Advocacy Group Calls on Insurers to Modify Step Therapy for Migraine Treatment

By Pat Anson. PNN Editor

The National Headache Foundation (NHF) is calling on health insurers to stop using rigid “step therapy” policies and make it easier for migraine patients to get access to new treatments.

Step therapy is a common practice in the insurance industry to control costs. It requires patients to try cheaper and often older medications first, before “stepping up” to drugs that cost more.   

“For too long, migraine patients have been treated differently than others with medical issues as it relates to access to prescription medications. Specifically, clinicians are often forced to use outdated prescription drugs in a stepwise approach to all patients, without considering the needs of the individual patient,” said Thomas Dabertin, Executive Director/CEO of NHF, a non-profit that seeks to raise awareness about migraine and headache disorders.  

“Unfortunately, the current care models adopted by payers have not kept pace with the many advances in treatment. As a result, clinicians are using older medications, some of which are not even designed for the specific treatment of migraine, even though new migraine-specific therapies now exist.”

Migraine treatment has been revolutionized in recent years by the introduction of neuromodulation devices and drugs that inhibit calcitonin gene-related peptides (CGRP), proteins that cause migraine pain. CGRP inhibitors cost several thousand dollars a year, while neuromodulation devices usually cost several hundred dollars.

Older drugs used to treat or prevent migraine, such as triptans, antidepressants and over-the-counter pain relievers, are much cheaper and often come in generic formulations. Many Insurers require patients to try at least two of the older medications first -- and for months at a time -- before authorizing newer therapies.

“NHF believes it is inappropriate to require all patients to follow this ‘try two and fail’ model before they may be offered treatment with any FDA-approved migraine preventive, including neuromodulation devices, with established lower adverse event profiles,” the NHF said in a position statement.

“For patients who are highly impacted or disabled by migraine, clinicians should not be directed to deliver outdated models of care that apply a predetermined algorithm in a stepwise approach to all patients, without considering the needs of the individual patient, and that encourage the use of older preventive drugs when targeted and migraine-specific therapies now exist.”

The NHF wants insurers to adopt modified forms of step therapy for migraine sufferers, based on the severity of their disease and the frequency of their attacks.

For patients who have seven or fewer migraine days per month, the NHF recommends that patients be required to try only one generic drug for migraine prevention. For patients who experience 8 or more migraine days per month, the foundation recommends that providers have “unfettered access” to FDA-approved prevention drugs.

For the treatment of acute migraine pain, the NHF recommends that two generic drugs be tried first, but if the drugs fail to work within two hours or have unwelcome side effects, providers be allowed to select “another suitable therapy” based on a patient’s needs.  

“The NHF advocates that payers adopt care models that are patient-centric, where the clinician, in collaboration with the patient, is the primary decision-maker and selects a treatment that addresses the patient’s treatment goals and needs,” Dabertin said.

Although the NHF accepts donations from the pharmaceutical industry, Dabertin told PNN the foundation’s new position statement was based solely on input from patients and providers.

Insurer’s ‘Internal Policy’ Prevents Patients from Getting Needed Healthcare

By Barby Ingle, PNN Columnist

Patients, caregivers and providers have been fighting with insurance companies for years over step therapy practices, prior authorization delays and changes in specialty tier medications. If a claim is turned down by a payer, there is usually a way to appeal – such as a peer-to-peer review between a provider and a physician at the insurance company.

An insurance policy has come to my attention which ends peer-to-peer reviews and ultimately is a way to limit access to healthcare and avoid paying for certain treatments. Blue Cross Blue Shield of Kansas no longer allows physicians to speak directly to their medical director.

A peer-to-peer review occurs after receiving an authorization denial. Often the first denial is by a claims adjuster, who is usually not a medical professional. When that happens, the treating provider may request to speak with the insurer’s medical director to discuss the rationale for the denial. This process is sometimes referred to as a “doctor to doctor" appeal.  

