1. 2010 © Arent Fox PLLC, Washington, D.C. 2010 © California Association for Health Services at Home (CAHSAH) Integration of Compliance Management into Organizational Performance Deborah Randall, Esq. law@deborahrandallconsulting.com www.deborahrandallconsulting.com

2. 2010 © Arent Fox PLLC, Washington, D.C. 2010 © California Association for Health Services at Home (CAHSAH) I. Why Develop An Internal Corporate Compliance Program?

3. 2010 © Arent Fox PLLC, Washington, D.C. 2010 © California Association for Health Services at Home (CAHSAH) At present, only HMO’s, publicly traded companies, and some states are required to have compliance programs — so why develop an internal compliance program that meets federal sentencing guidelines? The Patient Protection and Affordable Care Act of 2010 “ACA” requires it for all providers by Jan 2011 Because OIG underscores the savings from its investigations --$4 Billion in 2009($492 Million in audits) and OIG at $3 Billion mid-way in 2010.

4. 2010 © Arent Fox PLLC, Washington, D.C. 2010 © California Association for Health Services at Home (CAHSAH) IS IT JUST PHARMA? AVENTIS Pharmaceuticals to pay $95.5 million to federal government, State Medicaid programs and other federal insurers for misstating Medicaid price base for drugs sold

5. 2010 © Arent Fox PLLC, Washington, D.C. 2010 © California Association for Health Services at Home (CAHSAH) No---November 2009 Kaiser Foundation Hospitals - Kaiser Sunnyside Medical Center, Kaiser Foundation Health Plan of the Northwest and Northwest Permanente P.C., Physicians & Surgeons agreed to pay $1,830,322.41 in False Claims Act liability services billed hospice w/o written certifications of terminal illness 2000-4

6. 2010 © Arent Fox PLLC, Washington, D.C. 2010 © California Association for Health Services at Home (CAHSAH) Word from the Top JUNE 2010 OBAMA WHITE HOUSE ANNOUNCES THERE WILL BE A FUTURE “DO NOT PAY” LIST. Joint Letter of Department of Justice and Office of the Inspector General about intentions to intensify fraud enforcement.

7. 2010 © Arent Fox PLLC, Washington, D.C. 2010 © California Association for Health Services at Home (CAHSAH) A.Preventative Medicine Implement procedures and systems to ensure compliance with and avert violations of federal, state, and local laws regulating hospice providers

8. 2010 © Arent Fox PLLC, Washington, D.C. 2010 © California Association for Health Services at Home (CAHSAH) B. Insurance Policy in the Event the Agency Is Investigated or Prosecuted 1.Can persuade enforcement authorities to rely on less draconian remedies than criminal prosecution and/or exclusion from government programs 2.Can mitigate corporate penalties otherwise mandated under the Federal Sentencing Guidelines

9. 2010 © Arent Fox PLLC, Washington, D.C. 2010 © California Association for Health Services at Home (CAHSAH) C. Commercial Advantage Positions the hospice positively for acquisition, merger, networking, affiliation, managed care contracts, and relations with physicians, hospitals, and consumers

10. 2010 © Arent Fox PLLC, Washington, D.C. 2010 © California Association for Health Services at Home (CAHSAH) D. Medicaid Law As of Jan 1, 2007, the DRA requires entities with $5 million or more in Medicaid revenues in a federal year to: 1.Create policies and systems informing employees and contractors about fraud laws, compliance and whistleblower protections 2.Include similar information in employee manuals.

11. 2010 © Arent Fox PLLC, Washington, D.C. 2010 © California Association for Health Services at Home (CAHSAH) E. New Hospice Conditions of Participation Hospice COPs effective year- end 2008 and February 2009 change relationships between Hospices and Nursing Facilities Hospice COPs alter the role of physicians in hospice care delivery Hospice quality of care is a COP focus; failure = ?? unbillable claims

12. 2010 © Arent Fox PLLC, Washington, D.C. 2010 © California Association for Health Services at Home (CAHSAH) F. Changes in HIPAA Breach – access, acquisition, use, disclosure What is a discovery and when does it occur – when it would be found if the business used ‘care and prudence expected from a person seeking to satisfy a legal requirement under similar circumstances.’

