NYAHSA 2010 ANNUAL MEETING

1. NYAHSA 2010 ANNUAL MEETING FRAUD AND ABUSE CONCERNS IN HOSPICE AND HOME-BASED CARE DEBORAH A. RANDALL, J.D. law@deborahrandallconsulting.com www.deborahrandallconsulting.com 202-257-7073

2. LATEST NEWS….. • The CMS folks now say $ 5.2 billion in recoveries were returned to the Medicare Trust fund in fiscal year 2009 by combined efforts of HHS, Department of Justice and OIG. This is nearly double prior year. • $441 million returned to Medicaid program

3. Private Insurance Fraud • Blue Cross Blue Shield plans collected $510 million in fraud savings and recoveries during calendar year 2009, a 47% ↑ in 1 yr [May 26 BCBSA survey announced] • $318 million =“avoiding payment on fraudulent or mistaken claims”, 62% ↑1 yr. • $192 million =recovering fromfraudulent or mistaken claims, 28% ↑ 1 yr.

4. Medicare, Medicaid, and CHIP Program Integrity Provisions • Sec. 6401. Provider screening and other enrollment requirements under Medicare, Medicaid, and CHIP. • Sec. 6402. Enhanced Medicare and Medicaid program integrity provisions. • Sec. 6403. Elimination of duplication between the Healthcare Integrity and Protection • Sec. 6408. Enhanced penalties. • Sec. 6409. Medicare self-referral disclosure protocol. • Sec. 6410. Adjustments to the Medicare durable medical equipment, prosthetics, • orthotics, and supplies competitive acquisition program. • Sec. 6411. Expansion of the Recovery Audit Contractor (RAC) program.

5. INTEGRITY, cont. • Sec. 6404. Maximum period for submission of Medicare claims reduced to not > 12 month • Sec. 6405. Physicians who order items or services required to be Medicare enrolled • Sec. 6406. Physician documentation on referrals at high risk of waste and abuse. • Sec. 6407. Face to face encounter with patient required before physicians may certify HHA

6. INTEGRITY, cont. • Sec. 6408. Enhanced penalties. • Sec. 6409. Medicare self-referral disclosure protocol. • Sec. 6411. Expansion of the Recovery Audit Contractor (RAC) program. • Sec. 6501. Termination of provider participation under Medicaid if terminated • under Medicare or other State plan.

7. INTEGRITY, cont. • Sec. 6502. Medicaid exclusion from participation relating to certain ownership, control, and management affiliations. • Sec. 6601. Prohibition on false statements and representations. • Sec. 6604. Applicability of State law to combat fraud and abuse.

8. New Fraud and Abuse Laws A. PPACA 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.  B. MANDATORY COMPLIANCE PROGRAMS FOR ALL PROVIDERS

9. Role of the Board of Directors • “The most significant role is becoming sufficiently educated about the topic to ask appropriate questions and determine whether management has the expertise, the will, and the metrics to provide a reasonable assurance of compliance, and for the Board members to review intelligently the responses and submissions of management” Jim Sheehan

10. Looking at the full Spectrum of Home-based Care • This is where the expansion will continue. • This is where PPACA drives the process towards management of chronic disease. • This is where health information technology is finally showing with reliable data that telehealth can integrate with traditional care,but government is wary of abuses. • This is where staffing innovation must occur.

11. Hospice Investigations and Prosecutions • Subjects for review • Approaches of the investigators • Others in the mix---MedPac; MediCal; MACs; CMS; Congressional committees; ZPICs [which are successors to PSCs]

12. Department of Justice Announcement • SouthernCare, Inc. (SCI), several affiliated entities, and SCI executive paid the Federal Government $24.7 million and enter into a 5-year CIA. Operating in 15 states, SCI allegedly submitted claims for treating patients who did not meet Medicare’s hospice eligibility criteria. Qui tam lawsuits filed by former SCI employees.

13. Heightened Hospice Concerns- What Practices Need Review? • WHO • WHAT • WHEN • WHERE • WHY • HOW • HOW OFTEN

14. Heightened Concerns • WHO- Are you admitting to care • WHAT- Are your referral relationships • WHEN- Are you performing assessments • WHERE- Are your patients residing • WHY- Are you hiring physicians • HOW- Are you ensuring quality of care • HOW OFTEN- Are you seeing patients

15. Hospice Expenditures* • In 2008, more than 1 million Medicare beneficiaries received hospice services from more than 3,300 providers and Medicare expenditures exceeded $11 billion. *MedPac 2010

16. Challenges to Hospice Reimbursement • MEDPAC recommendations to alter reimbursement methodology and create “ U-shaped curve“ with higher payment at beginning and end/death; Congress includes directive in Healthcare reform bill · MEDPAC refers to ‘dark’ side of hospice industry

17. Hospice Quality Quality of care— ‘‘We do not have sufficient evidence to assess quality, as information on quality of care is very limited. Efforts completed or under way might provide a pathway for further development of quality measures’’. *MedPac 2010 report

18. Health Reform Enacted • After January 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. • Attestation of visit • HHS medical review of certain patients in hospices with high percentages of long-stay patients.

19. Changes to Hospice Certification and Billing Processes • CR #6540 (re-issued on 12/23/09) includes the requirements for the attending physician or Medical Director to provide written explanation of basis of terminality when certifying the terminal illness. But if certification is verbal, this narrative is not required until the first billing.  • CR # 6440 CMS seeking line-item services data, but clarifies rounding up 0 to 14 minutes=1 unit and allowing social work phone calls to be included in the data.

