New CPT for H. pylori Test Signals Higher Volumes

CMS has assigned a new CPT code (86318QW) for 31 quick, low-cost immunoassay blood tests for Helicobacter pylori.  But, unless you have had an ulcer or are in the GI field, you may not know what Helicobacter pylori (H. pylori) is.  H. pylori is a bacteria that in the 1980s was found to cause 90% of all peptic ulcers.  With ulcers costing hospitals $3 billion a year to treat, coverage for H. pylori tests could save a significant amount.

Currently, there are multiple tests for diagnosing H. pylori, ranging form antibody tests run on blood, urine, or stool samples to obtaining a biopsy sample.  The most recent is C13/C14 urea breath test.  Clinical trials have revealed that immunoassay blood tests have 96% sensitivity and 79% specificity.  In comparison, 13C breath tests have 95% sensitivity and 86% specificity.

One primary advantage of a breath-based technology, besides a slightly higher specificity, is it is a very convenient test to administer; the drawback is it is a $90 to $120 test.  On the other hand, immunoassay technology has been around for years, so new tests can be added with software upgrades and a test cartridge, allowing for the technology to process most tests in the $10 to $20 range.

I spoke to Dr. Paul J. Jannetto, PhD, MT (ASCP), assistant professor of Pathology, assistant director of Clinical Chemistry/Toxicology, and director of Rapid Response Lab, Department of Pathology at the Medical College of Wisconsin in Milwaukee, WI, about costs and utilization.  Dr. Jammetto said, “Everybody has to be cost conscious now.  The costs of some tests are so high that physicians are not ordering them.  Because of this, they may wait for more advanced clinical signs to appear.  This is a primary reason why not all tests have advanced as quickly as they could have.”

The immunoassay blood test for Helicobacter pylori (86318QW) is currently being reimbursed at approximately $20, which is considerably less than the $96 (830012) for a breath-based test.  But, with healthcare’s focus on cost control, more tests will be prescribed at the early stages of the disease.  This should assist providers in prescribing a treatment for a patient before an ulcer starts to bleed or worse, develops into cancer.

When you think about it, it’s an interesting concept.  Lower reimbursement and improved outcomes should lead the other way.  Let’s follow this and see how the numbers turn out.

Lung Cancer Breath Testing: A New Direction in Low-Cost Screening

Similar to blood, just about everything in the body ends up in a patient’s breath, allowing it to be an excellent medium for quick noninvasive diagnostic testing. Currently, there are several emerging breath tests for diagnosing asthma, H. pylori, and pharmaceutical levels in the body, and now, researchers are close to bringing a lung cancer application to market. Lung cancer is a difficult form of cancer to detect in its early stages, so an accurate breath test could have enormous and exciting benefits.

ScienceDaily has published several articles on emerging breath tests for lung cancer, and according Dr. Michael Phillips, M.D., FACP clinical professor of medicine at New York Medical College, The science behind biomarkers has been evolving for years. This type of technology will be able to look for biomarkers that can identify diseases such as breast cancer, lung cancer, tuberculosis, and much more. As a result, this should allow cancer screening to be easier and less costly in the future.

In my follow-up research using PubMed, I found that there were over 15,000 studies performed in the last 20 years for breath testing technologies. This parallels a recent interview I had with Dr. Stewart J. Levine, M.D., principal investigator in Pulmonary Critical Care Medicine Branch at National Institute of Health, in which he stated, The use of biomarkers is an up and coming field. n a couple of years, as mainstream technology catches up with science, we will start to see more of it. This is because research has really progressed in identifying biomarkers in a laboratory setting and in clinical trails.

In the last several years, I have been tracking at least four companies partnered with hospital researchers developing breath testing technology. Depending on the base technology, cost could be as low as $25 per test, which is good news for both clinicians and patients. Because this technology has the potential to make a huge impact, I will continue to follow this and provide information as lung cancer applications come closer to market.

Breath-Based P450: How Much in Savings?

One very exciting but rarely talked about technology is the identification of the P450 gene to predict drug compatibility and dosage. Now being studied in a breath-based format, it will make testing cheaper and quicker.  But why should we care?

I just read an article that discussed how over $3.5 billion of adverse drug events accrued in hospital alone can be avoided.  That’s almost $7 million for every hospital in the U.S!  According to the CFOs I speak with, that’s more than enough savings to become a focal point in any budget or safety meeting.

A recent article stated, “Genetic testing of the P450 gene is a relatively simple test that will help doctors determine how a patient will react to dosage amounts.  This test may help determine how effective or dangerous a drug may be for someone depending on their genetic makeup.

According to Dr. David Flockhart, M.D., Ph.D., professor and chief of the division of clinical pharmacology at Indiana University School of Medicine in Indianapolis, IN, one test will not solve all problems. He noted, “Preventable adverse drug reactions are a big topic. There are multiple factors that can cause a patient to have a bad reaction to a prescribed therapy. There can be prescription error, such as getting the wrong drug to the wrong patient. This problem is so important that the FDA is focusing on preventing prescription errors with technology such as computerized medical records and bar coding.

However, one reasonable question has come up: if P450 gene was first identified over 50 years ago, why isn’t it in regular use?

What it boils down to is cost and time. With current technology, the P450 test costs approximately $520, a blood draw, and hours to determine the results. Limited reimbursement has also checked its use. For example, you can compare this to existing breath-based technology for asthma and h pylori, which cost less that $50. Only time will tell if this will become a viable way to test a patient’s reaction to medicine.