2017 Pharmacy Education Series

Transcription

1 2017 Pharmacy Education Series August 16, 2017 Beyond Repeal and Replace: Restructuring Obamacare and Other Pharmacy Issues Featured Speaker: Brian M. Meyer, MBA Public Policy Consultant Online Evaluation, Self-Assessment and CE Credit Submission of an online post test and evaluation is the only way to obtain CE credit for this webinar Go to Webinar attendees will also receive an with a direct link to the web page Print your CE statement of completion online Credit for live or enduring (not both) Deadline: September 15, 2017 CPE Monitor (applicable to pharmacists and pharmacy technicians) CE credit automatically uploaded to NABP/CPE Monitor upon completion of post test and evaluation (user must complete the claim credit step) Attendance Code Code will be provided at the end of today s activity 2 1

2 How to Ask a Question Locate menu bar on your computer desktop Click orange arrow button to open menu box Type question into question box Click Send Do not close menu box This will disconnect you from the Webcast Please submit questions throughout presentation Enter question Click No! Click 3 Accessing PDF Handout No! Click the hyperlink that is located directly above the question box Do not close menu box This will disconnect you from the Webcast Click hyperlink 4 2

3 August 16, Pharmacy Education Series Beyond Repeal and Replace: Restructuring Obamacare and Other Pharmacy Issues Featured Speaker: Brian M. Meyer, MBA Public Policy Consultant It is the policy of to ensure balance, independence, objectivity and scientific rigor in all of its continuing education activities. Faculty must disclose to participants the existence of any significant financial interest or any other relationship with the manufacturer of any commercial product(s) discussed in an educational presentation. Mr. Meyer does not have any relevant commercial and/or financial relationships to disclose. Please note: The opinions expressed in this activity should not be construed as those of the CME/CE provider. The information and views are those of the faculty through clinical practice and knowledge of the professional literature. Portions of this activity may include unlabeled indications. Use of drugs and devices outside of labeling should be considered experimental and participants are advised to consult prescribing information and professional literature. 5 CE Activity Information & Accreditation (Pharmacist and Pharmacy Technician CE) 2.0 contact hours Funding: This activity is self funded through CHSPSC

4 Beyond Repeal and Replace: Restructuring Obamacare and Other Pharmacy Issues Community Health Systems August 16, 2017 Brian M. Meyer, MBA Public Policy Consultant 7 Nothing to Disclose 8 4

5 Learning Objectives List the major health policy areas impacted by Republican House and Senate proposals to repeal and/or replace the Affordable Care Act (Obamacare). Describe the impact on pharmacy services of the proposed phase out of Medicaid expansion in the House and Senate legislation. Discuss what actions the Trump Administration may/will continue to take in the absence of any repeal and replacement of the Affordable Care Act. Identify the political factors faced by Congress and the Trump Administration in addressing health policy with respect to the ACA. 9 Learning Objectives (cont d) Outline the major congressional proposals to address drug pricing and their implications for hospital pharmacy resources. Describe the legislative proposals to address the opioid addiction epidemic and its impact on pharmacy operations. Describe the 2018 proposed Medicare reimbursement to hospital outpatient departments for Part B drugs. List the advocacy actions pharmacists and technicians can take to adapt and improve patient care services

6 Overview Repeal and Replace, or Restructure? Drug Pricing Opioid Addiction Response Part B Outpatient Drug Reimbursement Recommended Advocacy Actions 11 Repeal and Replace, or Restructure? Post Obamacare Health Policy Medicaid Expansion Executive Branch Actions Political Factors

7 Repeal, Replace or Restructure? Affordable Care Act House Bill Senate Bills 13 Congressional Legislation & Action House Bill passed 5/4/17, H.R. 1628, American Health Care Act Repeal individual and employer mandates Phase out Subsidies to Insurers for Individual Cost Sharing Provides Premium Tax Credits for Younger Adults and Older Adults

8 House Bill, H.R American Health Care Act (cont d) Keeps Guaranteed issue of coverage Prohibits pre existing conditions Allows for dependent coverage to age 26 Financing/Elements Taxes Repealed Individual Mandate Late enrollment penalty (30% of premium) continues for not maintaining continuous creditable coverage Employer Mandate Cadillac tax High income Medicare tax Pharmaceutical Manufacturers Health Insurers Medical Devices Tanning Beds 3.8% tax on unearned income for high income taxpayers 15 House Bill, H.R American Health Care Act (cont d) Medicaid Expansion (or Contraction) Limits enhanced FMAP (federal match) to expansion states as of March 1, Sunsets enhances FMAP as of Jan 1, Grandfathers beneficiaries enrolled as of Dec 31, Converts FMAP to per capita allotment and limits growth beginning Prohibits federal funding for Planned Parenthood clinics

