SAMPLE

                             NEW PATIENT

Dear Sir / Madam:

I first saw XXXX  XXXXX  (Date of Birth: XX/XX/XX) on Month Day, Year.  

Mr. / Mrs. XXXX has had the disease for approximately XX years and that was a significant obstacle to overcome.  All other attempts at treating pain had failed in his/her rehabilitation and now suffers from spreading symptoms. His/her only hope for rehabilitation is the 3-day ketamine treatment.

CRPS is a neurological disorder, in which pain disproportionate to a precipitating injury is common in all cases. It is a malfunction of the autonomic nervous system, whereby nerves misfire and send constant pain signals to the brain. It develops in response to an event the body perceives as traumatic, such as an accident, a fall, or surgery. It can develop after even minor injuries, such as a sprain or IV insertion. The universal symptom of CRPS is pain, usually described as burning or stinging in quality. Another hallmark symptom is excruciating sensitivity of the skin. Even the lightest touch, such as clothing, bed sheets, shower spray, a light breeze, is perceived by the sufferer as intolerably painful. Other symptoms include swelling, color and temperature abnormalities in the affected part unusual sweating, and nail changes. Patients also experience difficulty initiating movement, muscle spasms, tremors, weakness, fatigue, frequent infections, and headaches. CRPS spreads in as many as 70% 0f patients. It can spread to contiguous areas of the body or cross over to affect the same area of the opposite limb. CRPS can also spread to an unrelated site, especially following another trauma.

The pain is real and devastating. Neuropathic pain does not show up on X-rays and cannot be measured by standard diagnostic tests. Patients try to put on a brave face, most will still try to maintain a well groomed appearance, keeping a stiff upper lip, even though they are in constant, extreme pain. Patients have even opted to have a limb amputated because the pain is so severe. As a result, patients sometimes develop psychological difficulties when families, friends, or physicians do not understand their pain.

The most effective treatment we have to date is the drug ketamine. Much like chemotherapy agents, or medications such as remicade, ketamine is administered intravenously. This is not an experimental drug. Rather, it is a use of an already approved drug.

Over 30 years ago, ketamine was approved by the U.S. Food and Drug Administration (FDA) as a drug for general anesthesia and for the treatment of breakthrough pain. At the RSD / CRPS Treatment Center in Tampa, Florida, ketamine infusions are administered to treat breakthrough pain, as approved by the FDA. It has been used historically for the treatment of breakthrough pain associated with CRPS (see Ketamine Infusions, Lubenow, Timothy, MD, Kirkpatrick, Anthony, MD and Friedberg, Barry, MD, online at:

http://www.rsdfoundation.org/en/Ketamine_Treatment.html

Ketamine’s effectiveness for pain relief in patients with CRPS has been proven in two recent and separate double-blind, placebo-controlled clinical trials. These studies are referenced at the following site:

http://rsdhealthcare.org/outpatient_ketamine.htm

Several practitioners are utilizing a low dose ketamine infusion treatment consisting of a series of 50 mg/hr infusions with limited success, requiring weeks of treatment in declining frequency. 

We have developed an alternative and highly effective protocol that utilizes an increasing dose of ketamine by IV infusion over a three day period, for 4 hours each day.  While we start the infusion at 60 mg/hr, it is increased to the tolerance of the patient in three stages at 90 mg//hr, 135 mg/hr and 200 mg/hr so that the patient is maintained at the highest ketamine level which can be maintained at a sub-anesthetic level.  The patient is constantly monitored electronically using constant pulse oxygen saturation readings and continuous monitoring of blood pressure and heart rate. In addition, the patient’s level of consciousness is monitored as well.  To further ensure that the patient does not become anesthetized, a series of simple questions (family members, town, where born, pet’s name) are regularly (at least every 10-15 minutes) placed to the patient and the patient’s response dictates whether to maintain, increase or decrease the rate the infusion.

We document the outcome of ketamine infusions using objective measurements before and after the 3-day treatment – it is very time-consuming but, in our opinion, it is essential in optimal rehabilitation of patients:

http://www.rsdfoundation.org/HonoraryDonors/Robinson.html

Our patients have derived great benefit from the treatment so they are pain free for the first time in years and they are able to do things they had assumed they would never do again.  We have found that some patients require a booster, generally after 2-3 months or longer, and the pain, if any, which returns is significantly less intense than before treatment. We expect most patients to eventually require no ketamine boosters.

We work closely with national and international specialists in CRPS. I am Chairman of the Scientific Advisory Committee for the International Research Foundation for RSD / CRPS. Our committee members are listed at the following website:

 http://www.rsdfoundation.org/en/en_sac.html

At this time, to our knowledge, this is the only location in the United States which offers a fully monitored and safely administered increasing dose sub-anesthetic ketamine treatment up to 200 mg/hr. Other governments recognize our increasing dose sub- anesthetic ketamine treatment. For example, the Canadian government provides full reimbursement for this treatment at our Center.

The RSD / CRPS Treatment Center is a licensed Surgical Center that is approved by the Florida Board of Medicine for Level II surgery. The facility is regulated pursuant to the rules of the Board of Medicine as set forth in Rule Chapter 64B8, F.A.C.

