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Wednesday, April 09, 2014
By James R. Roberts, MD
 
The overuse and overprescribing of opioid analgesics is a continuing issue in medicine. Addiction to and morbidity from prescription opioids have skyrocketed, as have deaths and ED visits. Numerous government agencies have attempted to limit prescribing and to close pain centers dedicated only to providing opioids to anyone who walks in the door. These actions have been helpful, but none has solved the burgeoning problem.
 
The FDA recently approved an extended-release hydrocodone called Zohydro ER (Zogenix, Inc.). This is a high-potency analgesic containing only hydrocodone with no acetaminophen. The FDA has also proposed changing the DEA scheduling of regular hydrocodone with acetaminophen from a Schedule III drug to a Schedule II drug. Hydrocodone mixtures used to be Schedule III, meaning they could be obtained with a phone call while a Schedule II drug required a formal prescription. This article provides an overview of this new drug, specifically its advantages and disadvantages, the potential for overdose, and how to treat those who have overdosed in the ED.
 
Extended-Release Hydrocodone: Gift or Curse?
Krashin D, Murinova N, Trescot AM
J Pain Res
2013;6:53
 
This article reviews the current role of hydrocodone and puts the potential advantages and disadvantages of the recently approved long-acting hydrocodone preparation into perspective. The authors note that hydrocodone, a semi-synthetic opioid, has been used for decades as a short-acting analgesic, and it’s combined with acetaminophen or ibuprofen. The advantages of any hydrocodone product is that it is familiar to many physicians, but adding acetaminophen and ibuprofen limits the safe use of high doses of currently available formulations. The obvious potential problem with high-dose hydrocodone is its potential to cause addiction and overdose.
 
Hydrocodone-acetaminophen is currently the most commonly prescribed opioid in the United States, marketed under a variety of names such as Vicodin and Lortab. The short-acting hydrocodone was previously mixed with 325 to 750 mg acetaminophen per tablet. Current products have a dosing schedule of every four to six hours, with the number of tablets per day limited primarily by the acetaminophen dose. The new maximum recommended dose for chronic acetaminophen use is only 3000 mg a day, which corresponds to about four to nine tablets per day of the mixed hydrocodone-acetaminophen products. High-dose acetaminophen can cause liver failure, of course, and the FDA mandated in 2011 that combination products contain no more than 325 mg of acetaminophen per tablet.
 
The DEA had previously classified hydrocodone combined with acetaminophen or ibuprofen as a Schedule III drug, meaning it can be phoned into a pharmacy with up to six refills. Schedule II oxycodone preparations cannot be phoned in and cannot be written for more than a one-month supply, and an appropriate prescription must be presented at the pharmacy to obtain the medication. Rescheduling the current hydrocodone products is currently in the works.
 
The use of opioids by even middle school or high school students has risen in the United States, but hydrocodone has one of the lowest rates of abuse given its volume of prescribing. It is also available in cough medicine, and changing it to a schedule II drug has been opposed by some medical personnel and pharmacies.
 
The most commonly used high-dose, extended-release opioids are morphine (MS-Contin, Purdue Pharma) and oxycodone (Oxycontin-Purdue Pharma). These medications are available in a variety of dosage forms without any acetaminophen, and these analgesics are a godsend to those in chronic pain. Both are frequently diverted, stolen, and highly abused. Long-acting transdermal fentanyl is another example of a sustained-release opioid that must be used by only the most sagacious clinician. (Read Dr. Roberts’ column about fentanyl abuse at http://bit.ly/18XH1bv.)
 
It is common practice among pain specialists to advance patients with chronic pain to daily long-acting opioids supplemented by short-acting opioids for breakthrough pain. Current information is insufficient to draw any firm conclusions about the relative role of long-acting versus short-acting opioid analgesics. It is generally thought that long-acting opioids have a higher incidence of abuse, and they certainly can cause addiction. Many chronic pain patients become addicted through genuine and honest attempts to treat them adequately.
 
The positive side of a long-acting hydrocodone is obvious. This drug has been used for acute and chronic pain for decades. The availability of the long-acting higher dose formulation might provide additional options for patients who cannot tolerate morphine or oxycodone, but that’s an unusual scenario. The lack of acetaminophen in higher dose hydrocodone decreases the risk for liver damage in those who require long-term maintenance.
 
The potential for abuse among morphine, oxycodone, and hydrocodone is similar. The longer acting drugs, such as MS-Contin and Oxycontin, had solid abuse monikers when the abuser crushed and dissolved the tablets to release all the opioid at once, and then they snort or inject the easily made liquid. Long-acting opioids were chemically reformulated in 2010 to resist this type of tampering. One side effect of hydrocodone is a sensorineural hearing loss that has been reported in patients taking high doses of the drug. Hearing loss did not respond well to discontinuing the drug or to corticosteroid therapy, and higher doses of hydrocodone could pose a more significant risk of hearing loss.
 
