Third cervical cancer screening paradigm may be on the way

Clinical trial data and a Food and Drug Administration panel’s full-throated endorsement stand to reshape cervical cancer screening practice recommendations in the U.S.

The FDA’s Microbiology Devices Advisory Committee in March voted 13-0 in favor of a new indication for Roche’s Cobas human papillomavirus test that would allow the assay to be used as a primary screen for cervical cancer in women 25 and older. At this article’s deadline, the FDA had not yet acted on the panel’s advice but the agency usually heeds its advisory committees’ recommendations.

My latest in CAP TODAY’s Put it on the Board section. Read the whole shebang.

Putting it on the board

A back-page section in CAP TODAY that I’ve been working to beef up is called “Put it On the Board.” I usually contribute a fairly well reported lead news item of a few hundred words.

Back in January, I examined the need for faster, simpler tests to diagnose infectious diseases. In February, the story looked at explosive growth in the field of genomics and how difficult it is to translate benchside discoveries into bedside treatments. And last month I reported on how labs will be affected by a new federal regulation giving patients the right to their test reports.

And, yes, it appears that Ken “Hawk” Harrelson’s home-run call did inspire the section’s name.

How high-tech approach may reshape the autopsy

Boosters of so-called virtual autopsy say it has the potential to revolutionize the practice of forensic pathology and could help increase the share of U.S. deaths subject to medical autopsy.

The technique involves the use of computed tomography, magnetic resonance imaging, and three-dimensional surface scanning technology to help resolve tricky forensic questions such as whether a woman was killed with a hammer or a bicycle wrench. The 3D scanning can help provide a “morphological footprint” to gauge against any kind of instrument that could have inflicted the damage, said Michael J. Thali, MD, chair of the Institute of Forensic Medicine at the University of Zurich in Switzerland. About 500 virtual autopsies have been conducted at the institute, Dr. Thali said in a June 8, 2013 lecture before the Royal Society of Medicine in London.

Postmortem imaging using CT and MRI—the former is better for evaluating skeletal injuries, while the latter excels with soft-tissue evaluation—can help give a 3D visualization of these blunt-force injuries, Dr. Thali said. He and his colleagues also have used the virtual autopsy approach in cases of strangulation, knife wounds, and more.

My latest in CAP TODAY. Read the whole shebang.

Guidance aims for safer use of lab data in EHRs

A wide-ranging set of recommended health information technology safety practices recently issued by the Department of Health and Human Services is likely to accentuate the essential role that pathologists and laboratory leaders play in minimizing the adverse consequences of health IT.

Pathologists and lab experts involved with developing the guidance say it could serve as a North Star for how health care organizations can improve IT safety, especially with regard to better test tracking and results display. But some of the functionalities the recommendations call for are not yet widely available, and the recommended practices could represent a big implementation challenge for laboratories.

My latest in CAP TODAY. Read the whole shebang.

Saving time on HLA testing’s final compatibility check

What would you give for a little more time? Take a vital task that you do every day, every week, or every month, and do it about three times faster—with no effect on the quality of the outcome. No, this is not another comfort-food recipe from Rachael Ray’s best-selling series of “30-Minute Meals” cookbooks. This is the story of how a growing number of histocompatibility laboratories are optimizing a test that can detect low concentrations of donor-specific human leukocyte antigen antibodies and help avoid post-transplant organ graft failure.

My latest in CAP TODAY. Read the whole shebang.

Clinician-friendly tactics slash unwarranted testing

A child born recently at Broward Health Medical Center was definitively diagnosed, without testing, as having a significant genetic abnormality. A medical resident eager to put his education into practice ordered genetic testing for the newborn, two normal siblings, and the child’s parents.

The tests would have cost the hospital up to $10,000—each.

My first bylined story in CAP TODAY. Read the whole shebang.

