Issue 130
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’s what’s happening in the world of FDA-regulated and pharma-focused digital health:
- The FDA quietly cleared the latest AliveCor KardiaMobile device via a 510(k). AliveCor named this one KardiaMobile Card, and its main difference looks to be a switch from the company’s proprietary high-pitch acoustic data transfer to the Bluetooth LE standard. AliveCor pointed to two predicate devices for the 510(k) — its 6L device for the Bluetooth LE transfer capability and its 2020 clearance for the most up-to-date single-lead, OTC KardiaMobile device for everything else. Read the summary document here. (I have to mention: This 510(k) took just 26 days. FDA received the submission on November 4th and granted it on November 30th. Now, it was just a switch to Bluetooth, but that’s the first SaMD to get through the FDA faster than Apple’s infamous 28-day de novo back in 2018, right? Rather ironic that AliveCor takes the clearance time crown from Cupertino.)
- Fitness wearable company WHOOP has hinted at plans to develop an FDA-cleared wearable in the past, but a recent job post makes clear the company is working toward it right now: “As an extension of that mission, we are exploring new opportunities to deliver value via Software as a Medical Device. This will propel WHOOP into the broader health and wellness arena with a creditable solution enabling us to further move the needle on public health. As a Tech Lead on the FDA team, you’ll be leading the development of a brand new product offering. A key component to leading the team will be developing software under a Quality Management System (QMS) that is compliant with the FDA guidelines. In addition, you will be collaborating with quality, legal, and other engineering teams to assess risk, development mitigation strategies, and play a vital role in ensuring compliance is met.”
- There’s more important CPT/HCPCS coding news below, but I wanted to mention that — thanks to a request from The Digital Therapeutics Alliance and Strive MedTech — two of the RTM-related Category III codes the AMA accepted at its September CPT Editorial meeting might be deleted at the upcoming February meeting. The two codes were: “Cat III – Remote Therapeutic Activity Measurement – ‘Establish codes 0X06T, 0X07T to report remote therapeutic dynamic activities.'”
- Here’s one other interesting item at the upcoming AMA CPT Editorial meeting in February: There’s a proposal that reads: “Establish two Category III codes 0X41T, 0X42T to report remote autonomous AI-based insulin dose calculation and titration.”
- The news you know: The FDA cleared Sound Life Sciences’ prescription-only breath sensing app via a 510(k): “The privately-held telehealth startup’s smartphone or smart-speaker app produces inaudible ultrasonic sonar pulses to detect reflections caused by nearby patient respiration.” The company tested the app with people who have COPD, asthma, congestive heart failure and anxiety as part of its 510(k) submission.
- Yet another week with no new reimbursed digital therapeutics in the German government’s DiGA formulary. And no new prices resulting from year-one price negotiations either.
- Not to be outdone by Akili Interactive’s series of marketing partnerships with social media influencers, which E&O has covered these past few weeks, Pear Therapeutics hired actor Susan Sarandon’s daughter Eva Amurri as a paid spokesperson for its chronic insomnia PDT, Somryst. Amurri, who runs a lifestyle and motherhood-focused blog called Happily Eva After, has not been prescribed Somryst and doesn’t use the product, but she does talk about having sleep issues as part of the pitch. The social media ads pull clips from a longer interview, which you can watch in full on YouTube.
- Of course, that’s not the biggest news for Pear this week, which officially started trading on NASDAQ following the closing of its SPAC merger last Friday. Trading started at around $10.20 a share on Monday, went as high as $11.75 a share on Thursday, and dipped as low as $7.27 a share earlier today before closing for the week at $7.46.
- The FDA posted the summary document for metaMe’s Regulora prescription digital therapeutic for IBS — read it here for more details on the latest PDT to secure market authorization.
- One more thing… The Australian government made changes to how it regulates SaMD back in February, but this week the country’s FDA-equivalent, TGA, published a new SaMD FAQ. Worth a read if you’re eyeing a SaMD launch in Oz.
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Pear asks CMS for HCPCS Level II codes for reSET, reSET-O, and Somryst
At the beginning of December, CMS convened one of its regular meetings for considering new HCPCS code additions. Interestingly, Pear Therapeutics applied for three new HCPCS codes that look to be worded specifically for its three PDTs. (In reaction to the applications from Pear, Aimed Alliance, a non-profit policy organization that counts Pear as its only prescription digital therapeutic company backer, submitted a letter to CMS in favor of new HCPCS codes for PDTs. More on that in a minute as it explains why Pear is taking this action.) First, here are the three HCPCS Level II codes that Pear applied for:
- “Request to establish a new HCPCS Level II code to identify reSET. Applicant’s suggested language: QXXXX ’12-week, outpatient prescription digital cognitive behavioral therapy for substance use disorder as an adjunct to contingency management.'”
- “Request to establish a new HCPCS Level II code to identify reSET-O. Applicant’s suggested language: QXXXX ’12-week, outpatient prescription digital cognitive behavioral therapy for opioid use disorder as an adjunct to transmucosal buprenorphine and contingency management.'”
- “Request to establish a new HCPCS Level II code to identify Somryst. Applicant’s suggested language: QXXXX ‘9-week, outpatient prescription digital cognitive therapy for chronic insomnia.'”
