Controlling Opioid Drug Excess - National Health Policy Forum

Controlling Opioid Drug Excess: Health Plan Interventions

F O R U M SE SS I O N A N N O U N CEM EN T

A D I SCUSSI O N FE AT U R I N G :

FRIDAY, JUNE 20, 2014

Thomas Kowalski, RPh Clinical Pharmacy Director, Health and Medical Management Blue Cross Blue Shield of Massachusetts

Cynthia Griffin, PharmD Senior Director, Pharmacy Government Programs Florida Blue

Kim Caldwell, RPh Director of Pharmacy Professional Affairs Humana Pharmacy Solutions

8:45AM–9:15AM—Breakfast 9:15AM –11:15AM — Discussion

LOCATION Reserve Officers Association One Constitution Avenue, NE Congressional Hall of Honor Fifth Floor (Across from the Dirksen Senate Office Building)

Deborah Kilstein, JD, MBA

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Vice President, Quality Management and Operational Support Association for Community Affiliated Plans

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NATIONAL HEALTH POLICY FORUM

The statistics are jarring: Drug overdose is the leading cause of injury death in the United States. Among people 25 to 64 years old, drug overdose causes more deaths than motor vehicle crashes. The Centers for Disease Control and Prevention has called prescription overdose an epidemic.1 The Trust for America’s Health (TFAH) in 2013 published a comprehensive analysis of what they too called the epidemic.2 In 2011, drug misuse and abuse caused 2.5 million emergency department (ED) visits, more than half of them related to prescription drugs. ED visits in 2011 involving the non-medical use of prescription drugs totaled 1,428,145, an increase of 115 percent over 2004.3 “Non-medical use” is the term employed for drugs taken for purposes other than the one for which they were prescribed. Nonmedical users may misuse drugs recreationally or to treat pain that could be managed otherwise, take them because they are addicted, or divert them for sale to others.

National Health Policy Forum 2131 K Street, NW Suite 500 Washington, DC 20037 T 202/872-1390 F 202/862-9837 E [email protected] www.nhpf.org Judith Miller Jones, MA Director Sally Coberly, PhD Deputy Director Monique Martineau, MA Director, Publications and Online Communications

A major share of the drug problem today concerns the use of opioids, a class of narcotic medication used to treat severe pain. Common brand names include OxyContin and Percocet. Rates of prescription are on the rise. CDC calculates that enough prescription painkillers were prescribed in 2010 to medicate every American adult continually for a month.4 An analysis by researchers at Johns Hopkins University revealed that rates of prescribing opioids for pain unrelated to cancer nearly doubled between 2000 and 2010.5 Over the same period, prescription of non-opioid analgesics remained essentially unchanged. Several prominent clinicians and researchers have pointed to prescription drug addiction as a gateway to heroin use.6 Heroin is, in fact, an opioid and may prove more readily available to some abusers who get their start with prescription drugs.

Forum Session Manager Lisa Sprague, MBA Principal Policy Analyst

Many stakeholders are involved in monitoring, supplying, or paying for prescription drugs. They are united in a conviction that inappropriate opioid prescribing and overuse are problems that cut across all levels of American society. Federal and state law enforcement agencies, federal and state governments, public and private health care plans, and professional groups such as the National Association of Boards of Pharmacy (NABP) and the American College of Physicians have identified varying strategies or implemented initiatives to attempt to stem the tide of addiction and abuse, but there is not yet a consistent, common strategy aimed at this growing national problem. The National Health Policy Forum is a nonpartisan research and public policy organization at The George Washington University. All of its publications since 1998 are available online at www.nhpf.org.

State law with respect to pharmacies differs depending on legislatures and boards of pharmacy. States’ commitment to providing medication management tools, in the form of prescription data registries and the ability to limit suspected abusers’ access to multiple 2

Controlling Opioid Drug Excess

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pharmacies and certain medications, varies considerably. Health plans may not have the same tools available to them when they operate in multiple states and multiple lines of business (such as fee-forservice Medicare, Medicare Advantage, Part D, Medicaid, and commercial insurance). Some Medicaid programs allow plans to impose limits on abusers, whereas Medicare Part D restricts participating health plans to monitoring and reporting fraud. A P ro g ra m fo r C ha n g e

