D has important protections for HIV treatment antiretrovirals, those protections do not solve every real-world access problem because people do not live inside one payer system forever. A person may move between Medicaid, Marketplace coverage, Medicare Advantage, Part D and Ryan White HIV/AIDS Program supports. Each program can have different rules, pharmacies, documentation needs and approval processes. Even when the medication is clinically the same, the access process may change. Prior authorization history, documentation and denial rationale should not disappear when a person changes plans or payer type.

HIV prevention medications, including HIV pre-exposure prophylaxis, or PrEP, can also involve different coverage pathways and access rules, which further reinforces the need for clear documentation, payer-to-payer exchange and continuity across coverage changes.

The access issue can (quickly) become a clinical issue. A lapse in therapy or delayed treatment can create avoidable risk for a person who has been clinically stable. With HIV antiretroviral therapy, sustained interruption can lead to viral rebound, immune decompensation or clinical progression, depending on the duration and individual clinical and social context. Similarly, interruptions in HIV PrEP can reduce protection and increase the risk (human toll and system cost) of HIV acquisition during periods of exposure. This underscores the importance of preventing avoidable gaps in medication access. When administrative barriers make obtaining medication too onerous, some patients may be pushed toward lost-to-care or out-of-care status despite efforts by the patient or care team to maintain adherence.

Denial reasons need to be clear enough to act on. The specific reason for a denial is not a procedural detail. It can determine whether a provider can correct documentation quickly, whether an appeal is viable, whether a patient is forced into fail-first or step therapy, or whether a care team must locate temporary bridge coverage, including Ryan White support, to prevent a treatment gap. CMS should finalize the requirement that impacted payers provide specific denial reasons to providers for drug prior authorization requests and should monitor whether those reasons are clear, structured and actionable.

The burden does not end with the initial prior authorization request or denial. For people with lifelong or highly complex conditions, and for those whose access is shaped by social determinants of health, what happens after a denial can shape the ongoing relationship among the patient, plan, pharmacy benefit manager, specialty pharmacy and provider.

As a person aging with HIV, I have experienced this dynamic firsthand, many times over. After challenging a prior authorization and quantity-limit decision, I still—had and have to—rely on the same payer, pharmacy benefit manager and specialty pharmacy structure for monthly medication access. That is the point. A contested prior authorization decision does not end when the appeal is resolved. The patient remains dependent on the same system for the next refill, the next shipment and the next coverage question. In plain terms, a prior authorization challenge or (worse) dispute can leave a long tail. The official decision may be done, but medication access, refill timing and trust in the system can still be affected.

This broader experience, echoed by many commenters, shows that prior authorization is not a single event. For many people with chronic, complex or time-sensitive medication needs, it means repeatedly navigating changing prior authorization and utilization management systems across a lifespan and healthspan.

Among people living and aging with HIV, those challenges can compound lifelong treatment needs, comorbidities, polypharmacy and coverage changes. Success should be measured by whether electronic prior authorization reduces real-world medication disruptions and gaps in access, rather than only by whether a transaction can be completed electronically.

These dynamics can strain trust in the systems people rely on for care, especially among people who have spent decades maintaining viral suppression while navigating changing plans, pharmacy rules, specialist care and other age-related health needs. When a patient has to challenge a prior authorization, appeal a denial or question a refill delay, they may be perceived as difficult or noncompliant, even when they are trying to maintain adherence and prevent a treatment gap. The burden can spill into relationships with pharmacies, plans and provider offices that must spend staff time resolving recurring administrative barriers.

Real-world implementation is the test of whether electronic prior authorization works. Implementation guidance and testing expectations need to reflect the real systems patients and providers use, including provider electronic health records, payer systems, specialty pharmacies, pharmacy benefit managers and pharmacy workflows. If the systems technically meet the rule but patients still face delayed medication access, vague denials or missing information, then the policy has not achieved its purpose.

Future oversight will need to examine whether electronic prior authorization reduces burden in practice for patients with complex medication regimens, including older people with HIV. Metrics can look beyond API use or prior authorization volume and help CMS understand whether electronic processes shorten time to therapy, reduce avoidable denials, improve appeal resolution and prevent gaps in access for people with chronic conditions.

In closing, HealthHIV urges CMS to:

• Finalize the proposed electronic prior authorization requirements for drugs, including pharmacy-benefit and medical-benefit pathways. 
• Finalize clear, structured and actionable denial-reason requirements for drug prior authorization requests. 
• Use Access APIs and payer-to-payer exchange to support continuity across transitions in coverage and care, including movement among Medicaid, Marketplace coverage, Medicare Advantage, Part D, Ryan White HIV/AIDS Program supports and other payer arrangements.
• Evaluate real-world burden, including time to therapy, avoidable denials, appeal resolution, refill disruption, provider and navigator workload and gaps in access. 
• Clarify a pathway for consumers enrolled through State-based Exchanges and State-based Exchanges on the Federal Platform to receive similar protections.

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