The DOD EHR Contract, Federal Funding for State HIE Networks, Flex-IT Act 2, and Other Health IT Policy Updates

August 4, 2015 Leave a comment

The U.S. Department of Defense awarded its estimated $9 million EHR technology modernization contract to Cerner/Leidos/ Accenture. The other two competing groups were Epic/IBM and Allscripts/Computer Sciences Corp/Hewlett-Packard. Cerner’s group is charged with providing an off-the-shelf commercial product that integrates across the Military Health System and works with other private sector systems.

The HHS Office of the National Coordinator for Health IT (ONC) announced the awardees of its trio of Recovery Act (ARRA) funding opportunity reboots. The awards, which resemble ARRA-era programs, are for statewide health information exchange (HIE) networks, health IT workforce training, and for a convener (AcademyHealth) to use health IT tools to address population health challenges in 15 communities.

ONC recently announced pre-registration for its fifth annual Consumer Health IT Summit, occurring October 1, 2015 in Washington, DC. The event is focused on various federal and private sector health IT initiatives to facilitate patient engagement, self-management, and precision medicine.

Representative Renee Ellmers (R-NC) introduced the Flex-IT Act 2 (HR 3309) on July 30.  The legislation would delay Centers for Medicare and Medicaid Services (CMS) promulgation of the Stage 3 “Meaningful Use” final rule and mandate a 90-day EHR reporting period every year, among various other tweaks.

As of this writing, final rules for the three MU-related rulemakings in the pipeline (CMS’ “Stage 3” and “2015-17 fix,” and ONC’s “2015 Edition Health IT Certification Criteria”) have not yet been submitted for Office of Management and Budget (OMB) regulatory review. This essentially means we still have at least one month (and likely more) to go before final rules are promulgated. As the last start date to begin a 2015 EHR reporting period (as proposed in the “fix” proposed rule) will be October 1, 2015, there will likely be a tight, last minute squeeze on MU participants waiting to leverage the imminent improvements to the MU regulations this calendar year.

ONC Releases the Health IT Safety Center Roadmap

July 23, 2015 Leave a comment

The HHS Office of the National Coordinator for Health IT (ONC) recently released a contractor-developed “Health IT Safety Center Roadmap.” This policy document by RTI, International provides a vision of the possible future scope and responsibilities of the Health IT Safety Center.

The center was previously discussed in the Food and Drug Administration (FDA)-Federal Communications Commission (FCC)-ONC joint “Health IT Safety Plan” in 2014. The 2014 tri-agency plan was mandated by the FDA Safety and Innovation Act of 2012 (FDASIA) to delineate agencies’ jurisdiction on health IT safety. The plan categorized which functionality types would be actively regulated by FDA and which would be unregulated and/or subject to non-regulatory safety activities under ONC’s umbrella. Under that plan, the Health IT Safety Center would be a public/private partnership supported by ONC to enhance safety via exclusively non-regulatory/voluntary activities.

The recently released roadmap by RTI, International shares the same vision of the center as a decidedly non-regulatory convener of stakeholders and safety enhancement activities. It includes a startup organizational model (advisory board/executive director-led with its own staff) and funding source recommendations (an initial cooperative agreement with 5 years of ONC or AHRQ seed funding). It suggested that the full cost over five years could be $17.8-$20.6 million, with a sustainability plan kicking in thereafter to eliminate federal funding.

In essence, the center’s infrastructure would appear somewhat similar to the modern Patient Centered Outcomes Research Institute (PCORI), albeit with a different initial funding mechanism and totally different scope.

Categories: EHR, FDA, IOM

HHS and NIST to Host HIPAA Security Conference

July 16, 2015 Leave a comment

The National Institute of Standards and Technology (NIST) and U.S. Department of Health and Human Services (HHS) Office of Civil Rights will convene the 8th annual conference on “Safeguarding Health Information: Building Assurance through HIPAA Security” September 2-3, 2015 in Washington, DC.

The event will focus on the technology- and electronic health information-related aspects of the Health Insurance Portability and Accountability Act (HIPAA) security requirements, including updates on the Omnibus HIPAA/HITECH final rule, breach management, business associate liability, managing 3rd party risk, securing medical devices, and more.

Online registration is now available.

Categories: EHR

National Physician Associations Share Meaningful Use Concerns

June 25, 2015 1 comment

The American College of Radiology (ACR) government relations staff participated in an American Medical Association (AMA)-hosted meeting of the national specialty societies regarding the future of the Medicare/Medicaid EHR Incentive Program on June 24, 2015.

Regulatory affairs staff from approximately 25-30 different national specialty societies participated in the discussions, and all presented their members’ concerns regarding the Centers for Medicare and Medicaid Services’ (CMS) and Office of the National Coordinator for Health IT’s (ONC) ongoing rulemakings to update the program’s requirements.

