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Specialty Docs Mobilize On Prior Authorization And Step Therapy
It is a central mission of the Alliance of Specialty Medicine to address barriers to specialty care. Two such barriers are prior authorization and step therapy.

Medicare Advantage (MA) and Part D plans employ utilization management practices with the main purpose of controlling costs rather than improving patient outcomes. Specialty physicians and patients often experience burdensome challenges and lengthy delays as a result of prior authorization and step therapy requirements when ordering diagnostic, medical, and surgical services, and when prescribing necessary medications. The lack of industry-wide standards for the use of electronic prior authorization further complicates this process.

The Medicare program requires MA plans to provide coverage equivalent to traditional fee-for-service (FFS) in Medicare Part A and Part B. Furthermore, the Centers for Medicare & Medicaid Services (CMS) instructions to plans preclude them from using prior authorization and other utilization control tools in a manner that imposes inappropriate barriers to access. Despite these requirements, MA plans are overusing and misusing these practices because CMS has not provided adequate guidance on what constitutes appropriate prior authorization, nor does the agency in its oversight role collect adequate data to assess the utility of these programs and their impact on patient access to care. Recognizing the problems with prior authorization in the MA program, Reps. Phil Roe, MD, (R-Tenn.) and Ami Bera, MD, (D-Calif.), spearheaded a letter signed by 103 bipartisan members of the House of Representatives urging CMS to improve how prior authorization works under MA.

In step therapy, insurers require patients, sometimes even those stable on a certain medication, to try and fail medications before agreeing to cover the initial therapy prescribed by the health care provider. This practice jeopardizes the health of patients and the physician-patient relationship. A 2018 article in the Food and Drug Law Journal discusses that such policy has been shown not to save money in the long run due to patient complications. Appealing step therapy protocols can be very timely and burdensome for physicians and patients and can take months to resolve — all while the disease is progressing.

Prior authorization and step therapy create burdens on clinicians and limit patients' ability to access the care and medications recommended by their physicians. These burdens are compounded by the use of multiple different prior authorization request forms used by plans across both programs, as well as by many plans’ failure to operate prior authorization processes using electronic transactions.

In 2017, the Alliance conducted a survey of its members, finding:
  • 95% of specialists report that this increased administrative burden has influenced their ability to practice medicine. One specialist noted: “Never have I spent more time on administrative issues that do nothing but delay appropriate diagnostic and therapeutic intervention.”
  • More than 80% of specialists have experienced an occasion during which a stable patient was asked to switch from his or her medication by the insurer even though there was no medical reason to do so.
  • Nearly 90% of specialists have delayed or avoided prescribing a treatment due to the prior authorization process associated with it.
The Alliance supported several bills in the 115th Congress which address the problems with prior authorization and step therapy. Two of them focused on improving the prior authorization process: the “Standardizing Electronic Prior Authorization for Safe Prescribing Act” (H.R. 4841) and the “Electronic Prior Authorization in Medicare Part D Act” (S. 2908). These two bills were included in the large package of measures Congress passed and the President signed into law to combat the opioids crisis. Another bill, the “Restoring the Patient’s Voice Act” (H.R. 2077), would provide for a faster and more transparent appeals process when a patient must meet step therapy requirements. This legislation would require employer-sponsored health plans to establish a clear and convenient process for physicians to appeal a step therapy protocol for their patients, grant patient exceptions to step therapy under critical circumstances, and expedite care by requiring a timely decision for appeals. The Alliance looks forward to further consideration of this bill in the next Congress.

On the regulatory side, the Alliance was troubled to hear of CMS’ recent decision to allow Medicare Advantage plans to institute step therapy for Part B drugs starting in 2019. The Administration proposed this significant change via a memo that has no formal commenting opportunity and leaves many implementation questions unanswered, including questions about how patient access will be protected. The Alliance wrote to CMS Administrator Seema Verma, expressing its opposition to this policy change because of its lack of protections for vulnerable patients who need access to Part B medications.

Alliance Advocacy Fly In. July 16-17, 2019. Liason Hotel, Washington, DC.

NOTE: Participation in Alliance events is by invitation-only, with some exceptions. To learn more about how you or your organization can participate, please contact your organization's staff liaison to the Alliance or email us at info@specialtydocs.org.


"Medicare Advisors Seek Solutions for Senior Opioid Misuse". Bloomberg BNA. -October 3, 2018.

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Join the most powerful group of specialty physicians!
Joining forces with specialty doctors from across the country helps amplify the concerns specialty doctors share. By working together, specialty medical organizations can work more effectively to influence health care policy and ensure our primary goal: to continue to provide our patients the optimal care they need. As a part of the non-partisan umbrella organization representing all of specialty medicine, your organization will:

  • Promote specialty specific issues as part of a larger coalition, increasing visibility and understanding of issues.
  • Help increase exposure for specialty medical care.
  • Gain access to insider information, background materials and research on health policy initiatives and the political landscape.
  • Receive expert analysis on proposed legislation.
  • Caucus with other specialty organizations at the AMA House of Delegates and other forums to promote key issues that are important to specialty physicians.
  • Coordinate physician and patient grassroots efforts through a large and robust network.
  • Participate in future Alliance Fly-In events in Washington, D.C. Past events have included Capitol Hill visits and presentations by health policy experts.
For information on joining the Alliance of Specialty Medicine, visit our website at www.specialtydocs.org or contact Vicki Hart at vhart@hhs.com

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