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8 Articles in Volume 5, Issue #6
Botox Treatment of Chronic Refractory Low Back Pain
DEA Enforcement versus Pain Practice
Group Psychotherapy for Chronic Pain Patients
How Expert Testimony Distorts the Standard of Care
Neurostimulation in Chronic Pain Patients
Physiological Consequences of Guided Imagery
The Role of Tertiary Gain in Pain Disability
Treating Muscular Dysfunction of Upper Limbs

DEA Enforcement versus Pain Practice

Aggressive DEA action against drug abuse and diversion ensnares some legitimate prescribers but education on both sides can diminish the possibility

There continue to be media reports on the so-called “war on doctors” especially with regard to pain prescribing. The coverage typically highlights investigations, prosecutions, and doctors leaving pain medicine and abandoning pain patients. Anxiety levels among pain doctors further increased late last year with the withdrawal of the federal Drug Enforcement Administration’s (DEA) policy statement or FAQs from their website. The about-face, especially regarding policies that had been thoughtfully crafted by discussions between DEA officials and pain experts, engendered a lot of confusion and fear among doctors about whether they could be prosecuted under the old rules, specifically in the areas of prescribing quantity and serial prescribing. But national experts, looking at this state of affairs from various professions, say two things: Yes, there is a lot of confusion, but there is a lot physicians can do to allay both their anxiety and their actual potential for getting in trouble.

Attorney Jennifer Bolen, formerly a DEA prosecutor for 14 years and now in private practice, has built a substantial practice on educating doctors how not to be afraid. She says that when they learn about the laws and regulations and are given efficient ways to handle procedures, “They tend to say, ‘Oh, yeah, I get it.’” And then go on to take care of their patients.

David Joranson, MSSW, director of the Pain and Policy Studies Group at the University of Wisconsin, says if it weren’t for the current dust storm caused by DEA statements, we would be able to see that states, in particular, “have done some spectacular efforts to improve the degree of balance in the policies that affect physicians who prescribe opioids.”

Sources of Confusion

Due to the apparently contradictory information coming from the DEA, it is hard for doctors in pain medicine to know how to practice to avoid becoming a target of investigation. It does not help that there are apparently no hard numbers on what is happening. According to several experts, including a DEA spokesperson, there is no comprehensive data source on whether investigations or other actions targeting physicians have increased. In fact, many news and other reports have focused on individual cases, sometimes the same individual cases, without providing evidence of trends. The DEA itself, although taking much of the flack for the controversy, says repeatedly that it has not changed its policies, that it investigates a miniscule percentage of physicians registered to prescribe Schedule II drugs and that those numbers have not increased over recent years. According to the agency, in 2004 it investigated 737 physicians and arrested 42, out of almost a million doctors registered.

It is interesting to note that the AMA’s CME program on prescribing issues states that state medical boards are the agencies most likely to investigate improper prescribing. Yet, Dale Austin, the vice president of the Federation of State Medical Boards, which keeps a database of all state medical board actions, says, “Those numbers have not changed. There are not more actions being taken today than there were five years ago.” Austin also indicates state board cases today are similar in type to those five years ago. And, he contends, “The individuals who have actions against them are folks who set up prescription mills, quite frankly.”

Joranson, whose center examines all states’ policies in this area and gives them grades accordingly, is very impressed with states’ progress, at least in policy. For example, he says, about 34 states have recognized that physicians are concerned about scrutiny and states have addressed that issue by offering basic parameters for what constitutes legitimate prescribing. “Medical boards and legislatures have been listening to what the issues are and they are making changes accordingly. It is a very hopeful note. But it is hard to hear that note with so much chaos in Washington,” he says.

But a range of observers say they know of no overview of what is happening, in total, with state boards, local and state law enforcement, health insurance plans and civil lawsuits. Questions about whether there is simply a lot of attention on particular actions—as some contend—or an actual increase in pressure are difficult to answer. On one hand, Austin does feel state boards have a sense of all kinds of actions related to physicians in their states and he says they are not reporting any change.

On the other hand, John Burke, vice president of the National Association of Drug Diversion Investigators, thinks there is no question there are now more investigations. He is quick to add he feels some of the increase is legitimate: it reflects actions against the few bad actors, the kind of actions that should have occurred more frequently in prior years. “Prescription drug abuse has long been an issue, but most law enforcement has not recognized that and still doesn’t today,” says Burke, who is a drug diversion investigator in Ohio and teaches other law enforcement officers about the issue. But perhaps, he says, national attention on the problem has induced local law enforcement officers to think more about Dr. So-and-So who has a line of patients outside his office.