9 House Bill, H.R American Health Care Act (cont d) Cost Sharing Subsidies Repealed effective Jan 1, 2020 (Trump Administration Threatening to eliminate sooner) Impacts Out of Pocket Costs for Individuals and Premiums Charged by Insurers Premium rates (based on community rating) allow age difference of 5:1 States using Patient and State Stability Fund grants or participate in Federal Invisible Risk Sharing Program can waive community rating for individuals that don t maintain continuous coverage (thereby permitting health status as a rating factor) 17 House Bill, H.R American Health Care Act (cont d) Benefit Design Ten Essential Health Benefit Categories Remain In 2020 state waivers available to re define categories Requirement for specific actuarial value for plans sunsets on Dec 31, 2019 Planned Parenthood Prohibits funding for one year, effective upon date of enactment. Family Planning Services In Medicaid block grant states, no longer a mandatory service. Redefines qualified health plan to exclude any plan that covers abortion services, beyond those for saving the life of the woman or in cases of rape or incest effective

10 House Bill, H.R American Health Care Act (cont d) High Risk Pools Patient and State Stability Fund Grants to fund high risk individuals Stabilize private insurance premiums Promote access to preventive services Provide cost sharing subsidies Maternity coverage and newborn care Mental health and substance abuse $100 billion over 9 years Federal Invisible Risk Sharing Program (a reinsurance program) $15 billion over 9 years; CMS to operate ; States operate beginning House Bill, H.R American Health Care Act (cont d) Annual fee paid by pharmaceutical manufacturers repealed after Dec 31, Phased in elimination of the Part D coverage gap (donut hole) remains in effect. Donut hole filled by Other ACA provision remain in effect: Center for Medicare and Medicaid Innovation Medicare Shared Savings Accountable Care Organizations Penalties for Readmissions and Hospital Acquired Conditions

11 Senate Action (or Inaction) Better Care Reconciliation Act with Cruz Amendment Failed Straight Repeal with 2 year delay Failed Skinny Repeal Failed Remainder of 2017: House Senate Consensus? Future Is Healthcare now a right?? Closer to Universal Coverage? Political Willingness to Address Cost? Moving Toward a Single Payer?

12 Potential Executive Branch Actions End cost sharing subsidies to insurers ($7 billion) Stop enforcing/collecting individual mandate End funding for enrollment outreach Allow expansion states to require able bodied enrollees to work and/or increase out of pocket costs. 23 Political Factors Congressional Budget Office Score House Republicans Senate Republicans House and Senate Democrats Trump Administration Governors

13 Congressional Budget Office Score Fiscal Impact of Major Legislation By 2026, Increase Uninsured by: House Bill: 24 million Senate Bills: million 25 Key Points From CBO Analysis of American Health Care Act (AHCA) THE UNINSURED NUMBER OF UNINSURED WOULD INCREASE BY 24 MILLION BY INITIAL CONSUMER IMPACT AVERAGE PREMIUMS IN NEW GROUP MARKET RISE 15% 20% IN 2018 AND (Relative to projections under the ACA) CONSUMER IMPACT DEDUCTIBLES RISE ON AVERAGE. AVERAGE PREMIUMS FALL ROUGHLY 10% BY 2026 AS FEWER OLDER CONSUMERS BUY COVERAGE. (Relative to projections under the ACA) FEDERAL SPENDING FOR COVERAGE (After tax credit) DECREASE OF $1.2 TRILLION ($880 BILLION IN MEDICAID AND $312 BILLION IN TAX CREDITS) OVER 10 YEARS. IMPACT ON FEDERAL DEFICIT DECREASE OF $337 BILLION OVER 10 YEARS

14 Political Factors: House Leadership Conservative Freedom Caucus Moderate GOP members Problem Solving Caucus 27 Political Factors: Senate Majority Leader McConnell Conservatives Ted Cruz, Mike Lee, Others Moderates Susan Collins Lisa Murkowski Wild Card John McCain Moderate Democrats Up in 2018 John Tester Joe Manchin

15 Political Factors: Trump Administration The President Vice President Pence Secretary Tom Price CMS Administrator Seema Verma 29 Political Factors: States Governors Democrats Republicans Medicaid Expansion States Non Expansion States

