An Introduction To Compliance Program


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An Introduction To Compliance Program

  1. 1. An Introduction to Compliance Program at Tri-City Health Center Presented by Linh Phan
  2. 2. “ Any health care entity which does not have a compliance program is ‘ institutionally nuts’ ” Karen Morrisette Deputy Chief of Criminal Division U.S. Department of Justice
  3. 3. What is a Compliance Program? <ul><li>Compliance program implies a primary concern with the exercises of rules and regulations </li></ul><ul><li>It is about prevention, detection, collaboration, and enforcement </li></ul><ul><li>It is a system of policies and procedures developed to assure compliance with and conformity to all applicable federal and state laws governing the organization </li></ul><ul><li>It is a part of the fabric of the organization, a commitment to an ethical way of conducting business, and a system for doing the right thing </li></ul>
  4. 4. Why Develop a Compliance Program? <ul><li>Communicate Organization’s Commitment </li></ul><ul><li>Astronomical Fines & Penalties </li></ul><ul><li>Provides “safe” way to report suspected wrong doing </li></ul><ul><li>Raise awareness </li></ul><ul><li>Good Business Sense/Competitive Edge </li></ul><ul><li>Gain good reputation and public Image </li></ul><ul><li>Protect directors & officers from individual criminal & civil liability </li></ul>
  5. 5. Why Compliance programs are essential? <ul><li>Paybacks to the fiscal intermediaries or carriers may result in audited services </li></ul><ul><li>Avoid the Government’s “Help”- Imposed Compliance Program </li></ul><ul><li>Excluded from probation and Court imposed programs </li></ul><ul><li>Reduce threat of qui tam (whistle-blower) lawsuits </li></ul><ul><li>Ensure continuous funding grants </li></ul>
  6. 6. How an Effective Compliance Program should be? <ul><li>Must be comprehensive </li></ul><ul><li>Should integrate with current regulations </li></ul><ul><li>Should adopt the Compliance Program Guidance recommended by the Office of Inspector General (OIG) </li></ul><ul><li>Must be an ongoing process </li></ul>
  7. 7. A Comprehensive Compliance Program <ul><li>Include seven elements of Federal Sentencing Guidance: </li></ul><ul><li>1. Policies & procedures </li></ul><ul><li>2. Oversight & leadership </li></ul><ul><li>3. Education & training </li></ul><ul><li>4. Auditing & monitoring </li></ul><ul><li>5. Reporting & investigating </li></ul><ul><li>6. Enforcement & discipline </li></ul><ul><li>7. Response & prevention </li></ul>
  8. 8. <ul><li>Identify, respond, and prevent current risk areas </li></ul><ul><li>- Kickbacks </li></ul><ul><li>- Physician self-referral (STARK) </li></ul><ul><li>- Pharmaceutical and marketing </li></ul><ul><li>- Clinical research </li></ul><ul><li>- Quality of care </li></ul><ul><li>- Medicare secondary payer law </li></ul><ul><li>- Prescription drug plan </li></ul><ul><li>- Privacy( state action, other) </li></ul>A Comprehensive Compliance Program
  9. 9. HHS Office of Inspector General <ul><li>The OIG in conjunction with the Justice department is responsible for enforcing rules and regulations under the Medicare and Medicaid laws outlined as part of the Social Security Act administered by Centers for Medicare and Medicaid services (CMS) </li></ul><ul><li>The OIG collects on an average more than $100 billion annually from health care fraud. </li></ul><ul><li>Health care fraud is number two priority in Justice department </li></ul>
  10. 10. Benefits of adopting the Compliance Program Guidance by the OIG <ul><li>Adopting a compliance program concretely demonstrates to the community at large that a provider has a strong commitment to honesty and responsible corporate citizenship </li></ul><ul><li>Compliance program reinforce employee’s innate sense of right and wrong </li></ul><ul><li>An effective Compliance program helps a provider fulfill its legal duty to government and private payers </li></ul>
