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''Florida Protocol'' Medicare and Lymphedema—How it Came to Be
by John M. Macdonald
In 1971, I had completed my training in Vascular and Thoracic surgery at the
University of Pittsburgh and St. Bartholomew's Hospital, London, England. As I
began my career as a surgeon in Ft. Lauderdale, Florida, I never imagined the
twists and turns that would lead to my present involvement in wound healing and
Lymphedema. The specialty of cardiovascular surgery is rich in mental and
physical demands and for more than 27 years I was involved as an active surgeon
in private practice and as an active member of local and national medical
organizations. Two experiences during these years redirected the focus of my
career. The forces of change began when, in 1987, I traveled to the nation of
Haiti. At that time, Jean-Claude Duvalier, ( Baby Doc), had been removed from
power and the government appointed General Henri Namphy to be the head of state.
A number of years prior to that time, good friends of the general had come to
the United States for elective surgery under my care. As my friendship with the
Haitian community evolved, my wife and I were asked to visit this fascinating
country one and one-half hours flight time from Miami. Shortly after our second
visit, General Namphy was exiled to the Dominican Republic. By this time my
fascination with Haiti and my contacts within the Haitian community had grown
considerably. This allowed us to return to Haiti many times over the next 13
years with opportunities to visit medical clinics, interview physicians and
nurses while enjoying the friendship of Haitian and American governmental
personnel. Haiti was unlike any nation in the Western Hemisphere. In 1997, there
were 7.2 million people in Haiti with fewer than 400 hospital beds in the entire
country.
One evening at a cocktail party in Port-au-Prince, William Swing, the
American Ambassador to Haiti at the time, said to me, "John, what is it
that you are doing with this new clinic you are developing in Florida"? I
began to explain my interest in wound healing and the relationship to Lymphedema
when He asked, "What is Lymphedema?" This was followed by, "Is
that the same thing as elephantiasis?" And, "Did you know that there
is an elephantiasis colony in the town of Leogane?" "In fact, the
Center for Disease Control has been working there for a year." The town of
Leogane is a once prosperous town 30 km. south of Port-au-Prince. The area is
very tropical with abundant moisture, greenery and verdant pastures, very
different than the deforested majority of the country. The blessing of the
fertile soil is balanced, Haitian style, by the abundance of mosquitoes. In a
population of 120,000, 5% of the people are afflicted with filiariasis---leg
Lymphedema being the most common limb involvement. 30% of the male population is
afflicted with genital filiariasis. It was evident to me that I had to visit
Leogane and see what kind of pneumatic pumps the CDC was using to treat
filiariasis.
The second event redirecting my medical career was a phone call made to
Marshall Webster, M.D. in 1992. Dr. Webster is Professor of Vascular Surgery and
a former fellow resident in thoracic surgery at the University of Pittsburgh.
Dr. Webster had published an article on wound healing and I noted that The
University of Pittsburgh had a clinic, founded in 1988, called "The Wound
Healing and Limb Preservation Clinic." My interest in this field was
further stimulated and eventually, in 1993, I founded the North Ridge Hospital
Wound and Limb Preservation Center in Ft. Lauderdale, Florida. I began to learn
more about wound healing but also, and probably more important at the time,
wanted to increase my vascular surgical caseload. Not knowing the difference
between algeron and alginate, alginate being an everyday wound care dressing, I
began to attend as many wound care conferences as possible and slowly developed
knowledge and an appreciation for the fascinating specialty of wound care. Also,
I had become aware that the majority of the physicians in the United States had
little appreciation for the value of this new/old discipline. There was an
obvious need for physicians to become involved. Knowledgeable nurses were
frustrated with the inability to gain acceptance for this new discipline. Sadly,
this scenario continues in our hospitals as this article is being written.
In January of 1997, we returned from our second Leogane visit. Daily, we were
impressed by the clinical improvement achieved in a primitive setting. One
physical therapist with only basic Vodder training supervised the program. The
results were impressive. The staff of seven to ten dedicated trainees tended to
hundreds of Lymphedema patients. Outcomes were recorded and evaluated by the CDC
under the direction of David Addis, M.D., a physician in the Public Health
Dept., Atlanta, Georgia. Returning from Haiti, I was convinced that
Comprehensive Decongestive Physiotherapy was the standard of care for
Lymphedema.