13. 2010 © Arent Fox PLLC, Washington, D.C. 2010 © California Association for Health Services at Home (CAHSAH) New HIPAA Regulation about Security Measures;Business Associates  Have you identified the e-PHI that you create, receive, maintain or transmit?  What are the external sources of e-PHI? For example, do vendors or consultants create, receive, maintain or transmit e- PHI?  The human, natural, and environmental threats to information systems that contain e-PHI?

14. 2010 © Arent Fox PLLC, Washington, D.C. 2010 © California Association for Health Services at Home (CAHSAH) G. Medicare, Medicaid, PPACA 2010 Integrity Provisions Sec. 6401. Provider screening/enrollment requirements.[Debt; compliance programs] Sec. 6402. Enhanced Medicare and Medicaid program integrity provisions. Sec. 6404. Maximum time to submit Medicare claims not >12 mo from service

15. 2010 © Arent Fox PLLC, Washington, D.C. 2010 © California Association for Health Services at Home (CAHSAH) INTEGRITY continued Sec. 6406. Physician documentation on referrals @ high risk of waste/abuse. Sec. 6407. Face to face encounter with patient required if physicians certify HHA;? MORE service lines possible Sec. 6408. Enhanced penalties.

16. 2010 © Arent Fox PLLC, Washington, D.C. 2010 © California Association for Health Services at Home (CAHSAH) INTEGRITY continued Sec. 6409. Medicare self-referral disclosure protocol. Sec. 6411. Recovery Audit Contractor (RAC) program extended to Medicaid. Sec. 6501. Termination of provider participation under Medicaid if terminated in Medicare or State plan.

17. 2010 © Arent Fox PLLC, Washington, D.C. 2010 © California Association for Health Services at Home (CAHSAH) INTEGRITY continued Sec. 6502. Medicaid exclusion from participation relating to certain control, ownership, and management affiliations. Sec. 6601. Prohibition on false statements and representations. Sec. 6604. Applicability of State law to combat fraud and abuse.

18. 2010 © Arent Fox PLLC, Washington, D.C. 2010 © California Association for Health Services at Home (CAHSAH) Overpayment Reporting (Sections 6402(a) and 6506) Affirmative obligation for any provider, supplier, Medicaid managed care organization, MA organization, or PDP sponsor that has received an overpayment to report and return the overpayment to the Secretary, state, intermediary, carrier, or contractor along with a written notification of the reason for the overpayment. Deadline for reporting and returning such overpayments is the later of 60 days after identified or the date that any corresponding cost report is due. False Claims Act liability ALREADY EXISTS for knowingly concealing or knowingly and improperly avoiding an “obligation” to pay money to the government. Overpayments retained beyond the deadline become actionable under the False Claims Act.

19. 2010 © Arent Fox PLLC, Washington, D.C. 2010 © California Association for Health Services at Home (CAHSAH) PPACA Hospice Target After 1/1/2011, a hospice physician or nurse practitioner must have a face-to-face encounter with each hospice patient to determine continued eligibility prior to the 180th-day recertification & thereafter. Section 3132(b)(2) PPACA Attestation of visit HHS medical review of certain patients in hospices with high percentages of long-stay patients— Congress allows CMS to set the %

20. 2010 © Arent Fox PLLC, Washington, D.C. 2010 © California Association for Health Services at Home (CAHSAH) II. Government Agencies Involved With Compliance Audits

21. 2010 © Arent Fox PLLC, Washington, D.C. 2010 © California Association for Health Services at Home (CAHSAH) Where are Certs/ReCerts Going? New CMS Regulation 180day face to face no more than 15 days before 180th day and before subsequent 60 day recerts. Narrative from medical director addt’l Dating documents by named physician ALL CERTs/RECERTs affected Dates of Certification Period required

22. 2010 © Arent Fox PLLC, Washington, D.C. 2010 © California Association for Health Services at Home (CAHSAH) Office of the Inspector General (OIG) Region 9 has 2 OIG offices; all other regions have 1 OIG office Department of Justice: US Attorney & FBI State Medicaid Fraud Control Units (MFCU) Fiscal Intermediaries (FI’s), now MACs & Enforcement: Medicare PSCs, RACs, ZPIC Audits, Fiscal Audits, CERT; Referral to OIG State Survey and Certification Agencies Office of Civil Rights (HIPAA)