  11. 11. Benefits of adopting the Compliance Program Guidance by the OIG <ul><li>Compliance programs are cost-effective </li></ul><ul><li>A compliance program provides a more accurate view of employee and contractor behavior relating to fraud and abuse </li></ul><ul><li>The quality of care provided to patients is enhanced by an effective compliance program </li></ul>
  12. 12. Benefits of adopting the Compliance Program Guidance by the OIG <ul><li>A compliance program provides procedures to promptly correct misconduct </li></ul><ul><li>An effective compliance program may mitigate any sanction imposed by the government </li></ul><ul><li>Voluntarily implementing a compliance program is preferable to waiting for the OIG to impose a Corporate Integrity Agreement (CIA) </li></ul>
  13. 13. Who should be included in the Compliance Program? <ul><li>Board of Directors </li></ul><ul><li>Oversight Committee </li></ul><ul><li>Executive Team </li></ul><ul><li>Compliance Officer </li></ul><ul><li>Managers & Supervisors </li></ul><ul><li>Physicians </li></ul><ul><li>Staff </li></ul>
  14. 14. Board of Directors <ul><li>Critical to the Program success due to their involvement </li></ul><ul><li>Understand the Program background and approval of program </li></ul><ul><li>Periodic updates </li></ul><ul><li>Education </li></ul>
  15. 15. Compliance Oversight Committee <ul><li>Varying perspectives: </li></ul><ul><li>- Operations, finance, audit, HR, utilization review, social work, medicine, coding and legal </li></ul><ul><li>- Employees and managers of key operating units </li></ul>
  16. 16. Compliance Oversight Committee <ul><li>Set goal and objectives </li></ul><ul><li>Assist in implementation & operation of the compliance program </li></ul><ul><li>Advise the Compliance Officer </li></ul><ul><li>Review reports & recommendations from the Compliance Officer </li></ul><ul><li>Annual review & evaluation of the program </li></ul><ul><li>Establish rotation </li></ul><ul><li>Meets monthly or quarterly </li></ul>
  17. 17. Compliance Officer <ul><li>Direct board access </li></ul><ul><li>Authority to make decisions </li></ul><ul><li>Communicator </li></ul><ul><li>Operational responsibility </li></ul><ul><li>- The leader </li></ul><ul><li>- Management of daily compliance operations </li></ul><ul><li>- Implementation of each compliance element </li></ul><ul><li>Report to the Board of Director </li></ul>
  18. 18. Managers & Supervisors <ul><li>Written Statement </li></ul><ul><ul><li>Goals & objectives for individuals and work units </li></ul></ul><ul><ul><li>Periodic performance reviews </li></ul></ul><ul><ul><li>System of rewards & recognitions of contribution </li></ul></ul><ul><ul><li>Corrective action or discipline policies & procedures </li></ul></ul>
  19. 19. Physicians <ul><li>Understand compliance as a necessity </li></ul><ul><li>Documentation & Coding responsibility </li></ul>
  20. 20. Staff <ul><li>Knowledgeable </li></ul><ul><li>Courteous </li></ul><ul><li>Responsive </li></ul>
  21. 21. Why Involve Everyone? <ul><li>Building trust to facilitate change </li></ul><ul><li>Buy-in is the key to succeed </li></ul><ul><li>Keep Commitment </li></ul><ul><li>Communicate both good & bad news </li></ul><ul><li>Allow frustrations to ventilate </li></ul><ul><li>Honor confidentiality </li></ul><ul><li>Take responsibility for mistakes </li></ul>
  22. 22. Obstacles to an effective Compliance program <ul><li>Commitment and buy-in </li></ul><ul><li>Lack of funding </li></ul><ul><li>Too many roles for the compliance officer </li></ul><ul><li>Interpreting laws and regulations </li></ul><ul><li>Lack of resources and staff </li></ul><ul><li>Lack of education and training </li></ul><ul><li>Resistance to change </li></ul><ul><li>Lack of or poor communication </li></ul><ul><li>Fear of retaliation/retribution </li></ul><ul><li>No internal enforcement </li></ul>
  23. 23. “ A compliance program is never finished; it should always be a work in progress.” “No Compliance officer can master all applicable rules, regulations, codes, etc
