Leveraging Corporate Integrity Agreements for Healthcare Compliance

Polsinelli PC. In California, Polsinelli LLP
Leveraging Corporate Integrity
Agreements for Healthcare
Compliance
Presented by:
Brian Bewley, Shareholder
Jennifer Evans, Shareholder

real challenges. real answers. sm
Back to the Basics
CIAs are an enforcement tool and the result of
negotiation.
– A part of fraud and abuse case settlements.
– Provider agrees to comply with CIA requirements.
– OIG agrees not to exclude provider from participation in
Federal health care programs.
Duration is usually 5 years.
Currently, there are around 210 CIAs in effect.
– 10 are Quality of Care CIAs.
There are common elements among CIAs, with
specific requirements tailored to each case.

Back to the Basics
CIAs typically include requirements to:
– Hire a compliance officer/appoint a compliance committee;
– Develop written standards and policies;
– Implement a comprehensive employee training program;
– Retain an independent review organization to conduct
annual reviews;
– Establish a confidential disclosure program;
– Restrict employment of ineligible persons;
– Report overpayments, reportable events, and ongoing
investigations/legal proceedings; and
– Provide an implementation report and annual reports to
OIG on the status of the entity's compliance activities.

CIAs provide timely, valuable insight into
the government’s point of view.
Why do CIAs Matter?
So, this is what compliance
looks like??

Why do CIAs Matter?
CIAs are the “Holy Grail” of all compliance programs
– OIG views CIAs as a way to educate providers on acceptable
compliance activities.
The Affordable Care Act requires compliance programs,
yet gives no specific requirements….
Providers may use CIAs as a guide to developing
compliance programs and structuring operations
accordingly.
– Useful for all providers but particularly so for at-risk providers.
– Note that because CIAs are tailored to specific providers and
situations, providers must assess each provision’s
appropriateness.

Lessons Learned: Recent Trends in CIAs
Emphasis on:
Board engagement
Senior management engagement
Organizational and individual
accountability
Effective, meaningful monitoring

Emphasis on Engagement
Board of Directors Obligations. CIAs may require the Board to:
– Actively oversee compliance programs and compliance officers
May include documenting those documents/materials reviewed and
additional steps taken by the Board
– Assess compliance programs (quarterly)
– Maintain an audit committee, in addition to a compliance
committee
Senior Management and Other Obligations. CIAs may also
require that:
– Senior management employees oversee compliance within their
area of authority
– Board members, senior management, and other employees
receive general and specific compliance training
May list specific areas of training related to legal requirements or
obligations

Emphasis on Accountability
Board Certifications
CIAs often require Board Members adopt resolutions
certifying the organization’s compliance and Board oversight.
Example: CIA for CVS Caremark (Mar. 2014)
CIAs may require Annual Reports to describe Board activity
(what was reviewed, what actions taken, etc.).
“The Audit Committee [or other authorized subcommittee] of the
Board of Directors has made a reasonable inquiry into the
operations of CVS Caremark’s Compliance Program including
the performance of the Compliance Officer and the Compliance
Committee. Based on its inquiry and review, the Audit Committee
[or other authorized subcommittee] has concluded that, to the
best of its knowledge, CVS Caremark has implemented an
effective Compliance Program to meet Federal health care
program requirements and the obligations of the CIA.”

Senior Management Certifications
Some CIAs require senior management (“certifying
employees”) to individually certify that:
1. They have been trained on and understand the
compliance requirements.
2. They have promoted compliance.
3. Their respective departments are in compliance
with the CIA and Federal Health care program
requirements.

Example: CIA for Dignity Health (Oct. 2014)
“I have been trained on and understand the compliance
requirements and responsibilities as they relate to [insert name
of department], an area under my supervision. My job responsibilities
include ensuring compliance with regard to the [insert name of
department] with all applicable Federal health care program
requirements, obligations of the Corporate Integrity Agreement, and
Dignity Health policies, and I have taken steps to promote such
compliance. To the best of my knowledge, except as otherwise
described herein, the [insert name of department] of Dignity Health
is in compliance with all applicable Federal health care program
requirements and the obligations of the Corporate Integrity
Agreement. I understand that this certification is being
provided to and relied upon by the United States.”

