Missouri Pharmacy Association

2019 Legislative Session Update Jorgen Schlemeier Disclosure

— Jorgen Schlemeier has no personal or financial conflicts of interest to disclose. Pharmacist Objectives: At the conclusion of this program, the pharmacist will be able to:

— Review the 2019 legislative session. — Discuss the 2020 legislative session. — Review the 2020 elections. Technician Objectives:

— At the conclusion of this program, the technician will be able to:

— Review the 2019 legislative session. — Discuss the 2020 legislative session. — Review the 2020 elections. 2019 Legislative Update — Budget ◦ Medicaid – Dispensing Fee – NAEDC – Expansion of Medicaid – 135% – Reform – looking for innovation – Managed Care versus Managed Benefit – Increased Health Status = reduction in costs – Health Homes – Value Based Reimbursement – Social Determinants – ICD-10 codes 2019 Legislative Update

— Drug Cost Controls ◦ Interim Committee – Importation – Middle man – PBM’s – Cost controls

— Te c h n o l o g y – Telemedicine – telepharmacy 2019 Legislative Update

— Pharmacists viewed by Policy makers/Legislators ◦ Poll on trusted profession ◦ BUT still confusion on “what do pharmacists do?” – telepharmacy feeds this narrative a bit. — How do we impact Policy Decisions — SB514 ◦ Te c h n o l o g y – Te l e m e d i c i n e – telepharmacy — Summer Project — How do we impact Policy Decisions — Questions Budget

— Should meet Revenue projection ◦ Short during Budget discussion ◦ Made up $625M deficit to meet Rev Projections ◦ July (1st month of new fiscal year) 8.25% growth Y over Y Medicaid

— $40M back fill of General Revenue (100% state funds) — Dispensing Fee ◦ Initial MoHealthNet plan was to reduce disp fee by enhanced, thereby all but eliminating the FRA tax, and reduce net fee ◦ New Plan – Cost to Dispense – Mercer – New result (??) - take to CMS for approval – FRA tax calculated as a cost?? How??? Medicaid

— NAEDC ◦ Specialty carve out – other states do it ◦ Sloooooow process because of pending State Plan Amendments (CMS is slow) ◦ Alternative reimbursement to backfill loss – Clinical service fee for administration on specialty drugs – Allowed in practice act under 338.010 - The "practice of pharmacy" means… “the compounding, dispensing, labeling, and administration of drugs and devices pursuant to medical prescription orders…” – Other states allow for Medicaid

— Reform timing ◦ January 2020 – yes in a few months ◦ Phase in of population and services over many years – ABD – 85% of poverty – Seniors – Disabled – focus on this population first – Blind – Mom and kids – (Moms – 19% of Poverty) (Kids – 300% of poverty) Medicaid

— Reform Themes ◦ Value Based Purchasing - 59 percent of healthcare payments expected to be within value-based care models by 2020 - Heath Payer Intelligence, August 2018 – Drug efficacy (in pharmacy world) ◦ Managed Care (benefit) vs Managing Health – Stop paying for the provision of service and start paying for health outcomes. ◦ One size does not fit all – i.e - Rural vs Urban ◦ Series of substantive pilots??? Medicaid

— Reform Themes ◦ Social Determinants of Health – Medical care is estimated to account for only 10-20 percent of the modifiable contributors to healthy outcomes for a population. The other 80 to 90 percent are sometimes broadly called the SDoH(Social Determinants of Health)” - GENEIA WHITE PAPER: Social Determinants of Health: From Insights to Action, March 2018 Medicaid

— Social Determinants of Health ◦ A 2016 study by the Robert Wood Johnson Foundation reported a 17 percent decrease in emergency department use, a 26 percent reduction in emergency spending, a 53 percent decrease in inpatient spending and a 23 percent decrease in outpatient spending as the result of referring 33,000 people to 106,000 community-based programs and services. ◦ Research conducted by WellCare Health Plans and the University of South Florida College of Public Health - when SDoH were addressed - generated a double-digit reduction in healthcare spending. Omnibus Pharmacy/Health Bill – SB514

— SB514 - sponsored by who? Senator Sater of course. — Governor Signed Legislation - To b a c c o C e s s a t i o n - E- Prescribing - MAT / SUD Task Force - Pharmacy Vol Compliance - Remote Prescribing TOBACCO CESSATION

