The Obama Administration's Covert Healthcare Disaster

I spent over 15 years practicing as a trauma and emergency medical specialist. During those years, I learned that many patients -- especially those facing death, imminent limb loss, or another devastating outcome -- are willing to try potentially risky, but cutting-edge interventions, as long as there's a reasonable chance of improving their outcomes.

Indeed, if you're suffering from a life-threatening illness or injury and traditional treatments aren't working, there's nothing to be lost by trying a riskier treatment -- and everything to gain.

Yet, a recent ruling from the Food and Drug Administration eliminates that option for thousands of late-stage breast cancer patients. And, even worse, that decision appears to be part of a broader push to put the government and its regulators between patients and their doctors, and to weigh cost over outcomes.

In December, the FDA rescinded approval for Avastin in the treatment of advanced breast cancer. Initially approved for the disease in 2008, the drug has been shown, when coupled with chemotherapy, to delay tumor growth by a median of 11 months -- almost five months more than chemotherapy alone.

But upon re-evaluating Avastin, FDA officials decided that the drug's potential side effects outweighed its benefits for breast cancer patients and voted to withdraw its approval for that disease.

 That decision is now being appealed, but assuming FDA approval for Avastin is withdrawn, public and private insurers will likely scale back their coverage of the drug for breast cancer, leaving these patients to either pick up the drug's $90,000 per-year price tag on their own, or forgo it. Most simply cannot afford it.

People in truly life-or-death situations will take on extra risk for the chance of months or years of additional life. Many advanced breast cancer patients are in exactly such a situation. Conventional treatments haven't worked, and the disease continues to progress. Without action, they can, and will, die quickly.

Avastin won't save all of them; for some, however, it could provide a significant extension of life. Yes, the drug might have some adverse side effects, but shouldn’t the ultimate determinant of that risk be the individual who stands both to benefit or to suffer from that choice? Neither I, as a physician, nor the government, have the right to make that choice for someone else.  

The Avastin ruling seems to be driven largely by cost concerns, and public insurance programs no doubt, stand to reap huge savings if they stop paying for the drug for breast cancer.

Unfortunately, the Avastin decision isn't an isolated incident. The Obama administration is pushing rationing, insidious as it may be, on multiple fronts.

Last year, the Agency for Healthcare Research and Quality changed mammography guidelines to tell women they shouldn't get their first exam until age 50. This modified guideline wasn't based on a new study evaluating the effectiveness of mammograms; it was based on an actuarial evaluation indicating that exams for women under 50 didn't have sufficiently high cost-benefit ratios.

In May, the National Institutes of Health (NIH) released the results of a comparison study between Avastin and the biological drug, Lucentis, for the treatment of age-related, "wet" macular generation (AMD).

This time, however, the government looks to be coming down in favor of Avastin -- but for the same purpose of blind cost-cutting.

Lucentis is officially approved by the FDA to treat wet AMD, which can cause blindness, while Avastin is not. However, when broken up into small bits and injected into the eye, Avastin has been shown to stop the progress of the disease, and doctors have taken to prescribing it off-label for this purpose.

These two drugs drew the government's attention because of their price difference: A Lucentis regimen for AMD costs about $2,000 per year. A similar course of Avastin clocks in at just $50.

The NIH found that Avastin is "as effective" as Lucentis -- even though 5 percent of patients on Avastin encountered more "serious adverse events" than those on Lucentis. Many fear that the government will use the NIH comparison to influence its public insurance policies. Specifically, officials could impose a "fail first" in Medicare for wet AMD treatment, forcing patients to try Avastin first.

There is a serious danger in such a policy. While these two drugs might be comparable for most wet AMD patients, there is a select group for whom Lucentis works better. Human bodies are amazingly complex and can react to drugs in vastly different ways, for reasons we don't yet understand. If that select group is forced to use less effective Avastin first, their eyesight could be permanently compromised.

In all these cases, the message from the government is clear: we're putting cost savings before human lives and outcomes.

Lowering healthcare costs will require identifying and eliminating wasteful spending and fraud in the system, improving the overall health of Americans, and allowing the free market to create natural cost pressures. But giving breast cancer patients a serious shot at additional years of life isn't a waste. Neither is screening women in their 40s for the disease. Or giving people facing permanent blindness the best options for saving their eyesight.

Our government needs to get out of the doctor's office.

Kelly Victory, M.D., is a residency-trained, board-certified trauma and emergency specialist and the President of Victory Health. She is advises a number of both public and private companies on healthcare issues and serves on the Leadership Counsel for the Harvard School of Public Health.

