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Minutes for HB2157 - Committee on Health and Human Services
Short Title
Establishing restrictions on the use of step therapy protocols by health insurance plans.
Minutes Content for Wed, Feb 3, 2021
Chairperson Landwehr opened the hearing on HB2157 and asked the Revisor to explain the bill.
Scott Abbott, Assistant Revisor, Office of The Revisor of Statutes, provide an overview of HB2157 and the statutes that it affects. There is a Fiscal Note for HB2157.
PROPONENTS
Dr. Marc Allen, Mid-America Gastro-Intestinal Consultants, PC, appeared before the Committee in support of HB2157. Dr. Allen spoke to the ever-increasing dangers of step-edit requirements imposed by insurance companies. Step-edit or step-therapy is a policy that insurers use to compel the use of certain medications first, before another medication can be used. These fail-first policies require prescribers to use Drug A before they can use Drug B. Sometimes, there are even two step edits, in other words, fail Drugs A and B before you get Drug C. Whether you or a member of your family has Crohn's disease, ulcerative colitis, diabetes, or multiple sclerosis, it is highly likely that you will be forced to follow step-therapy. Step-edit policies get in the middle of doctor-patient relationships and muddle the discussion. Those insurance companies are not sitting in the room with your doctor and you, deciding on what drug will work the fastest and the safest. What is worse is that step-edit policies can negatively affect the lives of the patients that doctors' care for. Dr. Allen provided a specific example and pointed out additional burdens that step-edit policies create. (Attachment 1)
Dr. Sherrie Vaughn, National Alliance on Mental Health, appeared before the Committee in support of HB2157 to protect against step therapy protocols that pose dangerous consequences for those who experience medical and mental health needs. For patients living with serious or chronic illnesses, including mental health conditions, prolonging ineffective treatment (and delaying access to the right treatment) may result in pain, disease growth, loss of function and mobility, and possibly irreversible damage. Step therapy protocols limit a health care provider's ability to tailor care to individual patient needs. It is critical that medical decisions are in the hands of patients and their doctors, not with insurance companies. Dr. Vaughn is also a concerned family member whose brother was subject to step therapy protocols which resulted in denial of a drug that was currently working for his situation. An appeal is being pursued. Dr. Vaughn asked the Committee to consider HB2157 to protect Kansans against this unnecessary and harmful practice. (Attachment 2)
Gayle M. Taylor-Ford, Board Member, International Pain Foundation; Government Relations Advisory committee for the Multiple Sclerosis Society, appeared before the Committee in support of HB2157 with patient protections in place. Step therapy and prior authorization practices in many cases are unethical and take decision making away from prescribers who have had the benefit of examining the patient, reviewing blood work, test results, etc., and transferring these decisions to the insurance company representatives. We are seeing an increase in patients who are facing restrictions to medication and less invasive options such as chiropractic and physical therapy through step therapy by insurance companies. HB2157 is written with protections in place to help to prevent these things from happening. Ms. Taylor-Ford stressed the importance to allow a prescribing provider, based on his or her professional judgement, to request a step therapy override determination from a health plan or insurer on behalf of a patient. The International Pain Foundation is looking to support step therapy bills and prior authorization bills which address the specific problems of patients in pain to highlight the inadequacies of the practices because a pain patient can tell immediately whether a pain medication is working or not, and they should not be forced to stay on medicine which does not relieve their pain. Additionally, any cost savings that the state is looking at by delaying care with prior authorization practices or enacting this type of Step Therapy legislation has been shown to increase costs. Even though potentially the number of dollars spent on medication may have decreased, that is offset by the increased number of emergency visits and increased phone calls, and office visits to the provider because of medication that is not working or undue side effects of medications that are not as effective as what could have been prescribed. (Attachment 3)
Courtney Eiterich, private citizen, appeared before the Committee in support of HB2157. When diagnosed with multiple sclerosis (MS) 14 years ago, Ms. Eiterich began a daily injection to try to slow down the progression of MS. This medication has terrible injection site reactions and her arms and legs developed large lumps under the skin. It also is a painful injection lasting 30-45 minutes similar to an insect sting. During the same time, a new medication had just come to market that was showing the highest efficacy rates of any MS treatment. Ms. Eiterich had to try a second medication before she could be given the new one which was a weekly injection. After switching to this medication, her new MRIs showed she had tripled the lesions on her brain. She was finally approved for the new medication and that was 8 years ago. She has shown no new lesions and has been stable on this medication since that time. However, a couple of years ago, her insurance company left the marketplace and she was forced to choose a new one. The new insurance company delayed her treatment over new prior authorizations for over 30 days which they knew they would approve when it was received. This medication was needed to keep her disease stable. Ultimately, this has put her health at risk for the profits of the insurance company without any way to speed up the process. Ms. Eiterich stated her doctor knows what is best for her, not her insurance company. This is an expensive disease with no known cause or known cure. Step therapy practices that are currently in place limit access to life changing medications. Ms. Eiterich asked the Committee to support HB2157 and give patients access to the medications that their doctors know are the best for them from the start of the diagnosis. (Attachment 4)
