Cooperation Essential as Physicians Leave a Practice
Anne M. Menke, RN, PhD, OMIC Risk Manager
Digest, Spring 2005
Physicians leave practices for many reasons, including illness, retirement, changes in employment status, and personal or family needs. Both the individual ophthalmologist and the practice need to take steps to promote continuity of care, prevent allegations of abandonment, and ensure that all involved physicians have access to the medical records in the event the care is ever called into question.
A successful transition, therefore, requires the cooperation of all involved parties. Strained relationships put everyone at risk and must be carefully managed to avoid patient harm, business disputes, and malpractice lawsuits. This article will address difficulties with patient notification and record sharing; for a discussion of other related issues, see “When Physicians Leave a Practice” in the Risk Management Recommendations section of the OMIC web site (www.omic.com).
Q I am leaving my current practice arrangement, and the medical director won’t allow me to notify my patients. Am I at risk for an allegation of abandonment?
A Yes, both you and the other physicians in the practice are at risk. Patient abandonment occurs when a physician fails to provide for necessary medical care to a current patient without adequate justification. In general, once a physician-patient relationship is established, a physician has an ongoing responsibility to the patient until the relationship is terminated. In order to terminate the relationship, the physician must notify the patient sufficiently in advance for the patient to secure the services of another physician. Physicians are generally aware of the need to notify patients when they will no longer provide care for them (e.g., when discharging patients from the practice or retiring). Questions arise when a physician leaves to practice elsewhere. Whose patient is it? What if the patient wants to follow the doctor? Or stay with the practice? While some of these issues may be spelled out by the employment agreement, it is nonetheless prudent to notify patients that the ophthalmologist is leaving and give them the choice to continue seeing the physician if he or she plans to remain in the area.
Q Which patients should I notify?
A There is no need to notify every patient in the practice or those patients whom you saw only occasionally while covering for another physician. Rather, inform those for whom you had primary responsibility. Send a letter by certified mail, return receipt requested, to all of your “high-risk” patients, and one by regular post to “active” patients who are not considered “high-risk” (see web document for examples). To notify patients who will not be receiving a letter – or for general notification purposes if you did not have primary responsibility for any patients – place a notice in the local newspaper with the largest circulation, put a sign up in the lobby, or prepare a patient handout. Also remember to provide a script for receptionists of what they should say to your patients who call after your departure and how they can contact you.
Q What should the notice say if I am staying in the area?
A Notify patients that you are leaving the practice but are still avail- able to care for them. Explain that they have the choice of staying with the practice or continuing to see you in your new location. Instruct patients who choose to follow you that, upon written authorization, a copy of their medical record will be forwarded to you. Consider including an authorization form with the letter to expedite the transfer of records. If your practice charges the patient for the cost of photocopying the medical record, inform the patient of this fee.
Q Who gets to keep the chart if I am still treating the patient?
A Any material related to patient care should be considered part of the medical record and provided to the departing physician. Both the practice and the departing physician should keep a copy of the medical records. A written agreement should determine who keeps the original and who pays the cost of copying the records. The departing physician and the practice need to come to a written agreement about who is the custodian of the records, and the conditions under which the departing physician will be granted access to the records of the patients he or she treated. The custodianship agreement should verify whether patient authorization is needed for the departing physician to access his or her former records or to obtain a copy of those records for his or her healthcare operations (such as a medical malpractice allegation). If not specified in the agreement, state law may determine whether patient authorization is needed for the departing physician to access or copy these records. Generally, physicians should be allowed access to the records of patients they treated. The records provided should reflect care up to and including the day of the physician’s departure.
