1. FDA Grants Delay in DSCSA Tracking Requirements

    The FDA granted a delay for dispensers to comply with the drug tracking requirements set forth in the Drug Supply Chain Security Act (DSCSA). Dispensers now have until November 1, 2015 to implement the requirements. BGOV reported that three pharmacy organizations recently asked the FDA to delay the enforcement of the requirement, citing a compressed implementation timetable of a 2013 law and the potential for disruptions in the pharmaceutical supply chain. The FDA issued the industry guidance in response to that request. Manufacturers, wholesale distributors and repackagers originally had to meet these same requirements by January 1, 2015, although the FDA also granted them more time to comply.

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  2. CMS Proposes Updates to ESRD PPS

    CMS released a proposed rule to update and make revisions to the End-Stage Renal Disease (ESRD) prospective payment system (PPS) for 2016. According to CMS, the proposals in this rule are necessary to ensure that ESRD facilities receive accurate Medicare payment amounts for furnishing outpatient maintenance dialysis treatments during calendar year 2016. This rule also proposes to

    • Set requirements for the ESRD Quality Incentive Program (QIP) for CY 2016.
    • Establish and revise requirements for quality reporting and measurement, including the inclusion of new quality measures for payment year (PY) 2019 and beyond.
    • Update programmatic policies for the PY 2017 nd PY 2018 ESRD QIP.
    Comments are due August 25, 2015.

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  3. NCPDP Testifies at June NCVHS Review Committee Hearings

    The National Committee on Vital & Health Statistics (NCVHS) held a hearing this week to obtain information from the healthcare industry on the currently adopted standards, operating rules, code sets and identifiers used in administrative simplification transactions.  NCPDP testified at the hearing; written comments are available on NCPDP’s Workspace Collaborative website.  The hearing focused on two main objectives:

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  4. CMS Issues Final Rule on MSSP ACO

    The Centers for Medicare & Medicaid Services (CMS) issued a final rule on the Medicare Shared Savings Program (MSSP) Accountable Care Organizations. According to CMS, the final rule updates the Medicare Shared Savings Program to “encourage the delivery of high-quality care for Medicare beneficiaries and build on the early successes of the program and of the Pioneer Accountable Care Organization (ACO) Model.” The modifications to the proposed regulations stem from comments CMS received from the December 2014 Notice of Proposed Rulemaking:

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  5. HHS Considers Changes to HPID Rule - Seeks Comments

    The Department of Health and Human Services (HHS) is considering changes to its health plan identifier (HPID) rule. HHS issued a Request for Information (RFI) seeking public comment on how the identifiers' use in healthcare transactions has changed since health plans began using them in 2012, and whether the identifiers still have value. Although they are not currently required to do so, covered entities will be required to include the HPID in HIPAA transactions starting November 7, 2016.  Comments are due July 28, 2015.

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