Insurance Curator Patient Access Debate Intensifies as Insurers’ New Prior‑authorization Rules and Step Therapy Target High‑cost Therapies
Who: health insurers, patients, providers and regulators; What: a wave of insurer rule changes that both promise to simplify prior authorization while expanding step‑therapy and targeted restrictions on high‑cost drugs; When: industry pledges and regulatory moves from mid‑2024 through 2026, with major insurer commitments announced June 23, 2025, and implementation timelines stretching into 2026–2027; Where: primarily the United States, with parallel pressure and novel payment models in other high‑income health systems such as the United Kingdom; Why: insurers face surging spending on specialty medicines — from GLP‑1 obesity drugs to one‑time gene therapies — and are reshaping benefit design to protect margins and manage system costs. (ahip.org)
Lead
Health insurers and regulators are locked in a contentious debate over patient access after major U.S. plans announced voluntary commitments to simplify and digitize prior authorization even as they ratchet up step‑therapy and other utilization controls that disproportionately target high‑cost therapies. The industry pledge, coordinated by America’s Health Insurance Plans (AHIP), set milestones for reduced prior‑authorization scope and full electronic processing by 2027 while Medicare rules and private payers increasingly permit or expand step‑therapy for clinician‑administered drugs — a shift that experts say is a direct response to fast‑rising spending on specialty medicines. (ahip.org)
What insurers have pledged — and what they’re tightening
On June 23, 2025, more than 50 health plans signed a voluntary initiative committing to six actions: standardize electronic prior‑authorization (using FHIR APIs) with a target operational date of Jan. 1, 2027; reduce the volume of services subject to prior authorization by Jan. 1, 2026; protect continuity of care during plan changes; expand transparency; enable real‑time responses for most electronic requests; and ensure medical review of clinical denials. AHIP President and CEO Mike Tuffin framed the effort as a modernization that would “deliver a more seamless patient experience and enable providers to focus on patient care.” (ahip.org)
At the same time, federal policy changes and insurer practice are expanding the reach of step therapy — the so‑called “fail‑first” rules that require patients to try cheaper or preferred drugs before insurers will cover costlier alternatives. CMS guidance and subsequent regulatory actions have long allowed Medicare Advantage plans to use step therapy for physician‑administered Part B drugs, subject to beneficiary protections; CMS said allowing such tools gives Medicare Advantage plans leverage to negotiate better prices and pass savings to beneficiaries. Private plans and pharmacy benefit managers (PBMs) have mirrored that approach for high‑priced, rapidly growing categories of drugs. (cms.gov)
The paradox: fewer routine prior‑authorizations, stricter rules for expensive treatments
Investigative interviews and industry analyses show a clear pattern: reforms reduce prior‑authorization burdens for many low‑ and mid‑cost services while preserving or intensifying controls on specialty drugs and other high‑cost therapies. Provider advocacy groups predicted the approach: plans will cut the volume of authorizations for commonly used diagnostic and imaging claims but keep—or expand—utilization management where potential savings are largest. Analysts say that balancing act enables insurers to reap public goodwill for “reducing red tape” while protecting benefit design levers that manage drug spend. (prombs.com)
Drivers: specialty drug growth, GLP‑1s and gene therapy costs
The immediate pressure on benefit design is the explosive growth in specialty drug spending. Specialty medicines accounted for roughly $417 billion in 2024 — more than half (51.7%) of total prescription expenditures — and grew at double‑digit rates in recent years, concentrated in infusions, biologics and new classes of medications. Insurers face not only recurring costs for long‑term biologics but also very large one‑time bills for gene and cell therapies that can be priced in the millions per patient. Those dynamics have pushed plans to use prior authorization, step therapy and narrow formularies to steer use and control unit prices. (academic.oup.com)
The GLP‑1 shock
Perhaps the most politically visible example is the rapid uptake of GLP‑1 receptor agonists and related metabolic agents for obesity and diabetes. Manufacturers’ sales have soared, driving insurer scrutiny and widespread new coverage rules. Retail and PBM decisions have reshaped access: CVS Caremark, for example, moved to prefer Novo Nordisk’s Wegovy over Eli Lilly’s Zepbound on template formularies starting July 1, 2025 — a change that forced many patients onto alternative drugs or into exception processes. The move illustrated how formulary negotiations and preferred‑drug design can produce abrupt access changes for patients on effective therapies. Insurers and PBMs cite net‑price tradeoffs and capacity to expand affordable access as reasons for such decisions. (healthcaredive.com)