These authors call for prudence and adherence to best practices in opioid prescribing designed to reap the benefits of these medications without producing harm. Conscientious prescribing likely helps to reduce diversion and misuse. It’s best to prescribe any long-acting opioid only for suitable patients. Emergency physicians should be rarely prescribing them. Appropriate indications and patient instructions will certainly be necessary. The authors suggest a number of parameters that would negate giving long-acting hydrocodone to patients, including an unstable or abusive living situation, inadequate social support, patients with poorly defined pain complaints, and those with limited response to moderate opioid dosages.
 
Comment: Zohydro ER has not met with great enthusiasm by all. In fact, a recent letter submitted to the Department of Health and Human Services seeks to overturn its FDA approval. That approval was granted last October despite an 11-2 vote against it in committee, an unusual outcome. The concern was that introducing long-acting hydrocodone essentially rolls out the welcome mat to a new, more powerful, and more easily abused super drug while policymakers and law enforcement officials are waging war on the growing prescription drug crisis. The abuse-deterrent mechanism that prevents users from crushing, chewing, injecting, or snorting other long-acting opioids is not present in this hydrocodone preparation, and may not be seen for years.
 
The abuse of prescription opioids is not a minor issue. It was reported in 2010 that seven million individuals 12 and older had abused prescription pain medication in the previous month. About eight percent of 12th graders reported in 2011 that they had abused Vicodin the previous year.
 
This new pure hydrocodone medication is classified as schedule II. Zogenix, the company making Zohydro ER, has made the drug available in 10, 15, 20, 30, 40, and 50 mg tablets, which they said are not for PRN use. The cost of 100 of the 10 mg tablets is about $700. The starting dose of hydrocodone ER is 10 mg. That’s equivalent to 10 mg of oxycodone, 10 mg of methadone, 15 mg of morphine, or 100 mg of codeine. The manufacturer provided a full black box warning about addiction and abuse in the safety information, and it also highlights misuse, respiratory depression, accidental exposure, and adverse interaction with alcohol.
 
The approval of Zohydro ER was a surprise to many lawmakers. An FDA advisory panel overwhelmingly voted against the recommendation for approval in December 2012. The FDA is not required to follow the panel’s recommendation, but it usually does. Given the well-known problems with opioid prescriptions, it was thought that the FDA would probably go along with the panel’s decision. Zohydro ER will be available sometime later in 2014.
EPs will likely see overdoses of this new opiate. It should respond to naloxone, but larger doses and repeated reversals will likely be required. Anyone presenting with an overdose of this product will have to be carefully observed for 18-24 hours, and one cannot release a patient who does not have immediate symptoms or seems totally reversed with 1 dose of naloxone.
 
Purdue Pharma, which makes tamper-proof extended-release oxycodone (Oxycontin), has stated that it plans to apply for regulatory approval for a tamper-resistant form of high-dose hydrocodone, a safety feature not found in Zohydro ER. Some U.S. senators have also lobbied the FDA requesting that Zohydro be removed from the market because the medication is not tamper-proof and can have substantial abuse potential when crushed, snorted, or injected.
 
Read this article in its entirety in the May issue of EMN.

Friday, March 28, 2014
By Christine Butts, MD, & Richard Cruz, MD
 
Last month’s column introduced using ultrasound to differentiate rapidly between the causes of acute or severe dyspnea by using the RADiUS protocol. (Ultrasound Clinics 2011:6[2];261.) The algorithmic concept is similar to the RUSH exam in undifferentiated hypotensive patients or the FAST exam in trauma patients. The RADiUS algorithm utilizes a focused cardiac exam and assessments of IVC, pleura, and lung parenchyma to identify and rule out serious causes of undifferentiated dyspnea.
 
This month we delve into the first part of the RADiUS exam — a focused cardiac exam to identify pericardial effusion, impaired left ventricular function, and evidence of pulmonary embolism. All of these conditions represent life-threatening causes of acute dyspnea that can be rapidly diagnosed with bedside ultrasound.
 
A bedside cardiac scan typically includes the parasternal long and short, apical, and subxiphoid views. Variations in patient anatomy, habitus, and clinical condition may keep you from getting certain views (e.g., patient may not tolerate lying flat). Thankfully, pathology can be evaluated in any of the views. (See sidebar below for detailed descriptions of each view.)
 
Pericardial effusion can be visualized in any of the four traditional cardiac views. It typically appears as an anechoic (black) area separating the myocardium from the bright stripe of pericardium. (Image 1.) Identifying the presence of an effusion can be helpful to identify the cause of a patient’s dyspnea, and identifying signs of tamponade can be life-saving. Classically, the right atrium is seen to collapse during systole and the right ventricle during diastole in tamponade. (Video 1). Identifying these findings may be difficult, especially in a tachycardic patient, and a diagnosis of tamponade should be strongly considered in patients with an effusion who are either in distress or hypotensive.
 
Image 1. Parasternal long axis view demonstrating pericardial effusion (arrows).
 
Evaluating the contractility of the left ventricle may seem intimidating, but can be quickly evaluated and can be helpful in evaluating the dyspneic patient. Again, any of the four classic views can be used, although the parasternal long and short axis views are often the easiest. Quantifying the contractility of the left ventricle (LV) can be done a number of ways, but a quick visual assessment is usually sufficient. Does the LV have good squeeze (the walls are far apart then nearly touch over a cardiac cycle), poor squeeze (the walls barely move), or something in between? (Videos 2 and video 3.)
 
