OIG Risk Areas: Anti- Supplementation; Therapy Services, Physicial Self-Referral & Hospice

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1 OIG Risk Areas: Anti- Supplementation; Therapy Services, Physicial Self-Referral & Hospice Presented by: Ken Burgess, Esq. Paul Pitts, Esq. Suzie Berregaard, Esq.

2 Where We ve Been & Today s Topics Review of prior webinar topics Mechanics of compliance programs OIG Risk Areas to date Today: Anti-Supplementation & Therapy-Ken Physicial Self-Referral-Paul Hospice- Suzie

3 OIG Risk Area: Anti-Supplementation

4 What is Anti-Supplementation? Anti-supplementation is the concept embodied in federal Medicare and Medicaid laws that a provider who accepts a resident whose care is paid for by Medicare or Medicaid may not charge any amount above and beyond what Medicare or Medicaid pays for a covered services. This includes not charging more than any permitted copay or deductible for a covered service. Note that this does not preclude a provider from charging additional amounts for services not covered by Medicaid or Medicare which a resident or their responsible party has requested.

5 Anti-Supplementation Risks Violation of the anti-supplementation laws can result in false claims and related criminal laws and violations of OBRA residents rights requirements. Prohibitions also extend to payments for covered services above and beyond what the program will pay by any third person on behalf of a resident (such as a family member). Supplementation payments may be cash or free or discounted services (such as free or discounted services a hospital may offer to a SNF to induce acceptance of Medicaid or Medicare residents). Note that a properly-developed and implemented reserved bed arrangement does not constitute prohibited supplementation (see discussion of requirements and limitations regarding reserved bed arrangements under separate discussion of that risk area in this compliance guidance).

6 Sample Auditing/Monitoring Approach Specifically, what are we being asked to measure or monitor? Specifically, where should we look to answer questions 1 8, above? What do we do with the results of our therapy monitoring efforts?

7 Specifically, what are we being asked to measure or monitor? Does the facility charge any amounts to any resident for a covered service paid for by Medicare or Medicaid, whether that amount is cash or a free or discounted service or item provided by another health care provider? Do we require any guarantees of payment (in any form) other than required copays or deductibles from any resident or any third party on behalf of the resident as a condition of admission or continued stay at the facility? Do our admissions and billing staff understand what supplementation means and the prohibition on supplementation?

8 Specifically, where should we look to answer questions 1 3, above? Interview applicable billing and admissions staff on a periodic basis [define schedule] to ensure they understand what supplementation is and the prohibitions on supplementation. This will be handled by [define staff]. Review all resident and Medicaid/Medicare bills, claims and/or invoices to ensure the facility only charges the amount paid by the applicable program for any covered service, along with any permitted deductible or copay. This will include a sample of [define number of claims/bills] to be reviewed [define schedule] and will be handled by [define staff].

9 Specifically, where should we look to answer questions 1 3, above? 1. Review a sample of [define size] resident or third party invoices to ensure that any services for which separate charges, above and beyond what Medicaid or Medicare pay, are for noncovered items (not paid for by Medicare or Medicaid) which the resident has specifically requested with full knowledge that they are not required to request such services but are required to pay for them if requested. This audit will be perfomed [define frequency] by [define responsible staff].

10 What do we do with the results of our monitoring efforts? Results should be provided to the facility s compliance officer and compliance committee for evaluation and response. Policies and procedures governing therapy services should be modified, as appropriate, based on these findings and appropriate training or re-training provided to relevant staff. Other corrective actions should be implemented as appropriate and explained to clinical and/or billing staff, with follow up to ensure compliance with same.

11 What do we do with the results of our monitoring efforts? This information should be provided to the Quality Assurance Committee and to the facility/company Board of Directors or owners, including the results of the audit, any problems identified and any corrective measures implemented, along with a plan for ongoing review and monitoring of corrective actions.

12 OIG Risk Area: Therapy Services

13 OIG Focus Issues on Therapy Services Improper utilization of therapy services to inflate the severity of RUG classifications to obtain additional reimbursement not warranted by the resident s condition and medicallyappropriate therapy needs; Overutilization of therapy services billedon a fee-for-services basis under Medicare Part B consolidated billing. According to the OIG, this practice can place medically frail residents at risk of injury and may obscure a resident s true condition; Stinting on therapy services needed by residents and which are billed under Medicare Part A. This practice may lead to a decline in resident s condition or failure to obtain their optimal functional status.

