Article

Risk Management Issues in Glaucoma

Examining risk in diagnosis and treatment.

When reviewing Ophthalmic Mutual Insurance Company (OMIC) data from the past 35 years, glaucoma-related claims and lawsuits arise infrequently compared to other subspecialties, representing only 4.5% of total claims. By the numbers, 4.5% represents the 226 closed glaucoma claims compared to 4,956 closed claims across all ophthalmic subspecialties. This low percentage of glaucoma-related lawsuits compares favorably to the data collected by the Medical Professional Liability Association (MPL) whose member companies collectively insure more than 100,000 physicians nationwide. The purpose of this article is to provide an update on the nature of glaucoma related claims (previously described by E. Randy Craven, MD, in the OMIC Digest1). In addition to updated statistics, recently released guidelines to minimize the risks associated with glaucoma claims and lawsuits will be discussed.

Claims Frequency and Severity

Of the 226 claims that were glaucoma related, 23% (53 cases) were settled (Table 1). This is slightly higher when compared to OMIC’s overall average across all subspecialties of 21%. Figure 1 shows claim frequency by subspecialty.

The average glaucoma settlement is approximately $177,000 and is essentially equal to the average indemnity payment in the history of the company of $177,000. The average settlements in glaucoma claims are in line with overall claims statistics. Approximately 23% of the glaucoma-related claims resulted in indemnity, whereas in cataract patients approximately 18% were closed with an indemnity payment. The average indemnity for cataract-related claims was $144,000. The vast majority settled without an indemnity or a low payment.

Table 1. Claim Frequency and Severity
Claims Frequency and Severity Total Claims Closed Claims Closed With Indemnity Average Indemnity
All Specialties (Medical Professional Liability Data) 316,000 316,000 91,000 $239,000
Ophthalmology Claims (OMIC) 5,384 4,922 1,031 $177,873
Glaucoma Claims (OMIC) 263 226 53 $177,511
Cataract Claims (OMIC) 1,526 1,387 246 $144,235

Figure 1. Total number of claims by subspecialty, as of March 1 2019.

Analysis of Glaucoma-Related Misadventures

Of the 226 closed glaucoma claims, there were 19 “companion files” in which the allegation was vicarious liability. Because there were no specific allegations, we omitted those 19 cases from the analysis of glaucoma-related misadventures. In this section, we will only analyze the 207 cases in which there was a specific allegation. The majority were medical (53.6%) as opposed to surgical (46.3%) misadventures. Of the 53 glaucoma settlements, only 28.3% were surgically related whereas the remainder of medical misadventures accounted for 71.7% of settlements. Tables 2 and 3 list the breakdown of settled glaucoma-related medical and surgical misadventures.

Table 2. Reason for Claim or Suit
Reason Number of Claims or Suits Number of Settlements Amount Paid
Failure to Diagnose 44 13 Average $187,000; $30,000-$500,000 range
Failure to Treat 20 7 Average $159,000; $12,500-$250,000 range
Failure to Monitor on Steroids 9 3 Average $140,000; $10,000-$450,000 range
Delay in Referral or Treatment 5 5 Average $240,000; $30,000-$450,000 range
Inappropriate or Negligent Treatment 27 8 Average $221,000; $50,000-$350,000 range
Injury During Exam 4 1 $745.54
Negligent Phone Advice 2 1 $60,000
Companion Files 19 - -
Table 3. Glaucoma Surgery Settlements
Claim Number of Claims or Suits Number of Settlements Settlement Amount Paid
Negligent Trabeculectomy 31 6 Average $211,000; $50,000-$325,000 range
Unnecessary Surgery 4 1 $199,000
Combined Cataract Trabeculectomy 12 3 Average $148,000; $97,000-$200,000 range
Wrong Eye 3 1 $40,000
Failure of Surgery and Treatment Combined 10 1 0
Bleb Needling 2 1 $30,000
Anesthesia Related 3 2 Average $112,000; $75,000-$150,000 range
Complications of Surgery 31 - $26,000

