Lots of Pain; A Sliver of Gain.
NEW REGULATORY standards are rarely met with joy, relief, or celebration. However, the new set of Joint Commission on Accreditation of Healthcare Organizations (JCAHO) standards related to pain management left many institutions foregoing the obligatory groan and jumping into their first taskforce meeting. Nurses are shouting "Finally!" and anesthesiologists are skipping down the corridors. Perhaps the JCAHO nailed a topic that was universally in need of improvement regardless of institutional prestige, specialty, or payer mix. These new standards seem to have deep and tangible meaning to caregivers. While no one denies that most JCAHO standards have some significance in terms of safe and organized care delivery, these standards relate to every day practice, not a highly unlikely disaster. Not surprisingly, staff nurses seem far more motivated to complete their pain flow sheets than the log of refrigerator temperatures. Aside from the ever-popular topic of conscious sedation, these standards required true collaboration among physicians, nurses, and other providers during the planning, education, and implementation phases of achieving standard compliance. Delightful.
The standards resulted from 2 years of work with the University of Wisconsin-Madison Medical School. A portion of the funding for the project came from the Robert Wood Johnson Foundation, emphasizing pain assessment and management as a national priority in health care. Expert panels and multidisciplinary groups, as well as professional and consumer groups, provided input. Prior to implementation, the proposed standards received a 92% approval rating.
Effective January 1, 2001, the standards are woven through the chapters of the 2000 Comprehensive Accreditation Manual for Hospitals by the JCAHO in the Patient Rights, Assessment, Treatment, Patient and Family Education, Continuity of Care, and Performance Improvement chapters. The standards in the Patient Rights chapter emphasize the involvement of patients and families in all aspects of care and that patients have and an explicit right to pain management. This right begins with an assessment and continues with education regarding treatment choices and side effects within the context of patient-specific beliefs. The Assessment chapter elaborates on the processes for assessing pain in the context of the patient's condition including examples of pain-assessment techniques. The Treatment standards emphasize safe and appropriate medication administration and monitoring including specific mention of delivery methods like patient-controlled anesthesia (PCA), spinal/epidural, and IV. Specific standards also address the assessment and treatment of pain during the post-procedure phase of care. The chapter on Patient and Family Education mandates that specific education regarding pain management be provided as a natural extension of the patient-focused care planning and education process. The Continuity of Care chapter now names pain as a key point in the discharge planning process.
The way in which the aspects of pain management were woven into the standards manual was not too surprising. However, the fact that explicit standards were established is a notable event. Pain joins nutritional status as the only other physiologic phenomenon that has such clear standards around the process of assessment. (Abuse and sensory deficits are also assessed, but with respect to the process of subsequent referrals or the manner in which care is provided.) Pain is the only discreet physiologic phenomenon that has specific expectations for the process of treatment. Interestingly, no specific standards exist for potentially more life-threatening conditions like hypotension, hypoglycemia, or hypoxia. According to Charlene Hill, media relations manager, the JCAHO has no plans to "prescribe" practice around any other specific physiologic occurrences or events. However, the evolving ORYX standards will clearly focus organizations on five major sets of performance measures related to specific clinical events by 2002. In this instance, measurement is being prescribed, the outcome is being watched, and the process must be examined if the outcome does not meet performance standards. Perhaps the practice of assessment and treatment of more life-threatening events is so routine that creating new systems and education to provide such care are unnecessary. Many proponents of evidence-based care would probably wager that the assessment and treatment of those conditions is as variable and sub-standard as is the assessment and treatment of pain. Make way for the fifth vital sign.
As with any JCAHO regulatory change comes heightened awareness and a flurry of new industries, products, and merchandising, by the JCAHO of course, and many other companies. William M. Slater, BS, RPh, now an independent consultant in Mundelein, Illinois, spent a significant portion of his career at Abbott Laboratories focusing on pain-related products and trying to "heighten awareness." His professional and personal commitment to improving pain management must have required stamina; he recalled clinical trials for the earliest models of the PCA pump at Duke University in 1967. Today, some hospitals still do not provide such devices.
Slater noted that the Agency for Healthcare Policy and Research's guidelines on pain management published in 1992 were a great impetus for change, as were the efforts of the American Pain Society. Several years ago, Abbott developed a unique assessment tool for pain management, Total Quality Pain Management (TQPM). This patient survey tool allows for the collection of subjective and objective data from individual patients and allows for comparison of patient symptoms and outcomes to national benchmarks. Several specific indicators have gained ORYX approval from this software product. Slater appreciates the impetus for more awareness and accountability for pain management provided by the JCAHO. Naturally, Abbott experienced a "bolus" of interest around TQPM in the last year. Greater awareness around pain management was bound to effect actual drug sales, too. According to Randy Ostroff, MD, medical director in Abbott's Hospital Products Division, the much needed and heighten awareness around pain management has generated a surge of activity around "cross-over products like OxyContin[R]" which ease a patient's transition from PCA to oral pain management.
