eLymphNotes: ^^Florida Protocol^^ Medicare and = Lymphedema=97How it Came to Be

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What=20 is Lymphedema?
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Home >&nb= sp; Past=20 Issues > ''Florida Protocol'' = Medicare=20 and Lymphedema=97How=20 it Came to Be

''Florida Protocol''=20 Medicare and Lymphedema=97How=20 it Came to Be
by John M. = Macdonald

In 1971, I had completed my training in = Vascular and=20 Thoracic surgery at the University of Pittsburgh and St.=20 Bartholomew's Hospital, London, England. As I began my = career as a=20 surgeon in Ft. Lauderdale, Florida, I never=20 imagined the twists and turns that would lead to my present=20 involvement in wound healing and Lymphedema. The=20 specialty of cardiovascular surgery is rich in mental and = physical=20 demands and for more than 27 years I was involved as an = active=20 surgeon in private practice and as an active member of local = and=20 national medical organizations. Two experiences during these = years=20 redirected the focus of my career. The forces of change = began when,=20 in 1987, I traveled to the nation of Haiti. At that time,=20 Jean-Claude Duvalier, ( Baby Doc), had been removed from = power and=20 the government appointed General Henri Namphy to be the head = of=20 state. A number of years prior to that time, good friends of = the=20 general had come to the United States for elective surgery = under my=20 care. As my friendship with the Haitian community evolved, = my wife=20 and I were asked to visit this fascinating country one and = one-half=20 hours flight time from Miami. Shortly after our second = visit,=20 General Namphy was exiled to the Dominican Republic. By this = time my=20 fascination with Haiti and my contacts within the Haitian = community=20 had grown considerably. This allowed us to return to Haiti = many=20 times over the next 13 years with opportunities to visit = medical=20 clinics, interview physicians and nurses while enjoying the=20 friendship of Haitian and American governmental personnel. = Haiti was=20 unlike any nation in the Western Hemisphere. In 1997, there = were 7.2=20 million people in Haiti with fewer than 400 hospital beds in = the=20 entire country.

One evening at a cocktail party in=20 Port-au-Prince, William Swing, the American Ambassador to = Haiti at=20 the time, said to me, "John, what is it that you are doing = with this=20 new clinic you are developing in Florida"? I=20 began to explain my interest in wound healing and the = relationship=20 to Lymphedema=20 when He asked, "What is Lymphedema?"=20 This was followed by, "Is that the same thing as = elephantiasis?"=20 And, "Did you know that there is an elephantiasis colony in = the town=20 of Leogane?" "In fact, the Center for Disease Control has = been=20 working there for a year." The town of Leogane is a once = prosperous=20 town 30 km. south of Port-au-Prince. The area is very = tropical with=20 abundant moisture, greenery and verdant pastures, very = different=20 than the deforested majority of the country. The blessing of = the=20 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=20 the most common limb involvement. 30% of the male population = is=20 afflicted with genital filiariasis. It was evident to me = that I had=20 to visit Leogane and see what kind of pneumatic pumps the = CDC was=20 using to treat filiariasis.

The second event = redirecting my=20 medical career was a phone call made to Marshall Webster, = M.D. in=20 1992. Dr. Webster is Professor of Vascular Surgery and a = former=20 fellow resident in thoracic surgery at the University of = Pittsburgh.=20 Dr. Webster had published an article on wound healing and I = noted=20 that The University of Pittsburgh had a clinic, founded in = 1988,=20 called "The Wound Healing and Limb Preservation Clinic." My = interest=20 in this field was further stimulated and eventually, in = 1993, I=20 founded the North Ridge Hospital Wound and Limb Preservation = Center=20 in Ft. Lauderdale, Florida. I began=20 to learn more about wound healing but also, and probably = more=20 important at the time, wanted to increase my vascular = surgical=20 caseload. Not knowing the difference between algeron and = alginate,=20 alginate being an everyday wound care dressing, I began to = attend as=20 many wound care conferences as possible and slowly developed = knowledge and an appreciation for the fascinating specialty = of wound=20 care. Also, I had become aware that the majority of the = physicians=20 in the United States had little appreciation for the value = of this=20 new/old discipline. There was an obvious need for physicians = to=20 become involved. Knowledgeable nurses were frustrated with = the=20 inability to gain acceptance for this new discipline. Sadly, = this=20 scenario continues in our hospitals as this article is being = written.

