House Passes SGR Patch that Delays ICD-10 By One Year – All Eyes on Senate
Key Takeaway: Last Thursday, legislation to delay implementation of ICD-10 until 2015 cleared the House; the Senate is expected to vote on the SGR patch today at 5 p.m. ET.
Why it Matters: If they delay is approved, CIOs who have made significant investments in resources, training, and implementing the needed workflow and clinical documentation changes to meet ICD-10 compliance on Oct. 1, 2014, will have to push back training schedules once again. If the SGR patch is passed, it will give hospitals and physicians an opportunity to conduct more testing and training to comply by Oct. 1, 2015.
Politics have once again prevailed in the quest for a permanent repeal of the SGR formula. A bicameral, bipartisan bill for permanent repeal has been the focus for a few months, but partisan disagreements on how to pay for the bill delayed passage. As a 24 percent decrease in physician Medicare reimbursements threatens to go into effect tomorrow, House and Senate leadership stepped in to negotiate another short-term SGR patch, which included another one-year delay for ICD-10. Senator Wyden, Chairman of the Senate Finance Committee, opposes the patch and would like to see the permanent repeal passed, but it looks as though the permanent repeal won’t be addressed until after elections.
CHIME, as part of a broad coalition from across the healthcare community – including hospitals, health plans, hospital and physician office coding experts, professional associations, vendors and the HIT community—wrote to Administrator Tavenner on March 12 applauding her February statement, saying, “We have already delayed the adoption standard, a standard the rest of the world has adopted many years ago.” On March 26, the Coalition released a statement blasting the decision to include the ICD-10 delay with the SGR patch, observing that the provision was included solely for political reasons, not because it was sound policy.
AHRQ Funds 12 Research Projects to Help Prepare for Stage 3
Key Takeaway: With the Stage 3 NPRM expected this fall, AHRQ teamed up with ONC and CMS to create 12 projects that will test proposed criteria to inform the Stage 3 rulemaking process.
Why it Matters: The 12 research projects announced this week have implications for clinical decision support, implementation best practices, care coordination, patient engagement and more in Stage 3 Meaningful Use.
Some of the research topics include:
- Assessing Readiness, Achievement and Impact of Stage 3 Care Coordination Criteria
- Best Practices For Integrating Clinical Decision Support Into Clinical Workflow
- Care Coordination Enabled by Health Information Technology: What Will It Take?
- Impact of Meaningful Use Patient Engagement Objectives in a Multicultural Practice-Based Research Network
In an announcement from AHRQ, the agency said the projects “will evaluate proposed objectives and proposed strategies for improving objectives at the policy level, EHR innovations that would support meeting the proposed objectives, and suggestions for primary care practices to increase the value of meaningful use objectives.”
ONC and CMS will have time to evaluate this research and use it in Stage 3 because of their December announcement that pushed back the start of Stage 3 until 2017. The change pushed rulemaking back from Spring 2014 to Fall 2014, which gives organizations time to complete these research projects.
FDA Publishes Proposed Rule, Updates Medical Device Classification
Key Takeaway: At a time when Congress and industry are looking for clarification on the definition of medical devices, FDA published a proposed rule that clarifies the classification of medical devices under the Food and Drug Administration Safety and Innovation Act (FDASIA).
Why it Matters: Industry groups and developers contend that the FDA’s ability to broadly interpret the definition of medical devices has stifled innovation and investment because of the lengthy FDA approval process required if a device is classified as a medical device.
Under the proposed rule, Stage 3 devices would now include:
- “Devices that present known risks that cannot be controlled
- Devices for which the risk-benefit profile is unknown or unfavorable
- Devices for which a full review of manufacturing information is necessary
- Devices for which premarket review of any change affecting safety or effectiveness is necessary.
- Combination products” (products that have a drug constituent or a biological product constituent)
Congress has joined the discussion on FDA regulatory oversight. To help give developers the ability to innovate with certainty on FDA’s regulatory authority over medical devices, the SOFTWARE and PROTECT Acts proposed by the House and Senate, respectively, have attempted to define health, clinical and medical software. Medical software would be subject to FDA regulation. For a CHIME analysis of the two bills, click here. Comments on the proposed rule are due by June 23, 2014.
Separately, any day FDA is expected to publish a regulatory framework for health IT in collaboration with ONC and FCC.