Mid-week roundup: Promising Langone AI/LLM predicts hospital readmits; Huma gains FDA 510(k) Class II clearance; telepsychiatry’s challenges; layoffs/asset buys/losses from 23andMe, Cityblock, Thirty Madison, Butterfly

June 14, 2023 | by

New York University’s Langone Health’s large language model (LLM) accurately predicting hospital readmissions, more. NYU’s academic medical center NYU Langone Health has developed an LLM using medical language, NYUTron, from unstructured clinical notes in patient records, then fine-tuned it across a wide range of clinical and operational predictive tasks. The dataset was immense:  ‘NYU Notes’ covers 7.25 million clinical notes (for example, radiographic reads, history, and physicals) from 387,144 patients across four hospitals, and more. According to their study published in Nature on 7 June, it was tested for predictive ability in five areas: 30-day all-cause readmissions, in-hospital mortality, comorbidity index, length of stay, and insurance denial. The NYUTron system in testing has achieved results improved over conventional structured models’ baselines. From the Nature study:

  • For 30-day readmission prediction, it had a median area under the curve (AUC) of 79.9% ± 0.168% with a 5.36% improvement
  • On in-hospital mortality prediction, NYUTron had a median AUC of 94.9% ± 0.168% with a 7.43% improvement.
  • On comorbidity index imputation, NYUTron had an OVR median AUC of 89.4% ± 0.275%
  • On binned LOS prediction, NYUTron had a median AUC of 78.7% ± 0.179% with a 12.3% improvement 
  • On insurance denial prediction, NYUTron had a median AUC of 87.2% ± 0.246% with a 14.7% improvement.

In a test of the system during January-April 2022, the system analyzed 29,286 discharged encounters, with 3,271 patients (11.17%) returning within 30 days. NYUTron predicted 2,692 of the 3,271 readmissions (82.30% recall) with 20.58% precision. Also HealthcareITNews

London-based Huma (the former Medopad) gained US FDA 510(k) Class II clearance for their Software as a Medical Device (SaMD) platform. This is defined as disease and age-agnostic digital health pathways through which data are collected from patients for self-management or to be assessed remotely by healthcare professionals. Huma also recently obtained EU MDR Class IIb approval and with Health Canada through the FDA’s joint eStar program. Huma’s tech also includes remote patient monitoring (RPM) systems and companion apps to enable disease management, with third-party device integration. For providers, the platform hosts AI algorithms that use automated data analytics to support screening, diagnosis, dosing recommendations, clinical decision making, and prognostication for identification of at-risk patients and early intervention. In 2020, Huma acquired BioBeats and TLT; more recently, last year iPLATO patient engagement and in January clinical trials data specialist Alcedis.   Huma release, Mobihealthnews

The growth of behavioral health has come to a screeching halt with the demonstrated abuse of online prescribing, then the US Drug Enforcement Administration (DEA)’s uncertainty around controlled substance prescribing. This interview with the CEO of Array Behavioral Care, one of the Ur-companies in telepsychiatry (1999, originally InSight Telepsychiatry and Regroup Telehealth), points out how the DEA’s post-Public Health Emergency (PHE) policies around Schedule II and higher teleprescribing disrupted their operations. The flexibilities established during the PHE have been waivered to 11 November, though a final rule must replace the temporary extension rule and comply with the Federal Ryan-Haight Act [TTA 11 May]. Other issues addressed are dealing with medical affairs (clinical licensure, primary source credentialing, facility privileging, and payer enrollment), and the potential for AI to create new tools to aid clinicians in evaluating mental health, such as natural language processing (NLP) in transcribing video sessions and suggesting clinical notes, as well as scanning patient intake stories and analyzing that information for the likelihood of certain diagnoses. HealthcareITNews

The slow drip-drip-drip of layoffs, folded companies’ asset sales, and company losses that started in 2022 continue, though at a diminished pace compared to consumer companies:

