It’s official – the ethics and compliance program your facility has probably been working on as a result of the Patient Protection and Affordable Care Act (PPACA) requirements is not required just yet. On Thursday, March 21, 2013, Centers for Medicare & Medicaid (CMS) officials noted during an Open Door Forum Call that the regulations for nursing home ethics and compliance programs have not yet been promulgated. If you haven’t produced a solid draft yet, reviewing the past voluntary compliance program guidelines provided by the Office of the Inspector General (OIG) is a great way to start forming your program so your facility is ready when the final regulation is completed.
The guidance provided by the OIG in March 2000 Federal Register sets forth guidance for an effective compliance program, using the Federal Sentencing Guidelines as a baseline. An effective nursing home compliance program includes these elements:
- Element 1: Implementing written policies, procedures and standards of conduct for the program
- The written standards for compliance will provide structure to the daily operations of your facility. Your code of conduct should contain information on the facility’s expectations of the staff and be distributed to all employees.
- Many states already require facilities to have written policies and procedures in place, so if your facility is in one of those states, then addressing the component of specific risk areas to prevent fraud and abuse and protect residents should not be difficult to meet. The OIG notes several risk areas that your policies and procedures should meet, minimally, including quality of care and residents’ rights, employee screening, vendor relationships, billing/cost reporting, and record keeping and documentation.
- The OIG recommends that nursing facilities develop quality of care protocols and tools to monitor and evaluate them to ensure they are providing services in accordance with F-309 Provide Care/Services for Highest Well Being.
- Some additional areas of concern include: F-279 Develop Comprehensive Care Plans, F-246 Reasonable Accommodation of Needs and Preferences, F-329 Drug Regimen is Free from Unnecessary Drugs, F-353 Sufficient 24 Hour Nursing Staff Per Care Plans, and F-312 ADL Care Provided to Dependent Residents.
- Your facility’s policies must address your residents’ right to autonomy, freedom of choice and the provision of reasonable accommodation of needs.
- Identification of billing and cost reporting should also be a component of your facility’s compliance program to help reduce fraud and abuse, as well as negative outcomes to the facility due to enforcement actions.
While not all States currently require background screening before hiring caregiving employees, the OIG recommends that all facilities undergo some form of screening and provide documented policies and procedures related to it. Information is available via the OIG’s List of Excluded Individuals/Entities, the GSA’s list of debarred contractors and more. - Your policies and procedures should be compliant with the federal anti-kickback statute and the Stark physician self-referral law as well as other relevant Federal/State regulations.
- Employee evaluations should help promote adherence to your facility’s compliance program.
- Element 2: Designating a compliance officer and compliance committee to oversee the program
- A compliance officer with the appropriate amount of authority to oversee your facility’s compliance program and guide the compliance committee should be appointed. This individual should be in charge of implementing and maintaining the compliance program, regularly reporting to key top management, and ensuring that all employees understand the program and adhere to its guidelines.
- A compliance committee should be established to advise the compliance officer and assist with implementing your facility’s compliance program. This committee will help with reviewing existing policies and procedures for vulnerabilities, providing recommendations for and assisting with monitoring internal systems, and developing a feedback system to evaluate and respond to complaints/problems.
- Element 3: Conducting effective training and education regarding compliance guidelines
- Training for all levels of staff on the compliance program, and relevant laws should be conducted. All formal training provided to the staff should be documented.
- The OIG recommends that participation in training programs be made a condition of employment.
- Element 4: Creating effective lines of communication for the entire staff
- Confidentiality and non-retaliation policies should be developed and distributed to all employees to encourage communications.
- The OIG recommends the use of hotlines and suggestion boxes to allow employees to report problems and concerns.
- Element 5: Enforcing standards by displaying and publicizing disciplinary guidelines
- One of the most beneficial ways to ensure compliance is to make sure your written disciplinary policies clearly state the consequences of violations of your facility’s policies and procedures.
- This information should be disseminated to all employees and education should be provided to ensure employees understand expectations and consequences.
- Element 6: Conducting thorough internal monitoring and auditing to ensure enforcement
- Ongoing monitoring for compliance should be completed and documented by the compliance officer. Periodic audits by internal or third-party consultants that focus on your facility’s operations and adherence to policies and procedures, as well as Federal and State laws can be beneficial in ensuring compliance.
- Element 7: Responding promptly to offenses observed and taking corrective actions to address them
- If non-compliance is suspected, the compliance officer or other senior manager needs to investigate and determine if the incident must be reported, as well as decide on corrective actions.
- Investigation files should be created that include documentation on the suspected violation, interview notes, witness logs, the results of the investigation, the corrective actions taken and any other relevant documents.
In the supplemental guidance provided in September 2008, the OIG further highlighted that areas such as sufficient staffing, comprehensive care planning, medication management, appropriate use of psychotropic medications, and resident safety receive strong attention in your compliance program. These areas are commonly cited for deficiencies on surveys, so it is prudent to ensure you have strong policies in procedures in high risk areas such as these.