29 Jun Fostering Physician Compliance with the Evolving Opioid Prescription Requirements
Written by: Jacob H. Raehn, Esq.
Why are Government Organizations “Targeting” Physicians?
Short answer: Law enforcement is seeking to stop the Opioid-abuse epidemic at the source.
Long answer: Opioids are the apex predators of the substance abuse world, and they are not choosy about their victims. This includes both prescription drug and street drug abuse. Moreover, prescription opioid addiction often spirals quickly to street drug versions of the same. If you have ever contemplated how someone goes from being a law-abiding citizen with chronic back pain, to picking up a needle to inject heroin into their arm, or the spaces between their fingers and toes, prescription opioids are often how it starts. “Drug poisoning deaths are currently at their highest ever recorded level, and every year since 2009, drug poisoning deaths have outnumbered deaths by firearms, motor vehicle crashes, suicide, and homicide.” In 2014, approximately 129 people died every day as a result of drug poisoning. In addition to the physical burden the opioid epidemic has caused for individuals and their families, the financial burden has been similarly crippling. In 2014 alone, almost 1.3 million people in the United States required hospital care for opioid-related issues.In 2014, the rate of opioid-related inpatient stays was highest among patients ages 25-44. Patients ages 65+ accounted for the second highest number of opioid-related hospital stays. For these reasons, federal grants for enforcement of opioid related prosecution have increased exponentially.
What are the Potential Consequences of a Compliance Investigation for the Physician?
We have always been taught to write beginning with the end in mind. With that mentality at the forefront of this conversation, and with the goal of preventing worst-case scenarios for physicians, the spectrum of sanctions for prescription noncompliance can include private reprimand by the state’s Medical Board, up to, and including, full criminal prosecution by the state’s Attorney General’s office, with substantial jail time attached., Hopefully we have your attention now.
What Happens During the Investigation Process?
The progression for triggering an investigation is typically a bit different for hospitals versus private practitioners or physician groups.This article will discuss the process for physicians, including pain management and opioid addiction-management specialists. Note that the five steps enumerated in this article are an example of how a Medical Board’s process may transpire. All steps discussed may not be necessary, they can occur in a different order, and are case-specific. Moreover, a complaint does not always lead to a full-blown Board investigation.
1. Complaint is Filed with the State Medical Board against the Physician:
The private practitioner may find themselves the subject of a complaint – either from a disgruntled patient or a patient’s family member. The highly-addictive nature of the prescribed medications makes pain management specialists more susceptible to having a complaint filed against them by patients who have been cut off – or cut back – regarding their opioid-related prescriptions. This means the rate of complaints may be higher for opioid compliant Physicians. Regardless of the motivation for the Complaint, the fact it has been filed with the Board against a physician may trigger the need to put their insurance carrier on notice and is a good time to discuss retaining counsel with their carrier.
However, there are other factors that private practitioners should evaluate when they receive notice that a complaint has been filed against them personally or against their practice group. For instance, if the physician’s – or physician group’s – patient records are in compliance with government requirements, their Prescription Drug Monitoring Program (PDMP) data is up-to-date, and prescribed drug amounts are reasonable in quantity and reasonable for the patient’s clinical condition(s), then the physician, or practice, is likely in compliance and dealing with a disgruntled current or former patient. However, the Board has no obligation to tell the physician the identity of the individual asserting a Complaint, and they have no duty to produce copies of the information they obtain in their investigation unless and until there is a hearing on the matter.
2. The Medical Board Reviews the Complaint for Substance and/or Assigns an Investigator:
The Board’s investigatory powers are broad. Any person properly conducting an investigation on behalf of the Board shall have access to and may examine any writing, document, or other material. The Board may issue subpoenas to compel access.
As discussed previously, the Medical Board will review the merits of a complaint and take into consideration the physician’s history of prescription compliance, the scope of the allegations, and the discernable accuracy of the complaint’s allegations from independent sources. One example of an obvious need for further investigation would be a complaint from a parent alleging the physician failed to perform drug screenings and prescribed their adult child opioids, of which the child had a documented history of abuse. The child then ends up in the hospital for a suspected opioid overdose. This would certainly be a situation – however fictional – where the Board would conduct a full investigation into the physician’s prescription practices.
