U.S. Senator Pat Roberts, a leading critic of the recess appointed Dr. Donald Berwick, the Administrator of the Centers for Medicare and Medicaid Services (CMS), today expressed frustration about a cursory hearing preventing effective oversight of an agency that controls one-third of all health care spending in America in the midst of the nation's largest health care overhaul.
"Five minutes of questions and answers for the Administrator is not enough time to examine the critical decisions he must make as head of CMS," Senator Roberts said. "Dr. Berwick was recess appointed in July to avoid a controversial nomination hearing in the Senate. His first appearance before the Finance Committee, this 80 minute hearing, was the best they can do?"
Senator Roberts submitted the following statement and questions for the record:
"I think most people in this room know that my number one concern with President Obama's health care reform law is the enormous potential for the government to interfere in the decision-making ability of the doctor and patient when it comes to treatment. Dr. Berwick, you have a long history of statements supporting government control of treatment decisions, what I would call "rationing' although that word has become an excuse by some to dismiss my concerns as irrational or paranoid.
"Knowing all of these past statements, I've been extremely distressed, but completely unsurprised by the path that you have started CMS on. This is the path of increasing government control, centralized decision-making, and top-down mandates that treat doctors as nothing more than cooks practicing "cookbook medicine', and patients as nothing more than numbers, totally discounting their individual needs and desires.
"One example of this command and control approach can be found in recent attempts by CMS to restrict the number of times seniors with diabetes can test their blood sugar by limiting them to one test strip per day, regardless of what their doctor recommends.
"As the American Association of Clinical Endocrinologists explains: "Diabetes care is an exceedingly complex enterprise.' "Any individual patient's risk for hyper- and hypoglycemic events is determined by complex events that cannot be predicted by a formula.' So why is CMS replacing the individualized treatment plans determined by a patient and a doctor with its bureaucratic government-knows-best approach?
"An even more egregious example of the government getting in between patients and doctors is your recent investigation into the Medicare coverage of the life-extending prostate cancer therapy Provenge.
"Provenge is a therapeutic vaccine approved by the Food and Drug Administration to treat late-stage prostate cancer through an innovative process that removes immune system cells from patients, exposes them to cancer cells and an immune system stimulator, and then injects them back into the patient. Provenge has been shown to increase life expectancy by an average of four months- but sometimes longer- for prostate cancer patients. In addition, Provenge is special because of its lack of side effects as compared to traditional chemotherapy. So not only can patients live longer, but their quality of life will be better.
"Medicare coverage for on-label uses of FDA-approved drugs is usually automatic. So why did CMS open up a national coverage analysis so soon after Provenge gained FDA approval? Why is CMS-- which is ironically meeting on this issue right now as we speak-- seeking to substitute its judgment for not only patients and doctors, but for the FDA- the gold standard for drug approval worldwide? Are you questioning the FDA's decision?
"My hunch is that cost- $93,000 for the complete treatment- was the driving factor behind this investigation. And I am very concerned about the precedent that this sets- not only for other cancer regimens like the promising breast cancer drug Avastin- but for all new medical innovations.
"Now some may say that an average of four months is not enough to justify this price tag. I have several responses to that argument. First of all, the government should not be in the business of placing dollar values on life. Period.
"Secondly, traditional chemo and all of its associated side effects costs Medicare upwards of $110,000 per patient per year. Provenge is actually a saver when viewed in that light!
"Third, this is exactly the type of innovative approach that we need to win the fight against cancer. Medical advances don't always come in giant leaps- they more often occur at the margins. Denying patients and doctors treatment options simply because they don't offer a complete cure is extremely short-sighted, not to mention cruel.
"And finally, if we want companies and investors to continue to pour their dollars and efforts into developing an ultimate cure for cancer, this is the absolute wrong approach. The investment into researching and developing Provenge approached $1 billion over 15 years and 15 clinical trials. Refusing to allow a return on this huge investment will send a chilling effect across the health research industry, resulting in less investment and less innovation. The government can never replace private investment as the major driver of innovation in this country, nor should it.
"But maybe less innovation is actually the goal of this Administration and of Dr. Berwick who has targeted the "entrance of new technologies, drugs, and devices' as "one of the drivers of low value in health care today.'
"Value is a subjective concept. I'd prefer that the value of health care be determined by the patient and the doctor, not the government. Dr. Berwick, would you agree?"
Senator Roberts is a member of the Senate Committee on Finance and the Senate Committee on Health Education Labor and Pensions. He voted against Obamacare.