In last month’s blog post, we noted that one strategy for converting a negative to a positive coverage policy involves encouraging payers to revise their evidence requirement(s). For example, a payer policy states something along the lines of “large-scale, randomized, blinded clinical trials with long-term follow-up are required to validate the safety and efficacy of this technology.” From both the manufacturer and provider point of view, given the initial favorable results of controlled studies, such trials are simply not feasible and, in some cases, unethical to conduct. Essentially the payer has established an evidence standard that is impossible to meet in the short-term and, probably, in the long-term as well. How can manufacturers and providers get payers to revise their evidence requirement(s) and accept the existing body of evidence?

Certainly, presenting the clinical evidence to payers is the most efficient method of gaining coverage; this top-down approach can be applied simultaneously across all payers. When this strategy is unsuccessful or hits a wall, a ground-up approach is required, relying on consistent and steady support from local physician champions that demonstrates broad acceptance of a technology. Direct, one-on-one interaction between local providers and payers is one aspect of this ground-up approach, but denials overturned on appeal (ideally, preauthorization denials vs. payment denials) are another powerful demonstration of physician support. In addition, such overturned denials, particularly if they involve outside third-party reviews (external reviews), are paid for out of the payer’s limited administrative budget. A consistent pattern of overturned appeals demonstrates the futility of maintaining the existing negative coverage policy and forces payers to make a business decision whether or not to maintain the high-evidence bar or rather to modify the evidence standard and accept the existing data.

Therefore, the appeal process is an important component of an overall reimbursement strategy. Typically, the process is initiated at the level of preauthorization/precertification. The provider can appeal a denied preauthorization one or two times internally with the payer (the initial denial may be noted by a nurse or payer professional, and the next level of review will typically be triaged to an internal medical director). While a patient’s particular circumstance may result in a positive coverage determination for the patient during one of these internal appeals, this represents a one-off individual case review and is unlikely to impact the overall coverage policy. If the denial is upheld, an external appeal may be the next option. As a general rule, an external appeal (also known as an independent medical review) may be pursued only after the health plan’s internal appeals process has been exhausted. An external appeal is generally requested through the States’ Department of Insurance, and if approved , conducted by an outside, independent review organization (IRO). This external review process is a required protection afforded by the Accountable Care Act (ACA).

However, a new, disturbing trend has emerged over the past year to two years: payers have begun to essentially shut down the preauthorization/predetermination process for services considered , “investigational” or “experimental”. Such payers include a number of BlueCross BlueShield plans, Aetna, and AmeriHealth. This tactic seems contrary to the efforts made under the Affordable Care Act to protect patients’ rights. Under the ACA, patients have the right to appeal adverse coverage decisions and the right to request reconsideration. In this situation, where preauthorization is not an option, the only recourse would be for patients and their physicians to proceed with the non-covered service, and then initiate the appeals process after the costs have been incurred. However, in this situation, there is also the risk of not getting reimbursed from the payer for non-covered, out-of-pocket health care costs.

This practice seriously undermines the ability to demonstrate physician acceptance of a technology and reverberates beyond simple coverage. For example, the CPT advisory committee will only consider a new CPT code if there is demonstrated utilization of a technology. The lack of a preauthorization appeal mechanism will inhibit utilization and will stall the CPT process, leading to a prolonged use of unlisted codes or Category III CPT codes, which payers may consider investigational and thus non-covered by default. This is a vicious circle: a new CPT code requires utilization, but there is minimal utilization without a recognized CPT code. The appeal mechanism was one of the most effective ways of “cracking” this cycle, but now payers appear to be trying to close that door. Patients and manufacturers are encouraged to make this situation known to advocacy organizations and trade associations, such that this important right is not further diminished.