Providers typically have a time frame where a peer-to-peer request must be made. For inpatient and pre-service requests, it is typically 5 business days. They have 60 days to complete the appeal from the date of denial.

Peer-to-peer requests are often not granted because they were made too late or there is insufficient clinical documentation. But they’re worth trying.

A Kansas provider recently requested a peer-to-peer meeting and received this email response from a representative of Blue Cross Blue Shield (BCBS) of Kansas:

“We used to have in our policy that we allowed requests for peer-to-peer reviews with our Medical Directors. We took that out a few years back and no longer give our providers that option. That is our internal policy.”

The email suggests this “internal policy” is not a known public policy or practice by BCBS of Kansas.

How are patients and providers able to get proper and timely care after an authorization denial if they are not able to request a peer-to-peer review?  I can see how this “internal policy” does save the insurer money over the short-term. But long term, not allowing physicians to speak directly to the medical director leads to delays and denials of care.

“Physicians are frustrated. Now this policy from BCBS of Kansas.  It is much easier to deny a piece of paper than a real human being.” says Gayle Taylor-Ford, a Kansas pain patient, provider and board member of iPain.

Step therapy and prior authorization policies are limiting access to healthcare for patients around the country. A recent study found that about 66% of prescriptions that get rejected at the pharmacy require prior authorization. Further complicating the situation is when a prior authorization is imposed, only 29% of patients end up with the originally prescribed treatment — and 40% end up abandoning therapy altogether!

This causes frustration, delay in care, depression, and poor adherence to treatment plans. The health of patients who don’t get the medication that could best treat their condition -- or who don’t get any therapy at all -- often gets worse. That leads to an increase in doctor and emergency room visits — and higher healthcare costs.

I wish we knew why BCBS of Kansas made this policy change. BCBS companies in other states still allow peer-to-peer reviews. Why is this a non-consistent policy and why is it even allowed in Kansas?

(Editor’s note: PNN asked for a comment from BCBS of Kansas and received this reply from a spokesperson: “While we appreciate you reaching out for comment, we respectfully decline to offer a response to the story.”)

There are already challenges in the peer-to-peer appeal process, as oncologist Rick Boulay, MD, described in KevinMD.com. Boulay wrote about his frustration getting cancer treatments approved when talking to the ‘insurance doctor’ who was supposed to be his peer.

“Most patients are unaware of this, but your physician is likely your biggest advocate when it comes to getting your care covered,” Boulay wrote. “At least weekly, and occasionally daily, insurance companies deny payment for some cancer treatment that I prescribe. In my career, I cannot think of a single aspect of the cancer care continuum that hasn’t been denied.”

At least Dr. Boulay was able to get peer-to-peer reviews and have some of those denials reversed. 

To deny our providers the ability to appeal is wrong. It’s just a new way to deny proper and timely access to healthcare. The fact that BCBS of Kansas is hiding its “internal policy” is also a sign that they know they are delaying and denying care that patients need.

It also raises a question. How many other insurance providers are doing the same thing?

Barby Ingle lives with reflex sympathetic dystrophy (RSD), migralepsy and endometriosis. Barby is a chronic pain educator, patient advocate, and president of the International Pain Foundation. She is also a motivational speaker and best-selling author on pain topics. More information about Barby can be found at her website. 

This column is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

How to Fight Step Therapy

By Barby Ingle, Columnist

With opioid medication becoming harder and harder to obtain, I want to put out some reminders of other access to care issues that we have had for many years. These challenges can’t be overlooked as we combat the fake news media on the opioid crisis and the lack of news coverage of the chronic pain epidemic.

Health insurance companies often find ways to delay or deny pain care, using step therapy, prior authorization, medication claw back, and poorly run clinical trials to keep their own costs down.

Step therapy is a tool that insurers use to control spending by requiring patients to try certain medications first before using more expensive drugs to treat whatever ails them. These “fail first” requirements mostly affect the care of chronically ill patients. Studies show that nearly 60% of commercial insurance companies use some form of step therapy. And three out of four large companies offer employees insurance plans that use step therapy practices.

