Corporate Compliance Revisited:

1. Corporate Compliance Revisited: OIG’s New Supplemental Guidance for Nursing Facilities

2. Background • Compliance Program Guidance for Nursing Facilities published in 2000 • Established fundamentals of an effective compliance program • OIG believes that compliance programs help SNFs: • provide quality care • avoid submitting false or inaccurate claims • avoid other illegal practices.

3. Background • OIG motivated to issue Supplemental Guidance by significant changes in: • delivery of care • reimbursement • enforcement environment • level of concern regarding quality of care

4. Background • On September 30, OIG published the Supplemental Program Guidance for Nursing Facilities • Based on: • Regulations • CMS transmittals and program memoranda • Anti-Kickback and Stark statutes • OIG Advisory Opinions and special bulletins

5. Background • The OIG recognizes that: • the guidance is not “one size fits all” • nursing facilities have different levels of resources • The OIG encourages each facility to adapt the guidance to fit its structure, operations, resources, and the needs of its residents.

6. Background • Think of the Supplemental Guidance as a roadmap to compliance; your route depends on the areas of risk most relevant to your facility and the resources at your disposal.

7. Benefits of a Compliance Program • Decreases likelihood of unlawful and unethical behavior • Identifies and permits correction of problems at an early stage • Encourages employees to report problems, which allows for corrective action • Minimizes financial loss • Improves quality of care • Enhances reputation

8. Fraud and Abuse Risk Areas • Quality of Care • Submission of Accurate Claims • The Federal Anti-Kickback Statute • Other Risk Areas • Physician Self-Referrals • Medicare Part D • HIPAA Privacy and Security Rules

9. Consolidated Billing • Pay attention to which services are excluded from consolidated billing. • Examples: physician professional fees, certain ambulance services • Be aware of which services are always subject to consolidated billing. • Examples: PT, OT, and ST services furnished to SNF residents

10. Quality of Care • OIG notes that by 2030, elderly population projected to grow to 71 million. • Aging of America is one of the major public health challenges of the 21st century. • Rise in population will create greater strain on an already-burdened system and will likely spur CMS to more aggressive survey actions.

11. Quality of Care • Failure of care on a systematic/widespread basis may result in SNF being found liable for submitting false claims under the False Claims Act and Civil Monetary Penalties Law. • Theory: Care was so bad that it is simply not compensable • Be aware of potential malpractice considerations (i.e., denial of payment = government statement that care was shoddy)

12. Quality of Care: Staffing • Federal law requires sufficient staffing to obtain or maintain the highest possible physical, mental, and psychosocial well-being of residents. • Staffing numbers and competency are critical pieces of the puzzle.

13. Quality of Care: Staffing • SNFs are strongly encouraged to regularly evaluate staffing patterns and staff competency. Factors to examine: • Resident case mix and staff-to-resident ratios • Staff skill levels and turnover • Disciplinary records, payroll, timesheets • Adverse event reporting • Interviews with staff, residents, and families.

14. Quality of Care: Resident Care Plans • A comprehensive, interdisciplinary care plan is essential to reducing risk. • Interdisciplinary team — development of the care plan should include complete and thorough clinical assessments and open lines of communication.

15. Quality of Care: Resident Care Plans • Every member of the facility has a role to play: • Residents and their families should be involved. • Nursing staff should ensure that physicians are supervising the residents’ care. • Each discipline should work together so that the end result is a complete picture of the resident’s status.

16. Quality of Care: Medication Management • Implement medication management processes that: • advance patient safety • minimize adverse drug reactions • enable prompt discovery/remedy of any issues

17. Quality of Care: Medication Management • One key for medication management is consulting pharmacist: • Specializing in medication needs of geriatric/institutionalized populations • Must review each resident’s drug regimen at least monthly • Must establish a system of records to ensure that records are in order and all controlled substances are accounted for and maintained

18. Quality of Care: Medication Management • SNFs may provide for medication management services through contractual agreement with a pharmacist or by direct employment. • Again, focus on the team approach—too much for one person to juggle.

