Archive
FDASIA Workgroup Gets Started
Over the past couple of weeks, the newly formed Food and Drug Administration Safety and Innovation Act (FDASIA) Workgroup, administered by the Food and Drug Administration, Office of the National Coordinator for HIT (ONC), and Federal Communications Commission, held its first series of virtual meetings and established subgroups. The three subgroups will address taxonomy, risk assessment, and regulatory levers.
The plan is for a series of draft FDASIA Workgroup recommendations to be presented to the ONC HIT Policy Committee on August 7, with final recommendations presented on September 4. The three agencies intend to publish draft strategies/recommendations for public comment between September 2013 and January 2014. The goal is to release a final report by the end of January 2014.
Recap of Recent Federal HIT Policy Developments
On April 18, the U.S. Department of Health and Human Services (HHS) released the roster of the Food and Drug Administration Safety and Innovation Act (FDASIA) Workgroup administered by the Food and Drug Administration, Office of the National Coordinator for HIT (ONC), and Federal Communications Commission. The important objective of the FDASIA Workgroup is to develop recommendations on a risk-based regulatory framework for health IT, including mobile applications. Richard Eaton (staff person, Medical Imaging and Technology Alliance) was selected as a member. Dr. David Bates (Brigham and Women’s Hospital) was identified as the workgroup chair, despite ONC’s informal announcement during the March 27 HIT Standards Committee meeting that Dr. Paul Tang (Chair, HIT Policy Committee) would serve in that capacity.
On April 25, HHS announced ONC’s revocation of certification for EHRMagic-Ambulatory and EHRMagic-Inpatient products by EHRMagic Inc. of Santa Fe Springs, CA. This is the first official revocation of product certification status by ONC.
On April 16, Senate Republicans published a white paper criticizing HHS’ implementation of the Medicare/Medicaid EHR Incentive Program. Most of the issues discussed in the October 2012 Senate and House Republican criticisms are addressed in the white paper, such as EHR-enabled upcoding, oversight concerns, lack of perceived progress on interoperability, and more.
On April 26, the Government Accountability Office (GAO) released a call for nominations for a research community representative slot on the ONC HIT Policy Committee. Nominations are due by May 18.
ACR Comments on CMS/ONC RFI on Advancing Interoperability and Health Information Exchange
On April 15, the American College of Radiology submitted comments to the HHS Office of the National Coordinator for HIT and Centers for Medicare and Medicaid Services regarding the March 7 Request for Information (RFI) on interoperability and health information exchange.
ACR’s comments focused on concerns regarding closed EHR donor-recipient exchange relationships facilitated, in part, by a combination of confusion with weak implementation of the interoperability prerequisite to the 2006 EHR exception/safe harbor to self-referral/anti-kickback requirements. The ACR provided recommendations that would push EHR donors to fully enable donation recipients to exchange with imaging providers outside of donors’ systems.
CMS and HHS OIG Publish Proposed Rules on Self-Referral EHR Exception and Anti-Kickback EHR Safe Harbor
On April 10, the HHS Office of Inspector General (OIG) and the Centers for Medicare and Medicaid Services (CMS) published proposed rules regarding the EHR exception to self-referral prohibitions and the EHR safe harbor under the anti-kickback statute. The two proposed rules would extend the expiration date for these items and update donated EHR “interoperability” requirements.
The ACR government relations staff are currently reviewing both proposed rules. Any ACR members interested in providing feedback should contact Michael Peters, Director of Legislative and Regulatory Affairs, at mpeters@acr.org/202-223-1670.
CMS Releases EHR Incentive Program Guidance on Audits
On April 9, the Centers for Medicare and Medicaid Services (CMS) announced additional guidance related to the pre-payment and post-payment EHR Incentive Program audits. The recently released material includes a fact sheet addressing supporting documentation that meaningful use participants need for an audit, as well as a sample audit request letter from the CMS contractor, Figliozzi and Company.
Of note, the fact sheet includes an extensive list of potential documentation to demonstrate compliance with the yes/no meaningful use measures (note that certified EHR technology is currently required to automatically calculate the percentage-based measures). Verifying compliance with the yes/no measures was one of the big sticking points of the November 2012 HHS Office of Inspector General report on “oversight of meaningful use.”
CMS and ONC Update the Public Meaningful Use Attestation Data; Radiology Numbers Are Up
On April 5, Dr. Farzad Mostashari (National Coordinator for HIT) announced a much needed update to the public data file that shows de-identified meaningful use attestation data by product, specialty, location, and other attributes. This data file is important because it is the only currently available way for all medical specialties to know how many of their physicians have successfully attested to MU and which products they have been using.
The updated data is apparently current as of January 31, 2013, which means the last minute February 2013 attestations for CY 2012 are not yet included.
The numbers for the American College of Radiology’s membership are as follows:
- Diagnostic radiology: 2657 total attestations from 2457 different diagnostic radiologists
- Interventional radiology: 152 total attestations from 130 different interventional radiologists
- Radiation oncology: 998 total attestations from 948 different radiation oncologists
- Nuclear medicine: 56 total attestations from 55 different nuclear medicine physicians
New Meaningful Use Educational Resources on ACR.org
The American College of Radiology added two new educational resources to its Meaningful Use (MU) Resources page:
- ACR’s Pocket Guide to Meaningful Use in 2013: A two-page pamphlet explaining the basics of MU in CY 2013 with links to pertinent federal resources.
- ACR’s Overview of Stage 1 Meaningful Use Objectives in 2013: This document shows the basic user requirements of all Stage 1 MU objectives in CY 2013. The explanations for each objective include short explanatory notes from ACR, and links to the related federal resources.