That month, Holy Cross Hospital encouraged me to give a presentation at their
weekly public forum called "Dinner with the Doctor". A newspaper
advertisement appeared in the Sunday edition of the local newspaper -
"Lymphedema, Diagnoses and Treatment ." The following Wednesday, I was
startled to discover an audience of 350 awaiting my lecture. I asked, "How
many of you are here for the Sweet and Low and how many of you are here because
of Lymphedema?" The majority raised their hands for the latter. During my
presentation I apologized because I realized that main stream American medicine
had ignored their plight. At that time, there was one clinic in Ft. Lauderdale
offering CDP. However, to my recollection, this was the only clinic with a
physician director in the state of Florida. Programs offered consisted of the
European standard of two sessions a day for four weeks. Very few insurance
companies would reimburse for this protocol. The average cost of $10,000-$15,000
was prohibitive for the majority. Clearly, the suffering Lymphedema population
of Florida deserved better.
For a number of years prior to these events, Medicare Florida had been
repeatedly petitioned for acceptance and reimbursement for CDP as the the
standard of care for Lymphedema. Dr. Robert Lerner, a pioneer in the
introduction of CDP in the United States, led the drive for medicare
reimbursement in Florida. He was assisted by numerous in state and out of state
Lymphedema activists and lobbying groups. The core of their petition requested
the standard program of four weeks of therapy with twice-daily therapy sessions.
In keeping with the European system, patient education and outcome documentation
was not stressed. Medicare's response to this drawn out, intense lobbying effort
was detailed in an advisory dated October 20, 1996, written by Sidney Sewell,
M.D. Dr. Sewell was, and remains, the Medical Director of Medicare Florida. Dr.
Sewell stated then that Comprehensive Decongestive Physiotherapy was considered
"experimental." As far as Florida Medicare was concerned, the case was
closed.
Because of the Haitian experience, I was convinced that professionally
presented medical logic could be used to reverse this decision. It was very
apparent that unless we could obtain some form of third party reimbursement, we
were never going to be able to support my vision of an integrated wound
care-Lymphedema center. Nancy Sims, a registered nurse, certified as a
Lymphedema therapist, had been working as a freelance caregiver in Lymphedema in
Florida since the late 1980`s. We met at an NLN conference in San Francisco in
September 1996. She shared her extensive Lymphedema experience with me and it
was obvious that her dedication and professionalism were exactly what was needed
to conduct a new Lymphedema assault on Medicare Florida. Attempting to gather
documenting medical data, we contacted the original medicare petitioners. To our
dismay, we were totally rebuffed. Sadly, even requests for reference articles
were refused. I was told personally by an out of state lobbyist that "This
was a business matter and that she had not received permission to assist our
efforts." We discovered that there were a number of main stream Lymphedema
leaders in the United States with little sense of professional collegiality and,
in fact, appeared to be severely compromised by economic and territorial
concern.
In retrospect, this experience strengthened our resolve. Nancy and I,
together with a local chiropractor gathered volumes of current world literature.
We were extremely fortunate to receive advice from Judith Purtell, an
occupational therapist practicing in Milwaukee, Wisconsin. Her insight into the
practical aspects of therapy proved invaluable. While the input from each of
these sources was important, the Haitian experience ultimately provided the
catalyst that captured the imagination of the authorities. If we could achieve
these results in Haiti, under primitive conditions, why not Florida?
Once our review of the literature was completed, packets of information were
sent to five highly regarded physicians, practicing in Florida. This group
included the specialties of Oncology, Physical Medicine, Cardiovascular Surgery
and Vascular Surgery. I spoke at length with each of these physicians. We
reviewed the statistics from Leogane, Haiti as detailed by Dr. Addis and the
Center for Disease Control. We abstracted what was available in the English
language medical literature. When each of these physicians was convinced that
CDP offered a viable medical option, they agreed to write a supportive letter to
Dr. Sewell. In response to this independent physician input, Dr. Sewell agreed
to review his previous decision. Our clinic then wrote a new proposal that would
allow the essential aspects of the European system to be defined using
established CPT codes. We felt it very important that physical therapy time
limits or monetary caps not define the program. It was essential that the new
protocol be medically correct, attentive to American socioeconomic realities,
easily documentable and fraud proof. It is important to note that documentation
of functional physical and occupational outcomes were stressed by the Medicare
evaluation office. Medicare then evaluated our recommendations and those of
other interested parties. To the enormous credit of Dr. Sewell and his staff,
the "Florida Lymphedema Protocol" became law one year to the day after
the original denial. October 20, 1997, was a day for celebration.
In essence, the "Florida Protocol" has five basic directives. #1
Diagnoses of Lymphedema must be made by a physician. #2 The physician must write
an order for CDP. #3 The patient is evaluated by a physical therapist prior to
therapy, at midpoint and at the conclusion of therapy for functional impairment.
