Step therapy legislation 'lacks teeth' to defend patient access to doctor-prescribed drugs
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Despite a mounting number of state-level laws enacted to protect vulnerable patients against step therapy protocols, without official enforcement, these laws safeguard less than 10% of patients, according to data published in Health Economics Policy and Law.
Study authors Louis Tharp, executive director and co-founder of the Global Healthy Living Foundation, and Zoe Rothblatt, MPH, a patient advocate and community outreach manager of the Global Healthy Living Foundation, described step therapy, or fail-first policy, as “a practice of insurance and pharmacy benefit management companies denying reimbursement for a specific treatment until after other treatments have first been found ineffective (ie failed).”
Findings from the study showed that laws to limit this practice have been passed in 29 states. Just six states have language in the legislation that covers all six of the most common reasons for requesting exemption from step therapy protocols. Moreover, 10 states do not allow appeals if an exemption is denied. With the exception of New York and New Mexico, current legislation regarding step therapy would not even apply to one-third of any given state’s population, due to stipulations pertaining to insurance coverage.
Of particular concern is the broad variability of step therapy laws from state to state. “The laws that have been enacted can be near impossible to enforce, and loopholes exist,” the authors wrote. “More than 90% of people in the United States with health insurance may still be unable to access the treatment chosen as most appropriate for them with their physician. Based on these data, we conclude federal step-therapy legislation is needed.”
Healio Rheumatology sat down with Rothblatt and Tharp to discuss the present and future of step therapy legislation in the U.S.
Q: How does it happen that the laws about step therapy can vary so greatly from state to state?
Rothblatt: Model language for step therapy legislation was created after 2016 and has since become the model for other states and the federal Safe Step Act. However, many other states enacted their laws before this language existed. There is a large variance in the number and type of exemptions to step therapy that physicians can apply for on behalf of their patients, plus variation in how insurance companies are penalized — or not — for responding to exemption requests. Even the model legislation does not have strong penalties for ignoring the law as it is written.
Q: Why, exactly, is it that so few patients are protected by step therapy laws?
Tharp: Our analysis showed that the step therapy laws only cover a small portion of Americans in each state, those who purchase state-regulated health plans. Anyone who is covered by employer insurance and employer-provided health plans are regulated by the federal Employee Retirement Security Act of 1974 (ERISA) instead, which has priority over state laws. While Medicaid covers around another 20% of people, only seven states include protections for Medicaid beneficiaries under the step therapy legislation. The lack of procedures to enforce the laws, combined with copious paperwork and work requirements, further diminish the benefit.
On average, revised step therapy legislation covers those with nongroup insurance who make up less than 10% of state residents. The state with the potentially highest proportion of people protected (~33.6%) is California, but that state happens to also be one of three with the weakest step therapy laws based on the number and kinds of exemption requests allowed combined with a lack of penalties related to enforcement.
Q: Considering these issues in California, what are one or two of the states with the most restrictive or unhelpful step therapy laws, and why they are so problematic?
Rothblatt: California and Missouri are two states with particularly weak step therapy protections for patients. Both states passed laws prior to 2016, when the State Access to Innovative Medicines (SAIM) Coalition agreed on compromise legislative language that sets loose standards on the number and type of exemptions that physicians can request. However, that same compromise language also lacks teeth, in terms of enforcement.
In California, the current step therapy law fails to cover any of the six most common reasons for requesting an exemption to this process, such as a doctor believing that the first-step medication will be ineffective or even detrimental to their patient, among other provisions. In addition, because the law states that step therapy that is not clinically effective shall not last longer than 60 or 30 days, the law in practice allows step therapy for a period of time when harm may still occur.
In Missouri, the current step therapy law only provides an exemption to step therapy if a person has tried a drug and failed on it already, and patients have to provide this paperwork to prove their trial of the drug, annually. It is worth noting that Missouri’s neighbor Kansas only covers Medicaid and does not include state employees or the state exchanges. Also, in Kansas, if the insurer responds within 72 hours, as required, with “not approved” for exemption as their response, there is no opportunity to appeal this.
Q: Let’s talk solutions – what are the major components of the Safe Step Act?
