Policy Corner – Key Legislation to Watch!

The Infusion Access Foundation Advocacy Team will arrived on Capitol Hill in Washington, D.C. on Thursday, April 27 for their first ever Hill Day. We brought along seven star advocates from across the country to advocate for the infusion community–talking to key members of the U.S. House and Senate about the importance of federal reforms that will lighten the burden of utilization management and reduce out-of-pocket healthcare costs.

While a number of states have enacted reforms related to step therapy, copay assistance, and prior authorization, state-level protective measures do not apply to federally-regulated plans (i.e., health insurance plans provided by your employer). Leaving close to 50% of the country unprotected by enacted state laws and in desperate need of federal protections in all three areas.

Step therapy or “fail first” is a utilization management tactic used by insurers requiring someone to try and fail a different drug or treatment before taking the one their doctor prescribed. Under a step therapy protocol, someone with Crohn’s disease may be required by their health plan to have “clinical documentation” that Humira is ineffective after three doses before they can move to Actemra. If this sounds familiar to you–but perhaps with different drugs– you have been impacted by step therapy.

What most state step therapy reform has done is allow for greater exceptions to the health plan’s protocol. For example, a patient can be exempt from step therapy if the protocol requires them to try a treatment within the same class as a previously ineffective medication or the treatment is expected to interact with other medications they are taking. While most state laws have not outright outlawed step therapy, they have made it easier for patients with state-regulated plans to apply for an exception and demand that health plans respond to those exceptions and appeals in a timely manner. So, what does that mean for someone with an employer-sponsored plan living in a state with enacted step therapy reform? Unfortunately, nothing.

If passed, the Safe Step Act (S. 652/H.R. 2630) would be the first federal step therapy law. It would ensure that even U.S. residents with federally-regulated plans (like most employer plans) are protected from onerous step therapy protocols. Originally introduced in 2021, the legislation seeks to improve step therapy protocols by codifying five scenarios in which an exception can be made. These include circumstances where:

Copay assistance is crucial for most patients on biologic drugs. These medications can be extremely expensive, and unless you won the lottery or have heaps of disposable income, you’ve probably used a copay card or signed up for a cost share assistance program to  cover the cost of your treatments. In response, insurers have begun implementing their own “programs.” With benevolent-sounding names like “copay accumulator policies” or “accumulator adjustment programs,” these insurance policies actually prevent copay assistance from counting towards an enrollee’s deductible or out-of-pocket maximum. For most patients, they only become aware of these policies after they’ve received several infusion treatments, and now they are stuck with a surprise bill. States have been fighting back against copay accumulator programs by enacting “All Copays Count” laws that would require insurers to count all contributions made by or on behalf of a patient toward their out-of-pocket maximum and deductible. Once again, these state laws only help patients with state-regulated plans.

Luckily, the U.S. House has a bill, the Help Ensure Lower Patient (HELP) Copays Act (H.R. 830), that would protect patients with federally-regulated plans. Essentially, the legislation would prohibit the use of “copay accumulator programs” and “accumulator adjustment policies” in the Affordable Care Act exchanges. In its 2021 Notice of Benefit and Payment Parameters (NBPP), the Centers for Medicare and Medicaid Services allowed insurers to use copay accumulator programs in the exchange markets, unless a state prohibition exists. The bipartisan HELP Copays Act would reverse this policy by prohibiting the use of these programs in exchange plans completely.

Lastly,  prior authorization is an insurer process by which a provider must obtain advance approval from a health plan before a specific treatment is provided to the patient. As most infusion patients and providers know, the prior authorization can be annoying and redundant at best (isn’t my doctor prescribing a treatment their attestation that the treatment is necessary? Why do you need to ask again?) and utterly demoralizing at its worst. Each insurer has its own process for prior authorization creating undue administrative burdens on patients and their prescribers. Recent data by the Office of the Inspector General (OIG) even confirmed that insurers often leverage prior authorization as a tactic to delay necessary care.

The persistence required by both patients and their providers to acquire prior authorization on often fairly routine procedures is incredible. While some states have proposed and even passed legislation with the intention of streamlining the prior authorization process or allowing automatic approval on certain treatments, these laws would only impact enrollees of state-regulated health plans.

The passage of the Improving Seniors Timely Access to Care Act would at least cover beneficiaries of Medicare Advantage plans. Among other improvements, the bill would establish an electronic process, require insurers to follow evidence-based medical guidelines, ensure that requests are reviewed by appropriate medical personnel, and reduce prior authorization for routinely approved services. The bill passed the House with overwhelming support last Congress, but has not been reintroduced just yet.

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