The importance of what you say

My son’s check-up at the pediatrician last week started the same as it usually does.

Dr. M. measured and weighed Brett, listened to his chest, checked his eyes and looked in his throat.

Thankfully, all was well.

“You have a great kid,” he said. It’s the next part I hadn’t planned on. “And now you need to go to the lab for blood work.”

Blood work? Really? I should have known it was coming, but somehow, I hadn’t prepared myself – or Brett – for this. And I had barely a minute to get my act together.

On the way to the lab, I explained things to Brett, trying my best to downplay the notion that (yikes!) a steel needle was about to plunge into his arm and extract his blood.

“Dr. M. checked out all your outside parts, and now another doctor is going to check out your inside. It’s going to be really cool. We’ll watch them take your blood and then they’ll analyze it to see what’s in it. There will be a pinch and then we’ll just watch your red blood go into the tube.”

In the packed waiting room, a more apprehensive bunch of patients listened in, enamored with Brett’s series of questions:

“Mommy, what are they going to look for in my blood?”

“They are looking at your red blood cells, white blood cells, platelets,” I said.

“Why are we still waiting? Why are all the other people waiting? Is the doctor going to look inside their blood?”

When they called his name, Brett jumped up and in we went. He sat on my lap and the phlebotomist told me to hold his arm back, presumably to lessen the risk of him yanking the needle out.

I braced myself.

The needle went in. And even though it took a few more excruciating seconds than I expected, my son sat quietly.

Amazingly, he didn’t cry, he didn’t flinch.

At one point he did announce “I’m all done,” but even when told they had to do it just one more time, he sat calmly and watched. When it was over, Brett was beaming with pride as he exited with multiple Spiderman stickers.

I was in awe. I was proud of my brave little boy – and also, I was proud of myself.

Truthfully, I wasn’t entirely surprised. This is a child who, somehow, likes getting a flu shot. He loves pretend doctor kits and giving my husband “an

allergy shot” when he sneezes. (A physician in the making perhaps? He already looks the part in this photo.)

But even more striking for me is the way this experience illustrates the importance of not only what you say, but how you say it.

The more carefully a medical professional explains to a patient the details of a procedure or treatment, the more likely the patient will walk in with a sense of ease. Clear expectations have the power to ground a person in even the toughest of moments.

Sure, Brett’s just three years old, but the lesson still applies.

And years from now when Brett is the one in the white coat, I can see him comforting a patient and then saying with a smile: “You’re all done!”

Physicians must prepare for new EHR regulations

Doctors hoping to obtain a share of an estimated $27 billion in federal incentive bonuses for implementing electronic health records would have to meet a wide range of new “meaningful use” requirements under proposed regulations released by the Centers for Medicare & Medicaid Services.

The two dozen benchmarks – which include such mandates as recording 50 percent of lab results and fulfilling 80 percent of patient requests for health information electronically by the end of 2012 – were issued by CMS on Dec. 30 as part of a long-awaited draft regulation defining “meaningful use” of electronic health records technology.

The proposal was published Jan. 13 for a 60-day public comment period.

Observers expect the final version will be quite similar to the proposed rules, and providers must be ready if they want to earn the maximum incentive payments.

“Depending on when you adopt … the bonus could be higher,” said health care attorney David Szabo, a partner at Edwards, Angell, Palmer & Dodge in Boston.

At some point after 2015, he noted, “the chance to earn a bonus goes away and all you can do is avoid a [Medicare or Medicaid] penalty.”

The new regulation implements provisions of last year’s $787 billion stimulus package, which called for incentive payments to eligible professionals and hospitals that achieve “meaningful use” of a certified EHR system starting in 2011.

The law left it to CMS to explain what “meaningful use” actually means. (A separate proposal, issued by the Office of the National Coordinator for Health Information Technology on Dec. 30, lays out the technical standards for a “certified” system.)

