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The burden of proof


Dirk Elston

In Practice

Dr. Elston, who serves as director of the Ackerman Academy of Dermatopathology in New York, has served on the AMA-CPT Advisory Committee.

By Victoria Houghton, assistant managing editor, January 1, 2018

Dermatology World: When it comes to managing coverage denials and/or prior-authorization requests, what value does evidence-based research offer?

Dr. Elston: The cost of medications continues to increase and physicians have to dedicate an ever-increasing portion of their time to prior authorizations. Fortunately, the Academy has created a valuable array of tools to help the practicing physician, including letters of medical necessity that cite relevant literature and make it easier to appeal coverage decisions. Even with these tools available, many unique situations require direct use of the literature to support an appeal and an understanding of how to use scientific data as a patient advocate will increase your chances of success. The dermatologic literature serves to advance our understanding of skin disease, allowing us to improve our approach to treatment and obtain better patient outcomes. It also creates an archive of vetted science that can be used to educate other important audiences, including patients, policymakers, and payers.

Dermatology World: When using evidence-based medicine to appeal a coverage decision, what do physicians first need to know?

Dr. Elston: It is important to understand who makes key decisions. While some insurance companies still sell health insurance, many have shifted to acting as benefits administrators for self-insured employers. For broad coverage policy issues, there may be greater value in having your state society work directly with policymakers at the employer. They are interested in maintaining employee satisfaction and minimizing lost man hours.

Dermatology World: How should physicians approach these key policymakers when managing the prior-authorization process?

Dr. Elston: Whether you are talking with a payer or purchaser, act professionally. They too are professionals who care about their work. Treat them with respect and you can build a positive relationship. You can serve as an important scientific resource for them and can have a positive influence on policy.

Dermatology World: When appealing a coverage decision, what do physicians need to know about the people they are working with?

Dr. Elston: It’s important to understand who you are communicating with, their role, and their scope of authority. The first appeal letter is often read by clerical staff or a nurse whose job it is to determine that correct procedure was followed and that the decision was in accordance with the local coverage determination (LCD) policy. Only a discussion with a medical director can result in a change of policy, and only in truly exceptional circumstances would it be appropriate to file a grievance with insurance regulators.

Dermatology World: Before identifying and providing evidence-based research to appeal a coverage decision, what should physicians do first?

Dr. Elston: It’s important to understand the differences between contractual exclusions and medical necessity decisions. The policies are usually posted online and the denial should note if it is a contractual exclusion. Establish whether the medication or service being requested is a contractual exclusion in the patient’s policy. If so, it will not be covered regardless of the body of evidence supporting its use. Those are not worth pursuing. Choose your battles wisely, and remember that credibility is your greatest asset.

Dermatology World: If the coverage decision appears to be based off of medical necessity and the physician appeals that decision, what are some best practices for providing evidence-based research?

Dr. Elston: Cite all published studies, including those with mixed results. This is important to establish your credibility and is an honest reflection of the state of science. Case reports carry less weight, but can be useful to establish proof of concept or add to an existing body of evidence.

Dermatology World: When it comes to appealing a coverage decision, what are the different levels of evidence?

Dr. Elston: Here are the different levels of evidence:

  • Level IA evidence includes evidence from meta-analysis of randomized controlled trials.
  • Level IB evidence includes evidence from at least one randomized controlled trial.
  • Level IIA evidence includes evidence from at least one controlled study without randomization.
  • Level IIB evidence includes evidence from at least one other type of experimental study.
  • Level III evidence includes evidence from nonexperimental descriptive studies, such as comparative studies, correlation studies, and case-control studies.
  • Level IV evidence includes evidence from expert committee reports or opinions or clinical experience of respected authorities, or both.
  • Level IV evidence can still carry weight if accomplished through an established methodology and vetted by a national society.

Also, don’t underestimate the value of textbooks. Textbook discussions of a treatment can establish that it has become accepted medical practice. If multiple texts describe use of the treatment, there is solid evidence that it has become mainstream.

Dermatology World: Beyond the individual appeals, what can physicians do on a broader scale to educate policymakers about the evidence-based care they provide?

Dr. Elston: All dermatologists should participate as active members of their local and state societies as well as the AAD and AMA. They are our collective voice in policy decisions. All politics are local, but precedents regarding treatment coverage are often adopted nationally — we share a stake in the outcome of every coverage decision. Your state society carrier advisory committee representative works with Medicare and other payers to provide expert review of cases and clarify policy. A coordinated approach by designated representatives who have established relationships with each company can be of tremendous value. As a specialty, we have demonstrated our commitment to improving patient care and value through evidence-based guidelines and appropriate use criteria and have established credibility with payers and policymakers. We are fortunate to have very talented individuals working on behalf of our patients — remember to thank them the next time you see them. 

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