A hemodynamically significant PE can cause acute dilation of the right ventricle (RV), normally about a third the size of the left ventricle. This appears on ultrasound as an RV size approaching or even exceeding the LV size, and is best seen on the apical or subxiphoid views. (Image 2.) Other signs of acute PE are septal bowing as the RV pushes the septum towards the LV. (Video 4.)
 
Image 2. Subxiphoid image demonstrating enlargement of the right ventricle (RV). Typically, the RV is less than half the size of the left ventricle (LV). However, in this image, the RV appears to be larger than the LV.
 
We will break down each of the components of RADiUS over the next few months, and examine how to perform and interpret each section of the protocol. Next month: IVC.

Understanding the US Views
of the Focused Cardiac Exam
A bedside cardiac scan typically includes the parasternal long and short, apical, and subxiphoid views. Variations in patient anatomy, habitus, and clinical condition may keep you from getting certain views (e.g., patient may not tolerate lying flat). Thankfully, pathology can be evaluated in any of the views.
 
The subxiphoid view is familiar to most emergency physicians because it is a component of the FAST exam. Place the patient as supine as possible, pushing down just inferior to the xiphoid process. With the indicator pointing toward the right shoulder, point the probe cephalad. (Image A). All four chambers are visible in this view, making it an excellent view to evaluate the acutely dyspneic patient. (Image B.)
 
Image A. Positioning of the transducer for obtaining subxiphoid views.
 
Image B. Subxihoid image with ventricles labeled.
 
Parasternal long axis views can be obtained in the left fourth or fifth intercostal space with the indicator pointing to the patient’s right shoulder. (Image C.) The parasternal long view offers an excellent view of the left ventricle and pericardium. (Image D.) It is often easiest to obtain the parasternal short axis view (Image E) by first finding a good parasternal long view, and then rotating the probe 90 degrees so that the indicator points toward the left shoulder.
 

Image C. Positioning of the transducer for obtaining parasternal views.

 
Image D. Parasternal long axis image with chambers labeled.
 
Image E. Parasternal short axis image with chambers labeled.
 
The apical view can be the most challenging to obtain, but it offers an excellent evaluation of all four chambers. (Image F.) It is typically found at approximately the fifth intercostal space near the mid-clavicular line. The indicator should be pointing toward the patient’s left side or left axilla. You can maximize your chances of obtaining a good image by adapting to each patient. Hearts come in multiple positions and sizes, and the approach often has to be tailored to each patient.
 
Image F. Apical image with chambers labeled.
 
Utilizing several techniques — starting at the fifth intercostal space at approximately the midclavicular line, starting at the PMI, or placing the patient in a left lateral decubitus — can maximize your success. — Christine Butts, MD, & Richard Cruz, MD

Friday, March 28, 2014

By Nii-Daako Darko, DO, MBA

Trauma care, with its estimated costs as high as $163 billion, represents close to 10 percent of U.S. health care expenditures. Studies have proven the worth of trauma centers by showing improved survival among seriously injured patients compared with care at non-trauma hospitals. Numerous studies have shown, however, that the overall cost of providing care to seriously injured patients is higher at major trauma centers than non-trauma hospitals.

Unfortunately, there is a paucity of data on the cost-effectiveness of trauma centers for less seriously injured patients. A recent study compared the costs of providing care at major trauma centers with non-trauma hospitals for patients without serious injuries. (Health Aff 2013;32[9]:1591.) Considering the cost per patient from EMS transport all the way to hospital discharge, the concept of overtriage — transporting patients without serious injuries to major trauma centers — took center stage. Of note, the majority of injured patients are not seriously injured.

The authors hoped to highlight the importance of eliminating overtriage and its associated potential cost savings by comparing all the costs of trauma care: EMS transport, emergency department evaluation, and hospital admission. The patient population included adults and children seen by 94 different EMS agencies who were transported to 122 hospitals in eight major cities in the western United States. More than 300,000 patients were included in the sample from January 2006 to December 2008; hospital care costs were more than $1 billion.

The average cost of care was $5,590 higher in major trauma centers when compared with non-trauma hospitals. The study found that 34.3 percent of patients were overtriaged. These patients were all identified as low risk by EMS algorithms, however, EMS still transported these patients to major trauma centers because of patient choice or hospital proximity. Redirecting overtriaged patients to non-trauma hospitals could bear cost savings as high as 40.6 percent. Stricter adherence by EMS personnel to field guidelines has large cost implications.

Trauma care is the second leading cause of health care costs in the United States. Regionalized trauma centers reduce mortality for seriously injured patients and ultimately reduce preventable deaths. But trauma care mandates a comprehensive evaluation of patients that often includes multiple specialists and expensive services. Society must accurately define which patients best benefit from these scarce resources in this age of cost containment and with such a large disparity in costs per patient at trauma centers and non-trauma centers.

