By Shantanu Agrawal, MD, Director, Center for Program Integrity and
Kate Goodrich, MD, MHS, Director, Center for Clinical Standards and Quality
“The opioid epidemic is one of the most pressing public health issues in the United States today.”
– Health and Human Services (HHS) Secretary Sylvia Mathews Burwell
Many Medicare and Medicaid beneficiaries and their families have been affected by the consequences of opioid misuse and opioid use disorder, commonly referred to as addiction. Given the growing body of evidence on the risks of misuse, highlighted by the Centers for Disease Control’s (CDC) new guidelines for prescribing opioids that was released earlier this year, and the Administration’s commitment to combatting the opioid epidemic, CMS is outlining our agency’s strategy and the array of actions underway to address the national opioid misuse epidemic. The actions outlined here do not include CMS’s vision for the treatment of cancer and hospice patients. Treatment of patients in these situations require careful medical supervision based on therapeutic goals, ethical considerations, and the balance of risks and benefits of opioid therapy.
Opioids are a class of drugs that can treat both acute and chronic pain. These prescription medications, including hydrocodone, oxycodone, fentanyl, oxymorphone, and morphine, can have benefits for many patients with serious pain, but in recent years we’ve seen increasing examples of their potential to cause serious and substantial harm. Opioids are potent pain medicines that can cause potentially fatal central nervous system and respiratory depression, and their high potential for misuse has led to alarming trends of opioid misuse, use disorder, and overdose across the United States. Those who engage in non-medical opioid use are at an elevated risk for future heroin use, exposure to diseases like HIV and Hepatitis C through injection drug use, unintentional overdose, and death. These patterns can be observed across all socioeconomic groups and geographic areas, and the statistics are staggering. In 2009, deaths from drug overdose, including those related to prescription opioids and heroin, surpassed motor vehicle crashes as the leading cause of injury death in the U.S., and numbers have continued to rise. In 2015, opioids, including prescription opioids and illicit opioids such as heroin, killed more than 33,091 people.
Underlying these alarming statistics is a dramatic increase in opioid prescribing. The number of opioid prescriptions written each year has quadrupled in less than two decades, yet pain reported by Americans has not changed during that time period. Now, after two decades of increasing prescriptions, there are nearly two million Americans in the United States with opioid use disorder. The Medicare population has among the highest and fastest-growing rates of opioid use disorder, currently at more than 6 of every 1,000 beneficiaries. For Medicaid beneficiaries, the prevalence of diagnosed opioid use disorder is even higher, at 8.7 per 1,000, a figure which is estimated to be over 10 times higher than in populations who have private insurance coverage. Recognizing the seriousness of the opioid crisis, the U.S. Surgeon General recently alerted 2.3 million health care practitioners to the scope of the problem and urged them to visit TurnTheTideRx.org to join the movement to help end the opioid epidemic.
As part of the HHS Opioid Initiative launched in March 2015, CMS has made addressing this devastating epidemic a top priority. Building upon the Administration’s priority of addressing the opioid epidemic and the HHS Initiative and its three priority areas, the CMS effort to combat opioid misuse and opioid use disorder in our programs focuses on four priority areas:
- Implement more effective person-centered and population-based strategies to reduce the risk of opioid use disorders, overdoses, inappropriate prescribing, and drug diversion;
- Expand naloxone use, distribution, and access;
- Expand screening, diagnosis, and treatment of opioid use disorders, with an emphasis on increasing access to medication-assisted treatment; and
- Increase the use of evidence-based practices for acute and chronic pain management.
The success of this strategy depends upon CMS effectively communicating with everyone who interacts with Medicare and Medicaid. We are working with Medicare and Medicaid beneficiaries, their families and caregivers, health care providers, health insurance plans, and states to improve how opioids are prescribed by providers and used by beneficiaries, how opioid use disorder is identified and managed, and how alternative approaches to pain management can be promoted.
Reaching out to Beneficiaries
Reaching patients is vital. CMS wants beneficiaries, their families, and caregivers to know what opioids are, the risk associated with their use and the role opioids may play in pain management. Our primary aim is to ensure that patients, their families, and caregivers have a better understanding of how to work with providers to identify treatment goals and successfully manage pain using current, safe, effective, and accessible treatments; for many patients this may not include an opioid. If opioids are an appropriate part of treatment, we want to ensure that beneficiaries and those around them are educated on the risks associated with opioids, including overdose, how to recognize it, and how to respond if an overdose occurs. Education will extend to opioid use disorder and how to identify common signs and symptoms, and how to help individuals who have developed an opioid use disorder access evidence-based treatment and recovery support services.
