Summer 2001 reporter

TEXAS MEDICAL LIABILITY TRUST
Summer 2001
Reporter
THE NEW HIPAA REGULATIONS
TO DISCLOSE OR NOT TO DISCLOSE
by Robin Bowles, Risk Management Representative Editor’s note: This article is the first in a series on new HIPAA reg- formats that will reportedly provide savings as well ulations. Even as this article goes to press, revisions to the regulations as increase efficiency, thus eliminating the adminis- are being considered. Most believe the revisions will be minor rather trative nightmare caused by the plethora of formats than the hoped for complete overhaul. Expect to see future articles as HIPAA compliance guidelines and revised forms become available. HIPAA applies to all forms of records, not just elec- Begat by the cry for health care reform, the Health tronic records. This was a change from the proposed rule.
Insurance Portability and Accountability Act of 1996 Health care providers will be required to develop a plan (Public Law 104-191), also known as HIPAA, was formu- to secure health information. Health care providers must lated. In a statement released on April 12, 2001, Tommy disclose policies and procedures for use and release of G. Thompson, HHS secretary, stated “President Bush health information to patients. Disclosure for routine wants strong patient privacy protections put in place now.
purposes such as treatment and payment of claims, will Therefore, we will immediately begin the process of require a written authorization from the patient. Providersimplementing the patient privacy rule that will give have full discretion regarding what information is sent to patients greater access to their own medical records and another provider for treatment purposes.
more control over how their personal information is used.” Non-routine disclosures (i.e., employer personnel The HHS office will begin issuing guidelines for imple- decisions, financial institutions determining mortgages mentation. The guidelines are intended to clear up some and other loans or selling mailing lists) will require a of the confusion regarding the impact of this rule on health separate, specific authorization. State laws which provide a higher standard of protection (i.e., mental health, Concerns to be addressed by the guidelines include: substance abuse, HIV/AIDS information) supersede • the ability to have access to necessary medical HIPAA regulations. Of note, the recently approved Texas information on a patient you are treating Senate Bill 11 bans the release of individual patient infor- • patient authorization prior to obtaining consultations mation for marketing purposes without patient consent. • timely and efficient delivery of health care not Patient entitlements include the opportunity to request hampered by confusion regarding consent forms restrictions on the use and disclosure of health information • parental access to information about their children and a disclosure history detailing all entities that received including mental health, substance abuse or abortion health information unrelated to treatment or payment within 60 days of the request. The right to review and copy their own records and to request corrections are also • improving efficiency, security and protection of • standardizing of claim forms to a few universal It has come to our attention that physicians are receiving materials via fax or mail marketing HIPAA compliance programs. Both TMA and TMLT will continue to provide the latest information on HIPAA through publications and in upcoming seminars.
• Examine, if applicable, the following contracts for language that ensures the compliance of “ business asso- Risk management considerations
• Assess your organization by revising existing policies and procedures, integrating the new HIPAA requirements.
Develop additional written policies and procedures as necessary regarding access and release of health information 4. answering services, especially text paging services for your practice including how it will be used and under what circumstances the information would or would not be disclosed to others. Providers may not refuse treatment because the patient refuses consent for disclosure. Thesewritten policies must be provided to your patients. Make Exceptions allowing disclosures without consent/approval
sure they are reasonable, and that you can ensure com- • health care oversight, e.g., quality improvement, pliance. Policies and procedures which are documented but not consistently followed create additional liabilities • public health, national security or defense • research, with IRB or Privacy Board approved These policies and procedures must include the • judicial, law enforcement and administrative pro- 1. Routine disclosure policy and consent form 2. Non-routine disclosure policy and consent form which ensures informed and voluntary consent 3. Policy on handling of inquiries or patient complaints If there is no other law requiring that information be
about privacy issues and a log for documenting disclosed, exercise your own judgment according to your
policies and ethical principles.
4. Policies should state that, except when transferred for the purpose of further treatment, the minimum The date for physician practice compliance is April 14, amount of information necessary should be dis- 2003. The law provides for significant financial penalties closed. Release authorizations should be specific.
• Establish documentation requirements for release of records which could include a file check-out log and med- • maximum penalty for all violations of an identical • Conduct and document a risk assessment which examines your business practices and physical facility for Wrongful Disclosure of Individually Identifiable Health • Conduct and document training for employees to • wrongful disclosure offense: $50,000, imprisonment ensure the internal protection of medical records. All employees should sign a confidentiality agreement which • offense under false pretenses: $100,000, imprison- ment of not more than 5 years, or both.
• Designate a privacy officer to ensure that procedures • offense with intent to sell information: $250,000, imprisonment of not more than 10 years, or both.
• Provide physical safeguards for the medical records, The regulations can be downloaded from DHHS’s web computer systems, building and equipment from fire and site at www.aspe.os.dhhs.gov/admnsimp/.
other environmental hazards, as well as intrusion.
Recommendations include daily back-up of patient infor- mation, storage of back-up diskette in a fire-proof safe and locking cabinets or rooms for record storage.
2. Tieman, Jeff. Modern Healthcare. March 26, 2001. • Implement protection, control, monitoring and access prevention processes to safeguard data transmitted over 3. www.physiciansnews.com/law/401kahn-oth- R I S K A L E RT M E S S AG E
TEXAS MEDICAL LIABILITY TRUST
SPECIAL PHARMACEUTICAL ANNOUNCEMENTS
Celebrex
On February 1, 2001, the Food and Drug Administration (FDA) issued a letter to the manufacturers of Celebrex
(celecoxib), addressing repeated violative promotion of Celebrex. Pharmacia Corporation has engaged in promotional
activities that minimize the potentially serious risk of using Celebrex and Coumadin (warfarin) concomitantly. The
minimization of the risk raises significant public health and safety concerns because it minimizes the risk of significant
bleeding. On two previous occasions, the FDA issued letters to Pharmacia objecting to the promotional materials for
Celebrex that, among other violations, minimized the Celebrex/Coumadin drug interaction. Pharmacia assured the
FDA that corrective steps had been taken in order to prevent future violations of this type; however, the activities have
continued.
