• Prior Authorization and Step Therapy (Position Paper)

    A physician's attestation of a clinical diagnosis or order should be sufficient documentation of medical necessity for clinical services, medications, and/or durable medical equipment (DME). In rare circumstances when prior authorization (PA) or step therapy is clinically relevant, the American Academy of Family Physicians (AAFP) believes these processes should be evidence-based, transparent, and efficient to ensure timely access and ideal patient outcomes. Additionally, family physicians that contract with health plans to participate in a financial risk-sharing agreement or those with historically high approval rates should be exempt from PAs.

    PA and step therapy protocols can create significant barriers for family physicians to deliver timely, evidence-based patient care by delaying the start or continuation of necessary treatment. These delays lower adherence to recommended treatments, which can lead to adverse health consequences for patients.1

    PA is the process by which physicians must obtain advance approval for a device, supply, or medication from the patient’s insurance plan to ensure coverage for the recommended service.2 The time-consuming manual processes used in PA burden family physicians and their practice staff, divert valuable resources away from direct patient care, and lead to adverse health outcomes for patients.1 The AAFP believes the growing number of PAs should be scrutinized for appropriateness and impact on patient care by an independent body—not left to those who stand to gain financially by denying or delaying appropriate care. PAs that remain should be standardized, including reliance on evidence-based criteria, and converted universally to more efficient electronic processes throughout the industry to promote conformity, improve timeliness, and reduce administrative burdens on practices and patients.

    Step therapy is a specific type of PA requiring patients to try one or more insurer-preferred medications or treatments prior to implementing a physician recommendation.3 This tool, primarily designed to contain the cost of prescription drugs, is used for many conditions such as cancer, arthritis, diabetes, skin conditions, heart disease, mental illness, and more. The AAFP believes step therapy protocols delay access to treatments and hinder adherence while risking severe side effects and disease progression for patients. Therefore, the AAFP maintains step therapy should not be mandatory for patients already on a course of treatment. Ongoing care should continue while PA approvals or step therapy overrides are obtained. Patients should not be required to repeat or retry step therapy protocols conducted under previous benefit plans. 

    The AAFP joins the AMA and other medical organizations in supporting policies that reduce the negative impact of PA and step therapy on patients, physicians, and the health care system.4 Clinical criteria used for coverage decisions should be publicly available, transparent, and allow for flexibility to accommodate patients’ unique clinical situations. Decisions in response to PA and step therapy requests, exceptions, and appeals must be made in a timely manner. All denials should include the clinical rationale for the adverse determination and allow physicians to provide supporting documentation when needed.

    References

    1. American Medical Association (AMA). 2022 AMA prior authorization (PA) physician survey. Accessed March 17, 2023. www.ama-assn.org/system/files/prior-authorization-survey.pdf
    2. AMA. Prior authorization practice resources. Accessed March 17, 2023. www.ama-assn.org/practice-management/sustainability/prior-authorization-practice-resources
    3. Centers for Medicare & Medicaid Services (CMS). Medicare Advantage prior authorization and step therapy for Part B drugs. Accessed March 17, 2023. www.cms.gov/newsroom/fact-sheets/medicare-advantage-prior-authorization-and-step-therapy-part-b-drugs
    4. AMA. Prior authorization and utilization management reform principles. Accessed March 17, 2023. www.ama-assn.org/system/files/principles-with-signatory-page-for-slsc.pdf

    (2017 COD) (October 2023 COD)

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