Medicare and other third-party payers have started predicating reimbursement on adherence to standards of care. Post hoc chart reviews have resulted in substantial take-backs for failure to adhere to those values in cardiology, pulmonology and expanding to other areas. Outpatient medicine is also being subjected to such scrutiny.
The question of standards and who sets them can be debated. After all, the product of a committee may not fully reflect the intent/perspectives of its members. The result is sometimes a range for such matters as monitoring medication safety. Such is the case with respect to disease-modifying anti-rheumatic drug (DMARD) safety surveillance.
The published safety surveillance range is one to three months, the latter representing the longest interval that the American College of Rheumatology and the 3E (Evidence, Expertise, Exchange) Initiative committee members recognized as safe—although most favored monitoring at the shorter interval.1,2 At some point, the insurance industry will demand adherence to that standard for DMARDs, as the legal system already has in malpractice cases.3
Prescribe & Monitor
Primary care physicians receive very little training/experience in musculoskeletal disease during medical school and postgraduate education, even less in how to prescribe and monitor medications in a manner that minimizes patient risks.
Does a rheumatologist new to a region or a facility have the responsibility to educate colleagues or should they simply modify their practice habits (related to their specialty by compromising standards) to fit in? Might acquiescing to an area’s practice habits (e.g., performing medication safety evaluations at six-month or yearly intervals and by performing incomplete examinations) be considered a form of Stockholm syndrome? And is it not another form of response to bullying to acquiesce to compassionate demands (e.g., it’s inconvenient for the patient to be seen more than twice a year, or the patient does not want to pay for more frequent visits)? And they are demands. We should not assume that patients and their families who talked/bullied a physician into monitoring outside of established standards will have compassion for the physician when morbidity or mortality results. The courts are replete with malpractice cases filed after a physician failed to follow medication monitoring standards.
Adherence to standards of care provides a safety net for both patients and physicians.
Patients with psoriasis were recognized early on to be at risk for hidden liver disease when treated with DMARDs. Request for liver biopsy after 1,500–2,000 mg cumulative methotrexate dosing is the standard of care, a standard more recently found appropriate for all patients receiving methotrexate. When a patient is found with cirrhosis (despite history of normal liver function tests), we all feel bad, so much more so when it could have been prevented by timely liver biopsy.
Standards are there because we practice in an environment of evidence-based medicine. That approach saves lives and is at the heart of rheumatology—attention to the restoration and preservation of the quality of life.
Why Deviations from the Standard of Care Occur
When physicians are unfamiliar with standards of care, it’s also the patient’s dilemma. When informed of the need for monitoring, the patient may feel it’s excessive and, appropriately, ask their primary care physician. The primary care physician, being unaware of the standards and not discussing the matter with the rheumatologist, may not support that rheumatologist’s approach. Thus, the patient may feel caught in the middle between two physicians. Or the patient may perceive the monitoring as inconvenient or expensive.
Of course, expenses do pale when compared with the fiscal and health (morbidity and mortality) expenses of late discovery of medication-induced pathology (e.g., liver or kidney failure). So convenience seems a poor rationale for deviating from standards of care. But what of expense?
As insurance companies raise co-pays, office visits become an additional expense, although a lot less than the cost of treating side effects discovered late. What co-pay amount is a burden? Perhaps the following anecdote will provide insight:
A 23-year-old woman presented with rheumatoid arthritis. Examination revealed a subtle breast mass. Her primary care physician had told her that “it was not significant.” I was sufficiently concerned to immediately send her for a mammogram. The mammogram documented cancer.
She had surgery and chemotherapy. The latter also brought her rheumatoid arthritis into remission. When chemotherapy wore off, her rheumatoid arthritis became active again. Specific treatment was initiated, with remission established. Subsequent evaluations were at three-month intervals to ensure regimen safety.
One day, she informed me that she had changed insurance. Her rheumatology co-pays would now be $10 more per visit. She recognized that my conscientiousness had saved her life. But she wanted to save the additional $40/year that came with the monitoring.
Adherence to standards of care provides a safety net for both patients & physicians.
Do limitations, such as high premiums, represent practice of medicine by non-physicians? Perhaps, insurance-related impediments should be examined as representing insurance company co-liability. And of course, patients with chronic diseases that require monitoring need to consider the additional cost of appointments and tests when choosing their insurance companies.
What about the other components of safety surveillance appointments—work schedules and travel expenses? The Americans with Disabilities Act should address the former. Insurance companies have the obligation to ensure access to the care for which they claim access and, if travel is required (because of the location of their network physicians or lapses in that network), should that not be their responsibility? Perhaps this represents a future matter for regulatory agency consideration.
Summing Up
When habit and evidence collide, the outcome appears to depend on commitment to the conscientious practice of medicine that defines and maintains its quality. Health outcome and medical–legal exposure are, of course, tempered by susceptibility to bullying by those committed to convenience and area habits. R
Bruce Rothschild, MD, is professor of medicine at Northeast Ohio Medical University and provides rheumatology services at the Indiana Regional Medical Center. He is a Fellow of the American College of Physicians, the ACR and the Society of Skeletal Radiology and was elected to the International Skeletal Society.
References
- Kremer JM, Alarcón GS, Lightfoot RW Jr., et al. Methotrexate for rheumatoid arthritis. Suggested guidelines for monitoring liver toxicity. American College of Rheumatology. Arthritis Rheum. 1994 Mar;37(3):316–328.
- Visser K, Katchamart W, Loza E, et al. Multinational evidence-based recommendations for the use of methotrexate in rheumatic disorders with a focus on rheumatoid arthritis: Integrating systemic literature research and expert opinion of a broad international panel of rheumatologists in the 3E Initiative. Ann Rheum Dis. 2009 Jul;68(7):1086–1093.
- FindLaw for Legal Professionals.