23. 2010 © Arent Fox PLLC, Washington, D.C. 2010 © California Association for Health Services at Home (CAHSAH) New Fraud Focus at CMS Medicare and Medicaid Program Integrity groups now linked in Center for Program Integrity headed by Peter Budetti, MD, JD Visiting Professor for Health Care Fraud at the National Association of Insurance Commissioners last year Counsel to the U.S. House Subcommittee on Health and the Environment under Chairman Henry Waxman Chair of the Board of Taxpayers Against Fraud (TAF): The False Claims Act Legal Center, a nonprofit, public interest organization

24. 2010 © Arent Fox PLLC, Washington, D.C. 2010 © California Association for Health Services at Home (CAHSAH) Department of Justice Letter 6/8/10 Obama directs 50% decrease in overpayment situations that lead to fraud Fraud prevention Summits regionally: LA, Vegas, Detroit, Boston, NYC, Philadelphia Fraud task forces every US Attorney area Double Senior Medicare Patrol on fraud CMS and Aging Ad’mn educating seniors

25. 2010 © Arent Fox PLLC, Washington, D.C. 2010 © California Association for Health Services at Home (CAHSAH) OIG Work Plan 2010 Hospice-Nursing Home relationships Physician billing and ? double billing for hospice patients by attending physicians and hospices Trends in Hospice growth Part D duplicate billing - pharmaceuticals

26. 2010 © Arent Fox PLLC, Washington, D.C. 2010 © California Association for Health Services at Home (CAHSAH) OIG Reports on Hospice and Nursing Facilities Sept. 2009 – OIG found 82% of claims for hospice/NF residents lacked one or more coverage requirements Second OIG Report was statistical and gave the intensity and frequency of NF- based hospice care….suggesting CMS might want to consider implications

27. 2010 © Arent Fox PLLC, Washington, D.C. 2010 © California Association for Health Services at Home (CAHSAH) New State Operations Manual Section 2085 - Operation of Hospice Across State Lines SOM section now states that when a hospice provides services across state lines, the involved states must have a written reciprocal agreement permitting the hospice to provide services in this manner. This is a consistent position of CMS BUT no effort is made to bring States to the table to make such agreements ‘expected behavior.’

28. 2010 © Arent Fox PLLC, Washington, D.C. 2010 © California Association for Health Services at Home (CAHSAH) Freeze in Transaction in Homecare for agencies less than 3 years old or sold within 3 yrs (aka “the 36-month rule) Indicates huge fraud concern in home health field and rampant related agency fraud schemes Where growth in hospice industry has been noteworthy, CMS simply allowing Regional Offices to stall and delay processing of 855s for providers

29. 2010 © Arent Fox PLLC, Washington, D.C. 2010 © California Association for Health Services at Home (CAHSAH) Medicaid Integrity Program In fiscal year 2007, there were roughly $627 million in overpayments, $568 million in recovered payments, and total recoveries of $1.3 billion. Overall, state program integrity initiatives cost $181 million. Testimony of MIP executive to Congress, October 2009

30. 2010 © Arent Fox PLLC, Washington, D.C. 2010 © California Association for Health Services at Home (CAHSAH) III.A Very Broad Risk of Liability and Sanctions Exists for Hospice Providers

31. 2010 © Arent Fox PLLC, Washington, D.C. 2010 © California Association for Health Services at Home (CAHSAH) A. Hospice Provider Must Know the Law Six laws are particularly important to health care providers Qui Tam lawsuit = whistleblower lawsuit

32. 2010 © Arent Fox PLLC, Washington, D.C. 2010 © California Association for Health Services at Home (CAHSAH) 1.Federal False Claims a. Criminal —May result in monetary penalties —May result in jail sentence b. Civil —U.S. and/or private party —civil action; multiple monetary damages —persons who “knowingly” make false or fraudulent claims OR false statements in support of claims against the U.S.

33. 2010 © Arent Fox PLLC, Washington, D.C. 2010 © California Association for Health Services at Home (CAHSAH) 1. False Claims continued False = Intentional or = “Reckless Disregard” for whether true/accurate or = Intentional Ignorance c.False Claims in Medicare or State Health Programs-other laws d.Per Service, episode, cost report

34. 2010 © Arent Fox PLLC, Washington, D.C. 2010 © California Association for Health Services at Home (CAHSAH) 2009 Fraud Enforcement Act May 20, 2009 Federal Enforcement and Recovery Act signed by Obama Indirect submissions to government Intentional retention of funds “Material” False statements/documents Whistle-blower protection for independent contractors/contractors More subpoena power