#4 Patient self-education is stressed and, in fact, if a patient is unable to
continue self-therapy either by themselves or with the cooperation of a
caregiver, the patient is ineligible for the program. #5 The therapy is limited
to ten MLD sessions. The determination to limit the basic protocol to ten MLD
encounters was made by the medicare office. With emphasis on patient education
and functional outcomes, we believed that these conditions were realistic. In
response to medicare approval we also felt an obligation to document the results
of this new protocol. It is emphasized that the standard European protocol
consists of four weeks duration with twice a day MLD encounters. Patient
self-care education is not stressed in the European system.
We knew immediately that this ruling would open Lymphedema therapy, at a
reasonable cost, to thousands of patients in our state. We also recognized that
while the four-week European program is the gold standard, a significant number
of patients would benefit from the ten-treatment program. The original directive
stated that it was understood that some patients would require extended
treatment sessions and that these patients could be reviewed for approval on an
individual case by case request. Numerous articles concerning the Medicare turn
around were written in the ensuing months. One article in the Miami Herald
quoted a prominent national Lymphedema authority who said, "Were this ten
session program accepted nationwide, it would be tragedy for the Lymphedema
patients." It was implied that we had distorted accepted therapy. We
countered that a half glass was better than an empty glass and began treating
patients.
In June of 2000, at the Symposium for Advanced Wound Care in Dallas, Texas,
we presented the statistical results on 232 patients treated since opening in
1997. From this group we recorded the volume reduction and percentage edema
reduction inpatients receiving exactly ten treatments. We compared these results
with previously published German, Australian and American reports using the four
week program. Our results were essentially the same as the Australian reports
and comparable to the German and American four week findings. We concluded that
the "Florida Protocol" compared favorably to the traditional methods
of therapy in stage I and II types of Lymphedema.
The journey to arrive at our present level of care for Lymphedema patients in
Florida has been both frustrating and exhilarating. Obviously, we are just
beginning to fulfill our obligations to Lymphedema patients here and throughout
the world. We are adjusting and refining our approach to the Lymphedema patient
and to the relationship of wound healing to the variables of Lymphedema. I am
excited that with each visit to various cities, hospitals and clinics, I can see
a growth of awareness. The dedicated efforts of the original visionaries both
professional and lay public are beginning to take seed. The accomplishments and
growth of the NLN have been and continue to make significant contributions.
Patients previously ignored are receiving proper attention. There is strong
evidence that the main stream American medical community is becoming involved
and that in the near future it will be the exception rather than the rule to
have large areas of North America without accepted Lymphedema support. I speak
for each member of our center and for the many dedicated friends who have
assisted and continue to assist in this effort. "We are proud to have made
a difference."
Florida medicare mandates the use of specific CPT and ICD-9 codes, and
requires that certain conditions have been met:
Conditions:
1. There is a physician documented diagnosis of lymphedema: and the physician
specifically orders CDP 2. The patient is symptomatic for lymphedema, with
limitation of function related to self care, mobility and/or safety. 3. The
patient or patient caregiver has the ability to understand and comply with home
care continuation of treatment regimen. 4. The services are being performed by a
health care professional who has received specialized training in this form of
treatment.
ICD-9 diagnosis codes: 457.0 - Post-mastectomy Lymphedema Syndrome 457.1 -
Other lymphedema 757.0 - Hereditary edema of the legs (congenital lymphedema)
CPT Codes:
97001 - Physical therapy evaluation
97002 - Physical therapy re-evaluation
97003 - Occupational therapy evaluation
97004 - Occupational therapy re-evaluation
97110 - Therapeutic procedure, one or more areas, each 15 minutes:
therapeutic exercises to develop strength and endurance, range of motion and
flexibility
97140 - Manual therapy techniques (e.g. mobilization/manipulation, manual
lymphatic drainage, manual traction), one or more regions, each 15 minutes
97535 - Self-care/home management training (e.g., activities of daily living
(ADL) and compensatory training, meal preparation, safety procedures, and
instructions in use of adaptive equipment) direct one on one contact by
provider, each 15 minutes.
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About the Author:
John M. Macdonald
John M. Macdonald, M.D., F.A.C.S.M
B.S., University of Notre Dame
M.D., University of Pennsylvania School of Medicine
Internship--Jackson Memorial Hospital--Univ. of Miami
Residency General and Thoracic Surgery--University of Pittsburgh
Fellowship, Thoracic Surgery--St. Bartholomew Hospital, London England
Board Certified--General Surgery
Board Certified--Thoracic Surgery
Private Practice--Thoracic/Vascular Surgery --Ft Lauderdale, Fla. 1971-1998
Medical Director, North Broward Hospital District, Wound Healing & Lymphedema Center.
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