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.
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 email@example.com/202-223-1670.
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.”
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
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.
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 firstname.lastname@example.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?
On February 6, the Office of the National Coordinator for HIT (ONC) HIT Policy Committee (HITPC) convened to discuss public comments on the November 26, 2012 Stage 3 Meaningful Use (MU) Request for Comments (RFC). As has historically been the case with previous HITPC RFCs, only a broad, high-level summary of the public comments was communicated to HITPC members. Though the summary was not at all inclusive of differing perspectives or detailed arguments, ONC staff mentioned plans to explore the comments more thoroughly at the workgroup level between now and April.
In terms of the imaging-specific items, the summary indicated that:
- Commenters do not support moving the imaging results accessibility objective from the menu set to the core in Stage 3.
- Commenters support including imaging and/or radiation dose data in the “patient view/download/transmit objective” objective for Stage 3, but expressed concerns about education, bandwidth, and availability of standards.
- While there was more variability in the comments on the CPOE objective, most did not support higher thresholds for lab-test and radiology orders. Appropriateness CDS during CPOE was not mentioned.
Moving forward, the various HITPC workgroups will discuss potential Stage 3 recommendation changes in light of the public comments. The plan is for the workgroups to present draft recommendations to the HITPC in April. The HITPC will likely approve a finalized version of the recommendations at the May meeting. The agencies will be free to use or not use HITPC recommendations however they see fit during the future Stage 3 MU rulemaking process.
On January 29, the Office of the National Coordinator for HIT’s (ONC) HIT Policy Committee and HIT Standards Committee held a rare joint meeting to hear from stakeholders regarding various health information exchange (HIE) issues. Invited panelists included representatives from Accountable Care Organizations, HIT vendors, integrated health care delivery systems, and state/regional HIE networks, among others.
ONC initially announced the hearing on December 20, 2012, alongside various other activities intended to take the place of a rulemaking to develop federal HIE governance regulations. Although ONC was essentially positioning itself for a rulemaking throughout the first half of 2012, public comments on a May Request for Information convinced the agency that federal regulations could potentially stifle innovation in the States and private sector.
On January 8, the Centers for Medicare and Medicaid Services (CMS) released new guidance regarding the optional significant hardship exception that will allow many radiologists to temporarily avoid payment reductions for noncompliance with the EHR Incentive Program (“meaningful use”) beginning in 2015. According to the new guidance, physicians with the primary Provider Enrollment, Chain and Ownership System (PECOS) specialty codes “diagnostic radiology,” “nuclear medicine,” and “interventional radiology” will automatically avoid penalties for noncompliance. Without future legislative intervention, CMS cannot grant a physician the significant hardship exception for more than five total years.
On January 14, The American College of Radiology (ACR) submitted feedback in response to a November 26 request for comments (RFC) from the Office of the National Coordinator for HIT’s (ONC) HIT Policy Committee regarding ideas for policy recommendations on Stage 3 meaningful use objectives. The HIT Policy Committee will use the lessons learned from the public comments to draft recommendations in mid-2013 for the future CMS and ONC rulemakings related to Stage 3 meaningful use. Both federal agencies will be free to use or not use the recommendations however they see fit while drafting the proposed rules.
On January 16, the ONC HIT Standards Committee convened for its monthly meeting. Of note, the advisors and ONC staff discussed the planned standards work ahead for 2013 which could include discussions about medical imaging standards. The HIT Standards Committee had previously planned to explore this area in 2012, but never got around to it.
On January 17, the ACR Government Relations Department published the December-January 2013 issue of the ACR Advocacy Update, featuring news and information about activities related to legislative, state, and federal affairs topics.