Let’s Get It Right The First Time
About Me:
My name is Karen and I am currently in the Family Nurse Practitioner Program at Arizona State University. I started this blog to jot down my thoughts and the things I have learned about Step Therapy, also known as the “Fail First” policy. Please share your thoughts and ideas!
First Post:
Late last year I went to a meeting hosted by the National Association of Pediatric Nurse Practitioners. Various topics were discussed, including autoimmune diseases, vaccines, involvement in policy change, and step therapy. The topic that caught my attention was the topic concerning the “Step Therapy” policy. The Centers for Medicare and Medicaid Services (CMS, 2018) define step therapy as “…a type of prior authorization for drugs that begins medication for a medical condition with the most preferred drug therapy and progresses to other therapies only if necessary, promoting better clinical decisions.” The aim of step therapy is to ensure prescribers initiate cost-effective drugs or therapies before initiating alternatives that may come with a higher price tag. This sounds like a great idea in theory; however, it’s less than ideal when patients experience a delay in effective treatment because they have to “fail” medication X before they can try the more effective medication Y. One of the speakers at the meeting I attended explained that she has seen how the step therapy policy has negatively impacted her young patients who suffer from rheumatoid arthritis. The speaker, who is also a nurse practitioner, reported that biologics have been highly effective in treating rheumatoid arthritis, yet are not the first line treatment. Although biologics may be more expensive than other treatments, the speaker expressed the frustration felt by parents. Many parents have expressed their desire to not have a decision made for them. Parents believe the decision regarding how to treat an illness should be made between the patient, prescriber, and or the patient’s caregiver. Prescribers at the meeting also expressed their dissatisfaction with the policy. Doctors, nurse practitioners, and physician assistants have obtained higher education regarding the management and treatment of patient health conditions. They utilize their knowledge to assess, diagnose, and treat patients. Yet, the prescriber’s best judgement and the patient’s preferences are not the primary deciding factors when it comes to patient care, it’s the cost. Many prescribers have accepted the fact that insurance companies, including Medicare and Medicaid, dictate how patients are cared for. However, healthcare providers should be encouraged to advocate for their patient’s needs.
Step-Therapy policies vary from state to state. Currently in the state of Arizona this policy is being addressed. The state legislature met on January 17, 2020 to discuss the current and future state of step therapy in Arizona. The bill HB2420 was introduced and there has been mention of a “Step Therapy Exception.” According to House of Representatives, step therapy exemption is the “…step therapy protocol that is overridden in favor of immediate coverage of a health care provider’s selected prescription drug” (2020). Although step therapy can’t be disputed in every circumstance, a prescriber can override the step therapy protocol if any of the following occurs:
- The medication is contraindicated and will potentially lead to physical or psychological damage.
- The medication is unsuitable for treating the patient’s disease. This can be known by reviewing the action of the medication and the patient’s specific needs.
- The prescribed medication, or a similar medication within the same medication class, failed due to lack of efficacy, weakened efficacy or because the medication caused harm to the patient. The medication may have been prescribed while he or she was on their current insurance plan or while they were on a different plan.
- The mandated medication does not suit the needs of the patient based on “medical necessity.”
- The patient has been established with a medication that was prescribed by their health care provider, and the medication has been effective in treating their disease or disorder.
If a health care provider is requesting an exemption, the insurance company, pharmacy benefits manager or utilization review organization has 72 hours to approve the exemption. Or in more urgent matters, they will have 24 hours to approve. If approval is not granted within a reasonable amount of time, the exception will be automatically granted.
Although this bill may potentially give prescribers more freedom in the future, it does not allow patients and prescribers to decide on a medication therapy without the approval of an outside entity.
References:
Centers for Medicare and Medicaid Services. (2018). Medicare advantage prior authorization and step therapy for part B drugs. Retrieved from https://www.cms.gov/newsroom/fact-sheets/medicare-advantage-prior-authorization-and-step-therapy-part-b-drugs
State of Arizona House of Representatives. (2020). Step therapy. Retrieved from https://www.cqstatetrack.com/texis/redir?id=5e2166244149
Step Therapy: A Blog About Failing First 
Thanks for this opening review. Note that HB 2420 was only introduced in the Arizona House of Representatives and (as of 2/3) has not been heard yet in committee. -HMR
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Karen-
Step therapy has long frustrated me as a patient, and now as a provider. As clinicians, we are ethically bound to suggest what we think will be most efficacious for our patients. Insurance companies are driven to keep costs low and produce higher profits. Our current profit-driven insurance system means that patients are secondary to the bottom line. As long as insurance companies are motivated by the cost of therapy, rather than the efficacy we will continue to have these issues. When patients have undesirable side effects, is this considered a step therapy failure? Nayak and Pearson (2014) recommend that insurers take such cases into consideration. Patient quality of life can be diminished while advancing through multiple steps.