The violations include promotional audio conferences presented on behalf of Pharmacia by Dr. James McMillen. Programs present false and/or misleading information, including: • minimizing Celebrex/Coumadin interaction• minimizing contraindication in patients with allergic-type reactions to sulfonamides• omission of important risk information (i.e. contraindication in patients experiencing allergic-type reactions with aspirin or other NSAIDs, liver and kidney disease, late pregnancy, as well as the possibility of GI toxicity) • unsubstantiated comparative claims (i.e. stating Celebrex is safer than other NSAIDs in combination with Coumadin)• promotion of unapproved new use and dosing regimen (i.e. Celebrex is safe and effective in treatment of acute pain) Violations also include a four-sided card and a wall chart used as sales aids that are false and misleading as they mini-mize the importance of Celebrex’s contraindication in patients who have demonstrated allergic-type reactions to sulfonamides.
The FDA requested a written response containing an action plan to disseminate corrective messages about the issuesto the audiences that received these misleading messages. Pharmacia must also issue a “Dear Healthcare Provider”letter to correct false or misleading impressions and information. To our physicians
• Be aware of misleading pharmaceutical information related to Celebrex.
• Review all Celebrex promotional information in your office for above violations.
• Question patients regarding previous allergic-type reactions to sulfonamides, aspirin and other NSAIDs prior to
• Question patients regarding liver, kidney and GI disorders prior to prescribing Celebrex. • Use caution in concomitant use of Coumadin and Celebrex.
• Closely monitor prothrombin time if prescribed for patients on Coumadin.
• Instruct patients in possible side effects and to report unusual symptoms.
Sporanox and Lamisil
On May 9, 2001, the FDA issued a Public Health Advisory to announce important safety-related updates to the label-
ing of Sporanox (itraconazole) and Lamisil (terbinafine hydrocholoride) Tablets. It is important for physicians to be
aware of the association of congestive heart failure (CHF) and hepatic adverse events with the administration of these
therapies.
The FDA is advising health care professionals not to prescribe Sporanox to treat fungal infections (onychomycosis) inpatients who have CHF or a history of CHF. The FDA believes that there is a small but real risk of developing CHFassociated with Sporanox therapy. Rare cases of CHF and pulmonary edema have been reported in the post-marketingperiod in patients treated with Sporanox capsules. Studies show that once the drug was discontinued the negativeinotropic effects resolved. Both Sporanox and Lamisil have been associated with serious hepatic toxicity including liver failure and death. Somecases involve patients who had neither pre-existing liver disease nor a serious underlying medical condition.
The FDA concerns about hepatic risks associated with the use of Lamisil do not apply to topically applied formula-tions of terbinafine, such as Lamisil Solution and Lamisil AT Cream.
Janssen Pharmaceutica Products, L.P. and Ortho Biotech Products issued a “Dear Health Care Professional” letterinforming providers of the cardiac risks associated with Sporanox therapy, including a package insert with the BoxedWarning.
For more information on these announcements, please contact the FDA at www.fda.gov/cder or Janssen Pharmaceutica Products at us.janssen.com.
Liability
The physicians of Texas are all too familiar with the These conditions, however, are not just occurring in Texas.
Nationwide, claim frequency and severity are at record levels. Jury current conditions in the medical liability industry — awards for malpractice claims jumped 7 percent in one year, from$750,000 in 1998, to $800,000 in 1999, according to data from Jury million dollar jury verdicts, lawsuit abuse, mass Verdict Research. The 1999 amount represents a 76 percent increaseover the 1996 figure of $454,000. Additionally, about 45 percent of the litigation, 20, 30 or 40 percent increases in rates for jury awards in 1998-1999 were $1 million or more, compared with 39 malpractice insurance. Once-entrenched insurance percent in 1997-1998. These increases occurred even though plain-tiffs won 2 percent fewer cases in 1999 than in 1998.
carriers are leaving the state, others are mired with As jury awards increase, so do the costs to settle malpractice claims. In 1999, the national median settlement amount reached financial difficulties, and serious questions are being $650,000, a 30 percent increase from 1998. 1 raised about the availability and affordability of medical High damage awards and the resulting malpractice premium increases are stretching the budgets of clinics, hospitals, and physi- liability coverage. A crisis is looming. cian practices across the country. According to the Medical Liability Summer 2001 5
Monitor, liability insurance premiums increased nationally by an Society will devote resources to state Supreme Court and other judi- average of 14.5 percent in 2000. The newsletter predicts they will cial races to ensure a favorable judicial environment for tort reform. increase again in 2001 by an average of 14.6 percent. 2 The severity of rate hikes varies widely by state and medical spe- West Virginia
cialty, and some states have been hit harder than others. However, Physicians in West Virginia are facing a similar situation. Over the the effects are especially apparent in states that lack strong tort past five years, one in two insured physicians were sued in West reform. Physicians in Pennsylvania and West Virginia are experi- Virginia, according to data from Medical Assurance, which repre- encing some of the highest rate increases in the country. sents 60 percent of physicians in the state. And while physicians won85 percent of the suits filed against them, settlements, jury awards Pennsylvania
and legal fees have driven insurance costs up. According to the West “Our analysis shows that Pennsylvania’s health care system has Virginia State Medical Association, average premiums rose 35 become like the Titanic. The bow is scraping against an iceberg and we’re all feeling tremors throughout the ship as we take on water.
Obstetricians practicing in the state pay an average of $75,000 for And, yes, like the Titanic, Pennsylvania’s health care system is in seri- liability insurance, while these same specialists pay $26,000 in ous danger of going under,” said, Carol E. Rose, MD, president of the Tennessee, $48,000 in Ohio and $29,000 in Virginia. West Virginia Pennsylvania Medical Society in testimony before the Pennsylvania internal medicine physicians pay an average of $12,500 per year, while premiums for their colleagues in Kentucky average $6,400. 11 In addition to purchasing malpractice insurance, physicians in To make matters worse, West Virginia’s $1 million cap on Pennsylvania are required to pay a surcharge to underwrite the non-economic damages for malpractice claims, the state’s primary Medical Professional Liability Catastrophe Loss Fund (CAT). The tort restraint, has been challenged in the state supreme court twice.
