The suit charges that the company generated at least 90 percent of its business by paying kickbacks to doctors for referrals and that unnecessary imaging tests put some patients at heightened risk for cancer.

U.S. Attorney Barbara L. McQuade of Detroit announced the suit last week. It targets Universal Imaging, Inc.; Phillip J. Young and Mark Lauhoff, identified by the government as “its current and former owners”; and Gwendolyn Washington, MD, of Southfield, Michigan. (At least for the moment, the Universal Imaging Web site lists “Phil Young” as president and founder; it doesn’t mention Lauhoff.)

The U.S. attorney also announced settlements totaling $1.56 million with 14 physicians or physician groups who, according to the government, accepted payments in return for referring patients to Universal.

A news release from McQuade’s office said:

McQuade praised radiologist Dr. Richard Chesbrough and his wife, Kim Chesbrough, who formerly worked at Universal and who filed a qui tam whistleblower suit under the False Claims Act bringing many of the facts in the case to the government’s attention.

The government alleged that, though Michigan law required Universal to be a nonprofit corporation, it transferred its equipment to a for-profit company with the same owners and made fraudulent lease payments to that for-profit entity, illegitimately benefiting the owners.

The government charged Dr. Washington—who after some apparently high-flying years faces a bleak future—with endangering the health of her patients. In November, the 67-year-old primary-care physician was sentenced to 10 years in prison for, according to an FBI news release, “public corruption, health care fraud, and conspiring to illegally distribute prescription drugs.”

The FBI said that from 2004 through 2010, she performed or ordered numerous unnecessary tests, billing Medicare and Blue Cross Blue Shield of Michigan more than $5 million. The news release said:

Most significantly, Dr. Washington ordered unnecessary and actively harmful nuclear stress tests for her patients at a frequency beyond that of any other medical practice in the country. Because each of these tests is the radiation equivalent of at least 80 to 120 chest X-rays and because excess radiation creates a greater risk of cancer, Dr. Washington exposed her patients to a substantial risk of cancer.

Sad.

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For today’s Facebook post, click here.

Related seminar: Cardiovascular & Pulmonary Imaging

Among the possible CHD tests, SPECT is popular in part because it’s noninvasive. A five-year study by researchers at the University of Leeds in England, involving 752 patients, found that equally noninvasive MRI was better at both diagnosing CHD and ruling it out in patients who did not have the disease.

John Greenwood, PhD, of the University of Leeds, who led the study, said:

We have shown convincingly that of the options available to doctors in diagnosing coronary heart disease, MRI is better than the more commonly used SPECT imaging test. As well as being more accurate, it has the advantage of not using any ionizing radiation.

Dr. Greenwood was quoted in a university news release. The study was published online today in The Lancet.

The study used a coronary magnetic resonance protocol that consisted of rest and adenosine stress perfusion, cine imaging, late gladolinium enhancement, and MR coronary angiography.

“The scans were all carried out on a standard 1.5 tesla scanner—exactly the type of MRI scanner that you would find in most hospitals today,” Dr. Greenwood said.

Peter Weissberg, MD, medical director at the British Heart Foundation, did note, “At present, not all hospitals have the expertise to undertake such scans, but these findings provide clear evidence that MRI should be more widely used in the future.”

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Speaking of cardiac matters, please accept our heartfelt wishes for a wonderful holiday season. We very much appreciate your reading us each day, or however often your schedule allows. We’ll continue trying to bring you the most interesting and useful information we can find via this blog, our Facebook page, and our Twitter feed. The best of the season to you and your loved ones.

Related seminar: Cardiac Imaging

Breast-cancer researcher Mina Bissell, PhD, explained:

Our data show that at lower doses of ionizing radiation, DNA repair mechanisms work better than at higher doses. This nonlinear DNA damage response casts doubt on the general assumption that any amount of ionizing radiation is harmful and additive.

Dr. Bissell, who holds the title of distinguished scientist at the Berkeley Lab’s Life Sciences Division, was quoted in a lab news release. The findings have particular significance for those who undergo such low-dose medical imaging procedures as mammograms.

The lab revealed the results of its research in a freely available study published online Monday in Proceedings of the National Academy of Sciences.

The decreased risk at low doses derives not from the amount of damage caused by the radiation but rather from how the body fixes the damage. The researchers found that after low doses of radiation, the body repairs double-strand DNA breaks (meaning the double helix is completely severed) on site. It’s a relatively simple procedure with relatively little chance of error.

But as doses increase, creating more double-strand breaks, the broken strands congregate at “radiation-induced foci” (RIF), which are aggregations of repair proteins. With lots of repairs going on at once, the opportunities for mistakes increase.

