Lessons From The Mammography Screening Controversy

[News]

The firestorm that followed the November 2009 release of guidelines that would have reduced use of screening mammograms in women aged 40 to 49 highlights challenges for implementing the findings of comparative effectiveness research (CER), according to a new analysis...

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[gdpawel]

The comparative effectiveness research panel does not tell any doctor what treatment or drug they can or cannot prescribe. It looks at "comparative" effectiveness, not "cost" effectiveness. When it compares two treatments, it does not take cost into account.

The panel's only mission is to figure out which treatment is most effective for patients who meet a certain medical profile. The panel's assessment is then made public so that doctors can take it into account when making decisions. The law says that the information cannot be used as the sole consideration when deciding what to cover.

The major use of this informaton will be to put it into Health IT (information technology) programs, flagging doctors who are treating disease X or Y, providing the comparative effectiveness information on which patients are likely to benefit from treatment A or B. Doctors are free to use the information, or ignore it. Some doctors will ignore it becuase they have always used treatment A and they're just not ready to be convinced by new medical evidence. Other doctors will ignore it because they are treating a patients suffering from 3 diseases and so while treatment A might be best for most patients, it wouldn't be best in her case.

In the UK, where the government does comparative effectiveness reserach and makes it available to all doctors, doctors comply with the recommendations about 88% of the time. The government considers this a good compliance rate becuase there are always situations where there is something unique about the patient or the cirumstance. They want doctors to use their judgment when "applying" the resarch.

On the other hand, in the U.S. doctors practice evidence-based medicine, doing the things that are recommended (beta-blockers after heart attacks, etc.) only about 50% of the time. This is a very low rate of compliance with "best practice" guidelines.

On the Health Business Blog, David Williams asks New England Health Care Institute’s Valerie Fleishman to explain the definition of comparative effectiveness research (CER), describe CER provisions contained in the new legislation and discuss the challenges in disseminating new information to be used at the point of care. It’s an excellent interview which tells you everything you need to know about Comparative Effectiveness Research --and how the research will be used at point of care.

http://www.healthbusinessblog.com/?p=3884

Fleishman begins by explaining that comparative effectiveness research was first established as part of the Recovery Act in 2009 as part of the stimulus legislation. That legislation had in it a $1.1 billion investment for comparative effectiveness research and laid the foundation for what appeared in the Affordable Care Act (ACA) in March. The ACA strengthens this plank of reform by

1. Establishing a non-profit corporation called the Patient Centered Outcomes Research Institute (PCORI). That institute is set up as a non-governmental, private entity to oversee the federally funded investment that in comparative effectiveness research. The ACA says that the institute will identify priorities for comparative effectiveness research, will help to carry out the research agenda, create advisory panels, establish peer review processes, and will also in part be responsible for releasing the research findings and coordinating the research that gets done.

2. Stipulating that comparative effectiveness research must take into account different subpopulations to avoid one-size-fits-all results.

3. Setting up a trust fund so comparative effectiveness research can be funded on an ongoing basis. The $1.1 billion put in as part of the stimulus was really just for the first couple of years. The trust fund creates a pool of funding of about $600 million per year from both the Medicare trust and a fee on health plans.

4. Stipulating that none of the reports or findings can be used as mandates, guidelines or policy recommendations and that the findings cannot be used as sole evidence in making determination decisions.

But physicians are free to make use of comparative effectiveness information as they see fit when prescribing treatments for patients, and Fleishman talks about the opportunities to disseminate the information. “There is an enormous opportunity, particularly when you think about the computerized physician order entry systems and others that will be part of this. Meaningful use clearly stipulates that these systems have to have some form of clinical decision support. One of the hurdles to adoption for CER is that clinicians themselves don’t have ready access to the latest information on what the evidence says about different forms of treatments or procedures. Providing the information technology infrastructure and tools to clinicians at the point of care so they can have access to the data will go a long way toward making the data accessible.”

[gdpawel]

It's been difficult for the Medicare program to contol the substantial costs of cancer drugs. In an issue of the New England Journal of Medicine, an article by Dr. Peter Bach stated that the costs to Medicare of injectable cancer drugs given in doctors' offices increased from $3 billion in 1997 to $11 billion in 2004, an increase of 267% at a time when the costs for the entire Medicare program increased 47%.

It also stated that there was a huge reduction in Medicare expenses that occurred when the off-label use of ESAs (drugs for anemia-related issues) was found to actually cause harm to patients. The drugs were proven to be over-used and the net result of expose was that use of these drugs quickly dropped and the costs to Medicare dropped from over $1 billion a year to just $200 million.

In 2003, in the political payback deal of the century, Congress guaranteed premium pricing for pharmaceuticals, by prohibiting Medicare from negotiating drug prices, and it provided hundreds of billions of dollars in U.S. taxpayer subsidies to pay for these premium drug costs.

Dr. Bach stated ways that the Medicare program could control costs. One of the ways the Medicare program could control costs is to fund a comparative-effectiveness program to assess whether or not treatments are really better than older treatments. Decisions can be made about what cancer treatments patients can actually afford.

Comparative research has the potential to tell us which drugs and treatments are safe, and which ones work. This is not information that the private sector will generate on its own, or that the "industry" wants to share. Companies want to control the data, how it is reviewed, evaluated, and whether the public and government find out about it and use it.

Comparative-effectiveness research can help doctors and patients, through research, studies and comparisons, undertand which drugs, therapies and treatments work and which don't. Doctors will still have the ultimate decision, along with the patient.

I've heard many times, in regard to health care reform, that the government is going to ration our health care with comparative effectiveness research (CER).

Let's take this issue with regard to NCCN and ASCO guidelines and see how fraternal organizations enlist rationing.

ASCO has issued guidelines on how physicians should discuss cost of treatment options with patients. I've never heard that ASCO has been knighted a regulatory agency. Some experts warn that their guidelines could raise costs even further, thus limiting access to cancer patients.

Allen Lichter of ASCO has said "Cancer sticker shock is hitting hard now, the cost of treating cancer is rising by 15% annually. Affordable treatment options are a particular issue for patients with incurable forms of cancer who are looking for both the longest possible survival and the best quality of life."

One of ASCO's suggestions is for oncologists to consider the cost, essentially as another side effect, when choosing a treatment. According to MSK's Leonard Saltz and other physicians at attendance at one of NCCN's meetings, many physicians do not know the cost of certain treatments because they are not included in treatment "standards." "If we can do it just as well less expensively, I think doctors should know that and be able to make a decision," Saltz said.

Why is our government being accused of health care rationing when others have suggested it themselves?