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gdpawel · 06-09-2013, 02:59 PM

Diagnostic tests typically supply information that’s fitted into a mosaic of other data. All of this information, combined, helps inform an overall judgment about a patient’s condition and a proper course of treatment. It’s rare that the result of a single test is – in isolation — determinative in guiding a treatment decision. It’s even less common that the outcome of a single test will itself improve a patient’s outcome.

To take a simple example, consider a stethoscope that helps a physician hear a patient’s lungs. The information gleaned from that exam may help the doctor judge that a patient has pneumonia, or heart failure. But by itself, the stethoscope exam can rarely nail the diagnosis, nor select the right treatment.

The stethoscope yields incremental information that helps tip the balance of a physician’s judgment in one direction or the other. It adds to the clinical mosaic.

The problem is that Medicare’s new requirements thwart the introduction of almost any new test. If a test has to show that it improves clinical outcomes before it gets introduced to doctors and patients, it won’t get introduced in the first place.

The way that the best molecular tests have traditionally become a mainstream part of practice is through deliberate validation from real world use by providers with expertise around a particular marker. The tests are often first performed by a small number of clinical experts who deploy the tests at academic centers of excellence.

By allowing molecular tests to enter the market, they can gain adoption among a small number of clinical thought leaders who are closest to a particular marker. This process of slow introduction and integration into practice has enabled new technology to gain the sort of validation the Medicare program seeks. That is how tests for now more mainstream markers KRAS and EGFR first earned more widespread acceptance. It’s a model that has worked to enable new science to be deployed into clinical practice, by doctors best equipped to make good use of them.

The Medicare agency may think that this process has led it to pay for some molecular tests that didn’t pan out, or reimburse tests before the science fully supported their use. They would be right.

Yet molecular tests represent only about 1% of total spending on laboratory services. It is a fraction of a fraction of the agency’s annual spending.

That doesn’t mean it should be ignored. But the modest spending means that Medicare has the ability to be cautious in how it addresses this category of spending, especially given the potential for this technology to lower costs by enabling the more targeted delivery of medical care. The agency’s abrupt decision to step back from the prior structure has put the market for new technology into turmoil.

If proof of clinical utility is required before the Medicare agency will reimburse a new test then most of these technologies will simply go undeveloped.

This was always the risk to product developers once the new coding scheme went into effect. Medicare was always likely to use its new codes in a punitive fashion, to set coverage policies around the clinical circumstances where certain tests could be used, and what tests it didn’t believe merited any coverage. Now Medicare will be in the position of setting the standard for diagnostic testing, rather than leaving these decisions to be meted out by patients, providers, and the marketplace.

The new transparency this coding system affords is a powerful tool to the agency. It gives Medicare the leverage to further embed itself into decisions around when it judges certain tests to be clinically useful. And when it doesn’t want to pay for them.

Dr. Gottlieb serves as a director to two diagnostic companies that work in clinical areas that have not been affected by the new payment policies.

Citation: Medicare Nixes Coverage For New Cancer Tests. Scott Gottlieb, Forbes. June 05, 2013.

06-09-2013, 02:59 PM	#28
gdpawel Senior Member Join Date: Aug 2006 Location: Pennsylvania Posts: 1,080	Diagnostic tests typically supply information that’s fitted into a mosaic of other data. All of this information, combined, helps inform an overall judgment about a patient’s condition and a proper course of treatment. It’s rare that the result of a single test is – in isolation — determinative in guiding a treatment decision. It’s even less common that the outcome of a single test will itself improve a patient’s outcome. To take a simple example, consider a stethoscope that helps a physician hear a patient’s lungs. The information gleaned from that exam may help the doctor judge that a patient has pneumonia, or heart failure. But by itself, the stethoscope exam can rarely nail the diagnosis, nor select the right treatment. The stethoscope yields incremental information that helps tip the balance of a physician’s judgment in one direction or the other. It adds to the clinical mosaic. The problem is that Medicare’s new requirements thwart the introduction of almost any new test. If a test has to show that it improves clinical outcomes before it gets introduced to doctors and patients, it won’t get introduced in the first place. The way that the best molecular tests have traditionally become a mainstream part of practice is through deliberate validation from real world use by providers with expertise around a particular marker. The tests are often first performed by a small number of clinical experts who deploy the tests at academic centers of excellence. By allowing molecular tests to enter the market, they can gain adoption among a small number of clinical thought leaders who are closest to a particular marker. This process of slow introduction and integration into practice has enabled new technology to gain the sort of validation the Medicare program seeks. That is how tests for now more mainstream markers KRAS and EGFR first earned more widespread acceptance. It’s a model that has worked to enable new science to be deployed into clinical practice, by doctors best equipped to make good use of them. The Medicare agency may think that this process has led it to pay for some molecular tests that didn’t pan out, or reimburse tests before the science fully supported their use. They would be right. Yet molecular tests represent only about 1% of total spending on laboratory services. It is a fraction of a fraction of the agency’s annual spending. That doesn’t mean it should be ignored. But the modest spending means that Medicare has the ability to be cautious in how it addresses this category of spending, especially given the potential for this technology to lower costs by enabling the more targeted delivery of medical care. The agency’s abrupt decision to step back from the prior structure has put the market for new technology into turmoil. If proof of clinical utility is required before the Medicare agency will reimburse a new test then most of these technologies will simply go undeveloped. This was always the risk to product developers once the new coding scheme went into effect. Medicare was always likely to use its new codes in a punitive fashion, to set coverage policies around the clinical circumstances where certain tests could be used, and what tests it didn’t believe merited any coverage. Now Medicare will be in the position of setting the standard for diagnostic testing, rather than leaving these decisions to be meted out by patients, providers, and the marketplace. The new transparency this coding system affords is a powerful tool to the agency. It gives Medicare the leverage to further embed itself into decisions around when it judges certain tests to be clinically useful. And when it doesn’t want to pay for them. Dr. Gottlieb serves as a director to two diagnostic companies that work in clinical areas that have not been affected by the new payment policies. Citation: Medicare Nixes Coverage For New Cancer Tests. Scott Gottlieb, Forbes. June 05, 2013.