1. 1 Legal Limits on HME Marketing Carrie Bryant, Esq., CHC Compliance Officer American HomePatient William T. Mathias, Esq. PrincipalOber|Kaler

2. 2 Outline of Presentation Background Background Legal Limits on Marketing Legal Limits on Marketing Anti-kickback Statute Anti-kickback Statute Stark Self-referral Law Stark Self-referral Law False Claims Act False Claims Act Prohibition Against Beneficiary Inducements Prohibition Against Beneficiary Inducements State Law State Law HIPAA/HITECH HIPAA/HITECH Medicare Anti-solicitation Law Medicare Anti-solicitation Law Recent Guidance Recent Guidance Changing Compliance Environment Changing Compliance Environment

3. 3 Some Things Don’t Change Medicare and Medicaid regulations remain incredibly complex Medicare and Medicaid regulations remain incredibly complex

4. 4 “There can be no doubt but that the statutes and provisions in question, involving the financing of Medicare and Medicaid, are among the most completely impenetrable texts within human experience. Indeed, one approaches them at the level of specificity herein demanded with dread, for not only are they dense reading of the most tortuous kind, but Congress also revisits the area frequently, generously cutting and pruning in the process and making any solid grasp of matters addressed merely a passing phase.” —Chief Judge Ervin United States Court of Appeals for the Fourth Circuit in Rehabilitation Association of Virginia v. Kozlowski, 42 F. 3d 1444, 1450 (4 th Circuit 1994)

5. 5 More Things That Don’t Change Government continues to view Fraud, Waste, and Abuse as a significant source of revenue Government continues to view Fraud, Waste, and Abuse as a significant source of revenue Enforcement remains aggressive Enforcement remains aggressive

6. 6 Have You Seen the OIG’s Website Lately?

7. 7 Aggressive Enforcement From new joint DOJ/OIG website www.stopmedicarefraud.gov From new joint DOJ/OIG website www.stopmedicarefraud.gov www.stopmedicarefraud.gov “A joint effort by HHS and the Department of Justice recovered a record $4 billion from fraudsters in FY2010.” “A joint effort by HHS and the Department of Justice recovered a record $4 billion from fraudsters in FY2010.”

8. 8 Fighting Fraud is a Good Investment The return-on-investment (ROI) for Health Care Fraud and Abuse Control (HCFAC) program The return-on-investment (ROI) for Health Care Fraud and Abuse Control (HCFAC) program Since 1997, $4.9 returned for every $1.0 expended. Since 1997, $4.9 returned for every $1.0 expended. 3-year average (2008-2010), $6.8 returned for every $1.0 expended 3-year average (2008-2010), $6.8 returned for every $1.0 expended

9. 9 Government [Mis]perception of DME Industry Government is skeptical of DME industry Government is skeptical of DME industry Lack of trust Lack of trust Few bad apples have poisoned the well with government Few bad apples have poisoned the well with government Lead to questions about the overall medical necessity of some DME Lead to questions about the overall medical necessity of some DME Central to government’s regulation and investigation of DME industry Central to government’s regulation and investigation of DME industry

10. 10 DME Industry Feeling Undervalued

11. 11 Government Balancing Issues Additional Cost Additional Cost Over, Under, and Mis-Utilization Over, Under, and Mis-Utilization Quality of Care Quality of Care Access to Care Access to Care Patients’ Freedom of Choice Patients’ Freedom of Choice Competition Competition Exercise of Professional Judgment Exercise of Professional Judgment

12. 12 Anti-Kickback Statute

13. 13 Anti-Kickback Statute Federal anti-kickback law generally prohibits the provision of any economic benefit in exchange for the referral of patients or business that will be reimbursed under any Federal health care program. Federal anti-kickback law generally prohibits the provision of any economic benefit in exchange for the referral of patients or business that will be reimbursed under any Federal health care program. 42 U.S.C. § 1320a-7b(b). 42 U.S.C. § 1320a-7b(b).

