Healio Special Report: Health Care and Politics

Healio Special Report: Health Care and Politics

April 09, 2019
3 min read
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ACR urges CMS to immediately implement Medicare Part B step therapy safeguards

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The American College of Rheumatology, along with 25 patient and provider organizations, has issued a letter calling on CMS to immediately issue safeguards mitigating the agency’s recent proposal to allow Medicare Advantage plans to use step therapy for Part B drugs.

The safeguards, which were included in a 2018 Medicare Part D and Medicare Advantage proposed rule, are not scheduled to take effect until 2020. However, according to the ACR, this leaves a nearly year-long gap in which patients could experience delays and denials in care related to step therapy restrictions.

“The proposed guardrails would not go into effect until 2020, leaving vulnerable patients unprotected from harmful step therapy practices. For patients with severe or complex diseases, this can result in irreversible damage, disability and even death,” the groups wrote in a letter to CMS Administrator Seema Verma. “We urge CMS to immediately publish guidance to plans that lays out, at a minimum, the patient safeguards proposed in the ‘Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out-of-Pocket Expenses’ proposed rule so that beneficiaries have some protections in 2019.”

Department of Health & Human Services 
The ACR, along with 25 patient and provider organizations, has issued a letter calling on CMS to immediately issue safeguards mitigating the agency’s recent proposal to allow Medicare Advantage plans to use step therapy for Part B drugs.
Source: HHS

In August, CMS issued a memo to Medicare Advantage plans that rescinded a Health Plan Management System memo from Sept. 17, 2012, titled “Prohibition on Imposing Mandatory Step Therapy for Access to Part B Drugs and Services,” and issued new guidance that will allow Medicare Advantage plans to use step therapy for Part B drugs starting this year. The new policy officially went into effect on Jan. 1.

According to the letter, the new guidance acknowledges step therapy as a utilization management tool that will “help achieve the goal of lower drug prices while maintaining access to covered services and drugs for beneficiaries.”

According to an ACR statement, step therapy “undermines the clinical judgement of physicians and often leads to delays in patient care. Step therapy can also disrupt continuity of care by requiring patients to halt an effective therapy due to formulary or protocol changes to their plan.”

“While common practice among commercial insurers, Medicare Advantage plans had been barred from using step therapy until the Administration issued a memo last year giving plans the option to do so at the start of 2019,” the ACR added in its statement.

In addition to calling for the immediate implementation of CMS’ proposed safeguards, the ACR is also urging the agency to clarify certain patient protections.

“Although we are pleased to see these safeguards, such as step therapy requirements only applying to new starts of medication, the safeguards do not go far enough to protect patients,” ACR stated in the letter.

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The ACR is urging CMS to make “explicitly clear” that providers, rather than insurance companies, are the authority of whether a patient “fails” a treatment. In addition, CMS should emphasize that any unwritten, implicit step therapy that is handled through a different management process, such as prior authorization, is prohibited.

The ACR is also urging CMS to confirm that patients can be exempt from step therapy if:

  • The treatment is contraindicated;
  • The provider determines the treatment is likely to be ineffective;
  • The provider finds that the treatment is likely to cause harm;
  • The provider believes the treatment will negatively impact the patient’s ability to perform daily activities; or
  • The provider determines the treatment would be life threatening or impair physical or sensory functions.

“We hope that CMS will publish guidance to the plans as soon as possible so that patients will have safeguards for the 2019 plan year,” the letter concluded. “We welcome the opportunity to work with CMS to ensure that no patient is left without the ability to get the treatment that can improve or save their lives.”