Ready Or Not? Final Compliance Program Guidelines Have Come

There are no more excuses for failing to adopt a comprehensive compliance program. Section 6401 of the Patient Protection and Affordable Care Act (PPACA), enacted on March 23, 2010, mandates that all health care providers enrolled in Medicare, Medicaid, and the Children's Health Insurance Program (CHIP) establish a compliance program as a condition of enrollment.1 Given this condition of enrollment, health care providers are urged to develop new, or update existing, compliance programs as quickly as possible. This is especially the case for Medicare Advantage (MA) organizations and Medicare Prescription Drug Plan (PDP) sponsors (collectively defined as "Sponsors"), in the wake of the Centers for Medicare & Medicaid Services (CMS)'s July 2012 issuance of Final Compliance Program Guidelines ("Final Program Guidelines").2 Although a set of final compliance program guidelines has not been released as to physician practices or other health care providers, the issuance of Final Compliance Program Guidelines applicable to Sponsors nonetheless serves as an important roadmap to all health care providers for the development and refinement of compliance programs.

MA Organization & PDP Sponsor Program Requirements

CMS has issued the Final Program Guidelines as both Chapter 9 of the Medicare Prescription Drug Benefit Manual and Chapter 21 of the Medicare Managed Care Manual. The content of both Chapters 9 and 21 is identical and applies equally to the MA and Part D Programs. CMS initially issued and solicited public comment on draft Compliance Program Guidelines ("Draft Guidelines") on February 8, 2012. CMS issued the revised, Final Program Guidelines, after its review of comments from 68 separately identified entities, including Sponsors, pharmacy associations, and health plan associations. Pursuant to 42 C.F.R. §§ 422.503(b)(4)(vi) ("Conditions necessary to contract as an MA organization") and 423.504(b)(4)(vi) ("Conditions necessary to contract as a Part D plan sponsor"), all Sponsors must implement an effective compliance program that incorporates a set of seven core requirements. The Department of Health and Human Services (HHS) and its Office of Inspector General (OIG) have consistently cited these components in guidance materials as the basic elements for inclusion in compliance programs for health care providers, regardless of industry sector or category type.3 The seven core requirements set forth in sections 422.503(b)(4)(vi) and 423.504(b)(4)(vi) serve as the framework for the Final Program Guidelines for Sponsors. The Guidelines are chiefly broken down into seven sections, each of which fleshes out the regulatory requirements and CMS expectations for Sponsors corresponding to each core requirement. The seven core...