I’ve observed the incessant complaints on various cancer blogs and discussion boards about BC/BS "denial of coverage" on the backs of injured and diseased human beings during their fight with the great crab.
In one case, the patient was denied a CT scan. As the poster said, "because BC/BS is practicing medicine and deciding that such a thing is not medically necessary." Without the CT scan, there was no way for the doctor to definitively tell if a swollen leg is cancer related or a blood clot. The physician couldn’t make a diagnosis based on the best available technique to make that diagnosis.
Another poster presented the case that BC/BS used to cover Pet Scans. Unfortunately, some study came out stating that Pet Scans aren’t more effective than CT Scans to find colon cancer. With that one study, BC/BS had decided not to cover the Pet Scan, even against the physician protest.
And one more described their situation while fighting prostate cancer that had metastasized to the hip bones, and a clinical trial using hormone therapy and Helical Tomo Therapy was looking to be the best opportunity to fight the cancer. The studies showed that is was really helping people with bone cancer, as it is very precise treatment that does much less damage to surrounding tissues. However, BC/BS had denied covering the Helical Tomo Therapy treatment. They said it was just too expensive and the hormone therapy should be enough for the patient.
These are just a few of the numerous complaints happening across the United States. I thought this was only a problem with reimbursement for cell culture assay tests. But it seems to be happening across the whole spectrum of diagnostic and lab tests.
One poster goes on to say, "It would appear to me that we in the USA are rapidly closing in on having all of the drawbacks of socialized medicine, with none of the purported benefits. It is partly privately financed, but the controls are given over to remote bureaucrats who determine who shall live and who just isn’t worth it."
In 1994, Blue Cross of California supported tumor cell drug resistance testing. It can improve results when the tests are used. California Blue Cross used to cover it when California Blue Cross was non-profit. Then they were taken over by Wellpoint, turned into a "for-profit" and abruptly without explanation stopped paying for it. I guess they had to show some kind of profit maximization for their corporate executives and shareholders by denying some coverages. However, numerous people have appealed their cases in small claims court and won (even one in superior court).
The Blue Shield of California Medical Policy Committee on Quality and Technology, in a meeting on March 2, 1994, unanimously accepted the validity of cell culture drug resistance testing. The official Blue Shield of California conclusion was drug resistance testing in oncology was accurate and reliable. The information can affect clinical decision making and can lead to the avoidance of ineffective and potentially harmful chemotherapeutic agents. There was sufficient published data to determine their safety, clinical utility, and impact on clinical decision making.
As Medicare contractor National Heritage Insurance Company (NHIC) found out in 2006, cell culture drug sensitivity testing was merely a point a little farther along on the very same continuum upon which resistance testing resides. This was one of their reasons for reimbursing coverage for both drug "resistance" and drug "sensitivity" testing beginning February 28, 2007. They (and the previous Medicare contractor) were paying for drug "resistance" testing since December 2000.
At injuryboard.com, editor Brent Adams said, "in recent years, insurance companies have become more and more involved in the practice of medicine by trying to dictate to doctors the procedures they should give to their sick patients and the fees for those services. Doctors complain that they cannot practice medicine independently and are hampered by insurance companies who look over their shoulders and dictate how they should practice medicine."
A group of Miami, Florida doctors sued twenty-three Blue Cross and Blue Shield Plans, as well as the Blue Cross and Blue Shield Association, because they alleged they had been systematically cheated by these insurance companies when the doctors filed claims for medical services.
It’s an interesting thing about outside of Medicare. Are BC/BS and the other private insurers practicing medicine? I thought that’s what physicians were for?
Reference to the injuryboard.com:
Reference to the discussion board postings:
It amazes me not only that some private insurance carriers don’t like to pay for cell culture assay tests but that they don’t emphatically mandate it as a requirement for obtaining chemotherapy reimbursement against ill-directed treatments.
Profit, as we have seen, is a powerful motivating force. Among the private payors, at least, the profit motive is entirely consistent with the goal of the test, which is to identify efficacious therapies irrespective of drug mark-up rates.
The evidence in support of these assays is more than sufficient to justify the funding of validation trials, if any more truly are needed, as claimed – speciously and self-servingly – by the medical establishment.
