The Backstory at CDG

Reimbursement, Universal Health Care, and Campaign Contributions

Medical device companies are shifting their allegiance from Republican to Democratic. In this election cycle, Democratic candidates have received $7.4 million in campaign contributions from political action committees and individuals associated with medical device and pharmaceutical companies according to the Center for Responsive Politics. In the past six election cycles, device and pharma companies contributed twice as much to the Republican candidates as to the Democratic candidates.

Why the shift from Republican to Democratic? Does the industry itself perceive change in the air? Overwhelmingly, Americans want some kind of universal health care in this country. I'm in favor of it too, but most Americans think Europeans have a dreamland situation—free health care for everyone, anytime. But it isn't so. In the UK, public health care is often augmented by private health insurance. And universal health care can lead to political tensions. In Denmark, 60-70% of salary goes to taxes, including taxes to finance the 'free' health insurance. Yet those who don't work and don't contribute to the system still have access to it, meaning a large minority of immigrants from Middle Eastern countries are taking advantage of the system.

If the Democrats are more likely to actually implement a universal health care system, then it makes sense that device and pharma companies would want to be in a position to influence how that system is constructed. Will there be a single-payer system, doing away with the 350+ health insurance companies in this country (I hope so)? Who will have access to it: all persons or only citizens? Will the entire reimbursement scheme be rebuilt? Today, devices are not usually reimburse as separate entities, but rather as part of a procedure. So an incremental improvement to your medical device doesn't automatically get you a better price, because the differential comes out of the hospital's pocket. How would the reimbursement system change and would it benefit the device industry?

CDG recently sponsored a conference on medical device reimbursement and it is now available on CD or On Demand video. You can learn more about our reimbursement practices today, and interpret for yourself the complexities of implementing a universal health care system, by viewing Mary Ann Clark, VP for Health Economics & Reimbursement for the Burgess Group, at CDG e Conferences, or call me          773-489-5721       .

FDA Bans Seven Investigators

FDA has banned seven doctors from doing clinical trials so far this year. That is the highest number since 2002, you can see the entire disqualification list at  http://www.fda.gov/ora/compliance_ref/bimo/disqlist.htm. Physicians or other medical professionals are banned from conducting clinical trials that will result in data being submitted to FDA; put another way, these people can still do clinical research, but no data generated by them can be used to support an FDA marketing application. Which means that medical device companies who have ongoing clinical trials with these investigators, or are considering using these investigators, should look elsewhere.

   

The list of investigators banned in 2008 is:

01/31/2008 Jamie Kapner, M.D.—Urologist, Scottsdale, AZ
02/15/2008 Bertrand Agus, M.D.—Rheumatologist at New York University
02/25/2008 Stephen D. Rossner, M.D.—Cardiology Associates of Central Connecticut
03/05/2008 William H. Ziering, M.D.—Pediatric Allergist, Central California Research Institute
03/05/2008 Mary Sawaya—Dermatologist, University of Florida, Miami, FL
03/21/2008 Patrick J. Daley—Pediatrician, Tulsa, OK
04/28/2008 Manjeet Kaur Achreja, M.D.—Family Medicine, Seagrove, NC
05/06/2008 David N. Lofgren, M.D.—Pediatrics, Sandy, UT
05/15/2008 James C. Vestal, M.D.—Urologist, Urology Associates of North Texas
06/02/2008 Maria Anne Kirkman Campbell, M.D.—Weight Loss Clinic, AL

The physicians come from various walks of medicine, but all contributed to fraudulent data being submitted to FDA. Fraudulent data is the omission of data, the fabrication of data, or the alteration of data. It can be committed by anyone who has contact with the data, but is usually committed by someone likely to experience financial gain. Investigative sites should be audited by third-party CROs whenever data are pivotal to proving your device's success. For information about site audits contact CDG. 

CLIA Waiver for IVD Medical Devices

I didn't understand until recently why in vitro diagnostic device companies had to worry about CLIA waiver. CLIA, the Clinical Laboratory Improvement Act, is a certification for clinical laboratories. An individual laboratory is certified according to the complexity of in vitro diagnostic test they are qualified to run. The idea is that laboratories who have the best trained technicians, experienced PhDs as laboratory directors, and the most modern equipment are the laboratories that perform the most complex of diagnostic tests; laboratories with lesser trained technicians and less equipment perform the simplist of IVD tests. But I always considered it to be a laboratory issue, not a medical device manufacturer's issue.

Then comes the new FDA guidance "Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices" 30 Jan 08, http://www.fda.gov/cdrh/oivd/guidance/1171.html#1, and suddenly a light-bulb comes on. Of course a manufacturer of IVD devices wants their product to be 'waived' because it means they can offer the device for sale to more laboratories. The marketplace increases as the level of complexity category decreases.

I got so excited I asked Dr. Gail Radcliffe to give a virtual e conference on the topic on 11 June. Learn more....