Comanagement

1. Comanagement

2. Comanagement of patients with physicians is a growing source of litigation for optometrists.Formal comanagement is used for the post-operative care of patients who have undergone cataract or refractive surgery.Informal comanagement exists for the care of patients with diabetes.

3. Comanagement is considered to be a "joint venture", in which both comanaging practitioners may be held liable for negligence committed by one.To minimize the risk of liability, in formal comanagement practitioners must discuss the evaluation and scheduling of patients to agree on a common protocol for care.

4. The protocol must be in writing and must describe pertinent details of care, such as: • the diagnostic workup to be performed • the procedure for referral of patients • the schedule of follow-up for patients • the procedures to be performed at follow-up examinations • how information is to be shared between practitioners.

5. Practitioners should forward examination findings to one another through facsimile transmission; each practitioner should have a copy of the examination findings for every patient being comanaged.Liability claims have emphasized failure to adhere to the standard of care in performing post-operative examinations and failing to conform to the requirements of informed consent when complications of surgery are observed.

6. Cataract Comangement • Patients with cataract are referred for surgery when reduced visual acuity affects quality of life. • Visual acuity levels at which this occurs are usually 20/50 to 20/60. • The optometrist usually selects the surgeon, but patients are free to choose (although insurance plans may limit choices). • Referrals for cataract surgery raise several legal issues, primarily due to post-operative care.

7. Cataract Comangement • The federal Medicare law prohibits referrals in which the purpose is to receive a kickback (the "anti-kickback statute"). Cases involving physicians have held that the sharing of fees constitutes a violation of the statute. • Thus, payments by a surgeon to an optometrist for post-operative care of a Medicare patient would be construed to violate federal law, even though the payments were primarily intended to compensate the optometrist for care actually rendered. • Violations of the law are punishable by fines and imprisonment.

8. Cataract Comangement • There are exceptions to the “anti-kickback” statute, which are termed “safe harbors”. If arrangements between practitioners satisfy the requirements of a “safe harbor”, then the practitioners are shielded from the provisions of the “anti-kickback” statute. • However, referrals from optometrists to ophthalmologists for cataract surgery, with post-operative care provided by the optometrists, do not automatically qualify as “safe harbors”.

9. Cataract Comangement • Optometrists who refer patients to an ophthalmologist for cataract surgery, on the condition that the patient be returned to the optometrist for postoperative care, would be in violation of the “anti-kickback” statute rather than in a “safe harbor”. • Prior to referral, patients must be asked if they wish to receive their postoperative care from the ophthalmologist or from the referring optometrist. If the patient chooses the optometrist, a “safe harbor” is created for the practitioners.

10. Cataract Comangement • The federal “Stark Law” regulates referrals to entities (such as a clinic or group of health care providers) in which the referring practitioner has a financial interest. • If such a referral is made, any health services provided by the entity cannot be legally billed to Medicare. Hefty fines are levied for violations. • The “Stark law” applies to referrals for cataract surgery where the optometrist has a financial interest in the clinic (such as a referral center) in which the ophthalmologist performs the surgery. • Practitioner to practitioner referrals, in which neither practitioner holds an interest in the other’s practice, do not fall under the “Stark law” prohibitions.

11. Cataract Comangement • If an optometrist performs post-operative care, a joint venture is created in which the surgeon may be held liable for the optometrist’s negligence. • Written protocols for care provide some protection for the surgeon: if the optometrist does not follow the protocol, and the patient is injured, the surgeon likely willnot be held jointly liable.

12. Cataract Comangement • Important complications of surgery include endophthalmitis, retinal detachment, elevated intraocular pressure, acute hyphema, and wound leak. • The most common cause of litigation is endophthalmitis, the usual allegation being that a delay in diagnosis caused the infection to worsen, significantly affecting treatment and outcome.

13. An elderly woman with decreased acuity received cataract extraction and posterior chamber intraocular lens implantation. She was examined the day after the operation, which was a Friday, with no complications noted by the surgeon. The following afternoon her eye seemed to become more painful, and her visual acuity seemed worse. The situation did not improve during the night, and the next morning she called the surgeon's clinic, but it was closed and she was referred to an optometrist, one of the members of the clinic staff who was "on call" for the day, which was Easter Sunday. After discussing her symptoms, the optometrist advised her that some pain and reduced acuity were an expected part of the post-operative period, and that she should call again if her symptoms worsened. After a restless night, she went to a local optometrist's office for examination. He found that she had endophthalmitis and referred her immediately to the surgeon. Despite aggressive therapy, she lost vision in the eye and it was enucleated. She filed a lawsuit against the clinic, alleging negligence in her care on the part of the optometrist, and she received damages.

14. Refractive Surgery Comanagement • About 1,000,000 refractive surgery procedures are being performed annually, and although poor outcomes and significant complications occur in only about 1% of cases, there are still about 10,000 patients a year who suffer adverse results. • Optometrists who perform post-operative care have been involved in liability claims; radial keratotomy and LASIK have been the most common procedures litigated.

