Washington Debrief: CMS Signals Additional Changes to MU

Key Takeaway:  The Centers for Medicare and Medicaid Services (CMS) will begin a regulatory process to change the 2015 EHR reporting period to 90-days and make additional changes to the design of meaningful use, chief medical officer Patrick Conway, M.D. announced last week.

Why it Matters:  A shortened reporting period will enable hundreds of thousands of providers to continue participating in meaningful use in 2015, thus maintaining momentum towards interoperability and improved care coordination.  

In a blog posting released last week, CMS announced its intent to give providers much-needed relief in the form of a 90-day reporting period in 2015.  The decision was long coming and a result of congressional and provider pressure.  However, the more direct reason for change can be tied to the long-term sustainability of meaningful use, which will enable improved patient-centered care and health outcomes, the agency said.

Specifically, CMS CMO Patrick Conway, M.D. said the agency is considering proposals to:

• Realign hospital EHR reporting periods to the calendar year to allow eligible hospitals more time to incorporate 2014 Edition software into their workflows and to better align with other CMS quality programs.

• Modify other aspects of the program to match long-term goals, reduce complexity, and lessen providers’ reporting burdens.

• Shorten the EHR reporting period in 2015 to 90 days to accommodate these changes.

The reaction from healthcare providers was immediate.  “CHIME applauds CMS for recognizing the pressing need to bring immediate flexibility to the meaningful use program in 2015.  We are pleased that CMS has announced their intent to make a number of changes to the program – in addition to a shortened reporting period – to reduce complexity and lessen providers’ reporting burden.  Meaningful use has the potential be a transformative program for the nation’s healthcare delivery system and we commend CMS for recognizing the need for a course-correction.”

Details concerning the timing of the announced changes are still unknown, but CMS indicated that these changes would be proposed following release of the Stage 3 notice of proposed rule making (NPRM) due by March.

Key Takeaway: The Office of the National Coordinator for Health IT (ONC) released the much-anticipated Interoperability Roadmap last week, which received broad support across the industry.  Also released was the “2015 Interoperability Standards Advisory,” a document meant to identify, assess, and determine the “best available interoperability standards and implementation specifications for industry use toward specific health care purposes.”

Why it Matters: ONC’s Interoperability Roadmap will be used to guide multiple Department of Health and Human Services (HHS) programs and address congressional criticism over the issue of interoperability.  The Standards Advisory is hoped to be updated annually to reflect industry adoption of key clinical standards.  In combination, these documents are hoped to drive consensus on a strategy to achieve functional interoperability in the next three years.

ONC last week released a pair of documents detailing how the National Coordinator hopes to address the multi-faceted issue of interoperability.  For months, the Office has received criticism from Congress and healthcare providers that meaningful use, EHR Certification and other programs have failed to deliver systems that demonstrate functional interoperability.  According to the 166-page document, the “Roadmap focuses on actions that will enable a majority of individuals and providers across the care continuum to send, receive, find and use a common set of electronic clinical information at the nationwide level by the end of 2017.”  While the details of the Roadmap are still under review, CHIME President and CEO Russell P. Branzell said, “This Roadmap incorporates a tremendous amount of stakeholder input and articulates a clear path towards interoperability. It is a cornerstone in the continuing evolution of federal health IT policymaking.”

Joining the release of the Roadmap was the 2015 Interoperability Standards Advisory – a non-binding, non-regulatory document meant to help facilitate discussion and debate on clinical standards currently used in healthcare and referenced in regulation. The Advisory identifies specific standards and references implementation guidelines across four areas of standards, including content, vocabulary, transport and services.

“This is a much-needed playbook for each and every health IT professional,” Branzell said. “Now, healthcare providers and health IT developers have a single source of truth, with an extensible process to align clinical standards towards improved interoperability, efficiency and patient safety. While we have made great strides as a nation to improve EHR adoption, we must pivot towards true interoperability based on clear, defined and enforceable standards.”

Both documents have asked for comment.  If you are interested in joining a CHIME workgroup, please contact Jeff Smith, Vice President of Public Policy.

Key Takeaway: Last week ONC announced that Thomas Mason, M.D. a community health doctor from Chicago, would become the agency’s next chief medical officer.

Why It Matters: Dr. Mason is the latest hire in ONC’s attempt to fill the key staff vacancies that remained at the conclusion of 2014. Dr. Jon White has served as acting chief medical officer for the ONC since the November 2014 departure of long-time chief medical officer Jacob Reider.

Dr. Mason is currently the Chief Medical Informatics Officer of the Ambulatory and Community Health Network of Cook County. In the announcement of Dr. Mason’s appointment, DeSalvo wrote in a note to staff that he has led implementation of multiple EHR systems, along with patient centered medical homes and disease prevention models. Dr. Mason will officially assume his new role on February 23.

Key Takeaways: After a series of roundtable discussions with experts across the healthcare industry, the House Energy & Commerce Committee released draft legislation last week aimed at expediting patient access to life saving cures. 

Why It Matters: The nearly 400-pages of draft legislative text left out many key health IT- related provisions, including reforms for the meaningful use program. 

The draft legislation set aside Section 2181 for the text of an interoperability bill from Representative Michael Burgess (R-TX-26), but it did not supply the language. The interoperability-focused bill has not been formally introduced, but is expected to define interoperability and require that EHR systems achieve interoperability by 2019.

The draft legislation also contained the latest version of the “Sensible Oversight for Technology Which Advances Regulatory Efficiency Act” or the SOFTWARE Act championed by Representative Marsha Blackburn (R-TN-7) and Representative Gene Green (D-TX-29). The draft defines ‘medical software’ as software that can generate a treatment or diagnosis without intervention from a healthcare professional, this classification of software would be subject to scrutiny from the Food and Drug Administration (FDA). Further, this section would characterize ‘health software’ (including EHRs), to be software that allows health professionals the opportunity for intervention prior to the delivery of a diagnosis or treatment directly to the patient. This section is still in draft form and the authors are soliciting industry feedback on how to ensure products that should be regulated are not falsely exempted from the FDA’s oversight. 

The draft incorporates language to allow CMS to exempt Medicare’s requirements on telemedicine to pay for its services. Another provision concerns clinical data sharing, which seeks to streamline informed consent.

Despite the early bipartisan support for the 21st Century Cures Initiative launched by the Committee last May, Democrats withheld their support for the draft legislation citing a concern that the legislation would create more issues for the healthcare industry than it solves. 

The draft legislation does allow an opportunity for stakeholder feedback, but no formal deadline was announced by the Committee. Energy and Commerce Committee Chairman Fred Upton (R-MI-06) announced his intention for this legislation to become law by the end of 2015.

Edited by Gabriel Perna for style