“His men would follow him anywhere, but only out of morbid curiosity.”
“This [bureaucrat] is depriving a village somewhere of its idiot.”
Anonymous
“He who is slowest in making a promise is most faithful in its performance.”
Jean Jacques Rousseau, Swiss/French philosopher (1712 - 1778)
“An ounce of performance is worth pounds of promises.”
Mae West, American playwright and actress (1893-1980)
In a way, the September-October issue of SpineLine brings the NASS year to an end. Not only is this issue distributed at the Annual Meeting, but the same meeting holds planning meetings for much of the next year’s NASS activities. At the meeting, the SpineLine Editorial Board meets to select topics and authors for future issues. We would like to take this opportunity, therefore, to invite you to contact us, by phone, email or in person in Toronto with your ideas for SpineLine. Feel free to respond to previous topics.
In Toronto, we will welcome new NASS President, Dr. Charlie Branch. In his last SpineLine Message as NASS president, Dr. Faciszewski details the society’s accomplishments under his able leadership. Major issues have included physician reimbursement and physician-industry relationships. He notes that we have led organized medicine in ourdisclosure requirements for NASS meetings and for those serving the society.
In recent months, other steps have been taken to foster greater organizational clarity and responsibility. An ethicist will be added to the NASS board. Further, a conflict of interest committee has been assembled to assist the society and its members in determining the significance and level of perceived conflict. It is not enough to identify a con- flict, attempts must be made to resolve that conflict. As Dr. Faciszewski notes, relationships with the spine industry improve patient care through innovation. These relationships should not be improperly vilified, but do create conflicts of interest which must be ddressed in an open and honest manner.
Other changes have been proposed for ratification at the annual meeting, including a streamlining of the NASS board and committees. In a complex social, scientific and regulatory environment, rapidly growing organizations could easily fall into a trap of inaction and ineffectiveness. In order to execute its central operating principle, Dr. Faciszewski notes that sideline projects have been cancelled. Other activities have been more properly aligned to NASS’s chief mission.
One area in which the complex regulatory environment crashes into physician and industry conflict issues involves the recent Department of Justice and Department of Health & Human Services (HHS) investigation into hospital admissions of kyphoplasty patients. Unlike vertebroplasty procedures, which are often performed on outpatients, most kyphoplasty patients have been formally admitted. Assistant US Attorney General Robert Trusiak and his associates have traveled to a number of hospitals around the country. These unannounced visits begin with study of hospital admission records followed by interviews with involved clinicians.
Their hypothesis: inpatient costs for kyphoplasty are five times higher than out-patient costs and kyphoplasty patients were improperly admitted. Remember that Medtronic, which now manufactures the kyphoplasty equipment, has settled a whistleblower suit for tens of millions of dollars under the contention that it influenced physicians to improperly admit these patients.
What the federal investigators seem to ignore: hospitals admit kyphoplasty patients because another branch of the HHS, CMS, ruled that kyphoplasty should be an inpatient procedure. Therefore, hospitals were only paid when kyphoplasty patients were admitted. Given that neither the clinicians nor the hospitals would purposefully seek this Medicare patient population as a means of enriching themselves, these unnecessary legal entanglements and federal doublespeak create an enormous source of cost and anxiety for those involved.
Over the last couple of days, I have discussed this investigation with colleagues elsewhere. One described this investigation as a “classic, schizophrenia-inducing governmental double-bind.” Another noted his surprise as he was confronted in his office by badge-flashing government agents. This particular physician practices in a very large single specialty group. He mentioned that regulatory compliance issues form an ever increasing slice of the practice’s overhead. It is not unusual for larger groups to spend $250,000 per year on legal and consulting costs to ensure compliance with the dense thatch of federal, state and local government entities.
Regular Columns
A rich variety of clinical and management data are presented in this SpineLine. In Radiology Rounds, Section Editor Dr. Francis Shen offers a case from Johns Hopkins Drs. Krabak, Klotz, Gokaslan, and Khanna. Their patient presents with an uncommon entity leading to progressive hip pain. Interestingly, despite the wide laminectomy needed to adequately remove these lesions, here, a bone-sparing laminoplasty, no-fusion approach was undertaken. Despite mild, residual numbness, the patient had an excellent outcome.