15. Refractive Surgery Comanagement • Optometrists frequently provide the pre-surgical evaluation of refractive surgery cases and must reveal to the patient any risks or contraindications for surgery that are found, while avoiding exaggerated claims or guarantees concerning the anticipated outcome of surgery. • Information provided to the patient should be of a general nature concerning the surgery rather than an effort at providing informed consent. • If the patient is convinced to undergo surgery based on the optometrist’s claims or inducements, and there is a poor outcome, with resulting litigation, the optometrist may be held liable for breach of informed consent. • As always, due care must be exercised in referring the patient to a surgeon.

16. Refractive Surgery Comanagement • Post-operative care of refractive surgery patients should be performed in accordance with a written protocol for care. • If the optometrist is negligent, joint liability may be imposed, unless the optometrist has failed to follow the protocol or was independently negligent. • Failure to advise patients of poor outcomes—a breach of informed consent—has also been a source of claims.

17. A patient was referred by an optometrist to an ophthalmologist for radial keratotomy (RK). The surgeon performed the procedure on one eye, and the first day post-op assessment, then returned the patient to the optometrist for further follow-up. Five days later the optometrist examined the patient and found that one of the keratotomy incisions extended all the way across the center of the cornea. The optometrist telephoned the surgeon to discuss the finding, but the surgeon said "don't worry about it", and the optometrist did not inform the patient of the finding or refer the patient to another practitioner for evaluation. Subsequently, the patient's poor acuity led to consultation with another doctor, and, ultimately, a lawsuit against both surgeon and optometrist for negligence and breach of the doctrine of informed consent.

18. Diabetes Comanagement • There are an estimated 16,000,000 persons in the US with diabetes mellitus; 50% are undiagnosed. For Type I insulin dependent individuals, after 10 years 60% will exhibit retinopathy; after 15 years, 25% will progress to the proliferative stage; after 20 years, the percentage rises to 50%. • Failure to timely diagnose diabetic retinopathy and refer for treatment is the leading cause of liability claims.

19. Diabetes Comanagement • The standard of care is medical and involves: • state of the art examination • coordinated comanagement with physicians • continuous patient education • timely referral when complications occur.

20. Diabetes Comanagement • a thorough history must be taken • the examination should include: • measurement of visual acuity • refraction (as indicated) • tonometry and slit lamp evaluation • ophthalmoscopy and fundus biomicroscopy • the fundus examination must be performed through a dilated pupil.

21. Diabetes Comanagement • Optometrists should educate patients with diabetes mellitus concerning the risk of ocular complication and the need for periodic examination. • Patients with retinopathy should be placed on a reasonable recall schedule or, if appropriate, referred to a physician. • Recall schedulesare based on the level of retinopathy observed.

22. Diabetes Comanagement • Non-proliferative retinopathy (mild, moderate, severe, very severe) • from 1 year to 2 to 3 months • Proliferative retinopathy (neovascularization at the disk or elsewhere) • referral for laser photocoagulation • Clinically significant macular edema • referral for laser photocoagulation

23. Diabetes Comanagement • If patients fail to return for periodic examination, or for recall or referral appointments, patients should be contacted and this non-compliance should be documented in the record of care. • Failure to adequately monitor patients with retinopathy is a major cause of litigation. A program of co-management should be established with the physician treating the patient and examination findings should be described in writing to the physician. This writing should be documented in the record.

24. Diabetes Comanagement • The timeliness of a referral is important, especially for patients with good vision and significant retinopathy. Failure to make a timely referral can result in litigation.

25. Example case: Diabetic retinopathy • Type 1 diabetic patient for 20 years, under seemingly adequate control • Doctor diagnoses open-angle glaucoma and background retinopathy • The optometrist starts treatment for the glaucoma, but in 6 months the patient returns with proliferative retinopathy and macular edema OU, and a pre-retinal hemorrhage • Despite laser treatment, the patient suffers significant loss of acuity in both eyes

26. Notice how the lawyer emphasizes that the severity of the retinopathy and macular edema implies that the doctor initially misdiagnosed the patient’s condition and that even if background retinopathy was found the patient should have been referred to an ophthalmologist.

27. CLAP Traps • Optometrists who comanage patients with physicians should describe significant findings, in writing, to these physicians. • If complications requiring treatment occur, a timely referral should be scheduled—delays can be a basis for litigation. • When a referral is made, a copy of the writing should be retained in the patient's record.

28. Diabetes Comanagement • Comanagement of patients with diabetes is potentially a significant cause of litigation for optometrists. • Ophthalmologists are sued by patients with diabetes more frequently than any other type of physician. • Because loss of vision from diabetes is often preventable if timely diagnosis and treatment are provided, failure to refer appropriately can result in significant awards for damages.

29. A man in his 50s was examined by an ophthalmologist, who found retinopathy that he assumed was secondary to diabetes. The physician did not discuss with the patient the significance of these findings—which he classified as background retinopathy—and so the patient sought no further eye care for two years. When the man did seek care, because of reduced visual acuity, it was discovered that he had proliferative retinopathy, and despite surgical treatment he ultimately suffered bilateral blindness. He filed a lawsuit against the ophthalmologist, alleging negligence and failure to warn of the retinopathy. The ophthalmologist defended the allegations by claiming to have written a letter describing his findings to the patient's family practitioner, but the practitioner denied receiving the letter. After trial, a $13 million judgment was entered against the ophthalmologist.

30. That’s all there is. We have described the significant liability risks in optometry—now that you know what to do, “just do it”. Good luck!