Annals of Health Law
READY OR NOT
issued Final Compliance Program Guidelines288 applicable to Sponsors that
confirms the core Compliance Plan elements referenced in PPACA.
Although a final set of program guidelines has not yet been released as to
hospitals, physician practices, or other health care providers, the Final
Compliance Guidelines for Sponsors nonetheless emerges as an important
indicator of what is to follow, and is certainly instructive for all health care
Through the guidelines, CMS has established that all Sponsors must
implement an effective compliance program that incorporates the set of
seven core requirements that HHS and OIG have consistently cited in
existing guidance materials290 as the basic elements for a sound compliance
program.291Originally, these core requirements emerged in the U.S.
Federal Sentencing Guidelines Manual which set forth the main elements of
an effective compliance program and focus on an entity’s commitment to
ensuring legal compliance through the exercise of due diligence aimed at
preventing, detecting, and correcting illegal and unethical behavior. 292
These compliance plan elements include: establishment of written
compliance policies and procedures; designation of a specific individual or
individuals to monitor compliance ( i.e., compliance officer and/or
compliance committee); commitment to conducting formal training and
education programs; development of internal system for communication of
suspected compliance violations; commitment to auditing and monitoring to
evaluate compliance and identify potential problematic areas; maintenance
of disciplinary policies which are consistently enforced; and development
of process for investigation of suspected violations and reporting to the
government and law enforcement authorities when necessary.293 It is
288. Ctrs. Medicare & Medicaid Servs., Prescription Drug Benefit Manual, Chapter 9 –
Compliance Program Guidelines and Medicare Managed Care Manual, Chapter 21-
Compliance Program Guidelines, available at http://www.cms.gov/Medicare/Prescription-
Drug-Coverage/PrescriptionDrugCovContra/Downloads/Chapter9.pdf. The content of both
Chapters 9 and 21 is identical and applies equally to the MA and Part D Programs.
289. Nicolas C. Harbist & Angela M. Guarino, United States: Ready or Not? Final
Program Guidelines have come, BLANK ROME LLP, Dec. 17, 2012, available at
290. See, e.g., OIG Compliance Program for Individual and Small Group Physician
Practices, 65 Fed. Reg. 59434 (Oct. 5, 2000); Publication of the OIG Compliance Program
Guidance for Hospitals, 63 Fed. Reg. 8987 (Feb. 23, 1998); Ctrs. for Medicare & Medicaid
Servs., Compliance Program Guidance for Medicare Fee-For-Service Contractors (Mar.
2005), available at http://www.cms.gov/Medicare/Medicare-Contracting/
291. Compliance Program Guidance, supra note 290. 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.
292. See U.S. SENTENCING GUIDELINES MANUAL § 8B2.1 (2010).