The brand new publication from the International Wholesome Dwelling Basis exhibits that present state tier remedy laws doesn’t shield most sufferers

UPPER NYACK, NY – (BUSINESS WIRE) – Today, the Global Healthy Living Foundation (GHLF) announced a newly published study that reports that, despite a well-intentioned investment of time and money to advocate for protective, patient-centered step-by-step therapy laws from state to state, the resulting resulting legislation generally protects less than 10 percent of the state’s population. Another mitigating effect of these laws is the lack of codified penalties, which means that most of these laws cannot be enforced. The peer-reviewed study “Health Economics Policy and Law”, entitled “Do Patients Benefit from Legislation Regulating Step-by-Step Therapy?” is the result of an analysis by the Global Healthy Living Foundation on the structure and language of step therapy laws in 29 countries.

“While most insurance companies use tiered therapy to control costs, there is no evidence that it improves patient outcomes, and patients certainly see no cost savings. Rather, patients risk a lot if their access to prescribed drugs is delayed waiting to “fail first” by trying drugs in an order set by their insurer to their doctor, “said lead study author Louis Tharp, executive director and Co-founder of GHLF. “It was incredibly frustrating to learn that our success in working with many other patient and provider groups advocating for better regulation for tiered therapy has not benefited our patients well. The laws cover too few people and are unenforceable in many states because the laws contain no penalties, removing any incentive for insurance companies to work together. However, step therapy is too harmful for patients to simply give up. We will return to the state legislatures to liaise with lawmakers – one at a time, if necessary – to inform them of why these laws need to be revised. ”

Zoe Rothblatt, MPH, co-author of the study, added, “Many patients and doctors are unaware of any laws to protect them, and insurers do not inform them of their rights when they force patients to fail first.”

Laws that are repealed the moment they come into force

As explained in the study, while no state bans step-by-step therapy protocols from insurers, 29 states have passed laws mandating a procedure to help health professionals protect their patients from step-by-step therapy protocols by providing a list of exemptions that insurers will accept have to. Some of the most common exceptions are obvious, but had to be codified in law as insurers ignored them. These include: Since a patient has already tried a first stage drug and has failed, the drug is expected to be ineffective by the doctor or the drug is likely to cause side effects or harm (to name just three). However, the laws vary greatly from state to state and offer little protection in practice.

  • Only six states cover all six of the most common reasons for applying for an exemption. California and Oregon don’t cover any, and Missouri, Arkansas, and Colorado only cover one.

  • 10 states do not have an appeal process if an exception is denied, which further weakens these laws.

  • Some states have specific time frames within which the insurer must respond, but nine states do not require insurers or PBMs to respond at all, rendering the law meaningless.

  • In practice, in California and Mississippi, the law allows one-step therapy for a period of time in which harm may still occur, as the law states that clinically ineffective step therapy cannot last longer than 60 or 30 days.

In addition to the laws about missing teeth, they only cover a small fraction of the Americans in any state who buy state-regulated health insurance. With that in mind, about half of Americans are covered by employer insurance, and employer-provided health insurance is covered by the Federal Employee Retirement Security Act of 1974 (ERISA), which means they cannot benefit from the protection of state step-by-step therapy laws. Medicaid covers about an additional 20 percent, but only seven states have safeguards for Medicaid beneficiaries under step-by-step therapy legislation, and the lack of enforcement procedures combined with extensive paperwork and work requirements further diminishes benefits.

Fully insured employees who would normally benefit from state step therapy legislation (unless specifically excluded, as in Kansas) may not be protected due to territorial privileges, and everyone on a fully insured plan cannot be assumed to be covered by the Laws on state step therapy is protected. Therefore, the percentage of citizens covered by state step-by-step therapy laws among fully insured beneficiaries ranges from thirteen percent (North Carolina) to 27 percent (California). In the few states that do away with Medicaid, protection ranges from 14 percent (Kansas) to 34 percent (New Mexico). On average, the revised tier therapy legislation covers those with non-group insurance who make up less than 10 percent of citizens. The state with the potentially highest proportion of protected individuals (~ 33.6%), California, is one of three states with the weakest stage therapy laws.

“It is time to shed some light on how these insurance protocols are – secretly – negotiated between pharmacy manufacturers, service managers and insurers in the pharmacy, and then enact new or revised laws at both state and federal levels to protect patients no matter which of our 50 states or territories do they live in? Added Steven Newmark, JD, MPA, Director of Policy and General Counsel of the Global Healthy Living Foundation. “We hope that in 2021 the Biden government will launch a new bipartisan effort in Congress to provide better access to the drugs they need for patients stuck in step-by-step therapy and barrier-inducing protocols. Federal law like Senate Law S.464 (The Safe Step Act) would remove the national network of loopholes in step therapy laws and protect patients consistently from these unhealthy policies, ”added Newmark.

In the meantime, the Global Healthy Living Foundation recommends that patient and provider groups continue their tier therapy reform efforts by:

  • Provide resources to assist in setting rules for existing government laws, including using subject matter experts to advise on changes to existing laws.

  • Educating patients, health professionals, social workers, employers, and government officials about existing laws to prevent laws from going unknown and unused.

  • Share model laws, such as those created by the Physicians Research Institute (2019), to help lawmakers develop effective laws to regulate tiered therapies and reduce the cost of advocating state laws in states where they still exist are.

  • Recommendation of an infrastructure to check compliance with regulations and the benefit of patients from existing and yet to be developed laws on step therapy.

  • Participation in patient-centered medical research projects to create patient-reported outcome data that enable an objective assessment of patient benefit in connection with step therapy.

The GHLF will also support the Safe Step Act, first introduced at the 115th Congress (2017-2018) to amend the 1974 Retirement Income Protection Act to require a group health plan or health insurance that is related Offered with such a plan is providing an exception procedure for each medication step therapy protocol and for other purposes. ”

Fail First puts patients and providers last

Graduated therapy is used to increase insurance profits and is the most commonly used restriction on specialty drug coverage, such as is commonly used by patients with severe chronic illnesses. In a “Fail First” step therapy protocol, an individual must have attempted one or more therapies that the insurance company considers to be a first step as ineffective before being reimbursed for a drug that is considered a second or higher step. The steps are based on negotiating the payment of drugs between the insurance company, the performance managers at the pharmacy, and the manufacturers. As a result, patients and doctors are not the main decision makers about what drugs are available, but insurance companies.

About the 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 of people with chronic diseases (such as arthritis, osteoporosis, migraines, psoriasis, inflammatory bowel disease, and cardiovascular disease) improve advocacy of improved access to health care at community, state and federal level and step up education and awareness-raising efforts in the context of social media. GHLF is also a staunch advocate for vaccines. The Global Healthy Living Foundation is the parent organization of CreakyJoints®, the digital community for millions of arthritis patients and caregivers worldwide who seek education, support, activism and patient-centered research through our ArthritisPower® research registry ( In response to the COVID-19 pandemic, the GHLF launched a patient support program that was informed by a patient council of people with a variety of chronic diseases who now care for more than 30,000 people. Via CreakyJoints, GHLF also hosts PainSpot (, a digital tool for risk assessment for diseases and injuries to the musculoskeletal system, and eRheum ( for supporting telemedicine and virtual care. Visit for more information.

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