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Facials, Fillers, and Physicians: Keeping the “Medi” in Medi-Spa

By Betsy Kelley OMIC Vice President of Product Management

Digest, Spring 2009

Undercover officers in Florida find an unlicensed cosmetologist injecting Restylane and another unlicensed individual performing sclerotherapy at a medical spa. The patients are not seen by a physician, nor are medical exams conducted. The cosmetologist is arrested for the unlicensed practice of medicine and possession of legend drugs with intent to dispense. The medical director is disciplined by the medical board, including a letter of concern, fine, and mandatory community service.1

Another doctor takes over as medical director of a North Carolina medical spa. Before reviewing the spa’s policies and practices, he authorizes the compounding pharmacy to continue supplying a numbing gel used with laser hair removal. Within one month of the doctor’s hiring, a 22-year-old college student dies of poisoning after using the lidocaine she had received from the pharmacy in anticipation of her treatment. The medical director’s license is suspended for six months for failing to ensure that the prescription gel was properly dispensed.2 The former medical director is also charged with unprofessional conduct for setting up the protocols that allowed the clinic to dispense the gel without individual prescriptions and for failing to train staff in its use.3 The resulting wrongful death lawsuit from this case settles for policy limits against each of the multiple defendants.

These publicized incidents illustrate some of the risks physicians take when they establish or agree to serve as medical directors or supervising or prescribing physicians for a medical spa. Physicians must educate themselves about the risks associated with these facilities in order to reduce their likelihood of liability claims, licensure actions, or other adverse consequences. By understanding and addressing these exposures, physicians can not only better protect themselves but also improve patient safety.

Now is the best time to act on this issue. Medical spas are the fastest-growing segment of the spa industry, increasing from 400 medical spas in the united States in 2004 to more than 2,000 by 2007.4 This number will continue to rise. While fewer patients are seeking elective surgery as a result of the economic downturn, many are turning to less expensive substitutes. Patients who previously would have undergone a facelift are now more likely to select skin resurfacing procedures, injections of fillers or Botox, or chemical peels as a more cost-effective alternative. And the lower cost of obtaining these services from non- physician personnel makes medical spas even more attractive. It’s not only patients who are drawn to medi-spas; seeking ways to supplement their declining revenues, some physicians may feel compelled to set up or expand their own medical spa business.

What is a Medical Spa?

A medical spa is a facility that provides a variety of aesthetic medical procedures and traditional spa therapies under the supervision of a physician, generally in a spa-like setting. The spa may be located within a physician’s office, within the physician’s medical building, or in a stand-alone setting. Medical spas may be physician-owned, or depending upon—or in violation of—state laws and regulations, they may be owned by entrepreneurs or franchises. Typically, services are rendered by aestheticians, nurses, or other allied health care professionals under the supervision of a physician who may or may not be on site.

Know the Laws

Although many states do not specifically regulate medical spas, all facilities where medical care is rendered are subject to the same laws and regulations as health care facilities, including those pertaining to corporate ownership and scope of practice. Corporate practice- of-medicine laws determine who must own or supervise the practice, and regulatory boards establish to whom certain activities can be delegated and under what circumstances. Some states may also require that the facility be licensed or certified by the state in which it operates. Other regulations may dictate facility and equipment requirements such as water, restroom, and health and safety requirements. Nonetheless, experts opine that most medical spas today operate in ignorance or violation of these laws and regulations.

Even well-intentioned, law-abiding physicians find scope-of-practice laws complex and confusing, in part because scopes of practice vary widely. Obviously, scope of practice varies among types of licensees within a given state. Physicians moving to a different state may not expect significant differences from state to state for a specific type of licensed practitioner. To make matters worse, different agencies within the same state may take opposing positions.

For example, according to the Alabama Board of Cosmetology, a cosmetologist or aesthetician can inject Botox and dermal fillers under the supervision of an on-site physician. However, that state’s medical board has ruled that cosmetic injections are the practice of medicine and must be performed by a licensed physician. Therefore, while it appears that an Alabama cosmetologist who performs such services under the direction and supervision of a physician would not be sanctioned by his or her licensing board, the supervising physician could be charged with unprofessional conduct and be subject to disciplinary action. When conflicts such as these exist, it would be prudent for the physician to adhere to the most restrictive regulations (see the Hotline for recommendations on how to safely make delegation decisions).

