Older Patients Need Additional Informed Consent Consideration

By Anne M. Menke, RN, PhD

OMIC Risk Manager

Digest, Fall 2010

To view the tables referred to, go to http://www.omic.com/new/digest/DigestFall_20110107.pdf

Older patients make up a significant portion of the patient population of most ophthalmologists, and their numbers will grow as life expectancy increases. At the recent American Academy of Ophthalmology meeting in Chicago, an ethics symposium addressed the challenges of obtaining informed consent from older patients. The panelists have agreed to allow OMIC to present some of their comments and suggestions here, particularly those related to aging, decision-making capacity, surrogate decision makers, and cognitive impairment.

Take the Impact of Aging Into Account

OMIC Director, Harry A. Zink, MD, speaking from the perspective of an ophthalmologist, pointed out that certain aspects of the physical condition of older patients impact the care and consent process. These include declining vision, hearing, and memory, as well as cognitive disorders such as dementia. Providing for the needs of these patients comes when many practices are already struggling with time constraints, so ophthalmologists will need to come up with a smarter process of care. Dr. Zink suggests enlisting staff and family members, repeating information and instructions, and providing them in writing, using large print whenever possible. Focus on a few main points and confirm understanding by asking the patient to repeat these main points. Ask a family member to be present during consent discussions, and ensure that decisions made by surrogate decision makers truly reflect the patient’s wishes.

Evaluate the Patient’s Decision-Making Capacity

Representing OMIC, I presented the medicolegal aspects of consent. Physicians know they have a legal obligation to inform patients of their condition, as well as the risks, benefits, and alternatives of the proposed treatment, including no treatment. If patients do not feel that surgeons have fulfilled this duty, they—as plaintiffs—may sue for “lack of informed consent.” To succeed, they must prove that the ophthalmologist did not inform them of the risks, benefits, and alternatives, AND that they would have refused treatment if advised of the risks. Plaintiff attorneys have alleged lack of informed consent on the basis that patients did not have adequate time to make an informed decision or the information on which to base it. Additionally, they have claimed that patients were under the influence of mind-altering medications that impacted their judgment. Attorneys representing older patients may challenge the patient’s ability to make an informed choice. Consider this scenario reported to OMIC by an oculofacial plastic surgeon.

A 70-year-old patient, accompanied by a man she identified as her boyfriend, requested a facelift. Her ophthalmologist determined that she was an appropriate candidate, clarified her goals, and obtained her informed consent. By the time the preoperative nurse called her to review the physician’s orders, the patient could not recall that she was having surgery. The nurse determined that the problem was not simply a matter of forgetfulness. Before the nurse could contact the surgeon, the boyfriend called her to assure her that the patient remembered the surgery and still wanted to proceed. After hearing from the nurse, the ophthalmologist contacted OMIC’s Risk Management Hotline.

While judges determine a person’s competency, physicians use their clinical skills to decide if a patient has “decision-making capacity” or DMC. Adult patients are presumed to have DMC if they understand their condition and the risks associated with the recommended procedure and are able to communicate their wishes. The oculofacial surgeon andI discussed the need to re-examine the patient to determine if she had decision-making capacity and whether there were signs of elder abuse. If the patient’s confusion persisted, the surgery would need to be cancelled.

Surrogate Decision Makers

If a patient lacks DMC, a surrogate decision maker must be found to make the informed consent decision before surgery is allowed to proceed. States recognize that some patients may temporarily or permanently lose their ability to make decisions on their own behalf and have developed mechanisms for determining who may decide in the patient’s stead (see this issue’s Hotline column).

