I. What Are Clinical Practice Guidelines?

A Clinical Practice Guideline is a document that defines a standard of diagnosing, care and treatment that is generally accepted and presumed followed by a group of health care providers. Radiologists might have a Clinical Practice Guideline for diagnosing and treating breast cancers; so might oncologists. PMR physicians and Orthopedists might have their own Clinical Practice Guidelines for treatment of various chronic conditions. Sometimes, organizations might have joint guidelines. Some organizations, such as the New York State Pain Society, could generate guidelines that are multi-specialty in nature.  A government agency such as the CDC or Workers’ Compensation often generates Clinical Practice Guidelines.

The key is if the guideline is based upon reliable standards and measures.  The guideline should present a systematic approach  to the subject at hand. It should be based upon reliable research and studies. It should draw upon physicians and healthcare providers who are knowledgeable and experienced in the topic at hand. The inherent value of a Clinical Practice Guideline is the willingness of a physician population to adopt the guideline into their daily clinical practice.  While a guideline might become part of a law or adopted by an organization, in the end, the guideline is only as good as its quality.

By quality, we mean applicability in a useful way to the patient. If the guideline presents a paradigm for treatment, can a practitioner reasonably follow it? Does the guideline call upon you to perform reasonable actions? Is the bar set too high before a definitive diagnosis can be made? Often, this can only be determined by taking the guidelines out for a test drive. In other words, good guidelines must work in the real world. Impractical guidelines will soon be ignored by the practitioner.

Clinical Practice Guidelines may be used to either defend or prosecute a physician administratively, as with the Office of Professional Medical Conduct, concerning a physician’s license.  Since the “rules of evidence” are not adopted at administrative hearings, the administrative law judge has wide latitude as to whether or not the guidelines can be admitted as evidence.  Administrative hearings include the Office of Professional Medical Conduct and hospital hearings. The physician has a better chance  of getting them  admitted  into  evidence if your  attorney can  make  a showing that the guidelines are accepted  by the medical  community.

Clinical Practice Guidelines also play a potential role in medical malpractice suits in New York.  Malpractice suits are civil in nature. As such, the “rules of evidence” apply. By definition, Clinical Practice Guidelines are hearsay. Hearsay is any statement made by somebody else, to prove the truth of the matter being talked about.  An example of hearsay is when an expert witness testifies that Dr. Jones’ injection of 1cc of 1% lidocaine into the trigger point was efficacious or indicated as per the Clinical Practice Guidelines of the “ABCD Society”.   Can the judge allow this hearsay into evidence? At the risk of sounding like an attorney, “maybe”. There are several hearsay exceptions. The trick is convincing the judge that the hearsay being  offered into evidence falls into one of the exceptions.

The highest court in New York State is known as the Court of Appeals, not the Supreme Court. Fortunately, the Court of Appeals actually considered this matter in 2006. There was a medical malpractice case involving an anesthesiologist.  As part of that anesthesiologist’s testimony,  he testified to following a flow chart  or paradigm in deciding  to allow  the surgery to proceed without  the patient  having a prior cardiac  evaluation. The judge allowed the flow chart into evidence.  The Court of Appeals agreed.  The witness, the treating physician, could use the guidelines or paradigm as evidence because he was not using it to prove the truthfulness of the guideline, but just to inform the Court as to the process he took in formulating his medical opinion prior to the patient’s surgery. That might seem to be a distinction without a difference, but there it is! A guideline may be admitted into evidence under the proper conditions. The Court also held that as long as the treating physician partially (not totally) relied on the guideline in his medical decision making, the guideline was allowed into evidence. Not only that, but the attorney can ask all sorts of questions to the witness about the guidelines, such as who formulated it, who it is endorsed by, and who else uses it.  If the guideline is endorsed by a reliable entity and widely used, it will carry more weight with a jury. Hinlicky v Dreyfuss, 6 NY3d 636 Slip Op (2006).  It is generally inadmissible for expert, non-treating witnesses to reference Clinical Practice Guidelines. When the defense attorney is cross-examining the plaintiff’s expert witness, the defense attorney may ask if the plaintiff’s expert considers a Clinical Practice Guideline as authoritative. In the rare instance when the expert admits that he/she considers it authoritative, it may be admissible in a state court. In federal courts, if the judge rules that the guideline in question was established as authoritative, the guidelines may be admitted into evidence. Most, but not all, medical malpractice cases in New York are in state courts.

