1. FDA NPRM on Paperless Labeling

    FDA has issued a notice of proposed rule making (NPRM) for Paperless Labeling (this applies to professional labeling, not package inserts or MedGuides).

    You can find the proposed rule by going to its entry in the Federal Register or by visiting fdsys.gov.

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  2. What's Happening in Regulatory and Legislative News?

    • NGA Recognizes Pharmacists' Role as Provider
    • Congressional Outlook: Healthcare in 2015
    • The Flex-IT Act of 2015
    • CMS Administrator Tavenner Resigns
    • AHRQ Hosts Webinar on Stage 3 MU
    • FDA GUDID Updates
    • FDA Published Draft Documents for Device Accessories and Wellness Products
    Note: Get more information on these regulatory issues through a subscription to RxReconn. If you are already a subscriber, your weekly updates on legislative and regulatory news are posted online.

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  3. What's Happening in Regulatory and Legislative News?

    • 114th Congress is Sworn In
    • HHS Seeks Comments on Safe Harbor & Anti-kickback Law
    • CMS Asks Industry to Weigh In on Risk Corridors
    • CMS Launches Rate Review Website Tool for Consumers
    Note: Get more information on these regulatory issues through a subscription to RxReconn. If you are already a subscriber, your weekly updates on legislative and regulatory news are posted online.

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  4. What's Happening in Regulatory News

    • ONC Publishes Updated Federal Health IT Strategic Plan
    • FDA Issues Draft Guidance on Reporting Requirements for Rx Drug Wholesalers
    • Final Rule on Medicare Provider Enrollment Published
    • Proposed Rule Seeks to Revise the Medicare Shared Savings Program
    • FDA Releases Guidance for Compounding Outsourcing Facilities
    • 2016 Benefit & Payment Parameters Proposed

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  5. CMS Offers 2nd Extension for EHR Incentive Programs

    CMS has extended the deadline for eligible hospitals and critical access hospitals to attest to meaningful use for 2014 Medicare EHR incentive programs through December 31, 2014 adding a month to the current deadline. The extension does not impact the deadlines for the Medicaid EHR Incentive Program.  Healthcare Informatics reports the extension will help provider groups, but will most likely not satisfy industry associations request for action from the federal government “specifically requesting a shortened, 90-day reporting period rather than the current 365-day reporting period for 2015.” 

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