Managing Healthcare Reform: Winning Strategies for Engaging the Government Ecosystem That Shapes Healthcare Policy

Managing Healthcare Reform:
Winning Strategies for Engaging the Government
Ecosystem That Shapes Healthcare Policy

Best Practices, LLC Strategic Benchmarking Research

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LLC

Table of Contents
I. Executive Summary pp. 4-17

 Research Overview pp. 5

 Universe of Learning pp. 6

 Overview of Data and Issue pp.7-10

 Key Findings pp. 11-17

II. Universe of Learning: Key Demographics of Participating Companies pp. 18-22
III. Align Structures, Resources & Groups To Manage The Healthcare “Ecosystem”
pp.23-40

IV. Intelligence Gathering: “The Capture” pp.41-55

 Being well-positioned to capture vital information From Within The
Washington Ecosystem

V. Intelligence Dissemination: “The Routing” pp.56-64

 How to share intelligence & insights with key executives and functions

VI. Intelligence Translation: “The Interpretation” pp.65-72

 Determining what Information Coming from the Government Ecosystem
means for brands, functions & business lines

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Table of Contents
IX. Intelligence Implementation: “The Response” pp.73-90

 Converting Government Ecosystem intelligence into strategies, plans, tactics
and messages

X. Government Affairs pp.91-97

 How Companies Place Their Government Affairs Resources To Monitor &
Manage Public-sector Healthcare Reform

XI. Public Policy Benchmarks pp.98-109

 How Companies Place Their Policy Resources To Monitor & Manage Public-
sector Healthcare Reform

XII. Government Affairs & Public Policy Staffing Benchmarks pp. 110-117

 What Staffing Investments Are Companies Making To Manage the
Government Ecosystem?

XIII.Future Trends & Lessons Learned pp. 118-121

XIV.Appendix pp. 122-125

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Business Issue & Objectives
The influence of CMS on healthcare policy and reimbursement is increasing as the US population ages and
healthcare reform unfolds. Consequently, the importance of understanding, translating, and engaging with
CMS and other influential healthcare groups continues to grow.

Objectives:
 Close gaps in how pharma engages CMS and other groups that influence federal healthcare policy, guidelines and reimbursement.
 Close gaps in how Policy, Government Affairs and Marketing collaborate to manage public sector healthcare changes to the benefit of
product portfolio.
 Identify best practices in organizational form, focus, and function to best position organizations for the future where the government
payer is increasingly influential.

Expert Sources: Harvesting Insights & Analysis: Study Objective:

Industry 23 Biopharma Companies Formulate a Strategic
Benchmark participated Approach for Optimizing

INFORM
engagement with CMS and
the ecosystem of agencies
and groups that shape
Expert 6 Companies participated in U.S. healthcare guidelines
Interviews deep-dive interviews and reimbursement policy.

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23 Healthcare Companies Provide Universe of Learning
This study engaged executives from 23 leading healthcare companies. Segmentation analysis was key to
examining trends and effective practices. Eight participants represent both the Large Pharma Segment
(LPS) and Mid-Cap Segment (MPS). The Emerging Segment consists of seven companies. In addition,
deep-dive interviews were conducted with six participating companies to gather additional insights.

Large Pharma Segment: Mid-Cap Segment: Emerging Pharma Segment:

(n = 8) (n = 8) (n = 7)

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Framework For Managing The Government Ecosystem
Field insights and observations emerged across a full spectrum of management factors –
including strategy, structure, staffing, process excellence, communication and cross-
functional coordination. The analysis, benchmark review and insights have been organized
into the following framework that represents key areas for engaging the government
ecosystem.

1. Align Resources &
Groups To Manage
6. Resource The Healthcare Eco-
Benchmarks: system
(What Cross-Functional
Resources Are Required To
Manage The Ecosystem)

2. Intelligence
Managing The Gathering:
(How To Be Well-positioned To
5. Intelligence Government Capture Vital Information)
Implementation:
(Converting Intel into Strategies,
Plans, Tactics & Messages) Healthcare
“Ecosystem”
3. Intelligence
Dissemination:
4. Intelligence (How To Share Intel & Insights With
Translation: (Determining Key Execs & Functions)
What It Means for Brands,
Functions & Business Lines)

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Pharma Coverage of the Federal “Ecosystem” Is Uneven –
With Largest Competitors Pursuing Most Strategic Approach
The patchwork of federal agencies and groups that shape healthcare policy is like an ecosystem of
influence in Washington, DC. Field research reveals that there is significant variation in terms of how
well different companies cover the various groups influencing public healthcare policy. The very largest
biopharma companies invest resources to cover all these agencies and influence groups.