CAT fund provides $700,000 of malpractice coverage, but It survived the most recent constitutional challenge, but by a slim Pennsylvania physicians are required to carry $1.2 million as a margin. In the latest case, a jury tried to award a plaintiff $2.5 millioncondition of licensure. The $500,000 balance must be purchased in even though West Virginia had a $1 million cap. The case involved a the private sector. In 2001, Pennsylvania insurance carriers raised patient who died from complications following anti-reflux surgery. 12 rates from 21 to 60 percent, and the CAT fund surcharge increased In February, more than 1,000 West Virginia physicians and other from 7 to 56 percent.4 Increases in CAT fund payments have been health care professionals visited the state capitol to discuss the attributed in part to the 1998 collapse of two medical malpractice malpractice crisis and the need for tort reform with legislators. The insurers, PIC Insurance Group of Montgomery County and PIE WVSMA will continue to work with legislators to draft reforms, and has launched judicial awareness campaigns.
Pennsylvania has always been among the states with the highest professional liability costs. According to the Pennsylvania Medical The solution
Society, obstetricians/gynecologists who practice in the Philadelphia The situation in West Virginia, Pennsylvania and Texas looks even region pay an average of $84,000 in malpractice premiums, while worse when compared with conditions in states that have enacted ob/gyns in New Jersey pay about $58,000, and in Delaware, $52,000.
strong tort reform measures. There is compelling evidence that Neurosurgeons pay $111,000 for coverage in Philadelphia, but $75,000 medical liability reform can protect both physicians and patients.
Long considered the “gold standard” of tort reform legislation, A main reason for the high rates in Pennsylvania — the state is California’s Medical Injury Compensation Reform Act was enacted plagued by huge jury awards and settlements. In 2000, a Philadelphia in 1975 in the midst of a medical liability crisis in the state. MICRA jury awarded $100 million verdict against four doctors and two contains several elements, such as a $250,000 cap on non-economic hospitals in a malpractice case involving surgeries and other care for damages and limits on attorney contingency fees, and has a proven an infant born after 26 weeks gestation. Prior to that $100 million track record in reforming an unruly system and ensuring fair pay- dollar verdict, Philadelphia juries had returned malpractice awards of $55 million and $49.6 million in two other cases. 7 “According to Jury Verdict Research, for the years 1994-1999, the The number of Philadelphia malpractice verdicts over $1 million median malpractice jury verdict in Pennsylvania was $650,000. In increased 75 percent from 1998 to 1999, putting the state in second contrast, over the same period of time, the median malpractice jury place for the highest median malpractice payment in the nation. (New verdict in California was only $350,000. The difference – California York has the highest.) From 1991 to 1998, aggregate payments made has had meaningful tort reform in place for 25 years,” said Dr. Rose. 13 for Pennsylvania physicians and other practitioners increased more Malpractice cases in Philadelphia alone generated more payout than 90 percent from $193 million to $370 million. 8 in 1998 than did malpractice cases in the entire state of California. 14 In response to the conditions in their state, the Pennsylvania Physicians in California also pay substantially lower rates for mal- Medical Society began lobbying the state legislature for a variety of practice insurance. The average rate for neurosurgeons in tort reforms, including a rollback of the constitutional prohibition on Pennsylvania’s highest rated territory is $111,296, compared with damage award caps. Lobbying efforts were intense. On several $58,164 in California — a 50 percent difference. 15 occasions, hundreds of Pennsylvania physicians shut down their Physicians in only a few states, including Utah, Colorado and practices and visited the state capitol to lobby for tort reform. Earlier Montana, enjoy this same kind of comprehensive tort reform. More in the year, a dozen orthopaedic surgeons at a Frankford, Pa., hospi- than 25 states have some reforms in place, but statutes are repeatedly tal decided not to renew their insurance coverage and stopped challenged in state court, and either scaled back or struck down alto-operating. The move forced the hospital to shut the trauma unit and gether. Moderate reform measures passed in Pennsylvania in 1996 send patients to other hospitals for four days. 9 were overturned a few weeks later by the state’s supreme court. The In addition to their lobbying efforts, the Pennsylvania Medical Illinois Supreme Court in 1997 struck down reforms passed in 1995, and in 1999, the Ohio Supreme Court completely overturned thatstate’s reforms. Even in California, tort reform advocates must standready to defend MICRA reforms from legal challenges. 16 Absent strong state or federal medical liability reform, conditions MICRA’s basic provisions
in Pennsylvania, West Virginia, Texas and other states will continueto deteriorate. Andrew Wigglesworth, president of the DelawareValley Healthcare Council in Pennsylvania, summed up the frustra-tion felt by the physicians in his state. “We have virtually none of the Limits on non-economic damages
tort reforms that other states have . . . We need an equitable system Non-economic damages in a claim against a health care that compensates people fairly but doesn’t result in excessive awards provider for medical negligence are limited to $250,000.
that, as a society, we can’t sustain.” 17 Economic damages, such as lost earnings, medical care, andrehabilitation costs, are not limited by statute. 1. Jury Verdict Research. Current Award Trends in Personal Injury.
Evidence of collateral source payments
2000 ed. Horsham, Pa: LRP Publications; 2001.
A defendant in a medical liability action may introduce evi- 2. Trends in 2000 rates for physicians’ medical professional liabil- dence of collateral source payments (such as from personal ity insurance. Medical Liability Monitor. 2000;25.
health insurance) as they relate to damages sought by the 3. Rose C. Affordability and availability of medical malpractice claimant. If a defendant introduces such evidence, the claimant insurance. Testimony presented to: Pennsylvania Senate Judiciary may also introduce evidence of the cost of the premiums for Committee and Pennsylvania Senate Banking and Insurance Committee; February 9, 2001; Harrisburg, Pa.