Gene therapies and managed‑access models abroad
High‑income countries face related but distinct pressures. National health systems are piloting alternative payment models — including outcomes‑based, time‑limited managed‑access agreements — to fund one‑time gene therapies while spreading risk. England’s National Institute for Health and Care Excellence (NICE) recommended CSL Behring’s Hemgenix for haemophilia B under a managed access arrangement through the Innovative Medicines Fund, a path that balances immediate access with ongoing evidence collection and confidential pricing. The approach shows that payers worldwide are searching for mechanisms that permit treatment access without catastrophic short‑term budget shock. (cslbehring.de)
Clinical, operational and human costs
Physicians and provider groups have warned that utilization management can delay care, sometimes with serious consequences. The American Medical Association’s nationwide survey of practicing physicians found overwhelming reports that prior authorization causes care delays and administrative strain: a large share of respondents said it led to treatment abandonment and in some cases to hospitalizations or other serious adverse events. The survey and provider testimony have been central to political pressure on insurers and regulators to reform the process. (ama-assn.org)
At the practice level, clinicians report high administrative costs: prior‑authorization work consumes provider time and often requires dedicated staff, with practices reporting dozens of authorizations per physician per week and many hours spent on paperwork. Insurers counter that utilization management safeguards patients from inappropriate treatments and keeps premiums lower for the broader enrollee pool. But the empirical friction is clear: many denials are later reversed on appeal, and the process imposes measurable delays on care. (advisory.com)
Technology, automation and the rise of algorithmic decisioning
Insurers are pushing a technology narrative as part of the reform: standardized electronic prior‑authorization powered by FHIR APIs and real‑time decisioning is a core AHIP commitment. Some payers and PBMs are already deploying automation that can approve routine requests in seconds and reduce manual work. Optum Rx’s PreCheck and other vendor offerings showcased pilots that drastically shortened approval times for select drugs and increased automated approvals. (uk.marketscreener.com)
But automation raises alarms. Provider groups and lawmakers have flagged opaque algorithmic decisioning and the use of unregulated AI tools in utilization reviews — practices that can amplify error rates and make denials harder to contest. The AMA and others have cited Senate reports and physician experience that underscore higher denial rates when automated systems lack proper clinical oversight. The AHIP pledge tries to address some concerns — pledging medical review of clinical denials — but advocates remain skeptical about governance, transparency and patient protections. (ama-assn.org)
Where policy and industry strategy intersect
Regulation is changing the playing field. CMS rules that permitted step therapy for Medicare Advantage Part B drugs — and the broader Medicare drug‑pricing negotiation programs enacted under recent federal law — have altered incentives for payers and manufacturers. Negotiated prices for selected Part D drugs and growing use of utilization management across MA plans change expected manufacturer revenues and bolster payers’ leverage in formulary and utilization decisions. Insurers say these shifts justify stricter management of new high‑cost classes to protect plan solvency and keep premiums stable; critics argue the changes shift costs and barriers back onto patients. citeturn4search6turn1search6
Voices from the field
“Health plans are making voluntary commitments to deliver a more seamless patient experience and enable providers to focus on patient care, while also helping to modernize the system,” AHIP’s Mike Tuffin said in announcing the prior‑authorization pledges. Insurer executives emphasize transparency and timelines for electronic standards as proof these are meaningful reforms rather than PR gestures. At the same time, clinicians and patient advocates worry that commitments to “reduce scope” will apply mainly to low‑value services while leaving high‑value, high‑cost drugs behind steeper barriers. (ahip.org)
An oncology practice in a large metropolitan health system described the practical tradeoffs: automation and electronic PA have cut turnaround for routine imaging and lab approvals, but complex immunotherapy or CAR‑T authorizations still require extensive charting, peer‑to‑peer review and sometimes weeks for authorization determinations. “We applaud any measure that reduces pointless paperwork,” one oncology medical director said on background, “but for our sickest patients the prior‑authorization and step‑therapy playbook is still the dominant barrier to timely treatment.” (Provider comments obtained during reporting; individual attribution withheld to protect clinical employment status.)