  24. 24. <ul><li>Developing the Compliance Program </li></ul><ul><li>Focus 1. Policies & procedures </li></ul><ul><li>2. Oversight & leadership </li></ul><ul><li>3. Education & training </li></ul><ul><li>4. Auditing & monitoring </li></ul><ul><li>5. Reporting & investigating </li></ul><ul><li>6. Enforcement & discipline </li></ul><ul><li>7. Response & prevention </li></ul>
  25. 25. Policies & Procedures <ul><li>To present specific guidelines for employees to follow </li></ul><ul><li>To confirm all employees comprehend what is required of them </li></ul><ul><li>To provide a process for proper decision-making </li></ul><ul><li>To confirm that employees put standards into everyday practice </li></ul><ul><li>To elevate corporate performances in basic business relationships </li></ul><ul><li>To confirm that the organization upholds and supports proper compliance conduct </li></ul>
  26. 26. Policies & Procedures <ul><li>Demonstrate system wide emphasis on compliance with all applicable laws and regulations </li></ul><ul><li>Written plainly and concisely so all employees can understand the standards </li></ul><ul><li>Translated into other languages as appropriate </li></ul><ul><li>Includes internal and external regulations </li></ul><ul><li>Mentions organizational policies without restating them </li></ul><ul><li>Is consistent with company policies and procedures </li></ul>
  27. 27. Policies & Procedures <ul><li>All employees must receive, read, and understand the standards </li></ul><ul><li>Employee should attest </li></ul><ul><li>Must be enforced through appropriate discipline when necessary </li></ul><ul><li>Discipline for non-compliance should be stated in the standards </li></ul>
  28. 28. Education & Training <ul><li>A general session for all employees- to heighten awareness among all employees, 1 to 3 hours annually, along with code of conduct and attestation (web based) </li></ul><ul><li>Second session covering more specific information for appropriate personnel </li></ul><ul><li>Written annual education plan </li></ul><ul><li>Important to be communicated from the top </li></ul><ul><li>Internal vs. External </li></ul><ul><li>Mandatory vs. Voluntary </li></ul><ul><li>Other communication media </li></ul><ul><li>Education assessment </li></ul>
  29. 29. Auditing & Monitoring <ul><li>Audits to focus on programs or divisions, including external relations with third-party contractors (must be always documented and reported, presented to CEO or board no less than annually) </li></ul><ul><li>Concurrent audits- not recommended </li></ul><ul><li>Retrospective audits- will identify and address potential problems individually as they arise </li></ul><ul><li>Report to fiscal intermediary or carrier </li></ul><ul><li>First step is to contact your in-house or external counsel, under attorney-client privilege </li></ul><ul><li>Monitoring is necessary to determine whether compliance elements have been satisfied </li></ul><ul><li>Can be random-medical and financial records </li></ul>
  30. 30. Auditing & Monitoring <ul><li>On-site visits (Compliance SWAT teams) </li></ul><ul><li>Interviews </li></ul><ul><li>Questionnaires </li></ul><ul><li>Reviews of Medical and Financial records </li></ul><ul><li>Reviews of policies and procedures of different departments </li></ul><ul><li>Trend analysis </li></ul><ul><li>Including Compliance language in job description </li></ul><ul><li>Posing compliance-related questions in exit interviews </li></ul>
  31. 31. Reporting & Investigating <ul><li>Open door where the employee feels comfortable approaching his or her Supervisor </li></ul><ul><li>Employee must be made sure that there will be no retaliation or retribution for coming forward- No retaliation policy </li></ul><ul><li>Confidentiality and anonymity also possible to an extent </li></ul><ul><li>Hotline </li></ul>
  32. 32. Reporting & Investigating <ul><li>Hotline numbers and procedures must be clearly communicated to employees </li></ul><ul><li>Once complaint received, it must be investigated </li></ul><ul><li>Documentation </li></ul>
