Iron Bow’s uncertain future with $258 million VA Home Telehealth contract

January 16, 2018 | by

Iron Bow Technologies’s setback with their VA contract confirmed. Iron Bow, which partnered last year with Vivify Health to provide telehealth services to the US Department of Veterans Affairs, received an unfavorable ruling on the US country of origin of the Vivify Health system that essentially stops the contract implementation.

Under Title III of the Trade Agreements Act of 1979, Federal suppliers must produce their products in the US or substantially transform the components in such a way that it becomes a product of the US. US Customs and Border Protection (CBP), Department of Homeland Security (DHS), makes this determination. Vivify Health contended that their Vietnam-produced tablet, because of their US-produced Vivify Health Pathways software and further US-based modifications to convert it into an FDA-regulated medical device, was transformed into a US product. In August, the CBP determined that the end product did not meet the transformation standard based on decades of precedent and the country of origin remained Vietnam. Transformation, yes, but not enough or the right kind for the CBP. Federal Register 8/22/17

An interesting Federal regulatory disconnect is that the FDA considers the Vivify tablet a regulated medical device. CBP considers it a communications device as the tablet transmits data from other medical devices but does not take those measurements itself. 

Vivify Health has publicly used in implementations with health organizations Samsung tablets. It is not known if the tablet reviewed by the CBP is manufactured by Samsung.

Both Iron Bow and Vivify Health were asked by this Editor for comments. Iron Bow’s response:

We have received an unfavorable ruling from United States Customs and Border Protection (“Customs”) regarding our proposed solution for the Home Telehealth contract. We respectfully disagree with the findings by Customs and have appealed the matter to the United States Court of International Trade. We are currently in discussions with our customer regarding the possible options for a path forward.

Vivify has not responded to date. 

Certainly, this is a sizable financial loss to both Iron Bow and Vivify if they cannot go forward with the VA, whether through a court decision or a different procurement process for the tablet to qualify it as US origin. Last February, we reported that the VA awarded the billion-dollar five-year Veterans Health Administration (VHA) Home Telehealth contract to four providers: incumbent Medtronic, Iron Bow, Intel Care Innovations, and service-disabled veteran-owned small business 1Vision. The award amount for each was $258 million over a five-year period, re-establishing the VHA as the largest telehealth customer in the US. All four awardees had in common that they were prior Federal contractors, either with the VA or with other Federal areas [TTA 1 Feb 17].

Medtronic and Care Innovations had long-established integrated telehealth systems but Iron Bow and 1Vision, as telemedicine and IT service providers respectively, did not have vital signs remote monitoring capability. In the solicitation, Iron Bow partnered with Vivify [TTA 15 Feb 17]. For 1Vision, it took nearly one year to announce that their telehealth partner was New York-based AMC Health, an existing provider of VA health services. It was also, for those in the field, a Poorly Kept Secret, as AMC Health had been staffing with VA telehealth veterans from the time of the award. (The joint release is on AMC Health’s site here.) The reason for the announcement delay is not known. AMC Health does not use a tablet system, instead transmitting data directly from devices or a mobile hub to a care management platform. They also provide IVR services.

Vivify has moved forward with other commercial partnerships, with the most significant being InTouch Health, which itself is on a tear with acquisitions such as TruClinic [TTA 19 Dec 17].

Hat tip to two alert Readers who assisted in the development of this article but who wish to remain anonymous.

Iron Bow partners with Vivify Health for $258 million VA telehealth contract

February 15, 2017 | by

One mystery solved! Iron Bow Technologies announced that its telehealth delivery partner for their award of $258 million in the Veterans Affairs Home Telehealth program is Plano, Texas-based Vivify Health. As noted in our original article [TTA 6 Feb] on the much-delayed VA remote patient monitoring award, Iron Bow was an existing contractor in other VA Telehealth services, Clinical Video Telehealth (video conferencing) and Store-and-Forward (clinical imaging review), but did not have vital signs RPM capability. The addition of Vivify with its mobile and tablet-based solutions and integrated peripherals adds that capability.

Vivify structures its main telehealth solutions based on escalating patient ‘risk’: 1) healthy and ‘at risk’ (may have early stage disease), 2) rising risk (has complex chronic disease) and 3) high risk (for hospitalization). The approaches are scaled up from engagement on BYOD mobile and web for (1), to vital signs monitoring and telemedicine clinician visits via mobile and tablet (2), to the highest level of an integrated kit with tablet and integrated peripherals (3). These further divide into five ‘pathways’ which are more product-oriented.