To protect public safety, and provide guidance to practitioners, regulatory boards in some states have established policies clearly defining their position. For instance, several nursing boards have developed policy statements or protocol guidelines regarding aesthetic cosmetic procedures. Other state boards make determinations on a patient-by-patient basis, or provide advice specific to each provider based upon the provider’s training, skills, and experience. Some counsel nursing staff to follow a decision model to determine whether a particular procedure falls within their legal scope of practice. Others indicate that scope of practice determinations will not be made until or unless a complaint against the provider has been filed and even then will depend upon the specific facts of the case.

Managing scope of practice issues is even more complex when one considers that regulations are continually in a state of flux, and new regulations that expand or restrict scope of practice can be passed at any time. Ignorance of local, state, and federal laws and regulations, however, is not an acceptable defense, and failure to abide by them can result in fines, other disciplinary action, or suspension or revocation of licensure. Therefore, it is important for physicians who associate themselves with a medical spa to personally research the applicable requirements and to ensure that the facility is in full compliance. Consult with each of the nursing, cosmetology, physician, and other professional boards as applicable in your state for final governance rules. Establish a policy to review scope of practice laws on a routine basis, perhaps annually or biannually.

Supervision Required

By definition, medical care is part of the practice of medicine, and must be provided by or under a physician’s supervision. This is true regardless of where the care is provided. Thus, while many medical services provided at medical spas can legally be performed by certain types of qualified non- physician personnel, the supervising physician’s role must be evident.

First, the physician must generally prescribe or order medical treatments (see the Hotline for assistance in distinguishing medical treatments that need a physician’s order from cosmetic procedures). In some situations, the physician may also be required to assess and evaluate the patient before ordering the treatment. ultimately, the supervising physician is responsible for the patient and could be held liable for any legal/regulatory violations and patient injuries that occur.

Before procedures can be delegated to non-physician personnel, the supervising physician has a duty to assess the health care provider’s qualifications. The physician should have direct knowledge of each individual’s licensure, training, certification status, knowledge, and experience in each procedure the provider will perform. In addition, the physician should verify that the procedure falls within the provider’s legal scope of practice (licensed staff) or services (unlicensed assistive personnel). No procedure should be delegated to a provider who has not satisfactorily demonstrated current competency in the necessary skills.

In order to adequately supervise the health care providers, the supervising physician must also be competent in each procedure that is performed at the medical spa. Many states have passed laws or regulations stipulating that the supervising physician have the knowledge, skill, and ability to personally perform each procedure. Some states further require that the physician actively perform such procedures in his or her practice.

The minimum level of supervision legally required while the treatment is being rendered varies from state to state and also depends upon the professional designation of the provider who will render services. In some situations, the physician may be required to be in the same room at the time services are rendered; in others, it may be acceptable for the doctor to be elsewhere in the building. In the case of licensed health care providers, the regulatory board may allow the physician to be “readily available,” to be physically available within a specified time frame, or to simply be available by telephone. To increase patient safety, minimize liability exposure, and reduce the possibility of disciplinary action for failing to properly supervise non- physician staff, a qualified physician should be available on site whenever medical services are performed. In addition, the supervising physician should routinely review, date, and sign the medical records. Written protocols clarifying the role and responsibilities of the physician and of non-physician employees will aid in the appropriate delegation of services. Such protocols also provide supporting documentation of the supervision extended should a complaint be filed.

Treat Medical Procedures as Medical Procedures

Members of the public often believe that procedures rendered at medical spas are cosmetic services with guaranteed results rather than medical procedures with risks; they are misled both by having the services provided by non-physician personnel in non- clinical settings and by brochures and advertisements. It is not surprising, then, that patients often fail to understand the risks involved, have unrealistic expectations, and become dissatisfied if complications or side effects occur.

Clients should be treated as patients, and treatments should be handled as the medical procedures they are, regardless of whether services are rendered in a spa or clinical setting, or performed by a physician or allied health care provider. Practically speaking, this means that HIPAA regulations are respected, and a qualified health care provider or physician obtains and documents a medical and medication history and performs a physical examination of each patient before a physician orders treatment. As with any other medical procedure, an informed consent discussion is held with each patient prior to treatment and the patient signs a consent form documenting understanding of the treatment goals and risks. Medical records are maintained that document the initial assessment, course of treatment, informed consent, and postoperative care rendered.