Everyone is scared to death – and rightly so – at what is going to happen to the healthcare economic system with the introduction of increasingly expensive new drugs that benefit only a small percentage of patients who receive them, hence the headlong rush to develop tests to identify molecular predisposing mechanisms whose presence still does not guarantee that a drug will be effective for an individual patient.
Nor can they, for any patient or even large group of patients, discriminate the potential for clinical activity among different agents of the same class, such as Sutent, Tarceva, Iressa, and Nexavar.
The FDA could benefit too, as they find themselves under increasing pressure to allow new drugs into marketplace while at the same time protecting the safety of potential recipients of those drugs as well as the financial interests of those who will have to pay for them.
It explains the new paradigm of requiring a companion diagnostic as a condition for approval of new targeted therapies. The pressure, in fact, is so great that the companion diagnostics they’ve approved often have been mostly or totally ineffective at identifying clinical responders (durable and otherwise) to the various therapies.
I think that in both of these areas – private insurance carriers and the FDA – there is a very real opportunity to make a substantial impact and contribution, an interest in saving the healthcare system perhaps billions of dollars a year (and thereby the healthcare system itself) by ensuring that expensive treatments are used appropriately.
Committee chairpersons, committee members and persons in congress who may have personal interests not only in discovering new cancer treatments – everybody wants that – but also, in the “here and now,” using currently-available cell culture assay technologies to improve the effectiveness of existing drugs and save lives today by administering the right drug to the right patient at the right time.
As we enter the era of “personalized” medicine, it is time to take a fresh look at how we evaluate treatments for cancer patients. The very idea of “personalized” medicine scares the hell out of pharmaceutical shills. It represents a radical departure in the pharma business model. Thanks to advances in biology and genetics, upcoming and existing technologies for personalizing cancer diagnosis and drug treatments are very real.
The key hurdle for these technologies is overcoming the pharmaceutical industry’s prevailing blockbuster economic model of the last twenty years. As one peruses the internet, they can see drug companies and so-called industry experts rush to suggest that personalized medicine and their blockbuster model are incompatible. Tests to identify individuals most likely to benefit from chemotherapy will certainly cut into their old and antiquated model.
The spate of recent blockbuster “miracle” drugs has failed to show statistical survival benefit anywhere close to a majority of patients. These drugs actually did work miracles, in “some” patients. How do the drug companies respond when tests show their drug to be highly effective, but only in 11% of the potential patient population, a fraction of affected patients? Charging significantly more for those therapies will only work to a point. Personalized medicine will take the wind out of the sails of big pharma.
Pharmaceutical companies and their industry shills will try to buck the trend as long as they can, but many realize that personalized treatments are inevitable and are making their way into a new paradigm of cancer treatment. The pharmaceutical industry will need to transform itself as “business as usual” will no longer be good enough. The old pharma “blockbuster” business model is incompatible with personalized medicine. Diagnostics will almost certainly trump pharmaceutics.
Barry, as with other health issues prevention is cheaper than treatment but takes political backbone. A healthy food policy for example, instead of the present subsudized glutenous food policy, will not happen until special interest money is taken out of policy decisions. I read a book many years ago (can’t remember the Dr. author) titled, “The Politics of Cancer”. We know what causes cancer. It is man made carcinogens in our environment. But industry as usual does not want controls and can, through the political bribery process, just carry on the great American past time – download the costs to someone else.
Barry, I also think our entertainment news industry helps to fuel the spend all at all costs decisions when it features stories that show so called “miracles”. My wife has seen parents of premature babies cling to useless treatments at others expense (either state funds or insurance funds) waiting either for the “miracle”, or for god to intervene. Personally I prefer sacrificing a chicken.
I guess one test they don’t include is the one that says, “What happens if we do nothing.”
Peter – I’m with you 100% on this one.
Cancer care is, perhaps, the most challenging segment of healthcare. The following issues are often (or always) present:
1. A similar patient population can respond very differently to the same course of treatment, and our ability to discriminate between those who will benefit and those who won’t is not very good (at least not yet).
2. A course of treatment, especially if it includes one of the newly developed specialty drugs, can be extraordinarily expensive.
