We are a boutique law firm that focuses on the areas of reimbursement for new medical technologies, intellectual property and research integrity. We work with laboratory technologies, medical device manufacturers, academic medical centers and individual inventors interested in commercializing their inventions. We offer a full-range of services through the various stages of development particularly appropriate for start-ups.
BREAKING NEWS
On August 25, 2011, the United States District Court for the Southern District of Florida granted Advanced Diabetes Treatment Centers' motion for summary judgment and denied the Secretary of Health's cross motion for summary judgment. The Court found not only were the Secretary's decisions denying coverage not supported by substantial evidence, no evidence supported the Secretary's decision and there was overwhelming evidence to the contrary. The Court also denied the Secretary's request that the case be remanded for rehearing finding that the issues had been fully developed below.
The case involved payment for monitoring during clinical trials for pulsed insulin treatment for diabetes. Although the Florida Medicare Coverage Advisory Committee unanimously found that pulsed insulin treatment was not experimental and investigational, the carrier medical director deemed it to be experimental. At the carrier's urging, ADTC began clinical trials to further validate pulsed insulin treatment for diabetes and the carrier paid for the monitoring claims for approximately five years. In 2008, the Florida carrier changed its position and began denying monitoring claims. These denials were appealed up to the District Court and were the subject of this decision. In December 2009, the Secretary issued a National Coverage Decision defining pulsed insulin treatment to include the monitoring test and effectively ended further clinical trials on the treatment.
Focus Areas
Reimbursement for
Medical Technology
Extensive experience with the Medicare appeals process Learn more>
Research Integrity
and Research
Misconduct
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Intellectual Property
Offering a full range of services including patent prosecution, copyright and trademark Learn more>
