<p>1 PLEASE NOTE: THIS RESOLUTION WILL BE DEBATED AT THE 2017 COUNCIL MEETING. RESOLUTIONS ARE NOT 2 OFFICIAL UNTIL ADOPTED BY THE COUNCIL AND THE BOARD OF DIRECTORS (AS APPLICABLE). 1</p><p>2 3 4 RESOLUTION: 38(17) 5 SUBMITTED BY: Connecticut College of Emergency Physicians 6 Emergency Medicine Residents’ Association 7 Geriatric Emergency Medicine Section 8 SUBJECT: Prescription Drug Pricing</p><p>9 PURPOSE: Create a policy statement: 1) recognizes how the threat of unaffordable prescription drug prices affects patients; 2) 10 supports Medicare drug price negotiation in Part D; 3) supports importation of prescription drugs; 4) supports value-based 11 pharmaceutical pricing; and 5) work with the AMA to support regulatory and legislative efforts. 12 13 FISCAL IMPACT: Budgeted committee, staff, and consultant resources. 14</p><p>15 WHEREAS, Per capita prescription drug spending in the United States is the highest in the world1; and </p><p>16 WHEREAS, Spending for prescription drugs constitutes nearly one-fifth of total health care costs in the United States1; and 17 WHEREAS, The price of prescription drugs continues to rapidly increase, outpacing spending increases for other health care 18 expenditures1; and 19 20 WHEREAS, Cost-related medication non-adherence is associated with increased emergency department utilization2; and 21 22 WHEREAS, Prices continue to skyrocket for medications necessary for the prehospital treatment of life-threatening 23 conditions, such as naloxone for opioid overdose3 and epinephrine auto-injectors for anaphylaxis4, where cost-related unavailability 24 may lead to unnecessary preventable death; and 25 26 WHEREAS, The Medicare Modernization Act of 2003 created Medicare Part D, which currently pays for 30% of all national 27 prescription drug expenditures, but prohibits the Secretary of the Department of Health and Human Services (HHS) from 28 negotiating prices1; and 29 30 WHEREAS, The majority of Americans believe that lowering the cost of prescription drugs should be a top health care 31 priority5; and 32 33 WHEREAS, Consistent with public opinion6, the American Medical Association has adopted policies to encourage 34 prescription drug price and cost transparency7, to support negotiation of drug prices under Medicare Part D8, to allow wholesalers 35 and pharmacies to import prescriptions drugs9, and to support the creation of objective, independent entities to determine value- 36 based prices of pharmaceuticals10; therefore be it 37 RESOLVED, That ACEP create a policy statement that: 38  recognizes the threat that unaffordable prices of medications used to treat acute and chronic diseases poses to our 39 patients and the challenges this imposes upon the emergency medical system; 40  supports the negotiation of drug prices under Medicare Part D; 41  supports the importation of prescription drugs; and 42  supports value-based pharmaceutical pricing; and be it further 43 44 RESOLVED, That ACEP work with the American Medical Association and other stakeholders to support regulatory and 45 legislative efforts to address these issues. 46 References 47 1. Kesselheim AS, Avorn J, Sarpatwari A. The High Cost of Prescription Drugs in the United States: Origins and Prospects for Reform. 48 JAMA. 2016;316(8):858-871. Resolution 38(17) Prescription Drug Pricing Page 2 49 2. Blanchard J, Madden JM, Ross-Degnan D, Soumerai SB. "The Relationship Between Emergency Department Use and Cost-Related 50 Medication Nonadherence Among Medicare Beneficiaries." Ann Emerg Med. 2013;62(5):475-485. 51 3. Gupta R, Shah ND, Ross JS. The Rising Price of Naloxone — Risks to Efforts to Stem Overdose Deaths. NEJM. 2016;375(23):2213- 52 2215. 53 4. Pepper AN, Westermann-Clark E, Lockey RF. The High Cost of Epinephrine Autoinjectors and Possible Alternatives. J Allergy Clin 54 Immunol Pract. 2017;5:665-8. 