Without ongoing treatment,  Mr. / Mrs. XXXX's CRPS will continue to spread and become more and more difficult to relieve. It is medically necessary that XXXX be allowed to continue treatment. On behalf of his/her I am requesting that you give his/her the opportunity to improve his/her quality of life by allowing coverage for treatment with ketamine administered in an outpatient setting.

Please contact me at 813 995-5511 with any questions or concerns you may have regarding this patient.

Sincerely,

Anthony F. Kirkpatrick, MD, PhD

Director

                                 SAMPLE
                   ESTABLISHED PATIENT

Dear Sir / Madam :

This letter is in response to a request made by XXXXX on Month Day, Year.

Mr. / Mrs. XXXX has had the disease for approximately XX years and that was a significant obstacle to overcome.  All other attempts at treating pain had failed in his/her rehabilitation and now suffers from spreading symptoms. His/her only hope for rehabilitation is the 3-day ketamine treatment.

On Month Day, Year, I evaluated XXXX XXXX and documented (based on objective findings) that his/her CRPS had spread from his/her right upper extremity to his/her left lower extremity. Thus the spreading to his/her left lower extremity is causally related to the right upper extremity. This spreading pattern of CRPS is well documented in the scientific literature. CRPS spreads in as many as 70% of patients. It can spread to contiguous areas of the body or cross over to affect the same area of the opposite limb. CRPS can also spread to an unrelated site, especially following another trauma.

The most effective treatment we have to date is the drug ketamine. Much like chemotherapy agents, or medications such as remicade, ketamine is administered intravenously. This is not an experimental drug. Rather, it is a use of an already approved drug.

Over 30 years ago, ketamine was approved by the U.S. Food and Drug Administration (FDA) as a drug for general anesthesia and for the treatment of breakthrough pain. At the RSD / CRPS Treatment Center in Tampa, Florida, ketamine infusions are administered to treat breakthrough pain, as approved by the FDA. It has been used historically for the treatment of breakthrough pain associated with CRPS (see Ketamine Infusions, Lubenow, Timothy, MD, Kirkpatrick, Anthony, MD and Friedberg, Barry, MD, online at:

http://www.rsdfoundation.org/en/Ketamine_Treatment.html

Ketamine’s effectiveness for pain relief in patients with CRPS has been proven in two recent and separate double-blind, placebo-controlled clinical trials. These studies are referenced at the following site:

http://rsdhealthcare.org/outpatient_ketamine.htm

Several practitioners are utilizing a low dose ketamine infusion treatment consisting of a series of 50 mg/hr infusions with limited success, requiring weeks of treatment in declining frequency. 

We have developed an alternative and highly effective protocol that utilizes an increasing dose of ketamine by IV infusion over a three day period, for 4 hours each day.  While we start the infusion at 60 mg/hr, it is increased to the tolerance of the patient in three stages at 90 mg//hr, 135 mg/hr and 200 mg/hr so that the patient is maintained at the highest ketamine level which can be maintained at a sub-anesthetic level.  The patient is constantly monitored electronically using constant pulse oxygen saturation readings and continuous monitoring of blood pressure and heart rate. In addition, the patient’s level of consciousness is monitored as well.  To further ensure that the patient does not become anesthetized, a series of simple questions (family members, town, where born, pet’s name) are regularly (at least every 10-15 minutes) placed to the patient and the patient’s response dictates whether to maintain, increase or decrease the rate of the infusion.

We document the outcome of ketamine infusions using objective measurements before and after the 3-day treatment – it is very time-consuming but, in our opinion, it is essential in optimal rehabilitation of patients:

http://www.rsdfoundation.org/HonoraryDonors/Robinson.html

Our patients have derived great benefit from the treatment so they are pain free for the first time in years and they are able to do things they had assumed they would never do again.  We have found that some patients require a booster, generally after 2-3 months or longer, and the pain, if any, which returns is significantly less intense than before treatment. We expect most patients to eventually require no ketamine boosters.

We work closely with national and international specialists in CRPS. I am Chairman of the Scientific Advisory Committee for the International Research Foundation for RSD / CRPS. Our committee members are listed at the following website:

 http://www.rsdfoundation.org/en/en_sac.html

At this time, to our knowledge, this is the only location in the United States which offers a fully monitored and safely administered increasing dose sub-anesthetic ketamine treatment up to 200 mg/hr. Other governments recognize our increasing dose sub- anesthetic ketamine treatment. For example, the Canadian government and Workers’ Compensation throughout the United States provides full reimbursement for this treatment at our Center.

The RSD / CRPS Treatment Center is a licensed Surgical Center that is approved by the Florida Board of Medicine for Level II surgery. The facility is regulated pursuant to the rules of the Board of Medicine as set forth in Rule Chapter 64B8, F.A.C.

Without ongoing treatment, Mr. / Mrs. XXXX’ CRPS will continue to spread and become more and more difficult to relieve. It is medically necessary that XXXX be allowed to continue treatment. On his/her behalf, I am requesting that you give his/her the opportunity to improve his/her quality of life by allowing coverage for treatment with ketamine administered in an outpatient setting.

Please contact me at 813 995-5511 with any questions or concerns you may have regarding this patient.

Sincerely,

Anthony F. Kirkpatrick, MD, PhD

Director