Definition of “Certifying employees” may be specific:
– CIA for CareAll, Inc. (Oct. 2014)
Includes “at a minimum, the following: the Government
Relations Officer, the Controller, Human Resources Manager,
Medicare Accounts Receivable and Billing Manager.”
– CIA for Dignity Health (Oct. 2014)
Lists 24 different positions, including even executives like the
VP for Sponsorship, Mission Integration, & Philanthropy
Or the definition may be broad:
– CIA for DaVita HealthCare Partners Inc. (Oct. 2014)
Includes “each Covered Person who is an officer, president,
general manager, vice president, group senior vice president,
division vice president, or other Covered person whose
position is equivalent to or above a division vice president.”

Individual
certifications
Individual must
take an active
role in
compliance
Emphasis is not just on the organization’s compliance.
Emphasis is also on the individuals that make or break
compliance.

Some CIAs further address accountability and
encourage compliance through restrictions on
employee compensation.
Potential compensation requirements:
– Utilize appropriate compensation structures
– Consider an individual’s compliance efforts when
determining incentive compensation
Restrict compensation accordingly
– Recoup incentive compensation in situations of employee
misconduct

Emphasis on Monitoring
Now, typically a standard CIA provision to engage an
internal review organization (IRO) or other independent
monitor.
– Review activities may vary widely.
– Recent reviews include:
The list goes on…
• General systems review
• General transactions review
• Review of drug restocking
practices
• Inpatient medical necessity
and appropriateness review
• Unallowable cost review
• Claims review
• Eligibility review
• Review of arrangements for
AKS/Stark purposes
• Review processing of third-
party liability claims
• Review of other items, as
later determined by the OIG

Claims review = assessing and evaluating claims submissions
Claims review process:
– Select sample of paid claims (e.g. 100)
– Review sample to determine if claim was correctly submitted/ reimbursed
Includes verifying there is documentation to support the claim
– Determine error rate (% of net overpayments) for the sample
< 5%, no additional sampling required but analyze the errors
> 5%, additional sampling needed
Additional review process (if needed)
– Select additional sample using commonly accepted statistical sampling
methods
– Review for proper coding, submission, reimbursement
– Estimate actual overpayment in claims population with 90%% confidence
level & max relative precision of 25% of point estimate
Example: CIA for CareMed Pharmaceuticals

Systems review = assessing systems, processes, policies, and procedures
relating to specified actions
Systems review related to claims submissions
– Involves review of:
Operation of billing system
Process by which provider prepares and submits claims requiring
authorization
Process by which provider maintains documentation
Safeguards to ensure proper claims submission and billing
Procedures to identify and correct inaccurate billing
– OIG suggests performing systems review if initial claims review sample
is > 5%
For each claim in the claims review sample, review systems and
processes that generated the claim and identify and problems or
weaknesses that may have caused identified overpayments
Example: CIA for CareMed Pharmaceuticals

Systems review for off-label marketing is extensive. Involves review of, for
example:
– How sales representatives and medical affairs personnel: 1) handle
requests/inquiries relating to information about uses of drugs, including off-
label uses and 2) distribute materials related to uses
– Form and content of disseminated materials
– How organization tracks requests for information about off-label uses
– Processes/procedures for identifying, investigating, documenting, resolving,
and taking disciplinary action for potential improper promotion
– Manner and circumstances under which medical affairs personnel
participate in meeting or events with HCPs or HCIs
– Plans for distributing samples
– Incentive compensation of sales representatives
– Speaker programs, speaker training programs, and related expenses
– Funding of third party educational activities
– Research and publication practices
Example: CIA for Johnson & Johnson

Arrangements review = review of arrangements or transactions involving the
offer, payment, solicitation or receipt of anything of value between the
organization and any source or recipient of health care business/referrals
Arrangement systems review involves review of systems, policies, processes,
and procedures for:
– Creation and maintenance of centralized tracking system for existing, new, and
renewed arrangements involving offer, payment, or provision of anything of value
– Tracking remuneration to and from parties in arrangements
– Tracking and monitoring various terms of the arrangement services and
activities to ensure parties to arrangements are performing services required
under the arrangement
– Monitoring the use of leased space, medical supplies, medical devices,
equipment, or other patient care items to ensure use is consistent with
arrangements
– Initiating arrangements
– Internal review and approval of arrangements
– Implementing responses when suspected violations of AKS are discovered
– Ensuring arrangement is written, signed, requires AKS training, provides AKS
policies and procedures, includes certification that parties shall not violate AKS

