STUDY ON MEDICAL DEVICE PREEMPTION - Your Thoughts?

Title Revision 2

I will go ahead and copy the report on this study word for word as I think it is important to see.

Your thoughts on this are appreciated.


Removing Medical Device Preemption Impacts Jobs, Health Care Costs, Patient Access

BOSTON, May 6 /PRNewswire-USNewswire/ -- In a white paper released today by Ernst Berndt and Mark Trusheim of the Massachusetts Institute of Technology, research shows that eliminating FDA's preemption protection would decrease patients' access to life-enhancing medical devices, increase health care costs and reduce medical device industry employment.
The paper, "The Economic Impact of Eliminating Federal Preemption for Medical Devices on Patients, Innovation and Jobs," comes as Congress considers legislation that would remove Federal preemption of state rules and litigation that exists for a small percentage of medical devices that undergoes the most rigorous FDA review. The report highlights the damaging economic, health and societal impacts the legislation would have on patients, medical device industry innovation and employees, and the public health.
"As economic and health care researchers, we felt it was important to examine how this regulatory change could harm innovation, and ultimately impact the patients who rely on these treatments and the people who are employed by the device industry" said co-author Ernst Berndt, Ph.D., Louis E. Seley Professor in Applied Economics, MIT Sloan School of Management. "Congress should carefully weigh any policies that could increase health care costs and reduce high-paying jobs, particularly during an economic downturn."
The authors' research highlights the consequences to multiple stakeholders - patients and the public health, medical device inventors and manufacturers, their employees and the government - if medical device preemption were eliminated. For example,
Patients' access to medical devices and the benefits they provide would be reduced; as prices increase, products may be withdrawn, and fewer new products will be developed.
Physicians will increasingly practice defensive medicine to avoid litigation and expose patients to added risks of otherwise unnecessary procedures.
For those employed by the medical device industry, the increased manufacturers' costs would discourage investment in medical device development, reducing the R&D pipeline of innovative new products created and brought to market, and lead to layoffs of high-paying jobs.
Medical innovation would be affected, as decisions about health care products shift from expert, science-based regulators to untrained, non-expert juries, creating a duplicative, fragmented and inconsistent national framework administered by state and federal courts.
The government would experience increased costs, as Medicare and Medicaid spend more than they otherwise would due to fewer new product innovations, and government pays for increasing judicial system, tort and duplicative state regulatory costs.
"The question is not whether eliminating preemption will reduce innovation, but rather by how much and how rapidly," said co-author Mark Trusheim, Visiting Scientist at the MIT Sloan School of Management. "High levels of tort risk discourage investment in new technology. Eliminating preemption substantially alters the benefit/risk ratio of complex medical devices, increases the costs for all stakeholders, and negatively affects patients' future access to treatment options."
"Given these findings, and current economic circumstances, Congress should carefully consider any change to current law as the ramifications could substantially harm patient choice and health," Trusheim concluded.
The report was made possible by a grant from the Advanced Medical Technology Association. The views expressed are those of the authors only, and do not necessarily reflect views of the sponsor or MIT.
SOURCE Berndt Associates

New Rule at the Deaprtment of Health and Human Services - may bring healthcare to it's knee's

A new rule at the DHHS could effectively bring our health care services to a halt. The new rule took effect in January and was put into place in the waning months of the Bush White House.

The rule could set a precedence for religious beliefs in publicly funded institutions which suspiciously seems to go against the spirit of the 1st and 14th amendment of the US constitution.

The rule is tagged : DEPARTMENT OF HEALTH AND HUMAN SERVICES 45 CFR Part 88 RIN 0991–AB48 Ensuring That Department of Health and Human Services Funds Do Not Support Coercive or Discriminatory Policies or Practices in Violation of Federal Law AGENCY: Office of the Secretary, HHS

The worrisome part is that medical workers whose religious beliefs would go against performing abortions, sterilizations and anything related to these procedures would be excused from performing them. But importantly these employees could not be relocated in the hospital to another department as this would be seen as discriminatory. Effectively, if there are no staff to perform the procedures or any part of it, even cleaning up the room afterwards, technically, then the hospital would not be able to offer the services. This could seriously limit access for women seeking these procedures.

Even more challenging would be a potential scenario where emergency room personnel who are currently required by law to advise victims of rape of emergency contraception may effectively refuse to do so under the terms of this rule.

Julie D. Cantor, M.D., J.D. In an article for the New England Journal of Medicine reported that "Lawsuits have already been filed in federal court, and Connecticut Attorney General Richard Blumenthal, who led one of the cases, has vowed to continue the fight until the regulation is "finally and safely stopped." The fear is that remmnants of the rule may be left behind causing havoc in the health care system.

However, with the change in government, the DHHS is working on rescinding the law.

Please view the rule here and also register your comments DHHS rule