Editor's note: This article is the second installment in a two-part series by Emily Friedman on the topic of rogue practitioners. Her first installment appeared in H&HN Daily on Dec. 3, 2013.
The patient was a wealthy man who suffered from chronic insomnia. He compensated his personal physician lavishly for his services, which included providing extremely dangerous drugs such as propofol — a surgical anesthetic usually administered only in hospitals — and other addictive pharmaceuticals. The patient died of an overdose of those drugs in 2009.
The patient was Michael Jackson. The physician was Conrad Murray, who was convicted of involuntary manslaughter in 2011 and was sentenced to four years in prison, of which he served two. He is no longer allowed to practice in California but, theoretically, he could do so in other states. Indeed, in November 2013, he sued for the right to practice in Texas. However, he cannot obtain malpractice insurance, so the chances are that he will not be able to practice anywhere in the United States. But then, there's the rest of the world.
Murray was hardly unique. The only singular aspect of his "work" was that he confined his provision of potentially fatal drugs to only one patient. Most rogue prescribers spread the wealth far beyond that.
A Real Rogues' Gallery
Last year, Lenwood Wert, D.O., was indicted on more than 500 felony counts for selling oxycodone and other powerful prescription drugs out of his Pennsylvania house; he was grossing an estimated $8,000 to $12,000 a week. Anand Persaud, a Long Island, N.Y., internist, wrote more than $1 million in prescriptions for painkillers for 5,800 patients. He accepted only cash, and many of his patients later were reimbursed by Medicaid. New York Attorney General Eric Schneiderman observed, "He is a drug dealer in a white coat … . He was dishing it out like candy." Some patients reported that the good doctor was "too busy" to do examinations or ask many questions, and would write a prescription for anything for $300. Other patients doted on him; one said, "He goes over the edge to help people." Apparently so.
Between 2008 and 2013, New York City internist Robert Gibbs provided at least 700 prescriptions for oxycodone, amounting to 130,000 pills, to Ronald Vaughan, head of a narcotics ring. The total street value was $7 million.
John Dimowo, a California anesthesiologist and pain physician, was writing nearly 40 prescriptions for narcotics a day until he was arrested last year; at least five of his patients died of overdoses. Undercover agents posing as patients were able to get narcotics prescriptions from him without being examined.
Fifteen patients who received prescriptions from prolific San Diego prescriber Naga Thota, M.D., have died of overdoses; Orange County, Calif., physician Doanh Nguyen lost 14 patients the same way. These physicians — both of whom were still practicing when they were profiled by the Los Angeles Times in 2012 — refused to accept any blame for their patients' fate. If patients misuse the drugs he prescribes, said Nguyen, "I don't allow myself to feel responsible."
Why Do They Do It?
There are at least three reasons for the overprescribing of powerful prescription medications: lack of knowledge, money and personal addiction.
In terms of lack of knowledge that can lead to unintentional overprescribing, Sue Foster, a vice president and director of policy research and analysis with the Center for Alcohol and Substance Abuse at Columbia University, or CASAColumbia, in New York City, notes, "Physicians are not well-educated about addiction. Most physicians do not receive education or training in medical school or residency about addiction, and many are uncomfortable discussing addiction with their patients."
It should be added that there are few reliable, scientific ways of assessing the presence and level of pain; it is mostly self-reported by patients. Thus, patients seeking narcotics can con physicians, especially those who are not experienced in dealing with such situations or who don't have much time to question and examine patients rigorously.
Physicians who overprescribe or sell prescriptions for profit are a different story altogether. Foster says, "In terms of those who intentionally overprescribe, that is an enforcement problem. But one of the gaps is that there is no national program; there is no way to enforce across states, so a pill mill [a clinical "practice" that exists only to provide medications, usually narcotics, to paying customers, no questions asked] can be closed in Florida and then will surface in Georgia."
