As physicians have expressed with increasingly louder volume in the last decade, one of their primary sources of frustration continues to be the prior authorization (PA) process. For years, doctors have lamented the administrative and financial impact of prior authorizations, as well as appeals for denials and mandatory reauthorizations for each new prescription. This laborious process is especially the case with rare disease therapies, almost all of which require PA.

"Sometimes the nurses are on the phone 30 minutes to one hour. Sometimes they'll have spoken to four people before they speak to the person they are supposed to," commented a doctor about communications with payors regarding PA in an influential AMA 2016 survey. "Pre-authorizations for us definitely require a couple of full-time people. It's a financial burden that's unnecessary for physicians to have to pay," wrote another about managing payor requirements for PA.

In 2018, a welcome collaboration between healthcare providers and payors were detailed in a consensus statement which included: defining criteria for selective application of PA; annual reviews of therapies to identify those that no longer warrant PA; improving communication between health plans, providers, and patients regarding PA requirements; ensuring patients' continuity of care when PA is needed; and moving toward automation for enhanced efficiencies.

Despite widespread recognition of the problem, progress has been slow. In 2019, the Council for Affordable Quality Healthcare (CAQH) reported that PA's time per manual transaction increased from 16 minutes the previous year to 21 minutes, with a corresponding increase in cost from $6.60 to $10.92. In 2020, total spending on prior authorization increased to $767 million, with 86% of the expenditure incurred by providers.

It's not surprising that Dr. Jack Resneck, immediate past chair of the AMA board of trustees, told Medical Economics, "The data show that the things that cause burnout are the things that get in the way of why you went into medicine in the first place, such as being able to provide the kind of care you want to provide to your patients. Prior authorizations have risen to the top of that list. It is incredibly frustrating not to be able to get your patients on the therapies that they need to get better." He also discussed the overall administrative costs stating, "When you think about the amount of time that every practice is having to spend doing this, and the amount of time that health plans are spending on the other end processing our requests and our appeals, it seems to me there's a tremendous amount of waste here."

At the end of 2020, a new AMA survey revealed many PA challenges remained, with reforms yet to be widely implemented, with findings that included:

• Almost 90% of physicians stated that the PA process delays their patient's access to necessary care and interferes with the continuity of care.
• 75% of physicians reported that issues related to the prior authorization process could cause patients to abandon their recommended course of treatment.
• 28% of physicians reported that preauthorization has led to a serious adverse event for a patient in their care.
• The administrative burden was significant, with physicians spending two business days (16 hours), managing 35 to 40 PAs per week.

Fast forward to October 2021: the Medical Group Management Association's Annual Regulatory Burden Report revealed that prior authorization was rated as 'very or extremely burdensome' by almost 90% of the physicians polled. The lack of progress was seen in response to the question: "How did payor prior authorization requirements change since 2020?" with the following reactions:

• 81% stating the PA requirements increased
• 17% stating the PA requirements stayed the same
• Only 2% rated the PA requirements as decreased

Respondents noted increasing rates of claim denials, slow responses, lengthy holds for phone calls, and requirements that vary by the payor. Their comments were hauntingly similar to those made five years before, including, "The requirements and inconsistencies have repeatedly delayed care and have required us to hire additional staff simply to keep up with the ever-changing prior authorization environment" and "Prior authorizations are incredibly time-consuming and often lead to multiple attempts to try to get patients the care they need."

Specialty Therapies Caught in the PA Predicament

Nearly half of drug spending is now on specialty drugs, a trend sure to rise as over half of the drugs approved by the FDA in 2020 fall into this category. Despite their growing prevalence, the PA process for essential specialty therapies reflects the same frustrations physicians feel regarding increased costs, uncompensated time, and obstacles to patient access, compliance, and satisfaction.

The PA process was examined from both physician and patient perspectives in an eye-opening 2021 Medication Access Report from CoverMyMeds, which highlighted some of the most prominent issues:

• One in four patients surveyed reported delays due to their medication requiring a PA.
• One in 10 patients experienced delays in receiving medications due to delays at their provider's office.
• 82% of physicians listed PA as a time-consuming part of their workday.
• Care teams and patients can spend more than two weeks trying to resolve prior authorizations alone.

It's a certainty that PAs will continue to increase in the future, as industry estimates predict a 20% rise per year in the number of drug PAs (IQVIA: Medical claims analysis, 2021), and by 2030 there could be 60 marketed cell and gene therapies, treating 350,000 patients cumulatively. 

Tap Into Specialty Pharmacy Expertise

While ongoing development and increased use of electronic PA (ePA) tools and proposed legislative changes may offer hope in the future, a specialty pharmacy like Orsini, with a laser focus on physician and patient satisfaction, provides unparalleled partnership and guidance now, and in the future. As an independent rare disease specialty pharmacy, Orsini leverages the following to expedite the PA process, assist with appeals, and prepare for reauthorizations:

• Over 525 direct payor agreements with the nation's largest health plans
• Certified status as a Medicaid provider in nearly every state
• Years of experience
  
  

What is the Process of Working with Orsini?

1. Our highly effective 'white glove' approach for certain medications begins with well-trained staff on therapy-specific benefit plan requirements.
2. When a PA is needed, we follow up immediately with the health plan to confirm requirements and assist the physician's office in completing the required forms and obtaining the supporting documents for submission.
3. If a PA is denied, we explore every possibility of starting the patient on therapy, identifying the cause for denial, and work with the physician's office to prepare an appeal based on the denial letter and patient clinical information.
4. We monitor reauthorization deadlines closely and start preparations with the physician's office six weeks in advance to ensure no lapse in therapy occurs.

The results were some of the industry's quickest turnaround times and an incredibly high success rate with PAs on behalf of our clients.

The relentless persistence and inspired collaboration needed are reflected in the Orsini team's recent effort to provide Duchenne muscular dystrophy therapy to a family in need. While a dedicated rep began contacting insurance networks to resolve the claim denial, two other Orsini team members continually shared reassuring status reports with the worried family. Another worked hard to receive the final green light for authorization and delivery. "We were finally able to ship, ensuring the patient will not miss a single dose," shared Orsini therapy manager Joel Flores, "and this was no small feat. It's a pleasure working with the dedicated healthcare professionals on this team."

Learn more about Orsini Specialty Pharmacy's essential services for rare disease therapies, supporting patients, physicians, payors, and manufacturers in our mission to improve care, simplify processes and achieve better outcomes.