35. 2010 © Arent Fox PLLC, Washington, D.C. 2010 © California Association for Health Services at Home (CAHSAH) Odyssey Case Odyssey HealthCare paid the United States $12.9 million to settle a qui tam false claims case ̶ VP got $2.3 million award Allegations that patients were not terminally ill The settlement covers a period from 2001 ̶ 2005 Odyssey HealthCare also entered into a Corporate Integrity Agreement (CIA) with the HHS/OIG

36. 2010 © Arent Fox PLLC, Washington, D.C. 2010 © California Association for Health Services at Home (CAHSAH) Faith Hospice Faith Hospice, Inc. allegations of fraudulent claims to Medicare/Medicaid Sample of medical records: 50% ineligible Forfeited approximately $599,000; half seized by civil forfeiture action

37. 2010 © Arent Fox PLLC, Washington, D.C. 2010 © California Association for Health Services at Home (CAHSAH) Home Hospice of North Texas Misrepresented condition of patients Misinformed physicians of patient data Half million $ payback Corporate Integrity Agreement Compliance program within 90 days False Claims Act; May 29, 2008

38. 2010 © Arent Fox PLLC, Washington, D.C. 2010 © California Association for Health Services at Home (CAHSAH) SouthernCare Hospice organization agreed to pay $24.7 million Five year Corporate Integrity Agreement with the Office of the Inspector General Alleged inappropriate admissions and LOS issues Extensive press coverage in Home Health Line

39. 2010 © Arent Fox PLLC, Washington, D.C. 2010 © California Association for Health Services at Home (CAHSAH) California Criminal Hospice Case May 2009 family run hospice paid outside person to be ”capper” and refer patients $500 per referral with continuing payments Patients paid $200 to agree to be “terminal” Physicians paid for sign-offs Significant sentences

40. 2010 © Arent Fox PLLC, Washington, D.C. 2010 © California Association for Health Services at Home (CAHSAH) Investigations Announced Large, for-profit hospice organizations have announced new or renewed DOJ investigations Subpoena are being issued Focus of investigations now length of stay as well as terminal condition at time of admission; nursing home focus

41. 2010 © Arent Fox PLLC, Washington, D.C. 2010 © California Association for Health Services at Home (CAHSAH) 2.Mail or Wire Fraud a.Electronic Billing b.Cost Reports and Claims c.Fraudulent Back-up Documentation Mailed to Payors

42. 2010 © Arent Fox PLLC, Washington, D.C. 2010 © California Association for Health Services at Home (CAHSAH) 3.False Statements Making an untrue statement Filing an inaccurate CAP report Nurses altering notes during QA or in response to ADR Is an untrue certification = false statement?

43. 2010 © Arent Fox PLLC, Washington, D.C. 2010 © California Association for Health Services at Home (CAHSAH) 4. Concealing or Failing to Disclose Overpayments Knowingly concealing, or failing to disclose occurrence of an event affecting right to payment Overpayment Duplicative billings Outcome of internal audits

44. 2010 © Arent Fox PLLC, Washington, D.C. 2010 © California Association for Health Services at Home (CAHSAH) 5. Medicare - Medicaid Anti-Kickback Statute Remuneration: In cash or in kind; direct or indirect; cross referral arrangements may be illegal Referring a patient, arranging service or recommending a provider Giver and receiver of kickback are liable Inducement of a beneficiary is a kickback

45. 2010 © Arent Fox PLLC, Washington, D.C. 2010 © California Association for Health Services at Home (CAHSAH) OIG ALERTS Nursing Homes And Hospice = 2 Joint Ventures Contractual Joint Ventures

46. 2010 © Arent Fox PLLC, Washington, D.C. 2010 © California Association for Health Services at Home (CAHSAH) OIG opinions www.oig.hhs.gov Hospice of Martin and St. LucieLucie /fraud/docs/advisoryopinions/2000/ao00_3.htm Contracting with Nursing Homes /2001/ao01-20.pdf Fundraising solicitations /2001/ao01-02.pdf Patient monitoring systems /2003/ao0304.pdf Pre-hospitalization assessments /2006/AdvOpn06- 01A.pdf Foundations giving free drugs /2008 /AdvOpn08- 17.pdf ; 2010/AdvOpn 10-06 Patient bonuses for referrals to Independent Lvg 2010/AdvOpn10-05

