The HHS Office of Inspector General’s (OIG) newest compliance guideline – created for pharmaceutical manufacturers – will celebrate its twentieth anniversary on May 5. The guidelines for individual and small group physician practices will hit the 23-year mark in October. But the agency announced plans for a major overhaul to its compliance program guidelines on April 25.
You could see the first round of the upgrades by the end of this year, according to the Federal Register notice “
Modernization of Compliance Program Guidance Documents.” The planned revisions are part of the agency’s overarching modernization plan. The renovation project will begin with a general compliance program guidance (GCPG) that can be used by any person or organization involved in the health care industry.
The GCPG will address topics such as: federal fraud and abuse laws, compliance program basics, operating effective compliance programs, and OIG processes and resources. We anticipate updating the GCPG as changes in compliance practices or legal requirements warrant. OIG plans to publish the GCPG by the end of calendar year 2023.
Industry-specific guidance will follow in 2024. The OIG says it will create individual guidelines “for different types of providers, suppliers, and other participants in health care industry subsectors or ancillary industry sectors relating to federal health care programs.” The agency currently anticipates that the first industry-specific guidelines will address Medicare Advantage and nursing facilities.
The OIG also made it clear that the voluntary compliance guidelines will remain voluntary.
… the goal of these documents has been, and will continue to be, to set forth a voluntary set of guidelines and identified risk areas that OIG believes individuals and entities engaged in the health care industry should consider when developing and implementing a new compliance program or evaluating an existing one.