Cost is, of course, a factor, with VA a very demanding client in this regard as individual VISN (region) budgets are tight. Medtronic, the incumbent, has not only been using the venerable Cardiocom Commander Flex hub, but also provides VA with Interactive Voice Monitoring (IVR) which is an inexpensive patient management solution. (Ed. note: having worked with IVR in the past, it can work well if used with primarily lower-risk patients, is structured/implemented properly and integrated with live clinical check-ins.) Vivify’s system is all new–and not inexpensive, especially at the high-risk level. From their website, Vivify uses BYOD for the lower levels and the integrated kit for the highest and poorer outcome patients. This Editor notes they offer a voice telephony care solution which presumably is IVR. This gives them a welcome flexibility in price, but also a complexity which will be a training issue with VA care coordinators.

Other factors affect mobile-based solutions. Many at risk at-home veterans are older and thus don’t have smartphones or tablets. Reliable broadband connectivity is also an issue. Many don’t have Wi-Fi, which is a prerequisite for tablet use, and may live in areas with poor cellular reception.

The other work and labor-intensive parts for Vivify and Iron Bow are to integrate their reporting platform into VA’s complex and secure systems, which also involves a highly structured updating process: CPRS (computerized patient record systems), the VistA EHR and whatever replaces it (Epic is being trialed in Boise, Idaho–scroll down to ‘Big Decisions’ and Dr Shulkin).

Founded in 2009, Vivify has compiled an impressive track record with CHRISTUS Health (TX), RWJ Health (NJ), Trinity Health (MI), Centura Health (CO) and other large systems plus home care. It has also been conservative in its venture funding, with $23.4 million to date and its last big round from LabCorp and others in 2014 (CrunchBase).

Release. Hat tip to Vivify’s Bill Paschall via LinkedIn.  P.S. Stay tuned for an announcement of 1Vision’s partner. 

Editor’s clarification: The VA Home Telehealth contract is structured as a one-year base period, followed by four one-year optional periods, for five years total. The awarded amount over the five-year period is $258 million for Iron Bow/Vivify. It is the same amount/term for each of the three other awarded companies, totaling just over $1 billion for the five-year program. This is comparable to the 2011 five-year program value of $1.3 billion divided over six awardees. Thanks to Josie Smoot of Iron Bow Technologies’ press office.

VA awards over $1 billion in Home Telehealth contracts–at long last (updated)

February 6, 2017 | by | 15 Comments

Breaking News, Updated  The Department of Veterans Affairs (VA) on 1 Feb issued over $1 billion in awards to four companies to provide Home Telehealth vital signs monitoring technologies to veterans in home care and monitoring. The four companies are Medtronic, Care Innovations, Iron Bow Technologies, and 1Vision LLC. The $1 billion is split evenly between the four ($258 million for each company over the five-year duration). The contracts are for an initial year (31 Jan 2018 end date listed on GovTribe.com), renewable annually for five years total. The bid process started in 2015 and the award had originally been scheduled for early-to-mid 2016.

On the suppliers:

  • Medtronic is the incumbent as a supplier since 2011, dating back to Cardiocom’s 2011 award for its home monitoring units (Cardiocom was acquired in August 2013). Medtronic is a Dublin, Ireland HQ’d company with a US headquarters in Minnesota.
  • Care Innovations is well known to our Readers as the developer of Health Harmony and the acquirer of the QuietCare telecare/behavioral monitoring used in senior housing. Their parent is Intel.
  • Iron Bow Technologies is a supplier to VA in other healthcare areas (telemedicine and store-and-forward) and is a large, privately held IT company with multiple Federal contracts and deep Federal contractor roots. Their revenue has been reported at over $462 million (Washington Technology Top 100 2016).
  • 1Vision LLC is a new company formed as a joint venture between HMS Technologies, Inc. and MBL Technologies, Inc. Neither are previously engaged as home telehealth providers, but both are Federal contractors. According to their individual websites, HMS is an IT systems integrator and MBL is engaged primarily in cybersecurity.

The question for this Editor is how Iron Bow and 1Vision, which are not telehealth (vital signs) monitoring companies but telemedicine and IT service providers respectively, will execute Home Telehealth with the VA. Have they partnered with yet-to-be disclosed providers in providing home telehealth services to the VA? (Watch this space)

While the award is the largest in US telehealth, the VA is, by this Editor’s experience in her last position with Viterion Corporation, extremely demanding on its service providers and will be even more so in the future. The future reasons are clear: 1) President Trump has put a Klieg light on the VA and 2) he’s named a new VA secretary, Dr David Shulkin, who is currently VA Undersecretary for Health (confirmation hearing notes courtesy of POLITICO, nomination approved by the Senate committee Tuesday, and easily confirmed Monday night 13 Feb), who has been highly engaged with HIT issues, including both the VistA EHR modernization/replacement and initiatives such as the recently unveiled Digital Health Platform [TTA 12 Jan]. (more…)