19. Quality of Care: Psychotropic Meds • Facilities cannot use any medication as a means of chemical restraint for purposes of discipline or convenience. • Facilities cannot administer any drug to a resident that is not required to treat the resident’s medical symptoms. • Residents’ drug regimens must be free from unnecessary drugs.

20. Quality of Care: Psychotropic Meds • Possible compliance measures: • Educate providers regarding appropriate monitoring and documentation practices • Conduct regular drug regimen audits • Review resident care plans to ensure that they incorporate an assessment of the resident’s medical, nursing, and psychosocial needs

21. Quality of Care: Resident Safety • SNFs are required to develop and implement policies and procedures to prohibit mistreatment, neglect, and abuse. • Effective P&P address prevention, detection, and response to mistreatment, abuse, and neglect. • Policies and procedures are just one component of an effective compliance program.

22. Quality of Care: Resident Safety • Compliance program considerations: • Implementing practices in addition to P&P • Broad definitions (staff-on-resident abuse, resident-on-resident abuse, abuse from unknown sources) • Confidential, 24/7 reporting • Staff and family education (consider posters, brochures, and online resources)

23. Quality of Care: Resident Safety • Resident on resident abuse • Increasing concern noted by OIG • Facilities must: • Screen • Monitor • Educate • Intervene

24. Staff Screening • SNFs cannot hire staff members who have been found guilty of abusing, neglecting, or mistreating residents, or who have a negative finding entered into a state nurse aide registry. • Effective recruitment, screening, and training are essential.

25. Staff Screening • Sources to evaluate: • Criminal records (check state law regarding State vs. Federal record checks) • Educational history • Licensure and certification • Training

26. Submission of Accurate Claims • A false or fraudulent claim is one where: • Items were not provided or not provided as claimed • Services were not medically necessary • Failure of care

27. Submission of Accurate Claims • Common pitfalls: • Duplicate billing • Insufficient documentation • False or fraudulent cost reports • Improper RUG classifications (upcoding)

28. Submission of Accurate Claims • Compliance considerations: • Train responsible staff to ensure the person gathering and analyzing data is knowledgeable about the purpose and utility of the data. • Train staff to ensure appropriate evaluation of resident case mix data. • Regularly audit and review.

29. Therapy Services • Common risk areas: • Improper use of therapy services to inflate the severity of RUG classifications • Overutilization of therapy services billed on a fee-for-service basis to Part B under consolidated billing • Stinting on therapy services provided to patients covered by a Part A PPS payment

30. Therapy Services • Compliance considerations: • Develop polices and procedures regarding therapy services • Develop a process to measure/evaluate whether residents are receiving medically appropriate services • Require therapy contractors to provide complete documentation of each resident’s services • Regularly reconcile MD orders with services provided • Interview residents/family members regarding services received

31. Restorative and Personal Care Services • Compliance considerations to ensure that services such as turning/positioning, range of motion, and incontinence are care provided: • Interview residents/family members • Review medical record documentation • Consult with attending physicians, medical director, and pharmacist • Observe the residents

32. Excluded Individuals and Entities • A SNF cannot hire or contract with a person or entity excluded from the Medicare program. • OIG strongly advises SNFs to screen all prospective owners, officers, directors, employees, contractors, and agents prior to engaging their services. • OIG’s searchable database of excluded individuals is available at: http://www.oig.hhs.gov/fraud/exclusions/exclusions_list.asp

33. Anti-Kickback Law • Anti-Kickback law prohibits offering or paying anything of value in return for patient referrals. • Also prohibits offering or paying anything of value in return for purchasing, leasing, ordering, or arranging for or recommending the purchase, lease, or order of any item or service reimbursable by federal health care programs.

34. Anti-Kickback: Free Goods/Services • Arrangements identified as areas of concern by OIG: • Pharmaceutical consultant services, medication management, or supplies offered by a pharmacy • Infection control, chart review, or other services offered by laboratories and suppliers • Gifts of equipment, computers, or software applications • DME or supplies offered by DME suppliers

35. Anti-Kickback: Free Goods/Services • Arrangements identified as areas of concern by OIG: • Administrative services provided by laboratory phlebotomists • Hospice nurses providing care to non-hospice patients • RNs provided by a hospital

36. Anti-Kickback: Hospice • Hospice arrangements are of particular concern: • Be leery of offers of free nursing services, additional room and board payments, or inflated payments—signs of improper arrangements to induce referrals. • Hospice staff should never provide services to non-hospice patients. • Patients should be given a choice of hospice providers.