Just as in hospitals, surgery centers, and physician offices, medi-spa facilities and staff be wise to expect and be prepared for the unexpected. While uncommon, serious medical complications and emergent conditions may arise coincident to or as a result of the procedure. Patients have suffered serious burns from laser procedures performed at medical spas and life-threatening allergic reactions to medications. Supply the medical spa with the medical personnel and equipment necessary to monitor patients and deal with any potential complications that may occur. To ensure that patients can obtain prompt emergency care, establish a written transfer agreement with the nearest acute care hospital and train staff on how to respond to an emergency.

Medical spas represent a new source of liability exposure, but the informed physician can minimize risk and improve patient safety by complying with scope of practice and other laws and regulations, providing the appropriate level of supervision, and recognizing that the services rendered are medical procedures subject to the same guiding principles as other medical services.

1. State of Florida Department of Health, DOH Case No. 2007-08728.

2. Avery S. “N.C. board suspends spa doctor.” The News & Observer, September 9, 2005. Retrieved April 21, 2009.

3. Shimron Y. “Doctor linked to numbing-gel death reaches deal.” The News & Observer, August 16, 2007. Retrieved April 21, 2009.

4. “Deadly Beauty Treatments.” In Prevention, March 8, 2007. Retrieved April 21, 2009 from http://www.prevention.com/cda/article/deadly-beautytreatments/46d268f271903110VgnVCM10000013281eac____/lifelong.beauty/anti.aging.arsenal/cosmetic.procedures.

Contact the following resources for additional information about medical spas:

The International Medical Spa Association, www.medicalspaassociation.org.

“The Bottom Line: The Business of Medicine–Medical Spas,” Medical Board of California, http://www.medbd.ca.gov/licensee/medical_spas-business.pdf.

Risk Management Issues in Failure to Diagnose Neurologic Illnesses

By Jean Hausheer Ellis, MD, FACS

Digest, Spring, 1994

 Although it occurs infrequently, failure to diagnose ophthalmic-related neurologic diseases exposes the practicing ophthalmologist to significant malpractice risk because neurologic diseases tend to be associated with permanent disability and even death.

A computer search of 3,000 ophthalmology claims in the Physician Insurers Association of America’s (PIAA) data base turned up only 15 closed claims alleging failure of an ophthalmologist to diagnose a neurologically related disease. These 15 claims showed the patients’ conditions to be distributed as follows: tumors of the pituitary gland or other endocrine tumors and surrounding nerves or tissue, 8 claims; tumors of the thyroid gland, 6 claims; tumors of the nerves or tissue surrounding the eye, 1 claim. (See box)

Of 15 PIAA closed claims alleging failure of an ophthalmologist to diagnose a neurologically related disease, 8 involved the pituitary glad and other endocrine tumors, 6 involved tumors of the thyroid gland, and 1 involved a tumor of the nerves or tissue surrounding the eye.

15 PIAA closed claims

All 15 claims allege that the patient’s condition was not diagnosed during an eye examination. Seven of the 15 resulted in an indemnity payment to the plaintiff. The average indemnity paid in these cases ($221,071) exceeded the average settlement for all ophthalmology claims by more than $100,000.

Nearly one quarter (3 of 13) of OMIC’s large loss payments (payments of over $100,000 to the plaintiff) have resulted from claims related to failure to diagnose an ophthalmic-related neurologic illness. The following lawsuits, culled from OMIC’s closed claim files, are instructive from a risk management standpoint because they illustrate the various ways an ophthalmic-neurologic claim can arise in an ophthalmologist’s practice and the different factors that contribute to these types of malpractice claims.

Case One: Pituitary Chromophobe Adenoma

The first case involved a 50-year-old male, who held two jobs to support his wife and three children. He was referred to an ophthalmologist (Ophthalmologist ##1) after complaining to his family practice physician that he was having difficulty with his vision. Ophthalmologist ##1 found normal vision, but did formal visual fields because of suspected glaucomatous cupping. Although not definitive, the fields were interpreted as possible early glaucoma, and the patient was started on Beta-blocker glaucoma drops. He was followed up one more time, and found to have excellent IOP control with therapy. A year later, the patient left the care of Ophthalmologist ##1 and was referred elsewhere by his family practice physician.