Analysts and advocates point out that the majority of people for whom opioids are prescribed are sufferers of acute or chronic pain whose access to alleviation should not be impeded. But as Mitch Betses and Troyen Brennan of CVS Caremark point out, “[In] the majority of cases of potential abuse, pharmacists face a patient who has a legal prescription from a licensed physician, and they have access to very little other background information.”7 When misuse or abuse is suspected, what latitude does the pharmacist have in deciding whether to fill a prescription? What recourse might the health plan have when it is expected to pay for drugs that may be diverted and sold for non-medical use? When stakeholders discuss what can be done to stop overprescribing and abuse, the term “multifaceted” is sure to be mentioned. Organizations from the U.S. Drug Enforcement Administration (DEA) to TFAH to the National Governors Association (NGA) have made recommendations. In general, the themes are education, interdiction, and medication management. Some common policy elements of a multifaceted approach are: Monitoring — With the single exception of Missouri, all states operate

or are in the process of implementing a Prescription Drug Monitoring Program (PDMP), which is a database that tracks prescriptions and purchases of controlled substances. Some are reactive, providing access to information when queried by an authorized user, while others are proactive, generating unsolicited reports when suspicious or “outlier” behavior patterns are detected. PDMPs vary among states in terms of who is eligible to query what information. Data may be available to clinicians, pharmacists, medical and pharmacy boards, health plans, and law enforcement personnel. In some states, a health plan’s access is restricted to its own members’ files. Prescribers may check a PDMP before writing a prescription, but in most states are not required to. A PDMP may be updated periodically— daily, weekly, or even monthly—or information may be posted in

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real time. Some states have made provision for interoperability with other states. Launched in 2011, NABP’s PMP InterConnect program had 26 states participating as of February 2014.8 Many hope that a link between PDMPs and patient electronic health records is on its way. Work on this is proceeding in a program called Enhancing Access to Prescription Drug Monitoring Programs Using Health Information Technology, under the direction of the Office of the National Coordinator for Health Information Technology in collaboration with CDC, the Substance Abuse and Mental Health Services Administration (SAMHSA), and the Office of National Drug Control Policy.9 Enforcement — Enforcing federal and state law governing transac-

tions related to controlled substances is a constant challenge. DEA, in recent congressional testimony, voiced its concern with two relatively new types of illegal commerce involving internet pharmacies and pain clinics.10 As a DEA administrator said in his testimony, “between 2005 and 2009, the diversion of millions of dosages of schedule III hydrocodone products was facilitated by rogue internet pharmacies.” As the law began to catch up with these, there was a rise in what DEA calls rogue pain clinics, particularly in Florida. Many of these are operated on a strictly cash basis. Kentucky responded to its own problematic pain clinic situation with legislation (nicknamed the “pill mill bill”) that mandates physician ownership and an onsite medical practice in order to legally operate as a pain clinic. It also required acceptance of insurance as a means of payment, on the grounds that claims are easier to track than cash transactions. Education — An NGA paper on reducing prescription drug abuse

exhorts readers to recognize public education as critical: “To help people make informed decisions about using and storing prescription drugs, it is essential to educate them about the risks posed by prescription drugs.”11 Education efforts are under way. The DEA in conjunction with the NABP has held conferences in 16 states to help pharmacists understand the growing problem. Senators in Ohio are considering a House-passed bill that would require schools to include in their health curricula information about addiction and prescription opioids. Education of health care providers is also a concern. Many reformers have suggested that medical schools should also update their curricula to give more attention to pain management, including prescription guidelines, non-pharmaceutical interventions, and screening patients for depression and anxiety. Further, a 2011 report from the Office of National Drug Control Policy noted that, outside of specialty addiction treatment programs, most health care providers have 4


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received minimal training in how to recognize substance abuse in their patients.12 Some federal resources have been directed to clinical education; for example the National Institutes of Health has designated 12 health professional schools as Centers of Excellence in Pain Education and has assisted these schools in building their curricula.13 SAMSHA offers courses in opioid prescribing.14 Treatment — One of the conclusions of the NGA report was that treat-

ment is essential to breaking the cycle of addiction. “Indeed,” it cautions, “reducing the availability of potentially addictive prescription drugs without also providing effective treatment may drive those who are addicted to seek illegal narcotics.” However, observers agree that treatment can be both hard to find and expensive, and abusers may not be willing to enter or complete such programs even where they exist. Medication disposal — Prescription drugs in a home medicine cabi-

net may be a source of supply for illegal non-medical use; however, as a general rule, the Controlled Substances Act (CSA) does not allow pharmacists to accept unused controlled substances from patients. CSA requires everyone who handles a controlled substance to be registered with the DEA. Consumers are allowed to obtain and possess medications containing controlled substances that they or a member of their household or their pet are prescribed without having to register with the DEA, but it does not allow them to transfer or distribute those drugs to anyone else, nor does it allow anyone else to accept drugs from them, even for the purpose of disposal. DEA tries to address this difficulty by coordinating Nationwide Prescription Drug Take-Back Days every six months. DEA reports that the seven nationwide Take-Back Days to date have removed a total of 3.4 million pounds of medication from circulation.15 To o l s a n d Ba r rie r s