Development of even more effective agents and devices seems hopeful, but grassroots efforts to raise awareness and establish a basic standard of care will likely have a profound impact on the manner in which patients experience their illnesses and their encounters with the health care system. The website, www.pain.com, published a lecture by Jeffery Katz, MD, an anesthesiologist at Northwestern Memorial Hospital in Chicago. He noted that research exploring the experience of patients undergoing surgical procedure revealed that "57% of patients worried more about postoperative pain than they did anything else."
"I'm so glad they finally made it a law."
OIG Ruling Opens Door for Physician Gain Sharing
A recent Advisory Opinion by the Office of the Inspector General (OIG) opens a window for a gain-sharing arrangement between one specific group of physicians and a hospital. An anonymous hospital and a group of cardiac surgeons gained "approval" to engage in a 1-year agreement whereby 50% of the cost savings on very specific physician-driven decisions would be shared with the physician group. The OIG expressed "approval" by stating that "the proposed arrangement would constitute an improper payment to induce reduction or limitation of services pursuant to the (Social Security Act), but that the OIG will not impose sanctions." While this window is very narrow and very specific, it offers hope for new creative and collaborative partnerships with physicians. For nursing leaders who are financially accountable for physician practice patterns, including test utilization or supply utilization, this event may spark new discussion. Regardless of whether you and your institution feel fit enough to take on the OIG, the facts of the case are a fascinating lesson in the gain sharing and anti-kickback regulations, the powerful use of data, quality improvement, physician partnership, and cost savings.
First, in order to appreciate the artful construction of the proposal that gained approval and the legal tests that it had to endure, the following briefly describes the relevant aspects of the Social Security Act. Gain sharing typically means an arrangement whereby a hospital shares a portion of the dollars saved with physicians as a result of changes in their practice. In July 1999, the OIG issued a powerful, absolutely clear Special Advisory Bulletin clarifying that gain-sharing arrangements are strictly prohibited by the Social Security Act and promising financial penalties to a hospital or physician who "knowingly (makes) a payment directly or indirectly to a physician as an inducement to reduce or limit services to Medicare or Medicaid beneficiaries under the physician's care" (OIG, 1999, p. 1). Prophetically, the OIG acknowledged that they could envision gain-sharing arrangements where patient care was not adversely affected and understood the need for hospitals to engage in collaborative efforts with physicians to manage costs. However, the potential for fraud and abuse and the resources required to monitor such arrangements for contractual and clinical appropriateness were beyond the scope of the office. The OIG also expressed doubt regarding the ability of such arrangements to have quality measures powerful enough to quantify the true impact on patient care. Perhaps this event was one of the wake-up calls that propelled the world of quality assurance into quality improvement. The fines for such violations were quoted as $2,000 per patient covered by the payments. This figure seems curiously close to a DRG base rate. Similarly, the anti-kickback statute included in the Social Security Act prohibits giving or receiving any form of compensation in exchange for referrals or services reimbursable by Medicare or Medicaid.
Several other facets to the existing regulations deserve mention. Obviously, hospitals may contract with physicians based upon a fixed fee or the fair market value for a service. Payment or bonuses based upon actual cost savings are explicitly prohibited. The Social Security Act was also amended to exclude managed Medicare plans. So, HMOs can "implement physician incentive plans, provided the managed care plan (does) not induce the reduction of medically necessary care to individual patients and (does) not place the physician at substantial financial risk for services not provided by the physician" (OIG, 1999, p. 2). Presumably, substantial financial risk might influence "independent professional judgment in the best interest of patients." At the end of this Advisory Bulletin, the OIG noted the difficulty in individually permitting and uniformly regulating institution-specific arrangements and predicted that issuing favorable opinions would be imprudent. They specifically feared every hospital in the country requesting an Advisory Opinion.
On January 11, 2001, the OIG placed a hand on the proverbial floodgate by granting approval to this proposed arrangement between a hospital and a cardiac surgery group (the requestors). The proposed agreement enumerated 19 cost-saving opportunities in the operating room during specific procedures that would contribute to a bonus pool. The first 14 cost-saving opportunities involved the practice of opening specific surgical trays and disposable supply items in the OR on an as-needed basis. The proposal noted that the supplies would still be readily available in the OR. Apparently, the OIG expressed concern over one item, a disposable supply used with the cell saver, fearing that a delay in handling the item at the time of need would jeopardize patient safety, but the physicians certified otherwise. Of the total cost-saving opportunities, 10% could be derived from this particular practice change. The next four cost-saving opportunities related to the direct substitution of less costly supply items. Seventy-five percent of the potential cost saving lay in the last item, administering aprotinin based upon clinical standards. Aprotinin is a protease inhibitor used to address the inflammatory response of the body during cardiac bypass and ultimately reducing blood loss.