Teresa L. Carter, private citizen, appeared before the Committee in support of HB2157. As a parent of a child with mental illness, Ms. Carter strongly urged the Committee to support HB2157 on Step Therapy. This bill will ensure that the medicine and treatments prescribed by her daughter's mental health care providers will be administered without external interference by insurance providers. When a person such as her daughter, who suffers from bipolar and schizophrenia, is prescribed a medication to help with the mood swings and voices she hears, it is done by a mental health care provider who has evaluated her and is educated in the exact medication they think will help her. Mental health medicines, unlike antibiotics, take weeks or months to be totally effective. So, when she is prescribed a regimen designed by her mental health care doctors, and then it is circumvented by a "clerk" at the insurance company that says she must "fail" on a cheaper medicine first before getting what was prescribed, it is a failure in her care and sets her back even further. In Ms. Carter's own healthcare, she was told she had to take two pills for high blood pressure, instead of the one combined coated pill because it was cheaper. She had to fail on it first and then her doctor could petition to have the more expensive one issued. So, she got the two required ones as part of step-therapy. Neither pill was coated causing Ms. Carter to throw up every time she took them. For several months as she appealed the decision of the "clerk" at the insurance companies, her high blood pressure was basically left untreated. Although she was lucky enough not to have a stroke while appealing, she has no idea what the long-term effects were on her kidneys. (Attachment 5)
Peggy L. Johnson, COO, Wichita Medical Research and Education Foundation, appeared before the Committee in support of HB2157. Komen believes, as do the other organizations Ms. Johnson represents, health care decisions should always be between a patient and their provider. Preventing breast cancer patients and all cancer patients from receiving the most effective therapy from the beginning of their treatment plan can further compromise their outcomes. Additionally, studies have shown the 'fail first' option results in much higher healthcare costs. In plans that currently utilize these protocols, it has been found that 53 percent of patients whose oncology medications were rejected because they did not meet step therapy requirements did not receive another drug within the recommended 30-day window. Timing of treatment is critical in the treatment of cancer. Anyone diagnosed with breast cancer, or any cancer, should never be forced to delay the recommended, or most effective treatment, due to insurance design or cost-containment strategies, especially when it is known that breast cancer becomes five times more expensive to treat once it has spread beyond the breast. In many cases cancer treatment will include 'quality of life' drugs to help patients tolerate the chemotherapy side effects. These drugs are often caught in the 'fail first' cycle and may cause a patient to simply stop treatment because of the side effects. When these 'fail first' strategies are employed the treating physician is required to 'state their case' in written form. All physicians, especially now, simply don't have the time. None of us want our physicians to take time away from direct patient care. (Attachment 6)
Corbin McGhee, National Multiple Sclerosis Society, appeared before the Committee in support of HB2157 which would establish procedures for step therapy protocols by health insurance plans, and to share how such utilization requirements impact those who live with Multiple Sclerosis (MS). MS is an unpredictable, often disabling disease of the central nervous system that disrupts the flow of information within the brain, and between the brain and body. Step therapy protocols do not take into account detailed conversations between healthcare providers and patients as they discuss the right medication for each person, factoring in things like efficacy, dosage, route of administration and side effects. In addition, step therapy protocols may involve significant paperwork and documentation from healthcare providers and patients. For those with diseases, such as multiple sclerosis, which may be severe or debilitating, delaying treatment can lead to serious outcomes such as the irreversible accumulation of disability. It can take years following an MS diagnosis to find the most effective course of treatment and when a patient does, they should remain on that drug uninterrupted. Considering the cost of MS medications, patients cannot afford to take drugs out of step order and without coverage. Although insurers utilize step therapy to control cost, research has demonstrated that step therapy can lead to higher spending over time. The use of ineffective treatment has been associated with higher costs due to additional office visits, increased drug costs, and the possibility of additional treatment or hospitalization. Additionally, in the case of MS, effectiveness of the drug should not be the only factor considered. The risk profile of the medication as well as side effects and the ability for an individual to adhere to the medication must also be considered. (Attachment 7)