Painkiller problem hits hard in workers’ comp

Rough Notes

Tighter monitoring of opioid prescribing is key to reining in costs

The dramatic increase in overdose deaths and emergency department visits related to the class of narcotic painkillers known as opioids has drawn national attention to the rise in abuse of the drugs as well as inappropriate prescribing by physicians.

But the problem, dubbed an “epidemic” by Centers for Disease Control and Prevention Director Dr. Tom Frieden, is not limited to teens looking for a cheap high by raiding their parents’ medicine cabinets. Rather, it is being felt in a big way by employers. Companies are seeing their workers’ compensation costs skyrocket to a reported $1.4 billion annually due to injured workers prescribed opioids such as OxyContin and subsequently experiencing a pronounced delay in return to work.

Experts say that a coordinated effort among all the key stakeholders – politicians, regulators, medical authorities and the general public – is needed to comprehensively address the opioid epidemic. But they note that there are some steps that employers and their insurers can take to discourage improper prescribing, help injured workers return to work more quickly and help rein in workers’ compensation costs.

“The majority of people misusing prescription drugs are employed,” Terry L. Cline told an audience of health and safety professionals at a keynote session of the National Safety Council’s annual meeting in Chicago in September.

“These are the people working at all of our companies. We all have a big stake in this. That’s the challenge in front of us,” said Cline, Oklahoma’s health commissioner and president of the Association of State and Territorial Health Officials. The organization has pledged to slash the rate of opioid abuse and overdose deaths by 15% by 2015.

The CDC estimates that about 16,000 Americans die of opioid-related overdoses each year. The epidemic extends much deeper, Cline said.

“For every one opioid-related death, 10 people are treated for abuse, 32 go to the emergency room, 130 abuse or are opioid dependent, and there are 825 nonmedical users,” he said, drawing on CDC data.

Impact on workers’ comp

The cost figures within the workers’ compensation world also are setting off alarm bells. It is estimated that more than half of claimants receive opioids for chronic pain relief. Narcotics now account for a quarter of work comp drug costs, and nearly half of those narcotics are medicines that contain oxycodone as an active ingredient, said a research brief released in September by the National Council on Compensation Insurance.

Of the top 20 drugs that cost workers’ comp plans the most nationwide, nine are opioid analgesic medications such as Fentanyl, Opana ER and Percocet. And the narcotic cost per medical claim is on the rise, growing by 51% since 2003. Meanwhile, more work comp claims involve injured workers who rely on narcotics over a longer period of time.

“The share of claimants who are getting five or more narcotic prescriptions has been growing over the last few years,” said John Robertson, who co-wrote the research brief and is the council’s director and senior actuary.

In 2005, 4.3% of claimants received five or more narcotic prescriptions in the year following their injury. That rose 30% to 5.6% by 2010, the most recent year of data available for this measure.

As if this steady growth in painkiller prescription drug costs were not enough cause for concern, it represents only a small slice of how the rising use of these medications is increasing workers’ compensation outlays, said Dr. Constantine J. Gean, regional medical director at Liberty Mutual Insurance.

A 2002-2003 study of more than 8,000 workers’ compensation claimants with disabling low back pain found that those prescribed opioids within the first two weeks of their injury saw their disability prolonged by as much as 69 days longer. These workers were six times likelier to use narcotics later on and had triple the likelihood of needing surgery even after controlling for illness severity, Dr. Gean said during his talk at the National Safety Council’s keynote session.

“We really need to do something about what’s becoming a national disgrace,” he said. “Opioids are not for low back pain and neck pain. And there’s no evidence that they work over the longer term.”

Painkillers tied to catastrophic claims

Subsequent research supports Dr. Gean’s argument. A 2008 study issued by the California Workers’ Compensation Institute found that patients getting high doses of opioids took three times longer to return to work than injured workers who got lower doses.

And it is not just high doses of opioids that are problematic, according to an analysis of more than 12,000 workers’ compensation claims in Michigan between 2006 and 2010. After controlling for age, sex, illness severity and legal problems, claimants who got short-acting opioids such as Oxycodone were 76% likelier to have total comp costs exceeding $100,000.