The family practice physician referred the patient to Ophthalmologist ##2 who diagnosed bilateral pterygiae. Because of the previously diagnosed glaucoma, a screening visual field was obtained of the left eye, but the patient was unable to complete the right eye field that same day. There was no chart documentation of visual field interpretation by the ophthalmologist, or discussion of these findings with either the patient or the family practice physician. Previous visual fields were obtained from Ophthalmologist ##1 but no comparisons or record reviews were documented. Formal visual testing OU was repeated several months later by Ophthalmologist ##2, but again the chart reflected only the technician’s notes of the testing. The patient continued using the glaucoma drops, but did not keep all his follow-up appointments because of his work hours.

Six months later, the patient was seen in the emergency room for complaints of severe headaches, for which he was admitted and discharged the same day. These headaches were felt by the ER physician to be migrainous. The next morning, the patient was found unconscious at his home and was taken back to the hospital, where he died the next day from subarachnoid hemorrhage related to a large pituitary chromophobe adenoma.

Lawsuit Targets Two Ophthalmologists

A lawsuit filed by the patient’s wife and three children named the family practice physician, the emergency room physician and the two ophthalmologists. The ER physician settled out of the case and paid nothing based upon a strong causation defense that, by the time the patient came to the ER, it would have been too late to operate anyway since surgery or radiation therapy are only effective before the lesion hemorrhages. The family practice physician settled for approximately $100,000.

The main targets of the lawsuit were the ophthalmologists, primarily Ophthalmologist ##2. Ophthalmologist ##1 paid approximately $100,000 to settle the lawsuit. Ophthalmologist ##2 was felt to have greater exposure than ##1 because he had consecutive visual fields that showed the evolving bitemporal hemianopsia. Expert witnesses and consultants in the case described the visual fields taken as showing “classic” signs of a pituitary tumor. Ophthalmologist ##2 paid more than $750,000 to settle the lawsuit against him. Total settlement by all parties in this case was approximately $1 million.

Close review of the formal visual fields show combined arcuate glaucomatous changes and bitemporal hemianopsia, as typically seen with pituitary tumors. The past history of glaucoma may have contributed to the misinterpretation of the visual field changes which, when compared with previous bilateral fields, clearly showed the progression of the bitemporal hemianopsia. While Ophthalmologist ##2 testified that he reviewed the fields and compared them, there was no record or documentation to support his testimony. Nor was there any communication to either the patient or the family physician regarding test results or contemplated follow-up.

Another problem in this case related to the patient being lost to follow-up. No system existed in the ophthalmologist’s practice for tracking patients who missed appointments, such as a recall card, telephone call from a staff member, or other form of communication to the patient or the referring physician, to inform them of the need for return testing and examinations.

Case Two: Giant Cell Temporal Arteritis

The second case involved a 67-year-old female who presented with complaints of extreme fatigue, loss of appetite, nausea, febrile illness, nasal congestion and purulent rhinorrhea. She also complained of migraine-like headaches across the forehead, and bilaterally down her face. She was treated for a viral syndrome and briefly hospitalized by her internist, who noted only slight improvement of the symptoms upon discharge.

The headache, fatigue, loss of appetite and nasal congestion persisted for another month, which the internist attributed to a prolonged viral illness. After experiencing these symptoms for six weeks, the patient went to the emergency room where she was treated for sinusitis, and given instructions to see the internist for follow-up. The patient returned to the internist as instructed with complaints of nausea and vomiting, persistent headache and neck pain as well as shoulder and calf pain. She was admitted to the hospital by the internist the same day for an ENT consultation, which confirmed acute sinusitis. Sinus surgery was scheduled for the next day.

During her hospitalization, the patient complained to her nurse of blurred vision in her left eye and a loss of vision for 2 to 5 minutes on the left side, immediately following the sinus surgery. Neither the patient nor the nurse informed the doctors of the 2 to 5 minute loss of vision and the nursing notes reflected only the persistent complaints of blurred vision and headache throughout the patient’s stay.

