2/4/2019 AkPhA Legislative Update: Pertinent Pharmacy Legislative Issues Purpose Statement: To educate pharmacists on current Government/Regulatory issues on both the national and state levels Objectives: 1). Describe potential implications to the practice of pharmacy from the passage of The Opioid Crisis Response Act of 2018 . 2). Identify national and regional regulatory steps being implemented or considered regarding the opioid crisis. 3). List three legislative bills that AKPhA will be monitoring in the 2019 Legislative Session. 2 1 2/4/2019 The 2019 session is the first session of the 31st Alaska State Legislature. Session convened on January 15, 2019. Each legislature has two regular sessions. Each session can go 90 days by law, plus any extensions or special sessions. Could go the full 120 days allowed by the Constitution. 3 2 2/4/2019 5 3 2/4/2019 Two Bodies – Senate and House composed of 20 state senators & 40 state representatives. Each senator’s area is divided into 2 House districts. 2-year terms in House. 4 years terms in Senate – with staggered election process, except during re- districting. Each body is further divided between two groups—the majority and the minority. To be a part of the majority, a legislator is typically required to vote to approve the budget and on all procedural votes on the floor. 4 2/4/2019 Senate organized House has Speaker Pro Tem Sen. Cathy Giessel (R) Neal Foster (D) Eagle RIver Nome President of the Senate Speaker Pro Tempore She leads a 14 – member Majority Coalition 13 Republicans 1 Democrat. 9 Majority Leader Minority Leader Rules Chair Sen. Mia Costello Sen. Tom Begich Sen. John Coghill Anchorage Anchorage North Pole 10 5 2/4/2019 New Legislators for the 31st Legislature House of Representatives Benjamin Carpenter Sharon Jackson William Zach Fields Sara Hannon Grier Hopkins Barton LeBon Laddie Shaw Kelly Merrick Sara Rasmussen Josh Revak Andrea Story Sarah Vance New Legislators for the 31st Legislature Senate Jesse Kiehl Elvi Gray-Jackson Familiar House Faces Now in the Senate Chris Birch Scott Kawasaki Lora Reinbold 6 2/4/2019 Brings fairness to the unregulated and expanding practice of pharmacy audits. Does not allow audits the first seven calendar days of each month because of the high patient volume, unless the pharmacy and auditor agree otherwise. Is designed to prevent the targeting of minor clerical or administrative errors where no true fraud, patient harm, or financial loss has occurred. 13 Establishes submission of data/medical record standards to allow for clarification where discrepancies are identified. Establishes a reasonable time frame for the announcement of an audit to allow proper retrieval of records under review. Establishes an audit appeals process for pharmacies. 14 7 2/4/2019 Establishes guidelines for PBM’s (Pharmacy Benefit Managers) to follow regarding patient confidentiality. Extrapolation cannot be used in assessing fees/penalties. Alaska pharmacists would not be penalized for providing mail-order service to their customers. Local mail-order service keeps Alaskan dollars in Alaska. 15 Legislation does not prevent the recoupment of funds where fraud, waste and abuse exist. 40 other states have already enacted fair audit legislation Bill will also include: 1). Registration of PBM’s 2). Set up guidelines for generic drug MAC pricing by PBM’s 3). Establish a mechanism for pharmacy to appeal MAC pricing Sec. 9. Sections 1, 3, 6(b), and 7 of this Act take effect immediately under 13 AS 01.10.070(c). 14 * Sec. 10. Except as provided in sec. 9 of this Act, this Act takes effect July 1, 2019 16 8 2/4/2019 The bills gives the the State Board of Pharmacy the authority to license and inspect the facilities of wholesale drug distributors and outsourcing facilities located out side the state under AS 08.80.159. It also gives the board the authority to establish the qualifications and duties of the administrator. Sec. 10. Sections 1, 6, 8, and 9 of this Act take effect immediately under AS 01.10.070(c). 27 * Sec. 11. Except as provided in sec. 10 of this Act, this Act takes effect July 1, 2018 17 An Act extending the termination date of the Board of Pharmacy; and providing for an effective date. Board of Pharmacy (AS 08.80.010) – June 30, 2022 [2018]. Effective Date – June 2018 18 9 2/4/2019 AkPhA Board Chair – Set-up Provider Status Working group. Named Colman Cutchins chair. Done Working Group met, educated members and discussed strategies. - Done Lobbyist discussed with Sen. Giessel/staff to develop a draft bill. - Done AkPhA needs to educate legislators, and state departments during 2019. Plans are to file 2020 Legislation if it can’t be worked out through regulations. 