Often times, however, the facts alleged are more superficial and require the Board to initiate other steps, such as reviewing the physician’s PDMP report. The Board Investigator may also simultaneously submit a subpoena to the physician for patient records. This is usually the first time the physician becomes aware that a Complaint has been filed. Notably, a physician has no right to due process during the investigatory period, because an investigation does not constitute charges against the physician.
Physicians should also be mindful that no part of the investigation record will be released for any purpose other than for a hearing before the Board. This is because physicians have no right of access to the Board’s investigative file. The exception being the hearing phase, which will be discussed below.
3. Medical Board Peer Review of the Physician’s PDMP report;
A physician’s PDMP reporting compliance is paramount to their early defense of prescription noncompliance allegations. PDMP reporting requirements are constantly changing and vary from state to state, including the amount of time a physician has to update and review their PDMP. For example, as of May 2017, all but three states – Missouri, Texas, and California – have enacted statutory authority requiring nonresident pharmacies to report to PMP. States also vary in their requirements for which prescription controlled substances must be reported. For example, Georgia requires reporting schedule II-V controlled substances. South Carolina only requires reporting schedule II-IV controlled substances.
In Georgia, the recently passed House Bill 249 would require prescription drug dispensers, among other requirements, to update the state’s Prescription Drug Monitoring Program (PDMP) every twenty-four hours and require physician prescribers to check the PDMP every time they prescribe a Schedule II drug beginning in 2018. H.B. 249 would also shift the Georgia PDMP’s administration from the Georgia Drugs and Narcotics Agency (GDNA) to the Georgia Department of Public Health (GDPH). The bill will also impose new requirements on physicians. PDMP compliance is especially important because it can help exonerate the physician early in the investigatory process.
For example, the Board will look to see if the physician is in compliance by having their prescriber identification number or prescriber’s DEA permit number associated with each prescription. They will examine the quantities of each prescription and the number of refills available for each prescription before physician approval is required. H.B. 249 will also change the requirements, such requiring a physician review PDMP information the first time the physician issues a prescription for specific controlled substances, and thereafter at least once every 90 days.
The physician’s PDMP compliance requirements will also vary by area of practice. Physicians engaging in medication-assisted opioid dependency treatment may be entitled to a Buprenorphine waiver under the Data Addiction and Treatment Act of 2000 (DATA) as an exception to the Controlled Substances Act. A waiver requires the physician meet strict notice requirements and course training, which is then reviewed by SAMHSA. Notably, Pain Management Clinics often have additional requirements for initial licensure and notice of office location changes. They are also subject to stricter prescription guidelines.
Once the PDMP findings are complete, recommendations are made to the Board as to whether or not to pursue further action against the physician. Overall, PDMP compliance is the easiest, most objective, and most effective information a physician can show the Board in defense of the Board’s investigation. Note, however, peer review recommendations do not preclude the Board from, or require the Board to, take further action.
4. Subpoena for Patient Records;
If the Board finds a Complaint holds merit, the Board will likely subpoena patient records. A physician should never ignore a subpoena from the Medical Board. To do so is at the physician’s own peril and puts the physician’s license at risk.
The Board will use subpoenaed patient records to determine whether or not the prescriptions in the patient records correlate to the medications for each patient in the physician’s PDMP. Among other considerations, they will also look to see if urine screenings for substance abuse are being properly utilized.
The subpoena can also be the most burdensome step in the process for the practitioner because it requires the physician to take the time to make patient files available outside of their medical records system – which may be hardcopy, electronic, or a combination thereof. This can take minutes or hours per patient file, depending on the physician’s records system and their support staff capabilities.
The first thing a physician can do to lessen the subpoena’s burden is to be proactive by staying on top of their charting and ensuring compliance with federal and state charting guidelines. The second thing they can do is request, through their counsel, the Board narrow the scope of their subpoena to a sample set of patient records. For instance, some jurisdictions have found a sample set of 5-10 patient records to be compliant with a medical board subpoena. However, often the Board will want to review the PDMP and request specific patient’s records comprising the sample set. Physicians are also permitted to release otherwise HIPAA protected patient information to the Board. However, the Board is still required to give the patient notice their information has been subpoenaed, and give the physician a copy of the notice sent to each patient.