47. 2010 © Arent Fox PLLC, Washington, D.C. 2010 © California Association for Health Services at Home (CAHSAH) 6. “Stark” Law Does not apply to hospices directly — but affects other relationships among health providers, so hospices within health systems should review their physicians’ relationship with affiliated institutions, such as hospitals and home health agencies of the system All financial relationships with Physicians are affected for Designated Health Services “DHS”

48. 2010 © Arent Fox PLLC, Washington, D.C. 2010 © California Association for Health Services at Home (CAHSAH) 7.Other Statutes a.Conspiracy to Defraud the United States b.Theft, embezzlement, conversion of public monies c.Theft or bribery concerning programs receiving federal funds d.Obstruction - of agency proceedings - of criminal investigations - of a federal audit e.Money laundering

49. 2010 © Arent Fox PLLC, Washington, D.C. 2010 © California Association for Health Services at Home (CAHSAH) 8. State Statutes a.Theft, larceny, false instruments b.Medicaid false claims [Attn! DRA] States with their own Federal False Claims Act to combat Medicaid fraud and abuse: CA, DEL, D.C., FL, HA, IL., IN., LA, MA, MI, MT, N.H., N.M., NV, NY,TN, TX, VA c.Health care false claims

50. 2010 © Arent Fox PLLC, Washington, D.C. 2010 © California Association for Health Services at Home (CAHSAH) B.Administrative Remedies – OIG Goes after the “Little Guys” 1. Civil Money Penalties [“CMP”] 3x Error plus >$11,000 for each claim “Know or should know” were not provided as claimed, or were false or fraudulent Exclusions in administrative proceeding for Medicare or Medicaid claims Beneficiary “inducement” is CMP

51. 2010 © Arent Fox PLLC, Washington, D.C. 2010 © California Association for Health Services at Home (CAHSAH) 2. CMS may refuse to enter or refuse to renew*, provider agreement for not complying a.With the statute or regulations or b.With the “requirements to be a hospice”** * 855 to be submitted every three years ** QAPI as the new standard in Hospice Conditions of Participation

52. 2010 © Arent Fox PLLC, Washington, D.C. 2010 © California Association for Health Services at Home (CAHSAH) 3.Suspension of payments for: Suspected overpayments, or if the FI has reliable evidence that the overpayment is a result of fraud or willful misrepresentation, without prior notice.

53. 2010 © Arent Fox PLLC, Washington, D.C. 2010 © California Association for Health Services at Home (CAHSAH) 4.State administrative sanctions: May be suspended from participation upon indictment, or some finding by an administrative agency prior to any hearing on the underlying facts. Suspension by state may trigger exclusion by the OIG and hence government wide exclusion.

54. 2010 © Arent Fox PLLC, Washington, D.C. 2010 © California Association for Health Services at Home (CAHSAH) IV. Essentials of Compliance Planning for Hospices

55. 2010 © Arent Fox PLLC, Washington, D.C. 2010 © California Association for Health Services at Home (CAHSAH) A. WHY? 1.Prevention 2.Insurance 3.Business 4.Medicaid Law for $5 million in revenue entities

56. 2010 © Arent Fox PLLC, Washington, D.C. 2010 © California Association for Health Services at Home (CAHSAH) B. WHEN? 1.Before a corporate integrity agreement “CIA” is imposed by the government, with harder terms and mandated reports to OIG 2.After a vote by Board of Directors/ Officers

57. 2010 © Arent Fox PLLC, Washington, D.C. 2010 © California Association for Health Services at Home (CAHSAH) C. WHAT? A RISK ASSESSMENT FOLLOWED BY: Seven Essential Elements of an Effective Compliance Plan

58. 2010 © Arent Fox PLLC, Washington, D.C. 2010 © California Association for Health Services at Home (CAHSAH) Hospice Risk Areas In OIG 1999 Compliance Guidance http://www.oig.hhs.gov/authorities/docs/hospice Prime Focus: * Admitting patients to hospice care who are not terminally ill * Under ‑ utilization * Falsified medical records or plans of care * Untimely and/or forged physician certifications or plans of care * Knowingly billing for substandard care

59. 2010 © Arent Fox PLLC, Washington, D.C. 2010 © California Association for Health Services at Home (CAHSAH) OIG 1999 Guidance for Hospice Billing higher level of care than substantiated Incentives to potential referral sources (physicians, nursing homes, hospitals, assisted living, patients) that may violate the anti ‑ kickback statute: focus on nursing homes www.oig.hhs.gov/fraud/docs/alertsandbulletins/hospice www.oig.hhs.gov/fraud/docs/alertsandbulletins/ SFANursingFacilities

