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B-list draft guidance documents CDRH will publish, if possible, include: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