Amy Campbell, Kansas Mental Health Coalition, appeared before the Committee in support of HB2157 to establish safety parameters for insurance step therapy policies. Step Therapy Policies put patients with mental illness at risk. Many mental health consumers need medication to recover, to alleviate symptoms and to make the illness "manageable". Continuity of the medication regime is essential. Finding and maintaining the most effective medications is often the key to a durable recovery that enable children with mental illness to attend school and graduate, enables adults to keep jobs and contribute to their communities, and enables families to stay together. Research indicates that fail first policies can have devastating consequences when patients with mental illness face rejection of their prescription at the pharmacy counter. When individuals face interruptions or delays in treatment, the consequences include emergency room visits, hospitalizations, homelessness, incarceration and even death by suicide. Navigating the complications of medication restrictions is complex. Individuals with mental illness often do not have the same resources and access to professionals as the average private insurance consumer or even a Medicare consumer. It is unlikely they will know if their policy has unique allowances for temporary prescriptions or if they are supposed to be "grandfathered" when they suddenly find their prescription can't be filled at the pharmacy. These uniform rules provide reasonable consumer protections. Individuals who leave treatment and decompensate rarely maintain private insurance in the long run, and ultimately their care and treatment falls to the public mental health care system and state mental health hospitals. (Attachment 8)
Steven Schultz, Arthritis Foundation provided written testimony to the Committee in support of HB2157. This bill would help restore the balance between an insurer's oversight and the provider's discretion to ensure Kansas patients receive the most appropriate treatment for their condition. HB2157 seeks to ensure that step therapy protocols are fair, transparent, evidence-based, and best support the health needs of the patient. In addition, HB2157 establishes standard time frames for a step therapy exception request. Arthritis is a chronic, degenerative disease, and delays in treatment can worsen disease progression and even cause permanent damage and disability. In some cases, patients may have no alternate therapy for an extended period of time if the drug that was initially prescribed was rejected. Accordingly, the standard time frames established within HB2157 will help to ensure that patients receive access to their necessary treatments within a reasonable time frame. Further, arthritis is a complex disease to treat and a drug may work well for one person but not for another who has the seemingly same disease profile. Personalized, individual care is critical for people with arthritis. There is currently no consistency in how insurers establish and apply fail first protocols. (Attachment 9)
Sara Prem, American Lung Association, provided written testimony to the Committee in support of HB2157. The Lung Association strongly believes that clinical care for lung disease patients should follow evidence-based guidelines including the National Asthma Education and Prevention Program (NAEPP) guidelines, the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines and the National Comprehensive Cancer Network (NCCN) guidelines for lung cancer treatment. However, coverage restrictions, like step therapy, can impede access to guidelines-based care and make it difficult for patients to get medications to help them breathe or treat life-threatening conditions like lung cancer. Navigating burdensome step therapy processes can also be challenging for both patients and providers. This can lead patients to delay or discontinue treatment, which ultimately leads to higher health care costs. The Lung Association supports the improvements that HB2157 will make to the step therapy process for patients, a pathway for patients to request exemptions from step therapy protocols, includes key conditions that automatically qualify patients to override step therapy protocol such when the patient has tried the protocol drug and it was unsuccessful and when the patient's current medical pathway is successful or trending positive and the step therapy protocol would hinder that success or cause a negative outcome. HB2157 is critical to ensuring patients have access to quality medicine and treatment prescribed from their doctors without external interference by insurance providers. (Attachment 10)