Along with the insurance companies, drug companies are increasing prices on existing medications. New medications are priced astronomically high. For many, they are being priced out of continuing their pharmaceutical therapies. Congress is loathe to act in the face of lobbying cash, even as their constituents are suffering from price gouging. Drug importation has to be considered as a possible remedy.
Reference
Nayak, R. K. & Pearson, S. D. (2014) The ethics of ‘fail first’: guidelines and practical scenarios for step therapy coverage policies. Health Affairs, 33(10). https:/doi.org/10.1377/hlthaff.2014.0516
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Hi Karen,
I found your blog particularly enlightening for me because this cost-cutting approach with its unintended consequences is new to me, probably because I haven’t recently had any personal experience with it. However as an advocate, the first thing I thought of were survivor experiences with cancer treatment, which often involve taking drugs to attenuate the side effects of treatment such as anti-nausea drugs; protection against potential side effects such as neutropenia; and novel combinations of new drugs based on oncologists’ experiences. Reading your blog, I envisioned how “step therapy” could impact all of these situations.
In general, I find that ACCC website (Association of Community Cancer Centers) is instructive when it comes to sophisticated treatment issues that affect patients. One of the great benefits of the ACCC approach is that the site makes information targeted at clinicians available to the public. Indeed, as recently as November 2019, ACCC’s blog focused on the impacts of step therapy and announced a just-completed 4-part series produced by ACCC to help clinicians (and proactive survivors) better understand the impact of step therapy on oncology.
First the blog explained the history of step therapy under Medicare. I learned that in August 2018, rules were promulgated that made Medicare Advantage (MA) plans subject to step therapy as a cost-cutting procedure effective January 2019. It has already been a year since the policy began, and the impact on Medicare patients is huge. According to ACCC, more than 20 million Medicare beneficiaries, about 34%, are enrolled in MA plans, including my husband.
The website describes additional, new changes including a May 2019 rule that expanded step therapy to Medicare Part B drugs, although there are some exceptions for patients under treatment. Still if my husband were to become a newly diagnosed patient, he would be affected; the step therapy rules apply to new patients.
The 4-part lecture series has a local connection. One of the four oncologists who comprise the panel is Rafael Fonseca, MD, Getz Family Professor of Cancer & Professor of Medicine at the Mayo Clinic here in town. The first two lectures focus on unintended consequences of the policy, and they aren’t good. Forcing patients to fail first can include side-effects that require immediate hospitalization, turning the cost-cutting theory into a costly and dangerous act. The second lecture focuses on barriers to prescribing drugs designed to prevent unwanted side-effects.
The link to this sobering information about the impact of step therapy on cancer survivors is https://www.accc-cancer.org/projects/step-therapy-lecture-series/lectures.
Thank you Karen for bringing this practice to my attention. While I never give advice about treatment, I can point survivors to the website if they wish to better understand how these policies and their implementation might affect them or a loved one.
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The ethics of step therapy sound reasonable in practice, but the idea that finances of big insurance companies get in the way of providing care is so ridiculous to me that I want to tell patients that have been harmed due to this kind of policy to seek legal action. I feel this would be more just and a possibly better way to force change in the industry compared to the “Physician Review Committees “, and other insurance company self-developed research.
This makes me think that the deciding factors for first-line choices need to be taken away from the insurance companies and given to saying the American Academy of Family Practice or other specialist organizations. There is little ethical justice without checks and balances in these organizations. Insurance companies have a bottom line and I feel this can get in the way of patient care when these same companies get to decide which medication is the first-line choice.
In regards to HB2420 it is a good first step with the limiting of a 24hr response the strongest step so far. Sadly, I feel all these means is that insurance companies are simply going to continue to do what they have always done. deny requests first until you as the provider push the issue further. Hopefully, this won’t be the case, but from my experience, I have little hope.