5. The Board will vote on whether or not to take further action in the form of a Hearing or Lesser Sanctions Not Requiring a Hearing;
If the evidence collected against the Physician is compelling, there will likely be a hearing on the matter during which the Physician can make their case. However, from experience, and through conversations with the Georgia Attorney General’s office, we believe it is generally considered a good course of action to reach out to the Board and schedule a meeting with the Board, the physician and physician’s counsel before a hearing takes place. This gives the physician the opportunity to informally make their case, appear cooperative with the process, and if the allegations are severe, discuss the possibility of lesser imposed sanctions, such as a private reprimand.
What does the Hearing Process Entail?
A Medical Board hearing plays by its own rules. If the physician’s case reaches the hearing stage, ensure proper notice of the hearing was received. Proceedings by the Board contemplating license suspension, termination, or public reprimand typically require prior notice to the physician and an opportunity for a hearing. For example, in Georgia, this is known by statute as a “contested case.” If the Board has not previously subpoenaed patient records, notice of a hearing could be the first time the physician learns an investigation has taken place.
A physician should never ignore a notice for a hearing. A physician should also never attend a hearing without counsel, and without first preparing with counsel. A physician should consider counsel to be a prerequisite to any Board hearing due to: (1) the type of evidence involved; (2) the triggering of the physician’s constitutional right to due process; and (3) the divergence from standard civil and criminal evidentiary rules for a hearing.
Once a hearing is noticed, a physician is entitled to the Board’s investigatory materials. Additionally, the physician is also entitled to the complainant’s identity, if the complainant’s identity could be viewed as exculpatory, favorable, or arguably favorable to the physician’s defense.
During a Medical Board hearing, the evidentiary rules diverge from typical civil or criminal litigation. In Georgia, for instance, Board hearing rules are defined by statute. During a hearing, any record relating to any patient of the physician shall be admissible into evidence, regardless of any statutory privilege applicable to the patient. No patient may withhold testimony bearing upon the physician’s fitness to practice based on privilege grounds. Any testimony or written evidence relating to a patient is reviewed by the board in camera and is not available to the public. The Board may also exclude all persons from its deliberation of the appropriate action to be taken. Finally, the Board may, by its own discretion, speak to a physician in private.
These rules also create potential issues when it comes to creating a record for appeal. For these reasons, it is vital the physician and physician’s counsel determine a plan for the hearing and collect all requisite exculpatory information prior to the hearing.
If the hearing is unsuccessful, the Board’s decision may be appealable. The Board may also refer the investigation and their findings to the Attorney General’s office for further criminal prosecution.
How Does a Physician Avoid Action from the Medical Board?
It is our goal to ensure physicians, practice groups, and hospitals are prepared for a complaint through best practices implemented long before a complaint comes down the pipeline. We are optimistic that once the intricacies of the rules are well-known and followed, practitioners will never find themselves in the situation where they need to decide what to do following a Board hearing. Ultimately, we believe this will also lead to a reduction in national opioid epidemic casualties, as practitioners become more familiar with the process for flagging opioid addiction risk through methods intended to buttress their clinical judgment.
We will be specifically addressing in further detail each topic discussed herein through separate articles. We look forward to your inquiries, and participation in the opioid enforcement conversation.
 We are aware there are myriad origins for substance abuse, but will use this article series to address the implications of prescription-sourced opioid abuse.
 From Student Athlete to Heroin Addict, CBS News, March 2, 2016, http://www.cbsnews.com/news/opioid-painkiller-guidelines/ (last visited June 28, 2016).
 Drug overdose deaths in the United States continue to increase in 2015, Centers for Disease Control and Prevention, https://www.cdc.gov/drugoverdose/epidemic/ (last visited June 28, 2017)).
 2016 National Drug Threat Assessment Summary, November, 2016, https://www.dea.gov/resource-center/2016%20NDTA%20Summary.pdf (November 2016)).
 Opiates – natural and synthetic – legal and illegal – which are intended for human use are: Heroin, Fentanyl, Morphine, Oxycodone, Hydrocodone, Oxymorphone, Hydromorphone, Codeine, Meperidine, Tramadol, Opium, and Methadone. Individuals are also now resorting to using synthetic opioids intended for animals, such as Carfintanil, which is an elephant sedative that is immediately lethal to humans. Chanen, David: Minnesota law enforcement agencies chasing new, deadly opioid, Star Tribune, April 30, 2017, http://adimages.startribune.com/mcu/startribune-interstitial_v3.html?sz=/7932/website/web_test/interstitial_core&w=640&h=480&dsmid=4315921&aa=9&cl=1&ref=http%3A//www.startribune.com/minnesota-law-enforcement-agencies-chasing-new-deadly-opioid/420856153/ (last visited June 28, 2017).
