April 11, 2019
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Proposed legislation would place exceptions on step therapy

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Paula Marchetta

The American College of Rheumatology has praised a proposed piece of legislation that, if enacted, would amend the Employee Retirement Income Security Act of 1974 to require group health plans to place exceptions on the practice known as step therapy.

The bipartisan bill, H.R. 2279, was introduced in the U.S. House of Representatives and referred to the House Committee on Education and Labor on April 10. It is sponsored by Rep. Raul Ruiz, D-Calif., who is a physician, and cosponsored by Rep. Brad Wenstrup, R-Ohio, who is a podiatrist.

“As physician leaders in Congress who have encountered step therapy in their own practices, Representatives Ruiz and Wenstrup understand the urgent need to streamline the step therapy process, which too often prevents or delays patients from receiving medically necessary therapies,” Paula Marchetta, MD, MBA, president of the ACR, said in a press release. “This common-sense, bipartisan legislation would place reasonable limits on the use of step therapy and create a clear process for patients and doctors to seek exceptions.”

 
The bill, if enacted, would amend the Employee Retirement Income Security Act of 1974 to require group health plans to place exceptions on the practice known as step therapy.
Source: Shutterstock

Marchetta added, “We applaud Representatives Ruiz and Wenstrup for championing this important piece of legislation.”

The text of the bill — titled “To amend the Employee Retirement Income Security Act of 1974 to require a group health plan (or health insurance coverage offered in connection with such a plan) to provide an exceptions process for any medication step therapy protocol, and for other purposes” — is not yet publicly available, and there is no summary posted on the Congress.gov website.

According to the ACR, step therapy can disrupt continuity of care by requiring patients to halt an effective therapy due to formulary or protocol changes to their plan.

Step therapy is currently used in a majority of public and private health plans, according to the ACR. In August, CMS issued a memo to Medicare Advantage plans that rescinded a Health Plan Management System memo from Sept. 17, 2012, titled “Prohibition on Imposing Mandatory Step Therapy for Access to Part B Drugs and Services,” and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.

Since the August announcement, the ACR has been working with CMS to implement certain protections for patients, such as step therapy requirements only applying to new starts of medication. However, ACR officials maintain that the proposed protections, which have not yet been implemented, “do not go far enough.”

“Step therapy is a prime example of payers interfering with patient care — what many have called practicing medicine without a license — and we are advocating to restore the power of the physician to treat their patients appropriately and in accordance with accepted guidelines,” Marchetta said in the release. “Our patients often try multiple drugs before finding one that works for them, so the ability to remain on a drug that works — without having to go through step therapy — is critical.” – by Jason Laday