The injured workers prescribed a long-acting painkiller such as Fentanyl were four times likelier to have catastrophic claims surpassing the $100,000 mark, said the August 2012 study published in the Journal of Occupational and Environmental Medicine.

“There is this even bigger public health matter of injured workers taking opioids and that being a leading contributor to disability,” said Dr. Gary M. Franklin, lead author of the study and medical director of the Washington State Department of Labor and Industries. “It’s not the cost of the drugs. It’s the cost of sending somebody down the tubes because they’re on chronic opioid therapy.”

Many experts cite Washington as one of the bright spots at the state level in addressing the opioid epidemic. In 2007, Dr. Franklin’s department collaborated with other state agencies to develop guidelines on the use of opioids. Among other things, the guideline – updated in July 2013 – said that doctors should consult with pain specialists before prescribing daily morphine-equivalent doses of 120 mg or more to injured workers.

“It wasn’t an absolute cap, but the guideline did say that if you’d gotten to that dose and you’re not seeing improvement then don’t keep pushing the dose up,” Dr. Franklin said. “In most doctors’ minds, they were taught 10 or 15 years ago that there was no ceiling on opioid dosing. Putting in place a threshold puts an anchor in doctors’ minds.”

The average opioid dose among injured workers has fallen by 27% since the guideline was enacted, and the share of claimants on daily morphine-equivalent doses of 120 mg or greater has dropped by 35%. The number of deaths fell by half, said an April 2012 study published in the American Journal of Industrial Medicine.

Few states get policy right

Other states are starting to get the message. Ohio enacted a similar policy setting an 80 mg opioid dosing threshold, while also cracking down on so-called pill mills in the same manner that Florida, Kentucky and other states also have done.

But according to an October National Safety Council report, only Washington, Kentucky and Vermont fully meet the group’s standards for implementing good prescription drug monitoring programs, encouraging responsible opioid prescribing and enacting overdose education and prevention programs. Thirteen states and the District of Columbia are graded as not meeting the standards at all. Another 35 states are partially meeting these benchmarks for helpful public policy, said the report, “Prescription Nation: Addressing America’s Prescription Drug Abuse Epidemic.”

In lieu of state action to help address the cost impact of the nation’s opioid epidemic, there are steps that can be taken in isolation by employers and insurers. They should take a hands-on approach to work with physicians to ensure that their prescribing of opioids is appropriate, said Liberty Mutual’s Dr. Gean.

Claims should be monitored to see whether the prescribing of narcotics falls within the acceptable standard for the area, and physicians should be encouraged to seek the free training that the Food and Drug Administration now requires makers of long-acting opioids to offer to doctors and other prescribers.

“It’s important to give doctors feedback,” Dr. Gean said.

Advice to seek this kind of collaboration with physicians is not limited to Liberty Mutual. Chicago-based insurer CNA is urging employers to “build a stronger relationship with their occupational health provider,” said Shari Falkenburg, the company’s assistant vice president of risk control.

“Employers are starting to ask questions of doctors,” she added. These questions cover territory such as physicians’ narcotic prescribing approach, how they screen patients with a potential to abuse painkillers, and their willingness to use nonnarcotic alternatives including physical rehabilitation or nonsteroidal anti-inflammatory drugs such as ibuprofen.

CNA is now training its workers’ compensation claims administrators to evaluate the care provided against the official disability guidelines and scrutinize the duration of disability claims and how opioid prescribing may be prolonging it. The company also is bringing representatives from underwriting, risk control and claims together to examine the accounts of insureds who have higher costs related to opioid prescribing to evaluate how these employers can improve training, education or other programs to address the problem.

