
MASSDEVICE ON CALL — Corporate heads at medical device manufacturers and other major health care enterprises are at increasing risk of criminal prosecution when corporations that work with Medicare and Medicaid get caught breaking the rules.
It used to be that corporations were held solely responsible in cases of health care fraud, such as submitting false claims, paying kickbacks to doctors, or marketing drugs not cleared for safety and efficacy. The company paid a hefty fine and everyone moved on.
In a growing trend, health care executives could face criminal charges and may be banned from doing business with government health programs, a potential a career-killer.
The feds say they are using tools that were already in the books but never used, taking action against repeat offenders that are costing taxpayers billions, the Washington Post reported. Health care fraud costs taxpayers $60 billion per year by some estimates, according to the Post.
Some worry that the new measures take too heavy a hand, handing down radical punishments to individuals whose guilt isn’t clear, according to the Post.
“Life sciences and medical devices have become a minefield with regard to regulation and prosecution by the FDA,” said civil liberties attorney Harvey Silverglate at a Massachusetts Institute of Technology discussion about federal prosecution of health care executives in April. “It’s an extraordinarily dangerous environment that you can’t believe until they come knocking at your door.”
Silverglate cautioned executives to keep all electronic communications, maintain detailed records of actions and intentions during all stages of product development, and never talk to federal investigators without a lawyer present.
Medical data breaches leave many concerned
More than 300 hospitals, doctors and insurance companies have reported significant breaches of medical privacy in just the last couple years, the New York Times reported, a problem that could impede President Obama’s efforts to shift medical records to electronic form.
The breaches amount to at least 7.8 million individual records improperly exposed.
In one case 1.7 million records belonging to patients, staff members, contractors and suppliers in Bronx hospitals and clinics operated by the Health and Hospitals Corp. were stolen from an unlocked van, according to the Times.
"The health care industry is not as vigilant as they should be about protecting private information in a patient’s medical records," Rep. Joe Barton (R-Texas) told the Times. Barton is co-chairman of the Bipartisan Privacy Caucus in the House.
Barton’s personal records were among those reported missing alongside thousands others from a research project at the National Institutes of Health after a disk containing the information was stolen from the trunk of a car.
Electronic prescriptions display mixed results in 12-month study
Federal incentives have health care providers rushing to switch to new electronic health care systems, but a new study found that certain types of prescribing errors became more frequent during the transition, the Wall Street Journal’s Health Blog reported.
Researchers followed 17 physicians at an outpatient clinic as it switched to a new system for electronic medical records. Prescribing errors decreased overall, dropping from 35.7 errors per 100 prescriptions to 12.2 errors after one year. But errors such as mistakes in directions and frequency were higher at 12 weeks than before the system was put in place, and some errors occurred even more frequently after a year, the Health Blog reported.
The study appears in the Journal of General Internal Medicine.
Spending more on health care leads to better outcomes for the elderly
Contrary to accepted wisdom, Medicare beneficiaries who spend more on medical treatment have better health outcomes, according to a new study from George Mason University and the Urban Institute. Researchers analyzed data from more than 17 thousand Medicare recipients and found that those who spent 10 percent more on medical care scored 1.9 percent higher on patient health scores and had a 1.5 percent greater survival probability.