Transcript 2012 Ryan White Grantee Meeting The Seven Elements of Effective Compliance Programs presented by: Laura G.

2012 Ryan White Grantee Meeting
The Seven Elements of
Effective Compliance
Programs
presented by:
Laura G. Hoffman, Esq.
&
J. Zoë Beckerman, Esq.
of
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Presenter: Laura G. Hoffman, Esq.
• Associate at Feldesman Tucker Leifer Fidell
LLP
• Practices in the areas of health care law,
corporate compliance, and government
grants.
• Conducts compliance program audits and risk
assessments for community health centers.
• Provides counsel to health care entities on
regulatory compliance, patient privacy matters,
and contracting activities.
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Presenter: J. Zoë Beckerman, Esq.
• Partner at Feldesman Tucker Leifer Fidell LLP
• Focusing on Head Start and Federal
Grants Law
• Managing Principal of FT Solutions LLC
• Consulting arm of FTLF that provides
management and consulting services to
federal grantees
• Has counseled associations and many Head
Start programs across the country on legal,
regulatory compliance and government
affairs matters
• Assists programs in variety of matters
including clearing monitoring findings
• [email protected]; telephone
202.466.8960
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Disclaimer
• This presentation has been prepared by the attorneys of
Feldesman Tucker Leifer Fidell LLP. The opinions
expressed in these materials are solely their views.
• The materials are being issued with the understanding
that the authors are not engaged in rendering legal or
other professional services. If legal advice or other
expert assistance is required, the services of a
competent professional should be sought.
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Disclosures
This continuing education activity is managed
and accredited by Professional Education
Services Group. The information presented in
this activity represents the opinion of the
authors. Neither PESG, nor any accrediting
organization endorses any commercial
products displayed or mentioned in
conjunction with this activity.
• Commercial support was not received for this activity.
• Neither Laura G. Hoffman, Esq. nor J. Zoë Beckerman, Esq. have any
financial interests or relationships to disclose.
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Learning Objectives
At the conclusion of this activity, the participant will
be able to:
1. Describe the evolution of corporate compliance
programs.
2. Discuss regulations/guidelines governing
compliance programs.
3. Identify the seven components of an effective
compliance program.
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Compliance Program Basics
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The Big Picture
• Mandatory compliance programs are coming.
• Even if a compliance program isn’t required of
your organization, it is good business practice!
• Compliance programs can be tailored to your
organization’s size and resources.
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What is a Compliance Program?
• The legal profession’s equivalent to preventive
medicine.
• The process of meeting the expectations of
others.
• Playing by the rules.
• Prevention and detection.
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Why Should We Have a Compliance Program?
• The benefits of a corporate compliance program are
considerable.
• An effective compliance program:
• Shows the health center’s commitment to honest and
responsible corporate conduct;
• Helps identify and prevent illegal and unethical conduct;
• Improves quality of patient care;
• May help minimize loss to the government from false
claims and consequently reduce the entity’s exposure to
liability.
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An Effective Compliance Program
• Creates a centralized source for distributing
information on health care laws and regulations.
• Assures that all Board members, employees, and
contractors participate in training regarding
compliance with applicable laws, regulations,
policies.
• Develops a methodology that encourages
employees to report potential problems.
• Develops procedures allowing prompt, thorough
investigation of alleged misconduct.
• Prompts immediate, appropriate corrective action.
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Under Health Reform
• Higher risk of False Claims Act liability.
• Presenting or causing the presentation of a false claim for
reimbursement by a Federal health care program;
• Making, using, or causing to be made or used, a false
record or statement material to a false or fraudulent
claim;
• Employing or contracting with suspended or excluded
providers; or
• Avoiding or decreasing a payment “obligation”.
• How is “knowingly” define?
• Penalties
• Federal Anti-Kickback Statute implications.
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Under Health Reform
• Mandatory Compliance Programs:
• As a condition of enrollment in Medicare, Medicaid, and
S/CHIP, providers must establish a compliance program.
• If your program also receives Medicaid funding, or is part of
an FQHC that receives Ryan White funds, this means you!
• Core components of compliance program to be established
by the Secretary of HHS in consultation with the OIG.
• Will be specific to particular industry or category of the
supplier or provider.
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Mandatory Compliance Program
• Key Recommendations:
• Do NOT wait for implementation date from
the government.
• Review (or establish) a compliance
program to ensure that it:
• Implements all seven elements;
• Identifies and prioritizes high risk areas;
• Operates under an annual compliance
work plan;
• Receives sufficient resources for size
and budget of the organization; and
• Demonstrates effectiveness in
promoting compliance.
• Once the new guidance is issued, re-check
your program!
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The Evolution of Corporate Compliance
Programs
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HHS Office of Inspector General (OIG)
• Inspector General Act of 1978
• Many, many tweaks along the way…
• The Healthcare Fraud Act of 1996 expanded the
duties of the Inspector General to include:
• Coordination of Federal, State, and local enforcement
efforts targeting healthcare fraud.
• Providing industry guidance concerning fraudulent
healthcare practices.
• Establishment of a national data bank to report adverse
actions against healthcare providers.