CMS included a preliminary response to Pear’s requests that read the same for all three:
“We understand that this application is intended to be used in conjunction with face-to-face treatment delivered by the clinician. HCPCS Level I (CPT) coding is the typical approach for physician services.”
And the RTM CPT codes would fit that bill. However, Pear and, by proxy, its friends at the Aimed Alliance argue that those RTM codes may not work for software-only devices like Pear. Here’s what Aimed wrote in its letter to CMS:
“As you may know, this year, the American Medical Association – the entity in charge of creating and maintaining CPT codes – proposed in its Level 1 CPT codes to include ‘remote therapeutic monitoring,’ for Cognitive Behavioral Therapy Monitoring. However, from our understanding, these codes are only applicable when a provider pays for the FDA-regulated medical device, dispenses it to the patient, and then bills the insurer for the device (i.e. buy and bill). This is different from PDT’s which are solely a software application; the provider never pays for or takes custody of the device and the provider never physically dispenses the device. The provider issues a prescription and the technology is dispensed by the specialty pharmacy who then bills for the device. As such, the proposed CPT codes for cognitive behavioral therapy do not apply to PDTs that are solely software-based technology.”
Here’s what Aimed suggests:
“CMS is currently considering whether PDTs should be given a HCPCS Level 1 or Level 2 code. Aimed Alliance strongly encourages CMS to provide PDTs with a HCPCS Level 2 code to ensure adequate patient access and reduce administrative coding barriers that impair or delay treatment coverage.”
“CMS has stated that Level 1 codes are appropriate for PDTs because they are ‘used in conjunction with face-to-face treatment delivered by the clinicians.’ Generally, HCPCS Level 1 codes, also referred to as Current Procedural Terminology (CPT) codes, are usually given to procedures and services performed by healthcare providers. While HCPCS Level 2 codes are given to medical devices, supplies, medications, transportation services, and other items not covered under CPT codes.”
“HCPCS Level 2 codes are used for equipment that is used outside of the physician’s office. With regard to PDTs, the doctor prescribes the PDT, the prescription is sent to a specialty pharmacy that dispenses the PDT content to the patient, and the patient then uses the PDT content at a time and place of their convenience. PDTs are not procedures that are performed by the healthcare provider. They are medical devices that are used outside the physician’s office by a patient on their smartphone or tablet. As such, they should be given appropriate HCPCS Level 2 codes.”
As far as I can tell, this discussion is mostly related to the supply codes (989X2 and 989X3) that were included as part of the RTM CPT suite of codes. What do you think? Are Pear and Aimed right? If so, why didn’t other PDT companies apply for HCPCS codes at the December meeting? Finally, is it unusual for the language of HCPCS Level II codes to be so specifically tailored to one company’s product?
Clinical trial updates from Renovia, Biogen, Takeda, Moffitt, and InCardia
This is a recurring feature of E&O Fridays that digs into new digital health-related clinical trials as well as updates to others E&O mentioned in previous issues.
Renovia completes trial of Ieva for stress urinary incontinence
No results yet, but Renovia did reveal one new detail: It managed to enroll 369 participants in its clinical trial for digital therapeutic Ieva:
“A virtual prospective randomized controlled study to evaluate the efficacy of using the leva PDHS to perform PFMT (leva arm) compared to standard care of a PFM exercise home program (Kegel arm) for the treatment of SUI or SMUI.”
Biogen and Takeda study of wearables in Parkinson’s pushed back
Small update: This study on how well mobile and wearable devices can detect PD disease progression is now set to finish up in February instead of this month:
“Subjects will be evaluated via both in-clinic and at-home assessments. The in-clinic assessments are designed to compare the ability of current Parkinson disease clinical trial measures with the ability of mobile and wearable devices to detect disease progression in the early stage of disease. The at-home assessments are designed to determine the feasibility of motor and non-motor assessments of disease progression using a commercially available wearable device/mobile application platform and to determine how this data compares with traditional clinical measures.”
Augmented reality study for smoking cessation
This Moffitt Cancer Center study has me wondering which “AR specialist” the provider partnered up with for the app. Pure speculation: Magic Leap is also in Florida and was at one time at least the biggest name in augmented reality. Here’s how the study describes one of its five arms:
“20 Participants will be instructed to use the AR app that presents smoking-related stimuli (cigarette, ashtray, lighter) in locations/situations where they typically smoke with the goal of at least 5 uses per day for 7 days. Usage and rating data will be collected in real-time. Participants will also be asked to rate their urge to smoke on the smartphone app at selected times. Participants will then return to the lab to provide additional feedback on the app, answer questions related to smoking behavior, and receive an in-person interview on their perceptions of the app as a potential cessation tool. Participants will use the smartphone application for 7 days.”
InCardia’s study of pre-FDA CorWatch wearable for HF patients pushes back to April
Small update: This 40-participant InCardia study is set to finish up in April now after missing its original November 2021 target for completion.
“This is an observational study to evaluate the agreement between the InCardia diagnostic technology CorWatch for the assessment of venous pressure in human subjects. This includes evaluation of InCardia technology in heart failure (HF) patients undergoing invasive right heart catheterization in a cardiac catheterization laboratory (cath lab) and in a cardiac intensive care unit (ICU).”
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