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SOC & Research BIlling Compliance

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Standard of Care - Trends and Case Studies - Holly Squires January 10, 2012

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SOC & Research BIlling Compliance

  1. 1. Standard of Care and Research Billing Compliance Holly Squires TTC,llc Bettye Briggs Merck Kelly Willenberg, MBA, BSN Synergism, LLC
  2. 2. Theme <ul><li>Definition of Standard of Care </li></ul><ul><li>Identifying realities </li></ul><ul><li>Creating solutions </li></ul>
  3. 3. Why Does it Matter? <ul><li>Medicare “double billing” has been the subject of numerous OIG/DOJ investigations/settlements </li></ul><ul><li>From a research and business perspective, it is important to track clinical customary care vs. “research only” or “routine research cost” </li></ul><ul><li>The Industry has benchmarks and regulations facing them now too </li></ul>
  4. 4. The Deadly Five for a Site <ul><li>Billing for services that are paid for by the sponsor </li></ul><ul><li>Billing for services promised free in the informed consent </li></ul><ul><li>Billing for services that are for research-purposes only </li></ul><ul><li>Billing for services that are part of a non-qualifying clinical trial </li></ul><ul><li>Billing Medicare Advantage Plans (Part C) when claims should be directed to the Medicare Administrative Contractor for drug trial </li></ul>
  5. 5. Lack of Coverage Analysis <ul><li>Medicare does not use the term “standard of care” </li></ul><ul><li>A thorough review must be done of the study to analyze what is billable and what is being done for research </li></ul><ul><li>Consent and Contract must match because if you promise something for free in a consent, you cannot bill it to a third party payer </li></ul>
  6. 6. Standard of Care <ul><li>Standard of Care is not in the CMS Guidelines </li></ul><ul><li>Medicare covers routine costs in a qualifying trial </li></ul><ul><li>Most pharmaceutical sponsors use the term “standard of care” and coverage review when presenting budgets to sites </li></ul><ul><li>Lack of coverage analysis makes it difficult for sites </li></ul>
  7. 7. Charge Capture: It Matters What is in the Budget <ul><li>Charges must match budget and contract </li></ul><ul><li>Remember that most sites are not savvy in billing compliance so the more information you can provide the better budget you will receive </li></ul><ul><li>Do Not Offer to Cover Everything for a Qualifying Trial! </li></ul>
  8. 8. Contact Information <ul><li>Kelly M. Willenberg, MBA, BSN, CHRC </li></ul><ul><li>President, Synergism, LLC </li></ul><ul><li>[email_address] </li></ul><ul><li>Bettye Briggs </li></ul><ul><li>Assoc. Director, MRL, Global Financial Specialists, Merck </li></ul><ul><li>[email_address] </li></ul><ul><li>Holly Squires </li></ul><ul><li>SVP, TTC,llc </li></ul><ul><li>[email_address] </li></ul>
  9. 9. TTC Corporate Headquarters 4548 Market Street Suite M-20 Philadelphia, PA 19139 (215) 243-4103 (Tel) (215) 895-4001 (Fax) TTC European Headquarters 136 Delaware Road London, W9 2LL UK 44 (0)7792 145 831 (Tel) 44 (0)2086 584 033 (Fax) Visit our website @ www.ttc-llc.com Thank You For Your Participation!

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