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.