On
November 18, 2015, a former doctor and others were charged with making misrepresentations to the Food and Drug Administration (‘FDA”) in order to obtain clearance for a "hyperbaric chamber" that Mr. O’Brien marketed under the name "Hyperox 101."
This case probably would not have been prosecuted but for the fact that approxmimately $15 million in claims for treatments were submitted to insurance carriers and Medicare. The Medicare billings in this case appear to have triggered the investigation.
William J. O’Brien III of Philadelphia, Pennsylvania was charged in an indictment with conspiring to defraud the FDA and a separate conspiracy to commit health care fraud.
A hyperbaric chamber is a sophisticated medical device in which patients breathe 100% pure oxygen for a prolonged period in a pressurized environment. To achieve a therapeutic effect, the chamber is pressurized to at least 1.4 atmospheres below sea level. The pressure creates a biochemical reaction that increases oxygen absorption into the blood. A hyperbaric chamber for treating patients must be constructed using pedigree steel and certified as a pressure vessel for human occupancy.
This case probably would not have been prosecuted but for the fact that approxmimately $15 million in claims for treatments were submitted to insurance carriers and Medicare. The Medicare billings in this case appear to have triggered the investigation.
William J. O’Brien III of Philadelphia, Pennsylvania was charged in an indictment with conspiring to defraud the FDA and a separate conspiracy to commit health care fraud.
A hyperbaric chamber is a sophisticated medical device in which patients breathe 100% pure oxygen for a prolonged period in a pressurized environment. To achieve a therapeutic effect, the chamber is pressurized to at least 1.4 atmospheres below sea level. The pressure creates a biochemical reaction that increases oxygen absorption into the blood. A hyperbaric chamber for treating patients must be constructed using pedigree steel and certified as a pressure vessel for human occupancy.
According
to the indictment, Hyperox 101 as constructed did not meet these standards;
rather, it was built by welding together pieces of a used propane tank.
The indictment charges that Mr. O’Brien knew of the deficiencies in
Hyperox 101, but passed it off as a medical device by submitting false documentation
to the FDA.
The indictment alleges that, due to its substandard construction, Hyperox 101 did not provide patients with the therapeutic benefits associated with hyperbaric oxygen treatment, but instead posed potential risks to patients.
The indictment alleges that, due to its substandard construction, Hyperox 101 did not provide patients with the therapeutic benefits associated with hyperbaric oxygen treatment, but instead posed potential risks to patients.
The indictment charges that defendant O’Brien used the unapproved device to defraud Medicare and other health benefit programs. From in or around March 2007 through in or around August 2011, it is alleged that Mr. O’Brien obtained millions of dollars based on fraudulent claims that he caused to be submitted to Medicare and IBC, among other health care benefit programs.
It is also alleged that Mr. O’Brien caused fraudulent claims to be submitted of approximately $15 million for medically unnecessary and potentially unsafe treatments. Mr. O’Brien obtained reimbursement from Medicare and other insurers of approximately at least $4.2 million based on the fraudulent claims.
Posted by Tracy Green, Esq.
