Comments from the American Academy of Pain Medicine (Docket HHS-OS-2018-0027-0001)
The American Academy of Pain Medicine (AAPM) wishes thank the HHS Pain Management Best Practices Inter-Agency Task Force for their dedication and efforts to improve pain care nationally. The document has been thoroughly reviewed by two major committees within AAPM: the Scientific Review and Guidelines Committee and the Behavioral Medicine Committee.
The emphasis on patient-centered and individualized care is appropriate, and special attention to particularly disadvantaged populations and often neglected populations such as children, adolescents, and older adults is appreciated.
A common theme throughout the HHS document is the inclusion of nearly all available options of treatments within a particular category with relative equal emphasis. While this approach provides a comprehensive review of the subjects, it is important to consistently acknowledge the level of evidence supporting any included therapies, as is the standard practice for the publishing of Practice Guidelines.
We provide below several key concerns and recommendations to improve the document and to better align its content with the biospsychosocial model of pain care and current evidence. We urge these recommendations be considered to improve the content of national policy and training needs for providers as well as information available for those who suffer chronic pain.
2.1 Approaches to Pain Management. We agree the biopsychosocial model of pain care has significant potential to improve patient outcomes and limit the unintended consequences associated with fragmented care. Pertaining to recommendation 1a. AAPM agrees with the HHS in the encouragement of coordinated care. We believe the strongest incentive to reach the goal of coordinated care is the allocation of resources to incentivize the multidisciplinary models of care, outlined subsequently in the HHS document.
However, an important addition to the section would be an emphasis on value-based healthcare delivery. Better management of pain in a comprehensive fashion improves both clinical outcomes and cost. Pain specialists are trained specifically to deliver multimodal care through the use of multidisciplinary services. Since the majority of what pain specialists treat is spinal pain, they are uniquely positioned as nonoperative spine care providers who are capable of enhancing value-based pain care management for some of the most expensive to treat groups of patients.
2.1.1 Acute Pain. We agree that the emphasis on the urgent needs of the patient in Acute Pain has tremendous potential to prevent and limit both long-term suffering from the development of chronic pain as well as the potential to prevent unwarranted overutilization of opioid analgesics and opioid addiction. Recommendations 1a-c, 2a-b have broad support from AAPM. Additionally, we recommend the allocation of resources for outcomes research in the assessment and early intervention of high-risk populations for the development of high impact chronic pain and addiction in the setting of acute perioperative and acute post-traumatic pain.
2.2 Medication. AAPM appreciates the significant effort in the review of available analgesics in the setting of acute and chronic pain and wishes to acknowledge that a multitude of guidelines, reviews, and comparative studies exist for the vast number of conditions associated with acute and chronic pain. We believe it is in the best interest of patient-centered care to make every effort to refer patients and providers to the specific guidelines or reviews appropriate to a particular clinical situation. As such, the general review of the diversity of medical options serves to remind the reader of the alternatives to opioid therapy, when such alternatives are desired. Specifically, reviewers of the document within AAPM have identified the following comments pertaining to the classification analgesics:
1. Consider the introduction of naloxone therapy in the recommendations and basic information regarding opioid utilization.
2. The unique and specific risks of methadone therapy should be integral to the discussion of opioid therapy for chronic pain.
3. The classification of anxiolytics as possessing “analgesic” properties is not widely recognized. Their utilization for concomitant symptoms associated with hyperarousal states and spasticity associated with some painful conditions is recognized, however. AAPM does not support their classification in the analgesic category. In particular, their utilization as an alternative or adjuvant to opioid therapy has the potential to encourage concomitant use with enhanced risks of adverse events.
4. The inclusion of abuse-deterrent technologies as a category designated as “being developed” misleads the reader from the consideration of the numerous abuse-deterrent formulations currently on the market. AAPM supports recommendations that encourage expanded access and further refined development of these formulations.
5. The category of topical analgesia is appropriate for this section of the publication. AAPM supports the inclusion of both prescription topical analgesics, including subcutaneous botulinum toxin, and compounded analgesics in this section.
AAPM supports recommendations 1a-d. We would support a collaborative effort amongst the various groups representing specific populations to develop practice guidelines that incorporate the biopsychosocial model of care.
AAPM supports recommendations 2a-e. We recommend clarification of the use of “oral and IV” relative to both “inpatient” and “outpatient” settings pertaining to the use of the limited list of nonopioid options. This topic may be more appropriately addressed in the section considering Acute Pain.
AAPM supports recommendations 3a-c pertaining to the utilization of nonopioids for the various types of non-cancer chronic pain.AAPM recommends references to specific guidelines that address these various subtypes to direct the reader to more specific information.
AAPM supports recommendations 4a-b and 5a-e pertaining to the use of buprenorphine for chronic pain and medication storage and disposal.
2.2.1. Risk Assessment. AAPM recommends the inclusion of risk assessment tools in which to direct readers for clinical utilization.
2.2.1.1 Prescription Drug Monitoring Programs. AAPM agrees with recommendations 1a-i. We would also encourage enhanced collaboration between private and governmental pharmaceutical providers.
