ARE YOUR PRESCRIPTIONS FOR A LEGITIMATE MEDICAL PURPOSE – THE FEDERAL GOVERNMENT MAY NOT AGREE
In 1996 the American Pain Society (APS) introduced the concept that pain was the fifth vital sign. This initiative emphasized that pain assessment was just as important as assessing the standard four vital signs and that clinicians needed to take action when patients reported pain. Fast forward to today and we are now facing a national prescription drug abuse epidemic. The national media regularly lament the large numbers of people needlessly dying every day in America as a result of narcotic prescription drug abuse, including high profile celebrities like Prince and Michael Jackson, to name a few. In response to this crisis, society has demanded the
government take action to better protect people from these powerful and deadly drugs.
While issues concerning overprescribing often lead to administrative investigations of physicians by state boards of medicine, physicians are increasingly becoming the targets of far more problematic and devastating criminal prosecutions by the federal government. Many health care providers do not appreciate the fact that under the federal Controlled Substances Act (CSA), it is illegal for “any person” knowingly or intentionally to distribute or dispense a controlled substance. 21 U.S.C. § 841(a). The overarching aim of the CSA is to combat drug abuse and to control the legitimate and illegitimate traffic of controlled substances. United States v. Tobin,
676 F.3d 1264, 1275 (11th Cir.2012). The CSA makes exceptions to this prohibition for certain individuals who are registered “practitioners” under the Act, such as physicians and pharmacists. See 21 U.S.C. §§ 821-23.
The Supreme Court has held, however, that these practitioners are still subject to criminal prosecution “when their activities fall outside the usual course of professional practice.” See United States v. Moore, 423 U.S. 122, 124 (1975); see also 21 C.F.R. § 1306.04 (providing that a practitioner “shall be subject to the penalties … relating to controlled substances” unless the prescriptions he or she writes are “issued for a legitimate medical purpose … [and he or she is] acting in the usual course of his or her professional practice”). Thus, a physician remains criminally liable and will be treated much as a drug dealer would if he or she ceases to distribute or dispense controlled substances as a medical professional should in the eyes of the federal government.
The field of pain management has generated controversy because of its reliance on opiate-based narcotic pain medications, which are also a target of the government’s war on drugs. See i.e. Diane E. Hoffmann & Anita J. Tarzian, Achieving the Right Balance in Oversight of Physician Opioid Prescribing for Pain: The Role of State Medical Boards, 31 J.L. Med. & Ethics 21, 22–23 (2003). Due to the ongoing prescription drug epidemic, the government has become more aggressive in prosecuting doctors who distribute opioids and other prescription drugs under the guise of legitimate medical practice. See United States v. Hurwitz, 459 F.3d 463 (4th Cir.2006); United States v. Feingold, 454 F.3d 1001 (9th Cir.2006); United States v. Williams, 445 F.3d 1302 (11th Cir.2006); United States v. Alerre, 430 F.3d 681 (4th Cir.2005).
Many health care providers do not appreciate the fact that if a prescription is issued without a legitimate medical purpose or outside the usual course of professional practice, that the person knowingly filling such a purported prescription, as well as the person issuing it, is subject to the criminal penalties of 21 U.S.C. § 841. This includes being subject to having your personal assets seized by the federal government in addition to the loss of your license to practice medicine anywhere in the country. For example, Section 841 makes it a crime for a person to unlawfully dispense or distribute a Schedule II controlled substance and provides for a maximum sentence of 20 years of imprisonment. It also provides a minimum prison sentence of 20 years and a maximum prison sentence of life if “death or serious bodily injury results from the use of such
substance.” See United States v. Joseph, 709 F.3d 1082, 1094 (11th Cir. 2013). Some courts have held that a patient’s hospitalization for withdrawal qualifies as a “serious bodily injury” and therefore justifies a life sentence enhancement for the offending medical provider.
