Whales sometimes beach themselves, but because of insufficient evidence, we don’t know why. There are several plausible explanations for such strandings: they get stuck in shallow waters while hunting prey or trying to escape a predator; they make a navigational mistake or become disoriented by sounds or changes in electromagnetic fields; they respond to other beached whales in distress. Some species of whales follow a leader, and from human behavior we know that leaders can take followers astray. It is reasonable to assume that some whale misadventures are due to faulty guidance.
There are guidelines some payers must follow, and guidelines some payers want to follow. The Affordable Care Act (ACA) requires all fully and self-insured plans, except those that are grandfathered, to cover in full any services recommended by four expert medical and scientific bodies, including the U.S. Preventive Services Task Force (USPSTF) and the HRSA-sponsored Women’s Preventive Services Initiative (WPSI). Many payers voluntarily base cancer-coverage policies on National Comprehensive Cancer Network (NCCN) guidelines and, in doing so, shift the burden of oncology market access decisions. While evidence-based guidelines often help payers save lives, they can also result in misadventures.
Evolving guidelines
Evidence-based guidelines evolve as new evidence emerges from a sea of trial evidence, updated analyses, and long-term follow-up data.
For example, in 2016, the USPSTF recommended initiating the use of low-dose aspirin for the primary prevention of cardiovascular disease (CVD) and colorectal cancer (CRC) in adults aged 50 to 59 who:
- Have a 10% or greater 10-year CVD risk
- Are not at increased risk for bleeding
- Have a life expectancy of at least 10 years, and
- Are willing to take low-dose aspirin daily for at least 10 years
In 2022, the USPSTF lowered the age range of its recommendation on aspirin use to prevent CVD. And based on new evidence, the USPSTF concluded that the evidence is inadequate that the use of low-dose aspirin reduces CRC incidence or mortality. While low-dose aspirin therapy is dirt cheap, the obsolete requirement to cover this therapy for CRC was, in hindsight, a misadventure.
CRC screening is another interesting example of changing guidelines. In 2016, the USPSTF recommended CRC screenings starting at age 50 and continuing until age 75. In 2021, the USPSTF amended its guideline, recommending CRC screening beginning at the age of 45. By the way, the current NCCN guideline is aligned with CRC screening starting at age 45.
While payer misadventures stemming from guidance based on outdated evidence are inevitable, more frequent updates would reduce avoidable mishaps.
Conflicting guidelines
Sometimes evidence-based guidelines conflict, but this typically reflects how current the guidelines are.
For example, WPSI recommends that women aged 40 to 74 with average-risk for breast cancer receive screening mammography on a biennial basis, whereas the USPSTF recommends biennial screening only for women age 50 to 74. To add to this dissonance, the USPSTF says that the decision to start screening mammography before age 50 should be an individual one, and younger women who place a higher value on the potential benefit than the potential harms may choose to begin biennial screening between the ages of 40 and 49. The guideline noted that, at this age, screening mammography may potentially have a greater benefit for women who have a first-degree relative (parent, child, or sibling) with breast cancer than in average-risk women in this age group.
In this instance, most payers are required to follow the WPSI recommendation because the target population is broader. Interestingly, the WPSI guidance notes that women at increased risk should also undergo periodic mammography screening, although WPSI is silent about the frequency of screenings or the need for additional services, recommendations for which are beyond WPSI’s scope.
The current NCCN guideline aligns with the WPSI guidance on age but is misaligned with both WPSI and USPSTF regarding frequency. NCCN recommends annual screening mammograms for those age 40 or older with average risk. For those with increased risk (e.g., due to family history or thoracic radiation therapy), NCCN recommends beginning screening mammography 10 years prior to when the youngest family member was diagnosed with breast cancer (but not before age 30), or begin at age 40, whichever comes first.
NCCN’s guidance on the target population and frequency of screening mammograms is based on more current evidence than the USPSTF and WPSI guidelines. How many payers follow the WPSI guideline because they are required to do so rather than voluntarily following the NCCN guideline? And, as a result, how many women at risk are left stranded without coverage? While an update to the USPSTF is in progress, the older guidance from both USPSTF and WPSI may lead to some misadventures in the interim.
The march of science
Fortunately, with the passage of time, new evidence emerges. We get smarter. And evidence-based guidelines can also help navigate payers closer to the truth. But payer policies grounded in evidence-based guidelines are current only to the extent that the guideline is current. We should not be surprised that guidelines and related coverage policies change over time, but we should be very frustrated if the guidelines and related coverage policies are not current.
Given the rapid advancements in the field of cancer research and management, payers’ cancer-prevention policies should not be based on USPSTF guidelines if those guidelines don’t keep pace with the evidence. Congress authorizes the Agency for Healthcare Research and Quality (AHRQ) to convene the Task Force and to provide it with ongoing scientific, administrative, and dissemination support. Each year, the Task Force submits a report to Congress identifying critical evidence gaps in research related to preventive services and recommending priority areas that deserve further study. Perhaps Congress or AHRQ should make support to the Task Force contingent upon more frequent updates to cancer-related guidelines. Alternatively, Congress could outsource or threaten to outsource the ongoing and iterative review and development of cancer prevention-related guidelines to NCCN. Let’s not view the pace of USPSTF guideline updates like a beached whale.
If the evidence-based guidelines that payers are required to follow were current, then we could be more confident that coverage policies would not lead to misadventures and not leave patients stranded.
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