The Problem of the Impaired Physician
Physicians who are addicts themselves present a special problem. One of many examples is Trevor Lineberry of Decatur, Ga., an obstetrician-gynecologist who was arrested last year and admitted to being addicted to prescription drugs and forging other physicians' names on prescriptions that he used himself. An investigator who interviewed a physician with whom Lineberry worked reported that "he and other physicians have been concerned about Dr. Lineberry's actions and appearance, which would be consistent with substance abuse." But they took no action.
Molly Cooke, M.D., president of the American College of Physicians, which recently issued a call to action on physician overprescribing, says, "There is a rising prevalence of substance abuse in anesthesia residents, and included in these reports are some very disheartening data on relapse rates and subsequent deaths [of the residents]. Some physicians are identified and enter programs, and may or may not get themselves turned around, but many relapse and are ultimately found dead.
"We need to do much better. Some day we may come to drug testing for health care workers more broadly. Physicians will object like crazy, but it will be hard to base their objections on any rational grounds, given what we know about substance abuse among physicians. And if other employees are subject to testing, it's hard to argue that physicians are so special that they should not be subject to it, especially when the recidivism rate is so high."
The Scope of the Challenge
It has long been acknowledged that the United States is something of a pill-popping society. In 2011, according to a survey by the Kaiser Family Foundation, Americans younger than 18 obtained an average of 4.1 prescriptions from retail pharmacies; those ages 19 to 64 filled an average of 11.9; and those older than 65 filled an average of 28. In recent years, the airwaves and the Internet have been filled with advertisements for prescription drugs. In both medical school and continuing education, physicians are bombarded with messages — indirect or in-your-face — about pharmaceutical solutions to health problems. Before limitations on the practice were implemented, physicians could earn very good money serving as members of pharmaceutical manufacturers' speakers' bureaus, advocating prescription products in speech or print, or serving as "consultants" to the field.
It is not surprising that many Americans believe that no matter what is wrong, there's a pill for that.
There is no arguing that the development of effective pharmaceuticals has saved uncounted lives (just look at the impact of antibiotics, especially before we began overusing them) and improved the quality of even more lives. From infectious disease to organ transplants, medications literally make the difference between survival and death.
But prescription drugs are not always benign therapies. Even when used correctly, they can produce organ damage, nasty side effects and sometimes addiction (as can many over-the-counter drugs). The Centers for Disease Control and Prevention report that:
- In 2010, overdoses were the leading cause of injury death in the United States.
- Overdose death rates rose 102 percent between 1999 and 2010.
- Of the 38,329 overdose deaths in 2010, 60 percent involved pharmaceuticals.
- Of those deaths, approximately 75 percent were attributed to opioids and about 30 percent to benzodiazepines.
- One-third of all deaths from prescription painkillers are attributed to methadone, which originally was developed to help wean addicts off heroin.
- In 2011, misuse of drugs led to 2.5 million emergency department visits, of which 1.4 million were associated with pharmaceuticals.
Who is most likely to be a victim of overdose? The CDC says that men are almost twice as likely to die as women are. Native Americans have the highest death rates, followed by Caucasians and then African-Americans. By age, those most likely to die are 45 to 49; the least likely are children younger than 15.
Last year, the CDC reported that what it terms the "epidemic" of prescription painkiller overdoses had developed a new dimension: a frightening increase in the number of women involved. Between 1999 and 2010, the agency reported, almost 48,000 women died of prescription painkiller overdoses, and for every one of them, 30 women ended up in an ED for treatment of misuse of these drugs. Whereas prescription drug deaths among men rose 265 percent between 1999 and 2010, it rose 400 percent among women. This is one gender gap we should not want to see closed.
It should surprise no one, then, that the CDC listed prescription drug abuse and overdose as one of the five biggest health threats for 2014; it placed second after antibiotic-resistant infectious disease.
Many of the prescriptions that made these deaths possible were written honestly by physicians in an effort to relieve pain and suffering. But some patients intentionally work the system, through "doctor-shopping," such as radio personality Rush Limbaugh was accused of doing, faking pain symptoms or other approaches. Some patients seek the drugs to end their lives; the CDC estimates that 14 percent of overdose deaths are suicides.