Distinguish the Effects of Aging from Dementia

Patients who lack DMC, especially if they previously demonstrated it, need further evaluation. If you think the cause of the cognitive impairment is Alzheimer’s, you would be right about 60% of the time, according to Chicago gerontologist Dr. Shellie Williams. As the proportion of the u.S. population age 65 and older increases, the prevalence of dementia (the general term for a decline in cognitive functioning) will also increase. In 2009, there were approximately 5.3 million patients with Alzheimer’s, with a new diagnosis rendered every 70 seconds. Researchers estimate that Alzheimer’s disease (AD) and other dementias affect approximately 5% of individuals age 65 and older and as many as 30% to 40% of individuals age 85 and older. In the absence of effective treatment to prevent AD, 8.5 million Americans may have this disorder by 2030.1

Far from a routine part of growing older, dementia is a progressive, terminal disease of the brain that destroys brain cells. (See WHAT’S THE DIFFERENCE?2) Dr. Williams explained that many diseases cause dementia, including Alzheimer’s, Parkinson’s, Lewy Body, and vascular disorders. Dementia increases the morbidity and mortality of other diseases and the risk of adverse events, and limits the patient’s ability to follow medical directions and consent to care. The disease burden is significant: despite care totaling $148 billion, and the unpaid assistance of some 9.9 million caregivers, Alzheimer’s is the sixth leading cause of death, Dr. Williams reported. Dementia is present when memory issues are accompanied by a decline in at least one other area, such as language, motor skills, recognition, or executive function (performance of complex tasks or judgment/reasoning). The combined impairment degrades the patient’s baseline cognition and functioning and leads to a decreased ability to care for oneself and live independently.

Screen for Cognitive Impairment

Clues that a patient needs to be screened for dementia include poor control of a previously controlled medical condition as well as many of the attributes of “difficult patients,” i.e., missed appointments, failure to refill a medication, change in behavior, and disheveled appearance. According to Dr. Williams, dementia is routinely unrecognized and undiagnosed despite its growing prevalence. Physicians were unaware of cognitive impairment in more than 40% of their cognitively impaired patients. Only 24% of patients had a documented diagnosis of dementia, even though their screening exam demonstrated moderate to severe dementia.

Family members failed to recognize a problem with memory in 21% of demented seniors. As many of those who did notice a change attributed it to the normal aging process, only 53% of seniors with memory problems were referred to a physician.3

Family members can help the ophthalmologist determine if there is cognitive impairment. Dr. Williams suggests asking them the following questions about the patient: Does your family member repeat questions? Forget words or names? Have poor recall of familiar people and places? Fall often? Have difficulty taking medications? Talk less? Show poor judgment? Wander? Have trouble using tools and appliances? Misplace items? Seem irritated, angry, or aggressive?

In addition to getting input from family members, physicians can use screening tools. Dr. Williams presented two brief screening methods, either of which can be utilized by ophthalmologists in a matter of minutes. The first is called the “Mini- Cog.” Ask the patient to repeat and remember three words: BALL-FLAG- TREE. Next assign the clock-drawing task (CDT). Ask the patient to draw a clock with the hands set for ten after eleven. Once the clock is drawn, ask the patient to recall the three words. The CDT is considered normal if all numbers are present on the clock in the correct sequence and position and the hands readably display the requested time.4 Abnormal clocks will be missing quarters or have bunched, repeated, or missing numbers. Each word the patient remembers is worth a point, and the CDT is scored as either normal or abnormal. (See MINI-COG SCORING ALGORITHM.)

The second possible screening test is called the “Six-Item Screener.”5 Short-term memory deficit is a hallmark of dementia. The authors chose to target disorientation in three of the questions, specifically temporal disorientation (problems recalling the day of the week, month, and year) since it occurs before disorientation to place and is rarely seen in those not experiencing dementia. Three-item recall helps to identify patients with cognitive impairment. Here is the script: “I would like to ask you some questions that ask you to use your memory. I am going to name three objects. Please wait until I say all three words, then repeat them. Remember what they are because I am going to ask you to name them again in a few minutes. Please repeat these words for me: APPLE-TABLE-PENNY.”5 The physician may repeat the names three times if necessary; the repetition is not scored. The script continues: “What year is this? What month is this? What is the day of the week? What were the three objects that I asked you to remember?” Each correct answer is worth a point. A score of ≤ 4 points is considered positive for cognitive impairment.

Arrange Additional Care for Cognitively Impaired Patients

Patients with a positive screening test for cognitive impairment need additional care. Explain to the patient and family member that the screening test indicates the need for a more detailed evaluation from the patient’s primary care physician or a specialist. Patients with cognitive impairment may exhibit denial or feel that treatment would be futile. Explain that there are many conditions that can cause cognitive impairment and that earlier treatment affords the best chance for optimal functioning. In addition to documenting your assessment and discussion, contact the PCP’s office to schedule an appointment for the patient, and send a referral note with the screening results.

