March 1, 2021
Dear Senators and Representatives,
We write this letter on behalf of the undersigned disability rights organizations. As organizations that advocate for the civil and human rights of people with disabilities, we remain highly concerned about access to appropriate treatment for people with addiction and people in serious pain, especially as the COVID-19 pandemic adds further barriers to accessing care.
As both pain and addiction may be disabilities under the Americans with Disabilities Act (ADA), we appreciate Congress’ work to address opioid addiction and overdose. We especially applaud legislative efforts to expand access to treatment for substance use disorder, including OAT (opioid agonist therapy) and overdose reversal medication.
We are, however, alarmed that as efforts to address opioid addiction have moved forward, the needs of people with serious pain have been addressed inappropriately or left out entirely. Indeed, many policies erect new barriers that increasingly leave people with disabilities unable to access pain medication or healthcare altogether. In addition, patients are being forcibly or abruptly tapered off of their medications in dangerous ways — often with devastating results, such as increased suffering, loss of function, drug overdose and suicide.
Observing these harms, the Centers for Disease Control (CDC),[1] the Department of Health and Human Services (HHS),[2] and the Food and Drug Administration (FDA),[3] issued safety alerts in 2019, warning against misapplication of the 2016 CDC Guideline for Prescribing Opioids for Chronic Pain. The CDC, itself, publicly stated that policies drawn from its Guideline which create inflexible limits on prescribed opioids, contravene the Guideline and incur serious risks to patient safety.[4]
Nevertheless, two bills introduced into the last Congress and whose re-introduction are impending—the Comprehensive Addiction and Recovery Act (CARA) 2.0 (S. 5000) and the Addiction Prevention and Responsible Opioid Practices Act (A-PROP) (S.4242/H.R.7701)—contain precisely the type of limits the CDC came out against. According to the CDC: “policies and practices purportedly derived from the guideline have in fact been inconsistent with, and often go beyond, its recommendations. A consensus panel has highlighted these inconsistencies, which include inflexible application of recommended dosage and duration thresholds.”[5] Inflexible application of the dosage and duration thresholds is exactly what these laws seek to enact.
Leading into the new legislative session, we hope to meet with and advise Congress on these and other bills dealing with prescription opioid legislation and pain treatment, many of which raise significant concern for the disability community and some of which we support.
The Comprehensive Addiction and Recovery Act (CARA) 2.0 & the Addiction Prevention and Responsible Opioid Practices Act (A-PROP)
Of greatest concern to our community are the Comprehensive Addiction and Recovery Act (CARA) 2.0 and the Addiction Prevention and Responsible Opioid Practices Act (A-PROP), which contain many good provisions but also provisions that exemplify the very misapplication of the CDC Guideline that the CDC’s recent correctives seeks to prevent.
Once again, the disability community finds itself fighting a strict limit to opioid prescribing with CARA 2.0.[6] Section 201 would limit initial opioid prescriptions for acute pain to 3 days on a nationwide basis with significant physician consequences for prescribing in excess of 3 days.
A primary reason for the CDC’s warning against policymakers creating strict limits from its more flexible guidance regarding duration for acute prescribing is the limited evidence behind this recommendation, which the Guideline rates as “poor,” or having the lowest possible evidence basis. Indeed it is a single recommendation in a Guideline designed to address chronic – not acute – pain.
Acute pain ranges considerably, and both the CDC and the FDA are working on better guidance for the broad array of conditions falling under the acute pain umbrella. For someone with serious pain from a surgery like a double knee replacement, returning to the doctor after three days may be painful and burdensome, especially if they live in rural area and have to travel to an urban provider, or face prohibitive added copays or extenuating circumstances like a pandemic or unprecedented recent snowstorms.
More concerning still to our community is that, in practice, policies like that in CARA 2.0 often reach those they intend to exempt.[7] The CDC has recognized as much in highlighting the unintended downstream effects on patients with cancer, acute sickle cell episodes or those who have undergone surgery, of its own Guideline, which exempted such patients.[8] Moreover, research on a similar 3 day limit in Florida found that the limit did not just restrict acute prescribing to 3 days but rather led to broad reductions in all opioid prescribing.[9] In addition,acute vs. chronic pain is a continuum, and many people who experience episodic or intermittent pain could be caught in the crosshairs of this requirement.
