FDA Issues 2014 Work Plan for Medical Device Guidance
The Food & Drug Administration’s Center for Device and Radiological Health (CDRH) last week released a list of planned guidance documents for Fiscal Year 2014. Additionally, CDRH announced a new website and public comment submission process for interested stakeholders to help FDA get safe and effective medical devices to market more quickly. On the website, the agency said it has two lists: (1) the guidance documents “that the Agency fully intends to publish (the ‘A-list’); and (2) a list of guidance documents that the Agency intends to publish as resources permit (the ‘B-list’).” The FDA did not list any specific final guidance topics in its B-list.
Among the A-listed final guidance document topics for FY 2014 on the agency website are:
- Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, the subject of a recent comment period for its draft; and
- Global Unique Device Identification Database, which was released in September as a draft along with a final rule.
B-list draft guidance documents CDRH will publish, if possible, include:
- Medical Device Decision Support Software; and
- Device Interoperability
Legislators Warn HHS against Accounting of Disclosures Rules
In a pair of letters sent from both the House of Representatives and the US Senate, lawmakers urged HHS officials to forego withdraw plans to update Accounting of Disclosures and Access Report rules. Under the HITECH Act, HIPAA is expanded to require covered entities to produce an accounting of disclosures through an electronic health record. Representatives Jim Matheson (D-UT) and Mike Rogers (R-MI) from the House and Senators Orrin Hatch (R-UT) and Amy Klobuchar (D-MN) issued letters saying HHS needs to adhere more closely to statutory language; they contend that HHS is neglecting a need to balance providers’ reporting burden. “The fact that more than four years have passed since enactment of HITECH underscores the difficulty in crafting accounting of disclosures regulations that are both technologically feasible and respond to demonstrated patient interest. We are not convinced that it is even possible to promulgate such regulations,” the lawmakers wrote.
Recently, CHIME submitted comments to the Health IT Policy Committee’s Privacy and Security Tiger Team on this subject. CHIME said the market for technical solutions was immature, that standards regarding audit logs and audit reports across various systems were nonexistent and that there was little demonstrated evidence to suggest current protections under the law were inadequate. CHIME recommended that HHS conduct further inquiry on the need for further regulation.
Stark and Anti-kickback Rules on the Horizon
CIOs worried about their safe harbor status with donated technology can rest a little easier. That’s because the Office of Management and Budget have indicated rules, proposing to extend the technology donation provisions to at least 2016, are in the final phase of approval. This does not guarantee CMS and the HHS Office of Inspector General (OIG) will extend the safe harbor, but simply that a decision is near. In a proposed rule, released in April, CMS and OIG proposed to extend donation provisions to either 2016 or 2021, and they sought comments on which date would be appropriate to revisit the issue. CHIME submitted comments, recommending a permanent extension to safe harbor provisions. “Even with the upward trends in adoption and meaningful use of EHRs, there remains a need to further accelerate and encourage progress using the tools of health IT to improve the quality and effectiveness of patient care,” CHIME said. “Regulatory protections have moved beyond the role of enticing adoption, but rather, are now necessities of a new and emerging payment paradigm.”
CHIME will continue to monitor this issue closely and alert members of the final decision once it’s rendered by CMS and OIG.
Shake-up at CMS amid Continued Healthcare.gov Woes
News surfaced last week that CMS CIO Tony Trenkle would be stepping down, effective November 15. The announcement was made as CMS Administrator Marilyn Tavenner and HHS Secretary Kathleen Sebelius testified to Senators on Healthcare.gov’s deficiencies. Mr. Trenkle joined CMS in March 2005 as director of the Office of E-Health Standards & Services and was responsible for Health Insurance Portability and Accountability Act and electronic prescribing standards. He also oversaw development of Stage 1 Meaningful Use regulations and was pivotal in the EHR Incentive Program structure.
An internal CMS memo said Dave Nelson, who heads the CMS Office of Enterprise Management, will fill in for Trenkle as acting CIO. And Niall Brennan, now the director of the Office of Information Products and Data Analytics, will fill Nelson's shoes as the acting director of the Office of Enterprise Management.
In his current capacities, Trenkle oversaw information technology products and services at CMS, which is a $2 billion annual program. He is reportedly moving to the private sector.
Upcoming CHIME Public Policy Briefing to focus on EHR Hardship Exemptions
Time: 12:00:00 PM - 1:00:00 PM
Session Speaker: Robert Anthony, Director of the Health IT Initiatives Group in the Office of E-Health Standards, Centers for Medicare & Medicaid Services
According to federal rules, hospitals that are eligible to participate in the Medicare EHR Incentive Program must meet meaningful use requirements to avoid the federally-mandated payment adjustments that begin October 1, 2014. To avoid payment adjustments next year, all eligible hospitals will have to begin collecting data by July 1, 2014 for a 90-day, quarter-based reporting period, regardless of which Stage or payment year they are attesting. Is your organization prepared? If not, there is good news. CMS has established EHR Hardship Exemptions and will be on-hand during this session to describe the program and who will be eligible. Hardship exceptions will be granted only under specific circumstances, and only if CMS determines that providers have demonstrated significant barriers to achieving meaningful use. Be sure to bring your questions to this can’t-miss webinar!
- Explain how payment adjustments are calculated based on MU participation start year
- Describe the different categories of EHR Hardship Exemptions
- Detail how eligible hospitals can apply for an EHR Hardship Exemption, if need be
Register here and look for the session title "Its FY 2014, Do You Know Where Your Certified EHR Is?"
Hospitals Must Attest by November 30 to Receive Payment for 2013 EHR Incentive Program Participation
The last day that eligible hospitals and critical access hospitals (CAHs) can register and submit attestation in fiscal year (FY) 2013 for the Medicare EHR Incentive Program is November 30, 2013. Eligible hospitals and CAHs must successfully attest to demonstrating meaningful use by November 30 to receive a 2013 incentive payment. Hospitals must attest to demonstrating meaningful use every year to receive an incentive and avoid a payment adjustment, which will be applied beginning FY 2015 (October 1, 2014) to Medicare eligible hospitals that have not successfully demonstrated meaningful use. The adjustment is determined by the hospital’s reporting period in a prior year. Read the eligible hospital payment adjustment tip sheet to learn more.