2017 Pharmacy Educations3.proce.com/res/pdf/CHS2017Aug16Handout.pdf · approved Section 1115...

Beyond Repeal and Replace: Restructuring Obamacare and Other Pharmacy IssuesCHS Pharmacy Education Series

ProCE, Inc.www.ProCE.com 1

2017 Pharmacy Education Series

August 16, 2017Beyond Repeal and Replace:

Restructuring Obamacare and Other Pharmacy Issues

Featured Speaker:

Brian M. Meyer, MBAPublic Policy Consultant

2

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– 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)

Online Evaluation, Self-Assessmentand CE Credit

Attendance Code

Code will be provided at the end of today’s activity



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2016 Pharmacy Education Series

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It is the policy of ProCE, Inc. 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.

August 16, 2017Beyond Repeal and Replace:

Restructuring Obamacare and Other Pharmacy Issues

Featured Speaker:

Brian M. Meyer, MBAPublic Policy Consultant

CE Activity Information & Accreditation

ProCE, Inc. (Pharmacist and Pharmacy Technician CE)

– 2.0 contact hours

6

Funding:This activity is self‐funded through CHSPSC.



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

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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.

10



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

12



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

14



House Bill, H.R. 1628American 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. 1628American Health Care Act (cont’d)• Medicaid Expansion (or Contraction)

• Limits enhanced FMAP (federal match) to expansion states as of March 1, 2017.

• Sunsets enhances FMAP as of Jan 1, 2020. Grandfathers beneficiaries enrolled as of Dec 31, 2019.

• Converts FMAP to per capita allotment and limits growth beginning 2020.

• Prohibits federal funding for Planned Parenthood clinics

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House Bill, H.R. 1628American 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)

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House Bill, H.R. 1628American 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 2018.

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House Bill, H.R. 1628American 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 2018‐2019; States operate beginning 2020.

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House Bill, H.R. 1628American Health Care Act (cont’d)• Annual fee paid by pharmaceutical manufacturers repealed after Dec 31, 2016.

• Phased in elimination of the Part D coverage gap (donut hole) remains in effect. Donut hole filled by 2020.

• 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

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Senate Action (or Inaction)

• Better Care Reconciliation Act with Cruz Amendment –Failed 43‐57

• Straight Repeal with 2‐year delay‐Failed 45‐55• Skinny Repeal‐ Failed 49‐51• Remainder of 2017: House‐Senate Consensus?

• Future 2018‐2020

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Is Healthcare now a right??

• Closer to Universal Coverage?

• Political Willingness to Address Cost?

• Moving Toward a Single Payer?

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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.

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Political Factors

• Congressional Budget Office “Score”

• House Republicans

• Senate Republicans

• House and Senate Democrats

• Trump Administration

• Governors

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Congressional Budget Office Score

Fiscal Impact of Major Legislation

• By 2026, Increase Uninsured by:• House Bill: 24 million

• Senate Bills: 22‐32 million

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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 DEFICITDECREASE OF $337 BILLION OVER 10 YEARS.

THE UNINSUREDNUMBER OF UNINSURED WOULD INCREASE BY 24 MILLION BY 2026.

INITIAL CONSUMER IMPACTAVERAGE PREMIUMS IN NEW GROUP

MARKET RISE 15% ‐ 20% IN 2018 AND 2019. (Relative to projections under the ACA)

CONSUMER IMPACTDEDUCTIBLES RISE ON AVERAGE.

AVERAGE PREMIUMS FALL ROUGHLY 10% BY 2026 AS FEWER OLDER CONSUMERS

BUY COVERAGE.(Relative to projections under the ACA)

Key Points From CBO Analysis of American Health Care Act (AHCA)

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Political Factors: House

• Leadership

• Conservative Freedom Caucus

• Moderate GOP members

• Problem Solving Caucus

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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

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Political Factors:Trump Administration

• The President

• Vice President Pence

• Secretary Tom Price

• CMS Administrator Seema Verma

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Political Factors: States

• Governors• Democrats

• Republicans• Medicaid Expansion States

• Non‐Expansion States

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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, 2017.http://kff.org/health‐reform/state‐indicator/state‐activity‐around‐expanding‐medicaid‐under‐the‐affordable‐care‐act/

Current Status of State Medicaid Expansion Decisions

WY

WI*

WV

WA

VA

VT

UT

TX

TN

SD

SC

RI

PA

OR

OK

OH

ND

NC

NY

NM

NJ

NH*

NVNE

MT*

MO

MS

MN

MI*

MA

MD

ME

LA

KYKS

IA*

IN*IL

ID

HI

GA

FL

DC

DE

CT

COCA

AR*AZ*

AK

AL

Adopted (32 States including DC)

Not Adopting At This Time (19 States)

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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.

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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.