— “The practice of pharmacy shall include the prescribing and dispensing of any nicotine replacement therapy product.” — nicotine replacement therapy product is defined as “any drug, regardless of whether it is available over-the-counter, that delivers small doses of nicotine to a person and that is approved by the Food and Drug Administration (FDA) for the sole purpose of aiding in tobacco or smoking cessation. “ — The Board of Pharmacy and the Board of Healing Arts shall jointly adopt regulations governing a pharmacist's authority to prescribe and dispense nicotine replacement therapy products. — NPI - MEDICATION-ASSISTED TREATMENT — Requires coverage for MAT ◦ shall include coverage for, but not be limited to, pharmacologic and behavioral therapies. ◦ Formularies used by a health insurer/PBM/medical benefit coverage shall include all certain specified MAT’s . ◦ MAT’s shall be placed on the lowest cost-sharing tier of the formulary. ◦ Shall not be subject to step therapy or other similar strategies when it interferes with a prescribed or recommended course of treatment from a licensed health care professional; or prior authorization. MEDICATION-ASSISTED TREATMENT

— shall not be subject to: annual or lifetime dollar limits; limits to predesignated facilities, specific numbers of visits, days of coverage, days in a waiting period, scope or duration of treatment, or other similar limits; financial requirements and quantitative treatment limitations that do not comply with the federal Mental Health Parity and Addiction Equity Act of 2008 (MHPAEA); — Nor subject to prior authorization. Other Opioid News

— No PDMP in Mo — Opioids used to be the go-to choice for treating surgical patients’ pain. Now some hospital officials are trying to get those patients through their surgery without ever receiving any of the highly addictive drugs. -AG’s filed suit against manufacturers -Manufacturers filing Chapter 11 -downward trend of prescriptions of Opioids (Mo in middle of pack w/o PDMP) Opioid Overdose Deaths Not Prevented By Medical Marijuana Laws

— Five years ago, a study of death certificate data suggested that states that passed medical marijuana laws saw 25 percent fewer opioid overdose deaths on average than states that barred medical” marijuana. Washington Post – June 10, 2019 — Following release of that study, “the cannabis industry” took up its findings “to help win passage of medical cannabis laws in more states, even as medical experts expressed skepticism.” Washington Post – June 10, 2019 Opioid Overdose Deaths Not Prevented By Medical Marijuana Laws

— A new study indicates that “states that introduced medical marijuana actually had...more deaths from opioid overdoses.” - Stanford University School of Medicine Published — The AP (6/10, Johnson) reports that after analyzing “data through 2017,” investigators found that “states passing medical marijuana laws saw a 23% higher than expected rate of deaths involving prescription opioids.” THE "TASK FORCE ON SUBSTANCE ABUSE PREVENTION AND TREATMENT"

The task force shall; 1. conduct hearings on current and future drug and substance use and abuse in Missouri, 2. explore solutions to such issues, and 3. draft or modify legislation as necessary to effectuate the goals of finding and funding education and treatment solutions. PHARMACIST VOLUNTARY COMPLIANCE AGREEMENTS

— Board may enter into a voluntary compliance agreement with a pharmacist to ensure or promote compliance with current law and the rules of the Board, in lieu of disciplinary action (Current law restriction). PHARMACY PILOT PROJECTS (BOP)

Board of Pharmacy may approve, modify, and establish requirements for; — pharmacy pilot or demonstration research projects related to technology assisted verification or remote medication dispensing — designed to; ◦ enhance patient care or safety, ◦ improve patient outcomes, or ◦ expand access to pharmacy services. PHARMACY PILOT PROJECTS

— Such pilot or research projects shall be limited to a period of up to 18 months, with 6 month one time extension. — The provisions of this act shall expire on August 28, 2023. — The Board shall provide a final report on the approved projects and related data or findings to the General Assembly on or before December 31, 2022. ELECTRONIC PRESCRIBING

— Beginning January 1, 2021, no person shall issue a prescription for any Schedule II, III, or IV controlled substance unless the prescription is electronic and made to a pharmacy ◦ Pharmacists receiving a written, oral, or faxed prescription shall not be required to verify that the prescription falls into one of the exceptions and may continue to dispense medication from an otherwise valid non-electronic prescription. ◦ An individual who violates this provision may be subject to disciplinary action by his or her professional licensing board. ◦ Matches Medicare requirements E Prescribing

— ePrescribing for controlled substances. Section 2003 mandates that prescriptions for all controlled substances covered under Medicare Part D must be transmitted electronically beginning on January 1, 2021 — Electronic prior authorization (ePA). Section 6062 mandates that all covered Part D drugs requiring a prior authorization must be electronically submitted to Part D sponsors and processors electronically — and responded to electronically — by January 1, 2021. MISSOURI RX PLAN

