1. Presentation prepared for
HCCA Compliance Institute
April 17, 2018
Compliance Design in a World of New Models

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OBJECTIVES
• Review core program integrity principles
• Consider compliance risks presented by new models of
payment and delivery
• Examine the role of quality and data analytics in improving
compliance under new models of payment and delivery
• Explore new regulatory flexibility for increasing access to care
and reducing costs
• Discuss how human resources can drive a compliance culture
• Discuss compliance program design considerations for new
models and non-traditional players

3. Core Program Integrity Principles

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Road
100 m
Menu
PREVENT
• Identifying trustworthy business
partners
• Establishing effective processes
and controls
• Knowing the rules of the road
DETECT
• Having tools to detect problems
• Creating a “Culture of Compliance”
so that people are empowered to
report problems
ENFORCE
• Taking meaningful actions to
address problems
• Training and new controls
• Self-reporting
Finding True North: Essential for Accurate Navigation

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Compliance Guidance
3) https://www.justice.gov/criminal-fraud/page/file/937501/download
4) https://oig.hhs.gov/compliance/101/files/HCCA-OIG-Resource-Guide.pdf
1) https://oig.hhs.gov/
2) https://www.ussc.gov/sites/default/files/pdf/guidelines-manual/2016

6. Compliance Considerations for New Models
of Payment and Delivery

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Examples of New Models of Payment and Delivery
 New models of payment
 Quality-based adjustments to fee-for-service payments
 Shared savings
 Episode-based payments
 Population-based payments
 Capitation
 Impact on delivery of care in many settings
 Hospital
 Physician
 Home health
 Dialysis
 Post-acute
 Behavioral health
 Ancillary services

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Alternative Payment Models (APMs)
FEE-FOR-SERVICE
(FFS) PAYMENTS
POPULATION-BASED
APMs
ADJUSTED FFS
PAYMENTS
APMs INCORPORATING
FFS PAYMENTS
$
$
Bank
A Pay for reporting
B Pay for
performance
C Pay/penalty
for performance
A Total cost of care
shared savings
B Total cost of care
shared risk
C Retrospective
bundled payment
D Prospective
bundled payment
A Condition-specific
population-based
payments
B Primary care
population-based
payments
C Comprehensive
population-based
payments
A Traditional FFS
B Infrastructure
incentives
C Care management
payments

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Compliance Considerations for
New Models of Payment and Delivery
OIG work plans in this area
Changed incentives under new models
Program integrity risk areas (e.g., stinting on care)

10. Role of Quality and Data Analytics in
Compliance

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Quality & Compliance
 New models rely significantly on data, EHRs, and
technology
 ACOs
 Complete, Accurate, Timely, Secure (CATS)
 Data quality
 Quality driving compliance
 Safety Culture Surveys
 Open lines of communication
 Non-retaliation policy

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Quality & Compliance
 How data is used for program integrity by the
government
 e.g., Merit-Based Incentive Payment System (MIPS)
 OIG CMS Validated Hospital Inpatient Quality Reporting
Program Data, But Should use Additional Tools To Identify
Gaming
 Insight into what’s actually happening in your
organization
 The rise of Patient Safety Organizations (PSOs)
https://oig.hhs.gov/oei/reports/oei-01-15-00320.asp

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Public Reporting: Hospital and Physician
https://www.definitivehc.com/

14. New Regulatory Flexibility for Increasing
Access to Care and Reducing Costs

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Most Recent OIG Regulations
 81 Fed. Reg. 88,368 (Dec. 7, 2016)
 Anti-Kickback Safe Harbors
 Exceptions to the Civil Monetary Penalty (CMP) Rules
on Beneficiary Inducement
 Goals
 Improving access to quality care
 Addressing needs of providers and patients in rural areas
 Considering underserved communities

