The Patient Protection and Affordable Care Act (the Act) included a new requirement that nursing homes have in operation a compliance and ethics program within 36 months of the effective date of the Act, or by March 23, 2013. The Secretary and the Inspector General of the Department of Health and Human Services must promulgate regulations by March 23, 2012 for an effective compliance and ethics program. The formality of the program, including the establishment of written policies and procedures to be followed by employees, will depend on the size of the organization. An organization that operates five or more facilities will be expected to have a more formal program.
The Act provides that a compliance and ethics program must be reasonably designed, implemented and enforced so that it generally will be effective in preventing and detecting criminal, civil, and administrative violations and in promoting quality of care. The compliance and ethics program must include, at a minimum, the following components:
- The organization must establish compliance standards and procedures to be followed by its employees and other agents that are reasonably capable of reducing the prospect of criminal, civil, and administrative violations.
- Specific individuals within high-level personnel of the organization must be assigned overall responsibility to oversee compliance of the standards and procedures and have sufficient resources and authority to assure compliance.
- The organization must use due care not to delegate substantial discretionary authority to individuals whom the organization knew, or should have known through the exercise of due diligence, had a propensity to engage in criminal, civil, or administrative violations.
- The organization must take steps to communicate effectively its standards and procedures to all employees and other agents. The organization may accomplish this component by requiring participation in training programs or by disseminating publications to employees and other agents that explain in a practical manner what is required by the compliance and ethics program.
- The organization must take reasonable steps to achieve compliance with its standards. The organization may accomplish this component by utilizing monitoring and auditing systems reasonably designed to detect criminal, civil, and administrative violations by its employees and other agents. The organization should also have in place and publicize a reporting system whereby employees and other agents could report violations by others within the organization without the fear of retribution.
- The standards must be consistently enforced through appropriate disciplinary mechanisms, including, as appropriate, discipline of individuals responsible for the failure to detect an offense.
- After an offense has been detected, the organization must take all reasonable steps to respond appropriately to the offense and to prevent further similar offenses, including any necessary modification of its program to prevent and detect criminal, civil, and administrative violations.
- The organization must periodically re-assess its compliance program to identify modifications necessary to reflect changes within the organization and its facilities.
By December 31, 2011, the Secretary of HHS must establish and implement a quality assurance and performance improvement program for facilities and must establish standards relating to quality assurance and performance improvement. The Secretary must also provide technical assistance to facilities on the development of best practices in order to meet standards. Not later than one year after the date on which regulations are promulgated to carry out these requirements, a facility must submit to the Secretary of HHS a plan for the facility to meet the standards and implement best practices, including how to coordinate the implementation of the plan with quality assessment and assurance activities under the Social Security Act, Sections 1819(b)(1)(B) (requirements relating to provision of services by a skilled nursing facility) and 1919(b)(1)(B) (relating to provision of services by a nursing facility, including nursing homes), as applicable.
Sections 1819(b)(1)(B) and 1919(b)(1)(B) require the nursing facility to maintain a quality assessment and assurance committee, composed of the director of nursing services, a physician, and at least three other members of the facility’s staff. The quality assessment and assurance committee must meet at least quarterly to identify issues with respect to which quality assessment and assurance activities are necessary and to develop and implement appropriate plans of action to correct identified quality deficiencies.
Although the deadline for the regulations for the required compliance and ethics programs is still over a year away, nursing homes should start now to develop, implement, and assess their compliance and ethics programs by incorporating at least the minimum requirements dictated by the Act. Nursing homes should also begin to develop their plans to meet standards for quality assessment and assurance activities.