Triage decisions by EMS personnel have large cost implications, and substantial savings can be attained by reducing overtriage. But the dilemma for emergency systems is twofold: What criteria should be used to determine “serious injury?” Are current EMS protocols robust enough to reduce both over- and undertriage?

The limitations of non-trauma hospitals play a factor in EMS decision-making, and the Affordable Care Act provides important funding for states to revamp their trauma systems and trauma centers to compensate for losses from uninsured patients. (http://bit.ly/ACAtrauma.) The ACA also provides for pilot programs to find innovative ways to further regionalize emergency care.

Dr. Darko trained in trauma/critical care at the University of Miami’s Ryder Trauma Center, and currently practices in Pennsylvania. He is a frequent contributor to the website Policy Prescriptions, where this article first appeared.
Policy Prescriptions, which advocates for evidence-based health policy, was created by Cedric Dark, MD, MPH, the site’s executive editor. Visit
www.policyrx.org, and follow them on Twitter @PolicyRx and on Facebook at http://bit.ly/PolicyPrescriptions.


Tuesday, February 18, 2014
By Ruth SoRelle, MPH
 
After years of investigation, the U.S. Department of Justice has intervened in eight false claims lawsuits in six states against Health Management Associates, Inc., signing on to allegations of payments to doctors and clinics in exchange for patient referrals and to claims that the Naples, FL, for-profit chain pressured emergency physicians and hospital administrators to admit patients to meet corporate benchmarks, regardless of medical necessity. (Read the DOJ announcement at http://1.usa.gov/1foNoIo.)
 
HMA’s activities have already generated considerable interest, including a segment on the CBS news program 60 Minutes that aired in December 2012. (Watch that report at http://cbsn.ws/1foNAHE.) The push to increase admissions to the hospital from the emergency department is described in several of the suits, including one filed jointly by Jacqueline Meyer, a former regional client administrator for EmCare, the firm that provided emergency physician services to many HMA hospitals, and Michael Cowling, a former HMA division vice president and CEO of Lake Norman Regional Medical Center in Mooresville, NC.
 
The qui tam, or whistleblower, suits were just recently unsealed, providing details of alleged wrongdoing for the first time. Many of the suits allege an illegal kickback scheme for referrals to HMA hospitals, but the Meyer-Cowling filing, among others, describes HMA practices in emergency departments, including a mandate that its hospitals increase admission rates by:
  • Setting benchmarks for hospital admissions from the emergency department: 50 percent for patients 65 and older and anywhere from 16 percent to 20 percent for the overall population.
  • Directing hospital administrators to monitor ED admission rates through daily, weekly, and monthly reports generated using a customized software program called Pro-MED. The plaintiffs said each emergency physician was tracked for the number and percentage of total patients admitted as well as the percentage of patients 65 and older admitted. Some hospitals also tracked physicians on a daily color-coded report card with green signifying that a physician had met the benchmark, yellow that he had almost met it, and red that he had missed the benchmark, according to the suit.
  • Using Pro-MED to flag each time an ED patient met criteria for admission, measures that were programmed right into the software. “Nevertheless, HMA used the criteria in conjunction with its customized Pro-MED software to coerce physicians to admit patients, regardless of the physician’s clinical judgment about the patient’s needs,” the Meyer-Cowling suit states. Physicians could manually override such actions, but according to the suit, physicians who had override rates of 35 percent or more received “failing grades.”
  • Holding daily “flash meetings” with emergency physicians “to interrogate them about so-called ‘missed’ admissions.” According to the suit, “During flash meetings, which were commonly referred to by the ER medical personnel as ‘daily inquisitions,’ hospital CEOs and their staff often overtly threatened the ER doctors and medical directors with termination if the physicians did not increase the number of patients they admitted.”
  • Distributing monthly Forced Rank Reports to hospital CEOs and administrator staff, emergency department directors, and EmCare management in which all HMA hospital EDs were ranked according to inpatient admission rates.
  • Directing hospital CEOs and emergency department medical directors not to place patients in observation status “even when medically warranted, but instead were to be admitted as inpatients so that HMA could recover larger fees for their care,” the suit alleges.
  • Implementing a Pro-MED software program “that identified a series of diagnostic tests to be immediately performed, according to what the triage nurse had specified as the patient’s chief complaint, before the patient had been seen by a doctor.” The Meyer-Cowling suit says HMA also required emergency physicians to order “85% of the tests specified in the protocol, despite the fact that in many instances the tests were medically unnecessary.”
  • Setting benchmarks for calling patients’ primary care physicians “85% of the time for patients 65 and over” and 35 percent of the time for younger patients “not to obtain a better understanding of patients’ medical needs but, rather, to ‘sell admissions’ to primary care physicians.” HMA anticipated that these physicians would defer to the emergency physician’s recommendation about hospitalization, the suit says.
  • Paying bonuses at some hospitals to emergency physicians and medical directors for meeting the benchmarks for ordering tests, calling primary care physicians, and keeping admission overrides low.
The suit also charges that “EmCare actively assisted HMA in unlawfully pressuring and inducing ER medical directors and physicians to sacrifice their medical judgment and recommend the hospitalization of ER patients and the ordering of diagnostic tests, irrespective of the medical needs of the patients.”
 
