The following newsletter was sent out by the BTER Foundation: www.bterfoundation.org/tbl/TBL_V4N5.htm This is the introduction:

"The BTER Foundation has just issued the following press release, which also can be found at: www.bterfoundation.org/indexfiles/BTER%20Foundation_PR_0811.pdf

"As you can see below, we are very pleased to announce that the American Medical Association (AMA) and the Centers for Medicare and Medicaid Services (CMS) took our concerns about maggot therapy coding seriously, and issued coding recommendations that should support your requests for insurance reimbursement.

"We are grateful for their efforts to work together in this way to improve patient services and clinician compensation. Their action demonstrates their support for all of us that use or receive biotherapy.

"Thank you all who wrote letters for us to take to the CMS Public Hearing in Baltimore, back in April, 2008. The words of Margaret Mead (which appear at the bottom of most of our newsletters), ring true, again: 'Never doubt that a small group of thoughtful, committed people can change the world. Indeed, it is the only thing that ever has.'"

The BeTER LeTTER newsletter archives, with all earlier issues, can be found at: www.bterfoundation.org/indexfiles/letter.htm

Maggots Finally Get Some Respect

At the risk of appearing conceited, let me devote today’s report to two instances where biotherapy was awarded some respect by the society in general, and the medical community in particular.

Maggot therapy began its current revival in the United States in the early 1990’s. In the United Kingdom, this occurred about 5 years later. There are many proponents of maggot therapy in the UK, and many people who deserve credit for creating the laboratories and clinics where it all started. Since those early days, Mary Jones devoted her time to spreading the word, and the skills, through her efforts teaching other health care providers to treat patients with maggot dressings. Earlier this year, her Maggot Therapy work was formally recognized by the Queen of England. Mary Jones was awarded an MBE in the Queen's New Year Honors for her services to nursing. Read more about it at: http://news.bbc.co.uk/1/hi/wales/7163148.stm

This past June, the Director of the BioTherapeutics, Education & Research (BTER) Foundation, Ronald Sherman (yes, that’s me), was recognized by the editors of Medical Device and Diagnostics Industry as one of the “100 Notable People” in the medical device industry for 2008. This tribute was published in the June, 2008 issue of the trade journal.

Among Dr. Sherman’s contributions listed in this cover story are his clinical trials of medicinal maggots for wound-healing, and his success in securing FDA marketing clearance for those maggots --- the first live animal to achieve such a status in FDA history.

Ronald Sherman began his interest in maggot therapy as an Entomology undergraduate, and wrote his first paper with Plastic Surgeon Ed Pechter while in medical school (published 1983). By 1989 he had the opportunity to design and conduct his first prospective clinical trials of maggot therapy. With funding by the Paralyzed Veterans of America (PVA), California PVA, and the Andrus Foundation (American Association of Retired Persons), he spent the next 5 years evaluating the safety and efficacy of the flies that he captured in Southern California. Sherman modernized methods for disinfecting them and applying them to wounds. He has supplied nearly 1,000 therapists in the United States with medicinal maggots for use in their patients, and he has assisted others worldwide in setting up their own maggot-rearing laboratories (today more than 25 laboratories supply medicinal maggots to patients in 35 countries). In 2003, the Food and Drug Administration (FDA) began regulating medicinal maggots. In January, 2004, Sherman’s Medical Maggots became the first living organism to receive marketing clearance by the FDA as a prescription medical device. found a safe and effective strain, which has been maintained with genetic purity until this day.

These two commendations are a landmark in biotherapy history, for they indicate that maggot therapy and those who promote it are now welcome back into the mainstream. Indeed, at least in Britain, they are even welcome in high society. Congratulations to Mary Jones and Ron Sherman. Congratulations to British and American Society, for making it back to the future of medicine.

Patients and their families weigh in about maggot therapy and reimbursement

What do patients and their families have to say about maggot therapy and reimbursement? Read for yourself -

During 2006 my mother developed a serious pressure wound at a skilled nursing home. The best conventional care . . . was woefully deficient in debridement of the necrotic tissue to promote healing. My mother’s primary care physician gave a prescription order for the MDT therapy. I then paid Monarch Labs and . . . practitioner nurse to administer about six dressings, for a total of about $1,200. The MDT treatments were vastly more effective than the Panafill ointment used by the home care nurse program. The head home care nurse observed the MDT treatment program and became so convinced of its efficacy that she tried to implement it into her own program with much resistance from management. When I applied for reimbursement our HPO was SCAN backed by Medicare. I provided all the data requested by SCAN and nothing came of it. Lots of red tape with no reimbursement due to no code for MDT. MDT was the only effective debridement method.

