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.

Plastic Surgeons Advocate for Coverage of Congenital Anomalies
Plastic surgeons play an important role in treating congenital defects and other craniofacial anomalies. In fact, there was a 13% increase in reconstructive procedures to treat congenital deformities, according to the 2017 National Plastic Surgery Statistics. These numbers shot from 23,173 cases in 2016 to 24,428 cases in 2017.

However, too often prior authorization is denied for these essential services and care is delayed while other funding is secured for the patient’s treatment plan. Even when denials are reserved by private insurers, plastic surgeons and their staff waste countless hours in the back and forth with representatives from the plan who run them around in circles. The status quo is not in the patient’s best interest and adds significant administrative burdens on to plastic surgery practices, which is why the American Society of Plastic Surgeons (ASPS) is working at the federal level to strengthen coverage requirements.

ASPS began working with Sen. Tammy Baldwin (D-WI) in 2018 to introduce the Ensuring Lasting Smiles Act, which would require all group and individual health plans to cover medically necessary services as a result of congenital abnormalities. The bill stipulates that coverage must include services and procedures that functionally repair or restore any missing or abnormal body part that is medically necessary to achieve normal body functioning or appearance.

Sen. Baldwin was committed to introducing this legislation with a Republican original sponsor in order to strengthen the bill’s likelihood to advance under a Republican controlled Congress. In March and April, ASPS conducted in-person meetings with several Republican Senate offices to discuss the merits of the legislation, as well as help answer questions regarding the cost of this new mandate.

In May, ASPS took a grassroots approach and emailed our members in several states encouraging them to sign on to a petition letter to their respective Senators and Representatives encouraging them to sponsor the legislation. These states were selected based on the original target list from March, which included Republicans who are not staunchly opposed to the creation of healthcare mandates. The Society also joined a working group with the American Association of Oral and Maxillofacial Surgeons (AAOMS) and the National Foundation for Ectodermal Dysplasias (NFED) to coordinate advocacy efforts.

While the bill had not been formally introduced yet, ASPS members educated their members of Congress about this measure during the June ASPS Advocacy Summit in Washington, D.C. ASPS plastic surgeons met with 83 congressional offices, where they discussed this important measure and detailed the role plastic surgeons play in the care team. Arun Gosain, MD, President of the Plastic Surgery Foundation at the time, is particularly passionate about this issue and met with lead sponsor Sen. Baldwin, who is also Dr. Gosain’s senator, to thank her for her leadership on this initiative.

Following a letter from ASPS in March and a letter from five ASPS members in Iowa in August, Sen. Joni Ernst (R-IA) agreed to become the lead Republican sponsor of the Smiles Act. The bill was swiftly introduced in the Senate, followed by introduction in the House by Reps. Reps. Collin Peterson (D-MN), David Young (R-IA), Kevin Yoder (R-KS), James McGovern (D-MA), and John Faso (R-NY). Advocacy Summit attendees had discussed this issue in length when they met with Rep. Yoder in June at the Advocacy Summit. The Society is extremely honored to have the support of these members of Congress on such an important initiative.

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Derm Surgeons Show Value
ASDSA’s Value Analysis Task Force created an infographic aimed at insurers, encouraging dermatologic surgeons remain in-network for effective melanoma diagnosis and treatment. Using verifiable data, this communication tool illustrates that ASDS members provide quality cost-effective care when compared to melanoma treatments performed in an in-patient setting.

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AGA advocates on Capitol Hill for GI Issues
Advocates from the American Gastroenterological Association (AGA) were on Capitol Hill recently advocating for passage of the Removing Barriers to Colorectal Cancer Screening Act, Restoring the Patient’s Voice Act and a $2 billion increase in NIH funding.

Advocates met with House and Senate offices to push for passage of the Removing Barriers to Colorectal Cancer Screening Act, legislation that waives the coinsurance for screening colonoscopies that become therapeutic and has broad, bipartisan and bicameral support. They made the argument that paying for prevention services saves the government money in the long term by preventing treatment costs on cancer treatment.

H.R. 2077, the Restoring Patient’s Voice Act, addresses step therapy protocols that threaten the physician-patient relationship and delay timely treatment to care. Support for the legislation is growing and our advocates were able to relay experiences they have encountered with their patients’ care being delayed and also the administrative burden this policy places on practices.