A routine ophthalmology consultation was obtained the day after surgery for “blurred vision.” The ophthalmologist took the history of blurred vision in the left eye, and obtained the patient’s description of seeing a “tree” in her left field of vision. No one explained to the ophthalmologist that the patient had been hospitalized at a different facility a month earlier, or that an elevated sed rate measuring 72 had been drawn at that time. Vision was found to be 20/80 in each eye at bedside, with normal IOP OU, and dilated fundus examination showed mild bilateral macular edema, which the ophthalmologist attributed to the recent sinus surgery. He recommended follow-up in his office upon discharge four days later.

Once at home, on the day of discharge, the patient told her husband she could no longer see out of her right eye. They immediately called the ophthalmologist, who instructed them to come in. He correctly diagnosed temporal arteritis.

At first, the patient refused to travel to a neighboring academic facility in another city for treatment. She was immediately started on 80 mg of oral prednisone and photographs were taken to document the fundus findings. The next day, the patient finally agreed to go to the recommended academic facility. Upon arrival there, she was placed in the Trendelenburg position and started on a high dose of I.V. methylprednisolone in an effort to salvage vision. A temporal artery biopsy confirmed the suspected diagnosis of giant cell arteritis.

Treatment was of minimal effect and the patient remains legally blind with Count Fingers vision OU. Unfortunately, there was no communication back to the referring ophthalmologist by anyone at the academic facility, nor did the referring ophthalmologist follow up with the patient.

A lawsuit was filed, naming the ophthalmologist, the primary care physician and the hospital nurse. The nurse settled out of court for $50,000, with the internist mediating for a total of $250,000. The ophthalmologist settled for $100,000, for a total settlement of approximately $400,000.

The nurse in this case was an important party because she claimed she had never heard of temporal arteritis before. At the time, it did not particularly concern her that the patient complained of a temporary loss of vision and continued bilateral blurred vision.

The controversial clinical issue in this case was the elevated sed rate. Expert opinions noted that a slightly elevated sed rate perhaps one in the 20’s or 30’s could be expected in anyone recovering from influenza. It was felt that the patient’s original sed rate of 72 probably would have been found to be elevated to 115 by the time of her second hospital admission, had it been repeated. Elevated sed rates should be followed and repeated to evaluate their rise and fall, to clinically correlate their course and to evaluate their suspected cause.

A second point of contention in this case concerned the role of the consulting ophthalmologist, who was expected to evaluate the overall clinical picture as well as the specific reason for being called in to see the patient. In addition to evaluating an ophthalmologist’s specialty training in the diagnosis and treatment of diseases of the eye, juries will consider whether a defendant-ophthalmologist’s overall training as a physician (i.e., medical school and internship) was applied to treating and assessing the causes of the patient’s ophthalmic illness.

Risk Management Suggestions

Both cases raise several liability issues and point out steps an ophthalmologist can take to reduce liability exposure to these types of claims. These measures include:

  • Have a system for reviewing incoming records and making notations in the chart. Consider reviewing incoming records in detail and outlining the crucial elements, making comparisons with your own records. Document that you did so in the patient record.
  • Always record interpreted visual fields in the patient record. Consider calling the patient back with the test results, or send a quick note. Include follow-up and medication schedules. Send the results to the referring physician.
  • Develop a system for follow-up of missed appointments, making sure that all “no shows” are brought to the physician’s attention. All follow-up efforts should be documented in the patient’s medical record.
  • Set aside all patient charts from the day’s appointments for quick review at the end of each day. Flag charts that you want to take a closer look at or to discuss with your partner or colleague. This is a good time to review missed appointments and prescription refills for that day.
  • When in doubt about a clinical finding, consider bringing the patient back for a “second look” when you are able to set aside time for an extended appointment to review the situation in greater depth.
  • Establish and maintain good patient communication skills. If a problem does develop, keep in contact with the patient and referring physicians. Be as caring, concerned and compassionate s possible. Do not give false assurances or guarantees, but take the time to be a good listener.

Conclusion

As observed in the above cited cases, the ophthalmic neurologic claim can be fairly complex and difficult to anticipate, and can arise in a variety of settings and circumstances. These patients could have entered any practicing ophthalmologist’s care. Although, in retrospect it may be easy to identify the problem areas contributing to these claims, neuro-ophthalmic diagnosis and correct management often remains an enigma. Unfortunately, the consequences of delay are uniformly severe.

