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  • Article

    CMS Posts Self-Referral Disclosure Protocol

    The U.S. Centers for Medicare & Medicaid Services posted its Medicare self-referral disclosure protocol describing how to disclose actual or potential violations of the Stark law and the associated Medicare overpayment.
    United StatesFood, Drugs, Healthcare, Life Sciences
    McDermott Will & Emery
    McDermott Will & Emery
  • Article

    Key Takeaways From The Stark Law Final Rule

    On January 19, 2021, the final rule modernizing and clarifying the regulations interpreting the Medicare physician self-referral law (Stark Law) takes effect.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Hodgson Russ LLP
    Hodgson Russ LLP
Article

HHS Tackles Barriers To Value-Based Care: Part 1 – New Protections For Value-Based Arrangements Under Stark And The AKS And Other Key AKS Changes

Nearly a decade after the Affordable Care Act signaled a transition of the U.S. health care system to value-based care, the Department of Health and Human Services
United StatesFood, Drugs, Healthcare, Life Sciences
Hogan Lovells
Hogan Lovells
  • Article

    OIG Issues Supplemental Compliance Guidance For Hospitals

    The Office of Inspector General has issued supplemental compliance program guidance for hospitals containing expanded discussions of risk areas and offering compliance recommendations for reduction of risk. The guidance is issued as a draft with a 60 day comment period.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Vinson & Elkins LLP
    Vinson & Elkins LLP
  • Article

    Final Regulations To Extend The Stark Exception And Anti-Kickback Statute

    The extension of the sunset period became effective December 31, 2013; all other changes to the Regulations will be effective on March 27, 2014.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Foley & Lardner LLP
    Foley & Lardner LLP
  • Article

    Chief Judge Stark Grants Defendants’ Motion to Transfer Patent Infringement Action to Northern District of California

    By Memorandum Order entered by The Honorable Leonard P. Stark in Selene Communication Technologies, LLC v. Trend Micro Inc., et al., Civil Action No. 14-435-LPS (D.Del., January 16, 2015),
    United StatesIntellectual Property
    Fox Rothschild LLP
    Fox Rothschild LLP
  • Article

    Health Law Diagnosed — Final Rules Amending The Anti-Kickback Statute And Stark Law Regulations: Part 2

    At the end of 2020, the US Department of Health and Human Services Office of Inspector General and Centers for Medicare and Medicaid Services issued...
    United StatesFood, Drugs, Healthcare, Life Sciences
    Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
    Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
  • Article

    Mintz Levin Attorneys To Discuss 340B Program, Overpayments And Stark Self-Disclosures At AHLA Medicare & Medicaid Institute

    This week, two of Mintz Levin’s health law attorneys will speak at the American Health Lawyers Association Institute on Medicare and Medicaid Payment Issues in Baltimore, Maryland.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
    Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
  • Article

    New Stark Law Exception Allows Hospitals, FQHCs And RHCs To Assist Physicians With Engaging Non-Physician Practitioners

    The Centers for Medicare & Medicaid Services recently released a new exception to the Physician Self-Referral Law intended to expand access to primary care and mental health services.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Dickinson Wright PLLC
    Dickinson Wright PLLC
  • Article

    OIG Seeks Comments To Anti-Kickback Statute And Beneficiary Inducements CMP Related To ‘Patient Centered Care'

    The Health and Human Services Office of Inspector General published today a request for information seeking ways in which it might modify or add new safe harbors to the federal Anti-Kickback Statute ...
    United StatesFood, Drugs, Healthcare, Life Sciences
    Cooley LLP
    Cooley LLP
  • Article

    More Stark Law Changes

    This prohibition applies to direct as well as indirect compensation arrangements.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Riker, Danzig, Scherer, Hyland & Perretti
    Riker, Danzig, Scherer, Hyland & Perretti
  • Article

    Federal Agencies Look To Ease Burdens Of The Anti-Kickback Statute And Stark Law

    As part of the U.S. Department of Health and Human Services (HHS) "Regulatory Sprint to Coordinated Care," the Centers for Medicare & Medicaid Services (CMS) and the HHS Office of Inspector General (OIG) published separate final rules in the Federal Register on December 2, 2020.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Lewis Rice
    Lewis Rice
  • Article

    HHS Proposes Sweeping Changes To AKS And Stark Law, Part 3: Personal Services And Management Contracts, Outcomes-Based Payments, And Warranties

    This post is the third installment of our blog series on recent proposed rules from the Department of Health & Human Services (HHS) that, if finalized, would implement major changes to the...
    United StatesFood, Drugs, Healthcare, Life Sciences
    Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
    Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
  • Article

    Key Provisions For Health Care Providers In Historic Health Care Reform Bill

    Late last month, in two historic pieces of legislation, President Obama signed into law the Patient Protection and Affordable Care Act of 2010 and the Health Care Education Affordability Reconciliation Act of 2010 (together, "Health Care Reform Bill").
    United StatesFood, Drugs, Healthcare, Life Sciences
    Thompson Coburn LLP
    Thompson Coburn LLP
  • Article

    New Jersey Enacts An Insurance Bad Faith Statute For Auto Insurers

    While it may not have received a lot of mainstream media coverage, the recent passage of the New Jersey Insurance Fair Conduct Act ("NJIFCA") was a huge victory for those injured in car crashes in New Jersey.
    United StatesInsurance
    Stark & Stark
    Stark & Stark
  • Article

    Court Of Appeals Affirms $237 Million Judgment Against Community Hospital

    Health care providers, government contractors, and others defending investigations and lawsuits under the False Claims Act ("FCA") face many difficult strategic considerations.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Jones Day
    Jones Day
  • Article

    Federal Appeals Court Amends Stark Law Opinion To Remove Controversial Volume Or Value Interpretation, But Uncertainty Remains

    On December 20, 2019, the Federal appeals court panel that heard U.S. ex rel. Bookwalter v. UPMC, No. 18-1693 (3d Cir.), amended its September 2019 opinion by removing a controversial interpretation
    United StatesFood, Drugs, Healthcare, Life Sciences
    Reed Smith
    Reed Smith
  • Article

    Federal Appeals Court Amends Stark Law Opinion To Remove Controversial "Volume Or Value" Interpretation, But Uncertainty Remains

    On December 20, 2019, the Federal appeals court panel that heard U.S. ex rel. Bookwalter v. UPMC, No. 18-1693 (3d Cir.), amended its September 2019 opinion by removing a controversial interpretation
    United StatesFood, Drugs, Healthcare, Life Sciences
    Reed Smith
    Reed Smith
  • Article

    The Sprint To Value: CMS Transforms The Stark Law

    As anticipated, the Final Rule included some major changes to the Stark regulations that will drive physician contracting, compensation models and compliance strategies for years to come.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Hall, Render, Killian, Health & Lyman
    Hall, Render, Killian, Health & Lyman
  • Article

    CMS Issues New Stark Law Waivers To Combat COVID-19 Pandemic

    Here are details regarding the breadth of the new guidance as well as additional considerations for interested providers.
    United StatesCoronavirus (COVID-19)
    Buchanan Ingersoll & Rooney
    Buchanan Ingersoll & Rooney
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