Many providers may summarily dismiss concerns over this issue under the mistaken belief that all of their prescriptions were reasonable and necessary and therefore legitimate. However, what the government contends qualifies as a legitimate medical purpose or within the usual course of professional practice may surprise you. While it is well settled law in Idaho that to prove a claim for medical malpractice requires a showing that the physician deviated from the local community standard of practice per Idaho Code §6-1012, the federal government in these criminal drug cases in Idaho relies upon a different standard. This spring two Idaho family practice physicians were convicted of violating 21 U.S.C. § 841 and are both currently awaiting sentencing. In both
cases the federal government argued that in order to determine whether the provider had issued a prescription for a legitimate medical purpose or within the usual course of professional practice required application of the Idaho Board of Medicine Policy for the Use of Opioid Analgesics in the Treatment of Chronic Pain.
Many providers in Idaho are totally unaware this Idaho Board of Medicine Opioid Policy even exists. Without question this policy was never intended by the Idaho Board of Medicine to be used to determine whether a provider was committing a federal drug crime. The potential implications of this latest strategy by the federal government are profound. If you are going to prescribe narcotics to any patient for the treatment of a chronic condition, I strongly urge you to visit the above link and carefully read and implement the Board’s opioid policy into your practice. This policy was adopted by the Idaho Board of Medicine in September 2013 and is modeled after similar policies which have been adopted by administrative boards of medicine in other states nationwide. The Idaho policy states within the preamble that “physicians should not fear
disciplinary action from the Board” for prescribing controlled substances provided they are for a “legitimate medical purpose and in the course of professional practice, when current best practices are met.” In prosecuting these two unfortunate Idaho family practice providers, however, the federal government was allowed to instruct the jury that if they concluded the Board’s opioid policy had not been complied with, that such a failure was proof of a criminal violation under 21 U.S.C. § 841. This was allowed despite the complete absence of any evidence that such a policy had been adopted in Idaho by any state statute or administrative regulation and was therefore nothing more than a recommendation by the Idaho Board of Medicine.
For those who have not reviewed it, the Board’s opioid policy is extensive and includes the following issues which must be addressed in order to comply with what the Board has determined to be the best clinical practice for chronic pain management:
1) Documentation. Compliance with the Board’s policy will be judged on the basis
of available documentation. Document a legitimate basis for prescribing
medication including complete system review, medical history, diagnosis, level of
pain, the degree of relief after receiving the pain medication and the plan for
follow up. Carefully structure a treatment plan that reflects the particular benefits
and risks of opioid use for each individual patient, including documenting
improvement in any pain associated symptoms. Whenever possible initiate
treatment with a non-narcotic pain medication first and include the use of nonpharmacologic
treatment therapies. Document appropriate referrals and diagnostic
testing to support the working diagnosis. Include in your initial work up a social
and vocational assessment including any histories of drug, alcohol, sexual and
physical abuse, depression and other mental health disorders as they are risk
factors for potential misuse.
2) Ensuring adequate communication with other providers. Document
communication between providers to ensure who is managing a patient’s pain
medication needs. This would include requesting records from prior providers
before agreeing to prescribe any narcotic pain medication without exceptions.
3) Ensuring use of existing safeguards in addition to using clinical judgment. This
would include not prescribing in excess of your diagnosis; documenting the
results of having regularly checked the state prescription drug monitoring
program to verify whether the patient had been receiving medication prescriptions
from other providers; and obtaining periodic drug testing of the patient to monitor
adherence to the treatment plan and to confirm that no other legal or illegal
substances were also being taken. Simple pill counting and patient self-reporting
cannot be relied upon to ensure compliance in the treatment of chronic pain
patients in this day and age regardless of the patient.
