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Five members of the U.S. House have revived the fight to keep employer-sponsored health plans from using step therapy provisions to limit patients' use of new, dangerous or very expensive prescription drugs.
Rep. Rick Allen, R-Ga., has introduced a version of the Safe Step Act for the 119th Congress, which started in January.
A health plan step therapy provision requires a patient to try a prescription drug that a health plan prefers before using another drug. Plans often use step therapy drugs to encourage patients to give low-cost drugs, such as aspirin, a chance before the patients get prescriptions for drugs like Humira, which may cost $25,000 or more per patient per year.
The new bill would add a provision to the Employee Retirement Income Security Act that would require employer plans with step therapy rules to create a process for asking for exceptions, to respond to requests for exceptions within 72 hours, and to allow exceptions for patients who may die, suffer severe health problems or suffer severe pain if those patients have to follow a step therapy protocol.
Allen introduced the new version of the Safe Step Act with help from two Democratic cosponsors — Lucy McBath of Georgia and Raul Ruiz of California — and two Republican cosponsors — Mariannette Miller-Meeks of Iowa and Robert Onder of Missouri.
Miller-Meeks, Ruiz and Onder are physicians.
Lawmakers have been introducing versions of the Safe Step Act since 2019.
In the House, the bill is under the jurisdiction of the House Education and the Workforce Committee.
Sen. Lisa Murkowski, R-Arkansas, has been the lead sponsor of the Safe Step Act companion bills introduced in the Senate.
Step therapy: Advocates for step therapy contend that well-designed therapy programs can protect patients' health and hold down wasteful spending.
Drug makers, many physicians and some patient advocacy groups oppose step therapy strategies, arguing that the strategies slow efforts by patients to get access to drugs that may save their lives or their ability to function.
Illinois prohibits health insurers from putting step therapy provisions in policies.
Other states prohibit or limit use of step therapy in some situations, such as situations involving access to birth control benefits.
Employers' perspective: Benefits groups have acknowledged that step therapy should be used carefully but objected to aggressive efforts to regulate the strategy.
The Employers' Prescription for Affordable Drugs, or EmployersRx, has objected to bans on step therapy and what it sees as overly strict efforts to limit use of step therapy. The coalition has not taken a public position on the Safe Step Act bills.
ERISA: Congress is interested in the step therapy issue partly because ERISA normally preempts state efforts to regulate self-insured employee benefit plans.
Illinois, New York and other states with step therapy rules have been able to apply the rules only to state-regulated group health insurance plans, not to employers' self-insured plans.
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