The Patient Protection and Affordable Care Act (ACA), enacted in 2010, brought about significant changes to the healthcare landscape in the United States. Beyond expanding health insurance coverage, the ACA also introduced stringent measures to combat fraud, waste, and abuse within federal healthcare programs. A key component of these measures is the mandate for healthcare providers and suppliers to establish and maintain compliance programs. Understanding the “Affordable Care Act Compliance Program Requirements” is crucial for any organization participating in Medicare, Medicaid, and other federal healthcare programs. This article delves into the essential aspects of these requirements, helping healthcare entities navigate the complexities of ACA compliance.
The ACA’s Mandate for Compliance Programs
Section 6401(a)(7) of the Affordable Care Act explicitly requires enrollment in federal healthcare programs to be contingent upon the establishment of “affordable care act compliance program requirements.” This pivotal section directs the Department of Health and Human Services (HHS), in collaboration with the HHS Office of Inspector General (HHS-OIG), to define the core elements of these programs through formal regulations and to set implementation timelines. This marked a significant shift from previously advisory compliance guidelines to mandatory obligations.
The implications of non-compliance are substantial. HHS is empowered to disenroll providers and suppliers who fail to meet these requirements, potentially cutting off access to federal funding. Furthermore, civil monetary penalties and other sanctions can be imposed, underscoring the seriousness with which the federal government views ACA compliance.
Building Upon Existing Guidance
Prior to the ACA, the HHS-OIG had issued voluntary compliance program guidance for various sectors within the healthcare industry for many years. This guidance, while not mandatory, was widely considered best practice and often based on the United States Sentencing Commission’s criteria for “effective” compliance and ethics programs. These criteria emphasize a comprehensive approach to ethics and legal compliance, focusing on prevention and detection of wrongdoing within organizations.
It is widely anticipated that the forthcoming regulations under the ACA will draw heavily from both the HHS-OIG’s existing guidance and the Sentencing Commission’s framework. This suggests that organizations with pre-existing compliance programs may need to enhance them to meet the new mandatory standards, while those without will need to develop comprehensive programs from the ground up.
Specific Compliance Requirements for Nursing Facilities
While the ACA mandates compliance programs broadly across healthcare, it includes particularly detailed requirements for skilled nursing facilities (SNFs) and nursing facilities. Section 6102 of the Act stipulates that “operating organizations” for these facilities must implement compliance and ethics programs demonstrably effective in two key areas:
- Preventing and Detecting Violations: The programs must be designed to prevent and detect criminal, civil, and administrative violations specifically related to the Affordable Care Act and other relevant healthcare laws.
- Promoting Quality of Care: Critically, compliance programs for nursing facilities must also actively promote and ensure high standards of patient care. This dual focus on legal compliance and patient well-being highlights the ACA’s commitment to both integrity and quality in healthcare.
To achieve these goals, Section 6102 outlines specific elements that SNF and nursing facility compliance programs must incorporate. These elements, directly mirroring the Sentencing Commission’s effectiveness criteria, include:
- Written Compliance Standards and Procedures: A foundational element is the creation and dissemination of clear, written standards of conduct and operational procedures that reflect the organization’s commitment to compliance and ethical behavior.
- Compliance-Related Training Programs: Effective training is essential to ensure that all staff members understand their compliance obligations and how to adhere to the organization’s standards and procedures. This training should be ongoing and tailored to different roles within the facility.
- Auditing and Monitoring Activities: Regular audits and monitoring are necessary to proactively identify potential compliance issues. This includes establishing anonymous reporting systems to encourage staff to raise concerns without fear of retaliation.
- Background Checks and Screening: To prevent individuals with a history of misconduct from compromising compliance efforts, programs must include procedures like background checks to screen potential employees and contractors.
- Investigation and Corrective Action: A robust program must have clear procedures for investigating potential violations when they are discovered. Crucially, it must also ensure prompt and effective corrective action to address identified issues and prevent recurrence.
- Disciplinary Systems: Fair and consistent disciplinary systems are needed to address compliance violations appropriately. These systems should be applied to all individuals responsible for violations, reinforcing accountability at all levels.
- Periodic Risk Assessments and Program Modification: Compliance is not static. Organizations must conduct periodic risk assessments to identify evolving compliance risks and adapt their programs accordingly to remain effective.
The detailed nature of these requirements for nursing facilities underscores the government’s heightened focus on this sector, given its vulnerability to fraud and its direct impact on vulnerable patient populations.
Enforcement Provisions: Strengthening the Fight Against Fraud
Beyond mandatory compliance programs, the ACA significantly bolstered the enforcement mechanisms available to combat healthcare fraud. These provisions, while extensive, are briefly summarized below to illustrate the enhanced scrutiny and potential penalties healthcare organizations now face.