2.2.1.2 Screening and Monitoring. AAPM supports the regular utilization of screening and monitoring techniques during concurrent opioid or controlled substance prescribing. The document refers to the AHRQ data pertaining to the lack of evidence supporting urine drug testing. AAPM supports a more balanced review of the topic as the utilization of UDT is included in recommendation 1a. AAPM supports recommendations 1a-b, 2a-b, 3a-b. AAPM agrees with the recommendation for referral to a pain specialist in “high risk” settings, and would recommend additional language indicating the alternative of behavioral medicine or a pain specialist in cases associated with “moderate risk or higher.” AAPM supports recommendations to educate providers regarding the appropriate actions arising from breaches of the opioid treatment agreement.
2.2.2 Overdose Prevention and Naloxone. AAPM supports recommendations 1a-c pertaining to Naloxone therapy.
2.3 Restorative Therapies. The general description of the techniques offers a very broad overview of a variety of non-invasive, non-pharmacological methods to address pain. AAPM recommends reference to specific guideline statements for the relevant conditions for which these alternatives are being considered. AAPM supports recommendations 1a-c. As indicated for other areas of treatment, trials of non-invasive therapies are generally warranted, and AAPM supports recommendations to improve patient access to restorative therapies through payer coverage determinations, with follow-up coverage of care determined by individualized outcome achievement. AAPM supports emphasis upon transitioning from “passive” therapeutic modalities to “active” and independent modes of therapeutic exercise when warranted by individual patient characteristics.
2.4 Interventional Procedures. AAPM recommends language acknowledging the role of interventional procedures for specific pain syndromes, and providing further information regarding relative evidence and availability of the interventional procedures described as a significant number of the interventional procedures remain “investigational” and therefore not recognized by payers, such as pulsed radiofrequency, peripheral nerve stimulation, and vagus nerve stimulation for headache, while others have demonstrated emerging patterns of lower efficacy, such as vertebral augmentation. AAPM also recommends clearly distinguishing the setting for which interventional procedures are recommended as the section blends indication for the acute perioperative and chronic settings. The section pertaining to intrathecal drug delivery omits the agent ziconotide as well as the utilization of many off-label medications in these devices. The utilization of adjuvants and opioid alternatives are believed to lower the risk or mitigate opioid-related adverse events and dose escalation. The utilization of agents other than corticosteroids for peripheral joint injections, as well as myofascial pain, has gained widespread acceptance. Examples include hyaluronidase, platelet-rich plasma, botulinum toxin, and prolotherapy. The inclusion of “Interspinous Process Spacer Devices” seems misplaced without a full review of the full range of treatment options for lumbar spinal stenosis. AAPM supports recommendations 1a-c, 2a-b, 3a-c. It is important to recognize that at the present time, the field of interventional pain management also encompasses the scope of practice of other skilled subspecialties such as neurosurgery, orthopedics, interventional radiology, and physiatry and there is currently no consensus pathway acknowledged by governing bodies regarding the performance of interventional procedures. AAPM supports language that promotes full training documentation and appropriate certification standards for the various interventional modalities available.
2.4.1 Perioperative Management of Chronic Pain Patients. AAPM supports the identification of this important need, and in addition to recommendation 1a, we recommend increased resources allocated to the research and development of care processes to mitigate the risks associated with this patient population in the perioperative setting.
2.5 Behavioral Health Approaches. AAPM recommends replacing this category with the term “Behavioral Medicine.” AAPM recommends discriminating the included forms of behavioral therapies according to relative evidence and utilization and highlighting the most effective forms of therapy. For example, emotional awareness and expression therapy has less evidentiary support than the other forms listed.
2.5.1 Access to Psychological Interventions. AAPM supports recommendations 1a-c in support of improving access to psychological interventions and recommends language supporting their utilization early in the course of treatment of pain conditions and patient populations at moderate risk or higher for development of high impact chronic pain or substance use disorder.
2.5.2 Chronic Pain Patients With Mental Health and Substance Use Comorbidities. AAPM agrees with the recommendations included in the section, 1a-d, and would recommend early referral to Behavioral Medicine and Pain Specialists in patients at moderate risk or higher for OUD and concomitant chronic pain in efforts to detect and institute early recognition and treatment of OUD in the setting of chronic pain. In addition to recommendation 2a, AAPM recommends enhanced training for providers in all disciplines that interact with the chronic pain patient of the need for early referral of patients at risk for OUD in the early stages of treatment for chronic pain. AAPM recommends enhanced training of providers pertaining to the concepts of integrated and interdisciplinary care in this patient population. Recommendations 3a-b pertaining to research support of the patient population affected by psychological co-morbidities and chronic pain with particular emphasis upon integrated models of individualized care. The utilization of technology in support of the needs of this population (Recommendations 4a-c) are supported by AAPM.
2.6 Complementary and Integrative Health. AAPM supports efforts to increase provider and public awareness of these modalities as part of an integrated, patient-centered approach. AAPM supports enhanced resources to identify specific patient populations and conditions amenable to these modalities with recommendations to consider enhanced resource allocation by CMS and private payers. (Recommendations 1a-b, 2a-b). AAPM supports language that would encourage the development of research protocols designed to evaluate the efficacy of herbal/medicinal remedies advocated as part of an integrative health plan (Recommendation 2c).
