The Patient Protection and Affordable Care Act (“PPACA”) mandates in Sections 6102 and 6401 that a broad range of providers, suppliers, and physicians adopt compliance and ethics programs. By March 23, 2013, skilled nursing facilities and other nursing facilities must have “in operation” a compliance and ethics program that meets the PPACA’s criteria. Although the PPACA’s requirements for nursing facilities are specific, the PPACA also contains broad compliance program requirements for all other healthcare providers and suppliers. The PPACA requires that such providers and suppliers “shall, as a condition of enrollment,” establish a compliance program that contains certain core elements established by Health and Human Services in consultation with the Office of the Inspector General (“OIG”) within particular industries or categories. However, the requirements as to other providers and suppliers are largely undefined and there is no specific implementation timeline for these compliance programs. Many larger healthcare providers already have some form of compliance program, but smaller providers and suppliers may need to create a compliance plan. Overall, the current climate calls for increased healthcare compliance measures. Organizations may be liable for failure to prevent or identify improper federal healthcare program claims and payments, which opens such organizations up for sanctions under the federal False Claims Act, Civil Monetary Penalties Law, and Anti-Kickback Law, including any state regulations.
The OIG has long promoted the voluntary adoption of compliance programs by the development of compliance guidance tailored to specific healthcare industry segments. However, the OIG has not created a “model compliance plan,” given its historic view that, when it comes to compliance programs, “one size does not fit all.” Therefore, a compliance program should be tailored to an individual organization and its size and scope of activities. One way to design a compliance program is to use the Federal Sentencing Guidelines for Organizations, which guide federal judges in sentencing companies and other organizations for federal crimes. The Guidelines define the elements of an effective compliance and ethics program.
The following healthcare organizations could benefit from implementing a compliance and ethics program:
- Nursing Facilities
- Physician Offices
- Ambulance Service Providers
- Organizations that provide services paid for by government programs (i.e., Medicare/Medicaid)
- Independent Diagnostic Testing Facilities (“IDTF”)
- Durable Medical Equipment Vendors
- Pharmacies
- Hospitals
- Health Systems
The list below shows some sample policies that an organization’s compliance plan could include. As noted above, compliance plans should be tailored to fit each organization’s size and scope of activities. Although the majority of the policies are applicable to healthcare organizations, business owners may want to implement corporate compliance programs with some of the policies below as well, such as document retention and workplace conduct.
- HIPAA/Privacy
- Document Retention
- Government Investigations
- Workplace conduct and employment practices, including conflicts of interest, diversity, harassment, health and safety, etc.
- Marketing Practices
- Billing/Collections
- Coding
- Physician Relationships
- Reporting Fraud and Abuse
- Training/Education on Code of Conduct and Policies