In January of 1997, we returned from our = second=20 Leogane visit. Daily, we were impressed by the clinical = improvement=20 achieved in a primitive setting. One physical therapist with = only=20 basic Vodder training supervised the program. The results = were=20 impressive. The staff of seven to ten dedicated trainees = tended to=20 hundreds of Lymphedema=20 patients. Outcomes were recorded and evaluated by the CDC = under the=20 direction of David Addis, M.D., a physician in the Public = Health=20 Dept., Atlanta, Georgia. Returning from Haiti, I was = convinced that=20 Comprehensive Decongestive Physiotherapy was the standard of = care=20 for Lymphedema.

That=20 month, Holy Cross Hospital encouraged me to give a = presentation at=20 their weekly public forum called "Dinner with the Doctor". A = newspaper advertisement appeared in the Sunday edition of = the local=20 newspaper - "Lymphedema,=20 Diagnoses and Treatment ." The following Wednesday, I was = startled=20 to discover an audience of 350 awaiting my lecture. I asked, = "How=20 many of you are here for the Sweet and Low and how many of = you are=20 here because of Lymphedema?" The=20 majority raised their hands for the latter. During my = presentation I=20 apologized because I realized that main stream American = medicine had=20 ignored their plight. At that time, there was one clinic in = Ft.=20 Lauderdale offering CDP. However, to my recollection, this = was the=20 only clinic with a physician director in the state of Florida.=20 Programs offered consisted of the European standard of two = sessions=20 a day for four weeks. Very few insurance companies would = reimburse=20 for this protocol. The=20 average cost of $10,000-$15,000 was prohibitive for the = majority.=20 Clearly, the suffering Lymphedema=20 population of Florida deserved=20 better.

For a number of years prior to these events, = Medicare=20 Florida had=20 been repeatedly petitioned for acceptance and reimbursement = for CDP=20 as the the standard of care for Lymphedema. Dr.=20 Robert Lerner, a pioneer in the introduction of CDP in the = United=20 States, led the drive for medicare reimbursement in Florida. He was=20 assisted by numerous in state and out of state Lymphedema=20 activists and lobbying groups. The core of their petition = requested=20 the standard program of four weeks of therapy with = twice-daily=20 therapy sessions. In keeping with the European system, = patient=20 education and outcome documentation was not stressed. = Medicare's=20 response to this drawn out, intense lobbying effort was = detailed in=20 an advisory dated October 20, 1996, written by Sidney = Sewell, M.D.=20 Dr. Sewell was, and remains, the Medical Director of = Medicare Florida. Dr.=20 Sewell stated then that Comprehensive Decongestive = Physiotherapy was=20 considered "experimental." As far as Florida Medicare=20 was concerned, the case was closed.

Because of the = Haitian=20 experience, I was convinced that professionally presented = medical=20 logic could be used to reverse this decision. It was very = apparent=20 that unless we could obtain some form of third party = reimbursement,=20 we were never going to be able to support my vision of an = integrated=20 wound care-Lymphedema=20 center. Nancy Sims, a registered nurse, certified as a Lymphedema=20 therapist, had been working as a freelance caregiver in Lymphedema in Florida since=20 the late 1980`s. We met at an NLN conference in San = Francisco in=20 September 1996. She shared her extensive Lymphedema=20 experience with me and it was obvious that her dedication = and=20 professionalism were exactly what was needed to conduct a = new Lymphedema=20 assault on Medicare Florida.=20 Attempting to gather documenting medical data, we contacted = the=20 original medicare petitioners. To our dismay, we were = totally=20 rebuffed. Sadly, even requests for reference articles were = refused.=20 I was told personally by an out of state lobbyist that "This = was a=20 business matter and that she had not received permission to = assist=20 our efforts." We discovered that there were a number of main = stream=20 Lymphedema=20 leaders in the United States with little sense of = professional=20 collegiality and, in fact, appeared to be severely = compromised by=20 economic and territorial concern.