60. 2010 © Arent Fox PLLC, Washington, D.C. 2010 © California Association for Health Services at Home (CAHSAH) OIG FOCUS TODAY?? Inflating general inpatient or continuous care: Higher reimbursement by “promising” NFs or hospitals a certain number of inpatient days or transferring patients to continuous care, to lower hospital LOS Using inpatient facilities owned by the hospice whose medical director is “controlled” Gaming the CAP

61. 2010 © Arent Fox PLLC, Washington, D.C. 2010 © California Association for Health Services at Home (CAHSAH) Where is OIG Focusing…  Improper marketing for admissions (versus allowable incentives to W-2 staff)  “Joint Ventures” that are kickbacks; Nursing Homes  Underserving and therefore delivering poor quality of care — judged by visit #, length, cost  Unnecessary additional Medical Directors

62. 2010 © Arent Fox PLLC, Washington, D.C. 2010 © California Association for Health Services at Home (CAHSAH) Narratives for Physician Certification; Visit Billing Integrity CR #6540 (re-issued on 12/23/09) speaks to the hospice reporting requirements for the attending physician and the physician certifying the terminal illness in written form CMS issued a clarification to CR6440 when rounding for the 15 minute increments in time reporting for all claims. 0 to 14 minutes=1 unit

63. 2010 © Arent Fox PLLC, Washington, D.C. 2010 © California Association for Health Services at Home (CAHSAH) The 180 Day Physician Visit New regulation to be issued this week; posted last week. Short comment period. <15days pre-180 th day and <15 every following cert period. In person, face to face [no telehealth] nurse practioner can inform the physician but attestation, in writing and specifics

64. 2010 © Arent Fox PLLC, Washington, D.C. 2010 © California Association for Health Services at Home (CAHSAH) Compliance and the New COPs Patients’ Rights; participation in care planning Quality as underlying the value of care Role of the Medical Director; suggestion that > 1 is not what CMS expects Credentials; Multiple Site Hospices Validation through documentation Signatures More…………

65. 2010 © Arent Fox PLLC, Washington, D.C. 2010 © California Association for Health Services at Home (CAHSAH) What are the Patient’s Rights? Effective Pain management Involvement in Care Plan Development Information on coverage, scope, limitations Refusing care or treatment Choosing the attending Confidential patient record, access/release HIPAA Freedom from mistreatment, neglect, abuse, property misappropriation, injuries of unknown source

66. 2010 © Arent Fox PLLC, Washington, D.C. 2010 © California Association for Health Services at Home (CAHSAH) Failures in COPs affect Billing Government theory is that really poor care means a bill should not be sent If you bill a claim when you know or should know the quality was inadequate, this could be a “False Claim”. Federal and State false claims act [FCA] cases growing Billing a claim without documentation to prove care, level of care, or terminal status could also be a “False Claim”

67. 2010 © Arent Fox PLLC, Washington, D.C. 2010 © California Association for Health Services at Home (CAHSAH) Assessments of Patients Initial 48 hour window; Comprehensive within 5 calendar days of NOE; q. 15 days = updated assessment  Signed and dated Election = Importance Content: the clinical presenting picture; the functional status and patient participation in care; risk factors in care planning; imminence of death; Drug Profiling; bereavement needs; Referral Needs => “Amalgam of documents” risks

68. 2010 © Arent Fox PLLC, Washington, D.C. 2010 © California Association for Health Services at Home (CAHSAH) Assessment of Patients: Update IDG and “collaboration of the attending”  How do you document/ prove Progress =>desired outcomes; response to care; did you ask patients? Uniform data outcomes measures Data systematic, retrievable for individual care planning and larger QAPI work

69. 2010 © Arent Fox PLLC, Washington, D.C. 2010 © California Association for Health Services at Home (CAHSAH) The Right Services from the Right People at the Right Time Credentialing Training and competencies Supervision Core Services from Hospice Employees or Contractors when permitted Waivers of Required Services Role of Personal Care Workers and NF employees as “Family-equivalents”

70. 2010 © Arent Fox PLLC, Washington, D.C. 2010 © California Association for Health Services at Home (CAHSAH) 418.56 Interdisciplinary Group: IDG RN IDG member must coordinate care and ensure “continuous assessment” of patient and family needs IDG must “work together”, “provide the care” “meet the needs” & reassess every 15 days Must have a “Super IDG” to set policies on day to day care, if >1 IDG in the hospice IDG must document patient’s understanding, involvement and agreement w care planning

71. 2010 © Arent Fox PLLC, Washington, D.C. 2010 © California Association for Health Services at Home (CAHSAH) Hospice Aide Supervision In-person: RN with the patient in the home every 14 days [no aide present] In-person with the aide to observe aide’s services with a patient = 1 time per year No therapist, and no LPN, can satisfy the supervision requirement What mechanisms to ensure compliance through what RN “observes” of patient?