The most frequent and most expensive misadventures are those involving delay in treatment, failure to diagnose, timing of referral, or inappropriate escalation of therapy. Similar results were found by Craven in 1994.1 Experts will explain to the jury that failure to perform timely, appropriate diagnostic testing (pachymetry, gonioscopy, visual field, optic nerve assessment) results in preventable loss of vision related to glaucoma. The plaintiff’s attorney will show the relation between breach of duty (diagnostic error) and cause of damage (blindness or vision loss). Documentation of reasons for and omission of appropriate diagnostic testing is imperative, as well as documentation of the interpretation of testing results. Glaucoma settled claims are significantly more likely related to diagnostic and treatment errors as opposed to surgery (72% vs 28%). The 38 diagnostic and treatment-related claims and suits that resulted in a settlement totaled $7,275,865 with an average indemnity payment of $191,000. The 15 surgery claims and suits that resulted in a settlement totaled $2,135,249 with an average indemnity payment of $142,000. The most expensive settled claim ($500,000) involved a combination of failure to diagnose and treat, lack of timely referral, and “abandonment” in a case where the plaintiff was followed by both an optometrist and an ophthalmologist.

Standard of Care

The diagnosis of glaucoma requires a complete ophthalmic evaluation, including IOP assessment, pachymetry, gonioscopy, optic nerve evaluation, visual field testing, documentation of all medications, and medical and pertinent family history. Commonly, the individual will require timely follow-up reassessment at varying times of day to determine possible IOP fluctuations. Glaucoma suspects should be seen for frequent examinations (1-2 times per year), compared to a non-glaucoma suspect of the same age, to monitor for changes. During the review of systems, it is important to document systemic factors that put patients at increased risk for developing glaucoma (eg, vasculopathic contributors). Educational materials should be offered and reviewed with the patient, and the ophthalmologist should document receipt of the materials and note all questions answered. An emphasis on regular checkups can assist in promoting long-term compliance if, and when, topical treatment is started. The patient should be told that failure to adhere to treatment guidelines can result in permanent vision loss. Of paramount importance, a glaucoma patient or suspect's record must have documentation of missed appointments, medication compliance, or adherence issues, because the ophthalmologist may be exposed to negligence or abandonment. In severe cases of noncompliance, refusal of treatment recommendations, and avoidance of recommendation for referral, releasing the patient from one’s care should be considered. This not only protects the provider but emphasizes to the patient the importance of their care and hopefully will encourage patients to seek treatment elsewhere. The Ophthalmic Mutual Insurance Company provides templates for these correspondences; however, each letter should be tailored specifically to the patient and mailed with confirmation tracking.

Standardized Record Keeping

Despite adoption of electronic health records (EHRs), challenges remain for data acquisition and standardized record keeping in the glaucoma practice as well as other subspecialties. Prior to EHRs, once the diagnosis was established with paper charts, it was relatively easy to monitor the patient’s progress with a single-page “flow chart” of glaucoma pertinent information that showed date, vision, IOP, gonioscopy findings, optic nerve assessment, and visual field. Depending on the EHR vendor, physicians may be required to click on multiple pages to see all of the information that was once present on a single page. Although EHR data acquisition and assimilation present challenges, monitoring progression has improved with increased technology (eg, glaucoma progression analysis). Within an examination, it is necessary to document interpretation of diagnostic tests, such as optical coherence tomography and visual field testing, as well as medication adjustments and their potential associated side effects. This not only protects clinicians from a billing audit but also maintains high standards for potential transference of care by providing a comprehensive assessment that is easy to follow.

Establish Treatment Goal

Although controversy surrounds documentation of the IOP goal, it is important nonetheless to set an initial “target range” of pressure based on the presenting stage of glaucoma. The target range should be continuously re-evaluated and documented during the patient’s treatment plan. The patient’s treatment goals must be discussed with the patient. Glaucoma progression is commonly insidious and moves at a glacial pace, so emphasizing the importance of monitoring the status of the optic nerve and corresponding visual field changes with patients increases their understanding of the disease. It also helps patients understand the importance of maintaining a “target range” pressure, with the caveat that it is the only treatable aspect. This documentation also complements measure 141 of the Merit-Based Incentive Payment System (MIPS), which describes a goal of reduction of IOP by 15% or documentation of a plan of care for primary open-angle glaucoma.2 For those using the IRIS Registry, this measure is completed automatically to document the percentage of patients aged 18 years or older whose glaucoma treatment reduced IOP by at least 15% when compared to preintervention IOP.

