Fail First Policies And How They Hurt Us

Have you ever been prescribed a particular drug by your doctor but your insurance company would not cover it until you tried, and failed, one or two (maybe more) other drugs first?  If you experienced this, it is called Fail First or Step Therapy.  Fail First policies are insurance policies, which require that the patient be prescribed the cheapest drug first rather than the one originally prescribed by the doctor. Fail First affects patients with chronic conditions, such as diabetes, arthritis, depression, cancer, hypertension, sickle cell anemia, COPD, asthma, and high cholesterol.

Insurance companies requiring that a patient fail first on a drug before having the original prescription approved hurts the patient, the physician, and public health suffers as a result.  These practices compromises the decisions the patient and physician have made for that particular medical treatment.  It is time-consuming and costs more money in the long run.  Not to mention all of the risks of unwanted side effects from taking drugs that are not beneficial to the patient's health or opportunity to better manage their symptoms/illnesses.

Step therapy is a tool used by health plans to control spending on patients' medications.  In 2010, nearly 60% of commercial insurers were using step therapy.  As of 2014, 75% of large employers reported offering plans that use step therapy.  If a patient changes insurance, they will have to restart on another step therapy plan.  The consequences of this fall hard on the patient, who has to endure taking useless and potentially dangerous medications, making him sicker in the long run. 

Step therapy has shown to have a negative impact on patients, including delayed access to the most effective treatment and disease progression.  It exerts a significant burden on health care providers and their patients, as well as increases health care costs.  The video below breaks down what step therapy is and how it adversely affects the doctor-patient relationship, increases disease burden, and delays treatment.

Fifteen states have effectively passed legislation to prevent insurers from needless interference with the doctor-patient relationship and course of treatment.  Louisiana was the first to do so in 2011, passing regulations in acquiring exceptions to step therapy protocols.

States in blue have passed legislation related to Step Therapy protocols. States in green currently have Step Therapy legislation pending. States in red have seen Step Therapy bills fail in the most recent session. States in yellow have not considered or signed any legislation regarding Step Therapy. Image & caption from FailFirstHurts.org

Global Healthy Living Foundation's website on Step Therapy, FailFirstHurts.org, explains the current outlook on passing regulations:

"Many other states are considering step therapy legislation in addition to a federal bill that is currently in the works and modeled after the Ohio step therapy bill.  The biggest difference between the federal bill and the various state bills is in the areas of impact.  The federal bill will hopefully regulate all commercial plans across the entire country, while the state bill has the opportunity to fill in the gaps by regulating public plans, like the bill in Texas to regulate Medicaid, or selected group plans, like the bill in Iowa to regulate HMO's  State bills also have the ability to sasaran specific diseases as well, like the bills in Georgia and Maryland that sasaran step therapy protocols related to certain forms of cancer.  Many of these bills contain similar language to the model bill put forward by the SAIM (State Access to Innovative Medicines) coalition that attempts to put a greater emphasis on patient protections."¹

Step Therapy in Virginia

In my state of Virginia, there is no step therapy law.  Legislation has been proposed several times, most recently in 2016 and 2017, but both times they were either stuck in committees or voted to be delayed until the next year.  The goal of the proposed legislation would be to reform step therapy in Virginia to require health plans to cite clinical review data as justification for denials, create a uniform and expedited appeals process, and establish a process for patients who transition from insurance plans.²

Read more on SB 332 introduced in 2016 by Senator Bill DeSteph (R-VA) and HB 1755 introduced in 2017 by Delegate Glenn Davis (R-VA)

Virginia does have a prior authorization law and a biosimilar substitution law.  The prior authorization law sets up a time frame of 10 days for when an appeal can be made if a prior authorization is denied (https://law.lis.virginia.gov/vacode/38.2-3407.15:2).  Governor Bob McDonnell signed into law the state's first law concerning substitution of biosimilars in March 2013.  "The biosimilar substitution provisions permit pharmacists to dispense a biosimilar in place of a prescribed biological product, but only if the biosimilar meets the safety standards for interchangeability pursuant to federal law."  Pharmacists are required by the law to keep records of substitutions, give notice of substitution to prescribers, and give notice of retail costs to patients (http://lis.virginia.gov/cgi-bin/legp604.exe?131+ful+CHAP0412).³

The Virginia Department of Insurance has links to file a complaint or to request an external review of a decision made by your insurer on their website.  There is also an extensive frequently asked questions section, stating what they can help you with and providing tips for dealing with your insurance, including:

• A list of insurance plans regulated by the Bureau.
• Insurance rights.
• A time frame for a response.
• How to check in on the appeals process.

If you are ever denied, there are steps that you can take to fight back:

1. Gather all the information you need.
2. Work with your provider's office.
3. Know your rights.
4. Fight back.
5. Share your story - You can do this online or call (800) 411-5840.

How You Can Fight Back

Every patient has a voice that needs to be heard.  The 50-State Network is a grassroots advocacy organization made up of patients like you and me.  They work to share the patient perspective, a crucial element in the State and Federal health policy and regulatory arenas.  The 50-State Network community is comprised of patients with a wide array of chronic illnesses and those who care about them.  Empowering patients to use their pain for a purpose and redirecting frustration and despair into mobilizing and action is the goal.  They are basically making lemonade out of the lemons chronic illness gives you.  If you'd like to join and become an advocate, fill out the form using this link - https://www.50statenetwork.org/join-the-50-state-network/.

Sources:

¹“Have You Been Forced to Fail First?” FailFirstHurts, failfirsthurts.org/ffh/regulations/analysis-of-current-regulations/.

²Richmond Academy of Medicine. “Proposal 3: Resolution to Improve Step Therapy in Virginia.” Medical Society of Virginia, 9 Oct. 2017, www.msv.org/programs/advocacy/2017-advocacy-summit/2017-advocacy-summit-proposals/proposal-3-resolution-improve.

³Ropes & Gray, LLP. “Virginia Enacts Nation's First Biosimilar Substitution Law.”Lexology, Globe Business Media Group, 22 Mar. 2013, www.lexology.com/library/detail.aspx?g=9c25a033-5e9a-409c-b8b3-d228953a9cce.

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