72. 2010 © Arent Fox PLLC, Washington, D.C. 2010 © California Association for Health Services at Home (CAHSAH) Background Checks Not “credentialed” if behavior or background do not meet standards 418.114(d) criminal background checks all who do patient care or affect patient record/billing. State law as guidance. Affirmative obligation to come forward? OIG and GSA exclusions list more than criminal activities; all claims un-billable

73. 2010 © Arent Fox PLLC, Washington, D.C. 2010 © California Association for Health Services at Home (CAHSAH) Hospice Medical Director If there is only one physician connected to the hospice, this physician is “expected to provide direct patient care to each patient.” Medical Director [MDir] provides “overall medical leadership” in the hospice. Numerous physicians in the MDir role “would likely result in inconsistent care and decreased accountability.” Certifications depend on information= review of DX, current medical findings, meds and treatments 418.102 (a) and (b)

74. 2010 © Arent Fox PLLC, Washington, D.C. 2010 © California Association for Health Services at Home (CAHSAH) 418.112: Patients Residing in Nursing Facilities Legally binding, written arrangement Designated liaison for both providers Primacy of the hospice in care decisions — ”full responsibility” Mandated strong communication and coordination — in written terms 112(e)(3) Absent revised SNF regulations, however, how will it “work”?

75. 2010 © Arent Fox PLLC, Washington, D.C. 2010 © California Association for Health Services at Home (CAHSAH) Special Requirements: Patients Residing in Nursing Facilities NF’s continue to provide services as before / room & board & support Core services = the hospice provides Use of the NF personnel Plan of Care planning, sharing, role of each provider, consistency Specific IDG member deals with NF coord’n

76. 2010 © Arent Fox PLLC, Washington, D.C. 2010 © California Association for Health Services at Home (CAHSAH) Nursing Facility Contracts Hospice must ensure NF staff trained Offer of bereavement services to facility staff goes in contract = 418.112(c) ??Hospices can use some of its own staff for NF staffing, if it is in the contract. Single, identified NF staff as liaison

77. 2010 © Arent Fox PLLC, Washington, D.C. 2010 © California Association for Health Services at Home (CAHSAH) Surveyors & QAPI Will access aggregated data and analysis Will access QAPI plan, minutes and notes Will access “individuals responsible” Will match data w actual experiences of employees/ patients to see if QAPI is “prevalent” and “positively influencing patient care”

78. 2010 © Arent Fox PLLC, Washington, D.C. 2010 © California Association for Health Services at Home (CAHSAH) V. Seven Essential Elements of An Effective Compliance Plan

79. 2010 © Arent Fox PLLC, Washington, D.C. 2010 © California Association for Health Services at Home (CAHSAH) Seven Essential Elements of an Effective Compliance Plan The degree of formality depends on the size and complexity of the organization ̶ OIG rejects “canned” plans Begins with a statement of corporate philosophy, a code of conduct and an employee manual If the Compliance Plan is not “effective” and “robust” OIG will ignore it

80. 2010 © Arent Fox PLLC, Washington, D.C. 2010 © California Association for Health Services at Home (CAHSAH) #1 Compliance Standards and Procedures that are reasonably capable of reducing the prospect of criminal conduct.

81. 2010 © Arent Fox PLLC, Washington, D.C. 2010 © California Association for Health Services at Home (CAHSAH) #2 Steps to Prevent and Detect Offenses which may occur in an organization engaged in this particular type of business.