Arrangement transactions review involves review of randomly selected
arrangements entered into or renewed in a specified period to verify:
– Involved parties to the arrangement were properly selected
– Organization maintains the arrangement in its centralized tracking system in a
manner that allows identification of the parties and terms
– Organization appropriately valued remuneration
– Arrangement was subject to internal review and approval and such is
documented
– Organization properly tracked remuneration
– Organization properly tracks and reviews services and activities to the
arrangement
– Parties are performing required services under the arrangement
– Organization properly monitors the use of leased space, medical supplies,
medical devices, equipment, and other patient care items
– Use of leased space, etc. is consistent with terms of the arrangement
– Specifics of the arrangement: written, signed; requires AKS training and provides
organization’s AKS policies and procedures; includes certification that parties
shall not violate AKS
Example: CIA for DaVita HealthCare Partners; CIA for Orthofix International

Eligibility reviews = review of organization’s Medicare & Medicaid
beneficiaries to determine if they meet hospice eligibility requirement
Eligibility review process:
– List all Medicare/Medicaid patients admitted to hospice and randomly
select number of patients
– List all Medicare/Medicaid patients who received uninterrupted services
for 180 days or more and randomly select number of patients
– Combine selected patients and review sample to determine percentage
of patients ineligible for hospice benefit
– Analyze identified errors
If error rate is > 10%, OIG suggests performing a systems review of the
systems and processes that generated the certification of hospice eligibility
any paid claim associated with the ineligible patients
Example: CIA for Three Rivers Hospice, Inc.

Recent CIAs also emphasize effective, meaningful
monitoring within the organization:
– May require an Audit Committee
– May require auditing of certain risk areas
May further require that audits not be performed under
attorney-client privilege
– May allow monitoring requirements to be modified
throughout the CIA
– May require legal counsel to identify and assess
risks associate with compliance and steps to
mitigate the risk

Practical Considerations
to the Lessons Learned
Engagement and Accountability: Board of Directors
The depth and breadth of required Board oversight in
CIAs has grown.
Boards have increased sensitivity to compliance issues.
may be more receptive to audit, compliance,
quality committees and other tools
Actions to take:
– Identify those committees that have oversight
responsibilities and what those responsibilities are
– Document Board and Committee compliance activities

Engagement and Accountability: Senior Management
Given the certification requirements in CIAs, the OIG is
holding senior management more responsible for more
compliance activities and oversight. . .
… Organizations should prepare to do the same
Actions to take:
– Give senior management the training and tools
necessary to carry out effective compliance roles.
– Identify and review existing policies and procedures, or
create additional ones, that support management
compliance activities.

Monitoring.
Outside monitoring vs. internal monitoring—which is
appropriate?
Identify
compliance
risk
Assess
risk
Fix and
mitigate
risk
Continue
monitoring
for risk
Repeat

Current Enforcement Environment
Amount Federal government audits and investigations
returned in FY 2013:
Four Billion Dollars
Number of criminal and civil actions in FY 2013 resulting
from OIG investigations:
849 criminal, 458 civil
Number of individuals/entities excluded from
participation in Federal health programs in FY 2013:
3,214 excluded
Avoid contributing to these numbers —How?

Effective Compliance Programs
Mandatory compliance programs.
Affordable Care Act:
– Mandatory for nursing facilities and new enrollees.
Require reasonable design, implementation, and
enforcement.
Must be generally effective in preventing and
detecting violations and promoting quality of care.
– More to come?

May prevent altogether:
– OIG investigations
– Government audits
– DOJ investigations
Proactive prevention is much better than reactive
correction!!!
Effective
compliance
program
Increased
prevention

Provide value during government audits
– Assess Overall compliance
– Management/board oversight Issues/findings
– Audit findings Be cautious of 60-day rule
– Corrective action ensure that issue is not replicated
Educate
Determine scope

Civil investigations:
– May be a defense to “knowingly”
standard in fraud and abuse
cases.
– May help convince the
government not to investigate
further.
– May help persuade the OIG to
abandon a CIA or lessen CIA
requirements.
Criminal investigations
– Lessens ultimate punishment for
organizations, per U.S.
Sentencing Guidelines.
– Factor U.S. Attorney’s consider in
determining whether to criminally
charge an organization.
– Demonstrates good-faith and
transparency.
Effective
compliance
program
Mitigating factor
in government
investigations

Questions?

Contact Information
Brian Bewley, Shareholder
– bbewley@polsinelli.com
Jennifer Evans, Shareholder
– jevans@polsinelli.com
Polsinelli PC
www.polsinelli.com

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