In Curve-Countercurve, Section Editor Dr. Heidi Prather presents an interesting case of small cell lung cancer with thoracic spine metastasis and soft tissue spill. In this patient, the cancer is limited to the thorax, but the tumor’s histology implies a grim prognosis. The described patient exhibits focal pain and kyphosis, but remains neurologically intact. Drs. Jeffrey D. Bradley, Jacob Buchowski and Peter S. Rose discuss the pros and cons of surgical stabilization and options for stereotactic radiosurgery. In a recent SpineLine Invited Review, Dr. Peter Gerszten from the University of Pittsburgh reviewed the
rapidly evolving field of Cyberknife and similar radiosurgery systems. This review is available online at the NASS Web site under previous issues [www.spine.org/publications/spineline]
Over the last couple of years, stereotactic spinal radiosurgery systems have rapidly become more available. Competing hospital systems advertise their newest high-tech acquisitions with highway billboards and television spots. These ads imply improved outcomes. Unfortunately, the data, so far, are limited. Yet, the increasing treatment options available to patients with metastatic disease is heartening. Increased survival times make quality of disease-free survival an increasingly important as well. While we do not want to subject a terminally ill patient to a lengthy surgical recovery, outcomes
data suggest improved functional and ambulatory levels in operatively managed patients. We hope to offer additional spinal radiosurgery reports and outcomes studies
as they become available.
In this issue’s Literature Review, Dr. Paul Slosar discusses a recent Journal of Bone and Joint Surgery SPORT discectomy outcomes report. This paper stratified the outcomes from surgical and nonsurgical management by herniation level. The benefits of surgery increased with more cranial disc herniations. These prospective, multicenter data should assist spine care practitioners when counseling their disc herniation patients.
Dr. Anil Sharma comment on a cervical medial branch block study. As noted by Dr. Sharma, difficulties with studies of this kind include diagnostic specificity in “non-specific” neck pain and the lack of a placebo control. He points out that while greater than 50% pain relief was reported, there was no impact on return to work or decrease in opioid usage. As with chronic, axial low back pain patients, the complex interplay between medical, psychosocial and secondary gain issues limits the strength of treatment recommendations from non-controlled studies. That daily opioids are so frequently used for chronic, “non-specific” neck pain represents a significant change, though not necessarily an improvement, from previous practice.
In this issue’s Coding column, Dr. Jon Wilson from North Carolina, discusses the coding issues surrounding needle and surface EMG. Helpfully, Dr. Wilson discusses the limitations of surface EMG, which is currently an unlisted procedure.
Health Care Policy and Clinical Integration
In their Advocacy and Legislative Affairs column, Dr. Jeffrey Wise and Nicholas Schilligo present other facets of federal health care policy by dissecting the Medicare Improvements for Patients and Providers Act of 2008 (HR 6331). This bill, vetoed by President Bush but subsequently enacted through Congressional override, restored the more than 10% pay cut physicians faced because of Medicare’s flawed rate formula. Wise and Schilligo also discuss new mandates covering quality reporting, prescribing
and imaging. Recognizing that imaging costs are accelerating faster than other health care costs, this bill orders CMS to work with medical societies to develop appropriateness criteria for MRI, CT and PET scans.
The bill extends a number of aspects of PQRI (physician quality reporting initiative) and includes a gradual transition to a pay-for-performance (P4P) system. Congress wants to improve health care efficiency and quality by promoting the transition to the electronic medical record. This involves initially rewarding physicians for electronic prescribing followed, in 2012, by penalizing physicians who continue to use hand-written prescriptions.
Initially considered for inclusion in this bill were “Physician Payment Sunshine” provisions which would require reporting any “transfers of value” from
industry to physicians exceeding $500 per year. These issues continue to be debated and are likely to be seen in other, upcoming legislation.
The increasing affect of federal regulations on medical practice is further discussed in this month’s Practice Management column by Brian Foley, MD, MBA and Stephen Kaelble. The authors present the concept of “clinical integration.” While still in its infancy, this concept refers to increased collaboration between private practice or independent physicians and the health systems in which they work.
The authors note that increasing payer and patient demands for quality measures and outcomes comes at the time of decreased reimbursements. Decreasing reimbursements only add to the time pressures which directly inhibit creative and cooperative ventures. Without reasonable reimbursement for time spent, quality improvement initiatives are exceedingly difficult to institute.
