Uroplasty Inc., a Minnetonka company that makes a nonsurgical device to help control overactive bladder, had tried for years to win Medicare reimbursement for the region that includes Minnesota. But, despite being covered by several local insurance providers and Medicare in most of the rest of the country, its efforts to be covered by it here kept falling short — until last week.
As of June 1, Uroplasty's Urgent PC Neuromodulation System is covered by Medicare in Minnesota, Wisconsin and seven other states. Medicare now will pay for Urgent PC in all but two states — New York and Connecticut. The addition of 8.7 million Medicare beneficiaries could have quite an impact on Uroplasty's bottom line, said Charles Haff, a senior research analyst with Craig-Hallum Capital Group.
"I believe there is a high level of pent-up demand," Haff said of doctors in the region. "This is a 24 percent larger opportunity than they had prior."
Called posterior tibial nerve stimulation (PTNS), Urgent PC calms an overactive bladder by sending an electric pulse through a needle inserted near the tibial nerve in the ankle. The pulse travels up the leg to nerves near the bladder that contribute to the urge to urinate. A 30-minute treatment once a week for 12 weeks — followed by ongoing therapy about once a month — achieves results, Uroplasty officials say.
Overactive bladder affects 34 million Americans, typically characterized by eight or more trips to the bathroom each day. Clinical trials and published studies have shown Urgent PC to be clinically effective in up to 80 percent of patients, said Nancy Kolb, vice president of global marketing for Uroplasty. Improvement can be sustained for years.
Uroplasty says that more than 60,000 people across the county have benefitted from Urgent PC, about one-fourth of them in the past year alone. The Food and Drug Administration approved the device in 2006. Kolb said Urgent PC is prescribed after other options, including behavior and medication, have not worked.
Doctors buy the hardware from Uroplasty for about $1,500 and receive an average of about $125 from Medicare for each patient treatment.
But convincing the powers that make Medicare coverage determinations here has taken time.
Making the case
Medicare is a federal program, but for most people it is administered by several regional jurisdictions. It is a complicated process to win coverage determinations, the folks at Uroplasty said. But, over the years, they used new studies and clinical data to chip away at those regional Medicare administrators
It probably helped that private insurers in Minnesota, including Blue Cross/Blue Shield, HealthPartners, Medica and Aetna, agreed to cover the procedure. Still, Wisconsin Physicians Services (WPS), which covers Minnesota, and National Government Services, which administers New York and Connecticut, held out.
Several weeks ago, officials at WPS would not comment on why they had not approved payment, other than to say that their decision was being reconsidered. Then, on May 31, they announced it would be covered as of the next day.
There are 48 million Medicare beneficiaries in the United States. About 92 percent of them now are covered, should they need Urgent PC.
"Coverage is really the most difficult part of the reimbursement process," Kolb said, adding that Uroplasty took the advice of the American Urological Association and increased clinical trial data to make their case. The company also beefed up its reimbursement department — to the tune of about $500,000 a year — to work with insurance and Medicare administrators.
"The company really made an investment in building a reimbursement department," she said. "I think there was a great deal of belief that we could do it."
Uroplasty's chief financial officer, Medi Jiwani, was asked what impact the recent Medicare decision would have.
"We believe it will have a positive impact on our revenues," he said. "Beyond that, there is no number that we can quantify."
Haff, however, said it could be significant.
The company, which also makes an injectable product to treat urinary incontinence, recently reported that fiscal fourth quarter 2013 sales in the U.S. increased 2 percent, driven by an 11 percent increase in sales of Urgent PC — to $2.6 million. Now, the prospective Medicare patient pool is increasing 24 percent.
While Uroplasty is not yet profitable, Haff said he expects that to happen in the next year or so. That would have happened even without the WPS decision for Medicare coverage, he said. "This is icing on the cake."