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Washington Debrief: Feds to Focus on Security of Medical Devices

December 7, 2015
by Leslie Kriegstein, Interim Vice President of Public Policy, CHIME
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Federal Affairs

Feds to Focus on Security of Medical Devices

Key Takeaway: The Food & Drug Administration is hosting a public workshop on cybersecurity and medical devices on Jan. 20-21.

Why it Matters:  As cybersecurity continues to garner attention in healthcare, the FDA is interested in learning more about medical device cybersecurity and is hosting an event in conjunction with the Department of Homeland Security. The workshop, “Moving Forward: Collaborative Approaches to Medical Device Cybersecurity,” will bring together diverse stakeholders to discuss complex challenges that impact the medical device ecosystem. The goal is to highlight past collaborative efforts; increase awareness of existing maturity models that are used to evaluate cybersecurity status, standards, and tools in development; and to engage the multi-stakeholder community in focused discussions on unresolved gaps and challenges that have hampered progress in advancing medical device security. The meeting will be held at the FDA campus in Silver Spring, MD. An agenda is still forthcoming, however, CHIME will share information as it becomes available.

Meaningful Use Comments Due

Key Takeaway: CMS has published new resources on Meaningful Use. Also, the deadline to file comments to CMS on Stage 3 is Dec. 15.

Why it Matters: To help eligible professionals, eligible hospitals, and critical access hospitals (CAHs) successfully participate in the Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs in 2015, CMS has posted new resources on the CMS EHR Incentive Programs website. As a reminder, on October 6, CMS released the final rule for the EHR Incentive Programs, which provides new criteria that eligible professionals, eligible hospitals, and CAHs must meet in order to successfully participate in the EHR Incentive Programs in 2015 through 2017 and Stage 3 in 2018 and beyond. CMS is accepting comments on Stage 3. The comment filing deadline is Dec. 15. Comments can be filed online here.

Providers Get More Time to File Quality Reports

Key Takeaway:  CMS has extended several deadlines for quality reporting programs involving appeals and participation.

Why it Matters: Clinicians may need to take action to avoid a financial penalty.


CMS has extended to Dec. 16 the deadline to file informal reviews for financial penalties for physicians who did not meet PQRS reporting in 2014. Providers who believe that the payment adjustment is being incorrectly assessed can file for an information review of their situation. Eligible providers receiving a negative payment adjustment in 2016 will be paid 2.0 percent less than the MPFS amount for that service. All informal review requests must be submitted electronically via the Quality Reporting Communication Support Page (CSP), which will be available until 11:59 p.m. Eastern Time, Dec. 16, 2015. The same deadline applies for those wishing to appeal their VPM decision and avoid a 2 percent cut in 2016. Additional information about the 2014 QRURs and how to request an informal review is available on the 2014 QRUR website and through the QRUR Help Desk at pvhelpdesk@cms.hhs.gov or 888-734-6433 (select option 3). Once CMS has reached a decision it is final and there are no further opportunities for a review. 

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