State of Arizona House of Representatives. (2020). Step therapy. Retrieved from https://www.cqstatetrack.com/texis/redir?id=5e2166244149
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Thank you for your informative post on step therapy. I have encountered this in my workplace. Often, a provider will make a recommendation for a prescription to manage overactive bladder symptoms. Patients will notify our office that they were unable to pick up the prescription because their insurance requires them to try an alternative class of the drug before they consider covering the prescribed medication. However, the alternative medications which insurance requires patients to try have been linked to increased incidences of dementia and Alzheimer’s disease, which were factors considered by the provider during the prescribing process. As a result, this had led to a personal inquiry as to how medications under step therapy are chosen. According to the United Healthcare step therapy program, medications approved under the program have been vetted through extensive peer-reviewed medical literature, clinical trials, drug comparison studies, clinical practice guidelines, efficacy, and side effects (United Healthcare, 2020). This is interesting to read as my clinical example contradicts the process of how medications are chosen under the step-therapy program.
While efforts in step-therapy aim to promote cost-savings, it unfortunately has costly effects on patients’ health. In addition to delayed care, social determinants of health are also affected by step-therapy. Step-therapy prevents availability and accessibility, social determinants of health. Consider patients of low socioeconomic status. Patients are already at a disadvantage in accessing adequate health care and may be subjected to a patchwork of health services (Longest, 2016). Additionally, they may be even more affected by limitations in step-therapy if high financial costs are associated with the first-trial medications in step-therapy. This process renders low income patients unable to seek care in an efficient and cost appropriate manner.
References:
Longest, B.B. Jr. (2016). Health policymaking in the United States. (6th ed.). Chicago, IL: Health Administration Press.
United Healthcare. (2020). Clinical program drug step therapy – commercial. Retrieved from https://www.uhcprovider.com/en/resource-library/drug-lists-pharmacy/clinical-drug-step-therapy.html
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As I read more about your topic, I was reminded of genetics and clinical decision support. In Clinical decision support: The road to broad adoption, Dr. Greenes discusses how the increasing knowledge in genetics has given rise to the pursuit of “personalized” or “precision” medicine (Greenes, 2014). The field of pharmacogenomics plays a large factor in the pursuit of this “personalized” medicine goal. I wonder if the pursuit of “personalized” medicine will eventually reduce the likelihood of step therapy. Or perhaps there will just be specific protocols and “steps” for certain genotypes. Pharmacogenomics is still early in its development, but eventually, it could bypass “step-therapy,” because we would naturally eliminate medications/ treatments that would not be beneficial or less effective than others, ultimately reducing cost.
Additionally, I would be curious to know if the insurance companies have done a work-flow analysis and deeply investigated the real cost of this policy. How many hours do agents spend analyzing/reviewing/processing clinician requests for exceptions? How much time is lost on the provider side to these requests? Some studies suggest that there is limited quality evidence demonstrating reduced cost from step therapy and that there may be increases in the use of other services such as inpatient and emergency room visits (Nayak & Pearson, 2014).
Greenes, R. A. (2014). Clinical decision support: The road to broad adoption (2nd ed.) [Kindle Version]. Retrieved from amazon.com
Nayak, R. K., & Pearson, S. D. (2014, October). The ethics of ’fail first’: Guidelines and practical scenarios for step therapy coverage policies. Health Affairs, 33, 1779-1785. https://doi.org/10.1377/hlthaff.2014.0516
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Your blog has been very informative and I really enjoyed the video you posted this week. Step Therapy policies are so frustrating for providers and patients. I have seen issues with “Fail First” policies in my work and in my clinical experiences. I am in the mental health NP track and it is so exciting to read studies about promising new medications. However, with the insane costs and insurance companies not willing to pay, it seems like getting patients these medications is far from reach. What shocked me in the video you posted was that 1/5 patients may not end up receiving treatment at all! These policies place such a burden on providers and healthcare agencies and sadly, some prior authorizations are not completed. I have seen patients who return for their follow up appointment and have not even started the medication that was prescribed at the last appointment. Gaps in care like this make patients suffer more. The bills you mentioned would make some difference, but place the cost back on tax payers and consumers. The article you cited had some very interesting points. Fischer and Avorn (2017) report that there are “clinical and economic nuances” that may not be addressed with simplistic policies and policies that only address step therapy may just add to the complexity of the healthcare system. They argue that insurers should have evidence-based policies for avoiding unnecessary expenses, while also having transparent policies about the criteria for covering medications (Fischer & Avorn, 2017). It should also be easier for prescribers to obtain permission for overriding step therapy.
