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IMPLICATIONS OF MPDIMA ON PHARMACEUTICAL COMPLIANCE PROGRAMS

IMPLICATIONS OF MPDIMA ON PHARMACEUTICAL COMPLIANCE PROGRAMS. Scott Willoughby Ernst & Young February 27, 2004. IMPLICATIONS OF MPDIMA ON PHARMACEUTICAL COMPLIANCE PROGRAMS.

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IMPLICATIONS OF MPDIMA ON PHARMACEUTICAL COMPLIANCE PROGRAMS

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  1. IMPLICATIONS OF MPDIMA ON PHARMACEUTICAL COMPLIANCE PROGRAMS Scott Willoughby Ernst & Young February 27, 2004

  2. IMPLICATIONS OF MPDIMA ON PHARMACEUTICAL COMPLIANCE PROGRAMS • This presentation is intended to provide a practical look at the areas of a compliance program that will be impacted by the MPDIMA • The compliance programs will not necessarily require significant changes, but many of the existing areas will need to be considered because of the MPDIMA

  3. IMPLICATIONS OF MPDIMA ON PHARMACEUTICAL COMPLIANCE PROGRAMS • Areas of the codes that may be impacted • Pricing • Relationships with health care professionals • False reporting to Federal Agencies • Antitrust laws • Securities laws • PDMA

  4. IMPLICATIONS OF MPDIMA ON PHARMACEUTICAL COMPLIANCE PROGRAMS Pricing ASP calculations AWP calculations

  5. IMPLICATIONS OF MPDIMA ON PHARMACEUTICAL COMPLIANCE PROGRAMS Relationships with health care professionals Influence to place products on formularies Use of samples to replace products utilized for part B coverage

  6. IMPLICATIONS OF MPDIMA ON PHARMACEUTICAL COMPLIANCE PROGRAMS False reporting to Federal Agencies

  7. IMPLICATIONS OF MPDIMA ON PHARMACEUTICAL COMPLIANCE PROGRAMS Antitrust Laws How were the bids determined? Are there tying arrangements? Market arrangements to split market?

  8. IMPLICATIONS OF MPDIMA ON PHARMACEUTICAL COMPLIANCE PROGRAMS Securities Laws Insider Trading? Anticipation of change in market conditions?

  9. IMPLICATIONS OF MPDIMA ON PHARMACEUTICAL COMPLIANCE PROGRAMS PDMA Samples distribution for Part B products?

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