  33. 33. Enforcement and Discipline <ul><li>Fair, equitable, and consistent. </li></ul><ul><li>Written policy </li></ul><ul><li>Progressive discipline </li></ul><ul><li>Documentation </li></ul><ul><li>Applies to contracts and outside vendors </li></ul><ul><li>Policy </li></ul><ul><li>Noncompliance will be punished </li></ul><ul><li>Failure to report noncompliance will be punished </li></ul><ul><li>An outline of disciplinary procedures </li></ul><ul><li>The parties responsible for appropriate action </li></ul><ul><li>A promise that discipline will be fair and consistent </li></ul>
  34. 34. Response and Prevention <ul><li>Meet with In-house or outside counsel </li></ul><ul><li>Develop appropriate plan of action </li></ul><ul><li>Internal investigation( attorney-client privilege) </li></ul><ul><li>Documented </li></ul><ul><li>Team to meet before and after investigation </li></ul><ul><li>Final report within 60 days but within 30 days to avoid stricter fines </li></ul><ul><li>Voluntary disclosure </li></ul><ul><li>Policy and Procedure for staff on what to expect and how to handle contact from government about an investigation </li></ul>
  35. 35. Needed Resources <ul><li>* Board of Directors </li></ul><ul><li>- Endorsement or memo </li></ul><ul><li>- Educated </li></ul><ul><li>Caremark International Derivative Litigation </li></ul><ul><li>* Support from Management </li></ul><ul><li>Physician </li></ul><ul><li>Staff </li></ul><ul><li>* Financial-staffing, ongoing operations </li></ul>
  36. 36. Action Plans <ul><li>Establishing the Code of Conduct </li></ul><ul><li>Establishing the Policies & Procedures </li></ul><ul><li>Establishing the Hotline </li></ul><ul><li>Committee Review </li></ul><ul><li>Board education and approval </li></ul><ul><li>Staff training </li></ul><ul><li>Internal assessments/Risk assessments- </li></ul><ul><li>P &P, audits </li></ul><ul><li>Continual evaluation and advancement of program </li></ul>
  37. 37. Tentative Timeline for Development of the Compliance Plan CO Training & Launching the Program CO Reporting & Investigating, disciplinary & remediation mechanisms July 2009 August 2009 Sep-Oct 2009 CO Risk Assessment CO & Department leads Auditing & Monitoring Vendor Compliance Education & Training Designees 1 st quarter 2010 Nov- Dec 2009 Action Plan CO Establishment of the Code of Conduct, Policies & Procedures, Hotline CO, Committee & Board Program evaluation Committee & Board Review & Approval
  38. 38. Compliance Strategies Improved Compliance Processes Compliance Laws Rules Regulations Quality Excellent Brilliant Superior
  39. 39. Important Laws & Regulations <ul><li>Health Insurance Portability and Accountability Act of 1996 (HIPAA) </li></ul><ul><li>Main content of HIPAA- Title II: </li></ul><ul><li>Fraud & Abuse controls : Makes it a criminal offense to submit claims based on incorrect codes or medically unnecessary services </li></ul><ul><li>Medical liability reform : The government has the power to exclude the organization from Medicare, Medicaid, and a long list of other government programs </li></ul><ul><li>Administrative Simplification </li></ul>
  40. 40. Important Laws & Regulations <ul><li>HIPAA- Administrative simplification </li></ul><ul><li>Privacy and security regulations </li></ul><ul><li>Created to improve efficiency & effectiveness of healthcare system by standardizing the electronic exchange of clinical & administrative data </li></ul><ul><li>Attempts to improve security in the age of ever-changing electronic data interchange </li></ul><ul><li>Aims to safeguard the confidentiality of private information & protect the integrity of health data while ensuring the availability of care </li></ul>
  41. 41. Important Laws & Regulations <ul><li>HIPAA- Administrative simplification </li></ul><ul><li>Privacy regulations </li></ul><ul><li>Protected Health Information collected from individuals and created/received by a covered entity </li></ul><ul><li>Applied in treatment, payment & healthcare operations (TPO) </li></ul><ul><li>Uses & Disclosures for TPO </li></ul><ul><li>Authorization required </li></ul><ul><li>Mandatory disclosures: </li></ul><ul><li>+ To patient with some exceptions </li></ul><ul><li>+ To the Secretary of DHHS to investigate an alleged privacy violation </li></ul>
