Legislative News

  1. New York ePrescribing Mandate Delayed One Year

    New York Governor, Andrew Cuomo, signed legislation, SB 2486, late last week effectively postponing a law that would have mandated prescribers use ePrescribing for all prescriptions for one year.  The provision was part of the I-STOP prescription-drug program adopted in 2012.  The mandate, which is intended to crack down on fraud and abuse of prescription drugs, will now take effect March 27, 2016.

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  2. 21st Century Cures: Interoperability Bill Introduced

    Representative Michael Burgess (R-Texas) released a draft bill recently focused on interoperability. Provisions include:

    • Requiring HHS to create a plan for achieving widespread interoperability of EHR systems by 2017.
    • Replacing the ONC's existing federal advisory committees with a new organization comprised of congressionally appointed members.
    • Defining EHR interoperability as the ability for authorized users to access the entirety of a patient's data from any EHR system without restriction and without the need for multiple interfaces.
    The draft bill is expected to be part of the House Energy and Commerce Committee's 21st Century Cures legislation. BGOV has provided a summary of the draft legislation.

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  3. Prescriber Outreach Letter

    Effective December 1, 2015 Medicare Part D prescription claims will only be covered if the prescriber is enrolled in Medicare or has a valid opt-out affidavit on file with his/her Medicare Administrative Contractors (MAC).  Based on CMS' evaluation of Part D claim data, 30% of the prescribers are not currently enrolled. To mitigate point of service rejections and patient care delays as of December 1, 2015, prescriber outreach is necessary.  The Definition of a Valid Prescriber Task Group has developed a prescriber outreach letter template to assist with this effort.  This letter may be used by pharmacy providers, PBMs, plan sponsors, and other impacted entities.

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  4. 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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  5. 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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