“We hypothesize that, contrary to what has long been thought, double-strand breaks are not static entities but will rapidly cluster into preferred regions of the nucleus we call DNA repair centers as radiation exposure increases,” said Sylvain Costes, PhD, a biophysicist who led the study.

“As a result of this clustering,” Dr. Costes said, “a single RIF may reflect a center where multiple double-strand breaks are rejoined. Such multiple repair activity increases the risks of broken DNA strands being incorrectly rejoined, and that can lead to cancer.”

The researchers are looking into whether their results, achieved with a single human breast cell line, will hold up with different lines and different breast cells. Stay tuned.

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MRI powers a tiny wireless camera that navigates the digestive system. Science fiction? Find out on our Facebook page.

Related seminar: ALARA — CT (As Low As Reasonably Achievable)

That may seem obvious, but a new study that came to that conclusion had a reason for exploring the question. The same researchers had found in an earlier study that “doctor’s choice” was not the best strategy for moderate- to high-risk patients, at least from a cost-benefit point of view.

Instead, the earlier study concluded that mandating a cardiac magnetic resonance (CMR) stress test in an observation unit rather than inpatient care was more cost effective.

Chadwick D. Miller, MD, of the department of emergency medicine at Wake Forest School of Medicine in Winston-Salem, North Carolina, led the researchers for both studies. The new study, published online last week in Circulation: Cardiovascular Imaging, looked at 120 patients at a single ED who presented with acute chest pain or other symptoms of acute coronary syndromes.

All received observation-unit care. Half got stress CMR imaging regardless. For the other half, the researchers left the selection of test up to the physician. In the doctor’s-choice group, 62 percent received a stress echo test, 32 percent CMR, 3 percent cardiac catheterization, 2 percent nuclear tests, and 2 percent coronary CT.

Length of stay and outcomes turned out to be similar for both groups. In each group, nontherapeutic catheterization was very low and the appropriateness of admission decisions was high.

But giving doctors options significantly reduced costs. The median cost was $2,050 for the CMR group, $1,686 for the “choice” group. Mean costs were $2,586 and $2,005, respectively.

The study drew the following conclusion:

In these lower risk patients, it appears the physician’s ability to tailor testing to the individual patient, while considering institutional imaging strengths, may be a key to enhanced healthcare efficiency.

So it’s better to let highly trained, highly skilled physicians implement that training and those skills. Imagine that.

Related seminar: Emergency Radiology (brand new)

B.C. Wang, PhD, studies molecules. (He’s Ramsey-Georgia Research Alliance Eminent Scholar in Structural Biology at the University of Georgia in Athens). X-ray crystallography—bombarding molecules’ crystalline forms with X-rays—reveals the position of chemical bonds and other important properties.

However, large molecules, which are especially important in drug development, don’t handle X-rays as well as small molecules do. In a University of Georgia news release, Dr. Wang explained:

A macromolecular crystal can only withstand a certain amount of X-ray dose before it is destroyed as a result of radiation damage. Obtaining accurate and complete diffraction data sets of these crystals is very important.

So Dr. Wang and his team tried doing several low-power scans of the same crystals (specifically, bovine insulin crystals) instead of a single higher-power scan. The weaker scans delivered the same total radiation dose as the single higher-power scan would have. They also produced much better data than the single scan. For details, see the study, published online this month (open access) in the journal Foundations of Crystallography.

Adapting this technique to human imaging could produce better-quality scans while reducing radiation exposure, though Dr. Wang cautions that such applications will not be ready for clinical use anytime soon.

Of course, there will be problems to overcome. For one thing, bovine insulin molecules are generally better at holding still than people are. And Dr. Wang’s team uses X-ray data in a different form from the familiar human X-ray image. But, obviously, such multislice technologies as CT have overcome similar issues.

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Follow us on Twitter, and we’ll feed you a handful of carefully chosen radiology-related morsels each week that we think you’ll find interesting, or at least amusing.

Related seminar: ALARA-CT (As Low As Reasonably Achievable) (free shipping ends tomorrow!)

It comes from the Medical Imaging & Technology Alliance (MITA), a trade group for makers of medical imaging equipment. So perhaps it’s not so surprising.

MITA said in a Wednesday news release that, according to its own analysis of Medicare data, spending on imaging for each Medicare beneficiary has decreased 13.2 percent since 2006. In addition, the release said, imaging utilization per beneficiary decreased by 3 percent in 2010. Spending for Medicare services other than imaging has increased by 20 percent since 2006, and overall utilization increased by 2 percent in 2010, MITA said.