Responding to “Dear Healthcare Provider” Letters
Anne M. Menke, RN, PhD, OMIC Risk Manager
Digest, Winter 2007
Within the last several months, ophthalmologists have received two “Dear Healthcare Provider” letters from drug manufacturers informing them of “important safety information” about medications they administer regularly. Bristol-Myers Squibb sent the first letter on November 22, 2006 at the urging of the food and Drug Administration (FDA).[1] Consistent with a prior warning on the prescribing information, the letter again reminded ophthalmologists that KenalogTM(triamcinolone acetonide) is not approved for intraocular administration. In response to reports of endophthalmitis, eye inflammation, increased intraocular pressure, and visual disturbances including vision loss— all known side effects about which ophthalmologists routinely inform patients—the company added additional prescribing information recommending against administering KenalogTM by intraocular, intraturbinal, subconjunctival, sub-Tenons, retrobulbar, nasal turbinate, and intralesional (about the head) routes. The second “Dear Healthcare Provider” letter was distributed by genentech Inc., manufacturer of AvastinTM (bevacizumab) and LucentisTM(ranibizumab), drugs both widely used for the treatment of age-related macular degeneration (AMD). In its January 24, 2007 letter, the company informed ophthalmologists that the ongoing SAILOR clinical study revealed a higher incidence of stroke in the 0.5-mg LucentisTM dose group compared with the 0.3-mg dose group (1.2% versus 0.3% respective- ly; P = 0.02).[2] These letters have prompted numerous calls to OMIC’s risk management hotline.
Q Can I still administer KenalogTM ?
A It is OMIC’s opinion that, despite the manufacturer’s warning, it remains legal for ophthalmologists to administer KenalogTM (TA) by the routes mentioned in the letter as part of “the practice of medicine.” In the event of a lawsuit, ophthalmologists who are challenged about their use of TA will continue to rely upon expert witnesses, peer-reviewed literature, and well-documented efforts to provide quality care. Moreover, OMIC feels that the ophthalmologist is in the best position to determine how to treat an individual patient and recognizes that “off-label” use of approved medications is a legal and necessary part of the practice of medicine. Accordingly, our professional liability policy provides coverage for such off-label use, including ongoing use of TA.
Q Do I need to tell my patients about the letter?
A Yes. Patients should be informed of TA’s off-label status and told that the manufacturer has recommended against ophthalmic use, but that the FDA and attorneys have confirmed that ongoing use is legal as part of the practice of medicine. They should also be advised of the long-standing and widespread use of TA to treat ocular conditions as described in many peer-reviewed articles, and that the National Eye Institute is conducting clinical trials on its use. OMIC has prepared a sample consent form for TA, available at www.omic.com.
Q The letter from Genentech did not provide any guidance. Am I required to assess a patient’s risk of stroke before I administer LucentisTM? Should some patients get the lower dose, even though only the higher dose has been approved by the FDA?
A The label produced when LucentisTM was approved warns of the theoretical risk of thrombo- embolic events with intravitreal inhibitors of VEGF,[3] a drug class that also includes Macugen and Avastin. Accordingly, the risk management recommendations that precede OMIC’s revised sample consent form advise physicians to consider conditions that increase the risk for such complications. Now that ophthalmologists have been warned of the higher risk of a second stroke in patients with a stroke history, they should specifically elicit and document any history of stroke. The need for a stroke risk consultation with an internist and the dosage amount both depend upon the patient’s overall health, extent of AMD, and risk tolerance. faced with the certainty of visual loss from AMD, some elderly patients may prefer to assume the risk of stroke in order to best preserve their vision. Others may refuse the medication at any dose. Carefully determine and document the patient’s clinical findings and preferences, and ensure that patients who refuse the medication understand the consequences of their refusal. Consider giving patients written instructions about how to contact you and a list of eye symptoms that should be immediately reported to you. Patients considered at high risk for stroke should be educated on its symptoms and directed to call 911 or to proceed to the nearest emergency room if they suspect they are having a stroke.
1. Lewis-Hall, Freda, MD, Senior VP for Medical Affairs, Bristol-Myers Squibb CO. Dear Healthcare Provider. 22 Nov. 2006.
2. Barron, Hal, MD. Senior VP Development, CHief Medial Officer, Genentech, Inc. 24 Jan 2007.
3. The full prescribing information for LucentisTM is available at http://www.gene.com/gene/products/information/pdf/lucentis-prescribing.pdf
Boost Practice Efficiency: Productivity, Liability and the Technician
By Anne M. Menke, RN, Ph.D, OMIC Risk Manager
EyeNet, October 2007
Incorporating ophthalmic technicians into your practice can help maximize your practice’s productivity and minimize its malpractice risk. As Risk Manager at the Ophthalmic Mutual Insurance Company, I urge technicians to play an active role in promoting patient safety and watching out for liability pitfalls.
