Comment on CMS-2026-1255-0001

The Denial Reason Requirement Must Distinguish Substantive from Procedural Denials: As currently proposed, the rule requires payers to provide "a specific reason" for drug PA denials. This is an important step forward, but the rule does not define what qualifies as a specific reason or require payers to distinguish between fundamentally different types of denials - the difference between a transparency requirement with teeth and one that legitimizes harmful payer behavior in more legible language. Denials fall into two distinct categories. Procedural denials are issued when a request fails administrative or formulary requirements; they reflect administrative criteria, not clinical judgment. Substantive denials are issued when a payer determines a drug is not medically necessary; a clinical judgment made without examining the patient and without accountability for the outcome. The proposed rule treats these identically. A payer satisfies the "specific reason" requirement by stating "step therapy requirements not met" -- telling a provider nothing about whether the patient's history was reviewed, prior treatment failures considered, or a medical necessity exception even exists. For individuals with serious mental illness, this distinction is not semantic; it is clinical. We urge CMS to amend the denial reason requirement to require: mandatory categorization of denials as procedural or substantive (defined in regulation); clinical basis disclosure for substantive denials; exception pathway disclosure for procedural denials, identifying the override process and timeframe; and a prohibition on characterizing medical necessity determinations as procedural denials. For antipsychotics specifically, step therapy denials are routinely issued as procedural matters when the payer has made a clinical determination that the prescribed medication is unnecessary. That determination is wrong, it is harmful, and the proposed rule does not yet require payers to make it visible. Existing Antipsychotic Protections Are Real but Critically Incomplete Antipsychotics are one of six protected drug classes under Medicare Part D, a protection we acknowledge. However, the existing framework contains significant structural gaps that leave large portions of this population exposed to harmful step therapy, gaps this proposed rule has the opportunity to close. Under Part D, plans must include all antipsychotics on formularies and may not apply step therapy to patients already established on therapy. This is meaningful, but it has critical limits. Gap 1: New patients on Part D are not protected. The policy permits step therapy for new starts - meaning a patient newly diagnosed with schizophrenia, or new to a plan, can face step therapy before accessing the medication their psychiatrist prescribed. Early treatment decisions in psychotic illness are among the most consequential - a failed medication trial can trigger relapse from which recovery is uncertain. This is not a technicality; it is a clinical vulnerability. Gap 2: Injectable antipsychotics under Part B are not protected at all. The protected class policy does not apply to Medicare Part B, which covers long-acting injectable (LAI) antipsychotics - critical for individuals who struggle with oral adherence. Medicare Advantage plans may apply step therapy to LAIs without Part D safeguards. For many individuals with severe psychotic illness, LAIs are not a preference. They are a clinical necessity. Gap 3: Existing protections are under active pressure. Cost-containment initiatives like the GUARD model risk eroding these protections. The protected class framework requires active defense and this rulemaking is an opportunity to strengthen it. Antipsychotic medications are not interchangeable, supported by decades of evidence, and we urge CMS to recognize: Psychiatric medication switches carry serious, sometimes irreversible risks. Each switch carries risk of relapse, hospitalization, and functional deterioration, including neurological changes that can make future treatment less effective. Forcing a patient off a stable regimen to satisfy a formulary preference is a clinical intervention made without physician judgment or accountability for the outcome. There is no "equivalent" antipsychotic. These medications differ substantially in mechanism of action, side effect profiles, delivery method, and individual response. What stabilizes one patient may destabilize another. Step therapy protocols that treat antipsychotics as interchangeable are not evidence-based; they are cost-driven, and the costs shifted onto patients are human ones. The consequences extend beyond the individual. Forced medication switches drive emergency visits, hospitalizations, criminal justice involvement, and family crisis - downstream costs that far exceed any short-term formulary savings. CMS has visibility into this data, and the pattern is consistent and clear.