David Fisher, MITA’s executive director, said the reduction in imaging spending and use may be harming Medicare patients:

It is unsettling to see these accelerating declines in Medicare beneficiaries’ use of medical imaging services during a time of tremendous advances in imaging and radiation therapy technologies, which have become increasingly integral to medical best practices and early disease detection. This disconnect raises serious concerns about whether or not patients are receiving the care they need.

Somehow, we can’t see the congressional “super committee” bursting out of its phone booth, or its locked meeting room, or wherever it’s been thrashing out deficit-reduction proposals, and saying, “Sure, cut spending on Social Security, the military, our salaries, and everything else, but we really need to increase Medicare spending on imaging.”

Still, as MITA points out, imaging reimbursements have been cut seven times in six years, with payments for such services as bone density screenings, arm and leg artery X-rays, and brain MRI reduced by more than 60 percent. And further cuts have been proposed. Are Medicare patients in fact now getting second-rate care … well, maybe that’s too strong; let’s say suboptimal care in terms of imaging?

MITA also quotes John A. Patti, MD, chair of the American College of Radiology Board of Chancellors, as saying, “Current evidence, including this analysis, debunks the myth that imaging is significantly overused and somehow responsible for escalating health-care costs.”

Dr. Patti adds:

According to these data, the goal of bending the cost curve has indeed been achieved for medical imaging. Any further reductions would represent socially irresponsible policy.

Of course, the fact that a piece of legislation might be socially irresponsible has never stopped Congress before.

Related seminar: Radiology Review Course

Interestingly, the study found that electronic health information exchange (HIE) use increased some types of imaging, notably chest X-rays.

Mark Frisse, MD, professor of biomedical informatics at Vanderbilt University Medical Center in Nashville, led the study. A Vanderbilt news release quoted him as saying:

This is the first study to show that, on a citywide basis, investments in technology can save medical costs by improving care. We took the ‘Tennessee simple’ approach and built a low-cost system that said, ‘Folks, if you do it simply and build it up, doing the right thing can save you money.’

ED physicians used the system, accessed through a secure Web portal, only when they thought it might be useful—which turned out to be 6.8 percent of the time.

Eleven EDs had full electronic access. The 12th did not until the very end of the study period. That hospital, which was the busiest (20 percent of total regional ED visits), relied on printed-out summaries and could inquire for more complete data. The study calls this the “mixed-access group.”

The 13-month study compared nine outcomes: ED-originated hospital admissions, admissions for observation, lab tests, head and body CT scans, ankle and chest X-rays, outpatient surgery, and echocardiograms. Each HIE-use patient was matched with a similar patient for whom doctors did not use the HIE.

Decreased admissions for the HIE-access cases over the 13 months saved $2,059,588, according to the study. CT scans also decreased, but not uniformly. At full-access EDs, head CTs and chest X-rays increased while body CTs and lab tests stayed flat. At the mixed-access hospital, head and body CTs and lab tests decreased while chest X-rays stayed flat.

The study (which is open-access) doesn’t comment on those differences except to say: “We speculate that the small but significant increase in chest X-ray use in inner-city ED within the direct access group is an example of differences in provider motivation.” Knowing the patient population each hospital serves would probably be enlightening, but the study does not identify the hospitals.

Patients could opt out of HIE participation, but only 1 percent to 3 percent did. Dr. Frisse said the system safeguards patient privacy. “It makes available only the information you choose, and it can only be used when you are needing care,” he said. “It is far more secure and useful than paper.”

He is definitely an enthusiast:

Our people believe that the savings from this study are less than 2 percent of the overall savings these technologies can afford if every physician’s office is connected. And we are absolutely convinced and committed to extending this approach to every health care setting.

Related seminar: National Diagnostic Imaging Symposium™

CardioGen-82, the generator, produces rubidium-82 chloride injections, used for PET myocardial perfusion studies. The rubidium has a half-life of 76 seconds.

But in June, two patients set off sensitive radiation detectors at U.S. borders months after undergoing PET stress tests. A third patient was found to be carrying similarly elevated levels of radiation months after the same test.

The Sarasota Herald-Tribune reported on the situation in September. (You may also have seen our Facebook post about it.) Two of the three patients had received their PET tests at the same Sarasota, Florida, cardiology center.

The incidents triggered a voluntary CardioGen-82 recall. As DOTmed News reports, the recall may have significantly reduced the number of PET scans and even affected the purchases of scanners.

On Monday, Bracco Diagnostics, the maker of CardioGen-82, sent a letter to its customers saying, “Bracco anticipates a limited and progressive reintroduction of the product to commence in the 1st or 2nd quarter of next year.” (The Society of Nuclear Medicine has an excellent Web page devoted to the CardioGen-82 issue, including links to the letter and other pertinent documents.)