16 Current Status of State Medicaid Expansion Decisions WA OR NV CA ID AZ* UT MT* WY CO NM ND SD NE KS OK MN WI* IA* IL MO AR* MS VT NY MI* PA OH IN* WV VA KY NC TN SC AL GA ME NH* MA CT RI NJ DE MD DC TX LA AK HI FL Adopted (32 States including DC) Not Adopting At This Time (19 States) NOTES: Current status for each state is based on KCMU tracking and analysis of state executive activity. *AR, AZ, IA, IN, MI, MT, and NH have approved Section 1115 waivers. WI covers adults up to 100% FPL in Medicaid, but did not adopt the ACA expansion. SOURCE: Status of State Action on the Medicaid Expansion Decision, KFF State Health Facts, updated January 1, reform/state indicator/state activity around expanding medicaid under the affordable care act/ 31 Opioid Addiction 2015: Over 2 million had a prescription opioid addiction 3 in 10 (30%) covered by Medicaid Senate bill would change formula for Medicaid funding to states either by Per capita cap Block grant Does appropriate $44.7 billion for 9 years, but only for substance abuse disorder and recovery; not other health conditions

17 Figure 33 In 2015, nearly a quarter of states had death rates exceeding 15.0/100,000, most of which were in Appalachia and New England. WA OR NV CA AK ID AZ UT MT WY CO NM ND MN WI SD IA NE IL KS MO OK AR MS TX LA VT NY MI PA OH IN WV VA KY NC TN SC AL GA FL ME NH CT RI NJ DE MD DC MA Deaths per 100, HI SOURCE: Kaiser Family Foundation analysis of Centers for Disease Control and Prevention (CDC), National Center for Health Statistics. Multiple Cause of Death on CDC WONDER Online Database 33 Figure 34 Between 2005 and 2015, the increases in the opioid overdose death rate were particularly prominent in CT, DE, MS, NH, NY, OH, and WV. WA OR NV CA AK ID AZ UT MT WY CO NM ND MN WI SD IA NE IL KS MO OK AR MS TX LA IN MI TN AL KY OH WV GA SC PA VT VA NC FL NY ME NH CT RI NJ DE MD DC MA Percent Increase in Death Rate <50% % % 250% HI SOURCE: Kaiser Family Foundation analysis of Centers for Disease Control and Prevention (CDC), National Center for Health Statistics. Multiple Cause of Death on CDC WONDER Online Database

18 Figure 35 Medicaid covered 3 in 10 nonelderly adults with opioid addiction in 2015, nearly double the share covered in This increase was largely due to the ACA s Medicaid expansion. 33% 32% 8% 8% 42% 37% 20% 10% 40% Uninsured Other Private Medicaid 17% 23% 30% 2005 (1.4 million) 2010 (1.9 million) 2015 (2.3 million) SOURCE: Kaiser Family Foundation Analysis of 2015 National Survey on Drug Use and Health 35 Figure 36 Medicaid coverage of nonelderly adults receiving outpatient treatment for opioid addiction grew from 27% in 2005 to 39% in % 30% 15% 10% 6% 12% 34% 28% 27% 31% 36% 39% Uninsured Other Private Medicaid 2005 (191,000) 2010 (380,000) 2015 (581,000) SOURCE: Kaiser Family Foundation Analysis of 2015 National Survey on Drug Use and Health

19 Figure 37 The share of nonelderly adults receiving inpatient treatment for opioid addiction who were covered by Medicaid doubled from 2005 to % 30% 14% 14% 4% 23% 18% 21% 20% 52% Uninsured Other Private Medicaid 26% 31% 2005 (146,000) 2010 (274,000) 2015 (299,000) SOURCE: Kaiser Family Foundation Analysis of 2015 National Survey on Drug Use and Health 37 Opioid Addiction If Senate or House bill passed, it would reduce Eligibility Coverage Provider payments Access to care For FY 2013 Medicaid spent $9.4 billion on 636,000 enrollees with opioid addiction. Services included: Inpatient detoxification Outpatient treatment Medication assisted treatment Treatment for other medical conditions

20 Opioid Addiction Of $9.4 billion, 9.7% spent on prescription drugs. Of note, $9.4 billion spending in 2013 does not include Hep C drugs since they launched after Thus, spending in 2014 and beyond is likely higher. In 2015, 20% of those with opioid addiction were uninsured. Partially due to residing in nonexpansion states. 39 Current Status of State Medicaid Expansion Decisions WA OR NV CA ID AZ* UT MT* WY CO NM ND SD NE KS OK MN WI* IA* IL MO AR* MS VT NY MI* PA OH IN* WV VA KY NC TN SC AL GA ME NH* MA CT RI NJ DE MD DC TX LA AK HI FL Adopted (32 States including DC) Not Adopting At This Time (19 States) NOTES: Current status for each state is based on KCMU tracking and analysis of state executive activity. *AR, AZ, IA, IN, MI, MT, and NH have approved Section 1115 waivers. WI covers adults up to 100% FPL in Medicaid, but did not adopt the ACA expansion. SOURCE: Status of State Action on the Medicaid Expansion Decision, KFF State Health Facts, updated January 1, reform/state indicator/state activity around expanding medicaid under the affordable care act/