Katherine Clark, D-MA, a member of the House Labor-HHS Appropriations Subcommittee, met with our advocates and let them know that the House-Senate conferees agreed to the $2 billion increase in NIH in the final bill. Rep. Clark is a strong supporter of NIH and called it the “pillar of our economy.” AGA members successfully encouraged legislators to support the final Labor-HHS package that includes this additional $2 billion increase, which amounts to an overall 5.5 percent increase.

AGA appreciates all those advocates who took time out of their busy schedules to advocate on behalf of their colleagues and patients. We also appreciate those who took time to participate in Virtual Advocacy Day. Remember, if Gastroenterologists don’t advocate for GI, no one will.

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Alliance Member Testifies at MIPS MACRA Hearing
Parag D. Parekh, MD, MPA of the American Society of Cataract & Refractive Surgery (ASCRS), an Alliance Member, testified this summer at the US House Energy and Commerce Health Subcommittee Hearing; “MACRA and MIPS: An Update on the Merit-based Incentive Payment System.” In his testimony, Dr. Parekh detailed the need to maintain a fee-for-service option and the importance of the MIPS program. In addition, he thanked Congress for the MACRA technical corrections that provided additional time to develop and refine cost measures, and shared Alliance member societies’ efforts to develop quality measures, and its opposition to MedPAC’s recommendation to eliminate MIPS. You can watch the entire hearing here.

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ASE Provides Access to Patients in Need
On October 20th the ASE Foundation partnered with the WVU Heart & Vascular Institute to hold its first domestic outreach event since 2014 and the impact was profound. During the span of just 7.5 hours across 4 sites in the Morgantown, West Virginia area, 375 patients were provided a free cardiovascular screening which included vitals, EKG, and point-of-care echocardiograms. The results of the diagnostic tests were provided instantaneously to the patients. All patients who presented with advanced disease that required prompt medical attention (29 in total) were provided a full echocardiogram exam and follow-up care was scheduled as needed. Over 140 dedicated volunteers comprised of physicians, sonographers, nurse practitioners, fellows, residents, and other non-medical staff donated their time and expertise to make this event possible.

This event was supported by the ASE Foundation, its donors, and by a grant from the Edwards Lifesciences Foundation’s Every Heartbeat Matters program. Ultrasound equipment, technical, and additional support was provided by AliveCor, Butterfly Network, Cloud DX®, Hitachi Healthcare Americas and Hitachi Healthcare Americas Informatics Division, Kencor, and Phosphorous Inc. Team leaders were Dr. Partho Sengupta from WVU Heart & Vascular Institute and Dr. Sanjeev Bhavnani from Scripps Clinic. Read more about the project online at ASEFoundation.org

The ASE Foundation also recently participated in “Project Chagas” in Mexico. Held in the city of Mérida, Yucatán in August, the event focused on pre-identified patients diagnosed with Chagas disease. The goal was to investigate the prevalence of Chagas cardiomyopathy, and to detect those individuals previously undiagnosed and connect them with local cardiologists that would provide proper cardiac care within the regional public system.

Chagas disease is caused by a parasite that is transmitted through a bug. Over the last 10 years, the Mexican Government implemented significant initiatives to extinguish the bug and developed campaigns to detect the blood infection of this disease that is mostly prevalent in rural areas. This situation created a unique opportunity for the ASE Foundation and its partners to build on the previous government initiatives and screen for Chagas heart disease, which occurs in roughly 30% of those infected.

In addition to the ASE Foundation, partners for this event included General Hospital Agustin O'Horan in Mérida, Philips Mexico Commercial S.A. de C.V., Yucatán Health Services, the Mexican National Center for the Prevention and Control of Diseases (CENAPRECE), and the Mexican National Association of Cardiology (ANCAM). All collaborating organizations had representatives on-site, working side-by-side for three days. Team leaders were Dr. Federico Asch from Washington Hospital Center, Dr. Pedro Gutiérrez-Fajardo from Hospitales Mac Bernardette, and Dra. Hilda Peralta from General Hospital Agustin O'Horan. Read more about the project online at ASEFoundation.org/Mexico-2018. You can learn more about imaging patients with Chagas disease in this ASE Guideline (also available in Spanish and Chinese).

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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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