                                  written by Kelly Victory Steamboat Springs

Kelly Victory for Kelly Victory Steamboat Springs Death Panels? The Reality of Healthcare Rationing

In a conversation that has received much attention since it occurred in November, conservative talk-radio host Mark Levin spoke with a neurosurgeon who reported some disturbing information regarding ObamaCare, and the sorts of insidious and surreptitious control that it gives the federal government over healthcare.  During the call in question, the physician reported that he had come from a recent meeting of neurosurgeons in which they reviewed new HHS guidelines for advanced neurosurgical care.  According to their reading of the documents, patients over the age of 70 who are on federally subsidized insurance (Medicare, Medicaid or other “public option” alternatives) should only receive “comfort care” in the case of a stroke, hemorrhage or brain aneurysm that would otherwise benefit from surgical intervention.  Mark Levin vetted the caller and confirmed his identity and profession, as well as his attendance at the referenced neurosurgical meeting.  The doctor went on to describe the so-called “ethics committees” that have been put in place by the administration to determine where monies will be appropriated and what medical and surgical procedures will and will not be reimbursed.  The conclusion of the ethics committee is that neurosurgical intervention is “generally not indicated” for patients over 70.  And so it begins.

Although Sarah Palin may have coined a somewhat inflammatory phrase in suggesting that the healthcare reform bill included “death panels”, in a sense, she was correct; we are clearly seeing the impact of the legislation as committees of primarily non-medical administrators make decisions that profoundly impact the way in which doctors and hospitals can render care to their patients.  And sometimes those decisions – as in the case of a 70 year old with a brain hemorrhage -- can be tantamount to a death sentence. 

The new mammogram guidelines are another case in point: In this example, the “United States Preventive Services Task Force”, whose members were appointed by the Obama administration, after reviewing years of data on breast cancer, came out with new guidelines for mammography that contradict those of the American Cancer Society. Instead of starting regular mammograms at age 40, the task force said that women who were not considered high risk could wait until age 50. And instead of once a year, the task force determined that getting screened every 2 years was adequate.  Interestingly, the ACS reviewed the same data and held their ground, choosing to stay with their previous recommendations. The issue here is that the guidelines were changed by the Task Force, not on the basis of any new scientific or medical studies, but purely on the basis of an actuarial analysis that determined that it was not cost effective to diagnose and treat women with breast cancer before age 50 and after age 74 – a decision that you might disagree with should it be your wife, mother or daughter with the disease. The new guidelines for mammography were published in November of 2009, pre-dating the actual passage of the reform bill the following March, but were clearly a harbinger of things to come, including the significant rationing of healthcare. 

Once the government’s guidelines for a particular medical condition have been set, the next step is for reimbursement to be denied for those tests and procedures that are no longer recommended.  The FDA’s recent rescinding of approval of Avastin for breast cancer, initially approved for the disease in 2008, was likewise an economic decision, and again reflects the obvious move toward rationing  which has been built into the ObamaCare plan.  The FDA, formerly tasked with assessing drugs purely based on their clinical safety and efficacy, was asked in this case to opine on the economic value of the drug, and determined that it was simply too costly to justify the “minimal extension of life” that it generated.  Both private and public insurance companies have scaled back on their coverage of Avastin as a result of the FDA’s decision, rendering many patients unable to pursue the treatment.  These are just a few examples of the provisions within the bill that granted authority to bureaucrats to promulgate rules and programs governing our healthcare.  Surgeons and other practitioners whose specialties require significant costly interventions will be the most impacted early on.  If certain screening exams and treatments are deemed to have unacceptable cost-benefit ratios, they will be cut. In all of these cases, the message from the government is clear: We are putting cost savings before human lives and outcomes.  Many, many more “new treatment guidelines”, rescinding of drug approvals, and changes in reimbursement for procedures will be coming down the pike, should the bill not be repealed. 

Lowering healthcare costs will require identifying and eliminating wasteful spending and fraud in the system, improving the overall health of Americans, and allowing the free-market to create competition and natural cost pressures.  But providing for the early diagnosis and treatment of breast cancer, and pursuing neurosurgical intervention for patients over 70 isn’t a waste.  While the healthcare reform bill might not include the classic and repugnant concept of a discreet panel that casts a “live” or “die” decision, individual by individual, what it does is perhaps more insidious: sweeping, depersonalized determinations that entire categories of people will be denied certain treatments based on economic and age criteria.  Although people have eschewed the phrase “death panel” as inflammatory, it is, if fact, a fundamentally correct descriptor; forcing physicians to follow guidelines set by panels of administrators, considering economic criteria over human lives, and weighing actuarial analyses over years of medical education, training and experience will have exactly that effect. 

                                                      story by Kelly Victory Steamboat Springs

Kelly Victory for: Kelly Victory Steamboat Springs The Truth About Obama Care

There was a time, not so long ago, when a career in medicine was both honorable and reliable, as well as reasonably lucrative. That was, however, before it was considered "un-American" to make a profit on the practice of medicine, and certainly before the passage of the now infamous "Patient Protection and Affordable Care Act".