According to the “meaningful use” regulation, providers who treat Medicare and Medicaid patients would receive incentives in three stages.

They would receive the first set of incentive payments if they meet all 25 benchmarks for “Stage I” of the phased-in implementation in either 2011 or 2012.

They would get further incentives for achieving increasingly rigorous (but not yet defined) benchmarks by the end of 2013 and 2015, after which non-compliant providers would face penalties. Early adopters who achieve compliance at all three stages could garner up to $44,000 in incentives.

Many doctors and other health care providers agree that EHR adoption is a laudable and necessary goal. In fact, they say that CMS has worked hard to produce realistic benchmarks that utilize physician-friendly measures.

However, they also predict that the statutory and regulatory framework will make it both challenging and costly for solo and small-group practices – as well as small community hospitals – to meet the requirements in the proposed time frame.

Tough for small practices

Some of the benchmarks are ambitious, and will be especially difficult for smaller medical practices to meet, experts said.

“It’s the smaller [entities] that will have greatest difficulties,” said Ray Campbell, CEO of the Massachusetts Health Data Consortium.

For example, the regulation calls for all physicians to use e-prescribing 75 percent of the time by 2012.

David Harlow, a Newton-based lawyer and health care consultant, said that this won’t be an easy task, noting that Massachusetts is considered a leader in e-prescribing even though only 10 percent of prescriptions are submitted electronically.

At the same time, other benchmarks seem pointless in light of what many physicians – especially specialists – do on a regular basis, Harlow said.

He referred to a requirement that electronic reminders for preventative care and follow-up be sent to at least 50 percent of all patients age 50 or older.

“Why would, say, an orthopedic surgeon be sending out reminders based on age?” he asked. “That’s really geared toward primary care, yet it’s a measure that’s required in order to get an incentive payment.”

Campbell criticized Congress for putting more funds toward the rewards that occur after doctors achieve meaningful use, while not earmarking enough money to help physicians implement EHR systems in the first place.

Massachusetts Medical Society president Mario Motta, a Salem cardiologist whose own 10-doctor practice has adopted EHR, agreed.

“I’d never go back to the dark ages without [electronic records], but it’s a huge expense,” he said. “We’re talking roughly $30,000 to $50,000 per physician [to start], and then you have [annual] maintenance costs that for higher-level systems – considering that the cheaper systems won’t make the cut for ‘meaningful use’ – can range anywhere from $8,000 to $15,000 per physician.”

Unlike most businesses that invest in infrastructure upgrades, doctors have no ability to pass on their costs, Motta added.

“If you do everything right and somehow don’t meet the benchmarks, you’re stuck with the entire cost,” he said.

Observers wonder if small providers who aren’t prepared to make the financial investment or workflow changes might simply opt out of Medicare and Medicaid or gamble that come 2015, Congress will lack the political will to stand firm on noncompliance penalties.

“I’m assuming [Congress will] stick with [the penalties],” says Campbell. “But if the transition is messy and sticky and there are lots of failures, they’ll have to revisit that policy. And I do think it will be messy and there will be a fair number of failures.”

Meanwhile, the Department of Health and Human Services meaningful use workgroup is recommending that CMS reduce the number of benchmarks required at least for the first year. And other groups are expected to weigh in.

Some requirements not as tough

Despite the extent of the requirements, legal experts say that some of them might not be as tough to implement as it seems at first glance.

For example, the proposed regulation would require providers to have a system in place for electronic drug-drug, drug-allergy and drug-formulary checks by the end of the first stage of implementation, said Szabo.

But physicians aren’t required to actually use the system at any point during Stage I – the system simply needs to be turned on during the provider’s 90-day “meaningful use” testing period. The provider determines when that testing period will be, and during that time he or she must meet all Stage 1 criteria.

Under the regulation, doctors would also be expected to provide health information electronically to at least 80 percent of patients who request it, but Szabo points out that these requests are still highly unusual in the first place.