Mr. D. (son), California

Letter from Massachusetts, requesting HCPCS code for medicinal maggots

Another letter to CMS, requesting reimbursement coding for maggot therapy and medicinal maggots -

Medicaid HCPCS Coordinator
Centers for Medicare & Medicaid Services
Mail Stop S2-01-16
7500 Security Boulevard
Baltimore, MD 21244-1850

Dear Medicaid HCPCS Coordinator:

I am a Registered Nurse who has worked in wound care facilities for 10 years. I have tried to obtain maggot therapy for many of my patients who failed IV antibiotics and conventional debridements, but because there is no assigned HCPCS code for this product and therefore no reimbursement available, this therapy has been unobtainable for clients who would benefit from treatment.

This lack of availability has led to higher cost for inpatient surgical debridements and greater length of stay in hospitals.

I feel that maggot therapy would be a lower cost choice and should be available for use and reimbursement to these clients who need this particular therapy.

Thank you for your consideration in this matter.

Nurse F, Massachusetts

In an addendum, she added:

I have tried to obtain maggot therapy for many of my patients who failed IV antibiotics and conventional debridements, but because there is no assigned HCPCS code for this product . . . this therapy has been unobtainable . . . . because we could not be reimbursed for them, it was stopped . . . . This . . . has led to higher cost for inpatient surgical debridements and greater length of stay in hospitals.

Letter to CMS from Michigan

We received many letters to present to CMS, explaining why reimbursement coding for maggot therapy is so important. I will post a few over the next several days. They speak for themselves, for the authors, and for the biotherapy community at large.

Dear Sirs:

While I can not be physically present at your meeting, I would like to comment via this email on Medicare coverage of medical maggot therapy. I treat diabetic ulcers on a daily basis in my podiatric medical practice. It is heartbreaking to see the loss of limbs and lifestyle changes my patients must undergo. Personally I have treated some of the worst of these patients with medical maggots and gotten very gratifying results. Unfortunately, this therapy is not covered by their insurance and the patient must bear this financial burden. The people that find themselves in this position are usually the least able to afford it. This means they are denied a treatment that could potentially save their limb. I have seen both sides of this: the saved limb by maggots and the lost limb because the patient could not afford the maggots. It is imperative that Medicare develop a code for medical maggot therapy.

Sincerely,
Dr. D, Michigan

At its upcoming Public Meeting on April 22, 2008, the Centers for Medicare and Medicaid Services (CMS) will solicit public input for the establishment of a Healthcare Common Procedure Coding System (HCPCS) for medicinal maggots.

Level II of the HCPCS is a standardized coding system that is used to identify products, supplies, and services not included in the Current Procedural Terminology (CPT) coding system assigned by the American Medical Association to describe most procedures. Together, CPT codes and HCPCS codes are the mechanism by which most procedures and medical products in this country are listed on insurance claim forms and subsequently reimbursed.

Medical grade maggots have been used in this country for almost 80 years, but it was not until 2003 that they began to be regulated by the Food and Drug Administration (FDA). In January, 2004, Medical Maggots became the first living organism to receive marketing clearance by the FDA as a prescription medical device. Based on efficacy and safety studies, Medical Maggots can be marketed for the treatment of non-healing necrotic wounds, such as pressure ulcers, most diabetic foot ulcers, chronic leg ulcers and traumatic wounds.

A treatment supply of medicinal maggots costs less than $100, but reportedly can save thousands or even tens of thousands of dollars in medical, surgical and hospital costs. Yet, CMS still has not provided the health care industry with a reimbursement code for this critical wound care product.

The AMA considered a CPT code for maggot therapy 3 years ago and again last month. Their decision remains unchanged: clinicians should be reimbursed for their time doing maggot therapy by using standard wound care procedure reimbursement (CPT) codes that already exist. Reimbursement for the additional cost of the maggots, they said, should be obtained by using a designated HCPCS code, to be assigned by CMS.

The purpose of the upcoming Public Meeting is to obtain industry and public reaction to CMS’ preliminary coding recommendations. According to the published meeting agenda, CMS officials plan to recommend that medicinal maggots not be given a reimbursement code because "No insurer (i.e., Medicare, Medicaid, Private Insurance Sector) identified a national program operating need to establish a HCPCS Level II code to identify Medical Maggots (http://www.cms.hhs.gov/MedHCPCSGenInfo/Downloads/SO-April22_2008.pdf).