Even with cognitive impairment, patients need to continue to treat their eye conditions. Review and simplify the patient’s medication regimen. Provide medication and care instructions both orally and in writing in simple terms. Involve family members and friends in the patient’s home care whenever possible. Evaluate the patient’s ability to drive.6 Alert staff to the patient’s status so additional time can be provided for appointments and education, if needed. Taking these extra steps to obtain consent and screen for cognitive impairment will help patients and their families meet the considerable challenges of aging and dementia.

1. “Alzheimer’s Disease.” http://www.alz.org/ national/documents/topicsheet_alzdisease.pdf. Accessed 12/3/10.

2. Alzheimer’s Association. “Ten Warning Signs of Alzheimer’s.” http://www.alz.org/national/documents/ brochure_10warnsigns.pdf. Accessed 12/3/10.

3. Chodosh J, Petitti DB, Elliott M, Hays RD, Crooks VC, Reuben DB, Buckwalter JG, Wenger N. “Physician Recognition of Cognitive Impairment: Evaluating the Need for Improvement.” J. Am Geriatr. Soc. 2004; 52(7): 1051-9.

4. Borson S, Scanlan J, Brush B, Vitaliano P, Dokmak A. Int. J. Geriatr. Psychiatry. 2000; 1021-1027.

5. Callahan CM, Unverzagt FW, Jui SL, Perkins AJ, Hendrie HC. Medical Care. 2002; 40: 771-781.

6. See “Visual Requirements for Driving” on the AAO’s web site (www.aao.org). The 2010 edition of the American Medical Association’s Physician’s Guide to Assessing and Counseling Older Drivers includes a 10-minute tool called the “Assessment of Driving-Related Skills,” which screens for problems in cognition, vision, and motor/somatosensory functions that may affect driving (www.ama-assn.org).

Payment Issues: Avoid Delays in Treatment

Hans Bruhn, MHS, OMIC Senior Risk Management Specialist

Digest, Winter 2011

By the time a patient is referred and examined by an ophthalmic specialist, he probably has already been seen by a primary care physician and a general ophthalmologist. Most health insurers require patients to go through a referral process before they can be seen by a specialist. This can be problematic if the patient’s eye condition requires rapid diagnosis and treatment by the specialist. Critical care can also be delayed when patients do not have health insurance and cannot pay out of pocket for these services. When delays in critical care result in less than desired or poor outcomes, some patients will file a claim against the specialist and all referring health care providers, alleging failure to provide timely treatment.

Q  Can I withhold care because of a patient’s inability to pay (including co-pays)?

A  This is always a tricky situation. Ophthalmologists may be required to collect co-pays or deductibles by third party insurers. If emergent care is needed, we recommend separating payment issues from decisions about care. Proceed with providing as much care as possible and sort out the financial issues after the patient is stable. This will avoid delays in treatment and reduce the risk of a claim. Notify the insurance company of the urgent care situation and the patient’s inability to pay the co- payment. The insurance company may allow you to waive the co-payment; however, waiving fees without first checking with the insurer can jeopardize your provider contract. You should make a reasonable effort to work out a payment plan with the patient; document your efforts and the results.

You may have less control over the situation in a surgical facility or hospital setting that requires payment up front as a condition of admission. But before you send the patient elsewhere, act as the patient’s advocate. Explain to the facility the urgent nature of the required treatment and ask if it will work out a payment plan with the patient. If not, promptly refer the patient to another facility that may be willing to do so. If all attempts fail, it may be necessary to refer the patient to the local emergency room, where federal law mandates that treatment be provided. Throughout this process, keep the patient informed about your efforts on his behalf. This will help reduce the likelihood that you will be perceived by the patient as withholding care. Document carefully.

Q  During follow-up, I noted that a patient I first saw in the ER needed surgery. Since I am not part of her HMO, I promptly called her primary care physician to secure a referral to a participating ophthalmologist, but the PCP was out of town. What action should I take?