Reduce Malpractice Risk
Some patients may find it easier to share their concerns with ophthalmic person- nel than they do with physicians. This provides technicians with an opportunity to improve patient care and, conse- quently, reduce your practice’s malpractice risk.
Technicians are knowledgeable yet approachable. Patients who are too shy to ask questions when speaking with the ophthalmologist are usually comfortable talking to technicians. For example, patients commonly do not take their medications as prescribed. Many of those patients worry that they will alienate the physician if they admit to this, especially if financial problems, lack of understanding of their disease or an inability to read contribute to the nonadherence. Technicians have an important role to play in addressing this problem. When a new patient is given a medication, the technician can instruct the patient by stating, “Many patients have questions or concerns about new drugs, or may not feel they are really needed. Do you have any ques- tions I can answer now? If you don’t have questions now, you may think of some later. In that case, please call me.” At the next visit, the technician can follow up: “I remember that the doctor started you on a new medication on your last visit. Tell me how you are using it.”
The knowledge base of technicians is vital to the process of informed consent. They can begin the task of educating patients about their condition and its treatment options. They also can use their conversations with patients to help identify and resolve misunderstandings. Legally, however, only the surgeon may obtain the patient’s informed consent by discussing the risks, benefits and alternatives of the procedure. Once that oral exchange has taken place, any staff member can review the form and obtain the patient’s signature.
Liability Pitfalls to Avoid
Written protocols play a critical role in minimizing your practice’s malpractice risk. These protocols must be carefully tailored to your practice, patient popu-lation and personnel. You can further reduce your malpractice risk by holding regular staff meetings that address threats to patient safety. Such meetings are an invaluable way of making each staff member a risk manager.
The challenge of telephone screening. This is one of the top three “scope of service” issues in ophthalmology.
However talented, technicians are unlicensed and are thus generally limited to performing tasks that do not require the knowledge and skills of licensed personnel such as nurses, optometrists and ophthalmologists. Indeed, techni- cians and their employers may face mal- practice lawsuits and/or medical board investigations if they perform tasks that are part of a licensed practitioner’s scope of practice.
Telephone care can be very compli- cated: The patient may be a poor histo- rian, may not be able to explain his or her symptoms and may not understand what is important. The health care team member on the other side of the line does not have the benefit of evaluating the patient’s nonverbal language, performing an exam or reviewing records. Unlicensed personnel may screen calls to determine the type of appointment (routine, urgent or emergent), but they need to have written protocols to guide them when they do. They cannot diagnose, treat, prescribe or renew medica- tions, and must instead ask the physician to make these decisions. If ordered to do so, they may communicate treatment recommendations or fax in a prescrip- tion refill.
For information on the screening role that nonphysician staff may play in after-hours calls, please see “Who’s On Call?” by Paul Weber at www.omic.com.
The challenge of knowing one’s limits. Experienced technicians may have the knowledge to determine the cause of the patient’s visual complaints, know exactly what treatment the ophthalmologist will recommend or feel certain that the prescription refill request will be honored. For legal and patient safety reasons, however, they may not share this information with the patient or refill the prescription, unless instructed to do so by the physician.
Withholding known answers may make the technician uncomfortable, especially when the patient asking for information is frightened. The best approach is to validate the patient’s concern and either encourage the patient to discuss it directly with the physician or offer to do so on behalf of the patient: “Mrs. Robson, thank you for letting me know that steroid drops helped you the last time you had this problem. Let me ask the doctor about this and call you right back. May I have your pharmacy’s number just in case?” If asked for a diagnosis, the technician can again reassure the patient and defer to the physician: “You sound very wor- ried about this sudden loss of vision. The doctor will explain what she feels is causing it after she examines you.”
Learn from your practice’s mistakes
Let’s say, for example, that the ophthalmologist discovers that he has implanted the wrong IOL. Suppose that a technician’s errors during the A-scan contributed to that surgical mistake. Many people’s instinct is to reprimand the person responsible. Instead, it would be both more productive and reassuring to everybody in the practice if you schedule a staff meeting and explain: “Today, our topic will be IOLs. I’ve learned that wrong IOLs are the most frequent cause of medical malpractice lawsuits. We recently had such a problem here and we can all learn from it. Leslie, why don’t you start by explaining what happened so we can all see how easy it is for such a mistake to go unnoticed. I’m sure everyone has some suggestions on how to improve our process of care to make it safer.”
