Saturday, January 30, 2010

Proposed Additions to a PCSS Guidance

A physician associated with the Physician Clinical Support System for prescribing methadone and buprenorphine has asked me, "do you have an edit or rewrite of the proposed guidance?  I would be very interested in what you would propose that would benefit our members as they are included in an audit."

My response follows:

  • Doctors are not accustomed to audits or investigations by law enforcement and are therefor vulnerable.
  • Doctors are unaware of their rights.
  • Doctors are easily intimidated by implied threats of criminal prosecution or revocation of licenses.
  • DEA agents are not accustomed to conducting audits or investigations of physicians.
  • DEA agents are not trained in how to conduct themselves in a way that respects the rights and privacy of patients.
  • DEA agents will base their conduct of audits on erroneous assumptions about medical practices.
  • Patients are at a disadvantage and unlikely to protest because of stigma and fear of loss of privacy
  • Patients are vulnerable to disruption of medical care.
  • These audits constitute fertile ground for violation of due process.
  • Unannounced and unscheduled intrusion of DEA agents will disrupt medical practice.
In many, if not most, jurisdictions there has been no written notice of impending audits. Different DEA field offices appear to have freedom to conduct audits in whatever manner they choose. There may be no national standard.

Questions arise even before the audit begins. If agents approach a physician outside the office, how must the physician respond? Must the agent identify himself/herself as such. Must the physician respond at all? What must agents do to properly identify themselves and demonstrate that their visit is proper. Can agents demand a physician provide identification if confronted in a hallway or parking lot?

Does the administrative order provide for more protection such that it may be preferable to unannounced audit? What does it entail? By whom must it be authorized? A judge? Must investigation under administrative order be scheduled?

How should a physician who uses electronic medical records handle the situation in which computer files cannot be accessed temporarily or permanently due to technical problems? May the physician postpone the audit until the problem can be corrected?

PCSS should offer guidance as to whether physicians can refuse to answer questions agents may ask that may not relate to buprenorphine records, for example:
  • Do you prescribe other scheduled drugs?
  • Any other “do you” question, not to mention Did you or Have you ever...?
  • Do you dispense other scheduled drugs?
  • Do you count pills?
  • Do you require patients to submit to random drug tests?
  • How often do you see patients?
  • Are you licensed to carry a concealed firearm?
  • Do you keep a weapon in your office?
  • Where do you live?
  • Do you have family members or colleagues who suffer from substance use disorders?
  • Have you ever been diagnosed with hepatitis? Opiate addiction? AIDS?
  • With whom do you live?
  • Have you ever used marijuana?
There may be a statute that specifies that agents may not ask about clinical matters. How is the boundary determined, and what are the consequences to the agent for crossing the boundary or the physician for refusing to answer? What recourse do physicians have for inappropriate conduct on the part of agents?

Physicians need to know whether we can decline investigation at a particular time because:
  • Office staff are not present
  • A witness is not present
  • Patients need attention
  • Records cannot be readily accessed
Can the physician terminate an investigation (and require agents to vacate the premises) if:
  • The witness or office staff must leave.
  • Patients need attention.
  • The physician believes the mission is completed and agents are extending their stay in order to intimidate.
  • Physician or staff becomes ill or incapacitated.
Will physicians be obligated to provide:
  • Copies
  • Access to a copier
  • Telephone
  • Seating (If we do not providing seating agents may be less likely to dally.)
How much will agents likely know about the physician before they arrive?
  • Criminal record?
  • Whether physician owns registered firearms?
  • Whether physician is licensed to carry a concealed weapon?
  • Whether physician has worked in the criminal justice system?
  • Whether physician has testified as an expert witness in criminal court?
  • Physician's immigration status?
Must physicians perform at the agents command, e.g. counting patients, or can we advise agents they must do that themselves? (Of course we must show them certain records as I fully expect to be asked.)

Agents may use audits as a pretext to investigate further matters they believe may lead to criminal charges, possibly subverting due process protection such as Miranda laws?

Buprenorphine patient count:

What determines whether a patient should be counted toward the 30/100 limit? Is it based on:
  • Date of last contact
  • Date of last prescription
  • Date when last prescription should have run out
  • Whether patient is alive or dead
  • Whether patient has been discharged
  • Whether patient has disappeared
  • Whether patient responds to phone calls
  • Whether patient has declared intention to stop using the drug, but may still have a supply
What about a patient who missed the last appointment, did not respond, has not obtained new prescriptions, but has scheduled an appointment in the future?

According to a recent article in Psychiatric News "agents will ask to see three months of records." If this is true, will the want the last three months counting backward from the day of the examination, the last three full months, or any three months. Will agents want to see records of any patient for whom the physician wrote a prescription during that period or for only those patients currently active?

Suggestions for strategy:

We cannot assume that DEA will answer any of the questions above. If DEA does answer the questions, we cannot assume that individual agents will abide by any answers provided. We must find alternatives means to collect information about how agents actually conduct themselves. We need to ask anyone who is audited to debrief, perhaps by developing a questionnaire which can be completed (anonymously) online, and perhaps modified as we learn more. We need to find out whether there is any covert, implied or overt threat that might result in physicians fearing to describe the experience, especially if agents inform them of any irregularity. We need to know whether any physician has initiated disciplinary action against an agent.

Each physician not yet audited should write a letter to the local DEA field office (return receipt requested) as follows:

I am writing to formally request that you schedule my audit of buprenorphine records. [Give date and time when patients will not be present, but physician and needed staff will be present.]

Please be advised that if your agents arrive unannounced, I will only be able to allow the audit if:
  • I have been able to confirm by telephone with your office that the agents are legitimate.
  • I am present
  • My office staff are present
  • No patients are present
  • There is no reason to believe that other practices sharing my office will be disrupted.
  • I will expect the agents to leave when asked and will allow them to schedule another encounter to complete any unfinished business.
Patients in my practice may work in state, local or federal law enforcement or related fields, or relatives of such. Because of this I need you to provide me with the identities of agents who will perform the audit at least thirty days before the audit. I will provide these names to my patients so they can determine whether they wish to risk being identified.

If individuals appear claiming to be DEA agents but have not been previously identified to me by you, I will contact your office by telephone and give you an opportunity to confirm their legitimacy. If I am unable to positively identify the agents as legitimate, I will ask them to leave. If they do not leave, I will contact local law enforcement. Anyone appearing at or remaining at my office without proper authority will be charged with criminal trespass.

Please be advised that no information that identifies a patient will be provided.

Even though DEA will not likely schedule the audit, evidence the agency received the letter will weaken any claim that the physician did not cooperate with the audit. 

More strategies:

We should establish a buddy system whereby physicians available will be notified by text (Twitter?), phone, or email when a colleague in the community faces an audit so they can travel to the office to provide support from a less threatened perspective, then gather and report on what they have observed.

We should suggest that all OBOT physicians abide by a complete or at least partial moratorium on new patients until DEA begins to schedule audits as I have done, and make sure that all concerned agencies know. This will underscore the likelihood that this policy has already discouraged many physicians from providing this treatment while preventing DEA from claiming that our protest is financially motivated. So far I have turned away 3 new potential buprenorphine patients.

I cannot imagine that this listing could cover all possibilities. Since I do not keep buprenorphine or other controlled substances in my office I have not attempted to include questions or strategies that might arise in relation to that aspect of the investigation. Perhaps someone even more paranoid than myself could add more items. Better yet, I invite comments from those physicians who have experienced audits already.

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