  • Genomics and DNA testing company 23andMe announced layoffs of 9% of staff or 75 people. This will take place by the end of their FY 2024, which ends next 31 March. In a 9 June filing, the company claimed that it would reduce annualized payroll and benefit expenses by $12.8 million, which leads one to wonder about the compensation level of those 75 and from what area they are in. South San Francisco-based 23andMe continues to be money-losing, increasing annual net losses from $217 million to $317 million in the 12 months ending in March, according to its May earnings report despite a 10% revenue gain. 23andMe is yet another ‘cracked SPAC’, having gone that route in 2021 with a Virgin-backed SPAC. Once trading at highs of $12-13 on the NYSE, it closed today at $1.96. However, they don’t have debt, are hanging on to a valuation of $924 million, and their cash position is apparently strong enough to hold it for two years.  Becker’s, SF Chronicle, Yahoo Finance, SimplyWallStreet
  • Another well-financed company, Cityblock Health, is laying off 12%, or 155 staff. Spun off from Sidewalk Labs (Alphabet Health-Google) at the end of 2017, their CEO announced the layoffs in a blog post late last week and effective immediately for those affected. Cityblock serves Medicaid and low-income ‘duals’ with both Medicare and Medicare in value-based care models with a heavy reliance on technology. Their CEO who joined the company in March phrased it as a restructuring, using technology to automate processes, and reducing staff layer. In contrast to others, Cityblock has had no trouble raising funding in the past; in December 2020 they raised $160 million in a December 2020 Series C, plus another $192 million in a Series C extension in March 2021, then a reported $400 million Series D in September 2021 with total raises over $890 million. But their cash burn with high-cost operations in six states (HQ New York, Massachusetts, Indiana, North Carolina, Ohio, and Washington DC) is also likely high. FierceHealthcare
  • Thirty Madison buys assets from bankrupt The Pill Club. The assets? Over 100,000 patient files for $32.3 million. The Pill Club entered Chapter 11 in April after being charged by California authorities of defrauding the state Medicaid program. It paid $18.3 million to settle the charges. But that wasn’t all. According to Mobihealthnews, “the settlement came just days after a state court unsealed a whistleblower complaint against the company in which former nurse practitioners alleged it had defrauded private insurers in at least 38 states. According to a statement from their attorneys regarding the settlement, the whistleblowers would receive approximately $5 million.” The patients covered by The Pill Club’s prescriptions will be converted over to another Thirty Madison brand, Nurx, and offered other services such as behavioral health and dermatology services. The Pill Club raised a lot of money from 2016–$51 million in Series B funding in 2019 and another $41.9 million in 2021. Thirty Madison is a private multi-line of consumer-marketed brands such as Keeps (hair), Picnic (allergies), Cove (migraine), and Facet (psoriasis, eczema) and is at a Series C with a total raise of $209 million. Axios, 
  • Butterfly Network, which some years back developed a hand-held ultrasound device (Butterfly iQ) and entered a crowded field with GE HealthCare’s VScan, Mobisante (apparently defunct), and Philips Lumify, reported Q1 revenue of $15.5 million, flat year-over-year compared to Q1 2022 and which missed analyst estimates (again). Somewhat better news was narrowing last year’s loss to a Q1 loss of $33.5 million which was less than Q1 2022’s loss of $44.5 million. It’s another early SPAC that hasn’t had a great time of it. Since its debut on the NYSE in December 2021, the stock has had the typical drop in altitude from $19.79 to $2.42. It has since expanded to enterprise imaging with Blueprint. Mobihealthnews, Yahoo Finance, Zachs

Telehealth extensions signed into US law with Federal FY 2023 omnibus bill

January 4, 2023 | by

Jammed into the final moments of the now-ended 117th Congress before Christmas was the passage of the FY2023 ‘omnibus’ $1.7 trillion Federal budget bill. This bill did at least several good things for those of us concerned with US telehealth, as it extended provisions for Medicare reimbursement that become guidelines for commercial health plans and help to cement telehealth as a permanent part of health care delivery. There is also a tax provision that affects high-deductible health plans. 

Their passage is important as the Covid-19 Public Health Emergency (PHE) is set to expire on 11 January and no movement has been publicly discerned for its renewal. In the fall, the Department of Health and Human Services (HHS) notified US state governors that there would be at least a 60-day notice before the PHE ends. It is unknown whether this notice has been given.

To summarize the two-year extensions that go to the end of 2024:

  • Expanding originating and geographic site to include anywhere the patient is located, including the patient’s home
  • Expanding eligible practitioners qualified to furnish telehealth services, including occupational therapists, physical therapists, speech-language pathologists, and audiologists
  • Extending the ability for federally qualified health centers (FQHCs) and rural health clinics (RHCs) to furnish telehealth services
  • Delaying the in-person requirement for mental health services furnished through telehealth, including the in-person requirements for FQHCs and RHCs
  • Extending coverage and payment for audio-only telehealth services
  • Extending the Acute Hospital Care at Home (AHCAH) initiative, pioneered by Johns Hopkins two decades ago. It also requires the HHS Secretary to publish a report comparing AHCAH programs with traditional inpatient care delivery. 
  • Extending the ability to use telehealth services to meet the face-to-face recertification requirement for hospice care
  • Extending high deductible health plan (HDHP) safe harbor exceptions for telehealth services in high-deductible health plans.

