Legislative News

  1. ONC Publishes Final EHR Certification Rule

    The Office of the National Coordinator (ONC) published its final rule defining its role in oversight of certifying electronic health records (EHRs).  The rule authorizes the ONC to decertify health IT products that are not meeting regulatory requirements or are deemed to pose a risk to patient safety.

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  2. HHS Publishes Final MACRA Rule

    The Department of Health & Human Services (HHS) issued a final rule to implement the Medicare Access and CHIP Reauthorization Act.  HHS expands exemptions and offers more flexibility to providers to meet the requirements of the law in the final rule, which requires physicians participate in one of two reimbursement tracks: a merit-based incentive payment system (MIPS) or advanced alternative payment models (APMs).  Under the rule, HHS will exempt physician practices with less than $30,000 in Medicare charges or fewer than 100 unique Medicare patients per year.  Additionally, the agency plans to provide $100 million in technical assistance to clinicians participating in MIPS who are in small practices, rural areas and in areas with a shortage of health professionals.  HHS also reduced the total number of required measures under its EHR incentive programs under the category to five from 11.

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  3. FDA to Hold Public Meeting on Abuse-deterrent Opioids

    The Food and Drug Administration (FDA) will hold a public meeting October 31-November 1, 2016 to discuss scientific and technical issues with the development and pre-market evaluation of abuse-deterrent opioids. According to the FDA, the public meeting is intended to give the agency the opportunity to discuss it’s guidance on the topic “General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products.”

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  4. FDA Publishes Fiscal Year 2017 User Fee Rates

    The Food & Drug Administration (FDA) published its application fee for Prescription Drug User Fee Rates for Fiscal Year 2017 and Biosimilar User Fee Rates for Fiscal Year 2017. According to the notice, the FDA is lowering the fees companies will pay for prescription drug and biosimilar user fees next year to at $2.038 million. The new rates will take effect October 1, 2016.

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  5. USP Letter on Biologics

    The United States Pharmacopeia (USP) requested NCPDP’s support in responding to a provision relating to biologics included in the Senate Health, Education, Labor & Education (HELP) Committee Medical Innovation Package. The provision would exempt biological medicines from the requirement to adhere to USP public standards for quality. NCPDP agrees that, if enacted, this provision would have potentially grave consequences for public health and safety. NCPDP is an Observer Organizational Member of USP and shares a common vision for patient safety.

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