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8 Articles in this Series
Introduction
AAPM's Advice for Evidence-Based Opioid Prescribing Guidelines
CBT for Chronic Pain and Insomnia Needs More Research
Farewell Opioid Therapy, Hello Mental and Behavioral Health
Ketamine’s Growing Use in Chronic Non-Cancer Pain Management
MR Neurography in CRPS Assessment
Navigating New Opioid Prescribing Requirements: Practical Legal Advice for PCPs & Pain Specialists
TACs: Identifying and Treating the Non-Migrainous Headache
Video: Dr. Aronoff on Shifts in Pain Care

Navigating New Opioid Prescribing Requirements: Practical Legal Advice for PCPs & Pain Specialists

With presentations from Lynn Webster, MD, and Michael Barnes, Esq

Perhaps one of the most well-attended sessions at the 2018 annual meeting of the American Academy of Pain Medicine was a unique presentation featuring Lynn Webster, MD, and Michael Barnes, Esq, on how changes in legislation and litigation are affecting patient care. The duo provided an engaging back-and-forth dialogue in which Dr. Webster posed common, but perhaps unvoiced, questions living in the minds of pain practitioners today, and Dr. Barnes offered a legal response.* Presented in the context of the United States’ declared national public health emergency on opioids, an increase in DEA investigations into physicians working with chronic pain patients, and a slew of legal shifts, the session provided practical recommendations for today’s healthcare provider who may be concerned about opioid prescribing.

 

State Trends in Dose, Duration & Documentation

Barnes provided an overview of trends in state legislation surrounding opioid prescribing, noting that 130 new bills were considered among 19 states in 2016 and 2017 alone, largely in response to the 2016 CDC Guidelines. “It’s imperative you and your staff understand the state laws that have been in place that affect your practice,” he told the audience. “You have to comply, and you have to document that compliance. This is in addition to meeting standard-of-care compliance.”

Some of these new laws address initial opioid duration and dose limits. For example, Florida has a 3-day limit for first-time opioid prescriptions. These periods go up to 14 days in other states, such as Nevada. For controlled opioid therapy, many states have a 30-day supply limit. Rhode Island has the most stringent per-day dose law (30 MME/day), but noted Barnes, there are exceptions that can be made to these dosage limits as long as they are documented, including, in some cases, getting a signed patient responsibility form and consulting a board-certified pain specialist. This consult could mean a phone call or a full evaluation depending on the state requirement.

“You can use these laws to distinguish yourselves from those who are unaware or not following the changes,” said Barnes. But how can a practitioner manage these shifts realistically, asked Dr. Webster, especially when they have patients suffering?

Barnes advised that physicians may have to run their practices differently—even if that means having patients come back on day 14 for an evaluation and potential prescription renewal. In the end, “you must follow the law” to stay out of trouble, he said. These adjustments may involve a lot of additional documentation, including specific conversations physicians have with their patients regarding the risks of taking prescribed opioid medications. In addition, there should be a written treatment plan that is individualized and updated as the patient’s circumstances change.

 

When You’re Not a Pain Specialist

It’s no secret that many primary care physicians (PCPs), nurse practitioners, and physician assistants are becoming more involved in managing chronic pain, and yet, they may not always have adequate training in chronic opioid analgesic therapy (COAT). West Virginia has enacted a law to address this trend by asking physicians to refer patients to a pain specialist or to prescribe an alternative therapy as their first step; the state also now requires execution of a patient responsibility form within 7 days of receiving an opioid prescription. (see also recommendations from former federal prosecurors Jason Mehta and Lee Bentley, III)

If a PCP does not have a pain specialist contact, Barnes recommended a tele- or e-consult with a specialist or a pain organization resource. (Dr. Webster pointed out that AAPM members who are board-certified pain specialists could consider offering consulting services in this regard.)

Some of these strict laws have to do with ensuring that the patient is not trying to trick the physician into obtaining additional medication that they could be abusing or distributing. There may also be situations in which undercover agents are trying to get illegitimate prescriptions, according to the presenters (see also, DEA & Doctors Working Together).

To avoid getting caught up in these situations, Barnes and Dr. Webster recommended that healthcare providers avoid continual escalation of a dosage without updating a patient’s treatment plan. In addition, if a referral is not made, the physician should document the reason for not doing so.

Finally, if a patient comes to your practice from another doctor and is already on opioid therapy, find out why they are coming to you, why they were referred, and verify the legitimate medical need for opioids on your own account. Do not assume their chart is accurate, said Dr. Webster. Always conduct your own physical exam.

 

Patient Opt-Outs

There are emerging statutes that allow patients to opt-out of receiving opioids, similar to a DNR. Patients may sign up for this if have a history of opioid or substance use disorder, or for other reasons. These statutes have been enacted in Connecticut, Massachusetts, Pennsylvania, West Virginia, and Alaska, according to the presentation. However, these directives can be revoked orally or overridden in emergency situations.