3. Our reimbursement system rewards doctors and hospitals for doing more, whether it is cost-effective or not. Hospice and/or comfort care are not nearly as lucrative.
4. Many patients and/or family members want to do everything possible to fight the disease, especially when they know someone else (taxpayer, insurer, etc.) is paying. It’s as though they think death is an option and not an ultimate certainty. At the same time, doctors may be reluctant to tell a patient that there is nothing more they can do.
5. Some cancers, when caught and treated early, may just change the proximate cause of death and not lead to longer life expectancy.
So, as a taxpayer, what I would like to know is how does the general approach to cancer treatment in the U.S. differ from the approach used in Western Europe and Canada? The issue is not even whether to explicitly ration care or not (via QALY metrics or age cutoffs) but how do doctors within the different countries define and apply good, sound medical practice?
Well it apears that “studies” are only marketing vehicles designed to push product and not an attempt to find useful best practise information. “Studies Show”, as they say.
I guess one test they don’t include is the one that says, “What happens if we do nothing.” No wonder people are turning to alternative medicine, their chances are just as good as a doctors at finding relief, even a cure, of symptoms.
EBM data is often murky. As a physician, I can state I am often confronted with population based RCTs, which weakly correlate with the patient you have to treat. Good example would be the “gold standard study” enrolled age <65 VA patients, your patient is a 74 yo female. Benefit to patient may be 10% or less of desired outcome, but cost to treat is very high. What do you do? Docs and insurance companies are stymied on a daily basis. While the consensus guidelines are issued on best evidence by the best and the brightest (we hope), you are still flying blind. That is not to say BC/BS are the benevolent keepers of the flame (they are not), but the more they approve, the more premiums go up. https://thehealthcareblog.com
Sometimes clinical practice guidelines are questioned on the basis of profit conflicts. Specialty medical societies work to insure their specialist members get reimbursement for common procedures/treatments, the drug industry works to produce evidence statements that promote use of their drugs, so some questions arise that do not seem comfortable that many trials are unobjective and balanced. How long would a drug company pay researchers who would continue to disappoint with poor efficacy trial results, since we all know that poor outcomes in drug trials are often not reported the the FDA or the public.
The entire premise upon which these societies base their evidence-based guidelines may be biased towards maintaining flow of their life blood-industry funded clinical trial dollars. Could it be that they focus on guidelines to both justify and feed the proposition that because cancer patients are probably going to die, then the FDA, CMS and taxpayers are supposed to pay for any combination of these wanna-be cancer drugs for any type of terminal cancer?
Evidence-based medicine has morphed into pharma-based medicine and HMO-based medicine. Evidence is based on data from medical journal articles, epidemiology and economics, which relies on randomized clinical trials, which doesn’t even require a medical education. Nonphysicians trained in social science, science or even public policy analysis, have judgement over medicine. Where doctors defined the “standard of care,” now payers and purchasers of medical services redefine the standards for appropriate medical care, encouraging doctors to act in ways to promote their financial interest when they make medical decisions.
The use of clinical trials to establish prescribing guidelines for evidence-based medicine is highly criticized because such trials have little relevance for the individual patient in the real world, the individuality and uniqueness of each patient. The problem is not lousy doctors, it’s a lousy system. In cancer medicine, the best reform to the system is to totally remove the profit incentive from chemotherapy administration. Take physicians out of the retail pharmacy business and force them to be doctors again.
Until the controlled, randomized clinical trial approach has delivered curative results with a high success rate, the choice of physicians to intergrate promising insights and methods remains an essential component to quality cancer care.
I’m sorry Barry, I do not have a prefix to my name. As for Medicare reimbursements for cell culture drug sensitivity testing BER, as of February 19, 2007, Medicare is paying for this test now too. They had been paying for the “resistance” part of the test since December 2000. What is of particular significance is that they abandoned the artificial distinction between “resistance” testing and “sensitivity” testing and are providing coverage for the whole FDA-approved kit.
Medicare bills for this testing are billed through Medicare contractors where these tests are being conducted. So far, this includes approved laboratories in Southern California and one in Pennsylvania. In 2006, Medicare officailly recognized cancer chemosensitivity tests as a special test category in Federal Regulations (42 CFR 414.510(b)(3), 71 FR 69705, 12/01/206). It is a bio-marker no different than a marker like estrogen receptor or CD20 or a gene expression pattern.