— Under current law, only Medicaid dual eligible individuals meeting certain income limitations are eligible to participate in the Missouri RX Plan. — This act removes the Medicaid dual eligible requirement, while retaining the income limitations. HEALTH INSURANCE REIMBURSEMENT

Virtual Credit Card — disallows fee based method of payment to providers as only option of reimbursement — Health Carrier shall allow another form of payment to provider without fee to redeem — Shall reimburse provider by method chosen by provider until the provider informs the health carrier otherwise. Interim Project

— Prescription Drug Transparency Interim Committee – Senate ◦ Senator Holsman D - KC ◦ Senator Arthur D - St. Louis ◦ Senator Sater R – Casseville ◦ Senator Wieland R – Jefferson County ◦ Senator White R - Joplin Interim Project

— Prescription Drug Transparency Interim Committee - House ◦ Representative Steve Helms R - Spgf ◦ Representative Anne Kelly R - Neveda ◦ Representative Dale Wright R – Farmington ◦ Representative Doug Clemens D – St. Louis County (St. Ann) Interim Project

— Committee as a result of several factors; ◦ Legislation – Importation – Middle man – PBM’s – Cost controls ◦ Medicaid Spend (Pharmacy) ◦ Media re Drug Price Increases (Epi-Pen, Generic, Specialty et al.) ◦ Consolidated ◦ Legislators own investigation/personal experiences Interim Project

— Drug Price Committee ◦ Power of a State Legislator to Impact Drug Prices? – Importation – nope – Price Controls on Manufacturers – nope – Rebate Amounts – nope – Middle man transparency and reform - yup PBM’s — The New York Senate Committee investigation into PBM practices and their impact on rising drug prices ◦ "the consolidation and vertical integration of PBMs has contributed to skyrocketing list prices and declining patient access" and ◦ "PBMs often employ controversial utilization and management tools to generate revenue for themselves in a way that is detrimental to health plan sponsors, patients, and pharmacies." ◦ a lack of transparency, oversight, and accountability enables PBMs "to engage in anticompetitive practices at the detriment of consumers and pharmacists across New York State,” January of 2019, Senator James Skoufis, Chair of the Senate Committee on Investigations & Government Operations, in coordination with Senator Gustavo Rivera, Chair of the Senate Committee on Health – Final Investigative Report – PBM’s in New York — We have heard this story numerous times and it is time to do something about it. Houston…We have a plan….. Legislators want to solve the problem – duh! But how? — Tempting to take the easy road; ◦ Price controls ◦ Importation ◦ Rebates direct to consumers — Focus on what you can change that affects the price ◦ P – B – M’s Pharmacists Trusted as Provider — The poll ranked pharmacists third among professionals in the United States for honesty and ethical standards, with 66% (up from 62% in 2018) of respondents rating their trustworthiness as “very high” or “high.”1

— Pharmacists ranked behind nurses (84% rated “very high” or “high”), who held the top spot for the 17th consecutive year, and medical doctors (67%).

— High school teachers (60%) and police officers (54%) rounded out the top 5 most trusted professionals.1 Pharmacists Trusted as Provider

— At the bottom of the 2018 ranking for trustworthiness were members of Congress and car salespeople, both of whom earned an 8% rating of “very high” or “high” for honesty and ethical standards. — Telemarketers (9%) were third from the bottom. Gallup Poll – 2019 Most Trusted Professions Assessment Question

The 2019 Legislative Session included all of the following except: a. Tobacco cessation prescriptive authority for pharmacists b. Board of pharmacy pilot projects c. A new pharmacist was elected to the legislature d. Requirements for E-prescribing controlled substances

Answer: C Assessment Question

True or False: Our 2020 Legislative agenda will focus on PBMs.

Answer: TRUE Assessment Question

The following Senators are on the Prescription Drug Transparency Interim Committee:

A. Senator Holsman D – KC B. Senator Arthur D – St. Louis C. Senator Sater R – Casseville Answer: F. D. Senator Wieland R – Jefferson County All of the E. Senator White R – Joplin Above F. All of the above Assessment Question

One way to impact drug pricing and decrease health care spending is to…

A. Import cheaper drugs from other countries. B. Legislate PBMs. C. Legislate PBMs. Answer: B,C, D. Legislate PBMs. and/or D! Any Questions?