And ill-informed or unscrupulous physicians are not the only source of oversupplies of prescription drugs. As more members of other health professions gain prescribing privileges, more potential rogues come onto the scene. In one case, a chiropractor hired an elderly retired physician to front for him by writing prescriptions after the chiropractor lost prescribing privileges. A Detroit podiatrist, Anmy Tran, was arrested in 2011 for writing inappropriate Part D prescriptions and encouraging patients to fill them in a pharmacy in her building, whose owner rewarded her with kickback payments. In 2008, CASAColumbia reported that despite a decline in the number of Internet websites peddling powerful drugs, 85 percent of the ones that were left did not require a prescription.
There is a double danger in obtaining drugs from the Internet: Not only is there no clinician input; one never knows what one is really getting. In that sense, the drug seeker is no safer than if he or she buys the product on the street.
There is also the lucrative practice of defrauding fellow physicians, government programs, pharmacies and other entities. Late last year, the public interest website Pro Publica ran a series on Medicare prescription drug fraud, including a story on a California psychiatrist, Ernest Bagner III, who was apparently a victim of medical identity theft. His Medicare prescribing pattern went from "a handful" in 2009, according to the story, to $3.8 million worth of psychotropics and non-narcotic medications; the total for 2010 was $2.6 million. He says he did not write those prescriptions, and has since gone into disability evaluation and prescribes nothing to anyone. The fraudsters, he says, "make more money off my name than I do."
"Almost Insurmountable Barriers"
Needless to say, physicians who overprescribe — intentionally or not — are in the minority. But as Lynn Webster, M.D., president of the American Academy of Pain Medicine, says, "I think we are doing a better job of identifying patients who need opioids and those who can benefit more from other therapies. We do need to do a better job of prescribing appropriately."
But when it comes to non-pharmaceutical therapies that might be more beneficial, Webster adds, "We face almost insurmountable obstacles. Much of the time, a physician only has a prescription pad available, and the government and other payers do not reimburse for therapies that can be very helpful, safer and more effective."
He adds that less dangerous pharmaceuticals would be a boon to pain medicine, but little development is being pursued. "A hundred million Americans experience chronic pain, yet we spend less than 1 percent of our research budget on this. We have not developed a new molecule for the treatment of chronic pain in 25 years. We need to find solutions; pain is not just a symptom — it's a disease. It destroys lives. It changes the structure of the brain and the spinal cord. There is a need to find new therapies, as we did for cancer."
He believes that the pharmaceutical industry would be more aggressive in developing newer, safer remedies if financial incentives made it worth their while. In the meantime, manufacturers would rather tinker with an existing molecule in order to gain a new patent on a painkiller that has barely been changed.
Government Solutions — or Not
It's not like no one is onto rogue prescribers. In 2013, CVS Caremark identified 42 of them. They were, according to Pat Gleason at Prime Therapeutics, who was quoted in AIS Health Drug Benefit News, "basically writing prescriptions illegally, like what you see on the television show ‘Justified,' where a doctor is set up in a trailer in rural Kentucky." It's an interesting statement, because Kentucky — likely due to its close proximity to several other states — is a hotbed of overprescribing of narcotics and other dangerous medications.
In 2013, the Office of the Inspector General of Health & Human Services issued a report identifying 700 physicians as having "questionable" Part D prescribing patterns. Questionable, indeed — one California physician wrote 151 times the average number of prescriptions, for a take of $9.7 million from Medicare. A Tennessee practitioner wrote an average of eight prescriptions for Schedule II drugs for each of 427 Medicare beneficiaries, who filled the prescriptions at 368 different pharmacies — which would make detection of this aberrant pattern more difficult to catch. Patients of an Illinois physician filled prescriptions from him in 47 states and Guam. And a Florida physician prescribed a 605-day supply of morphine, a 524-day supply of oxycodone, a 460-day supply of fentanyl, and a 347-day supply of hydromorphone to the same patient. That guy must have been in some pain.
