Friday, May 8, 2009

VCT Debate Heats Up Pre-May 12 Decision


Ms. PACS: While I wait for the PACSman to respond to my email that I'm posting...he'll probably be up soon from his nap...I wanted to see if anyone is following the heated debate over virtual colonscopy.

How does it relate to PACS? First off, if it helps you get over the fear of getting a colonoscopy, it doesn't matter if it relates to PACS. The first step in overcoming this fear is to click on the image of the colon. But, also, it's about radiology imaging, which is managed on a PACS, and the question is whether the diagnostic quality of virtual colonoscopy (CT colonography or CTC) is at least equal to optical colonography, and if so, whether Medicare should reimburse for it.

As you know, virtual colonoscopy is a noninvasive colon cancer screening procedure with the potential to increase low screening rates and save lives. But to the surprise...for some shock...of many doctors, it did not receive good marks when reviewed by CMS and was subsequently denied coverag. So, now, right before CMS makes its decision on May 12, medical professionals are trying to get their voices heard by posting comments on the CMS Web site (https://www.cms.hhs.gov/mcd/viewpubliccomments.asp). But will CMS listen?

Most comments reflect a strong urging toward reimbursement for virtual colonoscopy.
Here's one from Kyle Kreinbring, M.D., of Advanced Radiology, S.C.:

“I am writing to voice my strong disagreement with Medicare’s recent denial of coverage for virtual colonoscopy. We are all aware that colon cancer is a major concern to all American’s age 50 and older, that colon cancer kills more Americans each year than breast cancer and AIDS combined, and that appropriate screening is the only way to prevent colon cancer.

"As radiologists who have reviewed the literature, we are shocked by the conclusion. Large, randomized and blinded studies have been published in well-respected journals. This includes several articles in arguably the most esteemed journal, The New England Journal of Medicine. Using updated technique and software, the results have been very clear…CTC is a valid, sensitive and safe modality for detection of polyps and cancer. The concerns over radiation and incidental findings seem to be a technique to detract from the real success of CTC. With new protocols and effective dose control the radiation dose is negligible, especially in this population of older patients....This technology has the chance to be a life-changing event for many Americans. It will encourage more patients to be screened, which is the ultimate goal,” he said.

Here's a scathing one from Mark Albright:

“History is replete with examples of governments, politicians, philosophers and businessmen making colossal blunders while clinging to mistaken ideals even in the face of significant evidence to the contrary…Any failure to approve reimbursement of CT Colonography (“CTC”) for colon cancer screening would promptly take its place as among the biggest, costliest and deadliest gaffes in the history of public health. The effect of such a decision will be that (a) more Medicare patients will die from colon cancer, and (b) the costs of Medicare will continue to escalate because Medicare will be paying for treatment and care of colon cancer patients, rather than preventative care for an extremely curable disease.”

Now, a more tempered, voice of reason from gastroenterologist, Dennis Ahnen, M.D., Denver VA Medical Center and University of Colorado Denver School of Medicine:

He starts by expressing his disappointment that “to learn of the proposal to not include CT colonography as an acceptable and reimbursable option for colon cancer screening. I think this is a mistake."

1. It is now well established that CT colonography, if done by well-trained radiologists with state of the art equipment, is a highly sensitive test for detection of both cancer and significant (>6mm in size) adenomas of the colon; studies have shown that it is as good as optical colonoscopy for detection of these lesions.

2. The concern about variable quality of CT colonography in the community is real but it is equally true or even moreso for colonoscopy. It is well established that colonoscopy quality as measured by cecal entubation rates, withdrawal times, adenoma detection rates and/or complication rates varies widely among endoscopists so that high quality screening is required for both CT colonography and optical colonoscopy.

3. The concern about the cancer risk of radiation exposure with CT colonography is appropriate but theoretical (back-extrapolated from exposure data to much higher doses or radiation) and is much less than the radiation exposure of a barium enema which is covered as a screening option by Medicare.

4. The concern about extraintestinal findings possibly leading to higher costs without better health care is also a legitimate concern, but it is uncertain whether the overall balance of these effects is harmful or beneficial nor what the magnitude of the effect would be in practice. A similar argument is not made for the unintended consequences of other screening tests like false positive fecal occult blood tests that lead to negative colonoscopies, which may be followed, by upper endoscopy and/or capsule endoscopy to look for a source of the blood in the stool. I think that issue of extraintestinal findings could be minimized by guidelines about which lesions should be followed up and which workups Medicare will pay for.

5. The inability to biopsy or remove lesions is a real disadvantage of CT colonography, so it would not be a good choice in a population that would have a high pretest probability of having a polyp seen but there are populations that have a low risk such as those with a negative previous colonoscopy where CT colonography would be a good and cost effective alternative to colonoscopy.

6. CT colonography has some distinct advantages over optical colonoscopy in that it is less expensive, associated with less of a risk of both the procedure and the sedation and is much more convenient for the patient.

Overall, it seems to me, that CT colonography is being held to a higher standard than other screening tests, and I would urge you to reconsider your proposed ruling.

To his last point, that sounds a lot like the trouble with coronary CTA - CMS is holding CCTA to a higher standard than other screening tests. I thought that Obama's plan was to encourage early detection as an effective way of cutting healthcare costs. Or is his ARRA stimulus package confined to investment in EHRs - for which PACS will probably not see a dime despite leading the way to streamlining image data in healthcare...oh well. Maybe you should have waited for the hand outs like the rest of healthcare.

The resounding message here is - "enough of this beaurocratic b.s.!" I think Mark Albright, whomever he is - maybe a 10 year-old child prodigy wearing an oversized suit? - hit the nail on the head when he said: It takes its place "among the biggest, costliest and deadliest gaffes in the history of public health."

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