4. Wagner L. Malpractice awards, costs on the rise: states without Limits on attorney contingency fees
tort reform experiencing the largest increases. Physicians Financial In an action against a health care provider for professional negligence, an attorney’s contingency fee is limited to 40 5. La Torre D. Insurance bitter pill for doctors to swallow: med- percent of the first $50,000 recovered; 33 percent of the next ical malpractice premiums are driving some doctors out of state. The $50,000; 25 percent of the next $500,000, and 15 percent of any Morning Call. May 29, 2001: A1.
6. Pennsylvania Medical Society. Medical liability reform: did you know that . . . Harrisburg, Pa: 2001. LRAC fact sheet F7-01416. Advance notice of a claim
7. Stark K. In Philadelphia, malpractice awards have ‘gone hay- To further the public policy of resolving meritorious claims wire.’ The Philadelphia Inquirer. December 10, 2000:A1.
outside of the court system, MICRA requires a claimant to give a 8. Rose C. Affordability and availability of medical malpractice 90-day notice of intention to bring a suit for alleged professional insurance. Testimony presented to: Pennsylvania Senate Judiciary negligence. If the notice is given within 90 days of the expiration Committee and Pennsylvania Senate Banking and Insurance of the statute of limitations, the statute is extended 90 days from Committee; February 9, 2001; Harrisburg, Pa.
9. Wiggins O. Doctors protest premium increases. The Philadelphia Statute of limitations
10. Albert T. West Virgnia Supreme Court upholds limits on mal- In California, a claim for alleged medical negligence must be practice awards. American Medical News. February 5, 2001.
brought within one year from the discovery of an injury and its 11. Trends in 2000 rates for physicians’ medical professional lia- negligent cause, or within three years from injury. bility insurance. Medical Liability Monitor. 2000;25.
12. Albert T. West Virgnia Supreme Court upholds limits on mal- Periodic payments of future damages
practice awards. American Medical News. February 5, 2001.
A health care professional may elect to pay a claimant’s future 13. Rose C. Affordability and availability of medical malpractice economic damages, if over $50,000, in periodic amounts. This insurance. Testimony presented to: Pennsylvania Senate Judiciary avoids a claimant’s wasting of an award prior to actual need. Committee and Pennsylvania Senate Banking and InsuranceCommittee; February 9, 2001; Harrisburg, Pa.
Binding arbitration of disputes
14. Stark K. In Philadelphia, malpractice awards have ‘gone hay- Patients and their health care providers may agree that any wire.’ The Philadelphia Inquirer. December 10, 2000:A1.
future dispute may be resolved through binding arbitration.
15. Rose C. Affordability and availability of medical malpractice California statute requires specific language for such contracts insurance. Testimony presented to: Pennsylvania Senate Judiciary and also provides that all such contracts be revocable within 30 Committee and Pennsylvania Senate Banking and Insurance Committee; February 9, 2001; Harrisburg, Pa.
16. Maguire P. With malpractice costs skyrocketing, some physi- cians are talking ‘crisis’. Am Coll Physicians Obs. April 2001.
17. Stark K. In Philadelphia, malpractice awards have ‘gone hay- wire.’ The Philadelphia Inquirer. December 10, 2000:A1.
Summer 2001 7
Update on VBAC — Vaginal
by Jane Mueller, Director, Risk Management Department after thorough counseling regarding the risks and benefits.
Following discussion with the patient outlining the risks A trial of labor after previous cesarean delivery has been and benefits, consider using a printed informed consent to accepted by the health care community as a method to document the discussion and the patient’s understanding lower the overall cesarean delivery rate. The American of the discussion. (Please see sample on facing page.) College of Obstetricians and Gynecologists (ACOG) The ACOG bulletin describes candidates and recom- Practice Bulletin Vaginal Birth After Previous Cesarean mendations for trial of labor. Candidates include “most Delivery (Number 5, July 1999) indicated that the cesarean women with one previous cesarean delivery with a low- delivery rate in 1995 was high (27.5 percent). 1 Repeat cesare- transverse incision.” 12 The bulletin further states a physician an births accounted for one-third of all cesarean deliveries.
should be “immediately available throughout active labor The cesarean delivery rate in the US increased from 5 percent capable of monitoring labor and performing an emergency to 20.8 percent between 1970 and 1995 without significant As indicated above, VBAC is associated with a small but Improvements in obstetric care made trial of labor fol- significant risk of uterine rupture.13 ACOG recommends lowing cesarean delivery safer for both mother and infant.
that a trial of labor should not be attempted where there is However, the concept of VBAC is not universally accepted.
an “inability to perform emergency cesarean delivery In 1981, in conjunction with the National Institutes of because of unavailable surgeon, anesthesia, sufficient staff Health, ACOG encouraged trial of labor in an effort to or facility.” Such situations may influence the decision to rec- decrease the number of repeat cesarean sections.
ommend repeat cesarean delivery in lieu of VBAC.
Despite the numerous citations in the literature, there Discussions with the patient should be documented and are no randomized studies to prove across the board that should include information necessary for the patient to maternal and neonatal outcomes are better with VBAC than with repeat cesarean delivery. Published evidence Since the publication of the bulletin, there has been suggests that the benefits of VBAC outweigh the risks in much debate among obstetricians regarding the criteria most women with a prior low-transverse cesarean delivery.
recommending that a physician capable of monitoring labor However, most VBAC studies have been conducted in uni- and performing an emergency cesarean delivery be imme- versity or tertiary-level centers with in-house staff coverage diately available throughout active labor. and anesthesia. Few studies have been done which would In April 2000, Stanley Zinberg, MD, MS, FACOG, on provide information about VBAC outcomes in smaller behalf of the College, issued a statement confirming the need for those institutions offering VBAC to have facilities In assessing patients as potential candidates for VBAC, and personnel immediately available to perform emer- physicians should review the risks and benefits. When gency cesarean delivery when conducting a trial of labor VBAC is successful, it is associated with less morbidity for women with a prior uterine scar.