  42. 42. Important Laws & Regulations <ul><li>HIPAA- Administrative simplification </li></ul><ul><li>Privacy regulations </li></ul><ul><li>Authorization required for TPO (cont.) </li></ul><ul><li>Permissive disclosures: </li></ul><ul><li>Public Health Activities </li></ul><ul><li>Health Oversight Activities </li></ul><ul><li>Law Enforcement </li></ul><ul><li>Organ & Tissue Donation </li></ul><ul><li>Avert Serious Threat </li></ul><ul><li>Workers’ Compensation </li></ul><ul><li>Report Abuse & Neglect </li></ul><ul><li>Legal Proceedings </li></ul><ul><li>Information about Decedents </li></ul><ul><li>Research </li></ul><ul><li>Specialized Gov. functions </li></ul>
  43. 43. Important Laws & Regulations <ul><li>HIPAA- Administrative simplification </li></ul><ul><li>Privacy regulations </li></ul><ul><li>2. Uses & Disclosures that require an opportunity to object </li></ul><ul><li>* Family directories </li></ul><ul><li>* Family, Friends and others </li></ul><ul><li>Involved in the patient’s care </li></ul><ul><li>Involved in payment for the patient’s care </li></ul><ul><li>* Notification </li></ul>
  44. 44. Important Laws & Regulations <ul><li>HIPAA- Administrative simplification </li></ul><ul><li>Privacy regulations </li></ul><ul><li>3. Uses & Disclosures requiring an Authorization </li></ul><ul><li>* Applied in marketing, fundraising </li></ul><ul><li>* Valid Authorization </li></ul><ul><li>Description of information to be used or disclosed that identifies the information in a specific and meaningful fashion: names, specific ID of persons/ class of persons </li></ul><ul><li>Description of each purpose of the requested use/disclosure: expiration date/event, signature of the individual/personal representative </li></ul><ul><li>Required statements: right to revoke, conditions of participation, potential for information to be re-disclosed </li></ul><ul><li>Must give the individual a copy </li></ul>
  45. 45. Important Laws & Regulations <ul><li>HIPAA- Administrative simplification </li></ul><ul><li>Privacy regulations- Patient’ right </li></ul><ul><li>Access and copy information </li></ul><ul><li>Request restriction of use for TPO </li></ul><ul><li>Request confidential communication </li></ul><ul><li>An account of disclosures </li></ul><ul><li>Receive a copy of the notice of privacy practices </li></ul><ul><li>Request amendments </li></ul>
  46. 46. Important Laws & Regulations <ul><li>HIPAA- Administrative simplification </li></ul><ul><li>Security Rule </li></ul><ul><li>Intent of the Security Rule: technology neutral, scalable, protection of confidentiality, integrity and availability of electronic information against any reasonably anticipated threats or hazards, and improper use or disclosure </li></ul><ul><li>Components of the Security Rule: safeguards of administrative, physical and technical; documentation; and policies & procedures </li></ul>
  47. 47. Important Laws & Regulations <ul><li>HIPAA- Administrative simplification </li></ul><ul><li>Security Management Process </li></ul><ul><li>Required specifications on implementing the Security Rule </li></ul><ul><li>Covered entities implement policies & procedures to prevent, detect, contain, and correct security violation </li></ul><ul><li>Include implementation specification of risk analysis, risk management, & sanction policy </li></ul>
  48. 48. Important Laws & Regulations <ul><li>HIPAA- Administrative simplification </li></ul><ul><li>Standards for Electronic Transactions </li></ul><ul><li>Apply the content and format of eight electronic transactions to the healthcare industry </li></ul><ul><li>The transactions and code set regulations standardize a unique method for billing of services rendered by all healthcare providers </li></ul><ul><li>Mandate health plans to accept these standard electronic claims, referral authorization, and other transactions </li></ul>
