Troubled Waters ? Hospice and Homecare Heightened Compliance Concerns

1. Troubled Waters? Hospice and Homecare Heightened Compliance Concerns Deborah A. Randall, J.D. Health Attorney and Consultant www.deborahrandallconsulting.com

2. Medicare, Medicaid, and CHIP Program PPACA 2010 Integrity Provisions • Sec. 6401. Provider screening and other enrollment requirements. • Sec. 6402. Enhanced Medicare and Medicaid program integrity provisions. • Sec. 6404. Maximum time for submission of Medicare claims reduced to not > 12 month • Sec. 6405. Physicians who order HHA/DME required to be Medicare enrolled

3. INTEGRITY, cont. • Sec. 6406. Physician documentation on referrals at high risk of waste and abuse. • Sec. 6407. Face to face encounter with patient required if physicians certify HHA;?MORE • Sec. 6408. Enhanced penalties. • Sec. 6409. Medicare self-referral disclosure protocol.

4. INTEGRITY, cont. • Sec. 6411. Recovery Audit Contractor (RAC) program extended to Medicaid. • Sec. 6501. Termination of provider participation under Medicaid if terminated under Medicare or other State plan.

5. 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.

6. 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

7. 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]

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

9. 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

10. 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

11. 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

12. 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

13. 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.

14. 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.

15. 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

16. 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

17. 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)

18. 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”?

19. 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

20. 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

21. 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.

22. 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.

23. Compliance Cases • 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 w/o written certifications of terminal illness in 2000-2004. 11/09

24. 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

25. 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

26. 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

27. 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

28. 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 for new HHA branch; Dec. 18/Jan 1st Freeze

29. 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.

30. Iowa Medicaid Payments for Home Health Agency • http://www.oig.hhs.gov/oas/reports/region7/71001081.pdfIowa improperly claimed $303,000 ($199,000 Federal share) for home health agency (HHA) services provided by 190 HHA providers Although the State agency had a process to monitor some HHA claims on a postpayment basis, and although Iowa enhanced this processin January 2009,overpayments not prevented.

31. 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

32. 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