Requiring patients to try less effective medication delays access to the best treatment and allows some diseases to progress. This lack of proper and timely care denies patients the drugs they need when they need them, and allows insurance companies to practice medicine without a license.

Many patients can’t afford to wait or forgo needed medications. As these patients physically deteriorate, it only adds to future healthcare costs and increases the risk of non-compliance and self-medication.

Currently there are laws protecting patients from step therapy in over a dozen states, including California, Connecticut, Iowa, Illinois, Indiana, Kentucky, Louisiana, Maryland, Missouri, Mississippi, New York, Washington and West Virginia. But even in these states, there are often holes in the law that need to be addressed. In California, for example, the law only relates to fail first exceptions and uniform prior authorization forms.

Various groups such as the New Mexico Fail First Awareness Coalition, Minnesota Coalition on Step Therapy, Illinois Pain Alliance, Indiana Pain Alliance, International Pain Foundation, Kansas Affordable Access to Medication Coalition and others are working on pending legislation to stop step therapy practices in Florida, Georgia, Massachusetts, Maine, Minnesota, New Mexico, Ohio, Oregon, Rhode Island, Texas, Utah and Virginia.

There is also a step therapy bill in Congress sponsored by Rep. Brad Wenstrup of Ohio called the “Restoring the Patient’s Voice Act of 2017.” It requires insurers to have a clear and speedy process for patients to request an exception to the step therapy protocol.  In cases where the life and health of a patient are jeopardized by step therapy, the request must be granted no later than 24 hours after it is received.

For all of these state and federal efforts, the pain community needs patients to share their stories of how insurance practices have harmed them or denied them medication that is helpful.

What can you do? If you have already experienced step therapy and found it delayed your care, I suggest you speak out about the impact it has had on you. Talk to your congressional representatives and let them know how it has affected you.

An easy way to do this advocacy work is to call 1-844-872-0234 and wait for the automated message. Press 1 and enter your 5-digit zip-code. This will connect you to the office of a U.S. senator for your state. After the call concludes, it will automatically connect you to your other senator and then your representative in the House. Sometimes a live person will answer or you could be instructed to leave a message.

Craft a personalized message, such as “Good morning. My name is (name), and I am a constituent from (city, state). I am a chronic pain (patient, caregiver, family member or provider). I am asking for your support to help the pain community by supporting step therapy legislation for people in pain living in our state. Thank you.”

It is a simple way to become an advocate and make a difference. I hope that you will find it in you to be a cheerleader of hope, and fight for access to proper and timely care for yourself and others in the pain community.

Barby Ingle lives with reflex sympathetic dystrophy (RSD), migralepsy and endometriosis. Barby is a chronic pain educator, patient advocate, and president of the International Pain Foundation. She is also a motivational speaker and best-selling author on pain topics.

More information about Barby can be found at her website. 

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Power of Pain: Facing Insurance Challenges

By Barby Ingle, Columnist 

You may have heard about singer Avril Levine’s battle with Lyme disease, a tick-borne illness that left her bedridden for months with debilitating pain and fatigue.

It took a long time for Avril to be diagnosed correctly by doctors. She had to keep researching and advocating for herself before she was finally given proper treatment – a problem faced too often by people with chronic pain and illness.

Sometimes doctors cause these delays, but often insurance companies are responsible.

Americans receive their health care coverage from a variety of sources; through their employers, self-purchased policies, and public programs such as Medicare or the Affordable Care Act.

As the cost of healthcare rises, consumers have seen a significant hike in premiums and out-of-pocket expenses such as deductibles, copayments, and other cost sharing.

Insurance companies are also working to keep their costs down, through policies such as prior authorization, “step therapy” requirements, and specialty tier pricing on medications.

It can be a battle that is time consuming, frustrating, and depressing when an insurance company denies payments for a medication, procedure or medical device. Sometimes the issue is due to a provider entering the wrong code, but most often it is a cost savings issue. Insurance companies can make blanket denials and question whether a certain treatment is appropriate for you. 