than repeat cesarean delivery. The advantages include Recognizing the implications such “ immediate availability” fewer blood transfusions, fewer postpartum infections and has for smaller hospitals, obstetricians and the incidence of shorter hospital stays. 7,8,9 Most recent studies indicate that VBAC in general, the College notes uterine rupture, Discussions with the patient should be documented and should include
information necessary for the patient to make an informed decision.
major maternal complications such as uterine rupture, hys- although rare, has the potential for significant conse- terectomy and operative injury were more likely for quences for both mother and infant. Among these ruptures, women who underwent a trial of labor than for those who the rate of serious maternal and/or fetal morbidity or elected repeat cesarean delivery.10 Although rates could mortality is 10-25 percent. 14 Since VBAC is an elective differ based on many variables, the overall occurrence of procedure, caution needs to be used in assuming this small uterine rupture in women who underwent a trial of labor but significant risk. Dr. Zinberg states, “the operational def- after a previous low-transverse incision is estimated at 0.2- inition of ‘immediately available,’ personnel and facilities remains the purview of each local institution, and the It is reasonable for women to undergo a trial of labor in College strongly encourages these institutions to make the a safe setting, but the potential complications should be necessary resources available for eligible patients.” 15 thoroughly discussed with the patient and family and Statistically, patient outcomes should improve with thedocumented. The ultimate decision as to whether to availability of a physician who can immediately perform attempt a trial of labor or undergo an elective repeat cesarean cesarean deliveries in the event of a complication. delivery should be made by the patient and her physician Uterine rupture can occur in spite of excellent clinical Birth After Cesarean
care, and those cases are increasingly involved in litigation.
It is helpful to the doctor’s defense if he/she has docu- mented his or her discussions with the patient, obtainedthe patient’s consent to proceed with VBAC, and beenavailable for an immediate c-section in the event of an Informed consent for patients with previous Cesarean birth
In Evaluation of Cesarean Delivery published by the 1. I understand that I have had one or more prior cesarean(s) with an incision in the College in 2000, the issues confronting physicians relatedto VBAC were again addressed. It indicates that in most 2. I understand that I have the option of undergoing an elective repeat cesarean or attempting a vaginal birth after cesarean (VBAC).
cases, the cause of uterine rupture in a patient who hasundergone VBAC is unknown, but poor outcomes can 3. I understand that approximately 50-80 percent of women who undergo a VBAC result even in appropriate candidates with proper man- will successfully deliver vaginally.
agement. It also reinforces the need for physicians, 4. I understand that the risk of uterine rupture during VBAC in someone such as anesthesia and other personnel to be available to perform myself, who has had a prior incision in the non-contracting part of my uterus, is around 1 percent.
an emergency cesarean delivery in the event of a complica-tion. A number of studies indicate that a VBAC program 5. I understand that in all labors, emergency complications may occur that may not allow sufficient time to operate and prevent the death or injury of my baby. The can be a safe and important component of hospital-based risk can occur not only in VBAC trials, but also in normal vaginal deliveries.
programs to reduce the number of unnecessary cesarean 6. I understand that the decision to have a VBAC is entirely my own and the option of an elective repeat cesarean has been discussed with me.
Doctors should, whenever considering a VBAC, discuss 7. I understand that VBAC carries a lower risk to me than does cesarean delivery.
the risks and benefits with the patient, and document thosediscussions in the medical record. If the patient chooses to 8. I understand that if I deliver vaginally, I most likely will have fewer problems proceed with a trial of labor, then the patient after delivery and a shorter hospital stay than if I have a cesarean delivery.
should also be appropriately documented. Please contact 9. I understand that, in a majority of cases where an urgent cesarean is needed, there ACOG for copies of the above referenced bulletins.
will still be no ill effects to myself or my infant but occasionally urgent surgery may result in increased blood loss that requires a blood transfusion. In rare cases, the removal of my uterus may be necessary.
References
10. I understand that if I choose a VBAC and end up having a cesarean during labor, I have a greater risk of problems than if I had had an elective repeat cesarean.
1. Curtin SC. Rates of cesarean birth and vaginal birth after previous cesarean, 1991-95. Monthly vital statistics report; This form has been fully explained to me and I have read the ACOG brochure on VBAC and vol 45, no. 11 (suppl 3). Hyattsville, Maryland: National inquired about any risks or benefits of a vaginal birth after cesarean section. All questions have been adequately answered by the physician and staff. 2. Centers for Disease Control. Rates of cesarean delivery — United States, 1991. MMWR Morb Mortal Wkly Rep 1993; 42: I want to attempt VBAC ___________ I want a repeat cesarean section __________ 3. Stafford RS, Alternative strategies for controlling rising cesarean section rates. JAMA 1990; 263: 683-687.
Patient’s signature __________________________________ Date ___________________ 4. American College of Obstetricians and Gynecologists.
Witness’ signature __________________________________ Date ___________________ Vaginal delivery after previous cesarean birth. ACOG PracticePatterns 1. Washington, DC: ACOG, 1995. 5. Hawkins JL, Gibbs CP, Orleans M, Martin-Salvaj G, Beaty B. Obstetric anesthesia work force survey, 1981 versus1992. Anesthesiology 1997; 87: 135-143. 12. ACOG Practice Bulletin: Clinical Management Guidelines 6. Scott JR. Avoiding labor problems during vaginal birth for Obstetrician-Gynecologists. 1999. after cesarean delivery. Clin Obstet Gynecol 1997; 40: 533-541.