EBM data is often murky. As a physician, I can state I am often confronted with population based RCTs, which weakly correlate with the patient you have to treat. Good example would be the “gold standard study” enrolled age <65 VA patients, your patient is a 74 yo female. Benefit to patient may be 10% or less of desired outcome, but cost to treat is very high. What do you do? Docs and insurance companies are stymied on a daily basis. While the consensus guidelines are issued on best evidence by the best and the brightest (we hope), you are still flying blind. That is not to say BC/BS are the benevolent keepers of the flame (they are not), but the more they approve, the more premiums go up.
Barry C is right on the money btw, too much variation in care for sure, and we as docs share the blame, but believe me, if you think it is a black and white decision to pick and choose treatments, you are misguided. It is tough. When I hear the politicos throw around terms like "efficiency" and "comparative effectiveness" I snicker. It is laborious, time consuming work, and in the end, top level policy decisions will be akin to rationing. Who gets defibrillators, antibiologics, etc., is anyones guess. Factor in constituents who each have a vested interest in decision making, and you have gridlock.
Anyway, you get my point.
Couldn’t one appeal to an evidence based plan for dealing with each disease?
If a patient was diagnosed/suspected of a certain disease could there be a process, series of tests, that are understood to be necessary? Instead of appealing to a committee what does the scientific evidence say?
I think I am being overly optimistic…but this may be a good way to deal with things in the future.
Doctors are supposed to understand the studies and the outcomes for specific treatments or need for tests, isn’t that one of the reasons they get paid so much – all that literature reading. As long as doctors are tied to a hospital’s bottom line in the form of billings then where is the financial independence to practice medicine for best and most cost effective outcomes. If people continue to support a system that is not single-pay where hospitals set their own budgets that depend on the amount of billings over cost control you’ll have to enjoy the out-of-control costs for a while longer. There is no single controlling payer to direct the reforms we/you all want.
I agree with the spirit of the previous post. We have to put the payer-bashing aside and begin to realize that not everything that a doctor orders is necessary or beneficial to the patient. We desperately need comparative effectiveness studies that take both the cost of treatments and the addition of quality-adjusted life years into account. With such information, payers would be hard-pressed to make what seems like inappropriate denials of coverage.
By the way, I believe that Medicare also does not pay for cell culture drug sensitivity testing.
Sigh. My conclusion from reading Dr. Paweleski’s post is that we should just be prepared to pay for everything for everyone. If a doctor thinks a treatment might be useful, we should pay for it, no questions asked. Isn’t it possible that doctors sometimes do what is best for themselves financially? Doesn’t Medicare spend two to three times more per beneficiary in Miami than in Minneapolis with no difference in outcomes? Don’t doctors drive virtually all healthcare spending through hospital admissions, ordering tests, prescribing drugs, consulting with patients and doing procedures themselves? Doctors have a decades long history of staunchly opposing any reform that threatens their power, their independence or their income including opposition to both price transparency and P4P.. Most recently, the AMA is trying to thwart competition from retail clinics staffed by NP’s and PA’s. Medical costs are out of control, not because of insurance company profits or administrative costs, but because of rising utilization of healthcare services and aggressive billing by doctors and hospitals. If we are ever going to get healthcare cost growth down to a lower and more sustainable level, doctors will need to be an important part of the solution instead of the most significant part of the problem as they have been for decades now.
As for cancer treatments specifically, the medical profession might consider getting behind finding a way to finance credible, unbiased comparative effectiveness research to better understand what works and what doesn’t.
Here in North Carolina BCBS tried to convert, “for profit”. Usually nothing happens in health legislation here without the blessing of BCBS but in this case the opposition from the mistrusting public forced a legislative denial. My experience with BCBS as a so called “non-profit” (seen the bonuses) confirmed to me that as for profit its behavior could only get worse – hard to believe. I believe in results oriented treatment if we are to control costs but for insurance companies and their lawyers one remote study advocating denial is all they need. When reading this thread it is useful to read Matthew’s “Health Plans Behaving Badly” as a companion piece.