Lauren Marquette, Senior Regional Manager of State Policy and Advocacy, Susan G. Komen, provided written testimony to the Committee in support of HB2157. Access to effective and affordable drugs is a critical part of treating breast cancer, yet patients face a number of utilization management (UM) practices that impede access to the treatments prescribed by their physician. These strategies are employed so that payers, including private insurers and Medicare, can reduce their spending on drugs by shifting costs onto patients. One of these UM practices is step therapy, also known as 'fail-first', which requires patients to try and fail preferred or older treatments methods before accessing the most current form of treatment. Unfortunately, most step therapy protocols rely on generalized information regarding patients and their treatments. This prevents or delays patients from utilizing the most up to date treatments and hinders patients and physicians from deciding jointly which course of treatment will be best for the individual. Physicians must be able to make decisions based on the unique needs of each patient, and there must be clear and transparent scenarios under which physicians can override decision-making by health plans that endangers patients' health. The stake for these patients are high. Slight deviations in treatment and variations between drugs, even those in the same therapeutic class, can cause serious adverse events. The resulting disease progression can be irreversible, life threatening, and result in increased utilization of healthcare resources. HB2157 does not prohibit insurers from using step therapy but seeks to balance cost containment with patient needs. More specifically, the legislation protects patients by: (1) Ensuring that the exceptions process for step therapy is explicit, transparent, and accessible to patients and health care providers; and (2) Establishing a basic framework that enables physicians to override step therapy protocols where it is medically necessary. Forcing patients to endure unnecessary barriers makes it more likely that these patients could need additional medical interventions or even hospitalization, placing additional burdens on an already burdened healthcare system. (Attachment 11)
Cassandra Sines, private citizen from Wichita, Kansas, provided written testimony to the Committee in support of HB2157. Ms. Sines has two children, who both take medication to help them with their Autism. Some of these medications are psychotropic medications. Ms. Sines provided specifics on her family's experiences and frustrations with step therapy. Restrictions on step therapy need to be passed so individuals with mental illness do not have to suffer "trialing" medications, especially if they and their doctors know what will work. Insurance companies are not the medical providers. Medical providers need to make the decisions for their patients. (Attachment 12)
Christina Cowert, Kansas Grassroots Manager, American Cancer Society Cancer Action Network (ACS CAN) provided written testimony to the Committee in support of HB2157. As the nonprofit, non-partisan advocacy affiliate of the American Cancer Society, ACS CAN advocates for public policies that reduce death and suffering from cancer. Step therapy is a tool insurers use to limit how much they spend covering patient's medications. Scientific breakthroughs mean that, in many cases, a cancer diagnosis now can be managed and treated. Patients need the ability to quickly access their condition with their doctors and find the best course of treatment for their individual medical needs. Delays in access to the best treatment available, that could be experienced as a result of patients having to go through a step therapy protocol, can pose significant risk to the treatment of disease. Step therapy can undermine physicians' abilities to effectively treat patients, can lower quality of care, and lead to setbacks and disease progression for patients. Exemptions from step therapy do not prohibit insurers from using step therapy but seek to balance cost containment with patient needs. ACS CAN supports HB2157 because it protects patients: by ensuring that step therapy programs are based on clinical guidelines developed by independent experts; by ensuring that the exceptions process for step therapy is transparent and accessible to patients and health care providers; and by establishing a basic framework for when it is medically appropriate to exempt patients from step therapy. (Attachment 13)
Dantia MacDonald, private citizen from Manhattan, Kansas, provided written testimony to the Committee in support of HB2157. Ms. MacDonald explained her personal experience with anosognosia. If she is forced to do step therapy, she will first have to try a cheaper, older drug, with many scary possible side effects and health risks. If the medication does not work, and many medications do not work for her, she is sure she will immediately develop both delusions and anosognosia once again and will refuse treatment. This could also end up costing the system much more money due to stays in psychiatric hospitals or even jail. (Attachment 14)
Dr. Tyler Allison, Pediatric Neurologist, Children's Mercy, Kansas City, Missouri, provided written testimony to the Committee in support of HB2157. Dr. Allison explained that step therapy protocols for drug prescriptions have made a significant negative impact on his practice. These protocols provide a cookie cutter approach to what medications insurance providers will allow physicians to prescribe regardless of an individual patient's needs. Step therapy protocols are intended to keep physicians from prescribing medications that are more expensive when there are other cheaper and similarly effective medications available, but this good intention has led to physicians' hands being tied when a patient has a more severe presentation of disease that would require strong therapies not typically allowed in initial step therapy plans. Dr. Allison provided specifics on how this process has negatively impacted his patients and practice. (Attachment 15) (Attachment 16)
OPPONENTS
