Sharmin Rahman, BS Consultant, Compliance. Senior Manager, Compliance. Objectives. We the People - Government Authority

Transcription

1 Exclusion Checks: Who? What? When? Where? How? Sharmin Rahman, BS Consultant, Compliance Karen Voiles,MBA,CHC, CHPC, CHRC Senior Manager, Compliance Objectives We the People - Government Authority Legislative authority vested in Congress and delegated to the Office Inspector General ( OIG ) Great Expectations - Government Expectations Ambitious compliance programs America s Most Wanted - Enforcement Actions Consequences of hiring i a health care fugitive Friends - Screening Best Practices Choose wisely 2

2 We the People Government Authority Legislative authority for exclusions is vested in Congress and delegated to the OIG 3 The Social Security Act Provides Grounds for Exclusions The Social Security Act, 1128 (42 U.S.C. 1320a-7), provides several grounds for excluding individuals and entities from participation i in Medicare, Medicaid, id and other Federal health care programs Exclusions are required for individuals and entities convicted of the following types of criminal offenses: Medicare or Medicaid fraud Patient abuse or neglect Felonies for other health care fraud Felonies for illegal manufacture, distribution, prescription, or dispensing of controlled substances 4

3 The OIG has Exclusion Authority The OIG has the authority to exclude individuals and entities on several other grounds: Provision of unnecessary or substandard services Submission of false or fraudulent claims to a Federal health care program Engaging in unlawful kickback arrangements 5 Affordable Care Act (ACA) Adds New Exclusion Authority Section 6402(d)(1) provides authority to exclude providers and suppliers for false statements, misrepresentation in application/enrollment Section 6402(c) broadens permissive authority for failure to supply information by not only those who furnish, but also by those who order or refer for services or certifying the need for items or services 6

4 An Individual May be Excluded for Defaulting on a Student Loan The Social Security Act permits exclusion from Medicare, Medicaid, and all other Federal health care programs for nonpayment of student loans secured through the Health Education Assistance Loan (HEAL) program OIG is responsible for excluding individuals who have defaulted on HEAL loans from participation in Federal health care programs After being excluded for nonpayment of their HEAL debts, over 2,000 individuals entered into settlement agreements to repay their debts Year End Health Care Compliance & Enforcement Update The OIG reported exclusions of more than 4,017 individuals and entities from participation p in Federal health care programs. OIG is also responsible for reinstating providers who apply and have met the requirements of their exclusions. As part of their settlements, providers often agree to enter into Compliance Integrity Agreements with the OIG to avoid exclusions. 8

5 The OIG s Authority Includes Mandatory Exclusions The OIG s website lists the exclusion authorities: Mandatory Exclusions - The OIG is required by law to exclude individuals/entities convicted of these crimes: Conviction of program related crimes 5 years Conviction relating to patient abuse or neglect 5 years Felony conviction related to health care fraud 5 years Felony conviction related to controlled substance 5 years Conviction of two mandatory exclusion offenses 10 years Conviction of three or more occasions of mandatory exclusion offenses permanent exclusion 9 The OIG s Authority Includes Permissive Exclusions Permissive Exclusions The OIG has discretion to exclude individuals/entities for reasons including, but not limited to: Misdemeanor conviction related to health care fraud or controlled substances Conviction relating to obstruction of an investigation License revocation Exclusion or suspension under Federal or state health care program Claims for excessive charges/unnecessary services Fraud, kickbacks and other prohibited activities Entities controlled by a sanctioned individual Failure to grant access when required by law Failure to disclose required information Failure to take corrective action Default on student loan or scholarship requirements Making false statements or misrepresentations of material fact 10

6 The OIG has Posted Guidance for Implementing Permissive Exclusion Authority _1128b15_ pdf The OIG, in its 2010 Guidance for Implementing Permissive Exclusion Authority, indicates its intent to pursue officers and managers of an entity that has been excluded or convicted of certain offenses When there is evidence that an owner, officer, or managing employee knew or should have known of the conduct, the OIG will operate with a presumption in favor of exclusion 11 The Presumption in Favor of Exclusion Can Be Overcome in Certain Circumstances This presumption may be overcome when the OIG finds that significant factors weigh against exclusion: Circumstances of the misconduct and seriousness of the offense Individual s role in the sanctioned entity Individual s actions in response to the misconduct Information about the entity 12

7 Great Expectations Government Expectations The government expects an ambitious and diligent compliance program 13 The Government has Implemented Several Exclusion Related Guideline U.S. Sentencing Commission OIG Compliance Program Guidance Federal Acquisition Regulation CMS Letter to State Medicaid Agencies 2009 State exclusion lists OIG Special Advisory Bulletin on the Effective of Exclusion from Participation in Federal Health Care Programs