14. 14 Anti-Kickback Statute Prohibited Conduct Prohibited Conduct Knowing & willful Knowing & willful Solicitation or receipt or Solicitation or receipt or Offer or payment of Offer or payment of Remuneration Remuneration In return for referring a federal health care program patient, or In return for referring a federal health care program patient, or To induce the purchasing, leasing, or arranging for or recommending purchasing or leasing items or services paid by a federal health care program To induce the purchasing, leasing, or arranging for or recommending purchasing or leasing items or services paid by a federal health care program

15. 15 Anti-Kickback Statute “Two-way Street” “Two-way Street” Meaning that it is just as illegal to solicit or accept payments for referrals, as it is to offer or make such payments. Meaning that it is just as illegal to solicit or accept payments for referrals, as it is to offer or make such payments.

16. 16 Anti-Kickback Statute Penalties Penalties Criminal fines & imprisonment Criminal fines & imprisonment Civil money penalty of $50,000 plus 3X the amount of the remuneration Civil money penalty of $50,000 plus 3X the amount of the remuneration Exclusion Exclusion False Claims Act liability False Claims Act liability Section 6402 (f)(1) of PPACA makes Anti-Kickback violations actionable under FCA Section 6402 (f)(1) of PPACA makes Anti-Kickback violations actionable under FCA

17. 17 Relevant AKS Safe Harbors [42 C.F.R. § 1001.952] Personal Services & Management Contracts Safe Harbor Personal Services & Management Contracts Safe Harbor Employment Exception and Safe Harbor Employment Exception and Safe Harbor Space Lease Safe Harbor Space Lease Safe Harbor Equipment Lease Safe Harbor Equipment Lease Safe Harbor

18. 18 AKS Decision Tree 1. Is there an economic benefit? If No If Yes 2. Is there a referral or recommendation? If No If Yes 3. Is there a statutory exception? If Yes If No 4. Is there a safe harbor? If Yes If No 5. Is there a potential for abuse? If No Go to Stark Analysis If Yes, Problem!

19. 19 Stark Physician Self-Referral Law

20. 20 Stark Self-Referral Law The federal Stark physician self-referral law generally prohibits a physician from making referrals to an entity for any of eleven (11) designated health services if the physician (or an immediate family member) has a “financial relationship” with the entity. The federal Stark physician self-referral law generally prohibits a physician from making referrals to an entity for any of eleven (11) designated health services if the physician (or an immediate family member) has a “financial relationship” with the entity. 42 U.S.C. § 1395nn 42 U.S.C. § 1395nn

21. 21 Stark Self-Referral Law Physician may not refer: Physician may not refer: Medicare [or Medicaid] patients Medicare [or Medicaid] patients For “designated health services” For “designated health services” to an entity with which the physician or to an entity with which the physician or an immediate family member has an immediate family member has a “financial relationship” a “financial relationship” Ownership interest – through equity or debt Ownership interest – through equity or debt Compensation arrangement Compensation arrangement Unless the relationship fits in an exception Unless the relationship fits in an exception

22. 22 Stark Self-Referral Law “Designated health services” “Designated health services” Clinical laboratory Clinical laboratory DME DME Orthotics & Prosthetics Orthotics & Prosthetics PEN PEN Home Health Home Health Radiology Radiology Radiation Therapy Radiation Therapy PT/OT PT/OT Inpatient Hospital Services Inpatient Hospital Services Outpatient Hospital services Outpatient Hospital services Outpatient drugs Outpatient drugs

23. 23 Stark Self-Referral Law Penalties Penalties Denial of Payment Denial of Payment $15,000 per service $15,000 per service 2X damages 2X damages Exclusion Exclusion False Claims Act liability False Claims Act liability