The sad reality presently, is that many physicians, and more and more hospital systems, are already going broke and closing their doors – All at a time when there will be a predictably huge influx of new patients into the system as a result of Obama Care.

What most people don't understand about healthcare, is that it is the only industry where there is essentially no connection between the amount charged and the true cost of goods and services; it's largely a fabricated cost structure that relies on the insured and private payers to cover the cost of the un- or under-insured. In this regard, the "haves" have long been providing a healthcare subsidy for the "have-nots". Furthermore, medicine is a bizarre aberration where a third party pays the tab for services rendered, often months after the fact, based on a complex formula that is negotiated and independent of actual costs – sort of like filling your shopping cart with merchandise at Wal-Mart, without the benefit of prices on the shelves, and walking straight out the door past the cashier with a wink and a nod, having previously signed something that says "yes, I agree to have my people pay your people an amount of money for which I am not responsible at some as yet to be determined later date". To boot, Medicare and Medicaid, our historical "government healthcare insurance options", have notoriously under-reimbursed for care, leaving those shoppers with the better reimbursement plans to pick up the shortage.

For years, the "dirty little secret" in medicine is that most doctors (and the healthcare system as a whole) have survived by "making up" the deficit from the Medicare/Medicaid component of their practices by charging higher rates to those with private insurance. It's the only way to run a viable business. Despite the running joke about doctors' lack of business acumen, the reality is that doctors figured out what they had to do to take all comers (private insurance and Medicare/Medicaid), and still make ends meet.

At the root of all of this is the fact that Medicare was never intended to be an insurance program; it was conceived as a reimbursement mechanism, the sole purpose of which was to disburse funds set aside to subsidize the cost of healthcare services for seniors. Doctors negotiate Medicare reimbursements rates with the state (not the federal government), basing what they are willing to accept, in part, on the percentage of Medicare patients within their practices. Physicians who have 12-15% Medicare patients may be willing, for example, to accept a 78% reimbursement rate (accepting 0.78 on every dollar of true cost), knowing that they can make up the deficit on their 85-88% private pay patient base.

In addition, Federal law dictates annual adjustments in Medicare reimbursement rates to assure "fiscal sustainability" for the program – A program, which in and of itself, has never been sustainable. Every year for the past decade, those calculations have called for cuts in physician and hospital reimbursement, despite the fact that the cost to render care is, in fact, rising. Without a vote from Congress to block these reductions, physicians are looking at an impending 27.4% pay cut in 2012. Medicare has recently levied cuts as steep as 35-40% on certain cardiovascular testing, and private insurers have begun to follow suit.

Physicians quickly calculated ways to mitigate the impact of certain reimbursement changes by, for example, addressing patient complaints one at a time, over multiple appointments, rather than on one comprehensive visit to avoid the "bundling" of reimbursement by Medicare. While this clearly proves to be far less efficient, and less convenient, for patients, it has allowed many physicians to continue to operate, however narrowly, in the black. Short of taking out personal loans to fund their practices – which many have already done – playing the insurance loopholes has in recent years provided the narrow margins necessary to meet payroll and keep the lights on.

Now, to complicate matters further, along comes Obama Care that has threatened to double or triple the percentage of patients on some form of "public option" – Instead of having, as in the previous example, 12-15% of one's practice being Medicare/Medicaid, now it is likely to be well upwards of 50%. That same physician who previously accepted a reimbursement rate of 78% will now go bankrupt, as he does not have enough of a private payer base to cover the short fall.

There are currently 45 million Medicare beneficiaries in the United States. The bottom line is that with the aging of the population, and healthcare reform legislation that will exponentially increase the number of recipients in short order, the economics of providing healthcare in this country simply won't work.

On top of steadily decreasing insurance reimbursement, add increasing regulations, new mandates for electronic medical record keeping, escalating liability costs, and 30 million newly insured patients, and it all adds up to the collapse of an already tenuous system.

Despite all of its problem, its inconsistencies and high cost – hands down, Americans have had the best healthcare on the face of the planet; if you ever have the misfortune to find yourself ill or injured in a foreign country, that fact will come barreling home to you.

With the current strain on the system and more and more doctors crying "uncle", the idea that the United States will continue to lead the way with innovative research, cutting edge technology and aggressive therapies will be a dream of the past. Furthermore, there simply won't be enough of a private pay base left to run a practice –- or a hospital -- even if you are one of the dwindling few who has private healthcare insurance. The question to be posed in the new world order will no longer be whether or not you can keep your doctor, but whether or not your doctor can keep you.

                            Kelly Victory Steamboat Springs is produced by Kelly Victory M.D.