Yet, even when egregious cases like this surface, Medicare's response is often weak. For one thing, the investigative process is torturous — a complaint is made, or a suspicious pattern is detected, usually by one of the private insurers who are largely in control of Part D. The insurers can investigate the matter themselves or else turn it over to Medicare Part D's private contractor for fraud. The contractor can then ask the insurer for records, which the insurer must request from the provider, and, well, you get the idea. At some point the case may make it to the HHS Inspector General, but that office is understaffed and overwhelmed by potential fraud cases, which include all kinds of bad behavior, not just overprescribing.
The Pro Publica series found that "federal officials have done little to detect or deter these hazardous prescribing patterns." One example was that of Miami psychiatrist Fernando Mendez-Villamil, who wrote more than 96,000 prescriptions for psychotropic drugs in a three-year period, the most of any physician participating in Part D. Sen. Charles Grassley (R-Iowa) became aware of Mendez-Villamil's prescribing patterns and inquired of HHS Secretary Kathleen Sebelius what the department was doing about him. She responded that he was being investigated. A month later, the Florida Medicaid program expelled him. The state medical board accused him of giving psychotropic drugs to children as young as 3 without proper examination. And because a Florida physician who is terminated from Medicaid cannot renew his or her license, it is unlikely that Mendez-Villamil can practice in the state for long. Yet he remained qualified to participate in Part D, writing a total of 11,600 Medicare prescriptions in 2009 and 2010. He was still in the program as of June 2013.
Not surprisingly, government has come under criticism for what appears to be a lax attitude toward overprescribing. In mid-2013, Sen. Grassley wrote to every state to ask about their policies for sanctioning overprescribers and whether they inform the federal government when they do sanction someone. Although many states can terminate a physician from Medicaid "without cause," Grassley wrote, apparently that does not provide Medicare with sufficient justification to purge overprescribing physicians from the ranks of its providers.
At about the same time, the HHS Inspector General issued the report about the 700 questionable prescribing physicians. The report stated plainly that Medicare should "do more to investigate or stop them," according to Pro Publica.
Testifying before a Senate panel, Jonathan Blum, then director of the Center for Medicare at CMS, said that the agency took the problem "very seriously" and admitted that "we can and should do more." One would think so, especially when many of the most suspicious prescribers had been sanctioned by their state medical boards, expelled from Medicaid, or even arrested for or convicted of crimes involving prescription drugs, all the while remaining eligible to write prescriptions under Part D.
Fortunately, government on both the federal and state levels is finally taking more aggressive action. Medicare's 2013 drug utilization requirements asked participating insurers to periodically examine claims data and other records for suspicious activity. Insurers with a legitimate concern about a particular prescriber can take action, such as terminating his or her eligibility to be in the program, as long as they have made "reasonable efforts" to contact the person in question for an explanation. If contact with the prescriber is impossible or the explanation is unsatisfactory, the insurer may prevent the drugs from being dispensed. Although the process is still pretty klutzy, it does seem to be an improvement.
In January, Medicare announced that it was going further, and will now refer physicians with suspect prescribing patterns to their state medical boards for potential disciplinary action, according to Pro Publica. In addition, CMS has sent to Part D insurers a list of pharmacies whose dispensing histories suggest fraud, and plans to do the same for prescribers with aberrant patterns. It has also referred a small number of physicians to law enforcement authorities.
And, in a move bound to be controversial, CMS has proposed requiring that all physicians who write Part D prescriptions be certified Medicare providers. Unbeknownst to most people, any physician can write a prescription under Part D, even if he or she does not work with Medicare. Furthermore, Medicare wants the direct authority to remove rogue prescribers from the program.
Medicare is not the only federal agency that is stepping up. The Food and Drug Administration has begun requiring all opioid manufacturers to educate prescribers about their products and teach them how to warn patients about the drugs' potential dangers. And the CDC is implementing ways to strengthen states' prescription drug monitoring programs, including tracking prescribing of controlled substances, linking state and federal electronic data systems (I wish them good luck on that one), prevention of "doctor shopping," identifying and shutting down pill mills, and improving providers' knowledge of science and data to ensure more responsible prescribing.