WY

WI

WV

WA

VA

VT

UT

TX

TN

SD

SC

RI

PA

OR

OK

OH

ND

NC

NY

NM

NJ

NH

NVNE

MT

MO

MS

MN

MI

MA

MD

ME

LA

KYKS

IA

INIL

ID

HI

GA

FL

DC

DE

CT

COCA

ARAZ

AK

AL

SOURCE: Kaiser Family Foundation analysis of Centers for Disease Control and Prevention (CDC), National Center for Health Statistics. Multiple Cause of Death 1999‐2015 on CDC WONDER Online Database

15.1+

5.1‐10.0

1.0‐5.0

10.1‐15.0

Deaths per 100,000

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.

WY

WI

WV

WA

VA

VT

UT

TX

TN

SD

SC

RI

PA

OR

OK

OH

ND

NC

NY

NM

NJ

NH

NVNE

MT

MO

MS

MN

MI

MA

MD

ME

LA

KYKS

IA

INIL

ID

HI

GA

FL

DC

DE

CT

COCA

ARAZ

AK

AL50‐149%

<50%

150‐249%

≥250%

Percent Increase in Death Rate

SOURCE: Kaiser Family Foundation analysis of Centers for Disease Control and Prevention (CDC), National Center for Health Statistics. Multiple Cause of Death 1999‐2015 on CDC WONDER Online Database 34



Figure 35

Medicaid covered 3 in 10 nonelderly adults with opioid addiction in 2015, nearly double the share covered in 2005. This increase was largely due to the ACA’s Medicaid expansion.

SOURCE: Kaiser Family Foundation Analysis of 2015 National Survey on Drug Use and Health

17%23%

30%

42%37%

40%

8% 8%

10%

33% 32%20%

2005(1.4 million)

2010(1.9 million)

2015(2.3 million)

Uninsured

Other

Private

Medicaid

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Figure 36

Medicaid coverage of nonelderly adults receiving outpatient treatment for opioid addiction grew from 27% in 2005 to 39% in 2015.

27% 31%39%

34% 28%

36%6% 12%

10%34% 30%

15%

2005(191,000)

2010(380,000)

2015(581,000)

Uninsured

Other

Private

Medicaid

SOURCE: Kaiser Family Foundation Analysis of 2015 National Survey on Drug Use and Health36



Figure 37

The share of nonelderly adults receiving inpatient treatment for opioid addiction who were covered by Medicaid doubled from 2005 to 2015.

26% 31%

52%

23%21%

20%

4%

18%

14%48%

30%

14%

2005(146,000)

2010(274,000)

2015(299,000)

Uninsured

Other

Private

Medicaid

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

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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 2013.

• Thus, spending in 2014 and beyond is likely higher.

• In 2015, 20% of those with opioid addiction were uninsured. Partially due to residing in non‐expansion states.

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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, 2017.http://kff.org/health‐reform/state‐indicator/state‐activity‐around‐expanding‐medicaid‐under‐the‐affordable‐care‐act/

Current Status of State Medicaid Expansion Decisions

WY

WI*

WV

WA

VA

VT

UT

TX

TN

SD

SC

RI

PA

OR

OK

OH

ND

NC

NY

NM

NJ

NH*

NVNE

MT*

MO

MS

MN

MI*

MA

MD

ME

LA

KYKS

IA*

IN*IL

ID

HI

GA

FL

DC

DE

CT

COCA

AR*AZ*

AK

AL

Adopted (32 States including DC)

Not Adopting At This Time (19 States)

40



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 2015

• 23.4% for Community Hospitals from 2013‐15

42



Drug Pricing

AJHP Editorial, April 15, 2017

“…health care teams and executives in hospitals andhealth systems are struggling to manage thecumulative effects of unsustainable increases in drugcosts in a fragile healthcare financing system.”

Paul W. Abramowitz, Pharm.D. Sc.D. (Hon), FASHP

CEO, ASHP

Am J Health‐Syst Pharm, 74:8, 551.

43

Drug Pricing

• Seek market‐based solutions that address:

• Competition

• Transparency• Value

44



Public Attitudes

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Drug PricingLegislative 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

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• 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 30.

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• 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

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• 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.”

50



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

52



Part B Outpatient Drug Reimbursement

• July 13 CMS proposed rule for CY2018 Outpatient Prospective Payment System. Comments due September 11, 2017.

• 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 2015.

• 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

54



Recommended Advocacy Actions

• “C‐Suite” Leadership

• Colleagues

• Other Healthcare Practitioners

• State and Federal Legislators

• Professional and Trade Associations

55

Questions

???

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58

Jerry H. Reed, MS, RPh, FASCP, FASHP

Senior Director, Pharmacy Services

Community Health Systems

Update on Current Pharmacy Initiatives and Strategies

59

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