Know your state laws. State laws and regulations determine what tasks may be delegated to unlicensed personnel and when a license is required. Some states, such as California, have very explicit and accessible laws. Other states allow the physician to exercise professional judgment or are silent on this issue.
Hidden Costs of Non-Traditional Revenue Sources
By Anne M. Menke, RN, PhD,
OMIC Risk Manager
Digest, Spring 2008
Long before the national presidential debates focused attention on health care, ophthalmologists were experiencing firsthand the many obstacles to quality, affordable medical services. They have watched as increasingly complex health care delivery systems demand more but pay less. Judging by calls to OMIC’s Risk Management Hotline, the poster child for the injustices of this medical pressure cooker is the on-call physician, who at times is forced to provide uncompensated back-up for hospital emergency rooms. Drawing upon the innovative and entrepreneurial spirit that has long characterized ophthalmology, some eye surgeons have responded to financial pressures by offering new health care products, such as diagnostic testing or interpretive centers, cosmetic skin care clinics, and “Medispas.” Others promote their ability to serve as independent medical examiners (IME) and expert physician witnesses (EW) in profes- sional liability, workers compensation, and disability litigation and disputes. These business ventures tend to be characterized by a more limited physician-patient relationship, fee-for-service payment, and delegation of care—and even operations—to non-physician staff. Eyes fixed on the financial prize, some physicians ignore or remain unaware of the risks and duties these relationships entail. Whether provided in the trenches of a crowded emergency room or amid the soothing luxury of a Medispa, ophthalmic care poses medical-legal hazards, professional liability insurance coverage issues, and patient safety pitfalls.
ER Call
One of the most frequent reasons OMIC policyholders call our Hotline is for clarification of their ER-call duties. They wonder about hospitals where they have no privileges, other hospitals in a hospital system, patients in other states, and days when they are not on call. Their next question involves outpatient care of patients with or about whom they have had no contact, but who may show up, call for an appointment, or simply have discharge documents containing the physician’s name. Depending upon the circumstances, your duties range from none to diagnosis, treat- ment, and follow-up. The Table on page 5 and the Closed Claim Study provide brief remarks. See “EMTALA: An Overview” and “EMTALA: On-Call Issues” at http://www.omic.comfor detailed answers.
Forensic Consultations
During the course of litigation and disputes, insurance companies, employers, employees, plaintiffs, and defendants often need an objective opinion of the nature, cause, and prognosis of eye conditions. In this Digest, we will focus on expert witnesses and independent medical examiners in the context of medical malpractice lawsuits. Expert witnesses are hired by either the plaintiff or defense attorney to review medical records and testify under oath whether or not a physician has breached the standard of care. When the opinion of the expert witnesses differ, or the patient has not recently been evaluated, the disputing parties may ask a physician to conduct a single independent examination of the patient as well as a review of medical records; the physician’s written report is submitted to the requesting party and generally made available to the opposing party. For more on acting as an EW or IME, see the Table on page 5 as well as the Hotline. For a discussion of theories of liability, see “Forensic Consulting: From Immunity to Liability,” OMIC Digest, Summer 2003, Vol. 13, No. 3, at www.omic.com.
Diagnostic Services
Comprehensive ophthalmologists, primary care providers, and optometrists may lack the expertise or (latest) equipment to provide their own patients with visual field testing, fundus photography, IOL (intraocular lens) calculations, OCT (optical coherence tomography), fluorescein angiography, or corneal topography. Rather than request a formal consultation, which involves an examination, testing, interpretation, and treatment recommendations and may result in a transfer of care, these health care providers sometimes prefer to exercise greater control over their patients and send them for “testing only.” Our policyholders report being asked to either provide specialized tests or interpret them. At times, these requests come not directly from health care providers but instead from companies that serve as an intermediary between patients and experts. Requests tend to vaunt the benefits for the ophthalmologist. In the case of testing only, the requesting party points out that such tests can be carried out by technical staff, may be billed to the patient’s insurance company, and relieve the physician of the risk of misinterpreting the results. Mindful of the cost of the latest version of his or her notoriously expensive ophthalmic equipment and the talent and skill of staff, the physician may feel inclined to say yes. Companies that provide interpretation of tests emphasize this as a way to increase income, and note that the physician can access and report on the tests at his or her convenience using the internet. What is rarely mentioned is that risks persist that must be mitigated. Moreover, whether providing or interpreting diagnostic tests, ophthalmologists have duties to the patients who undergo them.