When Treatment Warrants Surgery

If surgery is recommended, emphasize that surgery is to maintain, not improve, a patient’s vision. Delaying or deferring surgery will most likely contribute to further visual changes and should be documented in detail to demonstrate patient’s deferral and their decision to delay treatment. Additionally, it is recommended that the following steps be taken when a patient is to proceed with surgery:

  • Provide educational material with regard to various surgical options.
  • Document surgical risks, potential complications, and postoperative care with educational handouts describing the various procedures.
  • Document that all questions are answered and obtain written consent. Both hospital-specific and glaucoma-specific consents are recommended. A plain-language glaucoma surgery consent can be found at www.omic.com/risk-management/consent-forms/ .
  • Physician-patient rapport requires keeping the patient apprised of the stage of the disease, its course to date, and what can be expected in the future. Omission of direct, honest appraisal of the patient’s status can increase an ophthalmologist’s risk of lawsuit. A potential legal instigator is when a patient feels betrayed if inadequately informed or finds out what should have been done.

Take-Home Points

In summary, here are recommendations all ophthalmologists should consider to mitigate risk:

  1. Document everything. For example, avoid conflicts with common defaults and “load lasts” in EHR systems. If something was not documented correctly, in terms of risk, it essentially did not happen.
  2. Provide educational materials to enhance patient understanding.
  3. Provide plain-language consent documents to increase patients’ understanding of their care plan.
  4. Maintain honest dialogue and document patients’ deferral of escalation of therapy.
  5. Work with staff to create and consistently review office protocol regarding noncompliant and emergent patients. Specifically, review glaucoma “no-shows” and “cancels” with staff on a daily basis and ensure timely follow-up. GP

CLOSED CLAIM STUDY

Failure to Appropriately Monitor and Treat Open-Angle Glaucoma

Allegation: Plaintiff alleged that insured ophthalmologist failed to monitor and treat open-angle glaucoma appropriately.

Disposition: Claims titled with indemnity

Case Summary: The case begins with an 83-year-old female monitored as an open-angle glaucoma suspect for greater than 10 years, with history of elevated intraocular pressures (IOPs) in the mid-20s. She was subsequently treated for open-angle glaucoma for greater than 10 years, including topical and laser therapy. The plaintiff noted to have a history of difficulty with adherence to meds and appropriate follow-up with variable “emergent evaluations” unrelated to glaucoma and occasional “no shows.” The insured noted the plaintiff to have missed appointments with subsequent poor follow-up as well as no documented follow-up noted. The patient called with complaints of “foggy vision” and was noted to be scheduled for 10 weeks later. When evaluated, the plaintiff’s IOPs were 48 mmHg in the right eye and 42mmHg in the left eye with hand-motion vision in the right eye and a central island of 10-degree vision in the left eye. The plaintiff subsequently underwent emergent bilateral filtration procedures 1 week apart with resultant stabilization of IOPs at 10 to 12 mmHg.

Outcome: Although this case has credible defense due to patient documented “no shows” and adherence issues, the settlement was felt appropriate as the time interval from documented call of “foggy vision,” though vague, was felt to be indefensible; that is, the plaintiff warranted appropriate timely follow-up assessment. As noted by the insured, there was failure of the staff to inform him of insured’s call and follow-up. The insured is the “captain of the ship” and responsible for oversight of staff and patient interaction.

References

  1. Craven ER. Risk management issues in glaucoma diagnosis and treatment. OMIC Digest. 1994. Available at: https://www.omic.com/risk-management-issues-in-glaucoma-diagnosis-and-treatment/ .
  2. American Academy of Ophthalmology. Measure 141: Primary Open-Angle Glaucoma (POAG): Reduction of Intraocular Pressure (IOP) by 15 Percent or Documentation of a Plan of Care. Available at: https://www.aao.org/medicare/quality-reporting-measure/141-primary-open-angle-glaucoma-pressure-reduction