A promising strategy for trying to manage overuse or abuse of certain medications, cited by health plans around the country, is known as “lock-in.” A consumer known to be an abuser or fitting an abuse profile is limited to obtaining prescriptions from one doctor and one pharmacy and, in some instances, one emergency department. This eliminates a common practice among abusers known as “doctor shopping,” that is, obtaining multiple prescriptions from multiple providers, and it allows pharmacists to monitor all dispensing to the individual. As of December 2013, 38 states had Medicaid lock-in programs.16 Some health plans have instituted such plans in their

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commercial populations. Medicare Part D and Medicare Advantage rules currently do not permit lock-in. One Medicaid sub-population for which lock-in may not be effective is the group known as the “full benefit dual eligible” beneficiaries, who, under the terms of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, had their prescription drug coverage transferred from their state Medicaid plan to Medicare Part D. Such beneficiaries are able to switch Part D plans as often as monthly, and thus these individuals’ prescriptions can be very difficult to track. Health plans report that under-65 dual eligibles have a high incidence of prescription drug abuse. Some health plans, working in concert with pharmacists and other stakeholders, have developed prescription guidelines and limitations on dispensing. For its commercial plan members, for example, Blue Cross Blue Shield of Massachusetts must authorize the dispensing of more than 30 days’ worth of a short-acting painkiller (lasting up to 6 hours) within a two-month period; patients are given an initial 15-day supply and allowed to renew it once. Authorization is always required for a longer-acting drug such as OxyContin. (Cancer and hospice patients are exempted.) Pharmacy benefit managers may allow an override to a pharmacist to dispense a three-day supply in emergency situations. Until very recently, Medicare maintained that it did not have the legal authority to track and sanction problem prescribers. Pharmacists and health plans were required, respectively, to dispense and pay for Part D prescription drugs even where a pattern of abuse had been identified. Under a scenario labeled by some as “pay and chase,” plans were encouraged to report suspected abuse to Medicare drug integrity contractors (MEDICs) for investigation, but still were required to pay the claim. However, in May 2014, CMS announced a final regulation whereby it will require prescribers to enroll in Medicare or to have a valid record of opting out of the program in order to have their prescriptions for Medicare beneficiaries reimbursed under Part D.17 These requirements are intended to help CMS ensure that Part D drugs are only prescribed by qualified individuals. Given that CMS reported more than 90 percent of United States physicians were accepting new Medicare patients last year, it is difficult to gauge the expected effect of this requirement.18 However, CMS has also assumed the authority to revoke Medicare enrollment for abusive prescribing practices and patterns or if the DEA or a state licensing authority has suspended or revoked a someone’s ability to prescribe. 6


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Some health plans would like to go farther with this, and be given the power on their own to cut off reimbursement where abuse can be demonstrated. H.R. 3392, sponsored by Rep. Gus Bilirakis (R-FL), would grant Part D plans this power, as well as require MEDICs to be more prompt in their investigations.19 Legislation remaining a strategy, several other bills have also been introduced in the 113th Congress, as well as in the various statehouses. The inspiration to all is Kentucky, which in 2012 passed a comprehensive bill dealing with controlled substances. In addition to the pain clinic provisions already mentioned, the law requires interagency sharing of information, the development of mandatory prescribing and dispensing standards, mandatory PDMP registration and use, exchange of information with other states, establishment of permanent drug disposal sites, and mandatory continuing education in pain management for all prescribers.20

SESS I O N There are many perspectives on and many issues involved in bringing this epidemic under control. This Forum session will present the experience of health plans working in multiple states and with multiple populations in efforts to balance the needs of patients with legitimate needs for pain relief with attempts to control misuse and abuse. The session will explore successful programs and ongoing challenges, as well as consider what policy changes might lead to further progress. S p ea ke r s Thomas Kowalski, RPh, clinical pharmacy director for health and

medical management with Blue Cross Blue Shield of Massachusetts, will lay out the dimensions of the problem of overprescription and the misuse and abuse of prescription drugs. He will describe what his company has been able to do in education and medication management in collaboration with the medical and pharmacy communities, and he will report on results in a commercially insured population. Cynthia Griffin, PharmD, senior director, Pharmacy Government Programs at Florida Blue will talk about the challenges her plan has faced in a state noted for its “pill mills” and the different challenges posed by different sub-populations of drug users. Kim Caldwell, RPh, director of pharmacy professional affairs for Humana Pharmacy Solutions will discuss his company’s

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medication strategies across 50 states and multiple populations. Deborah Kilstein, JD, MBA, vice president, quality management and operational support for the Association for Community Affiliated Plans, will relate the experiences of a multistate collaborative of Medicaid plans.

K E Y QU ES T I O N S • What do health plans observe in the incidence of prescription drug abuse across their different lines of business and within each line? • How does the way plans address inappropriate prescription and abuse vary by state? By business line? • Is there a move toward standardization of prescribing guidelines across organizations and states? • What programs or initiatives exist for cooperation among states to track and stop abuse? What about cooperation among law enforcement, public health, and business? • To what extent has the success of various strategies aimed at curbing overprescribing and abuse been documented?