Rothblatt: The Safe Step Act [H.R. 2163] has been introduced in Congress annually since 2017 and every year there is more and more bipartisan support. It mirrors to the model legislation in that it defines a clear process by which physicians can apply for exemptions on behalf of their patients, describes the eligible exemption reasons and sets time limits for insurers to respond to those requests. However, it does lack meaningful penalties should insurers simply ignore the guidance.
Q: Let’s be realistic about solutions, especially given the divided political climate in the U.S. right now: Do you feel optimistic that this act, or some close variation of it, will pass?
Tharp: Realistically, we do not believe that the Safe Step Act will pass during the current congressional session. However, we are encouraged by the increase in bipartisan support. We will continue to advocate for its introduction and eventual enactment, primarily by telling the stories of patients who are negatively impacted by step therapy. It is not ok that an insurance company’s decision about medications can override the medical expertise of a physician and the preferences of the patient regarding their treatment strategy.
Q: If it does not pass, what other solutions are you working on? Improving state-level laws? Pressure on insurance companies?
Tharp: As is evident from our analysis of how advocacy efforts led by numerous provider and patient organizations impacted the enactment of state therapy legislation, we have seen that pressuring insurers — even with laws in place — rarely leads to the desired effect. There are two paths forward: One is advocating for the Safe Step Act to pass in Congress; the other is to continue to work on the state level to increase the number of people who are included under patient-protective state therapy legislation.
For example, we are pushing for states to include Medicaid patients under the law, which is something that New York state recently implemented without impacting the state budget. As the New York law never explicitly stated that Medicaid is not included in the law, the state department of health and department of insurance have interpreted the law to mean that Medicaid is included.
In the meantime, Global Healthy Living Foundation recommends that patient and provider groups continue efforts to reform step therapy by:
- Committing resources to rule-making assistance for existing state laws, including deploying subject matter experts to consult on revisions to existing laws.
- Educating patients, health care professionals, social workers, employers, and state government administrators about existing laws to keep legislation from becoming unknown and unused.
- Sharing model legislation, such as that created by the Physicians Research Institute, to help legislators shape effective step therapy regulatory legislation and reduce the cost of advocacy for state laws in those states that do have them yet.
- Recommending infrastructure to audit compliance and patient benefit from existing and to-be-crafted step therapy legislation.
- Engaging in patient-centered medical research projects to create patient-reported outcomes data that provides an objective assessment of patient benefits related to step therapy.
We will invest in these efforts, for one key reason: no matter how much work in the states is accomplished, if the Safe Step Act is not passed there will always be a gap in the amount of people covered by step therapy reform laws. Even if we covered 100% of all state eligible plans, including Medicaid, 100% of Medicare and VA patients and 100% of all federal government employees, there would still be around 30% of the total insured population covered by ERISA plans that will still be subjected to step therapy.
Q: What can the average practicing rheumatologist do to impact this situation and improve care for their own patients who may need to switch medications?
Tharp: Rheumatologists have an important role to play in helping their patients access medications. In addition to checking their patients’ formulary coverage, they need to understand the laws in their state to determine how and when they can seek an exemption to step therapy. Frustratingly, we know that their commitment to this process and the related paperwork can consume one or more employees within a medical practice, contributing to overall health care costs in the United States.
Q: How about patients? What is their role in advocacy?
Rothblatt: At the Global Healthy Living Foundation, we educate patients about how to advocate for their best care with their physicians and, on a larger stage, by raising the volume of their disease journey with the people who make the laws and policies that impact them. Through our 50-State Network, we help patients identify their local lawmakers, participate in panel discussions or testify in front of committees, write letters and even participate in media engagements, such as by giving interviews or contributing op-ed articles to their local paper. We help patients tailor their engagement to their story and comfort level.
Q: Do you have any final comment to offer on the Global Healthy Living Foundation’s efforts in this regard?
Tharp: Step therapy isn’t going away. The Safe Step Act is ultimately a compromise where the insurance companies will still have ample opportunity to review patients’ medical history and deny access to medications prescribed by their doctors. However, if everyone is working under the same set of rules and expectations, we believe that is a step forward to reduce the process and help physicians and patients access medications more quickly.
For more information:
Zoe Rothblatt, MPH, and Louis Tharp can be reached at 515 N. Midland Ave., Upper Nyack, NY 10960; email: JessicaDaitch@hotmail.com.
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