Headaches, Jaw Pain and Missed Thrills

By Sharon Kuritzky, MD

Digest, Winter 1998

Sudden loss of vision, headache and a painful temporal artery in an elderly patient – bells ring! Temporal arteritis? But first ask yourself, what has this patient been experiencing in the weeks leading up to this crisis? She hasn’t felt like herself; she has headaches; she has lost weight; she thinks her dentures need repair since her jaws hurt; and she calls her ophthalmologist’s office for an appointment because, “My vision is funny. I see double sometimes and it gets blurry.”

At this point, consider the following risk scenarios:

Scenario 1: A scheduling clerk thinks this is a “routine exam” and gives the patient an appointment three weeks from the time of the call.

Scenario 2: The busy ophthalmologist doesn’t find much on exam except cataracts and forgets to ask about jaw claudication and weight loss. His technician notes “headaches” in the patient’s chart.

Scenario 3: The ophthalmologist thinks about the possibility of temporal arteritis and suggests that the patient see an internist. The ophthalmologist dictates a note that is typed and mailed early the following week to an internist who is on vacation.

Scenario 4: The ophthalmologist sees the patient as part of a contracted “vision care” exam and suspects temporal arteritis, but the ophthalmologist is not a participant in the patient’s HMO. He tells the patient that her condition is serious and that it is urgent that she contact her primary care physician. The ophthalmologist does no further follow-up.

All of the above scenarios represent missed opportunities for what should be one of the most thrilling events in the practice of ophthalmology: the chance to prevent blindness. And while the giant cell arteritis begins its visual damage, the stage is being set for liability damages for missing or delaying the diagnosis of temporal arteritis before irreversible visual loss occurs. Temporal arteritis claims are costly and difficult to defend; fortunately, they are rare. Less than 1% of all OMIC claims have involved temporal arteritis. Four of these claims were closed without payment. The remaining two involved allegations of delayed treatment resulting in bilateral blindness and failure to diagnose resulting in blindness in one eye. They were settled on behalf of the insured ophthalmologists for indemnities in excess of $100,000.

Nothing Routine About TA

Of the four scenarios mentioned above, the first is the easiest to correct. Everyone answering the phone in a medical office must be trained to recognize the difference between an emergency, an urgent visit and a routine appointment. Since scheduling staff usually already know the urgency of such complaints as vision loss, eye pain and new onset of floaters, it is a simple matter to add patients over the age of 60 complaining of recent headaches to the list of those who should be seen promptly and brought to the attention of the ophthalmologist.

Never Too Busy to Ask

Alertness to subtle complaints and a high index of suspicion on the part of the examining ophthalmologist addresses the problem in the second scenario. A thoughtful, “How have you been?” followed by a brief review of the patient’s general health system by system, including direct questions about headache, jaw ache and weight loss, is imperative for elderly patients with intermittent or vague visual symptoms. Other symptoms to look out for include fever, scalp tenderness, malaise, morning stiffness and muscle pain. Most patients will not recognize a connection between these symptoms and headache or vision problems and will be unlikely to mention them to an ophthalmologist unless specifically asked.

Suspicious Minds Work Fast

Once there is a suspicion of temporal arteritis, a rapid response and preliminary workup is indicated. The ophthalmologist must use clinical judgment to grade her or his level of suspicion. Direct contact by phone, if possible, should be made with the patient’s primary care physician and documented in the chart. An erythrocyte sedimentation rate (ESR) and C-reactive protein should be ordered and drawn on the day of the exam, with copies of results requested for the primary care physician. These two tests, when elevated, along with the symptoms of jaw claudication and neck pain have been shown to have the highest level of correlation with positive temporal artery biopsies (Hayreh et al, AJO, March 1997).

Patients graded as “extremely likely” should be started on corticosteroid treatment immediately after the blood is drawn and a temporal artery biopsy scheduled. Others can wait for treatment and biopsy until after the results of the lab work, but they should be told to call immediately if there is any change in vision.

The physician should document these instructions in the patient’s chart. Patients with normal ESR and C-reactive protein and few symptoms (excluding jaw claudication) can be followed by observation. Patients with elevated ESR and C-reactive protein require temporal artery biopsy, as do patients with a strong clinical picture and normal ESR and C-reactive protein. It is appropriate to refer patients to a primary care physician, rheumatologist or neuro-ophthalmologist to coordinate the workup and treatment as long as this can be done promptly.

