Health News Review | March 21, 2016 | By Trudy Lieberman
There were three ways news outlets could have responded to the Justice Department’s (DOJ) February announcement and its previous one last fall that revealed 508 of the nation’s hospitals in 43 states had been fined more than $280 million for implanting a cardiac device in 10,000 patients in violation of Medicare’s national coverage determination, potentially harming them and wasting billions of taxpayer dollars. They could have:
- Taken a pass.
- Published a piece that didn’t stray beyond the borders of the DOJ press release.
- Dug deeply into the disturbing medical and political issues raised by the government’s investigation.
Given that hospitals now are big media advertisers in their communities and revered corporate citizens that generate oodles of coverage centering on ribbon-cutting ceremonies, announcements of new technology, and special events for sick kids, we wanted to know which options the media would choose when news about the local hospital is unfavorable. The huge DOJ suit, one of the largest ever in terms of the number of hospitals involved with far-reaching ramifications for patients, gave us a chance to find out.
Media markets we examined
We looked at a sample of coverage of the DOJ’s announcement in 18 states plus the District of Columbia examining print media and zeroing in on state and local coverage where hospital violations would be of most interest to readers. Our sample included hospitals with some of the biggest names in the business—the Cleveland Clinic, New York-Presbyterian Hospital in New York City, Robert Wood Johnson Hospital in New Brunswick, New Jersey, Scripps Health based in San Diego, the University of Pittsburgh Medical Center, Emory University Hospital in Atlanta, as well as the giant Tennessee-based hospital systems like HCA with 42 hospitals involved, Community Health Systems with 31, and Health Management Associates with 27.
We looked at two major news databases, Proquest Newsstand and Factiva, searching the names of 77 hospitals involved in the lawsuit. We also conducted another search of all the major daily newspapers in the largest cities in states where a sample of hospitals we examined were located. These locations included New York City, New Jersey, San Diego, Dallas/Ft. Worth, Nashville, Memphis, Columbus, Cincinnati, Cleveland, Akron, and Atlanta. Our searches revealed scant coverage or none.
In some locales like the San Diego area, home to Scripps Green Hospital and Scripps Memorial Hospital, teaching facilities based in LaJolla, we found no print coverage. Ditto for Baylor University Medical Center in Dallas or the Ohio State University Wexner Medical Center in Columbus. Our New York search turned up no mention of New York-Presbyterian, a large TV advertiser. And the only coverage we saw for the North Shore-Long Island Jewish Health System, which includes Lenox Hill Hospital in Manhattan and Long Island Jewish Medical Center in New Hyde Park, was a brief, he said/she said story in Newsday that downplayed the significance of the settlement. In Tennessee with its mega, politically-connected hospital systems, our search of the largest newspapers turned up nothing about the settlement.
Short, shallow stories
The hospitals’ reputations would hardly have been tarnished by the news coverage we did find. Mostly it regurgitated the Justice Department news release. For the most part stories were short, shallow, and failed to discuss the important implications of the government’s prosecution and why it deserved more probing treatment from the media. “I’m not sure the significance of this investigation has been understood,” says Bryan Vroon, who represented the two whistleblowers—a registered cardiovascular nurse and a Medicare reimbursement consultant—in the false claims suit, the first national enforcement of a Medicare national coverage determination, which governs whether Medicare pays for services and procedures considered reasonable and necessary. “This is a huge important issue for anyone of us,” Vroon told me. “This number of hospitals don’t readily settle cases alleging violations of the False Claims Act unless there’s strong basis for the case.” (The False Claims Act, which dates back to the time of Abraham Lincoln, is the primary litigation tool the government uses to fight fraud.)
The Department’s investigation, which looked at surgeries from 2003 through 2010, involved a device called an implantable cardioverter defibrillator, or ICD, which is implanted in patients who’ve had heart attacks or coronary bypass surgery. It’s designed to detect and treat life-threatening heart rhythms or fibrillations. The devices deliver a shock to the heart and help restore normal heart rhythm. Medicare’s national coverage determination says, however, that ICDs should not be used for heart attack patients until after a 40-day waiting period or after a 90-day period for patients who’ve had bypass surgery or angioplasty. During the waiting period patients must be given appropriate heart failure medications, which sometimes help improve heart function. Because that happens, patients may not need the ICD implant.
Costs and harms from unnecessary surgeries
“Hospitals put ICDs in people outside the coverage guidelines who would not get a benefit and likely suffer,” says Dr. Rita Redberg, a cardiologist at the University of California San Francisco and editor of JAMA Internal Medicine, who reviewed cases for the Justice Department. “It’s a big invasive procedure, and the guidelines are there to make sure that for people who are getting the procedure the benefits outweigh the harm.” Sanket Dhruva, a Yale Clinical Scholar in cardiology, told me not only are there the usual risks associated with surgery, but the device is implanted for life and that always raises the possibility of infections. He says the device can also deliver painful shocks to the heart when the patient doesn’t need them. The cost of unnecessary surgery is also significant. Medicare’s payment is about $25,000. Redberg says she has seen bills that double that.