Brad Smoot, Blue Cross and Blue Shield of Kansas, appeared before the Committee and presented testimony in opposition to HB2157. We are familiar with the purpose and language of HB2157 which restricts the use of insurance tools to help reduce spiraling drug costs. However, the government mandate that would be imposed by HB2157 will make it even more difficult for many families, employers and even governmental entities to afford insurance premiums and pay cost sharing requirements of their insurance policies. Mr. Smoot highlighted some of the larger issues presented by this bill rather than just the troublesome specifics of the language offered. (Attachment 17)
Melodie Schrader, Pharmaceutical Care Management Association, appeared before the Committee and presented testimony in opposition to HB2157. Ms. Schrader expressed concerns that HB2157 seeks to create additional step therapy exception processes and its requirements will lead to the erosion of current drug management tools by interfering with the meaningful review of medical necessity that protects patients. Health plans and PBMs implement a variety of guidelines and programs that are designed to ensure that patients receive clinically appropriate and cost-effective drug therapies. Step therapy is one of these tools. For example, many drugs have harmful side effect or interact adversely with other medications; step therapy encourages trying safer, alternative therapies first. Health plans and PBMs use Pharmacy & Therapeutic Committees that are comprised of independent experts including physicians and pharmacists to develop evidence-based guidelines used in drug management programs, such as step therapy, and assure cost controls do not impair the quality of clinical care. Every health plan has an already established exceptions process that will permit the coverage of a drug that is not on a formulary, or that reduces out-of-pocket cost if a physician provides information about side effects the patient has experienced from a lower-tiered drug, or offers another documented medical reason. Finally, according to the Federal Trade Commission (FTC), "large PBMs and small or insurer-owned PBMs have used step-therapy and prior authorization programs to lower prescription is approximately one quarter the cost of a brand name prescription while still achieving optimal therapeutic results. Step therapy is designed to capture those savings for employers and individuals while producing the medically desired outcome. (Attachment 18)
Alexander Sommer, Prime Therapeutics, appeared before the Committee and presented testimony in opposition to HB2157. Prime Therapeutics (Prime), a pharmacy benefit manager (PBM) serves more than 30 million members nationally for its 18 non-profit Blue Cross and Blue Shield owners; employer groups; and government programs including the Federal Employee Program (FEP), Medicare, and Medicaid. Prime helps people get the medicine they need to feel better and live well by managing pharmacy benefits for health plans, employers, and government programs, including Medicare and Medicaid. To control costs, Prime's clients rely on our clinical expertise and drug management tools, such as step therapy. As an initial matter, our step therapy processes ensure members get their medically necessary therapy in a timely manner. Where a member's preferred treatment is subject to step therapy, that member's medical provider can help them navigate those requirements to help them timely get their preferred medication if it is medically necessary. At its core, step therapy is a clinical program that helps get the medicine they need to feel better and live well. This bill would undermine that core clinical purpose and drive prescribers and patients towards higher costs therapies without any added benefit. While we want to emphasize the value of step therapy programs, we are welcome to discussing alternative language that preserves step therapy. To be clear, our business practice is built on the fundamental purpose of getting people the medicine that they need to feel better and live well, with step therapy being a core component of that and thus must oppose this bill as currently written. (Attachment 19)
Bill Sneed, Legislative Counsel, America's Health Insurance Plans, appeared before the Committee and presented testimony in opposition to HB2157. Mr. Sneed spoke to three specific areas of opposition (1) Overly prescriptive clinical review criteria are redundant and unnecessary; (2) Legislation that broadens the criteria for exceptions to a step therapy protocol is potentially dangerous; (3) The use of step therapy protocols should be encouraged. (Attachment 20)
NEUTRALS
Steven Duerst, Blue Cross and Blue Shield, appeared before the Committee as neutral of HB2157. The limitations imposed in HB2157 will challenge our ability to provide affordable coverage as insurers as left with fewer tools to combat skyrocketing drug prices. Step therapy is an effective tool at combating over utilization of high priced drugs by encouraging generics or lower tiered drugs with the same efficacy. Exception processes are intended to provide patients with a path to get to the medication that is medically necessary for them, without having to first try the generic equivalent. Rising drug costs are one of the highest contributors to increased premiums for Kansans, and step therapy protocols are one of the only tools left for insurance companies to use to keep costs down while ensuring patients still have access to medically necessary therapies. HB2157 undoes any cost savings that a step therapy program may have achieved, which only results in higher drug costs for patients and our members. (Attachment 21)
Presenters responded to questions from the Committee.
The hearing on HB2157 was closed.
The Chairperson adjourned the Committee Meeting at 3:00 pm.