Helping doctors and other health care providers
For physicians and other clinicians, CMS is focused on advancing the most up-to-date, evidence-based best practices. CMS is raising awareness of current guidelines for appropriate prescribing (e.g., the CDC Guideline for Prescribing Opioids for Chronic Pain), so providers offer each beneficiary the safest and most effective combination of treatments for their pain. The CDC Guideline includes recommendations focused on the use of opioids in treating chronic pain (pain lasting longer than 3 months or past the time of normal tissue healing) outside of active cancer treatment, palliative care, and end-of-life care. CMS is also promoting resources and programs that support providers, such as training on medication-assisted treatment, methods for screening and tracking patients at high risk for an overdose, and policies regarding naloxone availability and use.
CMS also finalized a policy in November 2016 that removes the pain management dimension of the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey from the Hospital Value-Based Purchasing program to eliminate any perceived financial pressure that clinicians might feel to overprescribe opioids. We are continuing to research this issue and develop alternative survey questions, which will focus on provider communication about pain. CMS continues to require reporting of the current HCAHPS pain management questions for purposes of the Hospital Inpatient Quality Reporting Program, with the results reported on Hospital Compare. We believe this strikes the balance of ensuring that patients’ pain is treated appropriately, without the unintended consequences of encouraging inappropriate use of opioids.
Working with health plans
CMS is coordinating with private insurance companies to ensure that their policies are consistent with and supportive of Medicare’s efforts for patients and providers. As an example, CMS is helping to increase access to naloxone by requiring that this opioid overdose reversal medication be included on all Medicare Part D and Marketplace plan formularies. CMS also currently employs an Overutilization Monitoring System, which assists and Part D Drug Plan Sponsors in identifying Medicare Part D beneficiaries with potential opioid overutilization. Plan sponsors review each at-risk beneficiary’s case and provide the results to CMS to demonstrate that they have established reasonable and appropriate drug utilization management programs.
In addition, as part of its response to a Memorandum from President Obama requiring Federal Departments to address barriers to opioid use disorder treatment in Federal programs, in the CMS 2017 Call Letter to plans participating in the Medicare Prescription Drug Program, the Agency reiterated that reducing the unsafe use of opioids is a priority and made clear that Part D formulary and plan benefit designs that hinder access to medication-assisted treatment for opioid use disorder will not be approved. CMS also released a guidance document to States identifying “Best Practices for Addressing Prescription Opioid Overdoses, Misuse and Addiction” including effective Medicaid pharmacy benefit management strategies, steps to increase the use of naloxone to reverse opioid overdose, and options for expanding Medicaid coverage of and access to opioid use disorder treatment.
As other federal agencies’ responses to the opioid epidemic progress, CMS will continue to update health plans on CMS policy.
Working with states
CMS is also working with states to address substance use disorders, including opioid use disorder, among Medicaid beneficiaries. In 2014, CMS launched a substance use disorder initiative through the Medicaid Innovation Accelerator Program (IAP). This program area supports six states’ efforts to design, plan, and implement strategies to improve their substance use disorder treatment delivery systems.
In 2015, CMS also issued guidance describing a new section 1115 demonstration waiver opportunity designed to support states to provide more effective care to Medicaid beneficiaries with a substance use disorder, including the ability to provide treatment services not otherwise covered under Medicaid. Through the Medicaid IAP, CMS has been working with a number of states to develop comprehensive benefit, practice, and system reforms through section 1115 demonstration proposals, including targeted strategies to address opioid use disorder and prescription drug misuse. The IAP also helps states assess the availability and quality of medication-assisted treatment, and develop ways to pay for substance use disorder treatment services that have been shown to produce better outcomes. CMS is helping to analyze the results of this program and is maximizing its potential impact by communicating successes and lessons learned across states.
States may apply to SAMHSA to use funding authorized in the 21st Century Cures Act to support opioid use disorder treatment for un-insured and underinsured patients.
Working together for healthier people
CMS is committed to high quality care, including appropriate pain management. In order to best fulfill that commitment, we need to modify trends in opioid prescribing, use, misuse, and overdose, and increase support services to help individuals recover from opioid use disorder, as well as provide the full spectrum of evidence-based practices for acute and chronic pain management. We will continue our strong collaboration with community stakeholders, HHS agencies, and across government. We are focused on making a real, positive impact in the lives of our beneficiaries.
CMS’s strategy for addressing the opioid epidemic is available on our website. We welcome input from clinicians, patients, consumers, caregivers, manufacturers, researchers, and others to enhance our response and maximize the effectiveness of our activities. Millions of America’s older adults, low-income families, people with disabilities, and many others count on Medicare and Medicaid to keep them healthy. It’s our job to make sure these programs live up to this commitment, including being proactive by partnering to help curb one of the greatest public health challenges of our time.
CMS is committed to supporting opioid abuse efforts within federal, state, and public sector domains. The strategies outlined within this paper align with the Secretary’s initiative and the Surgeon General’s report, and also work in tandem with private payer initiatives, “Letter to Issuers” releases, beneficiary awareness communications through print and media and many other works. In the coming weeks, CMS anticipates the release of statements reflecting the agency’s Medicare and Medicaid goals, as well as priority work in collaboration with private payers.
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