Bracco said it had been “in constant communication” with the Food and Drug Administration to determine the cause of the elevated radiation in the three patients. The letter continued:

Our investigation findings, to date, continue to support that the unexpected radiation levels may have been due to user error or strontium breakthrough higher than what is expected with normal generator use or a combination of both.

“Strontium breakthrough” refers to strontium-82, used by the generator to make rubidium-82. If some of the strontium “breaks through” into the patient along with the rubidium, it can cause elevated radiation levels. Strontium has a half-life of four weeks.

Everyone, including the FDA, seems to agree that the radiation levels found in the three patients pose minimal risk, if that. And, fortunately for those who could benefit from PET stress tests, the Bracco letter says:

Bracco and the FDA are in alignment on expeditiously returning CardioGen-82 to the market and are working closely together toward that end.

Related seminar: Cardiac Imaging

Says a BCBSA report titled “Building Tomorrow’s Healthcare System”:

Private Radiology Benefit Managers have demonstrated success in the private sector and could make a substantial impact in public healthcare programs as well.

Not surprisingly, the Medical Imaging & Technology Alliance (MITA), a trade group of imaging equipment manufacturers, thinks the whole idea is terrible. In a statement, MITA Executive Director David Fisher said:

A proposal by an association of the health insurance industry to put medical decisions in the hands of the health insurance industry is simply a means to reduce access to medical imaging. Medical decisions should remain in the hands of physicians and their patients, rather than the insurance industry.

Pretty clear battle lines. And not new ones.

The BCBSA report points to Wellmark Blue Cross and Blue Shield, which operates in Iowa and South Dakota. It said Wellmark’s use of a radiology benefit management company “to ensure appropriate outpatient diagnostic imaging utilization” has consistently brought an annual return of at least 3 to 1.

On the other hand, MITA points to a physician survey in which 63 percent of the respondents said prior authorization delayed necessary medical procedures. And MITA said no peer-reviewed health economic research shows that prior authorization actually produces Medicare savings.

(A study in the June 2011 issue of the Journal of the American College of Radiology found that radiology benefit managers shift significant costs to physicians and that they sometimes actually increase costs.)

Blue Cross Blue Shield of Delaware (BCBSD) got in trouble last year when a claims administrator that it hired, MedSolutions of Franklin, Tennessee, denied 24 percent of requests to pay for nuclear cardiac stress tests.

The state insurance commissioner found that a provision in the contract with MedSolutions violated state law. Last month, she fined BCBSD $325,000, and the company agreed to drop prior authorization and instead use an American College of Cardiology computer program that determines whether imaging is appropriate based on a patient’s symptoms and medical history.

So which side will prevail in the prior-authorization battle? Given the budget-cutting fervor that grips Washington these days, radiologists would be right to feel nervous.

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Your Friday wouldn’t be complete without checking out our latest Facebook post, right?

Related seminar: The Business of Radiology

The sample size was small, but the devices malfunctioned for 25 percent of the patients in the study who had pacemakers or defibrillators (6 of 24). In each case, the device reset to its default settings. Said Steven DiBiase, MD, lead author of the study:

The memory was erased.

Dr. DiBiase, a radiation oncologist at the Robert Wood Johnson Medical School in Camden, New Jersey, explained, “What happens is, the devices go back to factory settings. The devices still work, but the specifics the cardiologist wanted” are lost.

None of the patients developed cardiac problems, but two of the devices could not be reprogrammed and had to be replaced.

Dr. DiBiase was quoted by DOTmed News. You can also find details of the presentation in this ASTRO news release.

Previous reports had suggested that such interactions with implanted cardiac devices were rare. Dr. DiBiase and his team weren’t even looking for them. They were studying a group of 505 men before and after they underwent IMRT treatment for prostate cancer, and 24 of the patients happened to have implanted devices. Said Dr. DiBiase:

It’s new data that everyone should be aware of.

IMRT, introduced about a decade ago, has quickly become a favored treatment technique because it allows more precise doses that spare healthy tissue. It also generates higher levels of radiation than older treatments, which may have something to do with the device interference.

Perhaps radiation oncologists should check with the Johns Hopkins University School of Medicine cardiologists we discussed in yesterday’s post. They developed a protocol for safely using MRI on patients with implanted cardiac devices.

Among other things, the cardiologists reprogram the device to a safe mode during the procedure, then restore the proper settings afterward. MR and radiation are two different things, obviously, and Dr. DiBiase’s team currently can only speculate about the interference mechanism.

Still, comparing notes couldn’t hurt.

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Yesterday’s tweets: Oregon’s whole-patient team model for health care and another TSA airport fiasco. Today’s? Check here and find out.

Related seminar: Abdominal & Pelvic Imaging: CT/MR/US