Preventing prescription drug abuse is a top health priority for state and federal policy makers, and one that requires a comprehensive approach.
In early 2016, several new opioid abuse prevention and treatment initiatives were announced. The Centers for Disease Control and Prevention (CDC) unveiled updated opioid prescribing guidelines and requested funds to set up Prescription Drug Monitoring Programs in every state1. The US Department of Health and Human Services (HHS) announced the availability of nearly $100 million to expand access for substance abuse treatment2. And retailers unveiled plans to loosen access to naloxone, a life-saving drug that counters the acute effects of opioid overdose.
This news should not surprise sponsors of Medicare prescription drug plans, who have been required since 2013 to use retrospective drug utilization review, point-of-sale edits, and formulary design to reduce opioid abuse. In 2017, the Centers for Medicare & Medicaid Services (CMS) is imposing additional requirements that reflect the evolving nature of this complex problem.
17,000 Lives Lost
"The opioid epidemic is one of the most pressing public health issues in the United States today," HHS Secretary Sylvia Burwell said in March 2016. Opioid dependence affects nearly 5 million people in the United States and leads to approximately 17,000 deaths annually3. Since 2000, there has been a 200 percent increase in the rate of overdose deaths involving opioids (opioid pain relievers and heroin).4
Burwell also has said that the opioid epidemic knows no boundaries, and indeed, Medicare beneficiaries are not immune. In 2014, more than 12 million (or roughly 30 percent of) Medicare Part D beneficiaries used opioids.5
A War on Three Fronts
HHS, the CDC, states, and private pharmacy retailers are focusing prevention in three areas:
Changing Prescribing Practices
In March, the CDC unveiled new recommendations so that opioids are less frequently prescribed for chronic pain. The guidance, which is voluntary, urges doctors to first prescribe over-the-counter pain medications, physical therapy, and counseling. If opioids must be prescribed, the CDC recommends a low-dose, immediate-release version to start.
Doctors are also urged, prior to prescribing, to check the patient's status with their state's Prescription Drug Monitoring Program (PDMP), state-based electronic databases that track the prescribing and dispensing of controlled medications7. The CDC requested a 2016 budget of $74 million to set up PDMPs in every state and educate doctors about the new guidelines.8
Naloxone access: Narcan®, the brand name for the medication naloxone, is essentially an antidote to heroin and other opioid drugs. If delivered while someone is suffering from an overdose, naloxone directly reverses the acute effects of opioids, such as respiratory depression, and can save lives. Often, family and friends of users are in the best position to administer Narcan, but until five years ago, access to Narcan was limited because laws required a doctor-patient relationship prior to a prescription. In the past five years, 45 states have changed laws to provide immunity to medical professionals who prescribe or dispense Narcan, and now some states allow people to obtain Narcan without a prescription. Recently, major pharmacy retailers have made naloxone prescription-free in 36 states.9
Expanding medication-assisted treatment (MAT): To help patients kick addiction, MAT combines counseling with methadone or buprenorphine, drugs that block users' ability to get an opiate "high" while reducing withdrawal symptoms. Under current law, buprenorphine prescribers must be certified and are then limited to treating just 30 patients at a time, per year. This results in long waiting lists for MAT. HHS in September 2015 promised to revise these rules to expand access to treatment while minimizing the risk of drug diversion. In March 2016, HHS announced plans to award $94 million to community health centers in 45 states to expand access to naloxone and MAT.10
How Part D Sponsors Help
CMS has long said that Part D plan sponsors are in an ideal position to identify prescription drug overuse, and since 2013, has required plans to implement safety and quantity edits for opioids at the point of sale. Plan sponsors are sent quarterly reports on beneficiaries with potential opioid or acetaminophen overutilization issues. Sponsors must review those patients' drug utilization and may implement case management with beneficiaries' prescribers, followed by beneficiary-specific point-of-sale edits.11
CMS has also suggested, but not required, that plans implement soft point-of-sale edits based on a cumulative morphine equivalent dose (MED) of 120 milligrams per day across the opioid class, and by 2016, 23.7 percent of Plan D formularies had such an edit in place. As a result of this work, from 2011 through 2015, there was a 47 percent decrease in Medicare Part D beneficiaries identified as potential opioid over-utilizers.12
New Requirements for 2017
In the 2017 Medicare Advantage and Part D Rate Announcement and Call Letter, CMS reiterated that it expects plan sponsors to further reduce opioid overutilization. CMS has asked sponsors to implement a series of formulary-level hard and/or soft edits around opioids, urged plans to consider the CDC's new prescribing guidance, and warned plan sponsors to provide access to MAT.