Whereas CARA 2.0 misapplies the CDC’s duration recommendation, A-PROP misapplies its dosage recommendation. A-PROP requires the Food and Drug Administration (FDA) to withdraw market approval for any opioid medication “for which the daily dosage provided for in the approved label exceeds the morphine milligram equivalents per day outlined in the [CDC Guideline].”
A-PROP thus instantiates into law a misunderstanding of the dosage recommendation in the CDC Guideline, which was intended to guide prescribers in how to begin a new, opioid naive patient on prescribed opioids,[10] not as a generalizable dosage limit to be applied across patients who take opioids long-term.
Experts in pain and addiction, including some experts involved in developing the CDC Guideline, have objected to using numerical thresholds as proxy for quality care.[11] Recent studies suggest that, although risks do rise generally with higher doses, no particular dosage in MME (morphine milligram equivalent) provides an inflection point for increased risk, given that the therapeutic window is highly variable.[12] Moreover, the CDC came out against such inflexible applications of its dosage recommendation because of its concern about risks to patient harm and the “low” evidence basis for this recommendation.
The significant negative consequences of policies like these and the pressures they exert on providers are being borne by patients who have no meaningful recourse to the harms they now suffer. New studies suggest that patients are experiencing increasing burdens at the pharmacy[13] and—most alarmingly—
in receiving healthcare altogether. With more than 50% of primary care providers unwilling to take on a prospective patient who uses opioids to manage pain and 81% reluctant to, the dangers of continuing to double down on inflexible limits can no longer be ignored.[14] Any policymaking derived from the Guideline should not contravene it and should certainly await the CDC’s updated Guideline, which is currently in process.
Reports and studies have confirmed that dosage reduction or cessation is on the rise and may increase harm.[15] One study in Colorado, for example, found that simply destabilizing dosage resulted in a three-fold increased risk for opioid overdose.[16] Tapering often occurs too abruptly – sometimes within 24 hours – and many patients require hospitalization or emergency care as a result.[17] And, tapering is associated with dissolution in healthcare relationships.[18]
It is also important to point out that the harms from these bills are likely to be borne disproportionately by already disadvantaged groups. People of color, for example, already face additional burdens in receiving pain care by having their pain rated lower by providers and more often being denied pain medication.[19] At least one recent study has found that opioid tapering happens disproportionately to people of color as well.[20] Thus these bills raise serious health equity concerns.
Approaching opioid prescribing more thoughtfully is especially important today in light of data suggesting that prescribing began to drop in 2012 and is soon to reach the same per capita levels as in the year 2000,[21] when what is commonly called an opioid prescribing crisis began. Recent data from the CDC suggests that between 2013-2019 drug overdose deaths actually escalated, growing by 57% overall, with deaths related to illicit fentanyl spiking by more than 1000%, second to rising heroin and stimulant related deaths; deaths related to prescribed opioids fell.[22] Recent studies have even suggested that laws limiting prescribing may, inadvertently, be resulting in more overdose deaths.[23]
Some 8 to 13 million Americans use opioids regularly to manage pain, and there continue to be many medically essential uses for prescribed opioids in treating acute pain. While we appreciate the effort to curb unnecessary prescribing, decisions about appropriate use cannot be made by blanket one-size-fits-all mandates. The CDC is currently in the process of updating its Guideline and is also looking at prescribing for acute pain, as is the FDA in consultation with the National Academy of Medicine. For all of the reasons outlined above, we respectfully request that A-PROP and CARA 2.0 be amended before reintroduction to exclude these provisions, and that any further attempts to legislate based on the CDC Guideline await its update and complementary ongoing efforts by the FDA.