 Weiss AJ (IBM Watson Health), Bailey MK (IBM Watson Health), O’Malley L (IBM Watson Health), Barrett ML (M.L. Barrett, Inc.), Elixhauser A (AHRQ), Steiner CA (Institute for Health Research, Kaiser Permanente). Patient Characteristics of Opioid-Related Inpatient Stays and Emergency Department Visits Nationally and by State, 2014. HCUP Statistical Brief #224, June 2017, Agency for Healthcare Research and Quality, Rockville, MD. (last visited June 28, 2017)).
 The Federal government, through the DHS, has earmarked $485 million in grant money contained in successful bipartisan legislation signed by former President Obama late last year. The funds, now under the Trump administration are aimed to: (1) access to treatment and recovery services; (2) make overdose-reversing drugs more widely available; (3) increase stepped-up public health surveillance of the epidemic; (4) support for research on pain and addiction; and (5) promote better ways to help patients manage pain. Foody, Kathleen: Feds to Provide $485M in Grants to Combat Opioid Epidemic, Associated Press, April 19, 2017, https://www.usnews.com/news/best-states/georgia/articles/2017-04-19/feds-to-provide-485m-in-grants-to-combat-opioid-epidemic (last visited June 28, 2017).
 For fans of Stephen Covey, this is also considered Habit No. 2 of ‘The 7 Habits of Highly Effective People.’
 “The Georgia Composite Medical Board is authorized to take disciplinary action for violations of laws and rules and regulations which relate to or in part regulate the practice of medicine.” See Ga. Comp. R. & Regs. 360-3-.03 (citing authority pursuant to: O.C.G.A. §§ 43-34-1 to 43-34-12; O.C.G.A. §§ § 16-13-2 to 16-13-3; 21 U.S.C. § 13. O.C.G.A. § 26-4-1; The Rules of the Georgia Composite Medical Board, Ch. 360, Rules and Regulations of the State of Georgia; The Rules of the Georgia State Board of Pharmacy, Ch. 480, Rules and Regulations of the State of Georgia, in particular those relating to the prescribing and dispensing of drugs; The Code of Federal Regulations Relating to Controlled Substances (21 C.F.R. par. 1306); and O.C.G.A. § 31-9-6.1 and Chapter 360-14 of the rules of the Georgia Composite Medical Board relating to informed consent.).
 Ludlow Doctor Sentenced to Jail for Illegally Prescribing Opioids to At-Risk Patients, Massachusetts Attorney General’s Press Release, May 16, 2017, http://www.mass.gov/ago/news-and-updates/press-releases/2017/2017-05-16-ludlow-doctor-sentenced.html(last visited June 28, 2017).
 Hospitals and Hospital Systems are typically surveyed by JACHO, which we will cover in a later article.
 “The Board” as used in this article is meant to represent a state’s Medical Board generally, and is not state specific. Where noted, Georgia’s Composite Medical Board may be used specifically for demonstrative purposes. DEA, DOJ, and other government enforcement agencies will be the topic of later articles.
 “A physician shall be required to maintain a patient’s complete medical record, which may include, but is not limited to, the following: history and physical, progress notes, X-ray reports, photographs, laboratory reports, and other reports as may be required by provision of the law. A physician shall be required to maintain a patient’s complete treatment records for a period of no less than 10 years from the patient’s last office visit.” Ga. Comp. R. & Regs. 360-3-.02(16)(a).
 CONTROLLED SUBSTANCES (SCHEDULE II, III, IV OR V): Rule 360-3-.02. requires appropriate records, which at a minimum, shall contain the following: (a) The patient’s name and address; (b) The date, drug name, drug quantity, and patient’s diagnosis necessitating the Schedule II, III, IV, or V controlled substances prescription; and (c) Records concerning the patient’s history. Ga. Comp. R. & Regs. 360-3-.02(7).
 Complainant’s identity and the physician’s right to access the Board’s investigation materials are not available until Due Process attaches, which is not until a hearing is noticed. See Gilmore v. Composite State Bd. of Med. Examiners, 243 Ga. 415, 254 S.E.2d 365 (1979); See also O.C.G.A. §§ 43-1-19(h)(2), 43-34-37(d); Const. Art. 1, § 1, Par. 2.
