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Washington Debrief: Senate Committee Chair Calls for Immediate Release of Modifications Rule, Delay in Stage 3 Rulemaking

September 21, 2015
by Leslie Kriegstein, Interim Vice President of Public Policy, CHIME
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Congressional Affairs

Senate Committee Chair Calls for Immediate Release of Modifications Rule, Delay in Stage 3 Rulemaking

Key Takeaway: Sen. Lamar Alexander (R-TN) last week called on the Centers for Medicare and Medicaid Services to immediately release the meaningful use modifications rule. Speaking at a Health, Education, Labor and Pensions (HELP) Committee hearing, the chairman also urged CMS to delay issuing Stage 3 final rules until 2017. Both rules are currently being reviewed by the Office of Management and Budget.

Why It Matters: Congressional leaders have taken note of the continued delay in the release of the meaningful use modifications rule for 2015-2017 and expressed concern for the imminent release of the Stage 3 Final Rule.

During last Wednesday’s hearing, which  focused on how health IT can improve patient access to medical records, Alexander highlighted the importance of delaying Stage 3 final rules until robust evaluation has been conducted of provider and hospital participation in Stage 2.

Sen. Elizabeth Warren (D-MA) similarly called on the administration to revisit proposed policies to ensure they have the necessary focus on interoperability. During her comments, Warren identified the need to be able to confidently match patients with their healthcare records as a key component of an interoperable healthcare delivery system.

Witnesses detailed how a truly interoperable system is critical for providers and patients to be better engaged in care delivery. They also discussed some of the key challenges and barriers.

The committee’s discussions are expected to continue in another hearing in early October, which is expected to include individuals from the Obama administration.

In the House

Efforts to hold off release of Stage 3 final rules have also been initiated in the House of Representatives, led by Reps. Renee Ellmers (R-NC), Tom Price (R-GA) and David Scott (D-GA).  The three initiated a bipartisan letter to be sent to the administration requesting that CMS withdraw the Stage 3 final rules that are currently under review at OMB and instead revise the rules to include better alignment with the Merit-based Incentive Payment System (MIPS) and to incorporate a greater focus on interoperability. 

Efforts continue to increase the number of cosponsors on the Further Flexibility in HIT Reporting and Advancing Interoperability Act (HR 3309) in the House, which among other important provisions, directs HHS to press pause on the Stage 3 Final Rule until 2017. If you have not yet contacted your Member of Congress to encourage their support on this important issue, but consider doing so by adapting form letter provided here to share your experience in the meaningful use program.

ONC Announces Website Devoted to Health IT Complaints

Key Takeaway: Last week, the Office of the National Coordinator (ONC) launched a webpage where providers (and presumably others) can formally register  complaints about the usability, interoperability and other issues related to health IT.  Complaints can be made anonymously.

Why it Matters:  After years of swirling criticisms that there is no recourse for healthcare providers to register concerns with EHR products, EHR usability, data blocking, and other related issues, this site offers some recourse.  The webpage complaint form lists the following complaint topics:  

  • ONC Health IT Certification 
  • Information Blocking
  • Health IT Safety
  • Usability
  • Privacy and Security
  • Clinical Quality Measures
  • Other

ONC made an attempt to satisfy providers in a 2012 blog post after they created an email box with which to share complaints over certified EHR functionalities, but noted that many of the complaints were outside of ONC’s domain. This was followed by a call-to-action from Congress to study data blocking with a mandate that ONC publish a study on the topic as part of the Consolidated and Further Continuing Appropriations Act of 2015 which was enacted on December 16, 2014. 

ONC's ability to enforce some of these areas, however, is fairly limited.  They are permitted to de-certify products and have done so in a limited number of instances.  Congressional pressure has been building over the past two years to address issues like usability and data blocking.  Congress began to take note of problems plaguing providers with their EHRs when Sens. Lamar Alexander (R-TN), Richard Burr (R-NC), Tom Coburn (R-OK), Mike Enzi (R-WY), Pat Roberts (R-KS) and John Thune (R-SD), issued, "Reboot: Reexamining the Strategies Needed to Successfully Adopt Health IT."

Precision Medicine Working Group Report 

Key Takeaway: On September 17th the Precision Medicine Working Group submitted a report, "The Precision Medicine Initiative Cohort Program – Building a Research Foundation for 21st Century Medicine, " to the National Institutes of Health (NIH).  NIH Director Francis Collins, M.D., tasked them with laying out a blueprint for the Precision Medicine Initiative Cohort Program (PMI-CP).

Why it Matters: In the State of the Union Address on January 20, 2015, President Obama announced his intention to launch a Precision Medicine Initiative (PMI) “to bring us closer to curing diseases like cancer and diabetes, and to give all of us access to the personalized information we need to keep ourselves and our families healthier.”  

The work group detailed a plan in which electronic health records play a central role in fulfilling the promise of PMI. However, the report points out that laws, regulations and policies “surrounding research, data security and privacy, and access and interoperability of EHRs” will influence just how far EHRs can help to move things forward.

“Gaps and conflicts in policies will need to be addressed,” the report states.

The working group anticipates that a wide range of healthcare provider organizations (HPOs) could help with the PMI cohort requirements. Such HPOs may include healthcare delivery systems, academic medical centers, and federally qualified health centers (FQHCs), among others. Among the requirements most participating HPOs would have to meet would include having an EHR that meets Meaningful Use Stage 2 requirements.  

They also envision the HPO being able to share core data elements from their EHR to the PMI cohort. They also anticipate electronic consent across digital platforms will be a core component of PMI cohort recruitment.  To reduce ambiguity they call for assigning a "research unique identifier (RUID) to each participant."  

As most data sources will not use a common identifier, the PMI-CP will need to employ record linkage strategies. Experience with health information exchanges and other data networks has shown the need for record linkage strategies that take into account the possibility of differences in identifying fields."  The needs of the PMI-CP are further indication of the need, from CHIME's perspective, for unique patient identifier which could substantially contribute to better data matching to facilitate improved, secure patient care while also reducing costs.

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