Ms. Meyer and Mr. Cowley claim they were fired — she from EmCare and he from HMA — because they did not go along with the push to increase admissions from emergency departments. The Justice Department is still deciding whether it will join the suit Ms. Meyer filed against EmCare.
 
The Meyer-Cowling suit also named Gary Newsome, CEO of HMA, as a driver of the plan to inflate patient admissions, and the Justice Department joined that action as well. Mr. Newsome headed HMA from 2008 until mid-2013 when he retired to head a Mormon mission in Montevideo, Uruguay, the suit says.
 
The suit lists several hospitals at which those admission activities took place. One is Carlisle Regional Medical Center, a 165-bed hospital in Carlisle, PA, that HMA had owned since 2001. Carlisle offers routine specialty care, but it is not a trauma center, and had no interventional cardiac catheterization services at the time the suit was filed in July 2011.
 
Ms. Meyer was assigned to oversee EmCare’s contract at Carlisle in 2009. Soon after, she attended a hospital meeting that included EmCare managers and the Carlisle ED medical director, assistant medical director, and emergency physicians. According to the suit, Frank Biondolillo, DO, the executive vice president of EmCare’s southeast region, told attendees, “‘If you want to be successful at an HMA hospital, you are going to have to admit more patients.’”
 
The suit continues, “Dr. [Cliff] Cloonan [assistant medical director of the ED] angrily responded that Dr. Biondolillo was not going to make him break that law and that Cloonan was going to do what was right for the patient.” After the meeting, the suit notes, EmCare managers told Carlisle CEO John Kristel what had transpired. “In response, Kristel told the EmCare group to fire Dr. Cloonan because he ‘was not on board,’” the suit states. Ms. Meyer, however, advised against that, suggesting that HMA and EmCare consult their legal departments.
 
“It was an insidious situation,” said Dr. Cloonan, who is not part of any of the lawsuits. “It was not really suddenly awful. Had it been, a lot more people would have [jumped] ship.”
 
Dr. Cloonan said he was an employee of the hospital when he first came to Carlisle, and he and his fellow emergency physicians continued that way for a couple of years after HMA took over and built a new emergency department. But about the same time that the hospital introduced Pro-MED, an HMA manager said they no longer wanted to employ the physicians, suggesting that the doctors consider a provider of emergency services like EmCare or form their own group. They ended up going with EmCare.
 
Dr. Cloonan said it seemed the best choice at the time. Besides, he and his colleagues were dealing with other issues. “I wasn’t pleased with Pro-MED Blue,” he said. “It was clearly constructed not to adequately document what physicians did and facilitate their work but as an accounting tool to capture revenue. It also, in my view, facilitated fraud in the sense that there was a lot of automated test ordering. It took extra steps to undo what the computer was automatically doing.”
 
Scott Rankin, MD, who worked part-time at Carlisle during this period, told EMN that Pro-MED “generated a nice bill, but it also pushed us to order studies that maybe we would not have ordered. If a patient showed up with chest pain, nurses were mandated to hit the chest pain box, and these studies were ordered before we saw the patients. Nurses told us, ‘We have to do this.’”
 
Dr. Rankin said the EPs were increasingly being pressured to admit toward the end. They came out with specific numbers — 50 percent for all patients over 65 and an overall 20 percent admission rate, he said, but such numbers were not realistic for Carlisle. “I realized I was being encouraged to commit most of the fraud being described in the government-mandated program [that physicians are required to take]. I printed out a screenshot, and went out and posted it around the computers in the emergency department.”
 
Dr. Cloonan said he remembers the meeting with Dr. Biondolillo well. He said he pushed back at that meeting, saying, “What I just heard is that if we don’t commit fraud, we are going to get fired.”
 
Before a monthly meeting of the ED staff, the medical director of the emergency department told Dr. Cloonan that he had been at a meeting at HMA headquarters and was told physicians would be fired — starting with him and Dr. Cloonan — if they did not go along with the program, Dr. Cloonan told EMN. He said he told the ED medical director that he would say nothing at the monthly physician meeting, but he would resign as assistant ED director immediately. He found a job in a nearby town.
 
One by one, meanwhile, other long-time emergency physicians at Carlisle began to resign. Dr. Rankin said the physicians who had worked there left voluntarily. “To have to leave their community hospital was a painful decision. However, we had that option to leave. There were other places we could work,” he said. Physicians in other communities were not as lucky, he said.
 
Dr. Cloonan said he was angry about what he saw happening. “There’s a huge amount of ongoing fraud, waste, and abuse that is taking place within specifically government contractual elements of health care,” he said. “When HMA was talking about admitting 50 percent of patients over 65, that’s Medicare. And it’s not confined to HMA. We have created a system that is ripe for abuse. That’s part of the problem.”
 
Dr. Rankin said the physicians’ concern was for their patients. “We put the patient ahead of profit,” he said. “For-profit medicine does not have that sum equation.”
 
Robert McNamara, MD, a former president of the American Academy of Emergency Medicine, said one thing that gets lost in the narrative is the risk to patients admitted to the hospital unnecessarily. “I’m not surprised at any of it. The suits lay it out,” he said.
 
