Washington Debrief: Feds to Focus on Security of Medical Devices

Dec. 7, 2015
The Food & Drug Administration is hosting a public workshop on cybersecurity and medical devices on Jan. 20-21.

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 [email protected] 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. 

IQR and MU for Hospitals

CMS has also extended the deadline to submit electronic clinical quality measure (eCQM) data for eligible hospitals participating in the Hospital Inpatient Quality Reporting (IQR) or the Meaningful Use program. Hospitals now have until Thursday, Dec. 31, 2015 at 11:59 p.m., Pacific Time to submit eCQM data using the QualityNet Secure Portal. The extension only applies to the eCQM voluntary submission option for the IQR Program and the e-Reporting option of clinical quality measure data for the Medicare EHR Incentive Program. If hospitals choose to meet program requirements using this data submission method, this change will not affect the Feb. 29, 2016 attestation deadline.  CMS has also noted they are aware of some problems with accessing reports and verifying submissions through the QualityNet Secure Portal and are monitoring the situation. Questions about the Hospital IQR or PCHQR Programs may be submitted through the Inpatient Questions & Answers tool at https://cms-ip.custhelp.com. You can also call the Hospital Inpatient Value, Incentives, and Quality Reporting (VIQR) Outreach and Education Support Contractor, toll-free, at 844-472-4477 or 866-800-8765 weekdays between 8:00 a.m. and 8:00 p.m. ET.

CMS Releases Quality Strategy

Key Takeaway: Agency officials detail efforts to closer align Medicare with alternative payment models.

Why it Matters:  CMS on Nov. 25 shared the updated 2016 CMS Quality Strategy, which incorporates progress made in shifting Medicare payments from volume to value, including payment reform initiatives, as well as new requirements from the Improving Medicare Post-Acute Care Transformation Act of 2014 and the Medicare Access and CHIP Reauthorization Act of 2015 legislation. CMS also published a blog that contains an overview of the Strategy at CMS blog.

The 2016 CMS Quality Strategy helps to align all of CMS to:

  • Drive improvement on specific quality strategy goals and objectives
  • Strengthen our relationships within the agency
  • Build advocacy across HHS agencies

CMS to Provide Update on Long-Term Care Quality Reporting Program

Key Takeaway: CMS is hosting a special call on the Long-Term Care Hospitals (LTCHs) Quality Reporting Program on Dec. 8.

Why it Matters: During this open call, CMS officials will provide a summary of the “All-Cause Unplanned Readmission Measure for 30 Days Post Discharge from LTCHs” and offer responses to frequently asked questions. The presentation slides will be available prior to the presentation at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/LTCH-Quality-Reporting/LTCH-Quality-Reporting-Spotlight-Announcements.html

Participant Dial-In Number: (800) 837-1935

Conference ID #: 95951738

Congressional Affairs

New Bill Calls for Examination of Telehealth Relative to New Payment Models

Key Takeaway: A bipartisan bill introduced last week directs the Center for Medicare and Medicaid Innovation (CMMI) to work with eligible hospitals to test the expansion of certain telehealth services in Medicare’s healthcare delivery reform programs.

Why It Matters: Federal policies concerning telehealth reimbursement have not kept pace with private payers. Lawmakers have had to get creative in ways to demonstrate telehealth and remote monitoring services would reduce costs for Medicare.

The Telehealth Innovation and Improvement Act (S. 2343) (HR 4155), introduced by Sens. Cory Gardner (R-CO) and Gary Peters (D-MI) and Rep. Diane Black (R-TN), would require CMMI to test expanding coverage for telehealth services that make use of remote patient monitoring tools, video conferencing, physiologic and behavioral monitoring technologies and software that allows clinicians to send clinical information such as medical images to each other and to patients.

The legislation also directs CMMI to review and independently evaluate telehealth models for cost, and improvement in quality of care without increasing the cost of delivery. If the telehealth model meets this criteria, then the model could be covered under the broader Medicare program.