The physician who offers tests may be liable for delays in diagnosis caused by malfunctioning equipment and has vicarious liability for training and supervising employed staff. Insurance companies may withhold or challenge payment if the physician is not present in the office during the exam or bills for interpretive services. And patients who are not advised of the limited role the physician plays in the testing may sue the physician for direct liability. To reduce your risks, give patients and referring physicians a copy of the results and a document explaining that: 1) the physician who owns the equipment has an indepen- dent practice; 2) the patient is being referred only for a test; 3) the test will be conducted by non-physician staff; and 4) the physician who owns the equipment will not review records, examine or treat the patient, interpret results, or provide recommendations.
Providing a diagnostic interpretation of a test performed elsewhere can be considered a form of telemedicine, since the images and data are usually sent electronically. Radiologists and pathologists have long furnished this type of medical expertise, and retina specialists may be familiar with centers that read fundus photographs of diabetic patients. More recently, some ophthalmologists have begun remote screening of retinopathy of prematurity. Special underwriting requirements apply to ROP, so contact OMIC immediately if you have not yet had a review of your ROP care. For other kinds of diagnostic interpretation services, conduct a due diligence evaluation of the entity requesting it to determine if its medical directors have the requisite knowledge and experience, and how they are obtaining patient referrals. Ask for a copy of the policies, procedures, and protocols to see if the following issues are addressed there: clinical information provided along with the image, image quality, technical issues, turnaround time, and scope of report (e.g., interpretation only, interpretation plus recommendations for additional tests and treatment, etc.). Check state law to determine if you need a license in the state(s) where the images are taken.
Cosmetic Skin Care Clinics Within an Ophthalmology Practice
As the specialty that pioneered Botox for therapeutic purposes, it is hardly surprising that ophthalmology has also championed cosmetic uses of this medication. Oculofacial plastic surgeons frequently offer many such non-therapeutic services to their patients, ranging from skin care products to laser resurfacing procedures, and we receive calls on our Risk Management Hotline from comprehensive ophthalmologists and other subspecialists who are considering adding cosmetic skin care services. OMIC policyholders need to understand their liability risks and contact us for assistance as needed when assessing these. State medical practice acts do not limit the scope of practice for physicians, so in the event of a malpractice claim, expert witnesses will focus on the standard of care and whether the ophthalmologist has the training, experience, and current competency to provide specific care.
Sometimes, policyholders themselves do not have this expertise but want to hire non-physicians who do; this raises several concerns. First, prescribing a medication and ordering treatment such as laser skin resurfacing almost always falls within a state’s definition of medical practice. If non-physician staff provide Botox, collagen fillers, or laser treatment before a patient is evaluated by a physician and/or without a physician order, they may face allegations of practicing without a license, and the physician may face disciplinary action for aiding and abetting the unlicensed practice of medicine. Many states allow only registered nurses to administer Botox and fillers, and perform laser skin treatment. It goes without saying that malpractice lawsuits arising from such care may be difficult to defend. To reduce liability exposure, contact your state medical and nursing boards to determine what is required of you and who can implement your treatment orders. Ensure that you are competent to supervise all care provided by your staff. If registered nurses manage your skin care clinic, review their evaluation of the patient, confirm patient candidacy, order the treatment, and be available to assist if complications occur.
Medispas Not Associated with a Physician’s Practice
Although the name evokes images of comfort and pleasure, serving as medical director of a Medispa could lead to headaches, uninsured legal risks, and licensure action. Regardless of the site of service, medical care is governed by the state’s medical practice act and scope of practice and pharmacy laws. Call for assistance before getting involved in a Medispa.