In retrospect, this = experience strengthened our resolve. Nancy and I, together = with a=20 local chiropractor gathered volumes of current world = literature. We=20 were extremely fortunate to receive advice from Judith = Purtell, an=20 occupational therapist practicing in Milwaukee, Wisconsin. = Her=20 insight into the practical aspects of therapy proved = invaluable.=20 While the input from each of these sources was important, = the=20 Haitian experience ultimately provided the catalyst that = captured=20 the imagination of the authorities. If we could achieve = these=20 results in Haiti, under primitive conditions, why not Florida?

Once=20 our review of the literature was completed, packets of = information=20 were sent to five highly regarded physicians, practicing in = Florida. This=20 group included the specialties of Oncology, Physical = Medicine,=20 Cardiovascular Surgery and Vascular Surgery. I spoke at = length with=20 each of these physicians. We reviewed the statistics from = Leogane,=20 Haiti as detailed by Dr. Addis and the Center for Disease = Control.=20 We abstracted what was available in the English language = medical=20 literature. When each of these physicians was convinced that = CDP=20 offered a viable medical option, they agreed to write a = supportive=20 letter to Dr. Sewell. In response to this independent = physician=20 input, Dr. Sewell agreed to review his previous decision. = Our clinic=20 then wrote a new proposal that would allow the essential = aspects of=20 the European system to be defined using established CPT = codes. We=20 felt it very important that physical therapy time limits or = monetary=20 caps not define the program. It was essential that the new = protocol be=20 medically correct, attentive to American socioeconomic = realities,=20 easily documentable and fraud proof. It is important to note = that=20 documentation of functional physical and occupational = outcomes were=20 stressed by the Medicare evaluation office. Medicare then = evaluated=20 our recommendations and those of other interested parties. = To the=20 enormous credit of Dr. Sewell and his staff, the "Florida Lymphedema Protocol" became=20 law one year to the day after the original denial. October = 20, 1997,=20 was a day for celebration.

In essence, the "Florida Protocol" has=20 five basic directives. #1 Diagnoses of Lymphedema must=20 be made by a physician. #2 The physician must write an order = for=20 CDP. #3 The patient is evaluated by a physical therapist = prior to=20 therapy, at midpoint and at the conclusion of therapy for = functional=20 impairment. #4 Patient self-education is stressed and, in = fact, if a=20 patient is unable to continue self-therapy either by = themselves or=20 with the cooperation of a caregiver, the patient is = ineligible for=20 the program. #5 The therapy is limited to ten MLD sessions. = The=20 determination to limit the basic protocol to ten=20 MLD encounters was made by the medicare office. With = emphasis on=20 patient education and functional outcomes, we believed that = these=20 conditions were realistic. In response to medicare approval = we also=20 felt an obligation to document the results of this new protocol. It is=20 emphasized that the standard European protocol=20 consists of four weeks duration with twice a day MLD = encounters.=20 Patient self-care education is not stressed in the European=20 system.

We knew immediately that this ruling would = open Lymphedema=20 therapy, at a reasonable cost, to thousands of patients in = our=20 state. We also recognized that while the four-week European = program=20 is the gold standard, a significant number of patients would = benefit=20 from the ten-treatment program. The original directive = stated that=20 it was understood that some patients would require extended=20 treatment sessions and that these patients could be reviewed = for=20 approval on an individual case by case request. Numerous = articles=20 concerning the Medicare turn around were written in the = ensuing=20 months. One article in the Miami Herald quoted a prominent = national=20 Lymphedema=20 authority who said, "Were this ten session program accepted=20 nationwide, it would be tragedy for the Lymphedema=20 patients." It was implied that we had distorted accepted = therapy. We=20 countered that a half glass was better than an empty glass = and began=20 treating patients.

