Blog: OIG Issues 2017 Work Plan – PAMA, Open Payments, Drug Manufacturer Rebates Among Areas of New Focus

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The U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued today its 2017 Work Plan. This annual publication summarizes new and ongoing reviews and activities by the OIG related to various HHS programs. For example:

  • There are at least three new areas of review related to each skilled nursing facilities and hospice.
  • OIG will conduct a review of Medicare payments for certain clinical diagnostic laboratory tests, as mandated by section 216 of the Protecting Access to Medicare Act of 2014 (PAMA).
  • OIG will conduct a review of the data reported to Open Payments under the Physician Payments Sunshine Act. Among other things, OIG intends to determine the volume and total dollar amount for drugs, devices and medical equipment ordered by physicians under Medicare Parts B and D who are contained in the Open Payments reports.
  • OIG will conduct an analysis to determine the amount the federal government could potentially collect from pharmaceutical manufacturers if inflation-indexed rebates were required under Medicare Part B. This analysis builds on prior OIG analyses.
  • OIG also will conduct an analysis to determine the amount the federal government could potentially save if pharmaceutical manufacturers paid rebates for drugs dispensed through the Medicare Part D program at 340B covered entities and contract pharmacies.

Pharmaceutical and medical device companies, clinical laboratories and other health care entities should carefully review the OIG 2017 Work Plan to determine areas of government focus. The Work Plan often serves as a useful resource for companies planning and prioritizing compliance activities for the upcoming year, including training, auditing and monitoring. Additionally, reports issued by the OIG after a review are a valuable resource regarding the OIG’s current analysis of industry activities.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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