Summer 2001 reporter
TEXAS MEDICAL LIABILITY TRUST
THE NEW HIPAA REGULATIONS
TO DISCLOSE OR NOT TO DISCLOSE
by Robin Bowles, Risk Management Representative
’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
R I S K A L E RT M E S S AG E
TEXAS MEDICAL LIABILITY TRUST
SPECIAL PHARMACEUTICAL ANNOUNCEMENTS
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
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
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.
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
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-
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
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
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
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
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.
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.
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
(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.
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
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
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
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
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
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
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
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
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
Summer 2001 11
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
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
Attorney contacts with physicians
Is an arbitration agreement included in your con-
This topic was addressed in a 2000 Reporter
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
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
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
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
Tom Cotten, President and CEO
Bob Fields, Executive Vice President, Claim Operations
Don Chow, Vice President, Marketing
Jane Mueller, Director, Risk Management
In memoriam: Robert G. Thumwood, MD
We are saddened to relay that Dr. Robert G. Thumwood, a
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
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
Findings ____________________________________________________________ The provision of school food in 18 countries _____________________________________________________________ This paper compares the provision of school food in 18 different countries around the world, with a focus on funding, catering providers, costs, free school meals (FSM), school meal take up and th
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