Prescription-Drug-Abuse-US-Legislation

Prescription Drug Abuse Cases Are Hitting Idaho Providers Hard

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

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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. See http://bom.idaho.gov/BOMPortal/BOM/PDF%20FORMS/

ModelPolicyUseofOpioidAnalgesicsinTreatmentofChronicPain.pdf.

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

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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

chart.

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,

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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

initiated.

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

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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

US Bank Plaza

101 S. Capitol Boulevard

Suite 1601

P.O. Box 1576

Boise, Idaho 83701

(208)780-3939 Telephone

(208)780-3930 Facsimile

tsj@quanelaw.com

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