Sunday, February 4, 2018

Proposed Medicare Changes to Limit Opioid Prescribing

by Chad Kollas

On February 1, 2018, the Centers for Medicare & Medicaid Services (CMS) published its Advance Notice of Methodological Changes for Calendar Year 2019. Included in these proposed rules were several directives intended to reduce "Opioid Overutilization” (see p. 202), including formal adoption of the “90 morphine milligram equivalent (MME) threshold cited in the CDC Guideline, which was developed by experts as the level that prescribers should generally avoid reaching with their patients (p. 203).” CMS proposed “adding additional flags for high-risk beneficiaries who use ‘potentiator’ drugs (such as gabapentin and pregabalin) in combination with prescription opioids (see p. 204).” CMS also proposes a 7-day limit for initial fills of prescription opioids for the treatment of acute pain. The proposed CMS rules are unclear about exceptions for patients enrolled in hospice or with cancer pain, but there seems to be a mechanism in place for prescribers to apply for an exception for each individual patient (p. 209-210).

On learning of these proposed CMS rules via social media, many members of the hospice and palliative medicine (HPM) community expressed several profound concerns: Foremost, how would these changes impact our patients and their care? How will the rules affect our daily practice? And, for the HPM policy wonks, how did the 90 MME threshold make its way into proposed federal policy without evidence from the medical literature.

As one of the aforementioned HPM policy wonks, I’d like to address the last question first. The 90 MME threshold was born in 2012, as part of a non-solicited petition to the Food & Drug Administration (FDA) from a group of physicians who identified themselves as subject experts and referred to themselves as Physicians for Responsible Opioid Prescribing (PROP). Ultimately, after reviewing open comments from stakeholders, the FDA declined adoption of PROP’s 90 MME proposal.

Undeterred, PROP successfully sought to place the 90 MME provision in the CDC Guideline for Prescribing Opioids for Chronic Pain, leading to criticism of the CDC for a lack of transparency by the pain management community. Ultimately, the CDC did recognize that certain patient populations, including patients receiving hospice and/or palliative care, might legitimately require opioid doses exceeding the 90 MME limit. The current CMS proposed rules, however, do not offer an exemption to this limit for these patients; they would instead further codify an opioid dose limit that was largely created in an arbitrary fashion based on a self-selected group of physician “experts” with no accountability to the HPM community.

This observation likely concerns those of us who ask how – as HPM practitioners – the proposed CMS rules will affect our practice. Of much greater importance is how these proposed rules would affect our patients. Opioid stigma in the setting of “The Opioid Crisis” is already a major barrier to patients receiving hospice and/or palliative care that adversely impacts their access to medications needed to maintain their quality of life. For example, in a recent study of 250 patients receiving outpatient palliative care at a cancer center, 54% reported feeling stigmatized for their use of opioid analgesics and 73% reported difficulty filling opioid prescriptions (Kollas CD, Boyer-Kollas B. Assessing Opioid Stigma in Oncology Outpatients Receiving Palliative Care for Cancer-related Pain. Accepted to 2018 AAHPM Annual Assembly). The proposed CMS rules, in their current form, would add to patients’ perception of opioid stigma and, at best, will result in delays in receiving medications to manage their chronic pain. At worst, some would not receive the amount of medication needed to relieve their pain, severely impacting their quality of life or driving them to desperate measures, like seeking illegal drugs. Ironically, CMS new rules could unintentionally accelerate the emerging trend in opioid overdose deaths: deaths from illicit drugs, like heroin or illegal fentanyl (see CDC data here).

While this sounds catastrophically bad, there is a small silver lining within CMS’s announcement; there will be an open period for comments from stakeholders. CMS will review all comments submitted via its website, whether submitted by an individual patient or physician or from a patient advocacy group or medical organization. And, as evidenced by the FDA’s response to the 90 MME proposal from PROP, these comments can make shape policy in a way that protects our patients’ access to critically-needed pain medication. Social media can be a great tool to help build a successful coalition of HPM stakeholders, but time is short – comments must be submitted by Monday, March 5, 2018. To submit comments as an individual, go to www.regulations.gov and enter docket number “CMS-2017-0163” in the search field, then follow the instructions for “submitting a comment.”

Dr. Kollas has provided outpatient palliative care at Orlando Health UFHealth Cancer Center for over 17 years. He first wrote about his personal experiences with chronic illness and pain in a 1997 article in the “On Being a Patient” series in Annals of Internal Medicine. You can find him on Twitter at @ChadDKollas.

Editor's note - The graphic was updated to reflect 2019 changes not 2018 changes as was indicated in the original post. Also, the wording was changed from 'no exemptions' to 'possibly (but not guaranteed).'

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