The CDC initiative is most welcome, because, as with health care serial killers (as described in this column in December 2013), the states vary greatly in their aggressiveness when it comes to suspicious prescribing practices. In addition, many states lack the capability to track aberrant prescribers or patterns.
On a more hopeful note, in July 2013, the Federation of State Medical Boards issued a new model policy on the use of opioids in the treatment of chronic pain. It lists several actions it deems inappropriate, including inadequate initial assessment of patients to determine if opioids are indicated, inadequate patient monitoring during use of potentially abusable medications, inadequate attention to patient education and informed consent, unjustified escalation of opioid dosage without adequate attention to risks or alternative treatments, excessive reliance on opioids for pain management, and lack of use of available tools for mitigation of risk.
The question, of course, is the degree to which state boards will adopt these new standards and use them to educate physicians and other prescribers.
State governments also have been active. Florida is one of several states that can terminate a suspect physician from Medicaid without revealing the cause of the termination. What this policy lacks in transparency, it gains in speed and efficiency, as long as it is not abused.
New York state has been particularly active: The New York State Prescription Monitoring Program Registry allows clinicians and pharmacists direct, secure access to patients' controlled substance history "to help them better evaluate a patient's treatment."
As of August 2013, all practitioners except veterinarians are required to check the prescription monitoring program, or PMP, before writing a prescription for Schedule II, III and IV drugs and they must have a "health commerce system account," which can be established only with state approval.
Attorney General Schneiderman is also heavily involved in the effort to stop what he terms "a prescription drug epidemic in New York state." In 2012, he proposed, and the state legislature unanimously passed, the I-STOP [Internet System for Tracking Over-Prescribing] program. When fully implemented this year, I-STOP will reinforce the state mandate that the PMP be consulted by practitioners before they prescribe controlled substances; will require real-time reporting by pharmacists of filling of prescriptions for Schedule II, III and IV medications; will require e-prescribing of all controlled substances by the end of this year; and will transfer certain drugs, such as hydrocodone, to Schedule II or higher so that automatic refills are no longer possible. The law makes New York the only state to require that the PMP registry be consulted before a prescription is written, and is "a model for the nation," according to Schneiderman. The law enjoys wide support.
On the other end of the spectrum, seven states don't even have prescription drug monitoring programs. And, as was noted in the first part of this series, states guard their regulatory territory jealously, making it very easy for rogue practitioners and patients alike to just hop a state line — say, from New York to New Jersey or from Kentucky to West Virginia — and set up shop, or seek inappropriate prescriptions in the state next door.
That may not be the case forever. As Cooke of the ACP says, "I can't see the state prerogative over the practice of medicine enduring indefinitely; there are too many pressures against it. The globalization of health care will not allow it to continue forever. The pressure to construct more functional and broader networks will force change. Multistate provider networks, integrated systems, physicians who are licensed in multiple states — the way we have organized the oversight of medical practice is going to have to change substantially."
In time, perhaps that could include a secure but shared national database of prescriptions and prescribing patterns. As Lauren Flynn Kelly, editor of Drug Benefit News, wrote last year, citing a study by PBM Progressive Medical, "There must be greater collaboration among all stakeholders in the system — claims processors, nurse case managers, physicians, employers, pharmacy benefit managers, etc. — to effectively curb the opioid trend." Not to mention government.
In December 2013, when the ACP position paper on prescription drug abuse was published, it received a lot of press, both good and bad. Supporters lauded the breaking of a code of silence; detractors said it was too soft on rogue prescribers.
In response, Cooke says, "We believe that the appropriate use of these medications is a responsibility of all physicians. Some people have asked, ‘Why isn't the paper more focused on prescription mills, where all the problem is?' The reality is that this isn't where ‘all the problem is.' Many patients who show up in EDs with overdoses and other consequences of misuse of these medications got the prescription, or a family member got the prescription, from a physician who was trying to do the right thing. We want to prompt all physicians to consider how they use these medications."
