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 . . . .