4) Pain contracts/treatment agreements. When prescribing narcotics beyond an acute
injury use signed agreements to clarify expectations with the patient including the
fact that they should not be getting pain medication from any other provider or
taking anyone else’s medications, that you check state pharmacy profiles from
your state and surrounding states before issuing prescriptions and that you employ
the use of periodic random drug tests to ensure compliance. Document the
intended goals of the treatment such as restoring daily functioning as well as
documenting the responsibility of the patient to use the medications only as
prescribed. A signed treatment agreement/informed consent must be in the patient
5) Documenting informed consent. Document a detailed discussion regarding the
risks of abuse, addiction, dependence, side effects, prescribing policies and
expectation such as rules for early refills, inability to replace stolen medications,
etc. should all be addressed and documented. Include the risks of constipation,
impaired cognitive function, motor skills and over sedation. Consider getting
input from an addiction specialist and/or psychiatrist or other mental health
provider regarding the use of narcotic pain medication in patients with histories of
drug, alcohol, sexual and/or physical abuse. For patients with a history of
substance abuse these consultations should occur before opioid therapy is
6) Consultation and Referral. Patients who are stable on mid to high level doses of
narcotic pain medication should undergo routine efforts to reduce the dose to
minimize addiction and/or dependence issues. Employ use of the 5A’s of chronic
pain management: determination of whether the patient is experiencing a
reduction in pain (Analgesia); have they demonstrated an improvement in level of
function (Activity); have there been any (Adverse) effects; is there any evidence
of (Aberrant) substance related behavior; and consider the mood of the individual
(Affect). In addition to seeking appropriate consultation and referrals, also
consider whether to discontinue opioid therapy and initiate and document a plan
for dosage reduction and/or referral to a pain specialist. For physically dependent
patients, a safely structured tapering regimen must be initiated and/or referral
made to an addiction specialist.
7) Verify your internal controls. Protect your prescription pads, do not allow anyone
authority to give prescriptions to patients you have not seen and do not have
signed prescriptions prepared ahead of time. Do not ignore drug seeking behavior.
Document and report drug diversion and prescription forgery and terminate such
patients. Take note of, and respond to, patients with obvious impairment,
accidental overdoses, etc. At least annually obtain a state pharmacy profile on
yourself and have your staff ensure that the only people listed to be getting
prescriptions from your office are actually your patients. Your medical record
must contain all prescription orders for opioid analgesics and other controlled
substances whether written or telephoned as well as documenting written
instructions given for those medications.
Good records will become crucial to establish that the prescriptions you provided were for a legitimate medical purpose and in the course of professional practice. It has been a very disturbing development for the U.S. District Court to allow the Board’s opioid policy to be used by a jury to determine whether a physician had illegally prescribed a controlled substance under federal drug trafficking laws. With the prescription drug abuse epidemic at an all-time high in the United States, the government has elected to target health care providers as a primary source for legal drugs which wind up getting diverted into the wrong hands and/or being abused by patients often through no fault of the health care providers. Providers need to be aware this is the reality we are seeing today and jurors are accepting the argument that the physicians must stop prescribing.
Even though the physician/patient relationship is grounded in trust and honesty, providers cannot rely on this time-honored expectation when prescribing narcotic medications so prone to abuse by patients and having such a high value on the street of over a dollar per milligram. In many instances, patients that have been arrested for diverting narcotic medications have been offered plea deals in exchange for turning in the physicians who were innocently and unknowingly providing medication for what they thought was a legitimate medical purpose.
In both cases involving the family practice physicians convicted in Idaho this spring, both had undercover officers (wearing audio and video recording devices) coming in posing as fake patients who were able to obtain narcotic pain prescriptions. These undercover officers gave compelling stories to the providers who believed them, provided prescriptions and then found themselves being charged criminally for every one of those prescriptions. These doctors were forced to try and defend themselves, not because they were bad doctors, but because did not comply with the dictates of the Board’s opioid policy. Unfortunately, both are now facing years of prison time. If
you are prescribing over 150 narcotic pain pills per month to any of your patients, the federal government may already be monitoring you via your state’s pharmacy profile.
Please take these recommendations to heart and do not let yourself become a casualty in our government’s latest war on drugs.
Terrence S. Jones
Quane Jones McColl, PLLC