Download Operationalizing ACO Participation: Risk Mitigation Best Practices

Operationalizing ACO
Participation:
Risk Mitigation Best
Practices for Physicians
Participating in Alternative
Payment Models
Massachusetts Medical Society
PPRC Talks: Mitigating Risk in Your
Practice
September 21, 2016
©2016 Foley & Lardner LLP • Attorney Advertising • Prior results do not guarantee a similar outcome • Models used are not cli ents but may be representative of clients • 321 N. Clark Street, Suite 2800, Chicago, IL 60654 • 312.832.4500
Agenda
■ CMS APM Participation Compliance
Requirements
■ Accepting Risk: Key Considerations
■ Compensation and Contracting
Requirements
− Fraud and Abuse Requirements
■ HIPAA Requirements
©2016 Foley & Lardner LLP
Alternative Payment Models:
Background
■ What are Alternative Payment Programs?
■ Affordable Care Act/ Chapter 224
■ Triple Aim
■ CMMI: Demonstration Programs/Testing Models
■ January 2015 Statement of HHS Secretary Burwell
■ MACRA
©2016 Foley & Lardner LLP
3
Overview of Alternative Payment Models
Gain-Sharing/OneSided/Asymmetric
Model
Coverage
Model
Risk Level
Financial
Incentives
Infrastructure
Requirements
Considerations
Care Management
Capabilities
©2016 Foley & Lardner LLP
Two-Sided/Symmetric/
Shared-Risk Model
Global Risk/
Partial Capitation
Model
Current contracts.
Primarily FFS but can
include bundled payments.
FFS and prospective fixed
payments.
No risk of losses regardless
of benchmarks.
At risk for losses beyond
benchmarks.
Higher risk; more downside
possible.
Modest due to limited risk.
Higher percentage of
shared savings.
Notable incentives if budget
is managed.
Moderate health IT
infrastructure.
Moderate health IT
infrastructure and track
record in managing care.
Robust health IT
infrastructure and
demonstrated track record in
finance and quality.
This is attractive to new
entities, risk-averse
providers, or entities with
limited organizational
capacity.
This increases the incentive
for providers to lower costs
due to the risk of losses.
This may need to comply
with state regulatory
oversight to take on financial
risk.
Evolving.
More advanced.
Sophisticated.
4
CMS Models
■ ACOs and ACO Models
− Medicare Shared Savings Program (Started April 2012)
− Pioneer ACO Program (Started January 2012)
− Next Generation ACO (Started January 2016)
■ Bundled Payment Programs
− Bundled Payment for Care Initiative (BPCI) (Started April 2013)
− Comprehensive Care Joint Replacement Program (Started April 2016)
− Cardiac Bundled Payment Pilot (Announced July 2016, Starts July 1, 2017)
■ Other Value-Based Programs
− Patient Centered Medical Homes
−
−
−
−
−

Comprehensive Primary Care Plans (Started October 2013)

CPC Plus (Starts 2017)
PQRS
Value-Based Purchasing
Hospital Readmissions
Hospital Acquired Conditions
Medicare Advantage – Value-Based Insurance Design
©2016 Foley & Lardner LLP
5
Compliance Requirements
■ BPCI, MSSP ACO, Next Generation ACO, Pioneer ACO, CPC+
■ CMS requires an ACO to have in place a participation
agreement that requires compliance with “the Shared
Savings Program and all other applicable laws and
regulations.”
■ This includes:
−
−
−
−
−
Federal criminal law
False Claims Act
Anti-Kickback Statute
Civil Monetary Penalties Law
Physician Self-Referral Law (Stark)
■ What does this mean?
©2016 Foley & Lardner LLP
Compliance Program Mandate
■ With the passage of the Patient Protection and
Affordable Care Act of 2010, physicians who treat
Medicare and Medicaid beneficiaries will be
required to establish a compliance program.
− Goal: prevent the submission of erroneous claims,
and combating fraudulent conduct.
■ Resources
− https://www.cms.gov/Outreach-andEducation/Medicare-Learning-NetworkMLN/MLNEdWebGuide/Downloads/MLNCompliance-Webinar.pdf
− https://oig.hhs.gov/authorities/docs/physician.pdf
©2016 Foley & Lardner LLP
Exclusion Checks
■ Representation: “none of its Personnel is subject to any
suspension or exclusion from participation in any federal or
state funded health care program.”
■ Best Practices
− Check lists upon hiring
− Recommend establishing processes for monthly exclusion
checks,
■ Resources
− https://exclusions.oig.hhs.gov/
− http://www.mass.gov/eohhs/gov/newsroom/masshealth/prov
iders/list-of-suspended-or-excluded-masshealth-providers.html
− https://www.sam.gov
©2016 Foley & Lardner LLP
Certification Requirements
Standard Language
■ Participant, for itself and its Personnel, agrees to submit all
data and information in a form and manner specified by
CMS. Such data shall be submitted with a certification from
an individual with authority to bind Participant and each
individual or entity submitting such data or information, as to
the accuracy, completeness and truthfulness of the data and
information, to the best of the information and belief of the
certifying individual.
■ Annually, the Participant and other individuals or entities
performing functions or services related to the ACO and
behalf of Participant shall make a similar certification
concerning their compliance with MSSP requirements and
the MSSP Regulations.
©2016 Foley & Lardner LLP
Key Considerations in Accepting
Risk
■ Understanding the scope:
− How will patients be assigned?
− What is included/excluded