A  Advise the patient about the situation (PCP is not available; surgery is needed and you are not in her insurance provider network). If the patient elects to pay out of pocket, get that in writing and proceed with care. If not, help the patient find another provider to assume care. Contact her HMO directly and request a referral to another ophthalmologist. Once another provider is identified, contact that new physician and facilitate transfer of care along with patient authorization and your recommendation for surgery. Advise the patient of your actions and document accordingly.

Q  A patient that I have been treating since June 2008 has developed a serious corneal ulcer (OS), possibly fungal. I prescribed Natamycin drops, but the patient has not gotten the drops and has canceled follow-up appointments because of the cost. The patient is blind in his right eye, and now his left eye is compromised with this serious condition. Am I obligated to continuing seeing him?

A  Contact the patient and tell him of your concern. Explain that many patients are having trouble affording care and ask if his financial situation is keeping him from getting the care he needs. Advise him of the seriousness of his eye condition, including the consequences of not using the drops you prescribed and not coming in for exams. Given the urgency of the situation in this functionally monocular patient, encourage him to come in to see you so you can conduct an exam and provide care, including drops, if possible. If the patient is still reluctant to see you, ask if there are any relatives to assist him. Offer to set up a payment plan for incurred medical expenses. As a last resort, advise the patient to go to the nearest emergency room for care. If the patient refuses, document your discussion and send a letter reiterating your recommendations and explaining again the consequences of not getting care. If the patient does not respond to your discussions and letter, consider sending OMIC’s “noncompliance” letter, which gives the patient one last chance to come in for care before the physician-patient relationship is terminated.

Contact OMIC’s Risk Management department for assistance or visit our web site, www.omic.com, for our recommendation “Discontinuing Treatment for Financial Reasons and Noncompliance Guidelines.”

Message from the Chairman

My biggest concern as a physician,

and one shared by most clinicians, is that a decision made or a procedure performed results in harm to a patient, leading to pain and suffering, and perhaps adversely affecting quality or length of life. Most patients understand and accept the reality that events occur in the practice

of medicine that fail to salvage vision or restore function. However, patients do not give consent to procedures expecting that they will result in loss of sight, loss of the eye, or injury. Fortunately, such events are rare. After experiencing an adverse outcome, an honest surgeon will ask himself or herself privately, “Did I do something to cause this? Was this my fault? Did I make a mistake? What if I had done things differently?”

Patients who have been harmed, their friends, and family members ask the same questions. Their assessment and answers to those questions are the basis of medical liability claims. It is left to the courts and juries to determine if the complication results from “malpractice” as defined by the courts. All too often, an acceptable complication that occurs in the normal conduct of medical practice results in a claim, particularly when there is observable physical damage, pain and suffering, or financial loss. Physicians may feel cheated if a settlement is paid out when they are certain that everything was done correctly and within acceptable standards of care. However, one can’t escape the reality that a patient lost an eye or vision, suffered a stroke, or passed away in the course of treatment. Even when an adverse outcome is the result of maloccurrence, not malpractice, juries often take the approach that someone has to pay. That “someone” is usually the professional medical liability insurance carrier, which provides protection for physicians both when there is clear evidence of wrongdoing and when there is a settlement in the absence of malpractice. This coverage provides a safety net for patients who have been harmed and protection for the physician’s assets.

When a claim comes in to OMIC, investigation and defense of the claim falls to the claims department headed by Mary Kasher, MSN, JD. Insureds are familiar with OMIC’s outstanding claims history: average indemnity 18% lower than average ophthalmology indemnity reported by other carriers; 79% of cases closed with no indemnity payment; expense per closed claim 30% below industry average; 85% win rate at trial. This remarkable record reflects Mary’s experience and direction and the dedication and skill of senior litigation analysts Ryan Bucsi, Richard Isom, Stacey Meyer, and Randy Morris. This team of claims specialists serves as the intermediary between the attorney and doctor, supervising each claim in their respective geographic jurisdiction and leading each ophthalmologist through the litigation process from beginning to end.

Mary’s biggest challenge has been finding outstanding attorneys in each of the 49 states where OMIC insures ophthalmologists and educating them about the specialty so they could knowledgeably and skillfully defend insureds.