Break Through the Gatekeeper

Anecdotal reports abound of delays in evaluation of patients by gatekeeper model HMOs. This could be a major problem in the fourth scenario. Simply advising the patient to contact the primary care physician probably would not be found to be adequate medical care by a jury reviewing the matter. By examining the patient under the “vision care” directive, the ophthalmologist has established a physician-patient relationship and most likely will be held responsible for that patient regardless of any contract. Direct contact must be made with the patient’s primary care physician and documented in the patient’s chart. Contact OMIC’s Risk Management Department for a copy of its managed care referral form for patients (see next page). One copy of this form should be kept in the patient’s chart and another copy faxed to the primary care physician. Finally, a follow-up call should be made to the primary care physician requesting results of the blood work and biopsy, if indicated.

The above guidelines do not apply to patients who present with visual loss in one eye from suspected temporal arteritis. This is a bona fide emergency requiring hospitalization and immediate treatment with high dose corticosteroids. In such cases, it is recommended that the general ophthalmologist obtain consultation and general medical support. Confirmation of a diagnosis of temporal arteritis before the patient loses vision is a tribute to the physician’s diagnostic acumen, supremely beneficial to the patient and a relief to the professional liability insurance company.

6 Things an Ophthalmologist Should Know About Malpractice Insurance

Did you know that you will pay nearly half a million dollars in malpractice insurance premiums over the course of your career? Here are some tips when evaluating your insurance policy that could save you tens of thousands of dollars and take full advantage of current and potential benefits you may not have realized are already available to you.

Reward yourself, not others.

Do not underestimate the dividend advantage. While publicly-traded insurance companies are pressured to meet shareholder expectations and to produce consistent quarterly profits for those shareholders, physician-owned carriers tend to operate in service solely for its policyholders, since those policyholders are usually also the “owners” of the company. The return of profits (above which are needed to prudently operate the company) to policyholders through dividend distributions or credits may translate into tens of thousands of dollars over the course of your career. Clearly everything should be considered in concert with everything else, in other words your net base rate must be sufficiently competitive over the long-term (look at a rate history of at least 10-15 years to account for both favorable and unfavorable insurance cycles) for the dividend “advantage” to be a key factor.

Avoid these like the plague.

Be wary of policies that are “assessable.” Under these policies the insurance company charges an initial premium, with the stipulation that it retains the right to charge you additional premiums, even years in the future, if their losses for that particular policy year exceeded the premiums originally collected. Insurance “trusts” are often subject to assessment. Also carefully weigh the requirements associated with “claims-paid” policies, where the policy is not triggered until the claim is paid, as opposed to when the claim was reported to the carrier. These policies may be more restrictive and not allow for switching to a new carrier while a claim is active, which could last for several years.

Be encouraged, not irritated, if your carrier asks a lot of questions.

Ophthalmologists or their administrators sometimes lament “long” insurance application forms, however it is important to remember that insurance is a shared pool of risk assumed by your carrier and the premium you pay is directly related to the collective claims experience of the carrier’s policyholders. In other words, if a carrier has weak underwriting standards that result in higher average payouts, this must be accounted for in higher rates or lower dividends. Applaud a carrier’s conservatism and competency when evaluating risk, as you will ultimately benefit through cumulative savings.

Don’t settle for the sticker price.

Research the ways you can lower your premium. Carriers often give discounts for risk management activities, loss experience, group or network associations, and practice characteristics such as hours per week, types of procedures performed, and length of time in practice. Make sure you’re getting all available discounts to reduce your net premium. Surprisingly, many policyholders never take advantage of the opportunity to reduce premiums by participating in risk management activities even though the time required (usually about an hour) and the credit earned (usually $500 – $2000) is probably a more monetarily “rewarding” event than a typical patient encounter. Education that enhances risk reduction also may be long-term “investment” as poor claim history requiring you to enter a higher cost “non-standard” insurance market could be particularly costly going forward.

Don’t overcompensate.