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Recent OIG Advisory Opinions
 No. 17-01 – Hospital’s free or reduced-cost of hotel lodging and
hospital cafeteria meals to financially needy patients
 OIG applies Promotes Access to Care Exception (see 42 CFR §1003.110
[2017])
 Does remuneration offered improve a beneficiary’s ability to obtain items
and services payable by Medicare or Medicaid?
 Giving patients the tools they need to remove barriers (e.g., socioeconomic,
educational, geographic, mobility) to getting necessary care or from following
through with a treatment plan
 Does provided remuneration pose a low risk of harm to Medicare and
Medicare beneficiaries and programs?
 Unlikely to interfere with, or skew, clinical decision making
 Unlikely to increase costs to federal healthcare programs or beneficiaries through
overutilization or inappropriate utilization
 Not raise patient safety or quality of care concerns

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Recent OIG Advisory Opinions (cont.)
 No. 17-05 – Retail pharmacy chain’s paid membership program that
includes discounts on certain prescriptions and clinic services and is
made available to federal healthcare program beneficiaries
 Exception to definition of “remuneration” under Beneficiary Inducement CMP (42
CFR §1003.110 [2017]) regarding certain retailer rewards programs
 Offer or transfer of items/services for free, or less than FMV, if:
 Items/services consist of coupons, rebates, or other rewards from a retailer
 Items/services offered or transferred on equal terms available to the general public,
regardless of health insurance status
 Offer or transfer of items/services is not tied to the provision of other items/services
reimbursed by a federal or state healthcare program
 Anti-Kickback Statute – facts and circumstances review
 No steering of federal healthcare program beneficiaries to retailer
 Unlikely to result in overutilization or otherwise increase costs to federal healthcare
programs

18. Human Resources Role
in Creating a Culture of Compliance

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HR as an Ally
 HR at the core of organizational culture
 Hiring the right talent
 Education and training
 Knowing with whom you do business
 Active prevention & detection
 Having tools to detect problems
 Compliance audits
 Hotline
 Sharing resources & best practices
 Communication & collaboration

20. Compliance Program Design and Work Plans

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Questions to Ask
 Are all your corporate entities and business lines part of
your corporate compliance plan?
 Updated corporate entity organization chart
 Who is responsible for compliance for:
 Joint ventures?
 Management Agreement arrangements?
 New Business Strategies/Models
 What role does compliance play?

22. Compliance for Non-Traditional Players &
New Models for Access to Care

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Compliance Considerations
for Non-Traditional Players and New Models for Access to Care
 Who are some new players?
 Technology, telehealth, data-aggregators
 e.g., eClinicalWorks’ False Claims Act case
 Rideshare companies
 What is different about compliance in the healthcare
industry?
 Medicare and Medicaid Fraud and Abuse Laws
 Privacy and Security Laws (specific to healthcare data)
 FDA Laws
 Licensing laws (e.g., DME licensing or registration)

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Use of Rideshare Companies for Transporting Patients to
Appointments
By Carolyn Y. Johnson, The Washington Post (March 1, 2018) -
https://www.washingtonpost.com/news/the-switch/wp/2018/03/01/uber-and-lyft-think-they-can-
solve-one-of-medicines-biggest-problems/?utm_term=.37721d950c80
“Uber, Lyft try solving one of medicine's
biggest problems: getting people to
appointments”

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Compliance Considerations: Use of Rideshare Companies
 New Model: Partnering with rideshare companies to offer free
or reduced-cost transportation to and from healthcare
providers
 Legal Considerations
 AKS Safe Harbor for Free or Discounted Local Transportation (42
CFR § 1001.952[bb] [2017])
 81 Fed. Reg. 88,379 – 88,389 (Dec. 7, 2016)
 CMP Beneficiary Inducement
 HIPAA Privacy/Security Rule
 Practical Considerations

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Questions

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26
Thank You!
Fatema Zanzi, Esq.
Partner
Drinker Biddle & Reath LLP
Fatema.Zanzi@dbr.com
Kristen M. Lilly
MHA, CHC, CPHQ, RHIA
Manager, PYA, P.C.
klilly@pyapc.com
Vicki L. Robinson, Esq.
Office of Inspector General
U.S. Department of Health
and Human Services
Vicki.Robinson@oig.hhs.gov

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Disclaimer
This presentation contains slides that have been combined for purposes of
presentation continuity. The speakers do not necessarily endorse the content
of each other’s slides. Moreover, the views expressed in this presentation
belong to the speakers and do not necessarily represent the views of their
organizations or other organizations.