The HHS Office of the Inspector General regularly responds to request for Advisory Opinions (most frequently on endless scenarios for anti kickback regulations). Sometimes, companies submit for an opinion on behavior of their competitor, hoping to get a negative opinion. Some opinions are deadly dull; others treat odd topics in a surprising way.
HHS has a homepage for Advisory Opinions, or AO's, here. There were 20 in 2021, and already 4 in 2022. (There were only 9 in the 2020 election year and even less, 6, in 2019.)
AO-22-05 Cost Sharing in Trials
AO-22-05 is about a manufacturer subsidizing cost-sharing obligations in a clinical trial. The context is Category B Investigational Device trials, which are paid by CMS (see webpage here.)
Note that when Medicare itself does Coverage with Evidence Development, a little widget of statute allows CMS to vary the cost-sharing rules to ensure masking (treatment vs control, don't get different payments). See my comment about SSA 1833(w) in an earlier blog here. Text at footnote.
This AO, in contrast, is about the manufacturer and copays, not CMS itself and copays.
In the case, the OIG found the scenario allowable, for example, because the trial enrollment was fixed, not open-ended (there would be exactly 260 patients with or without the copays), and the trial was a one-time surgical device (so there was no ongoing inducement to a patient.)
AO-22-04 Digital Apps, Payments to Patients
AO-22-04 handles "contingency management" rewards software used as part of addiction treatment software. The patient using the software completes modules and may get a reward (e.g. Starbucks card). Is this a kickback or inducement?
The OIG ruled no, for several reasons, one of which was that the app provider did not itself directly bill the federal government.
See also a recently introduced bill for FDA-approved digital medicine software, S 3791, HR 7051, here.
___
Text of 1833(w) re: patient copays in CMS-supported trials.
(w) Methods of payment.—The Secretary may develop alternative methods of payment for items and services provided under clinical trials and comparative effectiveness studies sponsored or supported by an agency of the Department of Health and Human Services, as determined by the Secretary, to those that would otherwise apply under this section, to the extent such alternative methods are necessary to preserve the scientific validity of such trials or studies, such as in the case where masking the identity of interventions from patients and investigators is necessary to comply with the particular trial or study design.
