ACS CAN submitted comments to FDA regarding the use of opioids at higher doses, in response to an FDA request for comments.
Cancer and the SUPPORT for Patients and Communities Act
In the fall of 2018 the House and Senate passed the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (the SUPPORT Act)1 – comprehensive legislation to address the opioid epidemic.
Overview of the SUPPORT Act[i]
- Expands opioid treatment and recovery by providing incentives for enhanced care, coordination and innovation; and establishes comprehensive opioid recovery centers.
- Encourages the use of non-addictive opioid alternatives for treatment of pain by focusing federal agencies on approving such alternatives quickly, covering them through insurance and incentivizing their use; improves data to help identify those at-risk of addiction; enhances state prescription drug monitoring programs (PDMPs), and addresses high prescribing rates.
- Provides resources and in some cases additional authority to federal, state and local agencies to address problems with illicit opioids, synthetic drugs and foreign shipment of illegal drugs.
ACS CAN supported passage of the SUPPORT Act in addition to other balanced public policies that address addiction while maintaining access to necessary relief for individuals fighting pain from cancer and other serious illness. ACS CAN is devoted to making sure the patient voice is heard in the current public policy debate on the problem of opioid addiction and overdose. As the provisions of this legislation are implemented through regulation, etc., ACS CAN will continue to ensure that cancer patients and survivors maintain appropriate access to pain treatment.
As the SUPPORT Act is implemented ACS CAN will actively engage with appropriate federal agencies, as well as advocate on behalf of cancer patients, survivors, and others with serious illness on necessary state policy changes; particularly as related to the following provisions:
Focus on Increasing Access to Non-Opioid and Abuse-Deterrent Pain Treatments: Several provisions in the bill focus on increasing access to non-opioid pain treatments. While opioids often are the standard of care for cancer-related pain, many cancer patients would benefit from having greater access to these treatments, whether or not they use opioids to manage their pain. These efforts include: (1) directing the Centers for Medicare and Medicaid Services (CMS) to issue guidance on options for state Medicaid programs to provide non-opioid pain treatments to Medicaid beneficiaries; (2) requiring the Food and Drug Administration (FDA) to address the challenges and barriers of developing non-addictive medical products used to treat pain; (3) requiring the Secretary of Health and Human Services (HHS) to submit a report to Congress on access and effectiveness of abuse-deterrent opioid formulations; and (4) requiring a report to Congress and an HHS review on how Medicare pays for pain treatment and if the system incentivizes opioid prescribing. ACS CAN supports increasing access to non-opioid pain treatments for cancer patients and survivors. (Sec. 1010, 3001, 6012, 6072, 6082, 6084)
Increasing Research and Improving Pain Treatment: The SUPPORT Act gives NIH new authority to focus on high impact cutting-edge research projects and finding new, non-addictive drugs for pain management. The law also directs the Interagency Pain Research Coordinating Committee to address opioid alternatives for pain treatment. Lastly, the bill requires the Secretary of HHS to submit a report to Congress on improving pain management. ACS CAN supports efforts to improve pain management treatments and techniques, as they will improve the quality of life of cancer patients and survivors. (Sec. 6086, 7041, 7042)
Enhancing State Prescription Drug Monitoring Programs: The law authorizes additional funding to improve state PDMPs, with a focus on data sharing between states. It also requires Medicaid providers to use PDMPs when prescribing opioids and encourages providers to integrate PDMP usage into clinical workflow. Effective use of PDMPs not only protects against abuse of opioids, but also can be an important care coordination tool for cancer and other seriously ill patients who receive care from multiple providers, which is why ACS CAN supports their continued use. (Sec. 5042, 7161, 7162)
Giving Patients Safe Disposal Methods for Opioids: The law contains several provisions to improve access to safe disposal methods for patients and their families in possession of unused opioid medications. It also allows hospice workers to more easily help families of a deceased loved one dispose of unused medication. ACS CAN supports measures that will ease the burden on cancer caregivers at an already difficult time. (Sec. 3032, 3222, 3223, 3251, 6103)
Studying the Effects of Opioid Prescribing Limits: The law includes a requirement for HHS, in consultation with the Attorney General, to submit to Congress a report on the impact of federal and state laws and regulations that limit the length, quantity or dosage of opioid prescriptions. This provision states that the report must address the effects on specific patient populations. ACS CAN welcomes such a report, as there is a lack of evidence about the true consequences – intended or not – of these opioid prescription limits. (Sec. 7024)
Exemptions to Limits on Opioid Prescriptions in Medicaid: Starting in October 2019, all state Medicaid programs (including managed care plans) will be required to have a drug review and utilization program that implements “safety edits” – checks at the pharmacy – for opioid prescriptions that are refilled, over a certain dosage amount, or that are prescribed concurrently with certain other drugs. The details of these limits are left to the states, but states are required to exempt individuals who are receiving hospice or palliative care or treatment for cancer. ACS CAN supports these exemptions as they will help cancer and other seriously ill patients maintain their access to necessary pain treatment. We also urge states to include all cancer-related pain treatment in this exemption so that cancer survivors who are still dealing with cancer-caused pain can maintain their access, and caution states against setting arbitrary, unreasonable limits for non-exempted patient populations. (Sec. 1004)
Working with Opioid Prescribers: The bill contains several provisions focused on identifying ‘outlier’ opioid prescribers – meaning doctors who prescribe opioids more often than their peers – and targeting those doctors with outreach and education on safe, guidelines-based opioid prescribing. The bill excludes patients who are in hospice or individuals with a cancer diagnosis from outlier calculations, recognizing that providers working with such patients will legitimately be prescribing more opioids than their peers. However, ACS CAN is concerned that non-cancer patients receiving palliative care are not similarly excluded. We encourage HHS to monitor implementation of these provisions carefully to ensure that patient access to palliative care is not harmed. (Sec. 3002, 6052, 6065)
Controlling the Supply of Opioids in the U.S.: The bill establishes mandatory factors for the Drug Enforcement Agency (DEA) to consider when setting annual opioid quotas (i.e. limits on supply), including diversion, abuse, overdose deaths and public health impacts; and requires DEA to explain the public health benefits if the agency approves an increase in any annual opioid quota. ACS CAN recognizes the potential for severe decreases in opioid quotas could cause drug shortages resulting in cancer patients and survivors being unable to get their pain medications from the pharmacy. We encourage the DEA and other agencies to monitor this issue closely and make appropriate adjustments – especially considering pharmacy lock-in policies that require some patients to only use one pharmacy for opioid prescriptions. (Sec. 3281)
[i] See additional summary here: https://energycommerce.house.gov/wp-content/uploads/2018/09/HR6_OnePageOverview_09252018_FINAL.pdf