You’ve probably heard the phrase “raise the bar.” While its origin is based on the high jump and pole vault, it is often applied to a personal or organizational context for which more challenging goals, targets, or standards are set.
Payers often require prior authorization (PA) before covering a procedure, service or medication. When a PA is required, one or more criteria must be met unless there is a medical exception. Payers often “PA to label,” meaning the PA criteria match the approved indications. But sometimes they raise the bar, adding clinical trial inclusion/exclusion criteria to the PA criteria.
10 reasons payers raise the bar
1. When payers fear population creep. Until real-world evidence emerges, the only evidence that a treatment is safe and effective is that from the clinical trial. And that evidence was based on a population defined by trial inclusion/exclusion criteria. Will the treatment work the same in other populations (younger, older, sicker, healthier)? Maybe, but maybe not. Payers can have legitimate questions about efficacy and concerns about safety when treating other populations.
2. When there is a lack of supporting evidence. Much to payers’ dismay, the FDA label is sometimes broader than the evidence. Sometimes, approval is based on a surrogate measure that has not been validated and despite uncertainty about the clinical benefit (think Aduhelm). And all too often, there are no head-to-head comparisons or clear proof of improvements that are clinically significant. Payers do not want to take a leap of faith.
3. When there is guideline support. Sometimes, evidence-based guidelines support additional PA criteria. Treatment algorithms may give payers a green light to apply step-therapy requirements, especially if that was also part of the trial criteria.
4. When the treatment is expensive. Clinical trial inclusion/exclusion criteria are more likely to be added to PA criteria for more expensive treatments, as the potential ROI for more aggressive management increases in tandem with the cost of a treatment. For expensive treatments, the cost of appeals is a small fraction of the potential cost savings. And the likelihood that a payer will add trial criteria to PA requirements increases in step with the delta between the costs of a new treatment and the standard of care.
5. When there is less sensitivity. Trial inclusion/exclusion criteria are less risky for conditions with lesser advocacy or urgency. There is often less sensitivity for chronic conditions that are not life threatening.
6. When self-insured employers demand it. Self-insured employers can aggressively restrict and even block access to certain treatments in pursuit of cost savings. When self-insured employers engage payers to provide administrative services only, payers give them what they want.
7. When there are no external reviews. Employees in a self-insured company typically don’t have external appeal rights (although some union contracts include such rights). So, more aggressive management does not incur the higher cost of appeals that go to external review.
8. When providers agree. Payers leverage trial inclusion/exclusion criteria only when their P&T or medical technology committees agree. Those committees consult with specialists in their provider networks who, often, are the KOLs at centers of excellence that participated in the trials. These specialists may support raising the bar.
9. When trying to extract larger rebates. Payers will sometimes add trial inclusion/exclusion criteria in an attempt to get manufacturers to negotiate their way out of such criteria. In essence, payers signal to manufacturers that they must pay to play. Manufacturers can then buy access to a larger population or earlier line of treatment. And payers can use a PA to label as their fallback position.
10. When other payers do it first. Payers watch each other. If other payers — especially large, high-profile payers — add trial criteria to PA criteria without a backlash, other payers are more apt to follow.
7 reasons payers don’t raise the bar
1. When there is strong, conflicting evidence. PA criteria not aligned with the peer-reviewed evidence are more likely to be challenged, and denials are more likely to be appealed and overturned. If too many denials are overturned, then why do it?
2. When there is no guideline support. Trial criteria not aligned with evidence-based guidelines are vulnerable. For instance, by allowing NCCN guidelines to drive their oncology access decisions, payers defer to the evidence and avoid controversy. Payers may be out on a limb if PA criteria include trial criteria not supported by guidelines. Worse yet would be adding trial criteria that conflict with guidelines.
3. When the treatment is not too expensive. The cost of appeals may not be offset by savings when the difference in cost between a treatment and a less-expensive standard of care is small.
4. When there is more sensitivity. Cancer care and pediatric care are often viewed as the proverbial third rail payers are reluctant to touch. The six Medicare Part D protected classes (e.g., antidepressants, antipsychotics, anticonvulsants, immunosuppressants for treatment of transplant rejection, antiretrovirals, and antineoplastics) are often hands-off where PA would otherwise be permitted for new starts (excluding antiretrovirals, for which PAs are not allowed in any case). The sensitivity surrounding these six classes often spill over onto other books of business.
5. When state mandates prohibit it. States may require insurers to offer at least one plan that includes mandated offerings, and this may conflict with trial inclusion/exclusion criteria that may otherwise be added to PA criteria. For example, most states have mandates allowing off-label use of cancer drugs.
6. When there are external reviews. The potential cost of an appeal rises when beneficiaries have a right to an external appeal. Such is the case with Medicare beneficiaries, Medicaid eligibles and some union employees. The cost of defending an appeal that goes to external review ranges from $1,500 to $3,000. This risk may give payers pause before bolting trial criteria onto PA criteria.
7. When providers disagree. Payers seek input from providers prior to making policy decisions. Sometimes, clinical trial criteria are added to make the study look good but have no meaningful clinical basis. Providers would surely reject the addition of such criteria. When providers disagree with a raised bar, provider satisfaction falls. Provider satisfaction is important to maintaining an adequate provider network. Which specialists are handled with kid gloves? Oncologists. Many roads lead back to cancer treatment!
Clearing the bar
When competing, high jumpers and pole vaulters get three attempts to clear the bar and advance to the next height. As the height increases, the number of athletes remaining in the competition decreases. When payers raise the bar for PA criteria, fewer patients will clear the bar — and this outcome is quite intentional.
Payers often set the bar low and simply “PA to label” because that’s the “right” thing to do under those conditions. But when the conditions are right, payers may raise the bar and “PA to trial.” If the bar is set too high or too low, then payers may make multiple attempts to readjust the height to land on the “right” PA criteria.
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