Injured workers’ initiative

There are limits to what employers and insurers can do, experts say. The unfortunate link between painkiller prescribing and extended disability is one that Dr. Donald Teator has seen many times in his Waynesville, N.C., practice as a specialist treating opioid dependence.

“These medications work on your brain more than on the pain,” said Dr. Teator, medical adviser to the National Safety Council. “People get the meds and it makes them feel relaxed and takes away a lot of their drive to get back to work. They just kind of mellow out taking these pills and don’t get up and do the exercises they’re supposed to or follow up with their doctors the way they’re supposed to.”

For the injured worker, the hard change of shifting away from opioids and back to work only occurs when that individual patient is prepared, Dr. Teator added.

“They have to really want to get back to that normal life.”

A blast from the past

In a July 2 editorial, the Tribune’s editorial board spoke out against Indiana’s more liberal fireworks laws, calling them a “farce.” I find it extremely ironic that when the 4th of July comes around, adults in Illinois aren’t allowed to freely celebrate what little liberty they have left.

So began my 1999 letter to the Chicago Tribune, which it recently occurred to me to dig up. Read the whole shebang.

Here is Lucas

Today marks the one-month birthday of our son, Lucas. Elizabeth is doing a marvelous job ensuring that he is properly nourished, and he is growing quite beautifully. Lucas has so many looks. Here he is being pensive.

Lucas-Baby Bella-05

You can stay updated on Luke’s evolving appearance at his (password-protected) website. For access, please send your request to the address below. Thanks.

emailimage

The next patient safety target: misdiagnosis

A 36-year-old woman recently presented with flu-like symptoms at Shonan Kamakura General Hospital in Kamakura, Japan. Just a week earlier, her son had been diagnosed with influenza, leading her doctors to think that might be the cause of her fever, fatigue, sore throat and dry cough.

But she tested negative for flu, so she was diagnosed with an upper respiratory infection, prescribed 1,200 mg of acetaminophen daily and sent home. The woman returned the next day, reporting symptoms of vertigo. Testing showed she had suddenly become anemic. Within days she was dead, felled by acute promyelocytic leukemia, which has a 5-year survival rate surpassing 70% when correctly diagnosed and treated.

The tragic case of delayed diagnosis, presented at the Diagnostic Error in Medicine 6th International Conference in Chicago in September, was one of those extremely rare “white zebras” that every physician dreads, expert diagnosticians said.

“These are tough cases at every level,” said David E. Newman-Toker, MD, PhD, associate professor of neurology and otolaryngology at Johns Hopkins University School of Medicine in Baltimore.

But new research shows that it’s not just the one-in-a-million diagnoses that get missed, Dr. Newman-Toker noted. Diagnostic errors are responsible for more patient deaths, disabilities and medical liability costs than any other kind of medical mishap.

My latest is in the December issue of ACP Hospitalist, a holdover from when I was still freelancing. Read the whole shebang.

Outreach to Latinos on health coverage faces obstacles

Valentin Torres is the kind of resident Illinois officials know they need to reach if their effort to vastly expand health insurance coverage under the Affordable Care Act is going to succeed.

Torres, a truck driver and the sole provider for his wife and three children under 18, said his family has gone uninsured since 2005 when he lost the coverage he had through an employer.

At a state-organized outreach event he heard about on Spanish-language radio, Torres learned the family would be eligible for Medicaid under the health law’s expanded income rules. He planned to complete his application from home through abe.illinois.gov, a site for Medicaid applicants separate from the troubled federal website where private insurance plans are sold.

“I came here to get health coverage for me and my family,” said Torres, 44, who is bilingual but spoke to a counselor in Spanish. “Without insurance, you can’t afford to get sick.”

Federal health officials estimate that Latinos make up nearly a quarter of Illinois’ uninsured population, inspiring a special effort by state officials to spread the word about options available under the health law. To help raise awareness, Illinois is partnering with nearly 50 community-based organizations with close ties to immigrant populations.

My latest is in the Chicago Tribune. Read the whole shebang.