Plan sponsors are asked to implement a soft edit, so that pharmacists receive messaging urging patient counseling, when a patient reaches a cumulative MED of at least 90 milligrams across the opioid class per day. Alternatively, sponsors can put in place a hard edit, such that pharmacists are required to obtain authorization before the sale, when a patient reaches a cumulative MED of 200 milligrams or more of opioids per day.13 Plan sponsors may also do both.
In addition, plans must put in place a soft edit when a patient taking buprenorphine, the medication used in opioid treatment, seeks to fill an opioid prescription.14
The agency also has asked plan sponsors to review claims data and drug utilization management strategies for patients who take opioids along with benzodiazepines, drugs commonly used to treat anxiety. Evidence shows using both types of medications, concurrently, increases the chance of respiratory depression, the cause of opioid overdose death.13
Finally, in keeping with broader HHS policies and recent CDC announcements, CMS has asked Medicare Part D plan sponsors' Pharmacy & Therapeutics committees to consider CDC recommendations and share the new guidelines with opioid prescribers. In addition, the agency said plans must ensure beneficiaries have ample access to medications for MAT. As the call letter states: "Part D formulary and plan benefit designs that hinder access, either through overly restrictive utilization management strategies or high cost-sharing, will not be approved." 15
CMS plans to develop – and share with sponsors – new patient safety reports on three measures of potential overutilization:
Separately, the NCQA is adapting these measures for potential inclusion in the Health Effectiveness Data and Information Set (HEDIS), a tool used by most health plans to measure quality of care and service.
An Evolving Battle
Combating opioid overuse is a bipartisan cause that has caught the attention of city, state, and federal health policy makers, public health agencies, pharmacy retailers, health plans, and providers. In the recent months, the administration has unveiled a national effort to attack the problem at its cause (prescribing) and to make it easier to help addicts recover (naloxone and MAT). As the providers of medications for more than 30 million Medicare beneficiaries, Part D plan sponsors must be part of the solution. Clearly, sponsors that press forward with their own innovations around opioid prevention will stay a step ahead of regulatory requirements and, more importantly, will save lives in the midst of this epidemic.
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3 Substance Abuse and Mental Health Services Administration, Results from the 2011 National Survey on Drug Use and Health: Summary of National Findings, NSDUH Series H-44, HHS Publication No. (SMA) 12-4713. Rockville, MD: Substance Abuse and Mental Health Services Administration, 2012.
4 CDC. Increases in Drug and Opioid Overdose Deaths — United States, 2000–2014. December 18, 2015.
5 Centers for Medicare & Medicaid Services. Effective Strategies for Addressing Overutilization and Abuse of Prescription Drugs in Medicare Part D. October 19, 2015.
6 HHS. HHS hosts 50 state convening focused on preventing opioid overdose and opioid use disorder, takes important step to increase access to treatment. Sept. 27, 2015.
8 CDC budget, ibid.
9 Walgreens. Walgreens Leads Fight Against Prescription Drug Abuse with New Programs to Help Curb Misuse of Medications and the Rise in Overdose Deaths. February 9, 2016.
10 CVS. CVS/pharmacy commits to Creating Safer Communities Through Multiple Prescription Drug Abuse Prevention Efforts. September 23, 2015.
11 Modern Healthcare. HHS gives health centers $94 million to treat opioid abuse. Steven Ross Johnson.
12 Cynthia Reilly, "Patient Review and Restriction Programs as a Policy Option to Address Polypharmacy and Potentially Inappropriate Opioid Use in Medicare Part D" (Letter to Medicare Payment Advisory Commission, April 10, 2015). http://www.pewtrusts.org/en/research-and-analysis/speeches-and-testimony/2015/04/address-polypharmacy-and-potentially-inappropriate-opioid-use-in-medicare-part-d
14 Jones, J. D., Mogali, S., & Comer, S. D. (2012). Polydrug abuse: A review of opioid and benzodiazepine combination use. Drug and Alcohol Dependence, 125(1-2), 8–18. http://doi.org/10.1016/j.drugalcdep.2012.07.004