Global Healthy Living Foundation Analysis Demonstrates Need for Federal Action
UPPER NYACK, NY (November 4, 2019) – According to a forthcoming step-therapy report from the Global Healthy Living Foundation (GHLF), too few patients were impacted and too much money was spent trying to stop patients from failing on drugs their doctor did not prescribe. In most states with existing or pending step therapy laws less than 10 percent of the population benefits from that legislation. Further, despite local, regional, and national patient and provider groups in states across the country advocating for and celebrating the passage of patient-centric step therapy legislation, including GHLF, these laws fail to include meaningful penalties if the law is broken. Whether intentionally or through unintentional oversight, a lack of penalty means most of these laws cannot be enforced. Global Healthy Living Foundation analyzed the structure and language of step therapy laws in 19 states, plus pending legislation (passed, but not yet in effect) in eight states to determine whether their efforts had benefitted patients, particularly those with chronic disease who rely on stable, reliable, and affordable access to prescribed medications.
The majority of Americans in these 27 states do not benefit from these laws because of the type of health insurance they carry. About half of all Americans are covered by employer insurance and almost all large employers are self-insured to some extent. Medicaid covers another 20 percent. Employer-provided health plans cannot benefit from the protection of state step therapy laws due to restrictions under the federal Employee Retirement Security Act of 1974 (ERISA). ERISA is the act that created private group market coverage and employee health coverage, and therefore it regulates employer-sponsored health insurance. In seven states, the legislation has protections for Medicaid beneficiaries. With that in mind, GHLF estimates that the percentage of state residents covered by state step therapy laws ranges from four percent (West Virginia) to 39 percent (New Mexico, which included Medicaid beneficiaries in its laws, thereby increasing coverage by 34 percent). Most cover less than 10 percent of state residents.
“Over the past five years, we’ve invested an enormous amount of our time, our patients’ time, and our limited resources to work with our members across the country who lobbied for legislation we hoped would benefit chronic disease patients, only to realize that our efforts haven’t benefitted enough people,” said Louis Tharp, co-founder and executive director of the Global Healthy Living Foundation. “It’s the definition of insanity to persist in this strategy and think we’ll get different results. Our research is helping us to define our next steps, including advocating for the federal Safe Step Act (Senate bill S.2546), which provides exemptions and an appeals process protocol that must be implemented by private, employer-based insurance plans. This federal legislation will provide uniformity and give more control to doctors to determine the best course of treatment for their patients.“
“In addition,” he adds, “we need to revisit existing state laws and make sure they are being followed.”
Existing Legislation Doesn’t Help Patients Navigate Step Therapy
There is no uniform definition or application of step therapy across insurance companies and their pharmacy benefit manager partners. The term refers to a practice that requires the least expensive drug in any class to be prescribed to a patient first, even if a patient’s physician believes a different therapy is medically in the best interest for their condition.
“However,” Tharp said, “when one insurer’s least expensive drug is not another’s, science takes a back seat and patients get the right drug only if they are lucky.”
State level step therapy legislation aims to define the conditions under which patients and doctors can apply for exemptions to step therapy and appeal exemption denials. According to the research conducted by GHLF, nine of 27 states with step therapy laws (enacted or pending) have no timeline for responding to an exemption request and there is no provision that the exemption is thereby automatically approved. Rather, there is no approval and no mechanism for avoiding step therapy. In the other states, insurers must respond to a request for an exemption, usually within 72 hours. If no response to an exemption request is provided, the prescribed medication is automatically approved.
“Step therapy is incredibly frustrating for people living with chronic disease(s) who have enough on their plate managing the ups and downs of their conditions. If they are insured, patients shouldn’t be required to ‘fail first’ on medications not recommended by their doctor,“ added Seth Ginsberg, president and co-founder of the Global Healthy Living Foundation. “Step therapy is one of the most obvious symptoms of an ailing healthcare system. The doctor’s best thinking about how to treat someone with a chronic disease, and the patients’ best interest for how to manage that disease, are negotiated – in secrecy – between the pharmaceutical manufacturers and the pharmacy benefit managers and insurers. A federal law needs to be passed to protect patients no matter where they live.”
The Global Healthy Living Foundation will publish their research in 2020.
In the meantime, the organization will support U.S. Senate bill S.2546 whose title is the Safe Step Act. The bill’s intent is “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.” S. 2546 is a companion bill to H.R. 2279, also titled the Safe Step Act, which was introduced in the U.S. House of Representatives earlier this year.
About Global Healthy Living Foundation
The Global Healthy Living Foundation is a 501(c)(3) non-profit organization whose mission is to improve the quality of life for people living with chronic illnesses (such as arthritis, osteoporosis, migraine, psoriasis, and cardiovascular disease) by advocating for improved access to health care at the community, state, and federal levels, and amplifying education and awareness efforts within its social media framework. GHLF is also a staunch advocate for vaccines. The Global Healthy Living Foundation is the parent organization of CreakyJoints®, the digital arthritis community for millions of arthritis patients and caregivers worldwide who seek education, support, activism, and patient-centered research through ArthritisPower®, the first-ever patient-centered research registry for joint, bone, and inflammatory skin conditions. Global Healthy Living Foundation recently launched PainSpot.org, a digital risk assessment tool for musculoskeletal conditions and injuries. Visit www.GHLF.org for more information.
 Health Insurance Coverage of the Total Population. Retrieved from: https://www.kff.org/other/state-indicator/total-population/?currentTimeframe=0&selectedRows=%7B%22states%22:%7B%22all%22:%7B%7D%7D,%22wrapups%22:%7B%22united-states%22:%7B%7D%7D%7D&sortModel=%7B%22colId%22:%22Location%22,%22sort%22:%22asc%22%7D
 10 Things to Know about Medicaid: Setting the Facts Straight. Kaiser Family Foundation. Last accessed on 10/31/2019 at https://www.kff.org/medicaid/issue-brief/10-things-to-know-about-medicaid-setting-the-facts-straight/
 Health Plans & Benefits: ERISA. (n.d.). Retired from https://www.dol.gov/general/topic/health-plans/erisa