Issue 117
Welcome back to E&O Fridays, a paying subscribers-only weekly newsletter focused on the world of digital pharma products and FDA-regulated digital health.
E&O Fridays.
Here are a few things happening in the world of pharma digital products and FDA-regulated digital health:
- This week I added executive compensation dollar amounts for CXOs at Pear Therapeutics and Doximity. Check out their salaries, bonuses, and other compensation — along with paycheck data about more than 80 public digital health company execs — in the E&O Salary Tracker here.
- Speaking of trackers: You’ve probably heard the FDA has a new feature that allows device companies to track the status of their 510(k) regulatory submissions via a new online dashboard. (Wish the FDA made this publicly accessible — why all the secrecy?)
- One more thing… I enjoyed this Neo [dot] Life profile of virtual reality-focused digital therapeutics pioneer Walter Greenleaf. Worth a read.
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ATA suggests RTM apply to more than MSK and respiratory devices; The RUC asks CMS not to overpay for inhaler sensors
After weeks of scrolling through form letters from physical therapists and mental health professionals, I managed to find two new and interesting comments on the proposed Physician Fee Schedule for 2022. (Revisit Issue 110 for the background on the Remote Therapeutic Monitoring codes in CMS’ proposed Physician Fee Schedule for 2022.) The American Telemedicine Association weighed in as did the American Medical Association’s RVS Update Committee (AKA the RUC), which helps CMS assign relative values and, in effect, reimbursement amounts for the billing codes in the CMS fee schedule.
ATA thinks the supply codes for Remote Therapeutic Monitoring devices should apply to devices beyond respiratory and MSK:
“ATA urges CMS to consider devices other than those currently contemplated for reimbursement via RTM codes. We recognize that other devices and direct patient input may collect important non-physiologic data on metrics such as pain, patient mood, and adherence. These devices, too, should be reimbursable under the CY 2022 PFS. The ATA urges CMS to consider broader use cases for RTM, including but not limited to behavioral and mental health therapies and services addressing vascular, endocrine, neurological, and digestive systems. Further, the ATA supports coverage and reimbursement of a condition-agnostic supply code, including through the creation of a new, temporary HCPCS G-code.”
The RUC claimed that CMS is creating confusion by stating the RTM codes can’t be used by PTs:
“CMS should clarify its position that the RTM codes may not be used by certain qualified health care professionals, such as physical therapists. CMS has created confusion among these stakeholders in providing the following rationale:
- CMS claims that physical therapists cannot bill the new RTM codes, even though the codes were created to be used by physicians and QHPs (including physical therapists) by specifically placing the codes in the medicine section of CPT.
- CMS explains that because the new RTM codes are modeled on the Remote Patient Monitoring (RPM) codes, “incident to” services became part of the all five codes 989X1-989X5 and because only physicians and certain other practitioners are authorized to furnish and bill “incident to” services physical therapists and other practitioners, who are not physicians or NPPs cannot report the services.
- CMS goes on to say that the codes would have to be designated as care management services (like RPM codes 99457 and 99458) to allow for general supervision rather than direct supervision for “incident to” services and because the codes are not E/M codes, they cannot be designated as care management services and would require direct supervision.
The RUC urges CMS to clarify that these codes are in fact general medicine codes and, as such, tasks performed by physical therapy assistants are billable when provided under the direct supervision of the physical therapist and under the physical therapist NPI number, making incident-to policy irrelevant.”
The RUC was also unhappy that CMS didn’t follow its advice on how to pay for the devices that make remote therapeutic monitoring for respiratory patients possible:
“The RUC also disagrees with the refinement to the direct inputs for the PE-only code 989X2. CMS is not proposing the RUC’s recommendation for a new supply item, Remote respiratory therapy system, stating that this $25 monthly rental fee would not be paid as a direct cost under the PFS.”
“The RUC recommends that CPT code 989X2 include a new supply input, Remote respiratory therapy system fee. This system and its related technology are required in order to appropriately perform the RTM services. The monthly fee per patient comprises the leasing of the Bluetooth sensors (2 provided in each rental) placed on top of the patient’s inhalers (typically 1 daily use inhaler and 1 rescue inhaler) as well as use of the app technology for tracking.”
