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Novel Program in Connecticut Hospital Drives Surge in Molecular Diagnostics

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Hoping to increase the use of its molecular-diagnostics capabilities, a Connecticut hospital has instituted a modest program that aims at bringing physicians up to date with new genotyping techniques and services at their disposal.

Yet this program, which is wildly successful in educating its clinicans about the diagnostic options available to them, also highlights some of the economic challenges of using molecular diagnostics in the real world.

A few years ago, Gregory Tsongalis, director of molecular pathology at Hartford Hospital, began publishing a quarterly newsletter that described the hospital’s molecular-diagnostics resources. He also began participating in at least four in-house seminars each year, all in the hopes of attracting more medical staff to those resources.

“I think the biggest stumbling block [to greater use of molecular diagnostics at Hartford] is educating physicians and clinical staff,” Tsongalis said.

Though his lab has been around for nine years, Tsongalis said he’d be “willing to bet there’s [still] a whole bunch of docs that don’t even know we do DNA testing,” he said. But the program has made strides and has helped drive a strong increase in the use of Hartford’s molecular-diagnostics resources.

Learning Curve

Since his program began, Tsongalis said there has been a 15-percent to 20-percent increase in the volume of diagnostics tests performed at the hospital. “It’s been like night and day,” he said. “Certain groups of physicians ... after every [clinically specific] seminar ask, ‘Hey, how do we do that? Is that orderable on the computer? What type of specimen do you need?’”

It is because of that increase that Tsongalis has begun evaluating new technologies and platforms that may save his lab some money. Currently, the lab uses “a lot of PCR-based testing,” mostly by gel-electrophoresis. But, said Tsongalis, “considering the volume of tests we perform each year, [PCR] is really no longer a cost-effective way of doing things.”

He said his lab has evaluated enzymatic liquid-array technologies from Promega and biochip technology from Nanogen — “those types of things that will allow us to do more with the same number of people,” he explained. “That’s a huge issue. I can’t tell you how much money we spent last year on PCR royalties.”

According to Tsongalis, his molecular-diagnostics department bills payors between $50 to $250 per test depending on the type of assay. All told, the lab, which employs seven people, will spend around $500,000 this year on SNP-genotyping and ancillary technologies, and that budget will increase between $50,000 and $100,000 each year (the budget does not include salaries). The lab operates more than 20 drawing stations statewide and will perform 45,000 tests this year from a menu of 36 individual molecular tests. It ran 38,000 tests in 2002.

The surge in testing has also caught the attention of hospital administrators. “We just went through that the other day,” he said. “Administrators from the hospital called me and said, ‘Hey, the budget in the molecular lab is up.’ They were referring to the increase in test volume we’ve had over the last year and a half, and some new tests we’re bringing on board that our physicians really want.”

Indeed, physicians “have made it very clear they want to have certain tests available, and in order for us to bring it in-house we needed to have additional moneys in our budget.” Tsongalis said his lab plans to add between three and five molecular tests next year, which is a pittance compared to what the facility can produce if given the right technology. “One of our biggest bottlenecks is that we can’t validate our assays quick enough,” he said. “We can easily do 10 or 15 [assays] if we could validate them quickly enough.”

Cost Containment

The increase in testing volume also means payors have been facing bigger bills, and Tsongalis has begun finding himself in the awkward position of encouraging the application of a technology while avoiding raising too many reimbursement issues. “It’s a huge stress” for payors, he admitted.

Of the $2.3 million to $11.3 million in molecular-diagnostics tests Hartford Hospital will bill this year, some will be reimbursed. “It’s great that we can look at a single base pair out of 3 billion, but if nobody is going to reimburse us for doing that even though it might have incredible clinical significance, then we’re going to have a lot of trouble” offering those tests.

But some of the responsibility to cut costs also rests with the labs, he said. “It’s easy to point the finger at the payors and say, ‘You need to pay us,’” Tsongalis said. “But I think there’s just as much burden on the shoulders of the lab directors to decrease their costs by really taking a close look at the techniques and technologies they use in their labs.”

As it is, a small number of hospitals in Connecticut have molecular-diagnostics departments. Besides Hartford, Yale-New Haven Hospital, Danbury Hospital, and University of Connecticut Health Center offer the tests. “But there aren’t many” in the state; “we have a lot of smaller community hospitals in the state, and it’s just too cost-prohibitive for them to be doing this type of stuff,” Tsongalis said.

At Hartford, Tsongalis, who has recently been named chairman of the Med Tech program, has created a program for Med Tech students “so the people coming up through the program … will at least be familiar with what can be done.” He said he also tries to ensure that residents and fellows at Hartford, which is a teaching hospital, all come through his lab on rotations.

“I don’t think very many people here are going to be asking to diagnose genetic diseases that have an incidence of one in every 4 billion people,” said Tsongalis. “But when you start talking about things like hemochromatosis and thrombophilia — the common things they see routinely in their practice — they need to be very well aware of what the testing armamentarium is.”

— KL

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