The ACP paper supports:
- appropriate and effective efforts to reduce all substance abuse;
- a comprehensive national policy on prescription drug abuse;
- consideration by physicians of the full array of treatments available for management of pain;
- establishment of a national prescription drug monitoring program, and, in its absence, efforts to standardize state PDMPs through the federal National All Schedules Prescription Electronic Reporting Act of 2005;
- efforts to educate physicians, patients and the public on appropriate use of controlled substances;
- a balanced approach to permit safe and effective use of controlled substances while reducing abuse;
- recognition that defined maximum dosages are not applicable to every clinical encounter;
- requiring patients who have been identified as being at high risk of addiction to participate in drug monitoring programs and random testing;
- consideration of patient-provider agreements in terms of treatment of pain;
- approval by all states of e-prescribing of controlled substances.
Physician and nurse education initiatives are also available; among them is Boston University School of Medicine's SCOPE [Safe and Competent Opioid Prescribing Education] of Pain program, which includes both Internet-based and live conference activities designed to improve pain treatment and management.
Probably the most controversial private-sector programs are those launched last year by the CVS Caremark and Walgreens drug store chains. CVS paid an $11 million fine last year in connection with accusations by the federal Drug Enforcement Administration that it violated laws regarding monitoring of narcotics sales. A few months later, the chain announced that, following up on its 2012 survey that identified 42 outlier prescribers, it will now "tap its extensive database to identify and halt inappropriate prescribing of high-risk drugs such as opioid painkillers," according to a press release.
If a prescriber fails to respond to inquiries from CVS, or to adequately explain his or her prescribing patterns, his or her prescriptions can no longer be filled at CVS pharmacies. The chain has already terminated 36 of the 42 physicians it had identified previously.
Similarly, Walgreens paid an $80 million fine last year after the DEA found that it had not adequately controlled narcotic sales in some of its stores. The firm subsequently launched its "Good Faith Dispensing" policy, through which its pharmacists are required to use a checklist before dispensing controlled substances. The checklist requires checking the PDMP, the amount of the drug prescribed, and calling the prescriber to ask such questions as whether the prescription is within the practitioner's scope of practice, the diagnosis and the expected length of treatment. Red flags include a pain medication for which a prescription has not been previously filled by Walgreens, a different physician writing the prescription for a previously used medication, a prescription written by a physician who is located some distance away, or a patient wishing to pay in cash, seeking an early refill, asking for an excessive number of pills, or being on the same medication for more than six months. The pharmacist must sign the checklist and, if a prescription is refused, fax the documentation to the DEA.
The initiative does have some draconian elements, and it produced a firestorm of protest, including calls for a boycott of the chain by pain patients and their advocates. There were also complaints that the checklist was "secret." If it was, Walgreens didn't do a very good job of concealing it; I obtained a copy of it without much trouble.
But will these programs make a difference? Webster has his doubts. "I don't believe that what CVS and Walgreens are doing will be effective in addressing the problem," he says. "Prescription drug abuse is not so much about the prescriber as it is about demand. There will always be a prescriber to fill the demand." And small "mom and pop" pharmacies may not be able to afford to turn down the business the way the big chains can. This is one of the unintended consequences of the big-boxification of America.
What Hospitals and Systems Can and Should Do
This is not primarily a hospital or health system problem. Any institutional pharmacy worth its salt (as it were) should easily detect aberrant prescribing and/or dispensing of controlled substances if the activity takes place within the hospital or system. Required e-prescribing, electronic health records and databases that include all physicians with privileges will only make this easier.
This does not mean that hospitals and systems do not have an important role to play, or a big stake in solving the problem — those 2.5 million ED overdose visits every year aren't being paid for by the tooth fairy. And there is also the widespread hospital and system commitment to patient safety and quality