Reference
Fischer, M., & Avorn, J. (2017). Step therapy—Clinical algorithms, legislation, and optimal prescribing. JAMA, 317(8), 801-802. doi: 10.1001/jama.2016.20619
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Thank you for this review of the federal and state bills that have been introduced. Do you have any updates on these bills? Who are the key institutional actors engaged on this issue?
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Hi Karen,
This such a concerning subject, I personally have had many friends affected by these protocols. It was very frustrating for them and potentially could have led to an adverse effect on their health. One such friend had stop taking an diabetic medication that was effectively controlling her diabetes. Her insurance company had changed and the new company would not cover her current diabetes medication and she was forced to change to a medication that was not as effective at controlling her diabetes. This resulted in her having uncontrolled diabetes for months before the insurance company would agree to pay for the medication she had originally been on.
As future nurse practitioner I am sure I will encounter this and will need to jump through hoops to get medications covered for my patients. This concept is difficult for many providers and for their patients, providers want to do what is best for their patients. Shryock (2018) the editor at Medical Economics suggests that physicians and patients work together to encourage legislative change regarding fail first. In addition he suggests physicians work with professional societies and leverage their advocacy resources.
That is good to hear there are current bills at both federal and state levels addressing some aspects of this problem.
References
Shryock, Todd. (2018). DRIVING CHANGE IN MEDICINE. Medical Economics, 95(12), 10-35.
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Thank you for your interesting blog this week, Karen. It was great to catch up on reading your blog! It is interesting that companies have to increase their prices to compensate for those meds that are no longer patented. The private sector plays a huge role in step therapy because they set the prices for the medications. I was not familiar with pharmacy benefit managers (PBM) so I looked into that a bit more. PBMs provide medication coverage for over 200 million people in the US and create formularies for insurance companies that drive down medication costs (Shrank, Porter, Jain, & Choudry, 2009). They increase value in the healthcare system and improve quality of care by offering services like medication delivery services (Shrank et al., 2009). Medication adherence in those with chronic illnesses is a huge problem. PBMs can track whether or not patients are filling their prescriptions and provide education and patient outreach to those who are non-adherent (Shrank et al., 2009). PBMs are used to make sure that patients are receiving cost-effective medications. However, this could be an issue because it may not necessarily be the best medications that the prescriber is recommending. But, in other cases it can help manage patient costs when they identify formulary medications that may be as effective as or more than what the provider prescribed.
Reference
Shrank, W. H., Porter, M. E., Jain, S. H., & Choudhry, N. K. (2009). A blueprint for pharmacy benefit managers to increase value. The American journal of managed care, 15(2), 87-93. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2737824/
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Karen, I agree that electronic health records and e-prescribing are helpful for those affected by step therapy. Individuals are able to receive the right medication quickly, and make changes promptly if needed. One area I think there could still be improvement with the use of technology is medications that require prior authorization. There are times when patients meet the requirements to receive a branded or high cost drug by insurance standards, but it still can take days or weeks to receive authorization. A system that can verify the patient meets requirements via simple data entry would be beneficial, so there are not delays. I have seen this while in a neurology clinic. Patients are often given samples in hopes to fill the gap between being prescribed the medication, and when they will be approved to pick it up. There have also been times where patients wait until authorization to start on critical medications, or are prescribed a less appropriate medication in the interim. It will be interesting to see how technology evolves to allow for easier prescribing in the future.
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Hello Karen,
I agree with you in that technology has a significant role in the healthcare system. It took us a century to go from scribbled notes to the ability to access medical information on hand-held devices and cell phones. Taking this into consideration almost 75% of all communication among healthcare organizations still happen via fax machines (Nguyen et al., 2015). It was interesting to read how the advancements in technology impact your step therapy. Advances in technology and communication and innovation helps patient safety significantly. The Institute of Medicine’s report, Preventing Medication Errors 2007, states that poor communication and exchange of medical information at transition points for patients from one provider to another are responsible for many medical errors and adverse drug events (Eysenbach et al., 2019). Great blog Karen!
References
Eysenbach, G., Huang, Y., Bestek, M. Wen, H., Chang, W., Hsu, M., . . . Chu, C. (2019). An
Assessment of the Interoperability of Electronic Health Record Exchanges Among
Hospitals and Clinics in Taiwan. JMIR Medical Informatics, 7(1), E12630.
Nguyen, C., Mcelroy, L., Abecassis, M., Holl, J., & Ladner, D. (2015). The use of technology for
urgent clinician to clinician communications: A systematic review of the
literature. International Journal of Medical Informatics, 84(2), 101-110.
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