Clinical integration initiatives recognize the inevitability of physician report cards and performance measures. These measures will range from pure cost metrics to quality ratings. Payers seek to influence patient and physician behaviors. Patients are directed toward lower-cost providers through decreased co-pays or deductibles. Physicians are rewarded for improved outcomes or decreased costs through increased reimbursement.
Obvious difficulties include the payer’s conflicts of interest when using their significant economic clout to affect medical decisions. The authors contend that both physicians and hospitals will accommodate to these changes more easily if they combine forces. Productive negotiations for appropriate quality indicators and fair reimbursements are more likely with cooperation.
Elements of successful integration begin with us as individual clinicians. We must spend more time looking closely at our own outcomes. We should assess how our patients see us and poll them as to what they like and don’t like about their experiences in our practices. The next step involves physician-hospital collaboration. Hospital committees should be reorganized to reflect new realities in medical care. Use evidence-based guidelines to develop disease specific patient pathways. Ideally, these pathways include data collection structures.
Clinical integration is powered by collective negotiation. Meaningful and substantive physician-hospital collaborations require intensive cross-advocacy. Financially, these systems will only survive if they reward the additional work required. Thus, some form of collective negotiation for fees is required. On the other hand, antitrust and self-referral laws have long discouraged hospital-physician collective bargaining. To date, the government has accepted some proposals and has rejected others.
Federal acceptance requires evidence of patient benefit and documentation that the collective negotiation is truly required for the efficiencies to be realized. Given the reams of laws, regulations and statutes administered by several federal agencies, attempts at integration require legal counsel and, to date, have principally been established using outside consulting firms (usually for hefty fees).
Gainsharing
Gainsharing represents one variety of clinical integration. Here, physicians and hospitals work closely together to decrease costs. Physicians are rewarded with a percentage of the money saved. To date, gainsharing programs acknowledge three key principles:
- Physicians know what is best for patients.
- Physician choices result in more than 80% expenses incurred by hospitals in
care of patients.
- Across the country and within individual institutions, there is marked variability in the utilization of expensive technologies.
In one-level lumbar fusion procedures, a threefold variation separates implant costs among surgeons. Medical device prices have increased 3%-6% per year for the last 10 years. To date, however, there is little evidence that these increased costs have improved outcomes. These facts and principles, taken together, suggest that physician involvement might significantly curtail rising care costs.1-4
In the past, hospitals’ attempts to provide physicians incentives to reduce those costs has met stiff resistance from federal agencies. For example, when the Diagnosis Related Group (DRG) system was introduced, hospitals were paid by patient diagnosis and not based on length of stay or specific services offered. Hospitals offered financial incentives to doctors to limit length of stay. The CMS determined that MD incentives resulted in a reduction of Medicare services. Congress enacted the CMP provision to prohibit incentive payments from hospitals to MDs. Since then, most gainsharing requests have been deemed illegal; most doctor-hospital partnerships look at new services or products instead.5
Since 2001, however, the increased burdens on the US health care system have prompted renewed interest in gainsharing on the part of federal agencies. Several demonstration projects have been approved. Yet, they have not been declared legal. Rather, the Office of the Inspector General (OIG) has established safe harbors. That is, if appropriate safeguards are in place, the OIG will not seek sanctions against hospitals and physicians for their participation in gainsharing arrangements. 6 To date, these programs are limited to a one-year run. Other stipulations include the need for very specific measures of savings, patient notification and quality of care measures. These programs cannot induce patient referrals. Payments accrue to physician groups and
not to the individual doctors.5,7,8
While gainsharing programs remain rare, interest continues to increase. With increased interest has arisen increased concern about the ethics and inherent conflicts. Some have argued that these cost savings programs might induce physicians to withhold care.3,9,10 The implant industry trade organization and their Washington, DC lobbyists, naturally, oppose expansion of gainsharing programs. They claim these programs will decrease innovation. Ultimately, these cost savings programs require either decreased utilization of expensive technologies or decreased prices for those technologies.
The American Academy of Orthopaedic Surgeons has stated that its members are ethically obligated to contain costs. On the other hand, their guidance document states that benefits from these programs cannot accrue to physicians or their practice groups. Rather, savings must be invested into patient care or other departmental programs (aka limited gainsharing or program reinvestment).11
Most of these arguments are purposefully naïve. Any health care system engenders conflicts of interest. For physicians, there is an inherent conflict between the duty to provide high-quality patient care and the desire to maximize his or her financial gain. The government’s whole DRG system was devised to save it money. Later, layers of legalese were added to suggest that the “patient comes first.” In this era of declining revenue, it is hard to imagine physicians, especially in a nonacademic setting, expending great and ongoing personal effort to save “the system” money. In that these arrangements systematize care and add efficiency (theoretically), they may decrease conflict.