24. 24 Relevant Stark Exceptions Personal services Personal services Employment Employment Space rentals Space rentals Equipment rentals Equipment rentals Fair market value compensation Fair market value compensation Non-monetary compensation (<$359 in 2011) Non-monetary compensation (<$359 in 2011)

25. 25 Relevant Stark Exceptions (cont.) In-office Ancillary Services Exception In-office Ancillary Services Exception Limited exception for DMEPOS items Limited exception for DMEPOS items Canes, crutches, walkers, and folding wheelchairs Canes, crutches, walkers, and folding wheelchairs Blood glucose monitors Blood glucose monitors Infusion pumps that are DME (not infusion pumps used for parenteral and enteral nutrition) Infusion pumps that are DME (not infusion pumps used for parenteral and enteral nutrition) No other DME covered by this exception No other DME covered by this exception

26. 26 Stark Decision Tree If No If Yes Okay! If Yes 6. Is there a regulatory exception? If Yes 5. Is there a statutory exception? If No 4. Is there a designated health service? If No 3. Is there a referral? If No 2. Is there a direct or indirect financial relationship? If No 1. Is there a physician or immediate family member? If No, Problem!

27. 27 False Claims Act

28. 28 Federal False Claims Act Prohibits Prohibits filing, or causing to be filed filing, or causing to be filed “false or fraudulent” claims “false or fraudulent” claims Using false statement to “conceal, avoid or decrease” a government obligation Using false statement to “conceal, avoid or decrease” a government obligation Intent Intent “Intent to defraud” not required “Intent to defraud” not required Filing claims with “reckless disregard” of their truth or falsity is sufficient Filing claims with “reckless disregard” of their truth or falsity is sufficient Liability Liability 3X Damages 3X Damages $5,500 to $11,000 per claim $5,500 to $11,000 per claim

29. 29 Prohibition Against Beneficiary Inducements

30. 30 Prohibition Against Beneficiary Inducements Prohibits offering or paying remuneration to any Medicare or Medicaid beneficiary that the offeror knows, or should know, is likely to influence the recipient to order an item from a particular supplier. Prohibits offering or paying remuneration to any Medicare or Medicaid beneficiary that the offeror knows, or should know, is likely to influence the recipient to order an item from a particular supplier. 42 U.S.C. § 1320a-7a(a) 42 U.S.C. § 1320a-7a(a) Exception for items of nominal value – $10 per item and $50 per beneficiary per year Exception for items of nominal value – $10 per item and $50 per beneficiary per year

31. 31 State Laws

32. 32 State Laws Don’t forget about state laws Don’t forget about state laws State fraud and abuse laws State fraud and abuse laws State mini-Stark laws State mini-Stark laws Fee splitting prohibitions Fee splitting prohibitions Patient brokering laws Patient brokering laws State licensing laws State licensing laws Corporate practice of medicine Corporate practice of medicine State False Claims Acts State False Claims Acts

33. 33 Health Insurance Portability and Accountability Act (HIPAA)

34. 34 HIPAA/Privacy HIPAA requires “covered entities” to adhere to certain basic requirements aimed at protecting the privacy of “protected health information” (PHI) HIPAA requires “covered entities” to adhere to certain basic requirements aimed at protecting the privacy of “protected health information” (PHI)

35. 35 HIPAA/PHI Protected Health Information Protected Health Information Information related to past, present, or future physical or mental health condition or provision of health care services –and– Information related to past, present, or future physical or mental health condition or provision of health care services –and– Information related to payment for health care services. Information related to payment for health care services. Information can be linked to a particular individual. Information can be linked to a particular individual. Information regardless of form or medium (electronic, written, or verbal). Information regardless of form or medium (electronic, written, or verbal).

