Step Therapy Reform Will Help Physicians Put Patients First

Although many people have heard of the Hippocratic Oath, they may not be familiar with the Declaration of Geneva, which was adopted in 1948 by the World Medical Association to define a physician’s dedication to the humanitarian goals of medicine. The declaration is intended as a modern formulation of the oath’s moral truths, and includes a statement that every physician takes to heart: The health of my patient will be my first consideration.

Unfortunately, patients aren’t always able to benefit from the treatment plan and medications that physicians prescribe. Some patients are forced to try one or more medications that end up not helping them before insurers allow the recommended treatment path.

This approach is called “fail first” or “step therapy,” and is intended to control costs associated with prescription drugs by starting with the most cost-effective drug therapy and then progressing to other costlier therapies only if necessary. While this may seem like a good idea, it often subverts the physician’s judgement and discretion and places patients at more risk than necessary. Instead of focusing on which medication is best for the patient, priority is given to medications which may cost less but also may be less effective.

In our gastroenterology practice in Cincinnati, we use a broad spectrum of medications to treat patients with digestive disorders like inflammatory bowel disease. Moderate to severe IBD can potentially lead to hospitalization, surgery and disability. Our individualized medication recommendations focus on controlling active disease and maintaining health, and many of the newer medications are more effective. They are often less toxic for our patients as well. A study comparing spending in Georgia’s Medicaid program found that while there were savings in the cost of medications when “step therapy” was used, the program spent more money on outpatient services because less-effective medications often led to higher health costs later.

A common experience with “step therapy” for a patient diagnosed with moderately active Crohn’s Disease or Ulcerative Colitis, requires multiple follow up appointments over 3-6 months. If there is still no improvement – as we often expect – we can then request our first choice of therapy a second time. If approved, yet another appointment is needed to initiate the new medication. Throughout this months-long delay, the patient remains ill, is sometimes not able to work. All while the disease worsens, perhaps creating a long-lasting impact on the patient’s health.

The medications that gastroenterologists prescribe are not the only drugs insurers are subjecting to “step therapy.” Treatments for arthritis, diabetes, multiple sclerosis, and cancer are also being denied in favor of a less expensive therapy on which the patient must “fail first.”

Efforts are underway at the state and federal levels to change this practice. More than a dozen states have passed “step therapy” reform (for state regulated plans) in recent years and more are considering similar legislation, including our state of Ohio.

At the federal level two physicians, Rep. Brad Wenstrup (R-Ohio) and Rep. Raul Ruiz (D-Calif.) have proposed legislation to bring protections to those who have federally regulated insurance. The “Restoring the Patient Voice Act” (H.R. 2077) will give healthcare providers the final say in how to treat our patients. Under the proposed federal bill, the “step therapy” process would become more transparent, requiring health plans to provide a reason for denying a prescription drug – and cost cannot be the only basis for the decision. Patients and their doctors would also have the option to override the decision if the treatment option identified by the insurer is likely to be ineffective based on the patient’s medical history or clinical practice guidelines.

H.R. 2077 does not ban the practice of “step therapy,” but rather provides a clear process to appeal “step therapy” decisions, and ensures that the most appropriate treatment options are available for doctors to prescribe. It does not limit the number of steps that can be required, or ban prior authorization for medication, but rather makes the process more transparent and avoids undermining clinicians’ medical expertise in diagnosing and recommending treatment protocols for patients, rather than simply relying on a preset formulary.

Physicians like us are driven by a responsibility to protect the health of our patients and communities. Our elected leaders at the state and federal level should help us fulfill our duty and the oath we took to put our patients first by reforming “step therapy” policies and allowing our patients to benefit from the treatments we prescribe on a timely basis.

Michael D. Kreines is a practicing gastroenterologist with Ohio Gastroenterology and Liver Institute in Cincinnati, chief of gastroenterology at The Christ Hospital of Cincinnati, and a founding member of the SW Ohio Chapter of the Crohn’s & Colitis Foundation of America. Pradeep K. Bekal is a practicing gastroenterologist and president of Ohio Gastroenterology & Liver Institute in Cincinnati, and also serves on the executive committee of the Digestive Health Physicians Association.

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