EN DN OT ES 1. Centers for Disease Control and Prevention, “CDC Grand Rounds: Prescription Drug Overdose: A U.S. Epidemic,” Morbidity and Mortality Weekly Report, 61, no. 1 (January 13, 2012): pp. 10–13, www.cdc.gov/mmwr/preview/mmwrhtml/ mm6101a3.htm. 2. Trust for America’s Health, Prescription Drug Abuse: Strategies to Stop the Epidemic, October 2013, http://healthyamericans.org/reports/drugabuse2013/. 3. Drug Abuse Warning Network (DAWN), Substance Abuse and Mental Health Services Administration (SAMHSA), Center for Behavioral Health Statistics and Quality, The DAWN Report: Highlights of the 2011 Drug Abuse Warning Network (DAWN) Findings on Drug-Related Emergency Department Visits, February 22, 2013, www.samhsa.gov/data/2k13/DAWN127/sr127-DAWN-highlights.htm. 4. Centers for Disease Control and Prevention, “Vital Signs: Overdoses of Prescription Opioid Pain Relievers — United States, 1999–2008,” Morbidity and Mortality Weekly Report, 60, no. 43 (November 4, 2011): pp. 1487–1492, www.cdc.gov/mmwr/preview/mmwrhtml/mm6043a4.htm. 5. G. Caleb Alexander, Stefan P. Kruszewski, and Daniel W. Webster, “Rethinking Opioid Prescribing to Protect Patient Safety and Public Health,” Journal of the American Medical Association, 308, no. 18 (November 14, 2012): p. 1865, http://jama.jamanetwork.com/article.aspx?articleid=1391927.

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6. Benedict Carey, “Prescription Painkillers Seen as a Gateway to Heroin,” New York Times, February 20, 2014, www.nytimes.com/2014/02/11/health/prescriptionpainkillers-seen-as-a-gateway-to-heroin.html. 7. Mitch Betses and Troyen Brennan, “Abusive Prescribing of Controlled Substances — A Pharmacy View,” New England Journal of Medicine, 369, no. 11 (September 12, 2013): p. 989, www.nejm.org/doi/full/10.1056/NEJMp1308222. 8. National Association of Boards of Pharmacy, “NABP InterConnect,” fact sheet, p. 2, www.nabp.net/programs/assets/PMP%20Interconnect%20Fact%20Sheet.pdf. 9. HealthIT.gov, “Linking PDMPs to Health IT,” www.healthit.gov/PDMP. See also the agencies’ September 2013 report to Congress on PDMP interoperability standards, www.healthit.gov/sites/default/files/fdasia1141report_final.pdf. 10. Statement of Joseph T. Rannazzisi before the Subcommittee on Oversight and Investigations, Committee on Energy and Commerce, U.S. House of Representatives, April 29, 2014, p. 6, http://docs.house.gov/meetings/IF/IF02/20140429/102161/ HHRG-113-IF02-Wstate-RannazzisiJ-20140429.pdf. 11. National Governors Association, “Reducing Prescription Drug Abuse: Lessons Learned from an NGA Policy Academy,” February 2014, p. 5, www.nga.org/files/ live/sites/NGA/files/pdf/2014/1402ReducingPrescriptionDrugAbuse-Paper.pdf.

12. Executive Office of the President of the United States, “Epidemic: Responding to America’s Prescription Drug Abuse Crisis,” p. 2, www.whitehouse.gov/sites/ default/files/ondcp/issues-content/prescription-drugs/rx_abuse_plan.pdf. 13. See http://painconsortium.nih.gov/CoEpes.html. 14. See www.dpt.samhsa.gov/providers/prescribingcourses.aspx. 15. Statement of Joseph T. Rannazzisi, p. 5. 16. National Conference of State Legislatures, “The Burden of Prescription Drug Overdoses on Medicaid,” December 2013, www.ncsl.org/documents/health/ PrescriptionDrugOverdoseMedicaid122013.pdf. 17. Centers for Medicare & Medicaid Services, “CMS makes improvements to Medicare drug and health plans,” press release, May 19, 2014, www.cms.gov/ Newsroom/MediaReleaseDatabase/Press-releases/2014-Press-releases-items/2014-05-19. html.

18. Kelly Kennedy, “Report: More doctors accepting Medicare patients,” USA Today, August 22, 2013, www.usatoday.com/story/money/business/2013/08/22/reportmedicare-physician-access/2682301/. 19. http://thomas.loc.gov/cgi-bin/bdquery/z?d113:h.r.3392:. 20. For bill summary, see Kentucky Board of Medical Licensure, House Bill 1, http://kbml.ky.gov/hb1/Pages/default.aspx.

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