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  • Inspector General Contacting Providers, Patients for Eylea Audit

    Ophthalmologists and their patients have begun receiving inquiries from the U.S. Department of Health and Human Services’ Office of Inspector General for an audit of Medicare Part B payments for Eylea injections, according to reports from Academy members.

    The Office of Inspector General is specifically looking into whether services were reasonable, necessary and met Medicare requirements. Its investigation is just one of several actions taken by HHS and other government agencies actions to reduce Medicare spending on Part B drugs like Eylea and Lucentis.

    In June 2019, the Centers for Medicare & Medicaid Services first announced an audit of Eylea and Lucentis intravitreal injections,  reviewing claims for other physician services billed on the same day as the injections, including evaluation and management (E/M), to determine whether they were reasonable, necessary and met requirements. The CMS investigation should conclude this year.

    In a separate move this summer, the U.S. Attorney’s Office in Boston filed a lawsuit against Eylea’s manufacturer, Regeneron Pharmaceuticals Inc., alleging it paid tens of millions of dollars in kickbacks for its macular degeneration drug Eylea using a foundation as a conduit to cover co-pays for Eylea.

    The goal was to promote Eylea over less-costly drugs to treat age-related macular degeneration, the suit says. The Medicare Part B program has spent nearly $11.5 billion on Eylea since 2013, according to the lawsuit.

    Academy members report that the Office of Inspector General has asked practice staff or patients to provide details on the clinical decision-making that led to using Eylea or Lucentis over less-costly alternatives like Avastin.

    Although the Academy is not offering legal advice or providing input on the Inspector General’s audit, members should be aware of their responses:

    Know your options if the Office of Inspector General contacts you for its investigation.

    • Your response is voluntary — you can choose whether or not to participate.
    • If you choose to participate:
      • A provider should participate in any conversations with the Inspector General, since the agency may ask about clinical decision-making.
      • You have the right to include legal counsel in any conversation with Inspector General, if you wish.
    • If the Inspector General contacts your patients, they may contact your practice to request medical record information about their treatment.

    The Academy supports your and your patients’ right to choose the most appropriate treatment. As Academy CEO David W. Parke II, MD, wrote in 2011 upon release of the landmark Comparison of AMD Treatments Trial results:

    “The choice of treatment plan [for AMD] should be made in concert by the treating ophthalmologist and the patient. The choice can be complex, involving issues of prior treatment, coincident systemic disease, cost, logistical factors and personal preference. Both drugs need to be available to patients to maximize choice, but the choice should be based on scientific evidence from carefully controlled trials such as CATT.”

    The Academy most recently updated its Preferred Practice Pattern® guideline on AMD in 2019.