The National Practitioner Clearinghouse, part of the Federal Government’s AHRQ (Agency for Healthcare Research and Quality)  is the  website  for thousands  of Clinical Practice  Guidelines  that  meet  some  pretty  stringent federal standards  for quality. Frankly, the authors of guidelines that make the cut on this website have jumped through many hoops.

To demonstrate the maze of guidelines that are out there, I typed in the search terms “chronic pain” on the National Practitioner Clearinghouse website.  454 different guidelines appeared! What is useful, and what is not, often involves common sense.  If you practice in New York,  the Chronic  Pain  Disorder  Medical  Treatment  Guidelines  from the Colorado  Division  of Workers’ Compensation will  not be as helpful  to you as compared  to the New York version. The ACR Appropriateness Criteria Chronic Foot Pain will apply more to a radiologist than a similar guideline written for a physical therapist.

Clinical Practical Guidelines are hardly new. They have been around for over 20 years. Of course, guidelines must be updated periodically to keep up with new treatment regimens and scientific discoveries.  Depending on the subject, updates might have to be more frequent. For example, guidelines concerning the Zika virus might have to be updated more often as it is currently more thoroughly studied, than perhaps the efficacy and dosage of Tetracycline.

One of the big raps on Clinical Practice Guidelines is that it promotes cookbook medicine.  If properly written, a good guideline will leave room for clinical judgment. A well-written guideline will promote better and more consistent medical decisions.

One might ask what happens if you decide not to follow a generally accepted Clinical Practice Guideline.  The short answer is, you better have a good reason for departing from the guideline and you should definitely explain it in that patient’s medical record!

II. CDC Practice Guideline for Prescribing Opioids for Chronic Pain

In March of 2016, the Center for Disease Control (CDC) issued national Clinical Practice Guidelines “on prescribing opioids for chronic pain, for patients who are at least 18 years old, outside of active cancer treatment, palliative care and end-of-life care.” (CDC Guideline for Prescribing Opioids for Chronic Pain, United States, 2016). This guideline is a potential game-changer for the primary care physician who treats this type of chronic pain. The CDC stated that it felt that the guideline was necessitated by primary care physicians’ concern with misusing opioid pain medication in patients with chronic pain, defined as pain more than 3 months. Due to concern of addiction and over-dosage, these physicians desired authoritative guidance in opioid prescribing for chronic pain in non-cancer patients.  Many organizations, states and federal agencies, such  as  the  American Pain  Society,   the  American Academy of  Pain Medicine,  the US Department of Veterans Affairs, have developed their own guidelines for prescribing opioids. The CDC guideline purports to include  the  most  up-to-date  scientific evidence  along  with a systematic  review  of the evidence, review by experts in this area. The guideline is targeted for use by family physicians and internists who treat patients for chronic pain.

The guideline states:  “In summary, evidence on long-term opioid therapy for chronic pain outside of end-of-care remains limited, with insufficient evidence to determine long-term versus no opioid therapy, though evidence suggests risk for serious harms that appears to be dose-dependent.”  It also states that several non-opioid therapies have  been found effective in treating chronic pain, such as exercise therapy, behavioral  modification techniques,  mixing exercise with  psychological approaches, acetaminophen, NSAIDS COX-2  inhibitors, some anticonvulsants and some antidepressants, and for short-term  relief of chronic  pain, an epidural  injection.

The guideline then goes on to deal with 12 issues dealing with determining when to initiate or continue the use of opioids for chronic pain. Each will be discussed after being quoted, with its implications on your practice:

1.          Nonpharmacological therapy and nonopioid pharmacological therapy are preferred for chronic pain. Clinicians should consider opioid therapy only if expected benefits for both pain and function are anticipated to outweigh risks to the patient. If opioids are used, they should be combined with nonpharmacologic therapy and nonopioid pharmacologic therapy, as appropriate.