In June of 2000, at the Symposium = for=20 Advanced Wound Care in Dallas, Texas, we presented the = statistical=20 results on 232 patients treated since opening in 1997. From = this=20 group we recorded the volume reduction and percentage edema=20 reduction inpatients receiving exactly ten treatments. We = compared=20 these results with previously published German, Australian = and=20 American reports using the four week program. Our results = were=20 essentially the same as the Australian reports and = comparable to the=20 German and American four week findings. We concluded that = the "Florida Protocol"=20 compared favorably to the traditional methods of therapy in = stage I=20 and II types of Lymphedema.

The=20 journey to arrive at our present level of care for Lymphedema=20 patients in Florida has been=20 both frustrating and exhilarating. Obviously, we are just = beginning=20 to fulfill our obligations to Lymphedema=20 patients here and throughout the world. We are adjusting and = refining our approach to the Lymphedema=20 patient and to the relationship of wound healing to the = variables of=20 Lymphedema. I=20 am excited that with each visit to various cities, hospitals = and=20 clinics, I can see a growth of awareness. The dedicated = efforts of=20 the original visionaries both professional and lay public = are=20 beginning to take seed. The accomplishments and growth of = the NLN=20 have been and continue to make significant contributions. = Patients=20 previously ignored are receiving proper attention. There is = strong=20 evidence that the main stream American medical community is = becoming=20 involved and that in the near future it will be the = exception rather=20 than the rule to have large areas of North America without = accepted=20 Lymphedema=20 support. I speak for each member of our center and for the = many=20 dedicated friends who have assisted and continue to assist = in this=20 effort. "We are proud to have made a difference."

Florida medicare=20 mandates the use of specific CPT and ICD-9 codes, and = requires that=20 certain conditions have been = met:

Conditions:
1.=20 There is a physician documented diagnosis of lymphedema: and=20 the physician specifically orders CDP 2. The patient is = symptomatic=20 for lymphedema, with=20 limitation of function related to self care, mobility and/or = safety.=20 3. The patient or patient caregiver has the ability to = understand=20 and comply with home care continuation of treatment regimen. = 4. The=20 services are being performed by a health care professional = who has=20 received specialized training in this form of=20 treatment.

ICD-9 diagnosis codes: 457.0 - = Post-mastectomy Lymphedema=20 Syndrome 457.1 - Other lymphedema 757.0=20 - Hereditary edema of the legs (congenital lymphedema)

CPT=20 Codes:

97001 - Physical therapy = evaluation

97002 -=20 Physical therapy re-evaluation

97003 - Occupational = therapy=20 evaluation

97004 - Occupational therapy=20 re-evaluation

97110 - Therapeutic procedure, one or = more=20 areas, each 15 minutes: therapeutic exercises to develop = strength=20 and endurance, range of motion and flexibility

97140 = - Manual=20 therapy techniques (e.g. mobilization/manipulation, manual = lymphatic=20 drainage, manual traction), one or more regions, each 15=20 minutes

97535 - Self-care/home management training = (e.g.,=20 activities of daily living (ADL) and compensatory training, = meal=20 preparation, safety procedures, and instructions in use of = adaptive=20 equipment) direct one on one contact by provider, each 15=20 minutes.
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About the Author:
John M.=20 Macdonald
John M. Macdonald, M.D., F.A.C.S.M
B.S., = University of Notre Dame
M.D., University of Pennsylvania = School=20 of Medicine
Internship--Jackson Memorial Hospital--Univ. = of=20 Miami
Residency General and Thoracic Surgery--University = of=20 Pittsburgh
Fellowship, Thoracic Surgery--St. Bartholomew=20 Hospital, London England
Board Certified--General=20 Surgery
Board Certified--Thoracic Surgery
Private=20 Practice--Thoracic/Vascular Surgery --Ft Lauderdale, Fla.=20 1971-1998
Medical Director, North Broward Hospital = District,=20 Wound Healing & Lymphedema=20 Center.

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Links to external websites were active at = the time=20 of posting.

=A9 2008 eLymphNotes, The First = Online=20 Magazine on Lymphedema
Published=20 by The Lymphedema=20 Awareness Foundation (LAF), The Community Network
172 = Lakeside=20 Circle, Sanford, FL 32773
laf@elymphnotes.org