Over the last couple of months, Goodroe Healthcare Solutions, LLC http://www.goodroe.com/), a consulting firm focused on improving hospital economic performance, announced the first gainsharing project for procedures performed by orthopedic surgeons and neurosurgeons approved by the Office of the Inspector General. Participating physicians are to be paid as much as 50% of the savings generated through increased hospital and physician collaboration. The project requires demonstration of “quality” patient outcomes. The program is built around a comprehensive data gathering system which measures costs, identifies waste-saving opportunities and uses nationally accepted quality benchmarks and standards to assure quality patient care.
Because of complex regulations that govern and limit structures and relationships that are legally permissible, any hospital-physician collaborations will be closely scrutinized by OIG. Any program at your institution must be carefully structured. Government enforcement of Civil Monetary Penalty statute, Anti-Kickback Statute and Stark laws continues to increase, and applicability of these laws remains murky at best. It is essential that these programs are structured with a knowledgeable health care attorney.
In an interesting contradistinction to the integration columns, Ken Yonemura, from the University of Utah, and Attorney Catherine Gale from New York use the ethics column to discuss issues surrounding hospital privileges and their revocation. Often physicians have little understanding of their rights under hospital bylaws until they are in the midst of a disciplinary proceeding. The authors point out that the hospital bylaws always look to protect and indemnify the institution first. These rules and physician’s rights, as the authors suggest, are “mutually exclusive.” Disciplinary actions often arise from spurious
events, but rapidly take on a life of its own leading to automatic reports to state licensing boards and the National Practitioner Data Bank. These reports cannot be expunged and become a permanent part of the physician’s record.
Whereas integration and hospital disciplinary issues are diametrically opposed, the authors of both columns have the same strongly worded recommendation: increased physician involvement! Active contributions to relevant hospital committees are the only way to protect a physician’s local interests. Active involvement in local, state and national organized medicine bodies remain the only effective way (outside of running for office) to protect our specialty and our patients from increasing bureaucratic onslaughts.
Laws of Unintended Consequences
Federal laws, regulations and statutes certainly have an impact on physician behavior and patient experiences, but not always in the expected manner. Stephen Dubner and Steven Levitt, the authors of Freakonomics, relate an interesting story about the Americans with Disabilities Act (ADA) in their New York Times column of January 20, 2008.
They describe “a top Los Angeles orthopedic surgeon” from whom a deaf patient sought a consultation. The patient demanded that the surgeon hire a signlanguage interpreter. The surgeon found that the interpreter cost $120 an hour, with a two-hour minimum, and the expense wasn’t covered by insurance. Recognizing that his average new patient evaluation for a similar knee problem netted him $58, the encounter would cost him $180 before taxes and overhead.
When the surgeon suggested they make do without the interpreter, she informed him that the Americans With Disabilities Act (ADA) gives the patient the choice of interpretation, at the physician’s expense. “Flabbergasted,” the doctor researched the
law and found that he was indeed obliged to pay for the interpreter. Discussion with several colleagues revealed that most would refuse to treat a similar patient. He notes, “It’s got to be widely pervasive and probably not talked about, because doctors are just getting squeezed further and further. This kind of patient will end up getting passed on and passed on, getting the runaround, not understanding why she’s not getting good care.”
While medical data documenting the impact of the ADA on patient care are not available, Dubner and Leavitt reported on the work of economists Daron Acemoglu and Joshua Angrist. They found that the ADA, enacted in 1992, led to a sharp drop in the employment of disabled workers. They concluded that, employers, concerned that they wouldn’t be able to discipline or fire disabled workers who happened to be incompetent, avoided hiring them in the first place.
In an interesting aside, the article also considers the effect on the Endangered Species Act (ESA) of 1973. Species are typically listed endangered months to years before official designation of “critical habitats.” This lag time allows developers, environmentalists and others to comment at public hearings. During this time, the same developers or private landowners rush to protect their investments by clear-cutting the timber or eliminating any other land feature than attracts or houses the endangered species. The economists argue the Endangered Species Act might actually be “endangering, rather than protecting, species.”