Craig Brummer, MD, a former medical director at Barrow Regional Medical Center and then Walton Regional Medical Center in Georgia, described in his suit against HMA the same pressures described by Ms. Meyer, Mr. Cowling, and Dr. Cloonan. He described several patients who he said were admitted to HMA hospitals without an appropriate medical reason, including:
  • An elderly Medicare patient who underwent “a chest x-ray (that showed no issues), an EKG, and lab work. [The patient] was improperly admitted with a clinical impression of ‘neck pain.’ This 71-year-old patient should not have been admitted for ‘a chest pain rule out’ assessment,” the suit says.
  • An 11-month-old Medicaid patient who presented to the ED with a chief complaint of fever but who was admitted even after his fever dropped to normal. “He had a temperature of 104 degrees upon presentation and looked well,” the suit notes. “The infant was given a full workup of chest x-rays and labs and all were normal, but he was given intramuscular antibiotics and admitted to the hospital. [The patient] was admitted with a temperature of 98.7 with a clinical impression of fever.”
  • An 18-year-old Medicaid patient who sustained a right knee laceration. “X-rays were negative, but he was admitted for repair of the knee laceration. This patient was admitted to the hospital for repair even though his injuries did not involve an open fracture and should have been treated on an outpatient basis.”
The Justice Department’s inquiry was described in many quarters as painstaking. Stuart F. Delery, the Assistant Attorney General for the Justice Department’s Civil Division, said in a statement that “schemes such as this one can contribute significantly to the rising cost of delivering health care and create needless patient risk.”
 
The U.S. Attorney for the Middle District of Georgia Michael J. Moore agreed, noting in another statement that “HMA’s submission of claims to Medicare, Medicaid and TRICARE for unnecessary inpatient stays is a serious matter that threatens the integrity of our entire health care system, and the end result is that those who need health care cannot afford it.”
 
HMA shareholders approved a $7.6 billion sale of the company to Community Health System (CHS) in January, merging the two systems to create the for-profit hospital operator in the United States with the largest number of facilities. Hospital Corporation of America remains largest in annual revenue. (Naples News; http://bit.ly/1ifr06p.)
 
CHS announced preliminary financial and operating results for 2013 on Jan. 6, noting that it was reserving $101.5 million to settle claims arising from the government’s investigation into the company’s short-stay hospital admissions and investigation at the CHS hospital in Laredo, TX. Or as the New York Times reported, “Investors seem to think that DOJ investigations, qui tam suits, and allegations of serious Medicare fraud are simply a cost of doing business,” said Sheryl Skolnick, PhD, the managing director and a head of research for CRT Capital. (http://nyti.ms/1euQmx3.) CHS is also negotiating a corporate integrity agreement with the Office of the Inspector General of the U.S. Department of Health and Human Services. (Read CHS’s 2013 operating report at http://bit.ly/1eNAD8V.)
 
HMA refused to comment specifically on the allegations in the suits or the Justice Department’s joining in the whistleblower lawsuits. “As a matter of policy, we do not comment on pending litigation. The existence of the government’s investigation into the issues raised in the unsealed qui tam cases has been disclosed for some time in HMAs’ public SEC filings. While our legal team addresses these matters and continues to cooperate with the Department of Justice’s ongoing investigation, HMA associates and physicians who practice at our facilities are focused on providing the highest quality patient care in all of our hospitals,” MaryAnn M. Hodge, the vice president of marketing and communications for Health Management Associates, wrote in an email to EMN.
 
Jennifer Whitus, the marketing communications manager for EmCare, said in an email that the company cannot comment on pending litigation.
 
 
Read the Suits for Yourself
These first four lawsuits focus on the emergency department’s role in inpatient admissions.
 
Jacqueline Meyer, a former EmCare regional client administrator, and Michael Cowling, a former HMA vice president and CEO of Lake Norman Regional Medical Center in Mooresville, NC, allege that HMA instituted certain practices that sought higher admission rates from the emergency department and that resulted in patients being admitted to the hospital who should not have been and in false claims being submitted to federal health programs (Medicare, Medicaid, etc.).
 
Craig Brummer, MD, the medical director of the emergency departments of Barrow Regional Medical Center and Walton Regional Medical Center, both in Georgia, alleges that HMA and the hospitals where he worked instituted policies (including forced ranking reports to spotlight percentages of patients admitted and flash meetings about whether ED patients were or should have been admitted) that resulted in patients being admitted from the emergency department unnecessarily. He alleges that false claims were submitted to federal health programs (Medicare, Medicaid, etc.). The Department of Justice agreed and signed on to the suit.
 
Drs. Folstad and Mason were emergency physicians with Mid-Atlantic Emergency Medical Associates, and served as the medical directors of emergency departments at two HMA hospitals. They allege that their medical group lost its contracts to provide emergency physicians to the hospitals because they objected to HMA’s use of the Pro-MED software and other practices designed to increase patient admissions and tests they said were unnecessary.
 
