'Guidance' poses challenges
'Guidance' poses challenges
Hospitals now held more accountable than ever
By Renee H. Martin, JD, RN, MSN
Associate, Kalogredis, Tsoules and Sweeney Ltd.
Wayne, PA
The Compliance Program Guidance for Hospitals, released this past February by the Office of the Inspector General (OIG), signals a change in the OIG's approach to corporate compliance programs. In the first compliance program released by the OIG, which was designed for clinical laboratories, the OIG referred to the clinical laboratory guidelines as a "model" compliance program. The hospital issuance is referred to by the OIG as compliance program "guidance." This is more than a mere label change. It represents an acknowledgment by the OIG that no one program is capable of serving as a template for a large portion of the health care industry, and that each hospital's program must be tailored to fit its needs, resources, corporate structure, and mission.
Guidance incorporates the seven elements of an effective compliance program as set forth in the United States Sentencing Commission Guidelines. One of those elements requires that a hospital develop and implement "regular, effective education and training for all affected employees." However, in Guidance, the OIG takes this requirement much further by requiring hospitals to conduct continual retraining of "independent contractors" and other "significant agents." Prior drafts of Guidance, which the OIG circulated for comment to some members of the hospital industry, did not include this requirement. This element of the guidance places responsibility onto hospitals to both educate and police all independent providers on staff. The OIG's explanation for this move is that "the hospital is in a unique position to deliver [compliance] information to healthcare professionals on its staff."
Medical necessity added to hospitals' burden
The OIG has created a new hospital obligation in another significant area as well. The Guideline states that a compliance program should ensure submitted claims be limited to services that the hospital has reason to believe are medically necessary and ordered by a physician. This requirement introduces the hospital into a matter previously left between the physician and Medicare. The Guidance maintains that although physicians must be able to order any services appropriate for treatment of their patients, Medicare will pay only for services Medicare deems reasonable and necessary. Here again, the OIG goes on to state that the "hospital is in a unique position to deliver this information about Medicare's applicable standards of reasonable and necessary services to the healthcare professionals on its staff."
The OIG fails to address precisely why a hospital, rather than the Health Care Financing Admini stration or the OIG, is better positioned to provide correct compliance information to independent practitioners. Many hospitals will be hard-pressed both financially and logistically to disseminate this information to their own employees, let alone to the many physicians on staff. This clearly places a very real and challenging burden on hospitals regarding how best to accomplish this task.
Guidance requirements also suggest that, in addition to educating independent providers, a hospital should monitor their adherence to applicable Medicare regulations and sanction them for failure to comply. The OIG clearly intends to hold hospitals accountable for these tasks. However, Guidance does not acknowledge the fact that hospitals lack the legal authority to police and to discipline physicians to carry out this mandate. It also fails to recognize the impracticality of requiring a hospital to monitor whether physicians' treatment decisions are reasonable and necessary. The OIG probably will attempt to assess a hospital's success in training and monitoring its independent contractor medical staff as one barometer of the effectiveness of a hospital's compliance program.
While hospitals must understand and acknowledge the OIG's Guidance, they will face significant practical and legal challenges in implementing it. Guidance is the second in a series of industry specific anti-fraud guidelines published by the OIG. The first were released in February 1997 for the clinical laboratory industry. The OIG has announced its intention to continue with guidance for home health agencies, third-party billing, health maintenance organizations, and durable medical equipment.
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