Your  chart  should  indicate,  in detail,  how  you  are  employing  these  specific recommendations, including  specific

reference to how you want  the patient  to functionally improve.   As an example-the goal to walk 10 blocks instead of

1 block.   The chart note should state how the patient is progressing or not in this regard.  Do not just mention a goal and ignore it later on.  What non-opioid therapies have been tried?  By whom?  How long?  Drill down as to detail.

2.          Before starting opioid therapy for chronic pain, clinicians should establish treatment goals for all patients, including realistic goals for pain and function and should consider how opioid therapy will be discontinued if benefits do not outweigh risks. Clinicians should continue opioid therapy only if there is clinically meaningful improvement in pain and function that outweigh risks to patient safety.

The “takeaway” from this recommendation, is that your medical chart should list specific realistic goals for each patient. General, lofty goals such as “walk better” are not sufficient. Quantify this in blocks walked. “Improved ability to lift” should be quantified perhaps by the weight of an object to be lifted when the patient is on opioid therapy as opposed to prior to the institution of such treatment. Quantify the pain as to type of pain; what precipitates it and in what ways it is ameliorated by the opioid therapy. Again, generalizations as to “increase function or activities in daily living,” will not suffice. If it is found that your patient is not obtaining sufficient benefits that outweigh the risks, an actual plan to wean them off the opioids should be included in your chart.  If a patient is at heightened risk to take

opioids due to some pathology, that should be noted in the chart and what  you, the physician, is doing to monitor this.

3.          Before starting and periodically during opioid therapy, clinicians should discuss with patient known risks and realistic benefits of opioid therapy and patient and clinician responsibilities for managing therapy.

This recommendation states that  there  should  be informed  consent  prior  to and while  the patient  is under  opioid therapy. Remember, informed consent is not just a signed consent form; it is a process of educating the patient.  It is highly recommended that this process be memorialized in your chart. When you educate your patient, which should be noted in your medical record; and not just the first time, but every time the patient is educated.  If a pamphlet or handout is given to a patient, note with specificity the handout given to the patient.

4.          When starting opioid therapy for chronic pain, clinicians should prescribe immediate-release opioids instead of extended-release/long acting opioids.

The key here is that it was found that longer-acting opioids appear to entail greater dosages than when shorter-acting alternatives were given on a p.r.n. basis. If you have a legitimate reason for starting therapy with an extended-release opioid, your record should spell out the reason why this is so.

5.          When opioids are started, clinicians should prescribe the lowest effective dosage.  Clinicians should use caution when prescribing opioids at any dosage, should carefully reassess evidence  of individual benefits and risks when considering increasing dosage to 50 or more morphine milligram equivalents (MME, and should avoid increasing dosage to 90 or more per day or carefully justify a decision to titrate dosage to 90 or more  MME/day.

While preparing this guideline, the CDC did not find that high doses of opioids for chronic pain was efficacious. It did find that high doses of opioids potentially compromised patient safety. Most practitioners are already titrating their patients’ doses when using opioids. However, it is of the utmost importance to clearly chart the titrating process and letting the reader of your chart into your thought process concerning how you arrived at the dosage you are currently prescribing; if  that  dosage   might  be  increasing or  decreasing, and  why.     Pain and function are not the only consideration; is the patient at increased risk to become addicted?  Was the patient addicted to opioids before? Does the patient have a history of addictive behavior? Does the patient have some type of pathology or genetic predisposition to having undesirable side-effects if dosage is too high? Your patient care should deal with all of these potential issues. Your chart should reflect that in fact, you did deal with these issues.

6.          Long-term opioid use often begins with treatment of acute pain. When opioids are used for acute pain, clinicians should prescribe the lowest effective dose of immediate-release opioids and should prescribe no greater quantity than needed for the expected duration of pain severe enough to require opioids. Three days or less will often be sufficient; more than seven days will rarely be needed.

The guideline now steps into the area of prescribing opioids in acute situations. Although this area is not the primary focus, this recommendation should not be ignored. We get back to medical justification of what dose is prescribed and how long the opioid is given.  Your record should justify your prescription. Your record should pay particular attention to acute situations where you want to prescribe for more than seven days.