20. ONE YEAR IN = Implementation of the New Conditions of Participation • 42 CFR 418; Dec. 2008 and Feb. 2009 • IDG [Interdisciplinary Group]; • Medical Director; • Nursing Facility contracts when hospice patient is a resident; • Patient Rights • Credentialing and Quality of Care

21. Where do the Compliance Risks Lie? QUALITY FROM THE 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

22. Medical Directors MEDICAL DIRECTORS • 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)

23. OIG is looking at Hospice/Nursing Facilities Are Hospice COPs an addition to Kickback Concerns because Quality of Care failures can be False Claims. COPs require ·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”?

24. OIG White Paper on Corporate Responsibility and Quality of Care • Point Four=Is the Board orientation and ongoing training inclusive of external quality and patient safety information. Are there Board members with expertise in these areas? • Point Six= How are quality assessment and improvement processes coordinated with the compliance program of the company? • Are quality and patient safety addressed in the company’s risk assessment and corrective action plans? • Use oig.hhs.gov website to obtain this document

25. QAPI= Proof of Quality • Formalized programs; strenuous work on outcomes • Governing Body responsibilities for oversight • Intersection between quality, incident reporting, risk management, compliance program audits, staff training

26. DEA Laws a new Focus • DEA has begun aggressive enforcement of position that NF nurses are not ‘agent’ of prescribing physicians. Pharmacies are enforcement targets. Pain medications are not being delivered timely to patients. • Senator Kohl of Wisconsin held a ‘listening session’ on this issue in late March. Hospice patients at risk, too.

27. RACs come to Hospice RAC REGION D ISSUES POSTED • DME Services related to a Hospice terminal diagnosis provided during a Hospice period are included in the Hospice payment and are not paid separately. • Services related to a Hospice terminal diagnosis provided during a Hospice period are included in the Hospice payment and are not paid separately.

28. Compliance Cases • Kaiser Foundation Hospitals - Kaiser Sunnyside Medical Center, Kaiser Foundation Health Plan of the Northwest and Northwest Permanente P.C., Physicians & Surgeons paid $1,830,322.41 in False Claims Act liability for services billed w/o written certifications of terminal illness [2000-2004]. Disclosed 11/09 • Multiple on-going OIG hospice investigations

29. OIG 2010 Work Plan • 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

30. OIG Reports for Hospice and Nursing Facilities • Sept. 2009 – OIG found 82 % of claims for hospice/NF residents lacked one or more coverage requirements; 31 % of cases provided fewer services than the care plan called for. • Second OIG Report was statistical and gave the intensity and frequency of NF-based hospice care….suggesting CMS might want to consider implications.

31. Heightened Homecare Concerns • WHO- Are you admitting to care • WHAT- Are your referral relationships • WHEN- Are you performing assessments • WHERE- Are your patients residing • WHY- Are you hiring physicians • HOW- Are you ensuring quality of care • HOW OFTEN- Are you seeing patients

32. Rise of Homecare Fraud Cases • Flat out corruption –Fake visits, fake orders • Kick-back referrals and Stark issues– Brokers; corrupt physicians and discharge planners • Un-credentialed staff • Manipulated frail or elder consumer • Bonus programs without safeguards • False data on OASIS, records, responses to ADRs

33. MEDICAID fraud enforcement is a competitive sport • 1/28/10--Massachusetts Medicaid Fraud Division Recovered Record $51.6 Million, breaking the previous high mark by $4.7 million and setting a record for the third consecutive year. •  Two large multistate litigations on off-label and illegal marketing and three on improper rebate or pricing programs. •  Interviews with Jim Sheehan in New York.

34. MEDICAID fraud enforcement is a competitive sport Massachusetts Medicaid Fraud Division Recovered Record $51.6 Million in 2009  • 2 large multistate litigations on off-label and illegal marketing, 3 improper rebate/pricing • “Our office takes very seriously our responsibility to hold accountable those who would defraud our state's Medicaid program,” •  Jim Sheehan interviews and profile

35. NYS OMIG Audits and Personal Care • OMIG audits are broad and deep. • Use of statistical extrapolation • Purely a “claw back” for political reasons? • Sheehan feels that weak or poorly maintained systems are avoidable, thus penalties are appropriate. • Growth and vulnerabilities in personal care.

36. MedPac & CMS’s Looking at Home Health Industry Behavior Yielded Results • Obama: PPACA included significant cuts in home health, with Congress “on board" • Behind the scene maneuvers to cut the profit from home health? • Concern about ill-prepared or unscrupulous new entrants into HHA field • Restraints such as cutbacks on surveys; declining to allow CHAP/JCAHO to qualify a new HHA branch; Jan 1st CHOW Freeze

37. Risk Management and Privacy Law • What steps to a better risk management assessment process do you have in place? • What recognition of the practical requirements of the new HIPAA laws on notice of breach of privacy, on Business Associates, on security of laptops/cell phones/PDAs? • How does your compliance program account for the privacy and security realities?

38. Faculty Contact Information Deborah A. Randall, J.D. Health Law Attorney and Consultant Law Office of Deborah Randall 202-257-7073 law@deborahrandallconsulting.com www.deborahrandallconsulting.com