Preventing Abuse and Fraud with Antibiotic Stewardship Programs
By:
Betty Frandsen, MHA, RN, NHA, CDONA, FACDONA, C-NE, IP-BC Director of Education, Med-Net Compliance, LLC and Jeannine LeCompte, Compliance Research Specialist, Med-Net Compliance, LLC
Between 20 and 50 percent of antibiotics prescribed in U.S. hospitals are considered either “unnecessary or inappropriate,” and result annually in the deaths of 23,000 people, the infection of two million more, open the door for fraud, and exact an incalculable financial toll-all of which can be avoided through the implementation of strictly managed antibiotic stewardship co-managerial agreements. The Centers for Disease Control and Prevention (CDC)-which provided these statistics-has also warned that the abuse of antibiotics has contributed to the increasing problem of antibiotic resistance, which has “become one of the most serious and growing threats to public health.” The CDC also advises that hospital-based programs dedicated to improving antibiotic use, commonly referred to as “Antibiotic Stewardship Programs (ASPs),” can both “optimize the treatment of infections and reduce adverse events associated with antibiotic use.” ASPs have been demonstrated to help clinicians improve the quality of patient care, enhance patient safety through increased infection cure rates and reduced treatment failures, and significantly reduce hospital rates of antibiotic resistance-all while saving hospitals money.
The urgency of the matter is perhaps best illustrated by the fact that the Centers for Medicare & Medicaid Services (CMS) has ordered all Skilled Nursing Facilities (SNFs) to have implemented antibiotic stewardship programs by November 28, 2017-or face legal sanctions. The CMS “Final Rule” on the matter was announced on October 4, 2016, and compelled all long-term care facilities to “establish and maintain an Infection Prevention and Control Program (IPCP)” which “must include antibiotic use protocols and a system for monitoring their use.” CMS said that implementing such a program and ensuring proper oversight would cost long-term care facilities $19,000 per year, a cost which, CMS said, will be offset by the savings achieved through lowered rates of infection-estimated to range between $4,000 and $11,000 per affected patient. ASPs, therefore, represent multiple opportunities and requirements for SNFs and physicians to collaborate, to cooperate, and to co-manage-with “co-management” being the key phrase, as effective implementation typically requires a co-managerial relationship between a healthcare provider and a physician.
Co-management agreements are financial agreements based on the premise that a collaborative effort between physicians and skilled nursing facilities will facilitate the achievement of certain pre-determined goals. This is most often done by allowing physicians to manage the services to achieve improvements in quality and efficiency. However, any time that a co-management relationship develops, a medical facility must consider the potential for increased compliance exposures which can attract the Office of the Inspector General (OIG). This is because the OIG views all such relationships as inherently suspect, and potentially in violation of numerous federal healthcare fraud laws, including, but not limited to, the Anti-Kickback Statute and the Stark Law. While it is true that hospitals often enter into co-managerial contracts with physicians, and SNFs typically do so only for Medical Directors, the fact remains that there is still a co-managerial relationship-and all healthcare fraud laws must be scrutinized to ensure that nothing triggers the ever-suspecting OIG.
Collaboration in creating and managing an ASP must focus on the goal of appropriate prescribing of antibiotics while ensuring there are no activities or alliances that give the impression of fraudulent practices. No personal gain should be implied or realized by the facility, medical director, attending physicians, pharmacy, or facility staff in this effort beyond what occurs in typical facility operations. It should be borne in mind that anytime that an SNF and physician co-manage, there is an inherent risk of fraud, waste, and abuse. This situation was perhaps inadvertently aggravated by the Affordable Care Act, in terms of which federal fraud, waste, and abuse laws and enforcement were relaxed to encourage cost-savings and improved quality of care. The challenge for physicians and SNFs is to recognize that co-management opportunities and requirements involving SNF residents are not subjected to any of these relaxed regulations-and indeed they might all soon be totally repealed as the ACA is struck down by the new administration.
There are bound to be challenges for compliance and ethics-minded SNFs when physicians, accustomed to financially benefiting from increased co-management within a hospital relationship, begin to ask how they are going to benefit from an ASP. Similarly, there will be challenges emerging when SNF competitors without a compliance- and ethical-minded approach see an opportunity to financially reward physicians for resident referrals. SNFs therefore should be prepared to explain to physicians that their co-management relationship differs from any such arrangement that might exist between a conventional hospital and a physician, particularly with regard to fraud, waste, and abuse requirements.
The CDC is well aware of the potential pitfalls SNFs face, and has provided seven key concepts for improving antibiotic usage in any nursing home. These seven concepts are:
Leadership that demonstrates support and commitment to safe, appropriate use of antibiotics.
Accountability that identifies who will oversee the antibiotic stewardship effort within a facility.
Development of drug expertise by establishing access to experts with experience or training in how to improve antibiotic use.
Action that implements at least one new tactic in the effort to improve antibiotic use.
Tracking to measure antibiotic use and related complications (e.g., C. difficile infections).
Reporting that shares information with healthcare providers and staff about antibiotic use in the facility, and
Education and resources that provide information to staff, residents, and families about antibiotic resistance and opportunities for improving antibiotic use.
Within a facility, those individuals who will hold a direct responsibility with regard to the effective implementation of an ASP will include persons holding the positions of Medical Director, Director of Nursing, Infection Control Nurse, and Consultant Pharmacist. Ultimately, the CDC advises it will be the Medical Director who must set standards for antibiotic prescribing practices in their facilities. Directors of Nursing can ensure that the nursing staff correctly assess, monitor, and communicate changes in a resident’s condition that could impact the need for antibiotics, while the Infection Control Nurse should track and trend antibiotic use, infection rates, and any negative outcomes. Collected data provides stewardship leaders and the Quality Assessment and Assurance (QAA) Committee with facts from which they can develop or revise action plans for improving facility practices. The CDC recommends that the Consultant Pharmacist provide education to staff about the different types of antibiotics and their appropriate use; reviews antibiotic prescriptions during his or her drug regimen review, looking for new orders and appropriate use; monitors for adverse events; and reviews laboratory culture reports and gives feedback on ensuring the correct drug is used, and identifying antibiotic resistance.
In addition, there are a number of important considerations to be factored in whenever any co-managerial arrangement-especially with regard to ASPs-is entered into. A co-management agreement allows industry experts to become the partners of SNFs and other long-term care institutions. This in turn can provide those bodies with the specialist skills they need without requiring physicians to become employees. However, it is vital that all co-management agreements are set up in a way to ensure compliance with civil monetary penalty and anti-kickback laws. In this regard, the US Department of Health and Human Services (HHS) Office of Inspector General’s Advisory Opinion No. 12-22 serves as a valuable template for creating a legally compliant agreement. In addition, all co-managerial agreements should have a pre-determined time limit, to enable regular revision to meet changing legal and quality requirements.
The upcoming legal compliance deadline for SNFs with regard to antibiotic stewardship should therefore not be taken lightly. It requires all institutions to carefully evaluate how they are going to introduce whatever measures are necessary to become legally compliant. The legal and medical intricacies outlined above would suggest that the quickest and easiest way to become compliant is through a co-managerial agreement with a specialist in the field.
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