Addressing Step Therapy Will Improve Patient-Centered Care and Reduce Paperwork

By Randall Rutta, Executive Director, Let My Doctors Decide

Strong and strategic clinician-patient relationships are essential to drive forward meaningful efforts on achieving positive outcomes for patients and facilitating a more workable system for all health care stakeholders. That’s why in AARDA’s joint filing with Let My Doctors Decide to the Department of Health and Human Services Centers’ Medicare and Medicaid Services (CMS) Request for Information on the Patients over Paperwork initiative, we strongly support a simple, critical goal: treatment decisions should always be made by patients and trusted health care professionals, not insurance companies or pharmacy benefit managers.

We commend HHS for its Patients Over Paperwork initiative to reduce unnecessary burdens and strongly advocate for policies that will enhance patient health, reduce clinician burdens, and system costs, however, there remains a significant disconnect between reality and policies that do not support patient-centered care, with serious negative implications for the most vulnerable patients.

In our filing and recommendations, we address the serious implications of access restrictions and misguided “one size fits all” approaches that add—rather than reduce—administrative burdens and that create barriers for patients and interfere with clinician-patient relationships. For example, rules and policies that expand onerous utilization management policies and other administrative hurdles that restrict access to care significantly undermine key principles of patient-centeredness and are overly burdensome for providers and individuals living with autoimmune diseases and other serious and chronic conditions.

In a study released earlier this year by Let My Doctors Decide, the vast majority of Medicare Part D and Medicare Advantage plans place significant prior authorization and step therapy restrictions on access to medicines for common autoimmune conditions. While the Patients Over Paperwork initiative could potentially address patient-centered care, health care innovation, and improved clinical outcomes, increasing the use of prior authorization and step therapy for non-medical reasons directly undermines the powerful force of the clinician-patient relationship, adds significantly to administrative burden, and increases unnecessary costs for patients, providers, and, ultimately CMS.

A recent American Medical Association (AMA) survey of 1,000 practicing physicians revealed that more than nine in 10 respondents said that prior authorization had a significant or somewhat negative clinical impact on patients. In the survey, 28 percent of doctors reported that prior authorization led to a serious adverse event for a patient, such as death, hospitalization, disability, permanent bodily damage or other life-threatening issues.  This is unacceptable, and yet it is representative of the costly, avoidable medical issues that arise when decision-making is driven by economic priorities instead of clinical reasons.

The AMA survey also showed that 85 percent of physicians reported that the administrative burden of prior authorization is “high or extremely high,” diverting time away from patients and adding significantly to physician expenses.

Similarly, a national survey published in Health Affairs found that on average, physicians spent the equivalent of three hours per week - and nearly three weeks per year - on interactions with health plans. Nurses reported an average of 3.8 hours per week, and administrative staff spent 29.8 hours per week. The survey reported that dealing with drug formulary requirements took the most physician time. Overall, the survey found that those added administrative costs amounted to $68,274 per physician per year in 2009. Since the study was published in 2009, physicians have reported that health plan use of prior authorization has increased, particularly in the past 5 years.

We strongly recommend CMS adopt several changes to address these challenges:

  • Require use of standard prior authorization forms, electronic filing, minimum response times, and other standard protocols to participate in Medicare and/or Medicaid.

  • Prohibit the practice of non-medical switching of treatment regimens. For persons with complex conditions who are already stabilized on a therapy, it is not appropriate to impose automatic substitutions or non-medical switching made by a payor without the intervention of or consultation with the prescriber and consent of the patient.

  • Establish mandatory policies that exempt patients, once stable on therapy, from step therapy or other prior authorization requirements to continue on their current therapeutic regimen. CMS should adopt a single, standard form that meets any documentation required to establish stability on therapy and require that patient coverage continue without additional requirements.

 In addition, the CMS Final Rule issued earlier this year included policies to facilitate increased use of utilization management tools by Medicare plans and to permit the previously-prohibited use of step therapy requirements by Medicare Advantage plans for Part B drugs. We are also deeply concerned about changes that may reflect an overarching trend toward policies that restrict, rather than facilitate, patient access to necessary and appropriate care that are contrary to the clinical needs of patients and significantly increases regulatory burden. These policies add burdens and more paperwork for providers and patients and create barriers to accessing medically-necessary care. The changes also jeopardize efforts to ensure that Medicare beneficiaries living with autoimmune and other serious diseases receive the clinically-appropriate treatment that they and their physicians determine to be best for them.

We urge CMS to reconsider existing policies that facilitate step therapy requirements and, in addition, to restore the prior position of the agency that prohibited the use of step therapy for Part B drugs in Medicare Advantage based on relevant statutory provisions.

Transparency is also critical, and we strongly encourage CMS to empower beneficiaries with information required to make informed decisions. People should know – up front -- what their health plan covers and what their cost responsibilities are. Policies that undermine informed decisions and transparency are unfair to patients, their families, and health care teams, and are extremely burdensome and add unnecessary paperwork and administrative hurdles and run counter to the important goals and objectives of the Patients Over Paperwork initiative.

We share CMS’ goals to reduce unnecessary burdens, increase efficiencies, and improve the beneficiary experience. While we understand the desire to contain costs, we do not believe that restricting patient access to appropriate therapies recommended by their treating physicians is the solution. We believe that treatment decisions should be made by patients and health care professionals, not insurance companies or pharmacy benefit managers. We urge CMS to support and advance policies that put patients first, and that do not place unnecessary administrative burdens and barriers to access between patients and their health care providers.

Let MI Doctors Decide