What can be done to change this?

Step Therapy and Fail First

We need to abolish the unethical “Step Therapy” or “Fail First” practices by insurance companies – which require a patient to use a different (and usually cheaper) medication than the one prescribed by their physician.

There are patients from all over the United States reporting how they are being forced to switch from one drug to another. This has personally happened to me twice. Both times, I fought the ruling using my medical records and providers support, and the insurance company reversed the decision. However, others are not so lucky. In my case, I had already tried all of the medications that the insurance company was willing to pay for, and I had documented records stating my reaction to each of the medications.  

Usually, a patient can tell immediately whether a medication is working or not, and they should not be forced to stay on drugs that don’t relieve their symptoms. Applying step therapy protocols rigidly to a chronic care patient is not in their best interest and simply creates more challenges.

This practice is especially hard on pain patients who are women, minorities, and economically disadvantaged. Studies have shown these groups are most affected and are either disproportionately undertreated or untreated for pain. We must urge insurers to reduce health disparities in our communities.  

If you are faced with a step therapy situation, what can you do? I would suggest you appeal immediately. If you have already tried that medication, get copies of your providers’ records, and your journal entries, and submit them with your appeal.

You can use a journal to help the provider document how step therapy drugs fail to help or make things worse.  Note when complications and bad side effects occur, and report them to your doctor.

You should also have your provider fill out and submit a Medform 3500 to the Food and Drug Administration when you have a bad reaction to a medication or medical device. Send a copy to your insurance company. That documentation can increase the chances of a successful appeal  favorable to you.

Prior Authorization

There are many insurance plans that require prior authorization for expensive drugs or treatments and they may not provide coverage if you do not get prior approval. Once again, this tactic is used as a cost containment measure. Prior authorization covers the correctness, suitability, and coverage of a service or medication. 

The process differs with each plan, but is supposed to ensure that a patient will receive the appropriate level of care in the appropriate setting. This is actually a technique for minimizing costs, wherein benefits are only paid if the medical care has been pre-approved. It can delay care months to years, and can be life threatening and health deteriorating to the patient in many ways. 

Services that may require prior authorization include hospital admissions, back surgery, hysterectomies, maternity stays longer than 48 hours, observational stays, cosmetic procedures, experimental and investigational procedures, and some outpatient procedures.  

Specialty Tier

Insurance companies have divided medications and treatments into four main insurance tiers, based on type and price. The top and most expensive tier is known as the “specialty tier” or “tier 4 medications.”

Insurance companies classify the most innovative, expensive, and most essential to life medications as specialty tier.  These drugs can cost hundreds to thousands of dollars each month. Patients with chronic illnesses such as arthritis, Reflex Sympathetic Dystrophy, hemophilia, HIV/AIDS,  Crohn’s disease, Hepatitis C, multiple sclerosis, and many forms of cancer need these medications to help them function on a daily basis.  

According to the National Minority Quality Forum, 57 million Americans depend on specialty tier drugs that are often expensive and have no generic form yet available. 

With specialty tier pricing, a patient often pays a co-insurance instead of a co-pay, resulting in an out of pocket cost that can become astronomical. This often happens to patients who are  disabled, need catastrophic care, and have little or no income.

It is difficult to appeal specialty tier pricing decisions, as the medications are classified and a list is available to the insured at the time of coverage or when a medication is released to the market.

Many patients and providers give up when they get the first denial letter from an insurance company, but it’s important to keep fighting. An appeal can show a pattern that other patients with the same condition also need the same treatment. This can lead to an easier situation for other patients down the line, or if you need the procedure repeated.   

Barby Ingle suffers from Reflex Sympathetic Dystrophy (RSD) and endometriosis. Barby is a chronic pain educator, patient advocate, and president of the Power of Pain Foundation. She is also a motivational speaker and best-selling author on pain topics.

More information about Barby can be found at her website.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.