More ACR MU educational resources will be coming in future months, including CY 2014 Stage 1 and Stage 2 pocket guides and objective overviews. We also plan to revise or retire older educational resources.
A special thank you to Adeel Siddiqui, MD (Clinical Fellow in Neuroradiology, Johns Hopkins Hospital and Research fellow in Radiology Informatics, Massachusetts General Hospital) for guiding the development of the objectives overview and reviewing the pocket guide.
FDA Safety and Innovation Act Workgroup Members to be Named Next Week
The Office of the National Coordinator for HIT (ONC) revealed that the roster of the FDA Safety and Innovation Act (FDASIA) Workgroup will be announced late next week. The workgroup’s first meeting is scheduled for April 9. This announcement was made during the HIT Standards Committee’s virtual meeting on March 27.
The purpose of the new workgroup will be to advise ONC, FDA, and FCC during the agencies’ development of a report to Congress on an appropriate regulatory framework for HIT, particularly in the area of mobile medical applications. The FDA Safety and Innovation Act of 2012 mandated this activity due to concern about FDA’s 2011 draft guidance on mobile medical apps, as well as potential jurisdictional overlap between the three regulatory agencies.
Interestingly, Dr. Paul Tang (HIT Policy Committee Chair) will chair the new workgroup even though it was not originally intended by Congress to fall under the ONC HIT Policy Committee.
House Energy and Commerce Committee Hearings on mHealth and HIT Innovation
On March 19, the U.S. House of Representatives Energy and Commerce Committee held the first in a series of three planned hearings on HIT innovation. The first hearing focused on the ongoing efforts to better define the Food and Drug Administration’s (FDA) role in regulating mobile medical applications. The other two hearings (March 20 and 21) will focus more broadly on the benefits of HIT to patients and the Administration’s perspectives on HIT regulation.
As you may recall, in July 2011, the FDA published for public comment its draft guidance to clarify oversight issues related to mobile medical applications. FDA’s efforts to finalize the draft guidance were eventually hamstrung by the discussions in Congress leading up to passage of the FDA Safety and Innovation Act of 2012. FDA’s plans for regulating certain mobile medical applications will remain cloudy until the guidance is finalized and published.
Most committee members and witnesses participating in the hearing seemed to agree that the FDA should expeditiously finalize the draft guidance to address the lack of clarity. Committee Republicans expressed concern about the potential application of the Affordable Care Act’s medical device excise tax to the mHealth domain. Democrats on the committee urged Republicans to not use mHealth innovation as a political tool for attacking the medical device excise tax and healthcare reform law in general.
HHS Releases RFI on Advancing Interoperability and Health Information Exchange
On March 7, the U.S. Department of Health and Human Services (HHS) published a Request for Information (RFI) on advancing interoperability and health information exchange (HIE). The public comment period will close at 5:00 PM (Eastern) on April 22, 2013. The American College of Radiology leadership and staff are currently reviewing the content.
The discussions and questions in the RFI relate to a wide variety of predominantly Medicare/Medicaid programs and initiatives. If ACR members have any suggestions or feedback on the below ten questions from the RFI, please email me at mpeters@acr.org.
1. What changes in payment policy would have the most impact on the electronic exchange of health information, particularly among those organizations that are market competitors?
2. Which of the following programs are having the greatest impact on encouraging electronic health information exchange: Hospital readmission payment adjustments, value-based purchasing, bundled payments, ACOs, Medicare Advantage, Medicare and Medicaid EHR Incentive Programs (Meaningful Use), or medical/health homes? Are there any aspects of the design or implementation of these programs that are limiting their potential impact on encouraging care coordination and quality improvement across settings of care and among organizations that are market competitors?
3.To what extent do current CMS payment policies encourage or impede electronic information exchange across health care provider organizations, particularly those that may be market competitors? Furthermore, what CMS and ONC programs and policies would specifically address the cultural and economic disincentives for HIE that result in data lock-in or restricting consumer and provider choice in services and providers? Are there specific ways in which providers and vendors could be encouraged to send, receive, and integrate health information from other treating providers outside of their practice or system?
4. What CMS and ONC policies and programs would most impact post acute, long term care providers (institutional and HCBS) and behavioral health providers (for example, mental health and substance use disorders) exchange of health information, including electronic HIE, with other treating providers? How should these programs and policies be developed and/or implemented to maximize the impact on care coordination and quality improvement?
5. How could CMS and states use existing authorities to better support electronic and interoperable HIE among Medicare and Medicaid providers, including post acute, long-term care, and behavioral health providers?
6. How can CMS leverage regulatory requirements for acceptable quality in the operation of health care entities, such as conditions of participation for hospitals or requirements for SNFs, NFs, and home health to support and accelerate electronic, interoperable health information exchange? How could requirements for acceptable quality that involve health information exchange be phased in overtime? How might compliance with any such regulatory requirements be best assessed and enforced, especially since specialized HIT knowledge may be required to make such assessments?
7. How could the EHR Incentives Program advance provider directories that would support exchange of health information between Eligible Professionals participating in the program. For example, could the attestation process capture provider identifiers that could be accessed to enable exchange among participating EPs?
8. How can the new authorities under the Affordable Care Act for CMS test, evaluate, and scale innovative payment and service delivery models best accelerate standards-based electronic HIE across treating providers?
9. What CMS and ONC policies and programs would most impact patient access and use of their electronic health information in the management of their care and health? How should CMS and ONC develop, refine and/or implement policies and program to maximize beneficiary access to their health information and engagement in their care?
10. What specific HHS policy changes would significantly increase standards based electronic exchange of laboratory results?