Mary’s approach to claims defense is shared by the OMIC Board and senior leadership: If a doctor is not negligent, provide the best defense possible, and settle those cases that need to be settled early and fairly.

John W. Shore, MD Chairman of the Board

Message from the Chair/CEO

John Shore, MD 

This summer I was flying on Southwest Airlines and picked up the June issue of Spirit, the magazine published by the carrier. It contained several articles celebrating the airline’s 40th anniversary. The lead article, “40 Lessons to Learn from Southwest,” intrigued me. Each lesson was a vignette on an aspect of the company that senior management felt was important to its success. As I was reading, I realized that several lessons could be applied to OMIC’s success.

 Target the overcharged and underserved. OMIC helped lower malpractice premiums in many states where ophthalmologists were subsidizing higher risk specialties.
The Web ain’t cool, it’s a tool. OMIC was an early adapter of web technology as a vehicle to disseminate risk management documents to a nationwide audience of policyholders. Every year, thousands of risk management documents are accessed through OMIC.com.

See your business as a cause. Not only does OMIC provide liability insurance, it partners with the American Academy of Ophthalmology and other ophthalmic organizations to improve quality of care for ROP, LASIK, and other eye care services ophthalmologists provide.

Beware of imitators but take them as a compliment. Many other insurance carriers have adopted OMIC’s underwriting guidelines and use our risk management information for their insured ophthalmologists.

In 2012, OMIC will celebrate its 25th year of providing professional liability insurance for members of the American Academy of Ophthalmology and risk management education for ophthalmologists worldwide. OMIC has enjoyed phenomenal growth and success during its 25-year history that parallels Southwest Airlines in certain respects.

Of course, OMIC doesn’t compare in size and capitalization to Southwest Airlines, yet there are similarities worth mentioning. Both companies were started in response to unfavorable market forces and a desire to provide an alternative to existing providers in their industry. Both companies struggled in the beginning to overcome tremendous roadblocks to success. Both companies stuck to their core principles and goals and grew the company from within under the direction of dedicated leaders and the support of loyal employees. Both companies had strong, intuitive, and tenacious executive leadership. In the case of Southwest, it was Herb Kelleher and Rollin King who directed its early growth and established its corporate branding. In OMIC’s case, Bruce Spivey, MD, and Reggie Stambaugh, MD, were the glue that held the company together through the early years. They established the corporate structure that would blend the company’s board of directors and staff into a successful team.

Southwest Airlines and OMIC have earned the respect and loyalty of a growing customer base and, as a result, both companies have cornered substantial market share within their respective industries. With growth and success comes the responsibility of living up to one’s reputation. And this, I believe, is another goal both companies share.

Finally, Please view my good friend and colleague, Tamara Fountain in this new video by the Academy. A true star indeed!

 John W. Shore, MD Chairman of the Board

RAC Audit. Cyber/eMD Breach. Who Ya Gonna Call?

Robert Widi, VP Sales

The Obama Administration continues to focus energy on fighting fraud & abuse within healthcare under the “Campaign to Cut Waste” established nearly three years ago. By some estimates, the government has recovered $7 in fraudulent payments for every $1 spent on the program so far.  The Department of Justice recovered over $2.8 billion in healthcare fraud in 2011 and began prosecutions for more than $1 billion in newly identified fraudulent claims.

The focus on healthcare fraud is no surprise given the government estimate of $90 billion in fraudulent payments of CMS’s funds each year. Until recently, however, most claims activity has targeted large hospital networks and facilities rather than smaller private ophthalmic practices. But this is changing.

To date, OMIC has recorded approximately 300 claims against our insureds for Medicare/Medicaid and Commercial Payor billing errors (“fraud and abuse”) allegations.

OMIC was one of the first malpractice carriers in the United States to include regulatory coverage within its malpractice policy. Called BRP (Broad Regulatory Protection) and eMD (Cyber Liability and Patient Notification Protection), policyholders are provided with a benefit sublimit that covers billing errors allegations as well as many other regulatory and electronic data liabilities.

Billing allegations covered:

• Billing for services not performed
• Upcoding of services
• Inadequate documentation to support the services provided
• Use of incorrect CPT codes
• Unbundling or fragmentation of services
• Providing medically unnecessary services