Enhanced Provider Screening and Enrollment
The ACA mandated more rigorous screening processes for providers and suppliers seeking to participate in Medicare. These procedures can include:
- State licensure checks
- Criminal background checks
- Fingerprinting
- Unscheduled site visits
- Database checks
Furthermore, newly enrolled providers may face a provisional period of enhanced oversight, including prepayment claim reviews and payment caps. HHS also gained the authority to impose temporary moratoria on new enrollments in specific service or supply categories deemed high-risk for fraud. Disclosure requirements regarding affiliations with problematic providers or suppliers have also been strengthened, allowing HHS to deny or impose safeguards on applicants with concerning connections.
Payment Suspensions Pending Fraud Investigations
A powerful tool granted by the ACA is the authority to suspend payments to providers or suppliers based on a “credible allegation of fraud.” HHS, in consultation with the HHS-OIG, determines the credibility of such allegations. This payment suspension can have immediate and severe financial consequences for providers under investigation.
Transparency and Data Sharing
The ACA introduced numerous transparency requirements across various healthcare sectors, demanding reporting of financial relationships and activities. Moreover, the Act mandated the creation of an Integrated Data Repository (IDR) to aggregate claims and payment data from all federal healthcare programs. This centralized database is accessible to law enforcement and oversight agencies, facilitating data matching and analysis to identify potential fraud patterns and schemes. The consolidation of data banks, like the Healthcare Integrity and Protection Data Bank into the National Practitioner Databank, further streamlines data collection and access for enforcement purposes.
Increased Civil and Criminal Penalties
The ACA significantly increased the penalties for fraudulent activities. Civil monetary penalties were raised, including substantial fines for false statements made in enrollment applications. The Act also clarified that violations of the Anti-Kickback Statute can serve as the basis for False Claims Act violations, and crucially, eliminated the requirement to prove “actual knowledge” of a violation or specific intent to violate the Anti-Kickback Act or criminal healthcare fraud statutes. General criminal intent is now sufficient for prosecution, lowering the bar for enforcement actions.
Overpayment Reporting Obligations
The ACA imposed a strict “60-day rule” for reporting and returning overpayments. Failure to return identified overpayments within 60 days of discovery transforms the overpayment into an “obligation” that can trigger substantial liability under the False Claims Act. This provision puts significant pressure on providers to proactively identify and rectify overpayments.
Conclusion: Embracing a Culture of Compliance
The Affordable Care Act’s compliance program requirements and enhanced enforcement provisions have fundamentally shifted the landscape of healthcare regulation. The message is clear: robust compliance programs are no longer optional; they are a mandatory condition of participation in federal healthcare programs. For healthcare organizations, understanding and implementing effective “affordable care act compliance program requirements” is not merely about avoiding penalties. It’s about fostering a culture of integrity, ethical conduct, and quality patient care. In this heightened regulatory environment, a strong compliance program is an organization’s most valuable asset in mitigating risk and ensuring long-term sustainability.
References
- Patient Protection and Affordable Care Act of 2010, H.R. 3590, March 23, 2010.
- http://www.hklaw.com/publications/Health-Care-Organizations-Targeted-With-Anti-Fraud-Enforcement-Efforts-New-and-ongoing-initiatives-will-affect-oversight-components-of-health-care-reform-06-22-2009/
- H.R. 3590, Sec. 6401 (a)(7).
- H.R. 3590, Sec. 6401 (a)(7).
- H.R. 3590, Sec. 6401 (a)(7).
- http://oig.hhs.gov/fraud/complianceguidance.asp
- 2009 United States Sentencing Commission Guidelines Manual, §8B2.1 Effective Compliance and Ethics Program (2009).
- H.R. 3590, Sec. 6102.
- H.R. 3590, Sec. 6102.
- H.R. 3590, Sec. 6401 (a).
- H.R. 3590, Sec. 6401 (a).
- H.R. 3590, Sec. 6402 (h).
- H.R. 3590, Sec. 6402 (h).
- H.R. 3590, Sec. 6002.
- H.R. 3590, Sec. 6402 (a).
- H.R. 3590, Sec. 6402 (a).
- H.R. 3590, Sec. 6403.
- H.R. 3590, Sec. 6403.
- H.R. 3590, Sec. 6402 (d)(2).
- H.R. 3590, Sec. 6402 (d)(2).
- H.R. 3590, Sec. 6402 (d)(2).
- H.R. 3590, Sec. 6402.
- H.R. 3590, Sec. 6402; see also 31 U.S.C. 3729(b)(3).
- H.R. 3590, Sec. 6402.
- H.R. 3590, Sec. 6402.
- H.R. 3590, Sec. 6402.
- H.R. 3590, Sec. 10104(j).
- H.R. 3590, Sec. 10104(j).
- H.R. 3590, Sec. 10104(j).
- H.R. 3590, Sec. 10606.