The RUC explained their argument further in the excerpt below, which makes clear they believe the proposed methodology by CMS will end up overvaluing the sensors for inhalers used in RTM for respiratory patients. If you recall in Issue 110, I calculated the proposed 2022 reimbursement for the respiratory supply code at $45 every 30 days, while the RUC suggested amount was a monthly fee of $25:
“CMS is proposing to value the practice expense for the PE-only codes using crosswalk methodology. CPT codes 989X2 and 989X3 would be crosswalked to reference code 99454 Remote monitoring of physiologic parameter(s) (eg, weight, blood pressure, pulse oximetry, respiratory flow rate), initial device(s) supply with daily recording(s) or programmed alert(s) transmission, each 30 days. While we acknowledge that using a crosswalk could result in similar total resource costs, the RUC questions the use of a crosswalk to CPT code 99454 which would overvalue the PE for 989X2 where the only input is the monthly fee of $25.”
“The RUC urges CMS to accept its recommendation that CPT code 989X2 warrants inclusion of a monthly fee for the remote respiratory therapy system and its related technology including leasing of the Bluetooth sensors and use of the app technology for tracking. This fee represents a per-patient, single-use item, and thus is appropriately included as a direct supply. The RUC recommends that CMS negate the need for a crosswalk by accepting the new supply item, Remote respiratory therapy system fee as a direct practice expense input for CPT code 989X2.”
Trial updates: Blue Note, Lucine, Koa, WWChild
Here’s E&O’s weekly roundup of changes and additions to clinical trials focused on FDA-regulated digital health devices and other pharma-related digital health.
Blue Note Therapeutics kicks off study with HITLAB for PDT targeting breast cancer
This just posted clinical trial description doesn’t give up too many details yet:
“BNT-103 is a prescription digital therapeutic specifically designed to treat the symptoms of anxiety and depression related to cancer.”
“This test aims to explore product development-focused usability and user engagement.”
“We will be testing an innovative peer-to-peer communication tool during this trial.”
Koa Health’s OCD trial is now recruiting
Koa Health’s RCT focused on two digital health interventions for OCD started recruiting this past week:
“The primary aims of this study are to test the feasibility, acceptability, and efficacy of two digital health interventions for adults with OCD recruited nationally. Eligible subjects (N=120) will be randomly assigned (50/50 chance) to 12 weeks of app-based CBT on their personal smartphone or 12 weeks of web-based health and well-being education in addition to completing clinical assessments and questionnaires from home. All participants will have access to a coach to help guide them through their assigned program. Total participation time for the study is approximately 6 months, and all study appointments (5 total) occur over secure phone or video conference call.”
Lucine completes its VR-powered endometriosis pain study
No results yet, but Lucine noted that its VR-powered digital therapeutic for endometriosis pain finished up on May 18, 2021 — about a month early. It ended up enrolling 45 out of the 50 anticipated participants.
“The medical device is a CE marked Class I device. Women suffering from endometriosis present recurrent pelvic pain impairing their quality of life… Endocare treatment intends to relieve pain thanks to its action on central nervous system. This study will describe the evolution of pain in patients experiencing endometriosis-related pain after a single treatment of Endocare or a digital control. The use of a digital control as a comparator is the only way to show a specific effect of the Endocare treatment. Therefore, a digital control displaying visual and auditive sequences with no expected effect will be used for the study. This digital control, for which only a placebo effect may occur, will be displayed on a tablet instead of VR.”
WW (formerly Weight Watchers) shuts down its UK-based kid weight loss study
Because of the COVID-19 pandemic, WW terminated its UK-based study of a kid weight loss program it referred to as WWChild. (Curious name since WW also acquired a startup focused on this named Kurbo Health back in 2018.) This study only managed to recruit two out of the 60 hoped-for enrollees:
“The purpose of the WWChild study is to determine the feasibility of assessing the potential impact of parents attendance at WW on their child’s weight status and weight-related behaviours. The feasibility study will randomly allocate 60 parent participants to either the WW programme (formally Weight Watchers) or to a control arm. Data will be collected from both parent and child at baseline and at three months to explore changes in weight status and weight related behaviours.”
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