21 Opioid Addiction Proposals/Response Limit prescribing Greater scrutiny of supply chain Legal action against manufacturers, distributors Coordination of payer data with state Prescription Drug Monitoring Programs Medication Assisted Treatment Additional funding this year 41 Drug Pricing Current Problem Increases in Brand and Generics High Cost of New Innovator Lack of Competition After Patent Expiry 11.7% Average Increase Prescription Medication Expenditures All Sectors in % for Community Hospitals from

22 Drug Pricing AJHP Editorial, April 15, 2017 health care teams and executives in hospitals and health systems are struggling to manage the cumulative effects of unsustainable increases in drug costs in a fragile healthcare financing system. Paul W. Abramowitz, Pharm.D. Sc.D. (Hon), FASHP CEO, ASHP Am J Health Syst Pharm, 74:8, Drug Pricing Seek market based solutions that address: Competition Transparency Value

23 Public Attitudes 45 Drug Pricing Legislative Response Various Proposals to Address: Faster Approval of Generics Notification & Justification of price increases Importation Transparency by PBMs of rebates and other terms Authority for CMS to Negotiate Prices for Part D drugs

24 Drug Pricing Legislative Response Faster Approval of Generics S. 297, Increasing Competition in Pharmaceuticals Act Prioritizes generic applications when drugs in shortage or there is only one manufacturer when tentative approval has not been granted to more than two applications. S.974, CREATES Act Promotes generic competition by allowing access to brand name samples H.R. 2051, FAST Generics Act Prohibits manufacturers from restricting access to a drug for testing purposes, including access to single shared REMS program. Some elements of the above bills may be included in FDA s reauthorization legislation that must pass by Sept Drug Pricing Legislative Response Notification and Justification of Price Increases Importation Require FDA regulations on Canadian importation for personal use Importation by wholesale distributors, pharmacies, and individuals Transparency by PBMs Disclose information on rebates, discounts and price concessions

25 Drug Pricing Legislative Response Negotiating Authority for CMS Directs Administration to negotiate and establish a formulary on behalf of Medicare beneficiaries 49 Drug Pricing Negotiating Authority produce savings? Not likely CBO letter to Sen Ron Wyden, April 10, 2007: The authority to establish a formulary, set prices administratively, or take other regulatory actions against firms failing to offer price reductions could give the Secretary the ability to obtain significant discounts in negotiations with drug manufacturers. providing broad negotiating authority by itself would likely have a negligible effect on federal spending

26 Drug Pricing Executive Branch Action Potential Executive Order this Fall Allow patients with high deductible plans ($1300/$2600) to fill chronic care prescriptions with just a copay before meeting the deductible. IRS directed to provide details and implement HRSA directed to review and revise 340B program Possible proposal to require rebates on Medicare drugs similar to Medicaid. 51 Drug Pricing Private Sector Trend Value Based Contracting Outcomes Based on Adherence Population health, clinical outcomes Disease specific pricing Avoided costs Regulatory Issues Lack of specific guidance from agencies Impact on Medicaid Best Price 340B Drug Discount Program ASP for Part B Drugs Safe Harbor under Anti Kickback Statute Manufacturer Communications re Unlabeled Use

27 Part B Outpatient Drug Reimbursement July 13 CMS proposed rule for CY2018 Outpatient Prospective Payment System. Comments due September 11, Overall payment update 1.75% Payment for drugs purchased with a 340B Program Discount: Average Sales Price minus 22.5% instead of ASP+6% Aligns with MedPAC estimate, May Payment for drugs purchased outside of 340B program continue reimbursement of ASP+6% 53 Conclusion Obamacare s Future Opioid Crisis Drug Pricing Part B Reimbursement Political Factors

28 Recommended Advocacy Actions C Suite Leadership Colleagues Other Healthcare Practitioners State and Federal Legislators Professional and Trade Associations 55 Questions???

29 Update on Current Pharmacy Initiatives and Strategies Jerry H. Reed, MS, RPh, FASCP, FASHP Senior Director, Pharmacy Services Community Health Systems