Authors: Julia Wermerskirchen, PharmD & Sydney (Sheffield) Murner, MS
The U.S. Centers for Medicare & Medicaid Services (CMS) has proposed the 2026 Interoperability Standards and Prior Authorization for Drugs rule (CMS-0062-P), a significant effort to modernize prior authorization (PA) and reduce administrative burden across the healthcare system. The rule would:
It primarily applies to Medicare Advantage, Medicaid managed care, Children’s Health Insurance Program (CHIP) managed care, and qualified health plans participating in federally facilitated exchanges, although its broader operational expectations may influence commercial market practices over time.
These reforms are intended to address longstanding concerns about PA-related delays, administrative complexity, and limited visibility into coverage decision-making. However, while CMS-0062-P may improve the speed, consistency, and transparency of the authorization process, its potential to meaningfully improve patient access, particularly for rare and specialty therapies, may be more limited.
CMS-0062-P addresses many of the administrative challenges that have long frustrated patients, providers, and manufacturers by enabling PA requests to move through the system more efficiently and transparently. However, the rule does not require plans to modify the coverage criteria, change evidentiary standards, or alter how therapies are evaluated during coverage decision-making. As a result, health plans would retain broad discretion over formulary design, utilization management requirements, and other policies that ultimately determine patient access.
This distinction is particularly important in rare and specialty disease, where PA often functions as more than an administrative checkpoint and instead serves as a tool for managing uncertainty related to clinical evidence, patient selection, anticipated treatment value, budget impact, and real-world implementation. While the rule may accelerate the exchange of information needed to support a coverage decision, it does not inherently increase payer confidence in the therapy itself. Consequently, access barriers rooted in uncertainty around clinical value, appropriate use, and long-term outcomes may persist even as authorization decisions are delivered more quickly.
In rare and specialty therapeutic areas, payer uncertainty is often multidimensional and extends beyond questions of clinical efficacy alone. This dynamic is particularly common among therapies that enter the market with small clinical trial populations, limited long-term follow-up, evolving treatment paradigms, or evidence packages that continue to mature after launch.
As a result, PA is often used to address three broad categories of uncertainty:
Considerations such as site-of-care requirements, provider qualifications, patient monitoring needs, adherence support programs, and care coordination requirements often shape payer confidence in a therapy's real-world implementation and can meaningfully influence coverage and utilization-management decisions.
For manufacturers, these dynamics reinforce an important distinction: improving the PA experience and improving access are not necessarily the same objective. While PA support programs, reimbursement support and administrative services remain important, sustainable access in rare and specialty disease is often tied to a manufacturer’s ability to address the clinical, economic, and operational questions shaping payer decision-making.
Manufacturers that proactively build payer confidence through evidence generation, patient identification strategies, and real-world insights may be better positioned to support broader and more durable access than those focused primarily on facilitating the authorization process itself.
Transparency is frequently positioned as a pathway to broader access, but increased visibility into PA practices may also produce unintended consequences. As CMS-0062-P expands reporting requirements, authorization practices will become increasingly visible to regulators, employers, and other stakeholders. In response, plans and pharmacy benefit managers (PBMs) may place greater emphasis on ensuring that coverage criteria are consistently applied, thoroughly documented, and supported by objective clinical evidence. This heightened scrutiny could reinforce efforts to standardize coverage pathways, tighten eligibility criteria, and strengthen documentation requirements rather than expand access.
Importantly, increased accountability does not necessarily translate into broader access. As plans and PBMs face greater pressure to support coverage decisions with consistent and well-documented evidence, more validation activities may occur upstream of the PA process itself. Greater emphasis may be placed on confirming patient eligibility, establishing clinical appropriateness, and ensuring documentation completeness before a PA request is submitted.
As a result, specialty pharmacies may become increasingly important partners in the access process by supporting patient validation, documentation quality, care coordination, and longitudinal visibility into treatment utilization and outcomes. In rare disease, these capabilities may further position specialty pharmacies as part of the broader access infrastructure supporting coverage decisions and payer risk management objectives.
As access controls become more structured and validation activities move upstream, manufacturers may need to rethink where and how they influence access. Rather than primarily focusing on navigating PA, manufacturers should focus on ensuring that payers have the information and operational confidence necessary to support coverage decisions before a PA request is submitted. They can do this by reducing:
Payers need confidence that therapies will be used in the right patients and produce meaningful clinical outcomes. Manufacturers can help reduce clinical uncertainty by:
Coverage decisions are increasingly influenced by questions surrounding value and affordability. Manufacturers can help address economic uncertainty by:
Even when clinical and economic value are established, operational challenges can create barriers to access. Manufacturers can decrease operational uncertainty by:
Ultimately, CMS may succeed in making PA faster, more transparent, and more consistent. However, access for rare and specialty therapies will continue to depend on payer confidence. As PA becomes increasingly standardized and measurable, manufacturers that focus on building payer confidence may be better positioned than those focused solely on reducing administrative friction. The future of access is not simply faster PA; it is greater confidence in the decisions being made.
If you would like to discuss strategies for strengthening payer confidence and supporting access for rare and specialty therapies, connect with our team to continue the conversation.