Section 6401 of the Patient Protection and Affordable Care Act (PPACA) grants the Secretary of the Department of Health and Human Services (the “Secretary”) the authority to require health care providers to adopt compliance programs as a condition of participation in the Medicare, Medicaid and CHIP programs. Before the PPACA, a corporate compliance program was only mandatory for a healthcare provider or supplier that was operating under a Corporate Integrity Agreement or had a contract with the federal government that exceeded $5 million and lasted longer than 120 days.
Although section 6401 lacks specific direction to the Secretary with regard to the health care providers that will be subject to the mandatory compliance programs and the core elements of the programs, the section gives the Secretary the authority to make these decisions. One exception to the lack of specific direction is found in section 6102 of PPACA. That section requires skilled nursing facilities (SNFs) and other nursing facilities to establish compliance programs. According to the language in section 6102, the SNF program must be “reasonably designed, implemented, and enforced so that it will be generally effective in preventing and detecting criminal, civil and administrative violations under this Act and in promoting quality of care.” The section lists eight required components of the compliance program, and requires that the programs be in place by March 2013. The eight required components include:
Although the requirements for compliance programs are still works in progress for health care industry sections other than SNFs, all Medicare and Medicaid providers should begin to prepare for the upcoming mandates from the Secretary. One avenue of preparation is for health care providers to review guidance given by the Office of Inspector General (OIG) to those in the industry that voluntarily adopt compliance programs. The OIG has provided guidance to a number of health care providers including: hospitals, home health agencies, clinical laboratories, manufacturers and suppliers of durable medical equipment, prosthetics, orthotics, and medical supplies (DMEPOS), hospices, physicians/medical practice, and ambulance suppliers. The OIG suggested seven core elements to a compliance program. It should be noted that these core elements serve as a foundation for a compliance program, but the Secretary may required additional elements once the mandate is created pursuant to section 6401. The seven core elements recommended by the OIG include:
For more information on health care reform or compliance programs, please visit www.wachler.com or contact a Wachler & Associates attorney at 248-544-0888.