Don’t automatically assume that higher liability limits are always the best option for your practice. When it comes to insurance this may simply distinguish you as a bigger target. A good rule of thumb is to prepare for the average not the outlier, and choose adequate but not excessive liability limits. There are several ways to determine appropriate liability limits. First, ask your carrier if they can identify the level of coverage maintained by the majority of ophthalmologists in your area. Second, look for required minimum limits in any contracts with hospitals or outpatient facilities, health plans or networks, and even lease or employment agreements. Third, ask your carrier about the frequency of high settlements or verdicts and likelihood of a claim exceeding average limits. Answers to these questions should give you a general sense regarding reasonably adequate limits for your area and specialty.

Be multifunctional.

Don’t ignore the value of “added” benefits in your policy. Risk management resources not only help lessen your (and your carrier’s) risk for claims and suits but also provide you an opportunity to distribute “ready-made” employee training materials. Look for sample forms, documents, or guidelines that will help your staff work more independently. Often claims are triggered by experiences your patients have with ancillary staff when you are not around. Make sure they know how to handle difficult situations that present in the office. Risk prevention hotlines or consultative services are particularly valuable. Added protection for your medical entities, ancillary staff, or regulatory exposures such as billing errors, privacy violations, premises contracts or licensure, or security breaches could fill coverage gaps and supplement or eliminate the need for other policies.

Reduce the Risks of Mapping the Visual Field

By Ralph Z. Levene, MD

Argus, May, 1993

Next to acuity, the visual field is the most important determinant of visual function. Mapping the field has become increasingly complex during the past decade. The variety of instruments, methods and strategies to choose from, as well as the sea of numbers, can be overwhelming. Confusion over which instrument to buy and how to set up a visual field protocol may be eased by talking to an expert.

Even before technology offered so many choices, visual fields often were the source of many malpractice suits. Faulty technique, misinterpretation of results, failure to test or to follow up on tests often were to blame. The following risk management considerations can help you avoid these and other liability problems related to visual field testing.

First, ask yourself how your office performs in technique and interpretation. Do you or your technician need a refresher course? Are fields interpreted shortly after they are done? Are all interpreted fields filed together in the correct chart? An unread or misplaced field is not a legal defense.

What is your protocol on routine screening? Some ophthalmologists perform a screening on all new patients and periodically on regular patients, following up with a definitive field if the screening is suspicious. Others prefer to perform a definitive test when there are suspicious clinical circumstances. Both strategies can be legally and ethically correct.

However, delaying or failing to follow up on suspicious or puzzling clinical circumstances is a frequent factor in malpractice suits involving visual fields. In a case from the OMIC files, a physician notes a suspicious pale optic disc and an acuity of 20/20, but misses a pituitary tumor. He schedules the patient for a return visit in one year by which time the tumor has become inoperable.

In another case, a physician notes a suspicious cupped optic disc, visual acuity of 20/20, and pressures of 16. He schedules the patient for a return visit in six months. The patient fails to keep the appointment and the physician does not follow up. When the patient finally returns two years later with frank glaucomatous disc and visual field changes, the diagnosis of low tension glaucoma has been significantly delayed.

Does the defect fit the diagnosis? An ophthalmologist takes over the care of a patient being treated with a topical beta-blocker for glaucoma. Many of the patient’s visual fields have a vertical midline defect and pressures of 10 to 12. Relying on the previous diagnosis of glaucoma, the ophthalmologist misses a brain tumor.

Do you recognize artifacts and evaluate the reliability of each field? Some patients never yield a reliable field and others do so intermittently. The newer static methods are more sensitive to detecting defects but probably are more prone to artifacts. When in doubt or in unusual circumstances, repeat the field.

Is the defect progressive? This is a critical point in patient management. Apart from artifact, variations from test to test often are underestimated with consequent errors in interpretation. Case in point: an ophthalmologist has been treating a patient with an advanced case of glaucoma and a stable field defect. On a recent visit, a visual field, performed with reasonable reliability, shows an apparent change and is incorrectly interpreted as a significant progression. The ophthalmologist suggests surgery. The patient seeks a second opinion. A repeat field shows a previous stable defect. Unnecessary surgery, with the potential for a lawsuit, is avoided. The change interpreted by the first ophthalmologist as significant was actually a normal variation from one test to another.

Another factor to consider when evaluating results is whether there has been a change in technique. Switching from tangent or Goldman instruments to newer computer assisted methods can skew results. Discuss ambiguous results with an expert or refer the patient for a second opinion. Don’t be afraid to ask for help.




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