1. FDA Issues Draft Guidance on Identifying Suspect Drug Products in Supply Chain

    The Food and Drug Administration (FDA) issued draft guidance this week under the Drug Supply Chain Security Act. The guidance, “Draft Guidance for Industry: Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification,” describes potential signs of suspect drug products, including:

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  2. CMS Regulatory Update

    The Centers for Medicare & Medicaid Services (CMS) has published a proposed rule seeking to change the meaningful use stage timeline and the definition of certified electronic health record technology (CEHRT). It would also change the requirements for the reporting of clinical quality measures for 2014.

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  3. Contract Year 2015 Policy and Technical Changes to Medicare Program

    The Centers for Medicare & Medicaid Services (CMS) has issued its Final Rule to revise the Medicare Advantage (MA) program (Part C) regulations and prescription drug benefit program (Part D) regulations to implement statutory requirements; improve program efficiences; and clarify program requirements. The final rule also includes several provisions designed to improve payment accuracy.

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  4. ICD-10 Update

    The following was provided to Work Group for Electronic Data Interchange (WEDI) from the Centers for Medicare & Medicaid Services (CMS): "On April 1, 2014, the Protecting Access to Medicare Act of 2014 (PAMA) (Pub. L. No. 113-93) was enacted, which said that the Secretary may not adopt ICD-10 prior to October 1, 2015. Accordingly, the U.S. Department of Health and Human Services (HHS) expects to release an interim final rule in the near future that will include a new compliance data that would require the use of ICD-10 beginning October 1, 2015. The rule will also require HIPAA covered entities to continue to use ICD-9-CM through September 30, 2015."

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  5. FDA Stops Issuance of NHRIC and NDC for Medical Devices

    In order to conform to changes made under the Unique Device Identification (UDI) final rule, the FDA has stopped issuing National Health Related Items Code (NHRIC) and National Drug Code (NDC) labeler codes to manufacturers for use with medical devices. See more information.

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