FDA issues final unique device identifier rule   09/20/2013
The Food and Drug Administration today issued a final rule requiring most medical devices distributed in the U.S. to carry a unique device identifier within seven years. Class III (or high-risk) devices must comply by Sept. 24, 2014 and Class I devices by Sept. 24, 2020. Devices intended for reuse must eventually bear a permanent UDI marking on the device, beginning with Class III devices in 2016. FDA also will create and administer a publicly searchable database to serve as a reference catalog for every device with an identifier. The rule and draft guidance on the database will be published in the Sept. 24 Federal Register. For more information, visit www.fda.gov. AHA and its Association for Healthcare Resource & Materials Management affiliate have long advocated for a UDI system to improve device tracking for patient safety and supply chain efficiency. A UDI is a unique numeric or alphanumeric code that identifies the labeler and specific version or model of a device, and production details such as the lot, serial number and date the device was made or expires. AHA members will receive a future regulatory advisory on the final rule.
House sends Senate short-term CR defunding ACA   09/20/2013
The U.S. House of Representatives today voted 230-189 to approve a continuing resolution that would fund most government programs at the current, post-sequestration rate through Dec. 15, and defund the Patient Protection and Affordable Care Act. The bill also would require the U.S. Treasury to make debt payments and pay Social Security benefits before other payments if the government reaches the debt ceiling. The legislation now goes to the Senate, which Majority Leader Harry Reid (D-NV) said will not pass any bill that defunds or delays the ACA. The administration also said the president would veto the bill if it reaches his desk. The current CR expires Oct. 1.
CMS posts FY 2015 hospital wage index data files for review   09/20/2013
Hospitals now have until Nov. 21 to review and request revisions to their wage and occupational mix data before it’s used to develop the fiscal year 2015 hospital wage index. The Centers for Medicare & Medicaid Services released the data a month early on Sept. 13, but hospitals have the standard amount of time to review the data and request revisions. Certain subsequent dates in the wage index development process also will be earlier than in previous years as a result of the advanced timeline. For more information, see the CMS notice.
HHS issues privacy rule guidance on drug refill reminders   09/20/2013
The Department of Health and Human Services’ Office for Civil Rights yesterday issued guidance on how changes to privacy rule marketing provisions effective Sept. 23 under the HITECH Act apply to refill reminders and other communications about drugs or biologics. The guidance explains the refill reminder exception to the marketing rule, the scope of communications that fall within the exception, and the types of third-party payments for such communications that are considered “reasonable” under the statute and regulations. According to OCR, HHS will not enforce the restrictions on remunerated refill reminders and other communications about drugs and biologics until Nov. 7.