13. Framer RM, Kirschbaum T, Potter D, Strong TH, 7. Flamm BL, Newman LA, Thomas SJ, Fallon D, Yoshida Medearis AL. Uterine rupture during trial of labor after previ- MM. Vaginal birth after cesarean delivery: results of a 5-year ous cesarean section. Am J Obstet Gynecol 1991; 165:996-1001.
multicenter collaborative study. Obstet Gynecol 1990; 76: 750-654. 14. Jones RO, Nagashima AW, Hartnett-Goodman MM, 8. Flamm BL, Goings JR, Liu Y, Wolde-Tsadik G. Elective Goodlin RC. Rupture of low transverse cesarean scars during repeat cesarean delivery versus trial of labor: a prospective trial of labor. Obstet Gynecol 1991;77:815-817. multicenter study. Obstet Gynecol 1994; 83: 927-932. 15. Leung AS, Farmer RM, Leung EK, Medearis AL, Paul 9. Rosen MG, Dickinson JC, Westhoff CL. Vaginal bith after RH. Risk factors associated with uterine rupture during trial of cesarean: a meta-analysis of morbidity and mortality. Obstet labor after cesarean delivery: a case-control study. Am J Obstet Gynecol 1991; 77: 465-470 (Meta-analysis) 10. McMahon MJ, Luther ER, Bowes WA Jr, Olshan AF.
16. Zinberg S. College recommendations on VBAC based Comparison of a trial of labor with an elective second cesare- on risk of uterine rupture. ACOG 1999;44(4):2.
an section. N Engl J Med 1996; 335:689-695. 17. Zinberg S. Cesarean delivery resources need to be avail- 11. Pridjiian G. Labor after prior cesarean section. Clin able during VBAC trial of labor. ACOG 1999;43(6):2.
Summer 2001 9
HEALTH LITERACY
by Barbara Rose, Risk Management Representative he cornerstone of health care lies withinthe physician-patient relationship and developed between the patient andthe plethora of health care providershe/she may encounter. How can it bethat the following statistics apply toone of the most advanced countriesin the world? Health care literacy: the numbers
Education conducted the NationalAdult Literacy Survey (NALS) toexamine literacy in terms of everydayfunctional tasks.1 Of the 26,000American adults interviewed, 15 per-cent were born outside the UnitedStates; the majority with low literacywere white and native born. Amongthe NALS findings: • 22 percent of adult Americans arefunctionally illiterate (they cannot pitalizations) is $73 billion dollars per services. Am J Public Health. 1997; 87: es. J Gen Int Med. 1999 In Press.
ship to health care costs. J Health Care Poor Underserved. 1994; 5: 99-111.
literacy. In Weiss B., ed. 20 Common Problems in Primary Care. New York, Pfizer Conference on Health literacy.
patients’ literacy skills. J Gen Intern the Institute of Medicine, To Err Is tion. Patient Educ Couns. 1996; 27: 33- aged care organization. JAMA; 1999; Summer 2001 11
perspective
by Howard Marcus, MD, Chairman, TMLT Board of Governors discussion has already been joined by the away from the next legislative session.
Texas Medical Association, various regional juries awarding amounts out of touch with medical societies, insurance and reinsurance reality, and of course increasing medical carriers, defense attorneys, individual physi- malpractice premiums to pay for it all.
cians, and associations representing different proud to be able to play an active role in When will this vicious cycle slow down or bringing this effort about. Medical Liability come to a halt? That’s the million (or multi- reform goes to the heart of our profession, million) dollar question we’re all asking around the discussion table, we have also which is to provide affordable health care started collecting information from other to all who need it. Medical Liability Reform states in which the malpractice climate is not information with its policyholders explain- in the crisis stages like it is in Texas. There ing the underlying factors of this crisis. We is no time to waste. We are only 17 months in accomplishing these important goals.
have also made suggestions to physiciansand others to talk to legislators, to talk topatients, and to put the spotlight on thisunbearable situation any time the occasionarises. We need to get the message out thatthe legal profession is benefiting at the Need CME?
expense of the consumer, who ultimatelypays the price in higher health care costs, ifthey can afford it at all.
Earn CME without leaving your home or office with TMLT’s new online risk management course, Fraud and Abuse
to take the dimmer switch off the spotlight Prevention: What Physicians Need to Know.
and to give this crisis the attention itdeserves. I am pleased to report, therefore, Learn about federal and state health care fraud and abuse that we are in the process of forming a con- laws and how to develop a compliance plan to help avoid sortium to tackle this problem. The goal of common errors. This course is currently available at this group is to promote legislation to get this “malpractice liability disease” undercontrol. We are not talking about tort By completing this course, you can receive: reform as it took place in 1995. While that may have been an attempt in earnest to get • 4 hours of education in medical ethics/professional a handle on out-of-control litigation, it turned out that its long-term effect on med- • 3 percent premium discount (not to exceed $1000) ical liability was minimal. Instead, our groupwants to focus on medical liability exclu- For more information or to see additional course offerings, please visit the TMLT web site at www.tmlt.org or call (800) benefits to the patients and to the healthcare system overall.
TEXAS MEDICAL LIABILITY TRUST
participate in this effort? While the consor-tium is still in its formative stages, the 12 Summer 2001
RISK hot topics
MANAGEMENT
Arbitration agreements
Attorney contacts with physicians
Is an arbitration agreement included in your con- This topic was addressed in a 2000 Reporter issue but bears repeating as TMLT’s claim and risk man- A recent risk management call revealed the need agement departments are frequently reminded that to remind our policyholders to confirm that forms our policyholders may be contacted directly by an signed by patients do not place the physician in an attorney. When physicians receive any calls from attorneys representing a patient or another party or Although TMLT appreciates physician efforts to potential party to litigation with a claim against manage liability exposures, the use of an arbitra- another physician, caution is the key. Bear in mind tion agreement is in violation of the terms of your that both defense and plaintiff attorneys have a client TMLT professional liability policy under Coverage Agreement B: “The Trust shall have the right and Whether a request to “answer a few questions duty to defend any claim or lawsuit brought with- over the phone,” “to schedule an appointment at in the United States of America or Canada seeking your office to discuss the represented patient with compensatory damages against the Named Insured another party as defendant,” or “to schedule a dep- under the terms of this policy, even if any of the osition,” it is unwise to agree to these requests.
allegations of such claim or lawsuit are groundless, TMLT advises that our policyholders not engage in these one-on-one exchanges with attorneys with- In addition, Texas law provides that no health out first contacting a representative of the claim care provider can require or even request a patient or prospective patient to sign an agreement to arbi- Establish a policy for the practice. Educate staff, trate a liability claim unless the form contains a and follow the procedure as written. Include the written notice that the agreement is invalid without name of the attorney/law firm, the plaintiff, the the signature of the patient’s attorney. The notice defendant, and determine the nature of the request.
must be in 10-point boldface type clearly and con- Then notify the TMLT claim department of the request and follow the directives given.
