In mid-April 2008, the Office of Inspector General for the U.S. Department of Health and Human Services (the "OIG") promulgated a draft supplemental compliance program guidance for nursing facilities. The draft guidance, once in final form, will supplement the OIG's 2000 Nursing Facility Compliance Program Guidance. Both sets of guidelines offer insight into what areas the OIG considers to be of high concern. Nursing homes should consider updating and implementing compliance programs based on these guidances.
The draft guidance highlights five risk areas, including quality of care, submission of accurate claims, the Federal Anti-Kickback statute, "other" risk areas, and HIPAA privacy and security rules.
Under the umbrella of fraud and abuse concerns, the draft guidance discusses quality of care and highlights the five areas that should be of importance to nursing homes. The draft guidance emphasizes that "sufficient staffing" implies sufficiency in both numbers and competency. In order to ensure this, the OIG advises that nursing homes regularly assess their staffing needs, which may change over time. With regard to comprehensive resident care plans, the regulations require nursing facilities to create a plan detailing the medical, nursing, mental and psychosocial needs of individual residents. The OIG further advises that nursing facilities ensure that physicians are involved in a supervisory manner.
Another area of concern noted in the draft guidance is the appropriate use of psychotropic medications. Here, the OIG has two primary concerns: that nursing homes not use psychotropic medications as chemical restraints or use them unnecessarily. Consequently, the OIG advises that nursing homes should document and review the use of these drugs.
In terms of general medication management, one concern is that there may be inappropriate drug switching or steering. The OIG suggests that nursing facilities employ proper medication management processes, including training all relevant staff members. Finally, the OIG recognized growing concerns regarding resident safety. This includes both harm caused by nursing facility staff and by other residents. To curtail these concerns, the draft guidance recommends that nursing facilities implement a confidential reporting system.
Not surprisingly, the OIG addresses the submission of accurate claims within the general fraud and abuse category. False claims may be "claims for items not provided or not provided as claimed, claims for services that are not medically necessary, and claims when there has been a failure of care." The draft guidance emphasizes the importance of proper reporting of resident case-mix. The guidance also addresses physical, occupational and speech therapy and reiterates that nursing facilities employ these services only when medically appropriate. The OIG advises that nursing facilities guard against the submission of false claims by screening prospective employees through both the OIG's List of Excluded Individuals and Entities and the U.S. General Services Administration's Excluded Parties List System. Furthermore, with regard to restorative and personal care services, the draft guidance encourages comprehensive procedures to ensure that these services are actually delivered to residents and are of sufficient quality.
The final issue under the umbrella of fraud and abuse is the Federal Anti-Kickback statute. For nursing facilities, the OIG identified several areas that should be closely monitored, including free goods and services, services contracts with both physicians and non-physicians, discounts, hospices and reserved bed arrangements.
Outside of fraud and abuse, the guidelines highlight "other" risk areas, in addition to compliance concerns with HIPAA privacy and security rules. For nursing homes, the guidelines provide strategies for minimizing the risks associated with physician self-referrals and supplemental payments. The guidelines also warn of the risk of frustrating any Medicare Part D beneficiary's freedom of choice.
In terms of HIPAA privacy and security rules, the draft guidance acknowledges that nursing facilities may develop some of their own privacy procedures. However, the OIG advises that nursing homes must assure that any procedures developed are compliant with the privacy rule, particularly with regard to the use and disclosure of personal health information.
While the supplemental guidance details specific strategies for nursing facilities to use in developing and updating a compliance protocol, the draft guidance also emphasizes that developing general ethical and compliance principles, in addition to reviewing specific compliance mechanisms, may be key in developing an effective compliance program.
If you have questions about this Alert or would like more information, please contact Frederick R. Ball, any other member of the Services for Long-Term Care and Assisted Living Providers Practice Group r the attorney in the firm with whom you are regularly in contact.
This article is for general information and does not include full legal analysis of the matters presented. It should not be construed or relied upon as legal advice or legal opinion on any specific facts or circumstances. The description of the results of any specific case or transaction contained herein does not mean or suggest that similar results can or could be obtained in any other matter. Each legal matter should be considered to be unique and subject to varying results. The invitation to contact the authors or attorneys in our firm is not a solicitation to provide professional services and should not be construed as a statement as to any availability to perform legal services in any jurisdiction in which such attorney is not permitted to practice.
Duane Morris LLP, one of the 100 largest law firms in the world, is a full-service firm of more than 650 lawyers. In addition to legal services, Duane Morris has independent affiliates employing approximately 100 professionals engaged in other disciplines. With offices in major markets in the United States and internationally, Duane Morris represents clients across the U.S. and around the world.