2.7 Special Populations. AAPM supports the language included in this section and recommends the additional inclusion of the needs of the LGBTQ community as they relate to acute and chronic pain and OUD.
3.1 Cross-cutting Clinical and Best Policy Practices. AAPM supports all efforts of public and provider education pertaining to the needs of the acute and chronic pain and addiction populations (Recommendations 1a-d, 2a) as they relate to “stigma.” Efforts to measure the success of public campaigns should be carefully assessed at appropriate intervals following implementation.
3.2 Education. 3.2.1-3.2.2. AAPM supports all efforts of public, patient, and provider education pertaining to the needs of the acute and chronic pain and addiction populations, with enhanced resources allocated to provider resources for patients, payer recognition, and follow-up strategies to improve outcomes particularly in the acute perioperative setting.
3.2.3 Provider Education. AAPM recognizes the need for provider education at all levels of training. AAPM supports the inclusion of the concept of the biopsychosocial model of care with emphasis upon integrated models of collaborating teams to ensure the concepts of individualized care are matched to current concepts of effective pain management (Recommendation 1a-c). AAPM supports efforts to incentivize training amongst the existing provider population through payer recognition, quality control measures of practice performance, and regulatory oversight of prescriptive authority.
3.3 Access to Pain Care. 3.3.1 AAPM supports collaborative efforts with the FDA and Drug Shortage Task Force to ensure the supply of medication is sufficient to meet the needs of the patient population.
3.3.2 Insurance Coverage for Complex Management Situations. AAPM supports the efforts listed for improved coverage of the increasingly complex responsibilities of providers to care for this patient population and encourage language to support the implementation of integrated models with built-in incentives for quality of life improvements, healthcare resource utilization, and functional outcome measurements.
3.3.3 Workforce. AAPM supports efforts to promote the development of a sufficient number of Pain Medicine specialists of all disciplines and advance the knowledge and expertise of non-specialist providers caring for the patient population. AAPM acknowledges these efforts require improved payer resources to maintain sufficient representation of the entire spectrum of providers necessary to implement integrated, multidisciplinary care.
3.3.4. Research.AAPM supports language recommending clinical and basic research associated with acute and chronic pain conditions (Recommendations 1a, 2a, 3a-b, 4a) and recommends additional resources devoted to the follow-up of integrated care models, provider, patient, and public education through quality-assurance reporting, registries, and technological measures (pharmaceutical data tracking) to continually measure and adjust the strategic efforts to reduce the burden of acute and chronic pain.
4. Review of the CDC Guideline. AAPM agrees with the Task Force in the principle concerns raised by the CDC Guideline and ensuing public health implications (Recommendation 1a-b). AAPM recognizes the need for high quality research pertaining to opioid duration of benefit. AAPM supports efforts to determine the most cost-effective means to obtain high quality population-based data. Traditional routes of pharmaceutical research, through RCTs and drug development, have demonstrated limits of applicability to clinical practice for many pain conditions. AAPM agrees with Recommendation 2 as subpopulations of opioid “responders” exist in clinical practice representing a vast number of clinical conditions, dosage ranges, duration of benefit, and specific regimen employed. (Recommendation 3a-c) AAPM supports efforts to develop individualized opioid dosing guidelines that take patient history and specific pain conditions into consideration. (Recommendation 4a-c) Opioid tapering and escalation guidelines are supported by AAPM with language supporting referral for integrated models of care and behavioral medicine assessments concurrent with and during considerations of opioid tapering. (Recommendation 5) AAPM supports thorough education of providers regarding appropriate alternatives, evaluation needs, and means of opioid escalation. (Recommendation 6) AAPM supports the cautionary language pertaining to concomitant benzodiazepine and opioid use and recommends supportive language of minimal effective dosing and benzodiazepine alternative strategies in patients with co-morbid conditions requiring anxiolysis. Recommendation 7 is supported by AAPM with recommendations to include language encouraging providers to educate patients regarding the risks of high-dose opioids. In addition to addiction, physical dependence, and overdose, risks include hyperalgesia, chronic respiratory depression, hormonal suppression, and impaired gastrointestinal motility. AAPM supports regular surveillance of high dose opioid adverse events in addition to the standard functional reporting requirements listed in the Task Force document. (Recommendation 8) AAPM strongly supports language identifying the individuality of the acute pain experience and the need for providers to perform regular assessments of patient status during the recovery period to ensure optimal outcomes, as well as the concepts of multi-modal and multidisciplinary care.
About AAPM
The American Academy of Pain Medicine is the premier medical association for pain physicians and their treatment teams with some 2,000 members. Now in its 36th year of service, the Academy’s mission is to advance and promote the full spectrum of multidisciplinary pain care, education, advocacy, and research to improve function and quality of life for people in pain. Information is available on the Academy’s website at painmed.org.
Approved by the AAPM Executive Committee on April 1, 2019