In April, the Centers for Medicare and Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC) issued a proposed rule that would, for the first time, require all federal healthcare programs — including Medicare Advantage plans, Medicaid and Children’s Health Insurance Program (CHIP) plans, and plans sold on the Affordable Care Act (ACA) marketplace exchanges — to adopt electronic prior authorization (ePA) standards for drugs that are already subject to prior authorization. To be clear, the proposed rule would not expand the use of prior authorization; rather, it would establish electronic processes for submitting and processing prior authorization requests. The proposed rule would also require plans to respond to prior authorization requests in a shorter time period, to be more transparent, and to provide a specific reason for a denial of a prior authorization request.
In response to the proposed rule, the Advocacy Council submitted comments supporting the adoption of electronic standards for processing prior authorization requests for drugs. However, the Advocacy Council also urged the agencies to strengthen prior authorization oversight by CMS.
ePA
The key provision of the proposed rule was the inclusion of drugs in ePA requirements across the aforementioned payers. The goal, as expressed by CMS and ONC, is to reduce the administrative burden placed on practitioners by creating a universal, expedited prior authorization process. The Advocacy Council expressed support for the inclusion of drugs in the ePA process, noting the considerable reduction in administrative paperwork time by embedding the process into already existing electronic health record standards, such as NCPDP SCRIPT.
Shorter timeframe
The proposed rule would also reduce the decision time frame of prior authorization requests for qualified health plan (QHP) issuers on the Federally Facilitated Exchanges (FFEs) to be in line with existing Part D time frames. Specifically, the agencies proposed requiring a 72-hour response time for standard prior authorization requests, and a 24-hour response time for an expedited request. In its comments, the Advocacy Council requested that the standard prior authorization response time be shortened to 42 hours for standard requests and 24 hours for expedited requests to prevent disruptions in patient care, which is especially critical for patients with allergies and asthma.
Transparency
CMS and ONC also propose to require that those payers provide a reason for a prior authorization denial. The agencies noted that the goal is to allow practitioners to correct the prior authorization requests without having to second-guess the reasoning or submit multiple requests. The Advocacy Council believes that providing a specific reason for a denial will reduce the time spent trying to translate the reason for the denial and ultimately ensure that a patient receives the appropriate treatment they need. However, the Advocacy Council urged the agencies to further improve the prior authorization process for practitioners and create additional appropriate oversight. Specifically, we requested that:
- CMS and ONC explain to plans that simply stating a drug is not “medically necessary” does not satisfy the requirement to provide a specific reason for a prior authorization denial.
- Plans must utilize physicians with relevant specialty experience in the review of prior authorization requests.
- CMS and ONC establish and administer a public reporting mechanism through which patients and practitioners can report noncompliance with prior authorization requirements.
Taken together, we believe these recommendations would improve the prior authorization requirements for practitioners and patients alike.
Step therapy
The proposed rule also requested feedback from practitioners on how the use of existing technology could be used to improve step therapy requirements. The Advocacy Council first urged that step therapy not be used for physician administered drugs, which could hinder the access to timely care for patients who are often receiving treatment for serious and life-threatening health conditions. When step therapy requirements apply, technologies such as a Payer-to-Payer API could facilitate the exchange of information on medications that a patient has previously tried and failed when transitioning between payers. This would help ensure continuity of care and avoid requiring patients to repeat therapies that have already proven ineffective.
The final rule has NOT yet been published. The Advocacy Council will continue to monitor for the release of this final rule. In the meantime, we hope that CMS and ONC will take our recommendations into consideration.
The Advocacy Council – ADVOCATING FOR ALLERGISTS AND THEIR PATIENTS.



