Note to readers: This column originally ran in 2010.
Humorist and social commentator Will Rogers once said, "Things in our country run in spite of government, not by aid of it."
He was right.
In 2009, I received a breast cancer diagnosis and underwent a double mastectomy. I could not shower until the post-surgical drains were removed or risk serious infection due to bacteria-laden tap water. I couldn't find a water-resistant garment to wear while showering, so I threw a plastic bag over my head for protection - a somewhat-humiliating experience.
However, it inspired me to develop a water-resistant garment to protect breast cancer/mastectomy patients from water while showering.
Since then, I have brought the product, officially known as the Shower Shirt, to the U.S. market. Hiring a lawyer to do the corporate work and the patent filings was the easy part. But in order to qualify the product for Medicare, I was told to apply for an "existing" government code.
Though I knew there were no similar products in existence, I did as I was told. After many months, the analysis group communicated what I knew all along - my product cannot be given an "existing" code because it is not comparable to any other product on the U.S. market.
Subsequently, the group instructed me to apply for a private code, while also working toward Medicare reimbursement. Now I am told the Shower Shirt has been preliminarily rejected for its own code because the analysis group has decided the mastectomy garment is a "convenience" item, rather than a "medical necessity."
I guess the government doesn't realize unprotected showering can risk further infection and ultimately cause hospital readmissions, additional surgeries and medication costs.
I am not trying to sell a drug or a medical device that needs clinical trials. My product won't be ingested, injected or implanted into a patient's body. However, it does support the physical, emotional and psychological aspects of post-mastectomy care.
This seems a small enough request, given nearly 240,000 women each year receive a devastating diagnosis of breast cancer - many of them needing surgery to survive.
With both political parties campaigning about strategies to grow small business, I want to ask President Barack Obama and GOP presidential nominee Mitt Romney: How can I grow my small business when the government is causing expenditures of tens of thousands of dollars a month on lawyers for coding? I've spent $2,500 alone on scientists, just to have them tell me whether my product has to be "approved" or "registered" with the FDA.
When I launched the Shower Shirt Co., I was not looking for a government grant, loan or subsidy. I just wanted to have the garment approved so patients who needed it could get reimbursed for a portion of the cost.
After a year and a half of fighting, I wonder if our government cares about small business. Maybe if Will Rogers had been a politician, our country would be different - maybe less complex and much more government friendly.
Crites is the inventor of The Shower Shirt, the first and only water-resistant garment to protect mastectomy patients post surgery. A corporate health care consultant and media strategist with 20-plus years of experience, she lives in Cocoa Beach.
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