36. 36 HIPAA/Uses & Disclosures PHI may not be used or disclosed unless use or disclosure is specifically permitted by HIPAA or authorized by patient. PHI may not be used or disclosed unless use or disclosure is specifically permitted by HIPAA or authorized by patient. Permitted Uses and Disclosures include: Permitted Uses and Disclosures include: Treatment Treatment Payment Payment Health Care Operations Health Care Operations Other uses and disclosures as specified in Notice of Privacy Practices Other uses and disclosures as specified in Notice of Privacy Practices

37. 37 HIPAA/Original Definition of Marketing Marketing means: Marketing means: “To make a communication about a product or service that encourages recipients of the communication to purchase or use the product or service....” “To make a communication about a product or service that encourages recipients of the communication to purchase or use the product or service....”

38. 38 HIPAA/Exceptions to Definition of Marketing Definition of marketing does not include: Definition of marketing does not include: communications to describe a health-related product or service (or payment for such product or service) that is provided by, or included in a plan of benefits of, the covered entity making the communication communications to describe a health-related product or service (or payment for such product or service) that is provided by, or included in a plan of benefits of, the covered entity making the communication communications for treatment of the individual communications for treatment of the individual communications for case management or care coordination for the individual, or to direct or recommend alternative treatments, therapies, health care providers, or settings of care to the individual communications for case management or care coordination for the individual, or to direct or recommend alternative treatments, therapies, health care providers, or settings of care to the individual

39. 39 HIPAA/HITECH Changes to Marketing HITECH Act made changes to the definition of “Marketing” HITECH Act made changes to the definition of “Marketing” Where covered entity receives “direct or indirect payment” marketing communication not considered “health care operation” (so patient authorization required) Where covered entity receives “direct or indirect payment” marketing communication not considered “health care operation” (so patient authorization required) Limited exceptions : Limited exceptions : Communication regarding a currently prescribed drug or biological (for which payment must be “reasonable”) Communication regarding a currently prescribed drug or biological (for which payment must be “reasonable”) Communication made by business associate according to the terms of business associate agreement. Communication made by business associate according to the terms of business associate agreement. “Direct or indirect payment” does not include payment for treatment. “Direct or indirect payment” does not include payment for treatment.

40. 40 HIPAA/HITECH Changes to Marketing – Proposed Rule PROPOSED Rule – not final PROPOSED Rule – not final Differentiates between “treatment” and “marketing” communications Differentiates between “treatment” and “marketing” communications Under PROPOSED Rule Under PROPOSED Rule Notice of potentially subsidized treatment communications must be included in notice of privacy practices with opt-out procedure Notice of potentially subsidized treatment communications must be included in notice of privacy practices with opt-out procedure Communication must identify what is subsidized. Communication must identify what is subsidized.

41. 41 HIPAA/HITECH Changes to Marketing – Proposed Rule Examples: Examples: Manufacturer pays practice to send out flier to all patients advertising new device – Marketing Manufacturer pays practice to send out flier to all patients advertising new device – Marketing Manufacturer pays practice to send out notice of new device to all patients whose treatment might be benefited by new device – Unclear Manufacturer pays practice to send out notice of new device to all patients whose treatment might be benefited by new device – Unclear Manufacturer pays practice to send out notice of new device to those patients that the practice (not the manufacturer) identifies as patients who could benefit from new device – Treatment Manufacturer pays practice to send out notice of new device to those patients that the practice (not the manufacturer) identifies as patients who could benefit from new device – Treatment

42. 42 HIPAA/Marketing & Authorizations If covered entity’s activities are “marketing,” the covered entity must obtain an individual’s authorization to use or disclose his/her information If covered entity’s activities are “marketing,” the covered entity must obtain an individual’s authorization to use or disclose his/her information An authorization is not required: An authorization is not required: if the marketing is a “face-to-face” communication made by a covered entity to an individual; or if the marketing is a “face-to-face” communication made by a covered entity to an individual; or the marketing is the provision of a promotional gift of nominal value provided by the covered entity. the marketing is the provision of a promotional gift of nominal value provided by the covered entity. 45 C.F.R. §§ 164.508(a)(3)(i)(A)&(B). 45 C.F.R. §§ 164.508(a)(3)(i)(A)&(B).