7.          Clinicians should evaluate benefits and harms with patients within 1 to 4 weeks of starting opioid therapy for chronic pain or of dose escalation. Clinicians should evaluate benefits and harms of continued therapy with patients every 3 months, or more frequently. If benefits do not outweigh harms of continued opioid therapy, clinicians should optimize other therapies and work with patients to taper and discontinue opioids.

It is very obvious  that  lower  doses  of opioids,  less  pills,  alternate therapies, such  as  NSAIDS,  physical therapy, biofeedback, are  preferred.  Forewarned is forearmed! Document what you are doing to decrease the dosage of opioids.  If you are trying physical therapy, note it. Then, note the progress or lack of same. Note if there is patient compliance or not. You not only have to ask, but you have to chart that you asked and note the answer.

8.          Before starting and periodically during continuation of opioid therapy, clinicians should evaluate risk factors for opioid-related harms. Clinicians should incorporate into the management plan, strategies to mitigate risk, including  considering offering naloxone when factors that increase risk for opioid overdose, such as history of overdose, history of substance use disorder, higher opioid dosages or concurrent benzodiazepine  use, are present.

Does your patient abuse alcohol?  Is your patient currently on a benzodiazepine? This should be noted in detail and factored in to your treatment plan.  Consider prescribing naloxone for the appropriate patient.  Please, note all prescriptions and patient recommendations in your chart.

9.          Clinicians should review the patient’s history of controlled substance prescriptions using state prescription drug monitoring program data (PDMP) to determine whether the patient is receiving opioid dosages or dangerous combinations that put him or her at high risk for overdose. Clinicians should review PDMP data when starting opioid therapy for chronic pain and periodically during opioid therapy or chronic pain, ranging from every prescription to every 3 months.

In New York, there is the ISTOP program.  Obtain the PDMP data as suggested in suggestion 9 for each chronic pain patient taking opioids. Make sure that your records reflect that you checked ISTOP and what was found. It would not hurt to place a copy of that patient’s PDMP data in your chart.

10.        When prescribing opioids for chronic pain, clinicians should use urine testing before starting opioid therapy and consider urine drug testing at least annually to assess for prescribed medication as well as other controlled prescription drugs and illicit drugs.

This might seem obvious, but do not forget to place the urine drug test results in the patient’s chart. Initial them and date it, if your EMR allows.  The results should also be incorporated in the body of your progress notes. For example, if the results show patient compliance, the note should state that. If there is any irregularity, such as the patient testing positive for cocaine, the record should state that too. Then, the record must state what action you took as a result of that.  That  might  vary  from  a warning  for the  first violation  to stopping  the  patient’s  opioid  prescription for any additional violations.

11.        Clinicians should avoid prescribing opioid pain medication and benzodiazepines concurrently whenever possible.

As prescribing opioids and benzodiazepines together places the patient  at greater  risk for respiratory depression,  you should  have  a very  good  reason  for the medical  necessity to combine  the two.  Use an alternate treatment regime instead and let your record show why.

12.        Clinicians should offer or arrange evidence-based treatment (usually medication-assisted treatment with buprenorphine or methadone in combination with behavioral therapies) for patients with opioid use disorder.

You yourself need not provide this treatment; you can refer such patients out for treatment for opioid use disorder. However, your chart should reflect what is occurring and what is recommended, and what you are doing for this patient.

In conclusion, your chart should reflect, in detail, how you are complying with all of the relevant guideline recommendations. Administrative agencies, such as the Office of Professional Medical Conduct might find this CDC Guideline authoritative. That will mean that if you did not follow the guideline’s recommendations, there will be a presumption of substandard patient care. Only a carefully worded and detailed medical record will explain why you might have deviated from the guideline recommendations. In any case, a complete and accurate medical record is the single best thing that the primary care provider can do to protect him or herself from the various agencies, insurance companies, malpractice attorneys and criminal prosecutors. If utilized appropriately, clinical guidelines will provide a shield for you and your treatment of your patients.

Kern Augustine Conroy & Schoppmann, P.C., Attorneys to Health Professionals, DrLaw.com, is solely devoted to the representation and defense of physicians and other health care professionals. Mr. Kobak may be contacted at 1-800-445-0954 or via email at LKobak@DrLaw.com.