14 Risks Re Therapy Services Potential for False Claims Act violations and resulting CMPs Potential survey violations on multiple OBRA regulations: Therapy services Clinical services Administration Highest practicable status for resident

15 OIG Recommendations Re Therapy Services Facilities should develop policies and procedures to ensure that residents receive only medicallynecessary and appropriate therapy services. Facilities should ensure that therapy contractors and staff provide complete and contemporaneous documentation of each resident s therapy services; There should be regular and periodic reconciliation of physician orders relating to thearpy services with care plans and other care orders, plans and documentation with the services actually provided;

16 OIG Recommendations Re Therapy Services Monitoring should include interviews with staff, residents and families to ensure the proper delivery of ordered therapy services; and There should be ongoing assessments and re-assessments of the propriety of ongoing therapy services by the inter-disciplinary care planning team, which includes the physician responsible for a resident s care.

17 Sample Auditing/Monitoring Approach Specifically, what are we being asked to measure or monitor? Specifically, where should we look to answer questions 1 8, above? What do we do with the results of our therapy monitoring efforts?

18 Specifically, what are we being asked to measure or monitor? For each resident receiving therapy services, are those services needed and appropriate, as evidenced by adequate documentation of the need for therapy services and specifically what those services are and who is providing them? Is the documentation of need for therapy services reflected properly in the resident s care planning documents? Is this information regularly reviewed by the care planning team and the resident s physician to ensure the services remain appropriate for the resident?

19 Specifically, what are we being asked to measure or monitor? Are therapy services ordered and provided based on need by the resident, without consideration of whether those services are paid for by Medicare Part A, Medicare Part B or some other payor source. Do our bills for therapy services match the services actually provided and are those bills supported by complete, accurate and contemporaneous documentation of the need for therapy services and the provision of such services consistent with current medical orders?

20 Specifically, what are we being asked to measure or monitor? Do we have in place facility policies and procedures reflecting the guidelines set forth in items 1 5, above? Are existing therapy orders reconciled with current physician orders for therapy services? Are we actually providing therapy services consistent with these orders?

21 Specifically, where should we look to answer questions 1 8, above? Periodically examine the facility s policies and procedures governing therapy to ensure the are consistent with these principles. This will be done annually [or more often as appropriate] by [identify responsible staff]. Monitor regular care planning meetings to ensure therapy services are reflected in the care plan as ordered, that documentation by therapy staff exists to support the orders and their proper delivery, and that the resident s physician is involved in development and ongoing monitoring of those orders. This will occur monthly [or other appropriate frequency] and be coordinated by [identify staff person(s).

22 Specifically, where should we look to answer questions 1 8, above? Interview X number of facility staff, residents and family members to determine if they understand the need for ordered therapy services and whether, in their view, these services are being provided as ordered. Audit a sample of therapy billing records [define sample size] on the following schedule [monthly, quarterly or other] to ensure bills are supported by appropriate documentation of the need for, results of and delivery of ordered therapy services. This should include ensuring that the proper RUG category is reflected in light of the therapy serviced being provided and the documented need of a resident for those services.

23 Specifically, where should we look to answer questions 1 8, above? Audit a sample of physician orders and related therapy orders and care plans on a [define time frame] basis to ensure consistency. This should also ensure the documentation by therapy staff is complete, accurate and contemporaneous with the delivery of ordered therapy services. This will be handled by [define staff].

24 What do we do with the results of our therapy monitoring efforts? Results should be provided to the facility s compliance officer and compliance committee for evaluation and response. Policies and procedures governing therapy services should be modified, as appropriate, based on these findings and appropriate training or re-training provided to relevant staff.

25 What do we do with the results of our therapy monitoring efforts? Other corrective actions should be implemented as appropriate and explained to clinical and/or billing staff, with follow up to ensure compliance with same. This information should be provided to the Quality Assurance Committee and to the facility/company Board of Directors or owners, including the results of the audit, any problems identified and any corrective measures implemented, along with a plan for ongoing review and monitoring of corrective actions.