Members of the BioTherapeutics, Education and Research (BTER) Foundation disagree with the CMS recommendation, and plan to demonstrate that beneficiaries, health care professionals and taxpayers do see a need for patients and their doctors to be able to use, code, and be reimbursed for using medicinal maggots. According to the charity’s director, Dr. Ronald Sherman, BTER Foundation representatives will remind CMS officials that the same efficacy and safety studies that FDA evaluated before clearing Medical Maggots for marketing in the U.S. also demonstrated lower medical costs and high rates of limb salvage. In fact, when used on patients who failed all other medical and surgical treatments for their gangrenous wounds were offered only amputation or maggot therapy, 40-50% of patients who chose maggot therapy healed their wounds and saved their limbs. BTER Foundation members also will present study data that shows that many doctors will not prescribe maggot therapy when their insurance companies do not, or are perceived not to reimburse for the maggots. “Not having a reimbursement code for medicinal maggots is like not allowing maggots on the formulary of any insurance company,” he says. “This is not what we would expect from Medicare, as the leading proponent of high-quality, equitable, cost-efficient medical care.“

BTER Foundation Board member Pam Mitchell will also defend maggots at the hearing. She recently published her own experience in which she attributes medicinal maggots as saving her legs and her life (Maggots, Miracles Me, published 2007 by Xulon Press). “Until a HCPCS code is established for medicinal maggots, she says, “maggot therapy may remain more available for the wealthy who can pay one or two hundred dollars out of pocket rather than the majority of Americans, whether they have medical insurance or not. It seems like it is often easier to get your legs chopped off, and insurance will even pay for it, but not maggot therapy, even though maggot therapy could save your legs and a lot of money, too.”

The BTER Foundation, established in 2003, is a not-for-profit organization dedicated to supporting patients, educating health care providers and furthering research in biotherapy such as maggot therapy, leech therapy, cancer-detecting and service dogs, and the use of other living animals to diagnose or treat illness.

More information about HCPCS coding can be found at: http://www.cms.hhs.gov/MedHCPCSGenInfo/

More information about the public hearing can be found at: http://www.cms.hhs.gov/medhcpcsgeninfo/08_hcpcspublicmeetings.asp

More information about the BTER Foundation can be found at their website: http://www.BTERFoundation.org

Why blog about Maggot Therapy and BioTherapy?

I never thought that I would be blogging, but today I was moved to set up this site about maggot therapy, leech therapy, and other forms of biotherapy. Why? Because I encountered another obstacle to health care. And I am frustrated.

For the past 25 years I have studied and shared the health benefits of maggot debridement (fly larvae that remove all of the dead or gangrenous tissue from a wound without harming the healthy tissue). We made it past the ethics committees, and through the years of minimal research funding. We taught therapists how to use the maggots, despite having to work outside of the conventional Medical School curriculum. In 2002, the FDA was called in to regulate our work, and by 2004 we came out of the experience with marketing clearance!

You would think (or at least I thought) that with FDA marketing clearance any doctor could now prescribe maggot therapy. Legally, they can. But in practice, many do not. Why not? There are many factors, but one of the most common is the difficulty in getting paid for it (reimbursement). Wayman and his group (2000) demonstrated a cost savings by using maggot therapy for venous stasis ulcers. But when insurance companies do not pay for maggot therapy then the health care practitioners and institutions (or the patients themselves) have to pick up the costs themselves. From their perspective, maggot therapy is not a cost savings.

It is a shame when our health care system pays thousands of dollars for an amputation but not $100 for maggots, which reportedly saved limbs in 50% of the cases where it was tried (Sherman, 2002).

The reason that it can be difficult to get reimbursement for maggot therapy --- sometimes requiring the doctors or patients to appeal an initial rejection letter several times --- is that there is no specific procedure ("CPT") code for the procedure of maggot therapy, nor a product ("HCPCS") code for the maggots. Just about every medical procedure, from drawing blood to transplanting hearts, is designated with a CPT code which can be listed on Medicare, Medicaid and private insurance forms. Just about every medical product, from empty syringes to ventilators, has a designated HCPCS code, which can be listed on the insurance forms so that the patient or health care provider can be reimbursed.

But in 2004, the American Medical Association (AMA) Committee for CPT Coding declined to issue a specific CPT code for maggot therapy, stating that reimbursement should come from a HCPCS code for the maggots. The Center for Medicare and Medicaid Services (CMS) issues HCPCS codes. Then the Center for Medicare and Medicaid Services declined to issue a HCPCS code for the maggots, stating that reimbursement for maggot therapy should come from billing for the procedure with a CPT code.

Today, the same volleying is playing out all over again: AMA says that CMS should provide a billing code, and CMS says that AMA should provide the billing code. Meanwhile, there is no billing code and patients and their care providers are forced to battle their insurance providers to get fair reimbursement for a safe, effective and appropriate (albeit unconventional) therapy.

That is what prompted me to begin writing about the contemporary issues (research, accomplishments, opportunities, and, yes, battles) concerning biotherapy.

I will have to continue this story tomorrow . . . .