On behalf of the more than 5,000 members of the American Academy of Hospice and Palliative Medicine (AAHPM), we would like to thank the Centers for Medicare and Medicaid Services (CMS) for the opportunity to comment on the Potential Opioid Overuse electronic clinical quality measure (eCQM) under development. AAHPM is the professional organization for physicians specializing in Hospice and Palliative Medicine. Our membership also includes nurses and other health and spiritual care providers deeply committed to improving quality of life for patients facing serious or life-threatening conditions, as well as their families and caregivers. The timely and effective management of pain and other distressing symptoms is central to providing these patients with high-quality palliative care, and opioid analgesics are a critical tool in alleviating that suffering. With that in mind, AAHPM is concerned with how best to balance the growing challenges related to managing pain with opioids with the need for ready access to appropriate pain medications for patients with serious or complex chronic illness and those at the end of life – patients for whom high-dose opioids may be necessary and medically appropriate. The Academy recognizes there is an indisputable public health imperative to curb opioid abuse, misuse, and diversion, and is deeply committed to both providing continuing education that results in optimal pain management and optimal care for all patients as well as to collaborating with professional, regulatory and industry stakeholders to maximize individual and public safety. At the same time, AAHPM believes public policies and accountability structures must recognize there is an equally important public health imperative to ensure that our sickest, most vulnerable patients have access to timely, effective treatment of their pain and suffering. In the case of the draft eCQM, while we support the adoption of valid and reliable measures that hold practitioners accountable for responsible opioid prescribing, we have concerns that the measure takes a blunt approach to controlling opioid usage that is not evidence-based and that does not include sufficient protections to ensure access to medically necessary opioid analgesics for the high-need, seriously ill patients that AAHPM members serve. Our concerns and recommendations are detailed further below. Use of Milligram Morphine Equivalents (MME) to Determine Overuse While we recognize that the Centers for Disease Control and Prevention (CDC) has issued guidelines for prescribing opioids for chronic pain, there is limited evidence to support the use of a 90 morphine milligram equivalent (MME)/day dosage limit as a standard of care. Further, lack of agreement on an accepted methodology for converting dosage across various opioids challenges the validity of the 90 MME/day limit upon which the draft measure is based. Additionally, the CDC guidelines do not mandate limits on the dosage of opioids, and they allow for clinically justified use above the 90 MME/day value used under the draft eCQM. With the exception of the limited denominator exclusions (see additional concerns below), the draft measure fails to provide opportunities for clinicians to justify clinically appropriate higher dosages. The measure name itself suggests that the opioid levels prescribed may only signal “potential overuse,” not actual overuse, and it is not clear how clinicians could be held accountable to a performance standard on the measure without additional clinical data for each patient included in the measure’s numerator. AAHPM would be happy to work with CMS to determine how best to address this concern, including through the use of an expanded set of denominator exclusions. Insufficient Denominator Exclusions We are concerned that the Potential Opioid Overuse measure fails to respect the balance between appropriate pain relief and opioid overuse, primarily at the expense of seriously ill patients with persistent pain. While we appreciate that the measure includes denominator exclusions for patients receiving palliative or hospice care during the measurement period, as well as for patients with cancer and sickle cell disease, other patients with advanced stage serious illness – for example, end-stage chronic lung disease – who lack access to hospice or formal palliative care would likely continue to be captured in both the numerator and denominator. And while patients such as these may benefit from palliative or hospice care, many barriers prevent access to such services, such as culturally linked patient preferences, residence in rural or underserved communities, or physician failure to refer. As a result, clinicians who appropriately prescribe opioids for the management of their pain may either inappropriately be identified as contributing to opioid overuse, or alternately, inappropriately restrict access to necessary treatment for pain relief. The draft measure also fails to take into account the appropriate use of opioids for the treatment of addiction, including drugs such as morphine sulfate and methadone. A denominator exclusion that considers treatment of addiction during the measurement period would also ensure that these patients would be able to continue receiving treatment necessary to prevent further harms associated with opioid abuse. In addition to concerns about the comprehensiveness of the exclusions, we also have concerns that heterogeneity in the capability of certified electronic health record technology (CEHRT) to capture and code data regarding the delivery of hospice and palliative care may also lead patients to not be accurately coded as receiving such care. We have previously noted the ongoing lack of a standard lexicon to define aspects of palliative medicine for purposes of quality improvement and have urged CMS to invest in the development of a dictionary of data elements that would provide the standardization needed to ensure the accurate collection of information on hospice and palliative care for the purposes of quality measurement and improvement. We believe that such standardization would facilitate the use of CEHRT for quality measurement and data submission and drive patient-centered and family-oriented quality care. Recommendations Given the above concerns, we urge CMS to take a careful approach to the implementation of new electronic clinical quality measures to assess opioid prescribing that takes into account the appropriate use of opioids. Such an approach should ensure that (1) the eCQM provides a valid, reliable, and meaningful measure of accountability that is based on evidence and clinical appropriateness; (2) consistent with the current draft specifications, an exclusion is included for patients receiving palliative or hospice care; and (3) additional exclusions are included for serious illness populations who lack access to palliative or hospice care and for patients undergoing ongoing treatment of addiction. Lastly, we request that CMS update its terminology regarding the palliative or hospice care exclusion. It currently reads “Patients receiving palliative or hospice treatment during the measurement period” (emphasis added). We believe it would be more appropriate to refer to “palliative or hospice care” since both typically focus on providing holistic support to patients with serious illness and their families that may not necessarily include “treatment,” as the term is typically used. Thank you again for the opportunity to provide feedback on the Potential Opioid Overuse eCQM. We look forward to further engagement on this important issue. Please direct questions or requests for additional information to Katherine Ast, MSW, LCSW, Director of Quality & Research, at kast@aahpm.org or 847-375-4818.