20 10 2/4/2019 With assistance from the CDC, the State of Alaska DHSS, and the UAA/ISU Pharmacy Program, AKPhA is currently conducting a demonstration project to validate payment for pharmacist cognitive services. This is a huge step towards supporting provider status, and even more importantly, demonstrating a sustainable business model for the future of our profession. Pharmacists in every practice setting will benefit from recognition of pharmacists as billable providers. Stay tuned for more news on this exciting project. 21 Today, most women have to refill their birth control every month. This can be burden for many women especially in rural areas, and women who work in professions that require them to be gone extended periods of time. HB 21 helps ensures all women have consistent access and it requiring that insurance cover one- year’s supply of birth control. 22 11 2/4/2019 1). Mandates insurance companies to pay both private and Medicaid claims. 2). Reimburse health care providers for and initial 3 month supply (to gage adverse reactions). 3). Then followed by a 12 month supply of contraceptives, including but not limited to birth control pills and hormonal contraceptive patches. 23 The Alaska Department of Health and Social Services released the 2018- 2022 Statewide Opioid Action Plan. The five-year action plan, compiled by the Office of Substance Misuse and Addiction Prevention (OSMAP). A final community summit in August 2018, coordinated by the Advisory Board on Alcoholism and Drug Abuse (ABADA), the Alaska Mental Health Trust and DHSS, brought together nearly 100 Alaskans from over 80 agencies and community organizations to provide final input for the action plan. Nationwide and in Alaska, the opioid epidemic has become known as this decade’s defining public health crisis. During 2010-2017, with 623 identified overdose deaths, the opioid overdose death rate in Alaska increased by 77 percent (from 7.7 per 100,000 persons in 2010 to 13.6 in 2017). 24 12 2/4/2019 Preliminary data for 2018 indicate that the ongoing response may be having an impact: During the first six months of 2018, 29 Alaskans died of opioid overdose, compared with 44 opioid overdose deaths during the first six months of 2017. In July 2017, OSMAP was formed to lead the state’s multi-agency response to the crisis under the direction of Alaska’s Chief Medical Officer. Six overarching goals are identified in the plan along with specific objectives and actions to reach those goals. 25 The plan’s broad public health approached fall into three areas: 1). Stronger environmental controls and improved social determinants which includes reducing the misuse of prescription opioids; 2). limiting access to illicit drugs and promoting mental wellness for all Alaskans; 3). improved screening and management of opioid addiction as a chronic disease combined with better access for all Alaskans to treatment and recovery services; and reventing opioid overdose deaths through widespread availability and the appropriate use of naloxone and improved health provider and drug prescriber education. 26 13 2/4/2019 The Alaska Department of Health and Social Services Section of Epidemiology released a report late 2018 on the "Health Impacts of Opioid Misuse in Alaska." The report provides a broad overview of Alaska’s opioid epidemic and related trend data to help Alaskans better understand the scope of this serious public health crisis. “While deaths caused by prescription opioids and heroin declined in 2017, we have seen more deaths caused by fentanyl, a more deadly synthetic opioid.” Overall, opioid-related deaths in Alaska have risen in recent years, similar to national trends. Between 2010 and 2017, 623 opioid overdose deaths were reported in Alaska, a 77 percent increase. Use of synthetic opioids like fentanyl increased dramatically in Alaska last year. Nationwide, efforts to control this epidemic are complicated by the increased use of synthetic opioids. In Alaska, the opioid epidemic has disproportionately impacted males, white and Alaska Native people, and persons aged 25-44 years. 27 Opioid deaths high, but data signals progress in Alaska's fight against opioids. Economic impacts are also significant. Between 2016 and 2017, hospital visits in Alaska due to opioid overdoses cost more than $23 million. While Alaska’s opioid epidemic continues, there are some encouraging findings in the report: Use of prescription opioids declined among Medicare patients in recent years, suggesting Alaska doctors may be prescribing opioids with more caution; Naloxone, a medication that can reverse the effects of an opioid overdose, is readily available statewide and is being used to save lives; and Self-reported heroin use among traditional high school students dropped in 2013 and has not increased since then. Controlling this epidemic requires many long-term strategies. The DHSS Office of Substance Misuse and Addiction Prevention is working with communities across Alaska to limit the dosage of first-time opioid prescriptions, better understand opioid misuse as a chronic disease, improve access to treatment and recovery services, and more.