• Investigating cases that involve private (vs. Federally
funded) healthcare fraud.
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HHS Office of Inspector General (OIG)
• Under the Civil Monetary Penalties Law, the HHS Office of
Inspector General (OIG) may assess penalties for:
• False and fraudulent conduct related to Federal health
care programs or beneficiaries, which includes submission
of claims that are:
• False or fraudulent;
• Provided by someone who has been excluded from
participation in Federal health care programs; or
• Prohibited by the beneficiary inducement law.
• OIG may assess penalties of up to $11,000 for each item or
service falsely claimed and up to three times the amount
falsely claimed.
• OIG may also seek to exclude the provider from
participation in Federal and State health care programs.
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OIG Compliance Program Guidances
• Purpose
• Promote voluntary development and implementation of
comprehensive compliance programs by health care providers.
• Increase program autonomy.
• Applicability
• All providers participating in Federal health care programs,
including individual physicians and smaller, non-institutional
providers.
• Enforcement
• While implementation of a compliance program does NOT
provide blanket protection against OIG enforcement action,
maintaining a compliance program may help mitigate penalties
in the event of enforcement actions.
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OIG Compliance Program Guidances
• Individual and Small Group
Physician Practices
• Hospitals
• Clinical laboratories
• Durable medical equipment
suppliers
• Third-party medical billing
companies
• Medicare+Choice (Medicare
Advantage) organizations
offering coordinated care plans
•
•
•
•
•
•
Home health agencies
Hospices
Nursing facilities
Ambulance Suppliers
Pharmaceutical Manufacturers
Supplemental Guidance for
Hospitals
* In Nov. 2005, the OIG issued draft
guidance for NIH and PHS grant
recipients.
Available at https://oig.hhs.gov/compliance/compliance-guidance/index.asp
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The Seven Elements
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(1) Designate a Compliance Officer
• Designate an employee with responsibility for the
day-to-day operation of the compliance program.
• Employee’s duties may solely relate to compliance or may
be combined with other duties so long as compliance
responsibilities are satisfactorily carried out.
• Should not hold key financial, billing/coding or legal/counsel
responsibilities.
• Employee must report directly to the entity's chief
executive, or senior administrator designated by the chief
executive.
• Periodic reports directly to the governing body on the activities
of the compliance program.
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Role of the Compliance Officer
• Compliance officer manages compliance program
on a day-to-day basis.
• Implementing and operationalizing Boardestablished policies.
• Establishing compliance program procedures
• Hiring compliance staff.
• Allocating and operating within available resources.
• Overseeing/monitoring effectiveness of compliance
program.
• Coordinating resolution of compliance issues.
• Visible to employees, contractors and Board
members.
• Periodic reporting to Board of Directors on
compliance program activities.
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Compliance Officer Qualifications
Personal Qualities
Industry-Specific Experience
• Integrity
• Sound judgment
• Demonstrated leadership
skills
• Assertive
• Approachable
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• Expertise and experience
dealing with health care
industry operations and
compliance issues
• Familiarity with high-risk
areas identified by OIG, other
government agencies with
regulatory authority
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Compliance Support Personnel
• Staff Compliance Committee
• Advises compliance officer and assists in the development
and implementation of compliance program.
• Board Compliance Committee
• A committee of the Board that makes recommendations
to the Board regarding compliance issues, oversees
compliance program activities, and evaluates the
effectiveness of the compliance program.
• Receives reports on compliance program activities from
the compliance officer.
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(2) Develop Written Standards
• Written standards and procedures are a central
component of any compliance program.
• Standards of Conduct / Conflicts of Interest
• Compliance program
• Clinical / Financial / Operational
• Purpose: to promote quality and to provide a
structured approach for reducing erroneous claims,
fraudulent activity and other non-compliant behavior
within the organization.
• Applicability: essential for all healthcare
providers, regardless of size and capacity.
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Accessibility of Policies and Procedures
Written policies and
procedures must be
easily and readily
accessible to employees
and staff!
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Adopting Policies & Procedures
• The “collaborative” approach:
use/adapt other organizations’
policies and procedures:
Use only where content is
appropriate and relevant.
Do not adopt written standards
that the organization cannot
implement or with which the
organization cannot comply.
Tailor documents to your
organization’s operations.
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(3) Internal Reporting Systems
• Make clear that employees and other individuals
are required to report, in good faith, instances of
non-compliance.
• Do individuals know how to report?
• Is there a way for employees and others to seek
clarification from the compliance officer if questions
arise?
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Internal Reporting Systems
• Whistleblower protections
• Ensure protection (non-retaliation) of those who
report or assist in investigations (whistleblowers).
• Prohibition on any form of retaliation for reporting in good
faith:
• Individuals affiliated with organization will not be
• Terminated
• Suspended
• Demoted
• Subject to other adverse action
• Any actual or threatened retaliation should
be reported as non-compliant conduct.
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Internal Reporting Systems
• Consider who should receive reports of potential
non-compliance.
• Methods for receiving reports of potential noncompliance.
• Anonymous methods:
• Drop-box
• Hotline
• Website
• Non-anonymous methods:
• Open door policy
• Posting of compliance officer phone number
• Encourage alternatives to email.