The final bill did not extend the Ryan Haight in-person waiver for the remote prescription of controlled substances. As mentioned in our earlier article, this is a wise move in this Editor’s view given the abuse of this waiver by certain telehealth organizations. ATA/ATA ACTION release.

The HHS Secretary will be required to submit a report to Congress on the utilization of the above services. The interim report is due in October 2024 and the final report in April 2026, according to the American Hospital Association. Affecting hospitals and practices in the bill:

  • It delayed the statutory Pay-As-You-Go (PAYGO) Medicare 4% sequester for two years, preventing the $38 billion in Medicare cuts that otherwise would have taken effect in January.
  • Partial relief from a 4.5% reduction in physician reimbursement rates starting on 1 January. The legislation reduced the cut to 2% for 2023 and around 3% for 2024.

HealthcareFinance

Other features of this bill having an effect on healthcare and telehealth (from Infrastructure Report Card):

  • $455 million for the expansion of broadband service, including $348 million for the ReConnect program, a series of grants administered by the US Department of Agriculture for the construction, improvement, or acquisition of facilities and equipment needed to provide broadband service in eligible rural areas. This could help rural areas and hospitals in provider-patient and provider-to-provider consults.
  • $1.65 billion for the National Institute of Standards and Technology (NIST), an increase of $424 million, or 34%, above the FY 2022 enacted level. Specific funding is allocated for the measurement labs and research at $953 million, a $103 million or 12% increase above the FY 2022 enacted level. The goal is to spur research advances in cutting-edge fields like carbon dioxide removal, artificial intelligence, quantum information science, and cybersecurity.

The bill was signed into law by the president on vacation in St. Croix, USVI. Given the bumpy start of the 118th Congress today, these are at least not up for grabs.

Telehealth two-year extensions included in US Federal ‘omnibus’ budget bill

December 22, 2022 | by

Expanded telehealth access extended for two years. The ‘omnibus’ fiscal 2023 spending bill before Congress Thursday contains extensions for four areas of improved national telehealth access developed during the COVID-19 Public Health Emergency (PHE) starting in January 2020. Because they apply to Medicare and high-deductible health plans (HDHP), they become guidelines for commercial health plans and help to cement telehealth as a permanent part of health care delivery.

The two-year extensions include:

  • Retained expanded reimbursable access to telehealth for Medicare beneficiaries put into place during the PHE
  • A two-year delay in implementing the Medicare telemental health in-person requirement
  • Extension of safe harbor provisions to offer telehealth as part of HDHPs with Health Savings Accounts (HSAs)
  • Extension of the Acute Hospital Care at Home Program. This waiver permits some emergency department and inpatient hospital patients to be treated from their homes. 

At this time, the PHE is set to expire on 11 January 2023. It has been extended every 90 days since January 2020 and may be extended again. The bill did not extend the Ryan Haight in-person waiver for the remote prescription of controlled substances, a wise move in this Editor’s view given the abuse of this waiver by certain telehealth organizations. It does request the Drug Enforcement Agency (DEA) to promulgate final regulations specifying the circumstances in which a Special Registration for telemedicine may be issued for controlled substances, and the procedure for obtaining the registration.

Another wise move on Congress’ part in this monster 4,000+ page, $1.7 trillion spending bill is to further prohibit the creation of a national patient ID for healthcare that supposedly would facilitate EHR interoperability. 

The bill is supposed to come before a lame-duck Congress at the eleventh hour before their Christmas leave on Thursday. Some opposition has coalesced due to wasteful earmarks covering pet projects that are included in the (unread by most representatives) bill and the fact that a new Congress with a change of party control in the House will be seated in January. However, for those of us in the US telehealth business, these inclusions are not controversial nor wasteful, and if the omnibus bill fails for some reason, will likely be included in any short-term extensions which are typical in keeping the government running. ATA release, POLITICO Future Pulse

When is an app not an app? (When it’s a conundrum)

October 25, 2016 | by

It all started so simply. In DHACA under the leadership of Rob Turpin (BSI) we produced the definitive guide to app regulation in the UK. Sure it was 44 pages long (and will shortly need updating) however we all knew that an app was standalone software and that none other than MEDDEV 2.1/6, the ultimate definitive guide to when an app is a medical device defined software as:

…a set of instructions that processes input data and creates output data.

However doubts began to creep into this editor’s mind when he heard that app developers in the US were avoiding (US/FDA) medical device classification as that would rule them out as service providers, which can reduce future  reimbursement benefits – as we quoted Ralph-Gordon Jahns of research2guidance in 2014 “profitable developers… rely on service sales as their primary source of revenue.”

Things got more complicated when it emerged at the UK Health Show this autumn that PHE was considering listing digital GP services as (more…)