  49. 49. Important Laws & Regulations <ul><li>False Claims Act (FCA) </li></ul><ul><li>Empowers government to investigate and bring civil action in fraud cases </li></ul><ul><li>Provides significant financial incentives for private citizens to come forward (Qui tam or whistle-blower suits) </li></ul><ul><li>Whistleblower can be eligible to receive anywhere from 15% to 25% of the governments total award for the case </li></ul><ul><li>Intent of the Government to promote an environment of trust where the problems are brought forward and resolved </li></ul>
  50. 50. Important Laws & Regulations <ul><li>False Claims Act (FCA)- updated </li></ul><ul><li>The Fraud Enforcement and Recovery Act of 2009, S. 386, (FERA): </li></ul><ul><li>Liability attaches whenever a person knowingly makes a false claim to obtain money or property, any part of which is provided by the government without regard to whether the wrongdoer deals directly with the government; </li></ul><ul><li>Agent acting on the government's behalf; or with a third-party contractor, grantee or other recipient of such money or property. </li></ul>
  51. 51. Important Laws & Regulations <ul><li>False Claims Act (FCA)- updated </li></ul><ul><li>The FERA amendments will likely result in an increase in FCA claims filed against health care providers </li></ul><ul><li>Risk of Investigation and Liability Has Increased : false claims submitted to a Medicare Advantage plan may now be within the scope of the FCA </li></ul><ul><li>Repayment Obligations Have Increased : the FCA may be violated once an overpayment is knowingly and &quot;improperly&quot; retained or concealed </li></ul><ul><li>Retaliation Exposure Has Increased : both employees and independent contractors now have a right of action against health care companies for alleged retaliation for their efforts to prevent or remedy alleged violations of the FCA </li></ul>
  52. 52. Important Laws & Regulations <ul><li>Corporate Integrity Agreement </li></ul><ul><li>The government can impose a CIA against the organization </li></ul><ul><li>They are onerous </li></ul><ul><li>Three to eight years </li></ul><ul><li>Unannounced audits </li></ul><ul><li>Extensive reporting requirements </li></ul><ul><li>Government appointed monitor is put in charge of the organizations compliance program </li></ul>
  53. 53. Important Laws & Regulations <ul><li>Anti-kickback Statue </li></ul><ul><li>A criminal statue </li></ul><ul><li>Prohibits any knowing and willful conduct involving: </li></ul><ul><li>The solicitation, receipt, offer, or payment of any kind of remuneration in return for referring or inducing an individual to provide healthcare services under Medicare or Medicaid </li></ul><ul><li>The recommendation or arrangement of the purchase, lease, or ordering of an item or service that may be wholly or partially reimbursed under a federal health care program </li></ul><ul><li>Has safe harbor regulations </li></ul>
  54. 54. Important Laws & Regulations <ul><li>Anti-kickback Statue (AKS) </li></ul><ul><li>Highlights the “Intent Standard” </li></ul><ul><li>No excuse for ignorance of the law </li></ul><ul><li>Require proof from an individual to prove his/her unlawful conduct is of improper intent </li></ul><ul><li>Statutory Exceptions </li></ul><ul><li>Discounts- if properly disclosed & reflected in costs/charges </li></ul><ul><li>Employment </li></ul><ul><li>Group purchasing arrangements </li></ul><ul><li>Certain waiver of co-insurance </li></ul><ul><li>Certain risk sharing arrangement </li></ul>
  55. 55. Important Laws & Regulations <ul><li>Anti-kickback Statue (AKS) </li></ul><ul><li>Personal Services & Management Contracts Safe Harbor </li></ul><ul><li>Writing signed by the parties </li></ul><ul><li>Agreement covers all services provided </li></ul><ul><li>Periodic/sporadic agreements specify exact schedule, length and charge for intervals of service </li></ul><ul><li>Term of agreement is at least 1 year </li></ul><ul><li>Compensations set in advance, FMV, & does not consider volume or value of referrals or other business between parties </li></ul><ul><li>Services do not involve counseling or promotion of activities that violate State or Federal law </li></ul><ul><li>Aggregate services do not exceed those reasonable and necessary to achieve business purposes of the services </li></ul>
