Richard H. Hughes, IV, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, authored an article in Health Affairs, titled “Clinical Preventive Guidelines Should Foster Patient Access: A Reply to Killelea and Johnson.”

Following is an excerpt:

In their recent response to my earlier article, Amy Killelea and Jeremiah Johnson take a position that overlooks patient access concerns and undermines innovation toward newer and better forms of PrEP to prevent HIV transmission.

First, they “disagree that the USPSTF [United States Preventive Services Task Force] has the authority or expertise to make recommendations with regard to whether every available and clinically effective PrEP medication should be covered without utilization management.” The Congresses that created the Task Force and enacted the Affordable Care Act (ACA) would disagree.

The Task Force had been in operation for over a quarter-century when Congress determined that all commercial payors would cover its A- and B-grade recommendations without cost sharing. In saying that “it is not the USPSTF’s job to set payer policy,” the authors ignore that Congress contemplated this very thing.

That is, when Congress enacted Section 2713 of the Public Health Service Act (“2713”), the ACA’s preventive services coverage requirement, it sought to remove the very barriers the authors suggest remain in place—namely, allowing payors to dictate coverage of preventive items and services and imposing patient cost sharing as a method of deterring utilization.

In suggesting that the Task Force lacks this authority, the authors fall in line with the plaintiffs in Braidwood v Becerra whose same argument led a Texas judge to overturn PrEP coverage for the entire country before a stay by the Fifth Circuit Court of Appeals.

Second, the authors overlook my suggestion that there are multiple better ways to ensure broad access to PrEP. I did not merely suggest “mandated coverage of all products without utilization management ...,” which the authors call irresponsible. While this is the manner in which vaccines are covered today (except “reasonable medical management” is permitted) under the very same provision of the ACA, I also suggested that Health Resources and Services Administration’s (HRSA's) one-per-category approach to contraceptives could provide a model.

If the purpose of re-opening the Task Force’s consideration of PrEP was to evaluate long-acting injectable (LAI) PrEP, and if it actually intended to recommend this new, life-saving form of prevention, that is all lost in the final recommendation statement. This is why I urged the Centers for Medicare and Medicaid Services to clarify that payors must cover LAI PrEP given that its rules would allow payors to otherwise decline coverage of “services not described.” This was a far more measured suggestion than the blanket approach, and it would at least assure that a LAI PrEP product would be covered without cost sharing in addition to oral PrEP.

As the authors note, LAI PrEP can significantly improve adherence, and thus effectiveness, for some patients. The authors state that they “... obviously support access to long-acting products for patients for whom those formulations could help with adherence.” Yet they find acceptable any recommendation that stops short of any meaningful specificity as to the modalities of PrEP it recommends or the notion that a patient should not have to endure an onerous exceptions process to obtain the most appropriate form of PrEP.

Accomplishing patient initiation and adherence amid all the problems of HIV stigma is already complicated enough, particularly in underserved areas and where providers may not have the requisite expertise to guide a patient through the clinical considerations, let alone coverage barriers, around PrEP. Killelea’s prior analysis lays bare the regional disparities in PrEP access, including a more than 16-fold higher rate of prior authorization in the American south versus the northeast. More generally, research has shown that “the use of [prior authorization] may disproportionately impact individuals who have been historically underserved, marginalized, and adversely affected by persistent poverty and inequality.”

By outlining their own clinical efficacy, safety and economic arguments in their response, the authors invert their position as they assume the role of deciding which forms of PrEP should be available and suggesting the Task Force should only do the same. The authors’ position necessarily enforces a decision on behalf of the patient who struggles to maintain adherence or experiences side effects, notwithstanding their increased risk of acquiring HIV.

Finally, the authors claim the Task Force must be given some new authority it does not currently have to assume the role of coverage arbiter. This is inaccurate.

HRSA acted on its own, with the advice of the National Academy of Medicine, when implementing the ACA’s requirement to cover certain recommended services for women. Specifically, it developed a framework by which payors must cover one contraceptive product per FDA-designated category. Moreover, the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices chose to update its charter to reflect its ability to recommend “antibody products” in addition to vaccines, reflecting innovative advancements in preventive technologies. In neither case did Congress provide an additional grant of authority outside of 2713.

Thus, it is not only possible for the Task Force to evolve its processes, procedures, and criteria. It is its obligation. I have suggested that it simply be more specific as to the type of modality to which it is referring, or that it incorporates by reference the CDC’s comprehensive PrEP guidelines, which are more specific. No additional authority is needed.

Archaic processes that perpetuate vagary, confusion, and non-coverage should be fixed. In this case, that is entirely feasible by quite simple administrative rather than Congressional solutions. I would welcome the authors to join me in supporting the Task Force in modernizing its approaches and facilitating access to innovative new forms of HIV prevention.

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