HHS OIG Reopens Investigation of Heart Valve Sales Across State Lines from 2003-2008 After Wisconsin Elected Officials Respond to Constituent's Concerns
Contact: Nalini Rajamannan, 312-498-9496
SHEBOYGAN, Wis., Oct. 18, 2017 /Christian Newswire/ -- Congressman Glenn Grothman (WI) and Senator Ron Johnson (WI) respond to Wisconsin Physician, Dr. Nalini M. Rajamannan's, Cardiologist concerns over secretive sales of heart valves in interstate commerce in the United States. According to the FDA listing database, 3 of the 4 heart valves in question were not listed from 2003-2008, despite hundreds and hundreds of these valves sold across state lines and placed in patients' hearts without FDA approval. The OIG for HHS primary role is to investigate payments from CMS medicare and Medicaid for valves sold across state lines without pre-authorization from CMS and the FDA.
According to the Device Listing Federal Laws, Title 21 CFR part 807:
"Registration and listing provides FDA with the location of medical device establishments and the devices manufactured at those establishments. Knowing where devices are made increases the nation's ability to prepare for and respond to public health emergencies."
On October 12, 2017, the Director of External Affairs, Office of Inspector General Mr. Christopher Seagle in an email wrote to Dr. Rajamannan:
We have received your allegations and we will take whatever action we deem appropriate. Please note that it is OIG policy to not respond to any inquiries about action taken on your complaint. We understand the natural inclination to follow up on a report but the OIG does not provide the status of complaints. More information can be found on our hotline webpage.
The IG has moved forward after recent press reports regarding the patients who received the ring and the efforts by Congressman Grothman and the Senate Committee Chair, Ron Johnson.
News article from WHBL
News from NBC affiliate, NBC26, in Green Bay, Wisconsin
To learn more about the response to the Inspector General's Investigation visit Most Sacred Heart of Jesus Cardiology and Valvular Institute located at 703 North 8th Street, at noon today October 18, 2017 in Sheboygan WI, for a press conference regarding the IG investigation after inquiries from Wisconsin elected officials.