43. 43 Medicare Anti-solicitation Law

44. 44 Medicare Anti-solicitation Law [42 U.S.C. § 1395m(a)(17)] Prohibits suppliers from contacting Medicare beneficiaries by telephone regarding covered items unless: Prohibits suppliers from contacting Medicare beneficiaries by telephone regarding covered items unless: Beneficiary has given supplier written permission Beneficiary has given supplier written permission Supplier has previously provided the covered item to the beneficiary and contact relates to such covered item Supplier has previously provided the covered item to the beneficiary and contact relates to such covered item Supplier has furnished a covered item to beneficiary in last 15 months, then contact may relate to any covered item Supplier has furnished a covered item to beneficiary in last 15 months, then contact may relate to any covered item

45. 45 OIG Special Fraud Alert on DME Telemarketing

46. 46 OIG Special Fraud Alert on DME Telemarketing First issued in 2003 First issued in 2003 68 Fed. Reg. 10254 (Mar. 4, 2003) 68 Fed. Reg. 10254 (Mar. 4, 2003) Updated in 2010 Updated in 2010 75 Fed. Reg. 2105 (Jan. 14, 2010) 75 Fed. Reg. 2105 (Jan. 14, 2010) Reflects OIG concerns about DME telemarketing Reflects OIG concerns about DME telemarketing

47. 47 Original Fraud Alert on DME Telemarketing OIG reiterated the statutory telemarketing prohibitions OIG reiterated the statutory telemarketing prohibitions OIG emphasized that “suppliers cannot do indirectly that which they are prohibited from doing directly.” OIG emphasized that “suppliers cannot do indirectly that which they are prohibited from doing directly.” DMEPOS supplier cannot hire an unrelated marketing entity to make unsolicited telephone calls to Medicare beneficiaries to market their products or services. DMEPOS supplier cannot hire an unrelated marketing entity to make unsolicited telephone calls to Medicare beneficiaries to market their products or services.

48. 48 Updated Fraud Alert on DME Telemarketing Largely repeated prior Alert Largely repeated prior Alert Added a concern about DME suppliers contacting beneficiaries based solely on treating physicians’ preliminary verbal or written order Added a concern about DME suppliers contacting beneficiaries based solely on treating physicians’ preliminary verbal or written order Added reference to criminal and civil penalties for using interstate telephone calls as part of fraud scheme Added reference to criminal and civil penalties for using interstate telephone calls as part of fraud scheme

49. 49 Additional Guidance on DME Telemarketing On February 17, 2010, OIG posted letter with CMS FAQs On February 17, 2010, OIG posted letter with CMS FAQs FAQs provide some helpful guidance but do not fully resolve issue FAQs provide some helpful guidance but do not fully resolve issue

50. 50 Additional Guidance on DME Telemarketing Not “unsolicited” to return beneficiary’s phone call Not “unsolicited” to return beneficiary’s phone call Not “unsolicited” if physician contacts supplier on behalf of beneficiary with beneficiary’s knowledge Not “unsolicited” if physician contacts supplier on behalf of beneficiary with beneficiary’s knowledge Does supplier need to collect documentation from physician reflecting beneficiary’s knowledge that physician would contact supplier? Does supplier need to collect documentation from physician reflecting beneficiary’s knowledge that physician would contact supplier? No, but it is business decision by supplier to collect such documentation. No, but it is business decision by supplier to collect such documentation. Supplier cannot ask beneficiary about other items during initial call, but may on subsequent call if beneficiary becomes a customer Supplier cannot ask beneficiary about other items during initial call, but may on subsequent call if beneficiary becomes a customer

51. 51 Practical Guidance

52. 52 Practical Guidance Various laws impose restrictions on HME marketing activities. Various laws impose restrictions on HME marketing activities. Compliance with 1 law does not necessarily result in compliance with other laws. Compliance with 1 law does not necessarily result in compliance with other laws.