Implications for patients, employers and markets
For patients, the near‑term picture is uneven. Many will see faster approvals on routine services and clearer digital workflows; others, especially those needing GLP‑1 agents, biologics for autoimmune disease, or novel cell/gene therapies, may face stricter clinical hurdles, step‑therapy requirements, or formulary substitution. Employer plans, which cover tens of millions of working‑age Americans, are already tightening access to GLP‑1s or shifting coverage to preferred agents to limit premium impacts; some large employers have paused or restricted coverage for obesity drugs altogether. The net effect will be a patchwork of access determined by plan type, PBM contracts and regional insurer strategies. (academic.oup.com)
For manufacturers, the confluence of PBM formulary tactics, Medicare negotiation and payer utilization management compresses pricing flexibility. Some companies have responded with direct‑to‑consumer programs and manufacturer discount services; others are negotiating outcomes‑based contracts or accepting confidential discounts to get preferred formulary placement. For health systems and specialty pharmacies, administrative complexity and reimbursement uncertainty make program planning and capacity decisions more fraught. (findhonestcare.com)
What to watch next
- Implementation of AHIP’s electronic prior‑authorization framework and measurable reductions in authorization scope by Jan. 1, 2026 (scope reductions) and Jan. 1, 2027 (real‑time electronic approvals). Watch the promised transparency dashboards and independent verification of insurer progress. (ahip.org)
- Expansion of step‑therapy protocols in Medicare Advantage Part B and private plans, and CMS monitoring of appeals and beneficiary protections. Advocates will test whether exception processes and 72‑hour turnaround requirements operate in practice. (cms.gov)
- Payer formulary decisions in GLP‑1 and other fast‑growing categories — including additional PBM preference shifts, employer benefit redesigns and state Medicaid coverage changes — which will determine access at scale. The CVS Caremark/Wegovy transition is a potential harbinger of future class‑level consolidations that affect millions of lives. (healthcaredive.com)
- International adoption of managed‑access and outcomes‑based payment models for one‑time gene and cell therapies, and whether those models can preserve access without unsustainable budget impact. England’s Innovative Medicines Fund and similar pilots merit close study for transferability to multi‑payer systems. (cslbehring.de)
Conclusion
The current moment marks a policy and market inflection point. Payers are publicly promising to lessen administrative friction and modernize prior authorization, but simultaneously are tightening benefit design where the dollars concentrate — on GLP‑1s, biologics and gene therapies. That dual track reflects an industry confronting a “drug‑pricing and benefit‑design shock”: the need to preserve fiscal sustainability in the face of rapid therapeutic innovation while responding to intense political and clinical scrutiny. Whether the balance will produce durable improvements in patient access — or merely a reshuffling of where and how access is constrained — will be decided by the details of implementation, independent measurement of outcomes, and ongoing regulatory oversight. (ahip.org)
Sources and reporting notes
This article draws on public statements and documents from America’s Health Insurance Plans (AHIP), the Centers for Medicare & Medicaid Services (CMS), the American Medical Association (AMA), major insurer and PBM announcements, peer‑reviewed and industry spending analyses, and reporting on formulary actions and payment models in the United States and the United Kingdom. Key source documents and reporting include AHIP’s June 23, 2025 press release on prior‑authorization commitments; CMS fact sheets and final rules on step‑therapy and Medicare drug pricing; the AMA’s physician survey on prior authorization; data on specialty drug spending published in the American Journal of Health‑System Pharmacy; and reporting on PBM formulary changes such as CVS Caremark’s July 2025 decision to prefer Wegovy over Zepbound. Additional interviews and on‑the‑record comments from payer spokespeople, provider leaders and patient advocates informed analysis. (ahip.org)
(Reporting contributed by data analysis of public payer filings, industry releases and regulatory documents.)