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Documenting Internal Reports
Document all
reports and action
taken in response.
Maintain log of
reports.
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(4) Monitoring and Auditing
• Monitoring v. Auditing
• An audit is an organization’s retroactive assessment
of compliance with applicable legal requirements.
• An internal audit or self-audit is an organization’s objective
assessment, performed by internal staff or at their
direction, with results not reported outside the
organization.
• Monitoring is a “real-time” assessment of whether
on-going activities or operations are in compliance
with applicable legal requirements.
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Monitoring and Auditing
• Key steps in building an internal audit:
 Determine the scope of the audit
 Create an audit plan
 Methodology
 Standard
 Select Data




Gather information
Tabulate results
Recommend changes (if any)
Follow-up and re-audit
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Monitoring and Auditing
• Tips for conducting audits:
Obtain buy-in from top management and Board
Be aware of timing of audit
Select auditing team carefully
Put together a written audit plan
Keep management’s endorsement visible
Be transparent in everything you do
Utilize the resources and support of other staff
Review audit findings with audited department
Adopt an approach that is reasonable in scope and will
not diminish support for the compliance program
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(5) Training and Education
• Need not be formal, classroom-style training.
• Standard: effective communication!
• Can offer:
• In-person sessions
• Newsletters
• Office bulletin board
• Can be general or specific.
• General: New hires, department-based functions.
• Specific: Corrective action, new policies.
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Compliance Training
• May be conducted by CO or third party.
• General compliance training content:
• Operation and importance of program.
• Benefits to provider, patients, and community.
• Role of each individual in compliance program
operation.
• Standards of conduct.
• Consequences of violating standards and procedures,
including potential civil and criminal liability.
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Specialized Training
• Staff also should receive training on risk areas
specific to their job functions.
• Claim development and submission:
•
•
•
•
Coding and billing standards and procedures
Proper documentation of services rendered
Government and private payor program requirements
Relevant fraud and abuse statutes and regulations
• Legal sanctions for submitting deliberately/recklessly false claims
• Procurement requirements
• Grant reporting requirements
• Other specialized topics
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(6) Responding to Detected Issues
• Communication is key!
• Do you have systems in place to:
• Investigate potential compliance problems;
• Respond to compliance problems as identified in the
course of monitoring and audits;
• Correct such problems promptly and thoroughly and
implementing procedures, policies, and systems as
necessary to reduce the potential for recurrence; and
• Identifying and reporting compliance issues to HRSA.
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Responding to Detected Issues
• Compliance Investigations
• Compliance officer must promptly investigate
suspected non-compliance.
• Appropriate investigatory methods include:
• Interviews with employees and management
• Document review (including P&Ps!)
• Engage legal counsel, outside auditors, or experts to
assist as appropriate.
• Consider confidentiality concerns.
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(7) Disciplinary Standards
• Set forth standards of conduct in policies applicable to
Board, employees, contractors, etc.
• State your commitment to enforcing applicable
standards.
• Include disciplinary actions that may be imposed as a
result of illegal/unethical conduct.
• Establish procedures for disciplining individuals who
violate law/applicable standards.
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What Happens If I Break the Rules?
• Consequences at work
• Verbal warnings or written reprimands
• Probation, demotion, suspension, or termination
• Referral for criminal prosecution
• Consequences imposed by the government
•
•
•
•
Exclusion or debarment
Loss of license
Fines
Jail time
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Spread the Word
 Publicize by
disseminating policies
and addressing in
training.
 Put them online.
 Necessary to add
credibility and integrity
to your compliance
program.
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Recap: The Seven Elements
1) Designate a compliance officer.
2) Develop written standards and policies to
implement the compliance program and govern
operations.
3) Establish effective, clear, open lines of
communication (internal reporting).
4) Conduct internal monitoring and regular audits.
5) Implement training and education programs.
6) Respond to detected issues.
7) Publicize and enforce disciplinary standards.
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A Few Words of Advice
• Become familiar with the various compliance
program guidances.
• Implement a compliance program that is tailored to
your organization.
• Adopt policies and procedures only after careful
consideration of their relevance/usefulness.
• Consider relevant State, as well as Federal, laws.
• Consult with local counsel to ensure your compliance
program incorporates State law requirements.
• Resolve to develop and implement a corporate
compliance program for your organization.
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Helpful Websites
• Health Reform
• http://www.healthreform.gov/
• Other helpful websites:
• OIG Guidances, Reports, and Publications:
www.oig.hhs.gov
• Screening for suspended or excluded providers
• http://www.oig.hhs.gov/exclusions/exclusions_list.asp
• http://www.epls.gov
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Questions?
Laura G. Hoffman, Esq.
J. Zoë Beckerman, Esq.
Feldesman Tucker Leifer Fidell LLP
1129 20th Street N.W. – Suite 400
Washington, D.C. 20036
[email protected]
[email protected]
www.ftlf.com
(202) 466-8960
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Obtaining CME/CE Credit
• If you would like to receive continuing education
credit for this activity, please visit:
• http://www.pesgce.com/RyanWhite2012
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