Meanwhile, though CMS expects providers to use computerized physician order entry (CPOE) for at least 80 percent of all orders during either 2011 or 2012, a provider would only need to demonstrate the capability to do so during his or her testing period, not the entire year.

That means that a doctor who manages to ramp up for, say, just the last three months of the year can still be a big winner, said Szabo.

Getting up to speed

Smaller practices need to get up to speed on how to implement an EHR system.

Harlow warns that a physician practice should not even attempt to roll out an EHR system if the physicians are only in it for the incentive payments. Though an effective system should ultimately start paying for itself through the internal office efficiencies it creates, a $44,000 maximum incentive payment won’t cover the implementation costs.

Additionally, said Campbell, successful implementation is at least as much about changing the way you practice and operate your business as it is about the technology itself.

That’s exactly why it can take a practice up to six months to get used to an EHR system, said Harlow.

“During that time, physicians will work longer hours while seeing the same number of patients,” he said. “They’re learning to interact with the patient and the computer screen simultaneously and that’s not the easiest thing in the world.”

To make the transition smoother, experts suggest working with a health care management consultant, seeking advice from a peer who has already implemented EHR, and/or taking advantage of seminars offered by the MMS IT Committee on such topics as getting started, choosing a vendor and using the system.   MMLR

Questions or comments may be directed to the editor at: reni.gertner@mamedicallaw.com

Family wins $15M suit against Children’s Hospital physicians

A Suffolk County Superior Court jury in Boston has awarded $15 million to the parents of a young child who died following a series of complications from a catheterization procedure.

Jurors found that two doctors at Children’s Hospital Boston, Dr. James A. DiNardo, an anesthesiologist, and Dr. James Lock, the hospital’s former physician-in-chief, caused the death of three-year-old Jason Fox.

Jason died in December 2004, a year and a half after he was treated at the hospital for a birth defect. Jason’s father Brian, an attorney in Pennsylvania, said the basis for the complaint was that Lock and DiNardo lied about their actions when treating his son, and attempted to cover up mistakes that were made during and after the procedure.

“We knew pretty early on after the procedure that Jason was very adversely affected,” said Brian Fox. “Before the procedure he was extremely interactive and engaging, then after he stopped talking, couldn’t walk independently. The doctors continued to insist he would just get better.”

Brian’s cousin, Sherman Oaks, Calif.-based James Fox, one of the attorneys that represented Jason’s family, said that his biggest challenge at trial was convincing jurors that such respected physicians would lie and deceive the parents of a patient. To do this, he structured his case around chipping away at the mystique surrounding the physicians.

Attorneys for the defense could not be reached for comment.

Preventing similar suits

Risk management consultant Jim Vaccarino, who practices in the Healthgroup at The Hays Companies, said he believes that the doctors were sued in the first place because Jason’s parents did not feel they were open about the complications that arose from their son’s procedure.

“The worse thing you can do is not be forthright with a family and then try to … cover up your mistake” said Vaccarino. He noted that many physicians are prone to panic if a patient or his or her family accuses them of malpractice.

“You should speak to an advisor or a lawyer on your hospital’s staff before you do anything,” recommended Vaccarino.

Vaccarino said doctors can side-step potential med-mal lawsuits early by being completely upfront about the procedure (particularly a risky one, like the one undergone by Jason Fox), and providing all of the risks in writing.

He suggests establishing “a rapport with a patient [or] a patient’s parents, and letting them know the risks, [including] long-term disability, death and complications, such as infection.”

On the patient’s chart, it is also essential to make sure each step of the procedure is outlined.

“If a doctor is accused of something, he might feel obligated to get rid of a part of the chart. … [But] that [could be the] part another doctor [or expert will] point to and say you didn’t deviate from the normal standard of care,” Vaccarino said.

Martin Foster, a med-mal defense attorney at Foster & Eldridge in Cambridge, agreed that the way the chart and accompanying documents are written is critical.