Indeed, attorney Bolen thinks that although doctors are freaked out about the “DEA stuff,” state law enforcement and insurance companies are far larger sources of pressure. And health plans, she notes, create further anxiety by sending directives to doctors, trying to get them to change their prescribing patterns. Or the insurance plans send drug utilization review letters. Insurance investigations, she notes, can actually prompt the beginning of criminal cases through a Medicaid fraud control unit or a state attorney general’s office. Bolen also thinks a large part of the actions are civil lawsuits, including allegations that a doctor got a patient addicted or was responsible for a death. Those actions, she notes, create problems for physicians whether the cases go forward or are tossed out of court. Bolen also feels there may be increased actions from some state licensing boards.

The DEA’s FAQs Controversy

But if DEA is not the source of most of the anxiety of doctors, it did provide a surprising new locus of confusion with its actions last year on “the FAQs,” as they were called. Over several years, the agency had worked with organizations of pain professionals and others to come up with guidelines that physicians could work with. Last August, it posted on its web site a set of “Prescription Pain Medications: Frequently Asked Questions and Answers for Health Care Professionals and Law Enforcement,” which was the product of a work group of DEA officials and pain experts.

But a few weeks later, the agency flabbergasted many in both health care and law enforcement by pulling the FAQs from its web site, saying they contained misstatements and, since they had not been officially published in the Federal Register, they were not to be construed as official DEA policy.

Then in November 2004, the agency published an “interim policy statement” in the Federal Register, saying, among other things:

Screening by the numbers: The FAQs had erred by stating that the number of patients in a practice who are getting opioids, the number of tablets prescribed for each patient, and the duration of therapy with these drugs do not, by themselves, indicate a problem, and they should not be used as the sole basis for an investigation. In fact, said the DEA, each of those “factors—though not necessarily determinative—may indeed be indicative of diversion.”

Serial prescribing: The FAQs had also erred, said DEA, when they stated that, although Schedule II prescriptions may not be refilled, “a physician may prepare multiple prescriptions on the same day with instructions to fill on different dates.’’ DEA said this practice of preparing multiple prescriptions (called serial prescribing by some) with instructions on some of the prescriptions not to fill them prior to a specified, future date is tantamount to the prohibited practice of authorizing refills of Schedule II drugs. The practice, the agency said, is used by physicians trying to avoid detection of unlawful prescribing. That was a shock to many professionals. Written statements from DEA officials, issued several years ago, had indicated serial prescribing was not a problem.

The November 2004 DEA statement also said it would publish a document in the future to provide guidance and reassurance, but also deter the “small number of physicians and DEA registrants” engaged in prescription drug trafficking. In January of 2005, the agency called for comments on the issue, with a March deadline.

A cursory review of the several hundred comments that arrived, made available for viewing at DEA headquarters offices in August 2005, indicate the great bulk of them—although not all—oppose the policies in the interim policy statement and the elimination of the FAQs. The American Pain Society wrote that, although DEA has “partnered” with the pain community, the interim policy statement “is an unfortunate step backwards.” The American Academy of Pain Management said it was greatly disturbed by the “abrupt withdrawal” of the FAQs. The Federation of State Medical Boards said, “Due to confusion surrounding the Interim Policy Statement many physicians are now fearful of investigations and enforcement actions.” Various types of pain professionals, psychiatrists, nurses, hospice professionals, as well as state boards of medicine, state and national physicians’ organizations, and other professional organizations have weighed in against the DEA statements. One hospice medical director wrote, “Physicians are already afraid to write Schedule II prescriptions and are only too happy to ‘dump’ the large number of chronic pain patients on pain practitioners.”

Serial Prescription Issue

Probably the majority of the comments focus, partially or totally, on the DEA repudiation of the serial prescribing practice. Letters from various states make it clear a number of physicians have, indeed, stopped writing serial prescriptions. Some of them are requiring pain patients to come back for an appointment every month, whereas previously they might have returned every three months.

It’s also clear some physicians have told their patients DEA is the reason for the more frequent visits. Numerous letters from pain patients and families, some of them handwritten, evidence fury at having to drive 120 miles roundtrip, or they give detailed budgets of how gas, parking and co-pays add up to hundreds or thousands of dollars a year, or they describe fear of losing a job due to taking time off every month. And they talk about increased pain and stress, with indications they feel they can’t go on or they know people who have committed suicide because of pain.