Beware of a sense of security or complacency in thinking it harmless to answer a few questions because the claim is not against you. Physicians have on many occasions agreed to a deposition or informally talked with an attorney and subse- quently found themselves added to the suit. Once a RIGHTS, INCLUDING YOUR RIGHT TO A JURY.
physician has gone on the record, even with assur- ances he/she will not be named in the suit, they are often added to the lawsuit. Apologies may be ATTORNEY. (Texas Civ. Stat. Ann. Art. 4590i, s.
extended by the attorney, but the reasoning will be it had to be done to properly represent the client.
There are cases where physicians’ comments havebeen recorded without their knowledge.
Write a policy and procedure for your practice and always notify the claim department if youreceive requests of this nature. Allow our staff theopportunity to research the situation and then fol-low their guidelines.
Summer 2001 13
claimstudies
Failure to perform an adequate exam and alteration of medical records by Michele Luckie, Risk Management Representative The following closed claim studies are based found the physician’s records to be inade- on an actual malpractice claim from TMLT. These records document a clinical exam showing a quate and difficult to defend. The re-created cases illustrate how action or inaction on the part 5 x 6 centimeter necrotic area, a large area of records were inconsistent with the develop- of a physician led to allegations of medical mal- erythema surrounding the rectum and a ment of the patient’s disease process. Although practice, and how risk management techniques fistula draining purulent debris. She was the progression of a perirectal abscess to may have either prevented the outcome or referred by a colorectal surgeon to a tertiary necrotizing fasciitis occurs dramatically and increased the physician’s defensibility. An attempt hospital where a loop sigmoid colostomy and quickly, the common opinion of the consult- has been made to make the material less easy to identify. If you think you may recognize your own formed. She was found to have a large area case, please be assured it is set forth solely for the been positively diagnosed with erythema, it purpose of assisting and educating Texas physi- diagnosis of fistula, perirectal abscess and is difficult to believe there was no erythema cians. It is our intention to keep confidential any necrotizing fasciitis (Fournier’s gangrene) or progression of the disease process in the identifying information that is not already part of period from the ER visit to the visit with the During a three-month stay in the hospital, family physician. The lack of findings on the patient had multiple debridements physical exam by the family physician did not appear consistent with the findings 24 diabetes, renal failure and respiratory insuf- hours earlier or 24 hours later. Based on this ficiency. According to the discharge summary, inconsistency, it was questioned whether a onset of rectal/perirectal pain, worse with the patient was fairly stable with the physical exam was done at all.
bowel movements and sitting. She also had expectation that she could be discharged to a long-term facility in the near future. The patient suffered a sudden hypoxic respiratory an area around the rectum. The patient’s behalf of the family physician and $200,000 history indicated medical problems including the nature of her existing medical problems, on behalf of his practice association. The re-creation of the medical records and the attorney, signed a DNR order and the patient inconsistencies in the re-creation were major factors in the settlement of this case.
• Failure to perform an adequate exam to final diagnosis of anal fissure and fistula. The diagnose necrotizing fasciitis. (The delay timely manner is essential to having a com- patient was discharged to follow up with her resulted in a long hospitalization leading to effort should be made to ensure that, by the end of each day, all patient visits have been following day. There were no charted notes appropriately charted. The outcome of this found for this visit. Five months later, this case may have been different if the family physician signed an Affidavit of No Record Breach of duty is any violation or omission physician had made a thorough entry in the for this visit. They were created after the of a legal or moral duty. The neglect or fail- patient’s chart at the time of her visit physician was put on notice of this claim, ure to fulfill in a just and proper manner the regarding his examination and assessment.
more than seven months after the visit. In duties owed to the patient, such as obtaining Defense experts felt they had a strong case in these re-created notes, he indicated he exam- past medical history, performing a complete support of the physician. This was based on ined the patient, found an anal fissure and an physical exam or appropriate testing, may be several consultants’ review of the case that external hemorrhoid, and cleared the patient found to be a breach of duty which can contri- believed the patient’s decline would not have bute to allegations of improper performance.
been prevented if she had been admitted a The primary strength of this case was day earlier. It could have been argued that family physician, the patient presented to a the progression of her condition to an emer- patient’s course would not have been altered gent status might or might not have been her daughter, with nausea, vomiting, weak- had she been admitted to the hospital by the ness, rectal bleeding and blood sugar of 690 family physician. However, the consultants continued on the bottom of page 15 14 Summer 2001
Failure to inform and alteration of medical records by Lynne Dakers, JD, Risk Management Representative operations. In this regard, there is some indi- this type of injury does not have a persuasive A 36-year old man with a history of exces- cation in the record that the plaintiff’s attorney visceral appeal to a jury that would have sive sweating on his hands presented to a intended to make the physician’s web site an thoracic surgeon for treatment of his hyper- issue. In addition, there was the magazine ad In this particular case, it was principally hidrosis. The patient had seen an ad in a mag- which had brought the patient to the physi- the alteration of records that weighed against azine in which the thoracic surgeon indicat- the physician. Because the change in records ed several treatment options for persons with was expressly to add an indication in the chart hyperhidrosis. The patient told the physician alteration of the patient’s medical chart by the condition had been a life long problem, the physician. Some time after the surgery operatively about the very surgical compli- which affected him socially and profession- occurred, the physician made a late entry on cation he developed, it could be persuasively ally. The patient said he had tried numerous the page referencing the risks and complica- argued that, since the physician admittedly medical therapies with no success, and he tions involved with the bilateral thoracic altered the medical records there is a strong came to the physician to learn more about possibility that he did not, in fact, advise the patient of the complication involving com- • Failure to offer other non-surgical treat- other non-surgical treatments available. The physician told the patient what a sym- • Failure to properly inform the patient $250,000 on behalf of the plaintiff.
by the thoracic surgeon. Postoperatively, the Informed consent
patient developed severe hyperhidrosis of his • Alteration of the medical record.