“You want a detailed narrative that explains what decisions you made, when you made them and why,” said Foster. “Especially when it involves a relatively new or advanced procedure, the first thing people are going to look at in the aftermath of an adverse outcome is what did the [patients] know beforehand.”

Birth defect

Jason Fox was born in July 2001 with a birth defect called Tetralogy of Fallot, which restricted the flow of blood through his heart. In Jason’s case, the defect prevented his blood from carrying enough oxygen to his organs and limbs.

By the time he was two, Brian Fox said his son had already undergone seven cardiac catheterizations at Children’s Hospital of Philadelphia to widen the arteries that carry blood to his lungs.

Doctors in Philadelphia finally referred Jason to Lock, a physician widely considered a pioneer in the use of catheterization to repair cardiac birth defects. On April 18, 2003, Jason went into Children’s Hospital Boston for his second catheterization there.

Hours after the procedure, he suffered a seizure. According to a subsequent CAT scan, contrast dye had leaked into his brain.

After the initial seizure, two MRIs were done to determine the extent of brain damage. The first MRI showed that a tiny piece of metal had become lodged in Jason’s brain, which the lawsuit alleged was caused by carelessness with one of the instruments used during the catheterization. During the second MRI, Jason’s heart rate dropped and doctors had to resuscitate him.

He was discharged three weeks after the surgery with severe brain injuries, and died in December 2004.

Records altered

The pivotal documents in the case, according to James Fox, were the anesthesia record and Jason’s medical record.

Fox said there were a number of inconsistencies that stuck out, including the fact that the anesthesia record had been signed off on by a physician who wasn’t present during the administration of Propofol, an intravenously induced anesthetic. (The drug gained notoriety after allegations that Michael Jackson abused it prior to his death.)

Another inconsistency came to light in Jason’s electronic medical record. One attending physician revealed during his deposition that he had made note of several key events during Jason’s stay, but those weren’t evident in the record. The physician insisted he made them electronically, and later provided a printed copy of the electronic record.

“When we saw it, it was identical to the printed record, but there were ten additional lines,” said James Fox. “So we started looking at the electronic record for dates and times when the information was put in, and we could see on a number of occasions that doctors had logged in [afterward] and changed the information.”

According to James Fox, the records included an adjustment in the dosage of epinephrine during resuscitation, which the complaint alleged had been botched.

The plaintiffs also uncovered a cardiologist’s note from the hospital’s ICU diagnosing Jason with “contrast toxicity due to high contrast load.”

“They screwed with major parts of the record, especially the ICU note,” charged James Fox. “That was a very damning indictment of Dr. Lock, and that note became the centerpiece of our liability argument against him.”

Doctor on the stand

According to both James and Brian Fox, jurors informed them after the trial that they were displeased with the arrogance Drs. Lock and DiNardo displayed over the course of the trial.

James Fox said that his strategy was to get jurors to see that despite their admirable credentials (both men have been cited in hundreds of publications and written textbooks), the doctors had made a mistake and simply assumed that their clout would get them off the hook.

Both doctors took the stand. James Fox said that he made it a point to cover even the smallest details of the procedure performed on Jason.

“I grilled [Dr.] Lock for a good day, going into a lot of detail,” said Fox. “I asked how you set up the infusion pump. I asked him if he gave .3 ccs or .03 ccs. He kept getting more and more frustrated until he yelled out, ‘I don’t make mistakes!’”

After six weeks of trial and four days of deliberations, the jury awarded $5 million for Jason’s pain and suffering, $5 million for his parents’ loss of their child and $5 million for wrongful death.

But James Fox said they won’t see the entire $15 million because the parties agreed to a high-low agreement during jury deliberations. He declined to elaborate on the specifics of the settlement. MMLR

Questions or comments should be directed to the editor at: reni.gertner@mamedicallaw.com

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