Noteworthy from the meeting was that all national physician associations continue to share many of the same concerns about the current status and future outlook of the program. While some specialists have unique challenges, the shared concerns include:

  • Alarmingly low participation levels
  • Overly optimistic agency outlook and timetables for the program
  • Health IT certification expansion beyond Meaningful Use (MU) applications
  • Yearlong reporting periods for all participants in 2018 and beyond
  • Lack of full alignment between PQRS and MU’s clinical quality measure reporting
  • Relevance of requirements to workflow/scope of practice
  • Uncertain future MIPS implementation hanging over the current pre-MIPS MU rulemakings
  • And more…

AMA has held one or two specialty society meetings per year on MU-related topics since the establishing Recovery Act was signed into law in 2009. ACR GR staff have worked closely with AMA GR counterparts on various advocacy activities and letters dedicated to improving the program over the years.  Yesterday’s discussions reinforced the fact that, despite some advances, CMS and ONC have a lot of work left to do on this issue.

Categories: EHR, meaningful use, Medicare

ACR Submits Comments on “Meaningful Use Reform” Proposed Rule

June 18, 2015 Leave a comment

The American College of Radiology (ACR) formally submitted comments to the Centers for Medicare and Medicaid Services (CMS) on June 15 addressing the agency’s proposed rule to reform the EHR Incentive Program in 2015 through 2017. The ACR’s comments are accessible here.

The ACR submitted similar comments in response to CMS’ proposed rule for Stage 3 MU last month.

Categories: EHR, meaningful use, Medicare

Senate HELP Committee Explores Challenges in Information-Sharing, Meaningful Use

June 11, 2015 Leave a comment

The U.S. Senate Committee on Health, Education, Labor and Pensions (HELP) convened a full committee hearing regarding “Health Information Exchange: A Path Towards Improving the Quality and Value of Health Care for Patients” on June 10, 2015. The witnesses were Neal Patterson (CEO, Cerner), Christine Bechtel (National Partnership For Women & Families), Dr. Thomas Payne (American Medical Informatics Association), and Craig Richardville (CIO, Carolinas HealthCare System).

The hearing broadly surveyed some of the general challenges facing health information exchange (the verb). A lot of time was also spent on anxiety related to the Medicare/Medicaid EHR Incentive Program (“meaningful use” or MU) and the recent Stage 3 proposed rule for MU in 2018 and beyond. The Chairman, Senator Lamar Alexander (R-TN), and a couple of the witnesses suggested that Stage 3 final rule be delayed until Stage 2 experiences have been collected and leveraged. It did not seem well understood that the Stage 3 proposals were more simplified and flexible for participants than the MU regulations that are currently in effect.

Christine Bechtel, who served on the Office of the National Coordinator for HIT’s Health IT Policy Committee from 2009 to 2015, also attacked the Centers for Medicare and Medicaid Services’ proposal to reduce patient action requirements in the “MU fix: 2015-2017” rulemaking. This proposed change has been misunderstood by some stakeholders as a proposed elimination of the patient electronic access requirement in MU. Bechtel’s written testimony stated:

“We must preserve both the requirement that the technology is in place, and the requirement that a percentage of patients use it at least one time during the reporting period. Regardless of whether the number is five percent or something else, CMS’s recent proposal to drop this threshold to just a single patient will completely undermine efforts by consumers who want to have and use their data. Requiring providers to actively engage with a percentage of patients is an essential mechanism for changing consumer expectations and enabling consumers as a force for change.”

No explanation was provided in the written or verbal testimony for why the proposed change would “undermine efforts by consumers who want to have and use their data.” The MU requirement that patients be enabled to view, download, and transmit their data would not be reduced; only the secondary requirement that a percentage of patients actively use this capability. This secondary requirement has been shown to be controversial and unfair to referral-based specialists, such as diagnostic radiologists, who do not typically have ongoing, continuous relationships with their patients.  It has also been shown to be unfair to rural providers with minimal internet/mobile connectivity and those with patient populations who do not enthusiastically engage with their personal health data online.

The Senate HELP Committee will convene additional hearings in the coming weeks to explore the issues of physician regulatory burden and ownership of exchanged health data.

Categories: EHR, meaningful use, Medicare

ACR Submits Comments on CMS’ Stage 3 Meaningful Use Proposed Rule

May 28, 2015 1 comment

The American College of Radiology (ACR) formally submitted comments to the Centers for Medicare and Medicaid Services (CMS) on May 28 addressing the agency’s proposed rule to implement Stage 3 of the EHR Incentive Program. The ACR’s comments are accessible here.

The ACR also plans to comment next month on CMS’ proposed rule to reform EHR Incentive Program participation requirements in 2015 through 2017. If interested in providing feedback on that rulemaking, please contact Michael Peters, ACR Director of Regulatory and Legislative Affairs, at 202-223-1670 or

Categories: EHR, meaningful use, Medicare

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