Additional concerns with A-PROP
A-PROP also requires a per-milligram tax on opioid medication manufactured and sold in the United States. When pharmaceutical companies pass these costs along to patients, people with disabilities bear a disproportionate burden. In states where such taxes are already in place, there is some suggestion that pharmaceutical distributors have narrowed their service areas, and patients have been hospitalized for lack of necessary medication.[24]
Finally, A-PROP requires the Center for Medicare and Medicaid Services (CMS) to impose new oversight measures in Medicare and Medicaid, although CMS has not yet completed outcomes tracking on existing measures enacted in the 2018 Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) Act. The SUPPORT ACT requires CMS to identify outlier prescribers for possible fraud investigation, yet the sole indicator of fraud by the Office of the Inspector General is dosage,[25] which is particularly problematic given the CDC’s corrective.
The Improving Medicaid Programs’ Response to Overdose Victims and Enhancing IMPROVE) Addiction Care Act (introduced in the 116th Congress as S.4702/H.R.8388)
The IMPROVE Addiction Care Act resembles the California Medical Board’s Death Certificate Project, which is currently being scaled back after reports that it resulted in unintended harm to patients. Investigations had a chilling effect on appropriate prescribing; overdose deaths actually rose; and only 1% of the doctors marked for investigation after reported overdose events were found to have prescribed unethically.[26] Before rolling out a similar policy nationally, Congress should track outcomes from the revised project in California.
The Block, Report, and Suspend Suspicious Shipments Act (H.R.3878)
The Block, Report, and Suspend Suspicious Shipments Act requires the Attorney General to promulgate a regulation to flag suspicious orders for controlled substances. We would request that Congress revise the bill to require a robust definition of what constitutes a suspicious order.
The Non-Opioids Prevent Addiction in the Nation (NOPAIN) Act (S. 3067/ H.R. 5172)
We applaud efforts to expand coverage of nonopioid options as a much needed policy change, so long as they do not create unnecessary barriers where opioid prescribing is appropriate. The NOPAIN Act appears to do just this. We also appreciate Congress’ willingness to recognize and center the continued importance of pain management. In fact, much more must be done to expand coverage for a range of multidisciplinary treatments for chronic as well as acute pain care.
We are nevertheless concerned by some of the language in this legislation, which perpetuates misconceptions that can end up stigmatizing patients who legitimately use prescribed opioids, including those with an opioid use disorder who use buprenorphine. The findings, for example, discuss a current overdose crisis related to prescribed opioids, yet the earlier-cited CDC statistics suggest that prescribed medication is neither a recent nor current driver of the crisis. We would request that the language be update to reflect current circumstances.
In sum, we, the undersigned organizations representing people with disabilities, urge you to take our concerns and recommendations into account, and to work with us in the upcoming legislative session. Please feel free to contact: Kate Nicholson ([email protected]) and Lindsay Baran ([email protected]), Co-Chairs of the National Council on Independent Living (NCIL) Chronic Pain / Opioids Task Force.
[1] CDC Advises Against Misapplication of the CDC Guideline for Prescribing Opioids for Chronic Pain, April 24, 2019.https://www.cdc.gov/media/releases/2019/s0424-advises-misapplication-guideline-prescribing-opioids.html (forwarding commentary by the CDC authors, No Shortcuts to Safer Opioid Prescribing, NEJM June 13, 2019, https://www.nejm.org/doi/full/10.1056/NEJMp1904190.
[2] HHS Guide for Clinicians on the Appropriate Dosage Reduction or Discontinuation of Long-Term Opioid Analgesics, October 2019. https://www.hhs.gov/opioids/sites/default/files/2019-10/Dosage_Reduction_Discontinuation.pdf
[3] FDA Drug Safety Communication, “FDA identifies harm reported from sudden discontinuation of opioid pain medicines and requires label changes to guide prescribers on gradual, individualized tapering,” 4/9/19, https://www.fda.gov/drugs/drug-safety-and-availability/fda-identifies-harm-reported-sudden-discontinuation-opioid-pain-medicines-and-requires-label-changes
[4] See supra note 1.
[5] See supra note 1.