Reporting Malpractice Claims to the Government
By Kimberly Wittchow
OMIC Legal Counsel
Digest, Summer 2009
As many of our readers may be aware, the federal government recently passed legislation requiring that liability insurers, such as OMIC, report to the Centers for Medicare & Medicaid Services (CMS) the resolution of claims (by settlement, judgment, award, or other payment) by Medicare beneficiaries for bodily injury and medical payments. OMIC is registered with CMS and is gearing up for submission testing and eventual reporting.
The purpose of this “Section 111” reporting (referring to Section 111 of the Medicare, Medicaid and SCHIP Extension Act (MMSEA) of 2007)1 is to ensure that Medicare makes payments in the proper order or recovers payments when another entity (such as an insurer) is required to pay for covered services before Medicare does. Section 111 requires that OMIC determine whether a claimant or a potential claimant for damages due to bodily injury or medical payments is entitled to receive Medicare benefits. If so, OMIC must report the identity of the Medicare beneficiary whose illness, injury, incident, or accident is the subject of the claim, and provide other information that will enable CMS to appropriately coordinate benefits. The law sets forth procedures that Medicare can use to bring legal action against various parties, including a liability insurer, for failure to make proper reimbursement, and subjects responsible reporting entities (RREs) to fines for noncompliance.
This Section 111 reporting is separate from and in addition to the reports OMIC already sends to the National Practitioner’s Data Bank (NPDB), under another federally mandated reporting scheme. OMIC is required to submit NPDB reports when OMIC makes a payment for the benefit of an ophthalmologist or other health care provider in the settlement or satisfaction of a claim or judgment. (Insureds may have their own reporting responsibilities to the NPDB, as well. See the OMIC Risk Management Recommendations letter titled “Responding to unanticipated Outcomes” found on OMIC’s web site at http://www.omic.com/resource/risk_ man/recommend.cfm#responding.)
In order to trigger OMIC’s reporting responsibility, there must be an exchange of money resulting from a written complaint or claim demanding monetary payment based on the provision or failure to provide health care services. Per the NPDB requirements, OMIC sends a copy of the NPDB report to the appropriate state licensing board. The Health and Human Services Office of Inspector General (OIG) has the authority to impose civil money penalties if these reporting requirements are not met. Whenever the Data Bank receives an NPDB report, it sends a Subject Notification Document to the subject of the report (the OMIC insured ophthalmologist or other health care provider, not the patient).
In addition to this federally mandated Section 111 and NPDB reporting, many states also are seeking reporting of the same or additional claims information through their departments of insurance, departments of health, boards of medicine, or other state agency or department.
OMIC was formed as a risk retention group under the federal Liability Risk Retention Act of 1986 (LRRA) to insure the liability risks of American Academy of Ophthalmology members.2 As a risk retention group, OMIC is governed by only one state, its state of domicile, which is Vermont. This eliminates the need for redundant regulation.3
When these state-specific claims data calls were infrequent and the data sought was minimally burdensome to acquire, OMIC voluntarily complied with the requests. Over the past several years, however, the requests have multiplied and the data sought has increased dramatically. For this reason, OMIC has begun to respectfully decline these requests from the various states. To provide the federally required CMS and NPDB reports, plus detailed closed claims reports in every state, each requiring reporting in a different manner and on different time frames, would be extremely burdensome. This runs contrary to the intent of the LRRA, which is to increase the availability of commercial liability insurance by allowing RRGs to offer insurance nationwide while avoiding regulatory redundancy.
It is OMIC’s position that voluntarily completing such reports would pose a substantial administrative burden, the cost for which would ultimately be borne by our insureds. We are also concerned that our members’ confidential claims data could be subject to potential disclosure under state freedom of information acts, which could be detrimental to our insureds’ interests.
In some states, this may mean that OMIC’s insureds must report claims data that is not on the NPDB report to the licensing agency, department of insurance, or other state governmental entity, as provided by state law. We apologize for any inconvenience this may cause to our insureds, but believe it is in our policyholders’ best interest to resist this encroachment by state agencies outside of Vermont. OMIC, via your appointed defense counsel or claims representative, will be happy to assist you with obtaining the necessary information for the report (for example, the plaintiff’s address or date of birth).
1. 42 USC § 1395y(b).
2. 15 USC § 3901 et. seq.
3. National Association of Insurance Commissioners. Risk Retention and Purchasing Group Handbook. Rev. June 1999, p. 11-2.