Dr. Sandeep Jauhar, in his September 8, 2008 New York Times column, “The Pitfalls of Linking Doctors’ Pay to Performance,” makes the case that P4P metrics force us to treat all cases the same. As an example, Medicare requires that antibiotics be administered to a pneumonia patient within six hours of arriving at the hospital. While this sounds great on the surface, doctors often cannot diagnose pneumonia that quickly. It takes time to talk to and examine a patient and wait for blood tests and chest X-rays. Under P4P, the physician is pressured to treat before the infection diagnosis is firm. Antibiotics use is increasing despite resistant bacteria, antibiotic-associated infections (like c. dif-ficile colitis) and other dangers.
Dr. Jauhar reports on a similar phenomenon, surgical report cards. In the early 1990s, cardiac surgeons were issued report cards with a view toward improving cardiac surgery quality. The grades were meant to point out deficiencies in hospitals and surgeons. Unfortunately, studies revealed a very different outcome. In a 2003 report from Northwestern and Stanford, surgeons were noted to be “cherry-picking” patients in states with mandatory report cards. “In a survey in New York State, 63% of cardiac surgeons acknowledged that because of report cards, they were accepting only relatively healthy patients for heart bypass surgery. Fifty-nine percent of cardiologists said it had become harder to find a surgeon to operate on their most severely ill patients.”
Attempts to legislate professional behavior conforms to one rule above others: the Law of Unintended Consequences. With surgical report cards, surgeons improved their numbers by avoiding those patients at high risk of peri-surgical mortality. Other P4P efforts are at risk for similar repercussions. In that innovation strays from “accepted” care, those doctors and institutions who attempt to advance care will have to suffer financially until performance measures catch up. On the other hand, if physicians can collect incentive payments for maintaining the status quo, why would they “push the
envelope?”
References
1. Dirschl DR, Goodroe J, Thornton DM, Eiland GW. AOA Symposium: Gainsharing
in Orthopaedics: Passing Fancy or Wave of the Future? J Bone Joint Surg Am. 2007; 89:2075-2083.
2. Healy WL. Gainsharing: a primer for orthopaedic surgeons. J Bone Joint Surg Am.
2006; 88:1880 -1887.
3. Teuscher D. Point/counterpoint: gainsharing raises more concerns than benefits.
AAOS Bull. 2006;54:38,43. Available at:
http://www2.aaos.org/aaos/archives/bulletin/feb06/feature4.asp.
4 Bono CM, Lee CK. Critical analysis of trends in fusion for degenerative disc disease over the past 20 years: influence of technique on fusion rate and clinical outcome.
Spine. 2004;29(4):455-463; discussion Z5.
5. Thornton DM, Weinreich G, Cavalier GM. Gainsharing: regulatory breakthrough but
challenges remain. Bureau of National Affairs Health Care Fraud Report. 2005;9:1-16.
6. Office of the Inspector General. Department of Health and Human Services. OIG Advisory Opinion. No. 01-01. 2001;Jan 11. Available at:
http://www.oig.hhs.gov/fraud/docs/advisoryopinions/2001/ao01-01.pdf.
Accessed Jun 24, 2006.
7. Imparato AJ. Testimony before the Subcommittee on Health of the US House Committee on Ways and Means, Hearing on Gainsharing Agreements. Oct 7, 2005. Available at: http://waysandmeans.house.gov/hearings.asp?formmode=view&id=3921.
Accessed: Apr 2, 2006.
8. Office of the Inspector General. Gainsharing arrangements and CMPs for hospital payments to physicians to reduce or limit services to beneficiaries. Special Advisory
Bulletin. 1999;July. Available at: http://oig.hhs.gov/fraud/docs/alertsandbulletins/gainsh.htm.
9. Peterson RN. Is gainsharing ethical? AAOS Bull. 2006;54:34-35.
Available at: http://www2.aaos.org/aaos/archives/bulletin/feb06/feature2.asp.
10. Halsey DA. Gainsharing: what, how, whyand why not? AAOS Bull. 2006;54:36,43.
http://www2.aaos.org/aaos/archives/bulletin/feb06/feature3.asp.
11. American Academy of Orthopaedic Surgeons. Position statement: gainsharing. 2006;Sep. Available at: http://www.aaos.org/about/papers/position/1171.asp.
Accessed: Oct 10, 2006.