The physician’s duty to obtain a patient’s informed consent prior to a treatment or pro- The patient consulted a dermatologist who cedure is his alone and is non-delegable. In told him the sympathectomy was irreversible, order to protect oneself against an allegation doctrines — fiduciary relationship and self- of failure to obtain informed consent, physi- for the rest of his life. The patient was referred determination. Fiduciary relationship requires cians must both educate patients as to known to a neurologist for a second opinion, and the a physician to inform and advise the patient complications and alternative forms of treat- in an understandable manner of the risks and ment as well as document these efforts. With patient then went to see his cousin, a gener- treatment. Self-determination is the patient’s al practitioner, who told the patient he made right to agree to or refuse treatment to the physician and patient, the physician should extent the law allows. A physician may be The plaintiff’s expert was critical of the liable for damages proximately caused by the versation in his office notes. A suggested physician’s failure to obtain informed con- failure to obtain informed consent or if the sent. One of the physician’s own articles on patient does not receive adequate informa- Advised patient of the need for ( ) due to ( ). Discussed risks, benefits and alterna- ing occurs. The expert felt this was a signifi- tives. Patient reviewed educational materials/ cant complication of the surgery and one that instructions and states he/she understands required full discussion with the patient. and agrees to proceed. It is my judgment that The plaintiff’s attorney made it clear dur- Although the patient in this situation most the patient does understand the treatment ing mediation that he would try to suggest likely did suffer from compensatory hyper- that the physician was, in effect, operating a hidrosis, a known complication of this type surgery mill, cranking out dozens of these of surgical procedure, it can be argued that defensibility. As was seen in this case, by only are essential to diagnosis and treatment apparent on the day of her visit with the months earlier, the physician only managed but can also assist in the defense of a mal- family doctor if the documentation for that to capture a summary of that encounter. The practice claim. Charting the information soon lack of detailed information in the family after a patient encounter promotes accuracy physician’s re-created note raised the question and completeness of documentation. In addi- cian re-created what notes were available for as to whether or not he actually examined the tion, the information will be available to you that encounter. After the fact entries may be patient. The inadequacy of the chart note and other members of the health care team.
viewed as alterations to the medical record became one of the major factors in the deci- and can greatly compromise the physician’s Summer 2001 15
Reporter
TEXAS MEDICAL LIABILITY TRUST
P.O. Box 160140Austin, TX 78716-0140 800-580-8658 or 512-425-5800 Fax: 512-425-5998 E-mail: [email protected] Web address: www.tmlt.org Editorial committee
Tom Cotten, President and CEO
Bob Fields, Executive Vice President, Claim Operations
Don Chow, Vice President, Marketing
Jane Mueller, Director, Risk Management
Editor
Dana Leidig
In memoriam: Robert G. Thumwood, MD
Managing Editor
Laura Hale
We are saddened to relay that Dr. Robert G. Thumwood, a Contributing Editor
family practitioner in Houston, passed away suddenly on July 25, 2001. Dr. Thumwood was a member of the TexasAcademy of Family Physicians and a Fellow of the American Risk Management Staff
Academy of Family Practice. He was a past president of Robin Bowles, Lynne Dakers, JD, Michele Luckie The Reporter is published six times a year by TexasMedical Liability Trust as an information and educa- Dr. Thumwood was one of TMLT's founding fathers, help- tional service to TMLT policyholders. All articles and ing launch the fledgling organization in 1979. At that time, any forms, checklists, guidelines and materials are he pounded the pavement, going door to door in the med- for general information only, and should not be used ical community to solicit support for the newly formed or referred to as primary legal sources nor construed TMLT. He was elected and served multiple terms on TMLT's as establishing medical standards of care. They are governing board and was a past chairman of the board. At intended as resources to be selectively used and the time of his death, he was chairman of the marketing and always adapted — with the advice of the organiza- risk management committees. Dr. Thumwood was a strong tion’s attorney — to meet state, local, individualorganizations and department needs or require- supporter of risk management and was continuously ments. The Reporter is distributed with the under- involved in the development of risk management for TMLT standing that Texas Medical Liability Trust is not and its policyholders. We will miss his enthusiasm, his engaged in rendering legal services. 2001 TMLT expertise and commitment to service.
Alteration of medical records
record, even if they are only attempting to make the record accurately reflect their rec- In addition to verbal interaction, patient ollection of events. In this case, the plaintiff’s education can take the form of pamphlets, include the reason for the lateness of the attorney was able to show that an earlier copy handouts, videos, and pre/post treatment entry, should reference the date and time of of the medical record did not contain the late instructions. Any form of patient education the actual encounter, and should clearly state entry. Even absent such a situation, howev- should be documented in the medical record the date and time of the actual chart entry.
er, forensic advances in handwriting and ink to verify the patient was provided pertinent Ideally, entries into the medical record should analysis have made dating of entries quite information regarding his/her care and was given information needed to make informed encounter or as soon thereafter as possible.
decisions and choices. If your practice routinely When late entries are made, particularly if Advertising
provides certain education materials, you they are not identified as addenda, they can may want to consider making a standardized be construed as attempts at alteration of the tiff’s attorney as an issue, advertising, list of such materials to incorporate into whether through traditional media such as patients’ charts in order to facilitate docu- magazines and office brochures or through a more modern form, such as a web site, can involved in litigation (some practices segre- also place the physician at risk. In any form, acknowledging that he/she has been provided gate records that are involved in litigation), it is necessary to avoid implied guarantees or these materials and has had the opportunity any language that may inadvertently cause against making any alterations to the original you to be held to a higher standard of carethan required by law. 16 Summer 2001

Source: http://www.tmlt.org/dam/TMLT/Newsletters/2001/Summer2001.pdf