[6] See Sen.Gillibrand on her bill with former Sen. Gardner, https://medium.com/@gillibrandny/i-hear-you-and-i-want-to-get-my-bill-on-opioids-right-1664f8b17f87
[7] See Nicholson et al.,https://www.washingtonpost.com/outlook/2019/04/04/problems-with-one-size-fits-all-laws-opioid-prescriptions/
[8] See supra note 1.
[9] See Hincapie-Castillo, J. et al., https://academic.oup.com/painmedicine/advance-article/doi/10.1093/pm/pnab017/6120817
[10] See CDC Response Letter from Robert R. Redfield on Health Professionals for Patients in Pain (HP3) website, https://healthprofessionalsforpatientsinpain.org/press-release
[11] See Kertesz, S et al. An opioid quality metric based on dose alone? 80 professionals respond to NCQA (March 22, 2017) https://medium.com/@StefanKertesz/an-opioid-quality-metric-based-on-dose-alone-80-professionals-respond-to-ncqa-6f9fbaa2338
[12] Yu-Jung, J. et al. “Performance of the Centers for Medicare & Medicaid Services’ Opioid Overutilization Criteria for Classifying Opioid Use Disorder or Overdose” JAMA February 12, 2019 Volume 321, Number 6. DOI:10.1001/jama.2018.20404
[13] See Brown, J., et al.,https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7305512/
[14] See, e.g., https://labblog.uofmhealth.org/industry-dx/pain-patients-who-take-opioids-cant-get-door-at-half-of-primary-care-clinics; https://mma.prnewswire.com/media/1011170/Quest_Diagnostics Health_Trends_Report.pdf?p=original
[15] See, e.g., Human Rights Watch Report, https://www.hrw.org/sites/default/files/report_pdf/hhr1218_web.pdf; Neprash, H. et al, https://link.springer.com/epdf/10.1007/s11606-020-06402-z?sharing_token=2wVMqsqrfFzZ5vrRsS-8qPe4RwlQNchNByi7wbcMAY7nOfm0DMmbSCnoZR8c0e3C4tgbsr4daToeUDwsOZH3dYBdbD9i4Td1SRc9lFUHYQh-1HzlDadrKbP_sOdoIr52u0UAUCb5tVw0D_Qy4LKchNVJ14uuBbuwFeJ2hP3VF-SazL3djLfx2ZNSnrC9khVw
[16] See Glanz J. et al., https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2730786
[17] See Mark, T. et al., https://pubmed.ncbi.nlm.nih.gov/31079950/
[18] See Perez, H. et al, https://pubmed.ncbi.nlm.nih.gov/31428983/
[19] See, e.g., Hoffman, K. et al., https://pubmed.ncbi.nlm.nih.gov/27044069/; Lee, P., et al., https://pubmed.ncbi.nlm.nih.gov/31186154/
[20] See Fenton, J. et al, https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2755492
[21] IQVIA Institute for Human Data Science, https://static1.squarespace.com/static/54d50ceee4b05797b34869cf/t/5fdd05e366149235d70ddfca/1608320487586/iqi-prescription-opioid-trends-in-the-us-1220-forweb.pdf
[22] See CDC Nat’l Vital Statistics, https://www.cdc.gov/nchs/data/nvsr/nvsr67/nvsr67_09-508.pdf
[23] See Lee., B. et al., https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2776301
[24] See Gliadkovskaya, “Patients struggle to access prescription opioids after New York tax drives away suppliers,” Fortune, November 15, 2020. https://fortune.com/2020/11/15/new-york-state-tax-opioids-prescription-pharmacies-supply/
[25] OIG, “Opioids in Medicare Part D: Concerns about Extreme Use and Questionable Prescribing,” OEI-02-17-00250, July 2017. https://oig.hhs.gov/oei/reports/oei-02-17-00250.pdf
[26] See Clark, “California Medical Board to Revise Dreaded Death Certificate Project,” November 17, 2020, https://www.medpagetoday.com/practicemanagement/medicolegal/89740
