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  • Article

    DEA Issues Final Rule On Safe, Secure Disposal Of Controlled Substances

    The Drug Enforcement Administration (DEA) has published a final rule to implement the Secure and Responsible Drug Disposal Act of 2010, which was intended to mitigate prescription drug abuse by providing safe and secure mechanisms for "ultimate users" to dispose of unused or unwanted pharmaceutical controlled substances.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Reed Smith
    Reed Smith
  • Article

    DOJ Reports $1.9 Billion In Health Care False Claims Recoveries In FY 2015

    Whistleblowers filed 638 qui tam suits in FY 2015, and whistleblower awards totaled $597 million.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Reed Smith
    Reed Smith
  • Article

    DOJ Tallies FY 2014 Fraud Recoveries

    The U.S. Department of Justice has announced a record $5.69 billion in civil False Claims Act settlements and judgments for FY 2014, including almost $3 billion in recoveries related to qui tam lawsuits.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Reed Smith
    Reed Smith
  • Article

    Draft HHS Guidance On Disclosing Risks In Standards Of Care Research

    The HHS Office for Human Research Protections published a notice announcing that it is seeking comments on draft guidance for the research community.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Reed Smith
    Reed Smith
  • Article

    Drug Companies Are Reminded - FDA Is Following Facebook

    The FDA’s Office of Prescription Drug Promotion has warned a Swiss drug company about statements the company made on its Facebook page.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Reed Smith
    Reed Smith
  • Article

    Energy & Commerce Committee Advances Medicaid/CHIP Legislation with Lower Provider Tax Limit

    The House Energy & Commerce Committee has voted to approve H.R. 4725, Common Sense Savings Act of 2016, which includes a number of Medicaid and Children's Health Insurance Program (CHIP) reforms.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Reed Smith
    Reed Smith
  • Article

    Energy & Commerce Committee Approves Bipartisan Health Bills

    On July 29, 2015, the House Energy & Commerce Committee approved the following bipartisan bills that aim to improve health care for newborns, infants, and children
    United StatesFood, Drugs, Healthcare, Life Sciences
    Reed Smith
    Reed Smith
  • Article

    FDA Hosting Workshop On April 1 to Discuss Clinical Outcome Assessments

    As mentioned on our Health Industry Washington Watch blog, the FDA will host a public workshop on April 1, 2015 to provide updates on the use of clinical outcome assessments (COAs)...
    United StatesFood, Drugs, Healthcare, Life Sciences
    Reed Smith
    Reed Smith
  • Article

    FDA Provides Direction On "Dear Doctor" Letters

    On January 16, 2014, the Food and Drug Administration (FDA) issued a final guidance document for industry providing specific recommendations on the content and format of Dear Health Care Provider (DHCP or "Dear Doctor") letters.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Reed Smith
    Reed Smith
  • Article

    FDA Public Workshop On Patient, Medical Professional Perspectives On Receiving Genetic Test Results (March 2)

    On March 2, 2016, the FDA is hosting a public workshop on "Patient and Medical Professional Perspectives on the Return of Genetic Test Results."
    United StatesFood, Drugs, Healthcare, Life Sciences
    Reed Smith
    Reed Smith
  • Article

    FDA Releases "Purple Book," Including Biosimilar Products

    The FDA’s new "Purple Book" lists biological products licensed by FDA under the Public Health Service Act (the PHS Act).
    United StatesFood, Drugs, Healthcare, Life Sciences
    Reed Smith
    Reed Smith
  • Article

    Final 2014 Medicare Clinical Lab Rates Set

    CMS has posted the 2014 Medicare clinical lab fee schedule, including the 2014 national limit amounts for new molecular pathology codes.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Reed Smith
    Reed Smith
  • Article

    Final CY 2015 Medicare Payment Rules In The Pipeline

    CMS is expected to publish several major final Medicare payment rules for 2015 in the coming days.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Reed Smith
    Reed Smith
  • Article

    Final HIPAA Rule Gives Patients Right To Access Test Results Directly From Labs

    On February 6, 2014, the Department of Health & Human Services published a final rule making changes to the Clinical Laboratory Improvement Amendments of 1988 and Health Insurance Portability and Accountability Act of 1996.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Reed Smith
    Reed Smith
  • Article

    Finance Committee Invites Comments On Health Care Data Transparency

    Finance Committee members are asking stakeholders for ideas on ways to improve the availability and utility of health care data, while protecting patient privacy.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Reed Smith
    Reed Smith
  • Article

    First Look At OIG's FY 2017 Fraud Recoveries/Enforcement Activities

    The report also highlights major OIG audits of HHS programs, including reports covering quality of care, Medicare Part D spending, the hospital two midnight rule policy, and other Medicare and...
    United StatesFood, Drugs, Healthcare, Life Sciences
    Reed Smith
    Reed Smith
  • Article

    First Meeting Of MACRA Physician-Focused Payment Model Technical Advisory Committee Set For Feb. 1, 2016

    The Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) includes payment incentives to encourage providers to participate in alternative payment models (APMs) that focus on coordinating care, improving quality, and reducing costs.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Reed Smith
    Reed Smith
  • Article

    Full Energy And Commerce Committee Approves Three Bipartisan Health Bills

    On June 10, 2014, the full House Energy and Commerce Committee approved by voice vote three bipartisan public health bills.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Reed Smith
    Reed Smith
  • Article

    GAO Examines Medicare Provider Eligibility Verification Safeguards

    The Government Accountability Office has issued a report examining the extent to which CMS's enrollment screening procedures are designed and implemented to prevent enrollment of ineligible or potentially fraudulent Medicare providers.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Reed Smith
    Reed Smith
  • Article

    GAO Highlights Differences In Federal Program Drug Prices

    The GAO has released data comparing retail prescription drug prices paid by the DOD, Medicaid, and Medicare Part D for a sample of 78 high-utilization drugs.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Reed Smith
    Reed Smith

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