ACR Meets CMS Medicare Part D and Medicare Advantage Rules

ATLANTA, GA – In comments submitted to the Centers for Medicare and Medicaid Services (CMS), the American College of Rheumatology (ACR) has expressed concern over a recent CMS policy allowing Medicare Advantage (MA) to use the treatment in stages for the B part drugs. In the comment letter, rheumatology officials urged the agency to put safeguards in place to protect beneficiaries from potential harm.

"While we appreciate the agency's efforts to make prescription drugs more affordable, we are seriously concerned about the decision to allow Medicare Advantage to put in place a staged therapy for the drugs in the party. B and cross-manage the use of drugs from parts B and D, "said Paula Marchetta, MD, MBA, president of the ACR. "We are starting the 2019 benefit year without any safeguards in place to protect beneficiaries from changes that could seriously jeopardize their access to needed medicines." At a minimum, CMS should immediately issue updated guidelines that will clarify patients' protections for the current year and the following years. "

Stage therapy, sometimes referred to as "failure first", is a use management technique used by most health insurers that requires patients to try the insurance company's preferred drugs before approving treatment. medication prescribed by the patient's doctor, even in the absence of evidence "the preferred insurer" will be effective. This practice often results in delays in patients' access to appropriate, evidence-based treatment, and undermines the clinical expertise and judgment of health care providers.

In its comments to the agency, the CAB urged CMS to put in place the following safeguards before continuing its phased therapy policy:

• Make it clear that the patient's care provider must determine if a patient "fails" a treatment. This
  decision should not be made by another entity such as an insurance company.
  • Provide exceptions to staged therapy if:
  • Treatment is contraindicated for the specific condition of the patient.
  • The claimant determines, on the basis of medical evidence, that the treatment will likely be
    ineffective, likely to cause a harmful reaction or to prevent the patient from
    perform daily activities or responsibilities and / or adhere to the treatment plan.
  • The provider believes that the new treatment will put the patient's life at risk or
    irreparably damage one's physical or sensory functions.
• Require that MA plan to disclose that Part B drugs may be subject to staged therapy in the
  annual change notice and proof of plan coverage documents.
• Set up a 365-day "follow-up" period for Part B treatments instead of the current 108 days.
  period used in Medicare Part D plans.
• Prevent projects from implementing phased therapy through a different utilization management
  process such as prior authorization.
• Increase monitoring of use by plans of use management practices and
  that all refusals include the clinical justification for the decision while specifying a
  beneficiary's right of appeal.

The ACR also commented on CMS's decision to make changes to the Part D program, namely the agency's new requirement that information on the price of drugs and alternatives Less expensive therapies should be included in the Explaining the Benefits of the Plan document. The ACR commended CMS for having put in place a ban on "restrictive covenants" preventing pharmacies from disclosing if the spot price of a drug is below price with insurance. He also urged the agency to consider defining common definitions for the terms used when negotiating the plan with the directors of pharmaceutical benefits.

"The CAB is committed to ensuring that rheumatologists and rheumatology professionals have the necessary resources to provide patients with appropriate, high quality care and that safe and effective treatments are available to all patients at the same cost. as low as possible, "concluded Dr. Marchetta. . "We are pleased to have the opportunity to respond to this rule proposal and look forward to serving as a resource to the agency in the pursuit of its work."

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About the American College of Rheumatology

The American College of Rheumatology (ACR) is the leading advocacy organization for rheumatologists in the country. She represents more than 7,700 rheumatologists and health professionals in the United States who are committed to improving the health care of Americans with rheumatism.

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