53. 53 Practical Guidance HIPAA Marketing Restrictions Medicare Telemarketing Prohibition Face-to-Face Communications OKOK Written communication without using protected health information (PHI) OKOK Written communication using PHI Depends on content: Describing health related products – OK Describing health related products – OK Treatment – OK Treatment – OK Care coordination or recommending alternative treatments or settings – OK Care coordination or recommending alternative treatments or settings – OK Selling item unrelated to treatment – NO (need authorization) Selling item unrelated to treatment – NO (need authorization)OK

54. 54 Practical Guidance HIPAA Marketing Restrictions Medicare Telemarketing Prohibition Telephone call to current patient Depends on content: Describing health related products – OK Describing health related products – OK Treatment – OK Treatment – OK Care coordination or recommending alternative treatments or settings – OK Care coordination or recommending alternative treatments or settings – OK Selling item unrelated to treatment – NO (need authorization) Selling item unrelated to treatment – NO (need authorization)OK

55. 55 Practical Guidance HIPAA Marketing Restrictions Medicare Telemarketing Prohibition Telephone call to former patient Depends on content: Describing health related products – OK Describing health related products – OK Treatment – OK Treatment – OK Care coordination or recommending alternative treatments or settings – OK Care coordination or recommending alternative treatments or settings – OK Selling item unrelated to treatment – NO (need authorization) Selling item unrelated to treatment – NO (need authorization) Depends on circumstances: Patient has given written permission – OK Patient has given written permission – OK Contacting patient only regarding covered item previously furnished by Company – OK. Contacting patient only regarding covered item previously furnished by Company – OK. Contacting regarding furnishing a different covered item – OK if within 15 months of when Company furnished service to patient. Contacting regarding furnishing a different covered item – OK if within 15 months of when Company furnished service to patient.

56. 56 Recent Guidance

57. 57 Advisory Opinions 10-23 & 10-24 OIG analyzed 2 different, but related arrangements between sleep testing provider and hospital OIG analyzed 2 different, but related arrangements between sleep testing provider and hospital OIG rejected proposed arrangement with part- time marketing and per-click payments OIG rejected proposed arrangement with part- time marketing and per-click payments OIG approved proposed arrangement with full- time marketing and fixed, annual fees OIG approved proposed arrangement with full- time marketing and fixed, annual fees Not all such arrangements are illegal Not all such arrangements are illegal High standard for favorable advisory opinion High standard for favorable advisory opinion Helpful discussion of risks associated with “under arrangements” transactions Helpful discussion of risks associated with “under arrangements” transactions

58. 58 Advisory Opinion 11-06 OIG analyzed payments for electronically receiving and responding to referral requests from hospitals through online post-acute care referral service. OIG analyzed payments for electronically receiving and responding to referral requests from hospitals through online post-acute care referral service. OIG found that the payments did not meet referral services safe harbor because they were not assessed uniformly and were not based solely on cost of operating referral service. OIG found that the payments did not meet referral services safe harbor because they were not assessed uniformly and were not based solely on cost of operating referral service. OIG issued unfavorable opinion out of concern that payments created an uneven playing field and that payments could be an unlawful pay-to-play fee. OIG issued unfavorable opinion out of concern that payments created an uneven playing field and that payments could be an unlawful pay-to-play fee. Many hospitals participate in online post-acute care referral services and need to re-assess those relationships in light of this Opinion. Many hospitals participate in online post-acute care referral services and need to re-assess those relationships in light of this Opinion.