37. Anti-Kickback: Service Contracts • Providing or accepting goods or services at below market value rates presents a heightened risk of fraud and abuse. • Periodically review contractor and staff contracts to ensure: • There is a legitimate need for the goods/services • The services or supplies are actually provided and adequately documented • Compensation is FMV resulting from an arms-length transaction • Arrangement is not related to volume or value of federal healthcare program business

38. Anti-Kickback: Service Contracts • Implement polices that ensure prescribing decisions are based on the best interest of the patient. • Physician contracts should also be reviewed periodically, just like any other service contract.

39. Anti-Kickback: Discounts • Discount must be: • in the form of a reduction • in the price of a good or service • as a result of an arms-length transaction • Discounts should be properly disclosed and accurately reflected on cost reports. • Discounts cannot be tied or linked to referrals for other federal healthcare program business.

40. Anti-Kickback: Swapping • Discounts from providers or suppliers are prone to “swapping problems”. • Price offer cannot be linked directly or indirectly to referrals. • Avoid accepting low price on an item or service covered under Part A in exchange for referral of business that the supplier or provider can bill directly to a federal health care program.

41. Anti-Kickback: Reserved Bed Payments • Reserved bed payments are permitted under certain terms. It is imperative to avoid: • Payments that result in “double-dipping” • Sham payments (beds are already occupied, etc.) • Excessive payments that exceed the actual cost of holding a bed • Reserved bed arrangements should only secure needed beds, not future referrals.

42. Physician Self-Referrals • Nursing homes should be aware of Stark law, which prohibits entities that furnish certain services from billing Medicare if referral comes from a physician with whom the entity has a prohibited financial relationship. • Nursing home services not included but lab, PT and OT are. • Pay close attention to relationships with physicians (treating and owners, medical directors, consultants). • Avoid issues by having written agreements with FMV compensation and track non-monetary compensation provided annually to referring physicians.

43. Anti-Supplementation (Cost Sharing) • A SNF may not charge a Medicare or Medicaid beneficiary or third party any amount over and above what is required to be paid under Medicare/Medicaid. • Cannot condition acceptance of a new resident on receiving a payment from the hospital or resident • Cannot accept extra payments or free services from hospital or other source, even though reimbursement considered inadequate

44. Medicare Part D • Covers all Medicare beneficiaries, including SNF residents • CMS encourages SNFs to provide education and information to residents regarding available Part D plans • SNFs should never: • Require residents to use a certain plan • Accept payments from a plan or pharmacy to influence a resident to select a particular plan

45. HIPAA • All SNFs that conduct electronic transactions governed by HIPAA must comply with Privacy Rules as of April 14, 2003 and Security Rules as of April 20, 2005.

46. Other Considerations • Organizational culture that promotes compliance • Code of Conduct • Fundamental principles and values held by the organization • Framework for compliance • Organization’s commitment to compliance • Annual review of compliance program and procedures

47. Self-Reporting • Prompt voluntary reporting will demonstrate good faith and effectiveness of compliance program. • Voluntary reporting is considered a mitigating factor in determining penalties. • Consult with counsel to navigate reporting process.

48. 2009 OIG Work Plan Risk Areas • SNF Consolidated Billing • Accuracy of Coding for RUGs • Part B Payments for Psychotherapy Services • Calculation of Medicare Benefit Days • CMS Oversight of MDS Data • Residents 65 and Older on Antipsychotic Drugs

49. 2009 OIG Work Plan Risk Areas • Hospice Care in Nursing Homes • Part B Services in Nursing Homes • ENT • DME, including pressure-reducing mattresses, wound therapy pumps, and power wheelchairs • Payment for Drugs Under Medicare Part D • Dual Eligible Beneficiaries

50. 2009 OIG Work Plan Risk Areas • Transparency Within Nursing Facility Ownership • Use of MDS and RAP to develop plans of care • States’ Use of CMP Funds • Medicaid Payments for Bed Holds