Compliance Observer
Compliance crosswalk: You're not off the hot seat
OIG model plans more different than similar
By Fay A. Rozovsky, JD, MPH, DFASHRM
President, The Rozovsky Group
Richmond, VA
The federal Office of Inspector General's (OIG) latest initiative targeted at hospitals, the Compliance Program Guidance for Hospitals released in early February, should by no means be interpreted as a signal that health care facilities are off the hot seat. On the contrary, it is probably just the beginning of a long process of ever-increasing scrutiny and accountability that will require innovative approaches to peer review, internal process controls, and quality improvement.
Those involved in hospital peer review owe it to themselves and their colleagues to keep pace with these developments because they're apt to find themselves playing a much larger role in the near future. Compliance is not a fad; it is part of how health care is doing business nowadays. As such, tying together compliance with systems and processes that monitor quality and utilization of care is fast becoming an important area of concern for hospitals and other health care organizations. Traditional notions of peer review are likely to expand as the momentum builds for ever-increasing levels of accountability for hospitals and other health care organizations.
Coming almost a year after the model for clinical laboratories, the incarnation for hospitals is not expected to be the last. Expected in the near future are a revised edition for clinical laboratories, model compliance guidelines for home health care and billing practices, and a plan for managed care health maintenance organizations.
Unlike its 11-step precursor for laboratories, the hospital guidelines include seven elements in what is offered as a minimum set of criteria for a compliance program. Comparing the 11 criteria to the seven, some similarities and differences merit review. (See the two sets of criteria, above.) Consequently, what is yet to come may be found in the expected revised guidance for clinical laboratories.
Both plans require large commitment
Taken as a whole, it is evident both plans require a large commitment to achieve success, stress education, and emphasize the need to deal with employees who violate the rules. Supervisors and managers will find that their own performance evaluations are tied to those of their subordinates.
Also common to both models is the need to provide pathways for reporting known or suspected violations. Although hotlines are mentioned in both models, this is not the only venue recognized for confidential reporting.
In both cases, the guidance provided by the government is just that - guidance. It provides a bare-bones approach to compliance. Most hospitals will want to go well beyond this minimum threshold to insulate their organizations from the rigors of fraud and abuse, false claims, and other exposures emerging from noncompliance with federal and state laws.
If a hospital or clinical laboratory implements a compliance program, it had better be more than window dressing. Federal regulators have made it clear that implementing an ineffective plan could result in greater liability than having no program at all. For clinical laboratories, this means carefully assessing the content of the new OIG revisions with a view to ratcheting up program content.
Both plans involve liability exposure. Even with a large commitment of resources and implementation of a compliance plan, hospitals are not guaranteed immunity from liability. But those that can demonstrate a good-faith effort and due diligence may be accorded leniency compared to those who cannot prove they "walked the talk" of compliance.
The government knows it is asking for a large commitment of resources. It is unapologetic about the fact that a hospital will need to expend considerable time and energy to meet even minimal thresholds.
Guidance extends beyond hospital
Some differences merit scrutiny, particularly for those responsible for designing and implementing a program. While the laboratory model is narrowly focused, the hospital plan goes beyond hospitals. In the section dealing with standards of conduct, it includes subproviders or affiliated providers operating under the hospital's control skilled nursing facilities, home health agencies, psychiatric units, rehabilitation centers, outpatient clinics, and dialysis facilities. It also encompasses hospital-based physician practices, nurse anesthetists, physician assistants, and physical therapists. Utilization review managers have been specifically mentioned.
The hospital model plan is far broader in its sweep than the clinical laboratory guidance and offers much more information on specific areas of concern. Unlike the clinical laboratory model, it emphasizes the need for general compliance with state and federal law, not just those requirements that target billing and coding activities. An indication of the breadth of its approach is the very fact that patient dumping is mentioned - a strong indication of the regulatory intent to tie quality of care and general adherence to legal requirements to corporate compliance.
The hospital model pinpoints a number of risk areas that are ripe for development of policy and procedure. These include billing for services not actually provided, upcoding, DRG creep, false cost reports, patients' freedom of choice issues, and failure to refund credit balances. Patient dumping, Stark self-referral issues, and fraud and abuse issues are also high-risk areas.
In addition, it delineates the duties and authority of the corporate compliance officer. They include making certain that independent contractors understand the hospital's perspective on coding, billing, and marketing activities. The officer needs to coordinate personnel issues with human resources so the National Practitioner Data Bank and Cumulative Sanction Report are checked with regard to employees, medical staff, and independent contractors.
Employee disciplinary action is highlighted throughout the hospital guidance. It goes beyond the content of the clinical laboratory model and includes background checks, exclusion for debarment from a federal health care program, and, in appropriate circumstances, removal of those with direct responsibility for any federal health care program pending the outcome of criminal charges or proposed program exclusion.
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