59. 59 Advisory Opinion 11-08 OIG analyzed existing and proposed CPAP set up arrangements between DME supplier and IDTF. OIG analyzed existing and proposed CPAP set up arrangements between DME supplier and IDTF. OIG issued unfavorable opinion. OIG issued unfavorable opinion. With regard to existing arrangement, the OIG found that “carve out” of Federal business was not sufficient protection for favorable advisory opinion. With regard to existing arrangement, the OIG found that “carve out” of Federal business was not sufficient protection for favorable advisory opinion. With regard to proposed arrangement, the OIG reiterated longstanding concerns about arrangements between DME suppliers and IDTFs as potential referral sources. With regard to proposed arrangement, the OIG reiterated longstanding concerns about arrangements between DME suppliers and IDTFs as potential referral sources.

60. 60 Advisory Opinion 11-08 Opinion represents warning about CPAP set-up services arrangements Opinion represents warning about CPAP set-up services arrangements... but does not rule out possibility that such arrangements could be appropriately structured.... but does not rule out possibility that such arrangements could be appropriately structured. Keys will be existence of a legitimate business purpose of arrangement and FMV of payments. Keys will be existence of a legitimate business purpose of arrangement and FMV of payments.

61. 61 Changing Compliance Environment

62. 62 60-Day Repayment Requirement §6402 of PPACA requires reporting and repayment of overpayments within 60 days of identification (or due date of next cost report, if applicable) §6402 of PPACA requires reporting and repayment of overpayments within 60 days of identification (or due date of next cost report, if applicable) What’s “identification”? What’s “identification”? Violations actionable under FCA Violations actionable under FCA Regulatory guidance will be forthcoming... (or so we’ve heard) Regulatory guidance will be forthcoming... (or so we’ve heard) Absent guidance, providers must struggle to come up with practical approaches to complying with the 60-day requirement. Absent guidance, providers must struggle to come up with practical approaches to complying with the 60-day requirement.

63. 63 Monthly Exclusion Checking Seriously.... every month Seriously.... every month Growing number of State Medicaid Programs are requiring monthly screening of current employees and contractors. Growing number of State Medicaid Programs are requiring monthly screening of current employees and contractors. See TennCare Policy PI 11-002 (effective 6/22/2011) See TennCare Policy PI 11-002 (effective 6/22/2011) State Medicaid Director Letter instructed states to “ require providers to search the HHS-OIG website monthly to capture exclusions and reinstatements that have occurred since the last search.” State Medicaid Director Letter instructed states to “ require providers to search the HHS-OIG website monthly to capture exclusions and reinstatements that have occurred since the last search.” HHS-OIG CIAs still only require annual screening. HHS-OIG CIAs still only require annual screening.

64. 64 Mandatory Compliance Programs It’s coming.... eventually. It’s coming.... eventually. § 6401 of PPACA makes compliance programs mandatory.... § 6401 of PPACA makes compliance programs mandatory........but only after implementing regulations establish the core elements for mandatory compliance programs....but only after implementing regulations establish the core elements for mandatory compliance programs Growing numbers of providers are establishing (or updating) compliance programs in anticipation of them becoming mandatory. Growing numbers of providers are establishing (or updating) compliance programs in anticipation of them becoming mandatory.

65. 65 What’s Next? OIG/DOJ increased emphasis on pursuing individual liability for fraud and abuse perpetrated by health care entities OIG/DOJ increased emphasis on pursuing individual liability for fraud and abuse perpetrated by health care entities Goal is “to alter the cost-benefit calculus of the corporate executives who run these companies” Goal is “to alter the cost-benefit calculus of the corporate executives who run these companies” Increasingly aggressive federal/state enforcement Increasingly aggressive federal/state enforcement Qui Tam Relators driving government priorities Qui Tam Relators driving government priorities Increasing importance of comprehensive and aggressive corporate compliance efforts Increasing importance of comprehensive and aggressive corporate compliance efforts

66. 66 “Be careful out there”

67. 67 Carrie Bryant, Esq., CHC Compliance Officer American HomePatient William T. Mathias, Esq. PrincipalOber|Kaler Questions?