55 5. Kirzinger A, DiJulio B, Sugarman E, Brodie M. Kaiser Health Tracking Poll: April 2017. http://www.kff.org/health- 56 reform/report/kaiser-health-tracking-poll-late-april-2017-the-future-of-the-aca-and-health-care-the-budget/. Published April 26, 2017 by the 57 Kaiser Family Foundation. Accessed July 26, 2017. 58 6. Kirzinger A, Wu B, Brodie M. Kaiser Health Tracking Poll: September 2016. http://www.kff.org/health-costs/report/kaiser-health- 59 tracking-poll-september-2016/. Published September 29, 2016 by the Kaiser Family Foundation. Accessed July 26, 2017. 60 7. AMA Policy Finder. Pharmaceutical Cost H-110.987. https://policysearch.ama-assn.org/policyfinder/detail/Policy%20H-110.987%2C? 61 uri=%2FAMADoc%2FHOD.xml-0-101.xml. Published 2017. Accessed July 26, 2017. 62 8. AMA Policy Finder. Prescription Drug Prices and Medicare D-330.954. 63 https://policysearch.ama-assn.org/policyfinder/detail/330.954?uri=%2FAMADoc%2Fdirectives.xml-0-1092.xml. Published 2017. Accessed 64 July 26, 2017. 65 9. AMA Policy Finder. Prescription Drug Importation and Patient Safety D-100.983. https://policysearch.ama- 66 assn.org/policyfinder/detail/D-100.983?uri=%2FAMADoc%2Fdirectives.xml-0-23.xml. Published 2016. Accessed July 26, 2017. 67 10. AMA Policy Finder. Incorporating Value into Pharmaceutical Pricing H-110.986. https://policysearch.ama- 68 assn.org/policyfinder/detail/value%20based?uri=%2FAMADoc%2FHOD-110.986.xml. Published 2017. Accessed July 26, 2017. 69 70 71 Background 72 73 The resolution calls for ACEP to create a policy statement that: 1) recognizes how the threat of unaffordable prescription drug 74 prices affects patients; 2) supports Medicare drug price negotiation in Part D; 3) supports importation of prescription drugs; 4) 75 supports value-based pharmaceutical pricing; and 5) work with the American Medical Association to support regulatory and 76 legislative efforts to address these issues. 77 78 The rising costs of prescription drugs is a multifaceted problem that has garnered greater attention from patients, providers, and 79 lawmakers over the past several years. A 2016 report in the Journal of the American Medical Association (JAMA) found that per- 80 capita prescription drug spending in the U.S. has increased at rates “far beyond the consumer price index.” The report cites market 81 exclusivity as the most important factor, with the main method of reducing prices – the availability of generic drugs – subject to 82 years of intentional delays. The report also indicates another key contributor to drug spending is physician prescribing choices when 83 cheaper alternatives are available. Many have also pointed to the growth in spending on new specialty or breakthrough drugs as a 84 major contributing factor in overall drug spending in the U.S. 85 86 Others note factors like the rapid growth of pharmacy benefit managers (PBMs) and a lack of transparency about their role in 87 negotiating drug prices and providing rebates, with questions about conflicts of interest arising as more PBMs have been acquired 88 by insurers or pharmacy companies. And while pharmaceutical manufacturers often cite the high costs of research and development 89 as a factor in pricing determinations, there appears to be little independent evidence that these costs account for drug prices. 90 91 Efforts to curb spending growth and reduce drug prices are varied. The resolution calls for price negotiation in Medicare Part D, 92 which was prohibited through a “noninterference” provision when the program was established in the Medicare Modernization Act 93 (MMA) of 2003. While calls to allow for price negotiation have been a common policy position for many Democrat legislators, 94 Republican lawmakers have largely opposed such efforts. However, as candidate, and now as President, Donald Trump also voiced 95 support for direct price negotiation throughout the Medicare program. This line of thinking appears to be popular among the public 96 as well – the Kaiser Family Foundation notes that this policy is supported by 82 percent of the public, including 68 percent of 97 Republicans. However, previous estimates from the nonpartisan Congressional Budget Office (CBO) suggest that allowing 98 Medicare to negotiate prices would have a negligible effect on federal spending. 