Dr. Plantz, a longtime emergency physician whose expertise is frequently sought about quality care in the nation’s emergency departments, alleges that HMA used Pro-MED software to order tests and procedures automatically and required physicians to order unnecessary tests and to admit patients at rates that met administration-set benchmarks. He also alleges that physicians who do not adhere to HMA’s criteria are subject to firing and that HMA mandates that emergency physicians admit patients to the hospital rather than use 23-hour observation.

These four lawsuits allege improper financial relationships that resulted in improper patient referrals.
 
Mr. Meyer, a former agent of the Federal Bureau of Investigation who worked for HMA in its corporate compliance department in Naples, FL, alleges that “the HMA hospitals have established prohibited, non-exempt financial relationships with physicians that refer Medicare patients to their respective hospitals and such physicians referred Medicare patients to such hospitals” and that the hospitals sought and received pay for that care. He also alleges that the defendants provided kickbacks and illegal remuneration or entered into “prohibited financial relationships in violation of the anti-kickback statute and the Stark Law, which prohibits physician self-referral, for patient referrals to HMA facilities that resulted in “claims for reimbursement for services rendered to patients.” He also said they unlawfully classified some patients as inpatients when they did not meet criteria.
 
Mr. Williams, an accountant with 30 years of experience, was employed by HMA as its chief financial officer between April and October 2009. He alleges that the HMA and Tenet hospitals paid financial inducements to Clinica de la Mama to refer pregnant women about to deliver their babies to their facilities. Undocumented women are not eligible for regular Medicaid coverage, but the federal-state program provides emergency medical assistance that pays health care providers for emergency services to undocumented aliens, including childbirth. He alleges that the payments violated the anti-kickback statute and that the “written contract provides for payments to Clinica for ‘interpreter services.’” He said in the suit that this was “a sham agreement that was designed to conceal the underlying financial motive, which was the purchasing of Clinica referrals.”
 
Mr. Nurkin, the former chief executive officer of Charlotte Regional Medical Center in Punta Gorda, FL, alleges that HMA and its hospitals “knowingly induced doctors to make patient referrals and hospital admissions by intentionally and knowingly providing the doctors with improper remuneration in violation of the federal anti-kickback statute and the Stark Law. He alleges in the suit that the hospital “paid unlawful remuneration amounting to hundreds of thousands of dollars to a physician practice group in North Port, Florida” that were subsidiaries of HMA. He said the improper remuneration consisted of “free office space, staff, equipment, and direct expense payments of up to approximately $20,000 to $40,000 per month from at least 2004 through mid 2007.”
 
Mr. Miller was the chief executive officer at Heart of Lancaster from June 2, 2008 to May 6, 2009 and the CEO of Lancaster Regional from June 2, 2008 until January 2009 when he was also CEO of 13 physician clinics related to the hospital. Mr. Metts was the system chief financial officer and compliance officer for Lancaster Regional, Heart of Lancaster, and 13 related clinics from June 2008 until December 2008 and also the chief financial officer and compliance officer at Lancaster Regional from December 2008 until September 2009. All those facilities are in Pennsylvania.
 
The suit alleges that HMA “uses whole-hospital joint venture schemes to induce local physicians to refer patients to HMA facilities in violation of the anti-kickback statute.” In their suit, they also allege that the “defendants submitted or caused the submission of false claims to federal and state health programs as a result of illegal kickbacks that … [HMA] … offered and paid, and kickbacks to physicians at HMA facilities.”

* “Ex rel” is an abbreviation for the Latin phrase ex relatione, meaning “out of the narration." It is most commonly used when the government brings a cause of action at the request of a private party, but the government typically brings an ex rel action only if it shares the interest advanced by that private party.

Wednesday, December 11, 2013
By Michelle Johnston, MBBS
 
Heart attacks are caused by a sudden blockage of a blood vessel supplying oxygen to heart muscle, and it is nearly always caused by a new blood clot that forms on a hardened and diseased blood vessel.
 
It took trials and studies on 60,000 heart attack patients to work out that clot-busters prevent deaths in heart attacks, but they only worked on one type of heart attack (which is only about five percent of all heart attacks). We took the time to get it right, refining study after study, until we were sure that introducing a potentially dangerous drug had benefits that outweighed the harm.
 
Every type of clot-buster that was studied worked, and the earlier it was given, the better. Interestingly, the one that caused the most brain bleeding was tPA.
 
Studies have been done on clot-busters in stroke. Strokes are also caused by a blockage to a blood vessel in the brain, but there are important differences between strokes and heart attacks:

 The cause of the blockage is never worked out about 30 percent of the time.
 Two very different types of blood clots cause strokes: new blood clots (like in heart attacks) and old blood clots called embolic clots (e.g., an old blood clot that has formed in the heart and travelled to the brain where it blocked a blood vessel).
 This difference between new and old blood clots is very important because clot-busters do not work on old blood clots.
 How many strokes are caused by new blood clots? No one knows for sure because we can’t work out what kind of clots (or other causes) are causing the stroke. The best guess is that it is a little less than half.
 