 

Insurance Coverage

There are also bills in the works that would require insurers to cover alternatives to opioids. Dr. Webster pointed out that many insurance companies often deny alternative therapies, so how can a physician best gain approval? Barnes suggested that the provider document any insurance denials along with related patient requests. And, when possible, try to find an alternative therapy that is accessible, such as recommending daily walks when physical therapy is denied.

At the federal level, draft bills requiring insurance to cover abuse-deterring opioids have been introduced as well. See PPM’s updated literature review on this topic.

 

Federal Changes

There is a lot happening in Congress that is moving fast, said Barnes. Other federal changes include the convening of an HHS Task Force (expected to launch by July 2018) to explore any gaps or inconsistencies between best practices for chronic and acute pain management. The task force has been asked to propose necessary updates by July 2019. “Things could be very different 18 months from now” as regulators work to update and codify the CDC guidelines on opioid prescribing, he noted.

In addition, the Opioid Addiction Prevention Act of 2017 has been introduced to amend the Controlled Substance Act. If enacted, the change would require that practitioners seeking registration or renewal of a license to prescribe opioids in Schedule II, III, or IV to agree to limit an opioid prescription for the initial treatment of acute pain to the lesser of a 7-day supply (no refill) or an opioid prescription limit established under that practitioner’s relevant state law.

Laws for prescribing from the emergency room/hospital setting are also in the works, as is the CARA 2.0 Act of 2018. This federal bill, which Barnes said is likely to pass, proposes a 3-day limit on initial opioid prescriptions for acute pain, requires prescribers to check and pharmacists to report initial controlled-substance prescriptions, and increases related civil and criminal penalties. While the 3-day limit may not make it into the final bill, said Barnes, “this Act is likely to definitely impact your practice.”

One point to keep in mind, he and Dr. Webster noted, is that “everything opioid-related is bipartisan,” especially given its emergency status. The intended or unintended consequences of many of these bills are unknown, and there may be some challenges as the bill creators are not necessarily those working in medicine themselves, or in this case, pain medicine.

 

How Can a Practitioner Protect Him/Herself?

After sharing the ongoing changes in state and federal law, Barnes and Dr. Webster discussed how such litigation is impacting healthcare providers on a daily basis. “We have an obligation to treat those who suffer, and on the other hand, if we are using a controlled substance like an opioid, there is a higher standard,” said Dr. Webster. With greater risk, comes greater duty, he said, and also with that comes potential legal, civil, and criminal sanctions that put physicians between a rock and a hard place.

Essentially, “you are treating your patient, but you are also always building your defense,” added Barnes. Physicians should be forewarned that any patient can testify against them should a case arise. The simple question, did you provide a full physical exam at EVERY visit, may very well come up, for example.

Some legal standards to keep in mind:

  • Verify the patient’s legitimate medical need
  • Pursue an ordinary course of professional practice
  • Take reasonable steps to prevent harm
  • Document thoroughly (see also: Barnes MC, PainWEEK J 2017:5:52-59)
  • Actively verify and be vigilant.

These best practices should help protect a physician facing any civil or criminal liability, said Barnes, who helped to write the standards. And, from a common sense approach, avoid “willful blindness,” advised Dr. Webster. Don’t ignore the red flags. Perform the codified screening tests. And never assume that because a patient is elderly or has a special circumstance that you will be able to work around the law. For instance, some documented patterns of improper prescribing that should be avoided include, 

a repeated failure to:

  • engage with the patient regarding his/her current state of health
  • consult with other HCPS for help or advice (eg, mental health specialist if needed)
  • follow-up with caregivers on patient well-being
  • attend to concerns of others (eg, pharmacists, family)

and a continued willingness to:

  • fill prescriptions despite the above issues
  • prescribe opioids in the absence of patient benefit
  • prescribe opioids in doses or combinations that are inappropriate for the patient.

According to the presenters, a court may look at these issues as well as any seemingly superficial or absent exams, prescribed quantities/doses of opioids that do not have a clear relationship to patient function, and a failure to record information regarding a patient’s prescription, diagnosis, or functional improvement.

 

At the End of the Workday

Two last tips offered to opioid therapy managers and prescribers by Dr. Webster and Barnes:

  1. Establish trust with your patient to ensure they are on board with the treatment plan.
  2. Be sure you can point to legitimate scientific research to support any action you have taken with a patient or treatment regimen.

Dr. Webster and Mr. Barnes closed their session by sharing two court case examples: the  State of Indiana vs Dr. Sturman and the State of Iowa vs Daniel Baldi, DO, which can be researched online or within the panelists’ slidedeck. Spoiler: Both doctors were acquitted as a result of standard-of-care documentation presented at the trials.

 

Source

Webster L, Barnes M. Legislation and Litigation: A Moving Target Impacting Patient Care. Presented at the American Academy of Pain Medicine annual meeting. April 26-29, 2018, in Vancouver, British Columbia.

*Of note, this presentation was supported by Pernix Therapeutics and was not sponsored or endorsed by AAPM. This presentation coverage and article do not claim to offer official legal or medical advice.

 

 

 

 

 

 

 

 

Next summary: TACs: Identifying and Treating the Non-Migrainous Headache
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