99 100 This resolution also calls for the importation of prescription drugs, which is not currently allowed under U.S. law. Supporters point 101 to lower patient costs in other countries for the same drugs available in the U.S. as a substantial benefit for consumers. For 102 opponents of importation, safety and efficacy are the predominant concerns, as it becomes more difficult to monitor the supply 103 chain and ensure the quality of the drugs. While President Trump has in the past declared support for importation, influential 104 members of his administration, including Health & Human Services Secretary Tom Price, MD, and Food & Drug Administration 105 Commissioner Scott Gottlieb, are on record as longtime opponents of drug importation. Resolution 38(17) Prescription Drug Pricing Page 3 106 107 ACEP is a member of the National Coalition on Health Care (NCHC), which is an alliance of national health care, consumer, labor 108 and business groups working to achieve affordable, high-value health care for patients. The NCHC is promoting several concepts to 109 curb prescription drug prices, including: accelerated FDA review of competitor drugs, prescription drug pricing transparency, 110 increased comparative effectiveness research and improved access to generic biosimilar drugs. The NCHC also has established the 111 Campaign for Sustainable Rx Pricing (CSRXP). This subgroup is a non-partisan coalition of organizations engaged in the drug 112 pricing debate and that is also developing bi-partisan, market-based solutions to lower drug prices in the United States. 113 Additionally, the ACEP Foundation also worked with Pfizer in 2010 as a supporter of the Partnership for Prescription Assistance to 114 ensure that emergency department patients know that assistance is available, especially for those who are uninsured, unemployed, 115 or on fixed incomes. 116 117 The AMA has multiple policies addressing this issue: Pharmaceutical Cost H-110.987; Cost of Prescription Drugs H-110.997; Price 118 of Medicine H-110.991; Reducing Prescription Drug Prices D-110.993; Prescription Drug Prices and Medicare D-330.954; 119 Prescription Drug Importation and Patient Safety D-100.983; and Incorporating Value into Pharmaceutical Pricing H-110.986. 120 121 ACEP Strategic Plan Reference 122 123 Goal 1 – Reform and Improve the Delivery System for Acute Care 124 Objective C – Pursue strategies for fair payment and practice sustainability to ensure patient access to care. 125 126 Fiscal Impact 127 128 Budgeted committee, staff, and consultant resouces. 129 130 Prior Council Action 131 132 Amended Resolution (13)15 ACEP and the Pharmaceutical Industry adopted. Directed ACEP to evaluate the expanding role and 133 cost for pharmaceuticals affecting emergency medicine, identify and collaborate with interested parties/stakeholders, including 134 pharmaceutical manufacturers, to assure appropriate, cost-effective, sustainable, access to emergency care treatments and identify 135 methods to best facilitate dissemination of factual and data driven information about alternative uses of medications and develop 136 appropriate policies to support this effort and provide a report to the 2016 Council. 137 138 Prior Board Action 139 140 Amended Resolution (13)15 ACEP and the Pharmaceutical Industry adopted. 141 142 143 Background Information Prepared by: Ryan McBride, MPP 144 Senior Congressional Lobbyist 145 146 Margaret Montgomery, RN, MSN 147 Practice Management Manager 148 149 Craig Price, CAE 150 Senior Director, Policy and Finance 151 152 Reviewed by: James Cusick, MD, FACEP, Speaker 153 John McManus, MD, FACEP, Vice Speaker 154 Dean Wilkerson, JD, MBA, CAE, Council Secretary and Executive Director</p>