Health IT Goes to the Hill; 3 Days of Hearings Look at mHealth and Health IT Following three days and several hours of scrutiny from Congress, the Office of the National Coordinator, the Food and Drug Administration and the CMS Innovation Center still exists. Health IT stakeholders from the public and private sector gave testimony and fielded questions from the House Energy & Commerce Committee regarding mHealth, mobile devices and the future of health IT regulation. Takeaways from these hearings included pledges from the FDA that iphones, tablets and other consumer mobile devices would not be regulated as mobile medical apps. Neither will FDA consider mobile platform manufacturers or medical apps distributors, such as the iTunes App store or the Android market, to be medical device manufacturers. FDA officials are finalizing guidance on mobile medical applications and officials said that the mobile medical apps guidance will focus on a “narrow” and “tailored” subset of mobile apps that fall into one of two categories: (1) those used as accessory to a regulated medical device, and (2) those that transform a mobile platform into a regulated medical device. Some lawmakers were not convinced, issuing statements that signaled continued concern that the FDA could hinder innovation in the mHealth space.
Although the bulk of activity in Energy & Commerce was focused on FDA, ONC head Farzad Mostashari also testified, speaking on topics ranging from the 2014 Edition of Certified EHR Technology to their efforts in patient safety and mobile technology. “Health IT holds tremendous promise for delivering “smart health” to patients right at their fingertips to help all of us achieve the best possible outcome for each individual,” he said. “We must carefully balance the need for the widest innovation possible, with protection of patient privacy, security, and safety.”
Meanwhile, the Senate Finance Committee held a hearing to scrutinize the CMS Innovation Center, also known as CMMI, and its $10 billion budget. Some lawmakers are concerned that CMMI has not been as public as it should with how it is using the funds and that CMMI may be duplicating efforts underway at CMS. “Like many of my colleagues, I remain concerned that CMMI has an enormous budget and very little accountability,” Senator Orrin Hatch (R-Utah) said. The Senator also voiced concern about being spread too thin and suggested CMMI reduce their focus from the current 17 initiatives. CMMI Director Richard Gilfillan, M.D. said that early assessments were positive on several fronts, including readmissions and preterm births. “We've been able to raise the consciousness, the awareness, of this problem [preterm births] nationally and we are seeing major changes across health systems, across state hospital associations, in hospitals putting that in place,” Gilfillan said during his testimony. Dr. Gilfillan assured the Committee that evidence of success would be forthcoming and that additional time was needed to test the payment and delivery models.
CMS Rolls Out More Educational Materials for Meaningful Use According to an announcement made this week, CMS has a new “Stage 2 Toolkit” that includes resources on Stage 2 Meaningful Use and the 2014 clinical quality measurement (CQM) requirements. The Toolkit is divided into three sections for a basic audience, eligible professionals and eligible hospitals / CAHs. Providers who use the toolkit will find information on the following topics:
- An overview of Stage 2
- Stage 2 FAQs
- How the Stage 2 provisions affect Stage 1 requirements
- Comparison tables of Stage 1 and Stage 2 criteria
- Details about payment adjustment and hardship exemptions
- 2014 CQMs, including descriptions, technical release notes, and the recommended core sets for EPs and eligible hospitals.
The Toolkit is part of a larger body of CMS work, which can be found on the Educational Resources page.
Lawmakers Introduce Bill to Encourage Remote Patient Monitoring Two Senators reintroduced legislation this week that would have HHS create pilot projects to reward home health agencies with financial incentives for using remote patient monitoring. Senators Amy Klobuchar (D-Minn.) and John Thune (R-S.D.) say Fostering Independence Through Technology Act is designed to reduce hospital readmission rates in rural and underserved parts of the country through the use of remote patient monitoring technology.