1. SAMHSA Notice of NPRM

    The U.S. Department of Health and Human Services, Substance Abuse and Mental Health Services Administration (SAMHSA) has issued a notice of proposed rulemaking (NPRM modifying 42 CFR Part 2, referred to as Part 2), pertaining to the confidentiality of substance abuse treatment records.

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  2. HHS Seeks to Revise Privacy Rule

    The Department of Health & Human Services (HHS) issued a proposal to revise a federal rule governing the privacy of substance abuse and addiction treatment records. The proposed rule would update the rules to allow for the sharing of “sensitive medical records by research institutions, data repositories, health information exchanges, accountable care organizations (ACO) and health homes.” Comments are due April 11, 2016.

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  3. CMS Publishes Covered Outpatient Drugs Final Rule

    The Centers for Medicare & Medicaid Services (CMS) announced it is publishing the long awaited Covered Outpatient Drugs. The final rule includes reforms to the rebate and reimbursement systems for Medicaid prescription drugs:

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  4. Senate Will Consider Bill Revising Medicare Appeal Process

    The Audit & Appeals Fairness, Integrity, and Reforms in Medicare (AFIRM) Act of 2015 (S. 2368) has been placed on the Senate legislative calendar. The bill was reported out of the Senate Finance Committee in June. The bill seeks to revamp the Medicare appeals process, including the creation of a Medicare magistrate program to settle simpler, less complex claims appeals with amounts between $150 and $1,500.

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  5. FDA Publishes Communication Guidance on Drug Development

    The Food & Drug Administration (FDA) recently published draft guidance entitled, “Best Practices for Communication Between IND Sponsors and FDA During Drug Development: Guidance for Industry and Review Staff.” According to the FDA, the guidance is a joint effort by the agency’s drug and biologics centers to describe “timely, transparent, and effective communications” in an effort to bring safe and effective drugs to the public sooner. The draft guidance addresses: 

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