82. 2010 © Arent Fox PLLC, Washington, D.C. 2010 © California Association for Health Services at Home (CAHSAH) #3 Compliance Oversight with the standards and procedures assigned to a specific individual within the high-level personnel of the organization. Essential qualities: effective, compelling, autonomous (reports to Board of Directors), unimpeachable integrity, holds confidence of senior management, respected by peers, approachable

83. 2010 © Arent Fox PLLC, Washington, D.C. 2010 © California Association for Health Services at Home (CAHSAH) #4Substantial Discretionary Authority Is Not Given to individuals whom the organization knew, or should have known through the exercise of due diligence, had a propensity to engage in illegal activities. Background and criminal records checks within the state law limits. OIG and GAO exclusion lists MANDATORY

84. 2010 © Arent Fox PLLC, Washington, D.C. 2010 © California Association for Health Services at Home (CAHSAH) #5 Effective Communication of Standards Through understandable documents Thorough, regular and repeated training

85. 2010 © Arent Fox PLLC, Washington, D.C. 2010 © California Association for Health Services at Home (CAHSAH) #6 Monitoring to Achieve Compliance OIG guidelines called for baseline audits but many providers installed programs without this Internal monitoring and auditing, penalty free reporting and confidential reporting mechanism (hotline)

86. 2010 © Arent Fox PLLC, Washington, D.C. 2010 © California Association for Health Services at Home (CAHSAH) #7 Effective Enforcement, all the way up the ladder. Responses That Are Reasonable, appropriate, prompt and effective to remedy problems, including modifying the compliance plan which must be a “living document.” Feedback is essential.

87. 2010 © Arent Fox PLLC, Washington, D.C. 2010 © California Association for Health Services at Home (CAHSAH) D. HOW? The On-Site Process: Start with the OIG Guidance and Attachment III – G, H, I and J and review all the following: a.Corporate organization, structure b.Corporate related organizations, e.g., pharmacy/ infusion, durable medical equipment suppliers, management holding companies, subsidiaries, etc. These are matrix documents for subsequent internal audits, plus medical records and billing records.

88. 2010 © Arent Fox PLLC, Washington, D.C. 2010 © California Association for Health Services at Home (CAHSAH) 1. Before On-Site Process a.Contracts with independent contractors, managed care organizations, physicians, referral sources, vendors b.Position descriptions c.Policy and procedure manuals with particular focus on trouble areas in hospice d.Employee manuals

89. 2010 © Arent Fox PLLC, Washington, D.C. 2010 © California Association for Health Services at Home (CAHSAH) 1. Before On-Site Process (continued) e.Orientation and training materials f.Financial statements g.Cost reports h.Internal and external audit reports i.Survey and certification reviews j.Outside survey and accreditation reports k.Election, informed consent and DNR

90. 2010 © Arent Fox PLLC, Washington, D.C. 2010 © California Association for Health Services at Home (CAHSAH) 2. Process Systems/operations review Interviews of employees “Spot-check review” by outside counsel

91. 2010 © Arent Fox PLLC, Washington, D.C. 2010 © California Association for Health Services at Home (CAHSAH) E.WHO? All Company Staff Contractors for Services (Clinical, Billing, etc.)

92. 2010 © Arent Fox PLLC, Washington, D.C. 2010 © California Association for Health Services at Home (CAHSAH) Some Legal Issues in Today’s Strategies for Hospice Contracting and Joint Venturing Expanding Geographically Adding Medical Directors/consultants – Documentation model: Attachment III-M Adding a physical facility; leasing offices near or in medical complexes Changed documentation protocols; software Exploring telehealth How to handle an outside investigation

93. 2010 © Arent Fox PLLC, Washington, D.C. 2010 © California Association for Health Services at Home (CAHSAH) Compliance Officer Tools OIG website resources OIG exclusion and GSA exclusion lists HCCA website information: www.hcca- info.org FI training and updates, for example: https://www.cahabagba.com/part_a/educa tion_and_outreach/newsletter/index.htm NHPCO website materials

94. 2010 © Arent Fox PLLC, Washington, D.C. 2010 © California Association for Health Services at Home (CAHSAH) Websites for Exclusion Review http://oig.hhs.gov/fraud/exclusions/databa se.html#1 http://oig.hhs.gov/fraud/exclusions/database.html#2 http://exclusions.oig.hhs.gov/search.html Basic download instructions: http://oig.hhs.gov/fraud/exclusions/instructions.html

95. 2010 © Arent Fox PLLC, Washington, D.C. 2010 © California Association for Health Services at Home (CAHSAH) Thank You! Deborah Randall JD and Consultant Law Office of Deborah Randall law@deborahrandallconsulting.com 202-257-7073 www.deborahrandallconsulting.com