We, the undersigned physicians and medical professionals, hereby express our collective concern regarding the inadequacies in the Independent Review Organizations' (IROs) adherence to external review requirements outlined in 45 C.F.R. §147.136.

Under 45 C.F.R. §147.136, all eligible health plans are mandated to offer both internal and external review processes for adverse benefit determinations. An adverse benefit determination entails a decision to either partially or entirely deny coverage for a specific benefit.

It has come to our attention that adverse benefit determinations are distressingly frequent and often diverge from the stipulations outlined in the plan. For instance, recent revelations in 2023 uncovered concerning practices at Cigna, covering 18 million lives in the US, where an artificial intelligence system was employed to unjustly deny claims at an alarming rate, disregarding individual clinical considerations. Reports indicated that a single reviewer rejected approximately 60,000 claims within a month, with an average review time of a mere 1.2 seconds per claim. Such insufficient review times cannot adequately address an individual's medical needs or determine the eligibility for requested care. Therefore, the internal and external appeals structure laid out in 45 C.F.R. §147.136 is imperative in ensuring patients receive the essential treatments and services rightfully due to them.

Moreover, certain IROs have consistently denied 100% of external appeals related to various medical device coverage requests over recent years. These denials often lack comprehensive explanations as to how the requested treatment or services fail to meet the plan's coverage criteria, instead offering superficial justifications for the denial. Federal law mandates that IROs provide a "rationale" for their decisions, yet it appears that HHS's enforcement of this "rationale" requirement may be insufficient.

In light of these pressing concerns, we, the undersigned physicians and medical professionals, petition HHS and CMS to provide Congress with a comprehensive report addressing the following points:

1. How CMS monitors the external review processes, encompassing both the federal review mechanism and IROs.
2. How the agency evaluates the adequacy of IRO independent analyses and external review decisions and opinions.
3. The percentage of external reviews that overturn health plans' adverse benefit determinations.
4. The significance of a Medicare National Coverage Decision (NCD) concerning a health plan's classification of a Medicare-covered treatment or service as "experimental or investigational."
5. Necessary measures to enhance CMS's enforcement of the external review processes and safeguards.