 O.C.G.A. § 43-34-8(d).
 Where no charges had been preferred against doctor, but investigator for the Composite State Board of Medical Examiners was attempting to gain information concerning doctor’s fitness to practice medicine, due process did not require doctor be informed of nature of charges made to the Board or the names of his accusers, nor was doctor denied due process because he was not permitted to participate in selecting documents to be collected by investigator or to participate in the deliberations prior to the decision to initiate proceedings against him. Gilmore v. Composite State Bd. of Med. Examiners, 243 Ga. 415, 254 S.E.2d 365 (1979).
 Rogers v. Composite State Bd. of Med. Examiners, 245 Ga. 364, 265 S.E.2d 1 (1980).
 Substances Monitored by PMP, The National Alliance for Model State Drug Laws, May 2016, http://www.namsdl.org/library/8D7261F8-E47D-B6A5-DD0CAFA98FEA4846/ (last visited June 28, 2017).
 Id.; see also, O.C.G.A. § 16-13-59(a).
 At the time of this writing, G.A.H.B. 249 was still awaiting signature by Governor Nathan Deal.
 Physicians in Georgia should also search the PDMP for an existing patient when the following clinical situations apply: (1) For each patient the first time the patient is prescribed a controlled substance lower than Schedule II – for purposes of establishing a baseline and a thorough medical record; or (2) if a prescriber believes or has reason to believe, using sound clinical judgment, that a patient may be abusing or diverting drugs; or (3) each time a patient is prescribed an opioid drug product or benzodiazepine by the prescriber. Additionally, as of January 1, 2017, all Schedule II-V dispensed prescriptions must be reported to the PDMP system no later than the close of the following business day.
 21 U.S.C. § 13 – DRUG ABUSE PREVENTION AND CONTROL.
 To receive a waiver to practice opioid dependency treatment with approved buprenorphine medications, a physician must notify the SAMHSA Center for Substance Abuse Treatment (CSAT) of their intent to practice this form of medication-assisted treatment (MAT). The notification of intent must be submitted to CSAT before the initial dispensing or prescribing of opioid treatment. This topic will be discussed in greater detail in a future article.
 See O.C.G.A. §§ 43-34-283(a-f).
 See O.C.G.A. § 43-34-283(g).
 When a subpoena is disobeyed, the board may apply to the superior court of the county where the person to whom the subpoena is issued resides for an order requiring obedience. § 43-34-8(d). Failure to comply with Court order is contempt of court. § 43-34-8(d).
 See for example Ga. Comp. R. & Regs. 360-3-.02(16)(a).
 See Med. Bd. of California v. Chiarottino, 225 Cal. App. 4th 623, 170 Cal. Rptr. 3d 540 (2014) (The Court found five patient medical records sufficient for the Board to “fulfill its monitoring responsibilities of public protection as mandated by California law.” The subpoenas were considered “reasonably tailored to seek only the records that are necessary and material to the Board’s investigation.”).
 Under HIPAA, federal regulations authorizing disclosure of medical records permit a “covered entity” to disclose protected health information in the course of any judicial proceeding, either in response to an order of a court or in response to a subpoena, a request for discovery, “or other lawful process.” Moreland v. Austin, 284 Ga. 730 (2008).
 Private reprimands are confidential and not even available through Freedom of Information Act request. See Morton v. Skrine, 242 Ga. 844, 252 S.E.2d 408 (1979); and 15 Ga. Jur. Personal Injury and Torts § 36:119. However, there is no notice requirement before the Board initiates a private reprimand. See O.C.G.A § 43-34-9.
 “If licensee makes general or specific request for exculpatory, favorable, or arguably favorable information which is relative to formal complaint brought by Composite State Board of Medical Examiners, State Constitution requires that Board furnish information requested in same manner as prescribed in Brady.” Wills v. Composite State Bd. of Med. Examiners, 259 Ga. 549, 384 S.E.2d 636 (1989) (citing Const. Art. 1, § 1, Par. 2; O.C.G.A. §§ 43-1-19(h)(2), 43-34-37(d)).
 O.C.G.A § 43-34-9.
 O.C.G.A § 34-43-8(e).
 O.C.G.A § 43-34-8(f).
 See O.C.G.A. §§ 43-1-19(h)(2), 43-34-37(d).