Burke, the diversion officer, says much of law enforcement is also aghast at the repudiation of serial prescriptions: “It’s absolutely insane.” Law enforcement had encouraged doctors to do the serial prescribing to help reduce diversion by keeping larger amounts of medication out of households, he says. And, he says, DEA’s statement implies that physicians using the practice are criminal. And that’s egregious, says Burke. “They did more damage in that one little piece to the relationship between law enforcement and physicians, than I can ever imagine,” he states.

Meanwhile, Joranson believes that doctors who have ceased the serial prescription practice because of DEA’s statements are right to be cautious—at least for the time being. However, he believes that requiring patients to come in for another appointment for every prescription is a misinterpretation of that DEA policy. Prescriptions may be mailed or patients may drop by the office to pick them up, Joranson says.

“Numerous experts agree and urge physicians to become familiar with their state licensing boards’ statements on pain medication and/or the Federation of State Medical Boards guidelines, which a number of states have adopted.”

As of late August 2005, the agency was considering the comments and had made no public indication as to when the next step will come.

Precipitating Factors

What brought us to this point? What’s engendering the pressure, real or perceived? Professionals of different backgrounds and expertise point to signs that we have walked into a new era and have poorly understood some of its ramifications. Over the last decade studies found that pain is routinely undertreated. Primary and specialty physicians were encouraged not to be afraid of prescribing pain medication, including opiates. The American Pain Society created a campaign promoting pain as the fifth vital sign and the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) developed standards with new expectations for pain management.

But in recent years, surveys also indicated a growth in prescription pain medication abuse. News stories detailed surges of OxyContin abuse in some areas. DEA officials say the agency has never seen such an increase in abuse as with OxyContin. Some suspect that some prescribers may have been encouraged to give pain medications more liberally without having solid background in all aspects of that arena. The Oncology Nursing Society told DEA in its comments there is a serious need for educating health professionals on stopping drug diversion and on how to keep records and to document assessments and prescriptions. That and other prescription drug problems brought pressure on government agencies to do something about it.

Burke acknowledges there may have been mistakes by some law enforcement agencies, but he does feel that the vast majority of doctors who have had trouble have made such flagrant violations that no other doctor would defend them. But he also says perhaps some law officers have become involved in cases without being as knowledgeable as they should be. “Prescription drug abuse has come more to the limelight than it ever was, in the last five years,” says Burke, and law enforcement officers see the same newspapers and television as the rest of us.

Unfortunately, Burke notes, some law enforcement officers still think a doctor prescribing 1000 milligrams of OxyContin “is an indication of a crook. And it is obviously not, necessarily, at all.” He tells the story of an officer who quietly worked on an investigation of a doctor for six months before getting some education on pain management. Then he realized, “This guy is not doing anything wrong.” One thing Burke wants all law enforcement to learn is the technique of looking into perceived irregularities without endangering a physician’s reputation. He teaches some of those methods in classes for law enforcement officers.

Contradictions in today’s environment abound. For example, attorney Bolen says health plans often tell doctors to give 90 days worth of medication, but the licensing board tells them to control the medication supply, especially if someone has a history of abuse: “The conflict is really, really nasty.”

Avoiding Problems

Despite the systemic issues, experts swear it is not time for physicians to get out of pain medicine, under-treat patients in pain, or head for the hills. Knowledge is power, Bolen tells physicians, and the criminal and legal side of things is what many of them did not get in their training. She says the majority of physicians she has seen in trouble have recognizable problems such as their own substance abuse or trading drugs for sex. But beyond that group, she says, the others have not even read their state materials on pain prescription.

Given that, Bolens questions their ability to understand what is required and to document correctly: “You have to look at the legal and regulatory requirements for prescribing controlled substances. They are very different from the rest of prescribing.” Investigator Burke concurs and says that, typically, doctors who have been targeted, “have not consulted with their peers, they have not been to CME programs, and they are not trying to learn how to do it right.”

Numerous experts agree and urge physicians to become familiar with their state licensing boards’ statements on pain medication and/or the Federation of State Medical Boards guidelines, which a number of states have adopted. Those guidelines call for consistently taking such steps as writing a history and doing a physical, developing a treatment plan, determining what other consults or diagnostic tests are needed, obtaining informed consent, and doing periodic assessment. The Pain and Policy Studies Group provides a guide to all state laws on pain medication is on its website. (See ‘Additional Resources’ section below.)