“It is important to note that the efficacy of thrombolytic drugs depends on the age of the clot. Older clots have more fibrin cross-linking and are more compacted; therefore, older clots are more difficult to dissolve. For treating acute myocardial infarction, the thrombolytic drugs should ideally be given within the first 2 hours. Beyond that time, the efficacy diminishes and higher doses are generally required to achieve desired lysis.” (Cardiovascular Pharmacology Concepts; http://bit.ly/1a5xt1D.)
 
Twelve important studies have been done: 10 were negative (they showed that clot-busting did not work in stroke), and four of these had to be stopped early because of harm (they were killing people). They have only studied this in about a sixth of the number of stroke patients compared with the heart attack studies. This is a completely different situation from the heart attack studies, where it worked in every study and with every clot-busting drug they tried.

The two positive stroke studies (i.e., they suggest a statistical benefit) have been widely criticized in the medical literature because of their scientific flaws. One of these looked at giving tPA within three hours of the stroke. Interestingly, this study proved that there was no benefit in the first 24 hours, which again is different from the heart attack studies. The other study looked at giving tPA from 3 to 4.5 hours after the stroke.
 
This second study also contains some major errors. The biggest flaw was an imbalance in baseline stroke severity. The placebo group (those who didn’t get tPA) were sicker, with more severe stroke; the tPA group was not as sick and had much more mild strokes. Everyone understands that people with milder strokes do better than those with more severe stroke. Obviously, the study favored tPA because the tPA group had milder strokes, which will do better anyway.
 
This study was re-analyzed later. If tPA really worked to improve the outcomes in sudden stroke, then there should be a much larger improvement in outcome compared with the placebo group. But there was no difference.
 
The studies show that tPA causes brain bleeding in about six percent of patients. Brain bleeding is the other type of stroke. It is strange that some people would advocate a treatment for stroke that can cause a (worse) stroke. Brain bleeding is very severe, and almost half the people die if this happens.
 
Why does brain bleeding happen with a clot-buster? Doctors think of clot-busters as being like Drano, the plumbing product used to unblock pipes. You have a damaged blood vessel inside a damaged part of the brain in strokes. It’s no surprise that putting “Drano” in there sometimes dissolves through the blood vessel and bleeds into the brain.
 
The largest study on clot-busting in stroke was published in 2012. This again was a negative study that showed tPA did not work, and it confirmed the increase in early deaths with tPA. Interestingly, the time to give the drug from the stroke studies is completely different from the heart attack studies.
 
After studying 60,000 heart attack patients, every study showed that the earlier the clot-buster was given, the better. The majority of the stroke studies do not show this effect. The reason for this is unclear, but may be because the patients who get to the hospital earlier are somehow different from the ones who arrive later.
 
One must always remember, however, that once the blood vessel is blocked, the brain cells will be dead in about three minutes. Giving a clot-buster later shouldn’t have any effect, and this may be what we’re seeing. It’s also worth remembering that heart muscle cells and brain cells are very different.
 
Researchers have used meta-analysis to “prove” that clot-busting works. The simple summary of the problem with this is summed up by the phrase: garbage in, garbage out. Badly done studies when put into a meta-analysis do not magically become good studies. There is at least one review of this that concludes “there is no consistent or proven benefit” to clot-busters in stroke. (The NNT; http://bit.ly/NNTthrombolytics.)
What is the problem here? Why is there controversy in the medical world? Shouldn’t it be black and white? Either tPA works, or it does not. Easy.
 
Sadly, it is not so easy. Statistical analysis of any medical treatment is rarely black and white. It is about the interpretation of the research. This is where the controversy has occurred here.
 
So why is tPA for stroke being pushed? Because we really want it to work.
 
Unfortunately, many of those pushing this treatment have conflicts of interest with the manufacturer of the drug. (BMJ 2013;346:f3830, http://bit.ly/17rQvju; BMJ 2013;347:f5535, http://bit.ly/1apXsjG.)
 
How do we resolve this problem? We think that patients and society in general expect that an offered medical treatment will have passed the test of science. The test of science requires elimination of bias, healthy scientific debate, and replication to see if a study that suggested a statistical benefit can produce that result again, which would make it more believable. Time and time again in medical research, we find that when larger more decisive studies are done, the initial exciting result becomes a disappointing one: it doesn’t work. This replication has not happened for stroke, but needs to if we want to maintain our trust in medicine.
 
Has anyone else raised concerns about this? Recently, the British Medical Journal published a debate and poll on this very subject. (BMJ 4 September 2013; http://bit.ly/172AnTK.) Other experts have also expressed similar concerns. These resources from SMARTEM.org offer further reading: “Delusions of Benefit in the International Stroke Trial” (http://bit.ly/1bEhUwt) and “The Guideline, The Science, and The Gap” (http://bit.ly/1aTVM4u).
 
Is there anything else that can be done if I have a stroke? We know that having your care in a stroke unit is much more powerful than any drug. And taking part in stroke research will help us answer these questions.
 
Dr. Johnston is a senior emergency physician at Royal Perth Hospital, an inner city trauma center in Perth, Western Australia, and runs the fellowship teaching program there. She writes for the blog Life in the Fast Lane (http://lifeinthefastlane.com/), where this article first appeared.