The proposal called for an independent program administrator to collect and analyze the financial and clinical data required to monitor the appropriateness of the clinical decisions and the legitimacy of the accounting practices for cost savings. For each of these individual cost-saving opportunities, the requestors used historical practice pattern data from this and other hospitals as well as other clinical standards to define a floor of acceptable utilization. Dipping below these established standards would result in no additional financial gain and trigger a violation of the anti-kickback statute. In addition to calculating savings based upon each measure, the program administrator would also monitor for changes in payer mix, severity, and age to assure that the physicians were not self-referring cases with cost-savings potential to this hospital and taking their more complex cases down the street. Individual physicians would be excluded from the plan if substantial shifts in these variables were demonstrated. Substantial variations in referral patterns would constitute physician self-referral violations. The volume of cases eligible to contribute to the cost-savings pool is also capped by historical volume targets. Dispersement of 50% of the bonus pool to the physician group members will be done on a per capita basis.
All the while, the hospital and the surgeon group must disclose the arrangement to patients (a) prior to admission if possible, (b) prior to consent, (c) in writing, and (d) offer them a chance to review the cost-saving measures applicable to their procedure. This measure obviously fulfills the obligation for ethical disclosure of potential conflicts of interest. In addition, it creates medical-legal exposure by empowering patients with information.
When analyzing the above proposal, the OIG noted that technically speaking, the cost-saving opportunities of opening trays on an as-needed basis, with the exception of the cell-saver items, were the only opportunities that would not trigger civil monetary penalty. Several aspects regarding the manner in which the proposal was constructed allowed for "approval" to be granted in the face of these technical violations. The OIG noted that discrete cost-saving actions resulted in real hard savings, actual acquisition costs. Other examples of gain-sharing plans defining aggregate savings such as length of stay reduction that are driven by many factors and shared by vaguely defined groups of physicians have no merit in the eyes of the OIG. The OIG also took comfort in the ability to monitor individual physician accountability, the transparency of the proposal to the public, and the ever-vigilant presence of the medical-legal community. Limiting the amount of financial gain through utilization thresholds and volume caps as well as time limiting the agreement to 1 year further limited the potential for fraud and abuse.
In general, the OIG cited direct and specific ways in which an arrangement like this could "(implicate) at least three legal authorities: (i) the civil monetary penalty for reductions or limitations of direct patient care services provided to Federal healthcare program beneficiaries, (ii) the anti-kickback statute, and (iii) the physician self-referral law" (OIG, 1999, p. 7).
While most everyone in health care has a sober new respect for the OIG based upon their intense efforts to stop fraud and abuse in the realm of billing issues, the insights expressed in this Advisory Opinion exemplified the depth of their understanding of health care. They drilled on aspects of the practices and challenging realities of hospital administration, the politics and behaviors of medical staff members, and the nuances of accounting and quality improvement. Specifically, the OIG pointed out very real concerns in gain sharing from "cherry picking" healthy patients to a "race to the bottom" phenomenon among hospitals with competing gain-sharing arrangements to lure physicians.
According to Deborah Gordon, a partner at the law firm of Piper, Marbury, Rudick, and Wolfe in Chicago, "the OIG opened a very small window on an issue that we believed was completely closed to discussion. The proposed arrangement had such specificity in its construction, that the OIG permitted the practice through issuance of their opinion under very tight reigns."
Nursing leaders are constantly challenged to form, stabilize, steer, and grow collaborative partnerships with physicians. This challenge is often complicated by inherited political history, conflicting financial incentives, individual personalities, or in this case, the added complexity of health law. Regardless of your aspirations to battle with the OIG, the example set forth in partnering with physicians over practice changes using clinical evidence and comparative data should inspire physicians and hospital leaders alike.
Joint Commission on the Accreditation of Healthcare Organizations. (2000). 2000 comprehensive accreditation manual for hospitals. Oakbrook Terrace, IL: JCAHO.
Office of the Inspector General. (1999, July). Special advisory bulletin: Gainsharing arrangements and CMPs for hospital payments to physicians to reduce or limit services to beneficiaries. Washington, DC: OIG.
Office of the Inspector General. (January 11, 2001). (PIG advisory opinion No. 01-1 Washington, DC: OIG.
Katz, J. (September 22, 2000). Is surgical pain inevitable? Changing attitudes and practices of pain management. [Online]. Available: www.pain.com
ALISON P. SMITH, BSN, RN, is Assistant Editor, Nursing EconomicS.
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|Title Annotation:||standards in pain management|
|Author:||Smith, Alison P.|
|Date:||May 1, 2001|
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