Q. Coverage of Federal Healthcare Groups: Which groups do you monitor as part of covering federal
government? (Percentage of Companies Covering Federal Agency)

VA 1) Many Cover
HRSA FDA, IRS
<15%
2) However, only <15% <15% FDA During
78% Product
the largest NIH, IoM, Introduction &
companies Cover 56% 44% CMS Regarding
Other Agencies AHRQ, Reimbursement
CDC
That Influence
39% 78%
Healthcare Policy,
HHS
Tax or Therapeutic CMS,
PCORI <15%
Issues.
94%
79% ONC
<15%
(n=18)

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Median Global Revenues for Participants Is $11.5 Billion
The global revenues in 2011 for research participants ranged from $200 million to $67
billion – illustrating how the study attracted organizations of all sizes. To better reflect
responses from like-sized companies, data is presented in three Segments when
appropriate: Total Benchmark Class, Large Pharma, and Mid-Cap pharma.
Q. Revenues: Estimate total sales revenues for your organization for the last completed fiscal year
(2011).

Global Revenues:

Total Benchmark Emerging
Large Pharma Mid-Cap
Class Pharma
Max
$67,400,000,000 $67,400,000,000 $17,000,000,000 $6,000,000,000
75th Percentile
$32,400,000,000 $43,886,750,000 $11,500,000,000 $872,000,000
Mean
$18,304,300,000 $36,905,875,000 $8,909,000,000 $1,695,200,000
Median
$11,500,000,000 $33,800,000,000 $11,000,000,000 $754,000,000
25th Percentile
$3,775,000,000 $29,250,000,000 $4,131,500,000 $650,000,000
Min
$200,000,000 $16,700,000,000 $3,100,000,000 $200,000,000

(n=20) (n=8) (n=7) (n=5)

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Companies Monitor Most Major Agencies & Influencing Groups
Most companies monitor major federal healthcare agencies and influencing groups. The
very largest companies also extend coverage to various groups – like HHS, VA, IRS and
ONC – that smaller and mid-cap companies seldom engage. Scope of coverage reflect
maturity.
Q. Coverage of Federal Healthcare Groups: Which groups do Q. Coverage of CMS Influencing Groups: Which groups do
you monitor as part of covering the federal government? you monitor as part of covering CMS?

Total Federal Agencies & Groups Covered Total Influencing Groups Covered

CMS 94% PCORI 79%

AHRQ 78% MedPAC 68%

NCQA 58%
FDA 78%
NQF 58%
NIH 56%
MACPAC 47%
IoM 44%
Regional CMS Offices 32%
CDC 39%
Quality Alliance Steering Committee 26%
Other 22% Other:
• HHS; ONC; VA, HRSA, IRS; None 11%
None 0% Various other agencies like
PCORI that resulted from Other 5% Other:
(n=18) ACA • MACs (n=19)

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Many Mid-caps Fail to Forge Formal Strategies for Engaging the Federal
Government. Big Pharma Is Far More Strategic
With the exception of the FDA and CMS, most companies have yet to devise formal
strategies for engaging and working with a wide range of federal agencies that affect
healthcare policy. The Large Pharma Segment is more than twice as likely to have formal
strategies to engage the Federal Government across multiple agencies.
Q. Strategic Engagement Strategy for Federal Government: Please note whether your organization
has an engagement strategy (detailed plans with groups assigned roles, responsibilities and tactics)
for working with each of these Federal Government groups or healthcare agencies
Total Benchmark Class: Formal Strategy:
No Strategy Informal Strategy Formal Strategy n= LPS: MCS:

Federal Drug Administration (FDA) 5% 19% 76% 21
100% 29%

Center for Medicare and Medicaid Services 9% 36% 55% 22
88% 43%

Veteran Affairs 14% 48% 38% 21
43% 43%

National Institutes of Health 24% 43% 33% 21
43% 0%
Dept. of Health & Human Services (HHS) At
19% 52% 29% 21
43% 14%
Large (overseeing CMS, FDA, NIH, etc.)
Agency for Healthcare Research & Quality
33% 38% 29% 21 71% 0%
(AHRQ)
Institute of Medicine (IOM) of National
57% 29% 14% 21 14% 0%
Academy of Sciences
Center for Disease Control (CDC) 50% 40% 10% 20 29% 0%
(n=8) (n=7)

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Merck Utilizes Influencing Groups to Promote Health, Business
Few companies are as adroit as Merck when it comes to utilizing influencing groups to improve the positioning of its
products. In the recent past there was Januvia and Gardasil, and most recently was Victrelis, the company’s new first-
in-class treatment for chronic hepatitis C. Through its support of both the Viral Hepatitis Action Coalition and the CDC
Foundation, Merck helped influence a more favorable environment for Victrelis. All of these products are important
therapies that together could save tens of thousands of lives and billions of dollars in healthcare spending.