Although some of the stories we examined (for example, this piece in The Ledger in Lakeland, FL) noted the waiting periods, they rarely mentioned the harms and risks of unnecessary implants. They did make clear that the hospitals accepted no liability for their actions, which is standard practice in false claims cases. And the stories did include statements from hospital PR officials who spun the DOJ’s action as a billing problem, a difficult interpretation of a complex regulation, or offered assurances to patients they were delivering good care no matter what the Justice Department said. It’s a shame the stories were not more thorough. Patients who read them could easily come away thinking this is no big deal. It’s just the government picking on our hospitals. Said Vroon, “what bothers me about the spin is that the DOJ went to extreme effort to apply the science to determine if these surgeries were indicated. Medical science led this case.”
“Billing problems” and “bad apples”
Instead the public got these kinds of responses from the hospital spinmeisters:
- Emory Healthcare said the government “focused on whether hospitals properly billed the ICDs, not on the quality of the patient care provided.”
- Mon General Hospital in Morgantown, WVA, claimed, “this is a billing issue. This isn’t a medical mistake issue. We misinterpreted the guidelines and inappropriately billed.”
- Commenting on the fine paid by one of its hospitals in Pennsylvania, Community Health Systems framed the problem as “a highly technical interpretation of a Medicare national coverage determination that was the subject of strong disagreement in the medical community.”
- The Cleveland Clinic defended the treatments it gave patients as “life-saving and life extending,” adding it “would provide the same treatment again if presented with the same illness. The only question was whether Medicare would reimburse part of the cost of the treatments.”
- MedStar based in Columbia, MD, which had eight facilities involved in the DOJ settlement including the MedStar-Georgetown Medical Center and the Washington Hospital Center, said it stood by its “solid record and long history of providing the highest quality heart care to residents of Maryland and Washington D.C.”
- The Arkansas Heart Hospital claimed it had followed “best clinical practices” but those practices had not been incorporated into Medicare’s payment guidelines at the time the procedures were performed.” In our sample, I saw only one statement that told patients they should talk to their doctors if they had concerns about the implants. That was California-based St. Joseph Health System.
A Baltimore Sun piece was longer than most, but fell short when it seemed to side with the hospitals and didn’t discuss the harms and risks of the ICD procedure. It introduced the “bad apple” defense for bad market behavior into the hospitals’ narrative. The reporter reached out to a cardiologist at Johns Hopkins, which was not named in the lawsuit, who told her, “No question there are some bad apples out there. But I don’t think these are all cases of health care fraud as the Department of Justice seems to imply.” He said there are a lot of “gray zone” cases—times when it doesn’t make sense to wait and doctors want to implant both a pacemaker and a defibrillator immediately. What about the bad apples and the gray zones, I asked Redberg? “This definitely was not one bad apple,” she said. As for the gray zones, “I can tell you none of the cases the DOJ litigated were gray areas.”
Four steps to securing Medicare reimbursement
A few years ago health policy expert Murray Ross, a vice president for Kaiser Foundation Health Plan, spoke to journalism students in New York City and explained the politics of getting Medicare to cover new services and procedures. He laid out four steps sellers and providers use to stymie attempts to control the use of new machines, drugs, or procedures and to achieve their goal of getting Medicare to pay for them. First they persuade an insurer to pay for it. Once one does, others usually follow. If that fails, they try to get a national coverage determination from Medicare, which ensures payment although there may be restrictions as there are for ICDs. If a coverage determination is not forthcoming, they appeal to friendly members of Congress to send letters and make calls to Medicare officials. That usually does the trick. If it doesn’t, the lobbyists go to work — perhaps adding an amendment to some “must-have” legislation like a budget reconciliation bill that authorizes payment for the service.
But what if the coverage determination that’s adopted isn’t to the liking of providers and sellers? The aftermath of the DOJ settlement shows there may be an additional route to take when things that appear to be settled aren’t working out for the industry. Vroon says the most revealing number of all is that since the beginning of the DOJ investigation in 2008, the number of surgeries to implant the device has dropped by about 28 percent, reaping a savings for Medicare of some $2 billion over the five years that followed. If Medicare saves more, doctors and hospitals get less.
Blowing up the rules
No wonder a nuclear option is emerging. Some medical specialty societies propose blowing up the national coverage determination and changing the rules — arguing that the determination may be too restrictive when it comes to gray areas. In the last few years Viewpoint commentaries (see here and here) appearing in the Journal of the American College of Cardiology have suggested the national coverage determination conflicts with practice guidelines that may be more “flexible” and “nimble.” In a Dear Colleague letter, Dr. John Day, president of the Heart Rhythm Society, a group representing professionals specializing in cardiac rhythm disorders, advised that his group and other specialty societies were working with Medicare “to identify the appropriate time to reopen the existing national coverage policy,” and that they will work to “update the clinical indications for reimbursement.”
Redberg told me, “Many of us who reviewed the cases for the DOJ felt this statement misrepresents the verdict.” She said it implied the problem was one of outdated guidelines, adding “many, if not most of the cases we looked at not only violated the CMS guidelines, but were also unjustified by any clinical data other than the MD’s opinion, and were clearly outside any boundaries of good or appropriate care.”
In the end it all comes down to money versus the scientific evidence with patients caught in the middle of the ongoing tug-of-war. If ever there were a story that needs more attention from the news media, this is it. If patients can’t trust their doctors or their hospitals to follow evidence-based guidelines and give them the best care that science and the evidence suggest, who can they rely on?