Rebecca Patchin, MD, an AMA trustee who has worked with DEA on this issue and deals exclusively with pain patients in her California practice, says that if physicians follow those guidelines and have good chart documentation, as the guidelines require, “they should not be overly concerned about harassment from any regulatory or enforcement body.” A doctor’s records, she says, can prevent any action from going further than record review. “They can be your best defense.” Whether it is two or three pills twice a week or a number of pills each day, Patchin advises physicians “to individualize the treatment plan and to follow up and to document how the treatment plan is improving the patient’s function or quality of life and/or reduced pain.” She also emphasizes that AMA’s training on pain is free online (see ‘Additional Resources’ section below).

Further, Bolen stresses the need to use care when a prescription varies from typical amounts—whether because of medical conditions, a situation in the person’s work life, or other issue. Those exceptions, she advises, should be explained as if someone were looking over your shoulder and trying to understand. But Bolen, who gives seminars on this, also urges physicians to get some specific training. Physicians need a background, she says, in what DEA is concerned about, what the state boards are looking at, and what issues come up with patients and their attorneys.

When doctors have that perspective from the enforcement side and know what they should be writing down, she says, they can go back and judge for themselves whether they are courting trouble. Investigator Burke knows one physician who actually attended the state conference for drug diversion officers to sharpen his understanding: “And I think he feels 100 percent better.” Bolen also tells doctors to expand their education on some basics: know what it means to do patient assessment, selection and monitoring; find out key phrases to use to signal correct procedure; use checklists for self audits; and understand the importance of a patient’s substance abuse history.

Burke, as a law official, also tells doctors to learn how to spot potential diverters. He suggests doctors learn about diversion specifically to understand what some patients may do to scam physicians and how to prevent it. Red flags will begin to show up, he contends, such as the stories about the dog eating the prescriptions. And he warns that if you don’t take some action, “you are going to be inundated with other people who see you as an easy hit.” Burke also suggests doctors invite law enforcement people to conferences to talk on diversion and how law enforcement and medicine can work together. He does caution: “You’ve got to get the right ones. There are some people who are going to come in, and by the time you get out of that room, you are going to think that you are all going to jail.”

More generally, Burke cautions doctors against being what law enforcement calls “hermit physicians,” those too isolated in their work for their own good. Burke says they can get in trouble because they don’t realize what is going on. In fact, Bolen suggests, that if family physicians feel their work is moving too fast, they might ask for a peer review by a pain specialist or even someone in their own practice. Likewise, Burke says if he were a doctor with any qualms about local law or other enforcement bodies, he would go to a physician who has some knowledge of the procedural and legal aspects and ask, “This is what I am doing: What do you see good or bad here? What should I change?”

Physicians’ Balancing Act

If this sounds like a lot of time-consuming work, AMA’s Patchin acknowledges that the press of time is basic to these problems: “It is sometimes difficult to write down on the chart your comprehensive treatment plan for each patient and to document the informed consent and to follow through.” Physicians, she says, are constantly balancing: “Trying to see the number of patients that want to see them with the time spent in record keeping: that can be a trade-off.”

But Bolen claims that keeping things straight can also offer some efficiencies. For example, practices can save time by having the tools and the professional manner for dealing with suspected diverters. She provides doctors paper forms, for instance, for those times when patients have a story about lost meds or whatever. The patient is asked to write the story, sign it and hand it back for the file.

Physicians will cheer Bolen for her demand to DEA that it focus on what many of them of thinking: health plans often don’t reimburse adequately for documentation effort. The plans often limit or even deny coverage, she says, for the very steps doctors are urged to do to control diversion such as enforcing a written treatment agreement; doing adequate periodic review; or using consultation or referrals when necessary.

Bolen tells DEA it would be a complete miscarriage of justice if the agency expects physicians to follow such directives without considering that health plan language limits their discretion. AMA’s CME unit also notes that managed care strictures can be barriers to adequate pain assessment in general.

Hopeful Signs

A reason for hope is that people in all corners of the issue are acutely concerned about the chilling effect on prescribing, including the DEA and state medical licensing boards. All parties involved are vowing to talk to each other. DEA has reportedly held meetings with a number of organizations, including AMA and FSMB, just to listen to their concerns. In fact, AMA has provided DEA with over 600 copies of its CME program on pain to educate DEA investigators.

In addition, Burke says the National Association of Drug Diversion Investigators (NADDI) is working on a joint effort with a national medical organization and wants to interact with other physician groups, perhaps to exchange speakers. He says, “Let’s kick this thing around.” NADDI is also developing some online training courses, he notes. “We want to get the message out that we want to work with them and make it better for everybody, and ultimately for legitimate patients,” Burke says. Admitting he too might be a little paranoid if he were a doctor in today’s climate, Burke says, “But we need to reduce that for everybody’s sake.”

Last updated on: June 29, 2016
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