May 9, 2011

800,000 patients x $26k =
The CDC estimates 800,000 $20B Drug for Merck Merck launches public
cases will be spotted early education/support programs for
through testing. Nearly 10,000 chronic hepatitis C (HCV) and
HCV patients die annually. announces funding to CDC-
affiliated VHAC (Viral Hepatitis
Action Coalition)
May 18, 2012
May 13, 2011

The FDA approves
Victrelis, a 1st in class
HCV treatment costing
CDC launches National Hepatitis Test Day $26k to $48k.
and, in a major policy shift, proposes all 75
million Baby Boomers get tested for HCV
11
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More than 50% of Companies Are Currently Engaging ACOs
Nearly two-thirds of the Large Pharma Segment have begun devising engagement
strategies for Account Care Organizations. More than half of mid-cap companies have
begun such work. Interestingly, mid-cap companies seem to have focused more closely on
the ACO’s than state Medicaid or Health Insurance issues.
Q. U.S. State-Level Relationship Engagement Strategy: Does your organization have an engagement
strategy regarding state-level relationships revolving around Accountable Care Organizations?
Accountable Care Organizations:
Total Benchmark Class: Large Pharma:
(n=20) (n=8)

No Yes
No 38% 62%
45%

Mid-Cap Segment:
No (n=7)
Yes 43%
55%

Yes
57%

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The Connection Between State Health Exchanges (HIX),
Essential Health Benefits (EHB) and Benchmark Plans
The Affordable Care Act is giving rise to the creation of state health exchanges – in short a state-
approved list of health plans for consumers and employers to choose from. Individuals will choose from
plans that will fall into four categories, from lowest premium to highest premium: bronze, silver, gold,
and platinum. Metal levels relate to cost-sharing features (e.g. bronze covers 60% of cost, silver = 70%,
gold=80%, platinum=90%).
What is a State Health Insurance Exchange?

State Health Insurance
• Plans in a State Health Exchange (HIX) • All exchanges must be
Exchange (HIX) must cover A set of standardized fully certified and
10 Essential Health insurance plans regulated operational by January 1,
Benefits (EHB) - one of by states and offered by 2014 – if states don’t set
which is prescription private insurers. up, the feds will.
drugs.

Benchmark Plan
Essential Health Serves as a reference
Benefits (EHB) plan, reflecting the
The EHB of the plans in scope of the services
the exchange will not
• Feds say EHB will be defined by a and any limits. Feds
differ significantly and benchmark plan elected by each suggest four benchmark
must be equal to “typical state. States told to select a plan types for 2014 and
employer plan.” benchmark plan by 4th quarter 2015.
2012.

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Most Policy Staff Located Where Legislative Action Is: DC
While organizations are divided about where Public Policy’s primary location should be,
this slide shows that, on average, participants have a majority of their policy staff located
in Washington, DC. Headquarters serves as the second largest location.

Q. U.S. Public Policy Staff Mix: Estimate the percentage of your Policy-focused staff in each job
location below. (The total of your percentages should equal 100% of your Policy staff.
Located in Washington, DC: Total Benchmark Class: Located at Headquarters:
Max 100% Max 100%
75th Percentile 75% Fractionally 75th Percentile 58%
dedicated, 6%
Mean 53% Mean 40%
Brand or BU, 2%
Median 53% Median 38%
25th Percentile 26% 25th Percentile 21%
Min 0% Min 0%
Headquarters
40%
Located with Brand or BU: Fractionally Dedicated:
Max 30% Washington, DC Max 50%
52%
Mean 2% Mean 6%
Median 0% Median 0%
(n=18)
Min 0% Min 0%

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About Best Practices, LLC

Best Practices, LLC is a research and consulting firm that conducts work
based on the simple yet profound principle that organizations can chart a
course to superior economic performance by studying the best business
practices, operating tactics and winning strategies of world-class
companies.

Best Practices, LLC
6350 Quadrangle Drive, Suite 200, Chapel Hill, NC 27517
919-403-0251
best@best-in-class.com
www.best-in-class.com

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Managing Healthcare Reform: Winning Strategies for Engaging the Government Ecosystem That Shapes Healthcare Policy

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Managing Healthcare Reform: Winning Strategies for Engaging the Government Ecosystem That Shapes Healthcare Policy