8 The Government Expects Careful Delegation of Authority and Due Care When Screening U.S. Sentencing Commission: careful delegation of authority and due care in hiring and screening employees OIG Compliance Program Guidance: employees, contractors, medical staff, and clinical staff checked routinely against the OIG List of Excluded Individuals and Entities (LEIE) and the General Services Administration s s (GSA) System of Awards Management age e (SAM) (f/k/a the Excluded Parties List System (EPLS)) Federal Acquisition Regulation: review SAM prior to contract award 15 The Government Expects Compliance as a Condition of Enrollment Centers for Medicare and Medicaid Services (CMS) Letter to State Medicaid Directors 2009: obligation to screen all employees and contractors compliance with screening requirement is a condition of enrollment OIG Special Advisory Bulletin on the Effect of Exclusion from Participation in Federal Health Care Programs 2013 OIG updates the LEIE monthly, so screening employees and contractors each month best minimizes potential overpayment and CMP liability * CMP Civil Monetary Penalty 16

9 Standard Language: - Ineligible Persons Non Compliance Can Lead to a Corporate Integrity Agreement Definitions. For purposes of this CIA: a) Ineligible ibl Person shall include an individual id or entity who: i. is currently excluded, debarred, suspended, or otherwise ineligible to participate in the Federal health care programs or in Federal procurement or nonprocurement programs; or ii. has been convicted of a criminal offense that falls within the scope of 42 U.S.C. 1320a-7(a), but has not yet been excluded, debarred, suspended, or otherwise declared ineligible. b) Exclusion Lists include: i. the HHS/OIG List of Excluded d Individuals/Entities id (available through the Internet at and ii. the General Services Administration System for Award Management (f/k/a Excluded Parties List System (EPLS) (available through the Internet at 17 America s Most Wanted Enforcement Actions Ekaterina Shlykova DOB: Height: 5'6" Weight: 121 lbs. Robert Allen Lopez DOB: Height: 5'7" Weight: 170 lbs. WANTED WANTED 18

10 Civil Monetary Penalties (CMPs) Resulting From Employee Exclusions Are on the Rise Number of violations of CMP law for not knowing that a person was excluded from participation in federal healthcare programs have increased 19 June 20, 2014 Recent Enforcement Actions Involving Excluded Parties Hospice by the Sea, Inc. (HBTS), Florida, agreed to pay $428,935 OIG alleged that HBTS employed an individual that it knew or should have known was excluded from participation in Federal health care programs January 30, 2015 Affinity Medical Center, LLC (Affinity), Alabama, agreed to pay $111,969 OIG alleged that Affinity employed an individual that it knew or should have known was excluded from participation in Federal health care programs 20

11 Friends Screening Best Practices Choose wisely 21 Check the OIG LEIE on a Monthly Basis The impact of exclusion by the OIG: No payment from federal programs (Medicare, Medicaid, SCHIP, etc.) for items or services provided, ordered, directed, or prescribed by an excluded individual or entity Payments that are received are considered overpayments CMPs: $10,000 per item or service 42 USC 1320a- 7a(a) and potentially treble damages for the amount claimed for each item or service Excluded party must apply for reinstatement reinstatement is not automatic 22

12 Check GSA SAM Upon Initial Hire and Annually Thereafter GSA s SAM If a person or organization is excluded or suspended from the Medicare Program, they are automatically placed in the SAM database maintained by GSA and are also "debarred" or excluded from being able to contract with the federal government (or any contractor of the federal government) - rule extends to any officer, director, or shareholder of an organization that has been excluded or debarred 23 Other Lists in Which You Should Be Aware Food and Drug Administration (FDA) Clinical investigator Inspection Search o Office of Foreign Asset Control (OFAC) Specifically Designated Nationals (SDN) and Blocked Persons List o Department of Commerce (DOC), Bureau of Industry and Security (BIS) Export Controls Denied Persons List (DPL) o Department of State (DOS) - Arms Export Control Act (AECA) and International Traffic in Arms Regulations (ITAR) Export Controls List of Statutorily Debarred Parties o 24

13 Process: Have a Documented Process for Screening Individuals and Entities Identify who will be screened (perform a baseline if they haven t done so already) Select routine check intervals Determine if checks will be done internally or through an external vendor Implement verification procedures for potential matches Initiate appropriate actions on verified matches Document all of the above in policies and procedures 25 What are Screening Best Practices? New Employees (BEFORE beginning employment): OIG LEIE (monthly) GSA SAM (annually) OFAC SDN (annually) State Exclusions List Contractors, Agents & Vendors: Prior to start of contract or renewal: o OIG LEIE (monthly) o GSA SAM (annually) o State Exclusions List Consider $$ (>$1,000) & whether entity has direct responsibility for coding, billing or the delivery of care 26

14 An ounce of prevention is worth a pound of cure. Benjamin Franklin Be proactive rather than reactive Incorporate the OIG s recommended seven elements of an effective compliance program into the hospital s everyday activities Establish a culture of compliance Where do you stand? 27 Resources OIG LEIE: GSA SAM: FDA Clinical Investigators: OFAC SDN Blocked Persons List: Export control lists DOC BIS: DOS ITAR: NPDB: HIPDB: 28

15 29 Thanks for Attending! Intended for internal guidance only, and not as recommendations for specific situations. Readers should consult a qualified attorney for specific legal guidance. 30