Site of Service
Providers
Service Areas
Referral Services
Diagnosis based
Additional Services that need to be provided
− Sharing of Information
− Interim Reporting
■ Ability to affect care delivery
■ Stop-loss, re-insurance
■ Access to Data
©2016 Foley & Lardner LLP
Compensation and Contracting
Requirements
■ Unless you are working under a specific
waiver, fraud and abuse and anti-trust
laws continue to apply.
©2016 Foley & Lardner LLP
Anti-Kickback Statute Risks
■ AKS prohibits someone from “knowingly and
willfully” giving (or offering to give) “remuneration”
to another person if such payment is intended to
“induce” referrals for the furnishing of health
services or to induce the purchase, order, lease, or
recommendation of items covered by Medicare.
− Intent-based statute
− Applicable Safe Harbors
©2016 Foley & Lardner LLP
12
Stark Law Risks
• Stark law prohibits physicians from having any financial
relationship with an entity that furnishes Medicare- covered
“designated health services” and from referring patients to
that entity. It prohibits the entity from billing the Medicare
program for any services performed as a result of such
referrals.
– Implicated by compensation and ownership
arrangements
– Strict Liability Statute
– Must meet an exception
• Risk Sharing
• Personal Services Agreements
• FMV Arrangements
• Employment Agreements
©2016 Foley & Lardner LLP
13
Anti-Trust Risk
■ The Federal Trade Commission and the
Antitrust Division of the Department of
Justice recognize that in certain markets,
ACOs could reduce competition and hurt
consumers by raising prices and/or
offering lower-quality care.
− Clinical Integration as a solution to joint
contracting
©2016 Foley & Lardner LLP
14
Incentivizing Physicians
■ Should never be based on volume or value of
referrals
■ Should be directly tied to care redesign
■ Payments should not induce the limiting or
reduction of the provision of medically
necessary services to Beneficiaries
■ Distributions should be tracked and are
auditable
©2016 Foley & Lardner LLP
Understanding Available Waivers
■ Waivers are specific to the applicable
program and are not general.
■ Beneficiary Inducement
− Allows for the provision of free or below-fair
market value items and services that advance
the goals of preventive care, adherence to
treatment, drug, or followup care regimes, or
management of a chronic disease or condition.
■ Shared Savings Distribution Waivers
©2016 Foley & Lardner LLP
Adopting Policies and Procedures
■ Beware of varying models for different patients.
■ Consider involvement in development and
implementation.
■ Understanding quality measures and ability to
perform.
■ Understanding the need for
− Data management
− Data reporting
− Connectivity Requirements
■ Engaging care managers and third parties
©2016 Foley & Lardner LLP
HIPAA Requirements
■ HIPAA
− To avoid interfering with an individual’s access to quality health care or
the efficient payment for such health care, the Privacy Rule permits a
covered entity to use and disclose protected health information, with
certain limits and protections, for treatment, payment, and health care
operations activities.
■ Just because multiple people participating together in an APM
does not mean free flow of information.
■ Data sharing is a key aspect of any successful APM and can
certainly be achieved in a HIPAA-compliant manner. However, this
is not a given or guaranty. Notably care coordination and quality
improvement activities, when performed by a covered entity or, by
a business associate, on behalf of a covered entity, qualify as
“health care operations” functions or activities under HIPAA.
■ Who is a covered entity and who is a business associate and are
there arrangements in place to protect beneficiaries.
©2016 Foley & Lardner LLP
Questions?
Alexis Bortniker
[email protected]
617-226-3177
©2016 Foley & Lardner LLP