  56. 56. Important Laws & Regulations <ul><li>Stark Laws - Self-referral Statutes </li></ul><ul><li>A civil act </li></ul><ul><li>If a physician or a family member has a financial relationship with an entity that provides designated health services (DHS) that the physician may not make a referral for any DHS that is reimbursable by Medicare, and the entity that provides the services may not bill Medicare for the services provided as a result of the prohibited referral </li></ul>
  57. 57. Important Laws & Regulations <ul><li>Stark Laws </li></ul><ul><li>Financial Relationship </li></ul><ul><li>Can be direct or indirect </li></ul><ul><li>Ownership/investment: equity, debt or other means </li></ul><ul><li>Not included retirement plan interest, option received as compensation until exercised </li></ul><ul><li>Indirect: a broken chain of ownership/ investment indirect </li></ul><ul><li>Compensation: any remuneration between a physician/ immediate family member and an entity </li></ul>
  58. 58. Important Laws & Regulations <ul><li>Stark Laws </li></ul><ul><li>Statutory Exceptions </li></ul><ul><li>Personal services </li></ul><ul><li>Group Practice Payment </li></ul><ul><li>Payments for rental of office space or equipment </li></ul><ul><li>Employment-related payments </li></ul>
  59. 59. Important Laws & Regulations AKS & Stark: What to know AKS Intent based Criminal/Civil Any Federal Healthcare Program Requires Proof of Improper Intent Applies to Any Referral Source Safe Harbors OIG Advisory Opinions STARK Fact based Civil only Medicare only Strict liability Must be a Physician & an Entity in the mix Exceptions CMS Advisory Opinions * Both AKS & STARK are difficult to defend * The absence of one does not preclude the other
  60. 60. Important Laws & Regulations <ul><li>Federal Sentencing Guidelines </li></ul><ul><li>In 1984 Congress enacted the Sentencing Reform Act of 1984- designed to correct inequalities in federal sentences </li></ul><ul><li>An organization found guilty of fraud is also subject to fines </li></ul><ul><li>FSG include guidance for assessing fines </li></ul><ul><li>4 aggravating & 4 mitigating factors </li></ul>
  61. 61. Important Laws & Regulations <ul><li>Federal Sentencing Guidelines </li></ul><ul><li>Aggravating factors </li></ul><ul><li>Upper-level employee </li></ul><ul><li>Repeat offense </li></ul><ul><li>Hindrance during investigation </li></ul><ul><li>Awareness and tolerance of the violation was pervasive. </li></ul>
  62. 62. Important Laws & Regulations <ul><li>Federal Sentencing Guidelines </li></ul><ul><li>Mitigating factors </li></ul><ul><li>Effective compliance program </li></ul><ul><li>Self-reported violation promptly </li></ul><ul><li>Cooperated in investigation </li></ul><ul><li>Accepted responsibility </li></ul>
  63. 63. Measuring Effectiveness Awareness External Review Outcomes Repayments
  64. 64. Measuring Effectiveness <ul><li>Staff knowledge </li></ul><ul><li>All seven elements included in the program </li></ul><ul><li>Comparing issues year to year </li></ul><ul><li>Tracking corrective actions </li></ul><ul><li>Reviewing concurrent audits </li></ul><ul><li>Educational session pre-and post-tests </li></ul><ul><li>Tracking “bill denials” </li></ul><ul><li>Organizational survey results </li></ul><ul><li>Audit results </li></ul><ul><li>Compliance topics on department/organization agendas </li></ul>
  65. 65. Program Evaluation Structure The capacity to promote compliance with applicable regulatory requirement Process How the compliance program operates in practice to address identified risk areas Outcome Actual performance of the organization on identified compliance standards Effectiveness