26 OIG Risk Area: Physician Self-Referral

27 Physician Self-Referral Law (Stark Law) OIG instructs Nursing Facilities to familiarize themselves with the physician self-referral law or Stark law Stark law is intended to address the concern that financial incentives have a tendency to corrupt the medical decisionmaking of those providing care. As such, the government wants to ensure that medical decisions are made in the best interests of patients.

28 Dual Prohibition A physician is prohibited from making a referral for designated health services (DHS), payable by Medicare or Medicaid, to an entity with which the physician or an immediate family member has a financial relationship. The entity furnishing DHS is prohibited from presenting a claim to Medicare for DHS furnished pursuant to a prohibited referral.

29 Designated Health Services 1. Clinical laboratory services; 2. Physical therapy, occupational therapy, and speech language pathology services; 3. Radiology and certain other imaging services; 4. Radiation therapy services and supplies; 5. Durable medical equipment and supplies; 6. Parenteral and enteral nutrients, equipment, and supplies; 7. Prosthetics, orthotics, and prosthetic devices and supplies; 8. Home health services; 9. Outpatient prescription drugs; and 10. Inpatient and outpatient hospital services.

30 Is there a special rule involving the definition of DHS when an SNF is involved? When determining whether a particular service constitutes a DHS in the SNF setting, the Stark Law excludes items or services that Medicare pays for on a per diem basis as part of a composite rate (e.g., the Part A RUG rate ). Therefore, if an item or service that would otherwise be a DHS is included as part of the SNF per diem rate, it is not considered a DHS for Stark Law purposes. However, if an SNF/NF furnishes DHS that are not covered under the composite rate, such as therapy services furnished under Medicare Part B, these services would be DHS covered by the Stark Law.

31 Exceptions to Stark Law Unlike the Anti-Kickback Statute and its safe harbors, arrangements implicating the Stark Law that do not fully comply with an exception are per se illegal; strict liability statute. Exceptions to the Stark prohibition include: Ownership Exceptions (e.g., rural providers and whole hospitals) Compensation Arrangement Exceptions (e.g., rental of office space or equipment, personal services, indirect compensation) Multi-Purpose Exceptions (e.g., physician services or inoffice ancillary services) Temporary Non-Compliance Exception

32 Relevant Compensation Exceptions a) Personal Services b) Non-Monetary Compensation c) Temporary Noncompliance d) Bona Fide Employment e) Compliance Training

33 What are the requirements for the personal services exception? a) be in writing, be signed by the parties to the agreement, and specify the services covered by the agreement; b) cover all of the services to be furnished by the physician under the arrangement; c) cover aggregate services that do not exceed those that are reasonable and necessary for the legitimate purposes of the arrangement; d) be for a term of at least one year; e) provide for compensation to be set in advance, not to exceed fair market value, and (except in the case of a permissible physician incentive plan) not be determined by the volume or value of any referrals or other business generated between the parties; and f) not involve counseling or promotion of a business arrangement or other activity that violates any state or federal law, such as the federal Anti-kickback Statute.

34 Analytical Approach to the Stark Law Step 1: Is a physician involved (M.D. or D.O.)? Step 2: Has a physician made a referral for DHS? Step 3: Is the service or supply payable in whole or in part by Medicare or Medicaid? Step 4: Is there a direct or indirect financial relationship with the entity? (includes immediate family of physician) Step 5: Does an exception apply?

35 COMMON QUESTIONS If one exception to the Stark Law is satisfied, is an entire arrangement between a physician and an entity protected?

36 Not necessarily. A Stark exception has to be satisfied for each financial relationship between a physician and an entity that will receive referrals for DHS. Also, the Stark Law applies to both direct and indirect financial relationships. A medical director agreement with a physician s practice entity, rather than the physician individually, is considered a financial relationship with the physician under the Stark Law.

37 COMMON QUESTIONS Is a medical director of an NF required to meet a Stark Law exception for the referral of one of his or her patients to the NF for the provision of non-per-diem services?

38 Very likely. Per diem items or services that are covered as part of a composite rate are not considered DHS for the purposes of the Stark Law. Items or services that are not paid for as part of a composite rate (i.e., nonper-diem services) are subject to the Stark Law if those items or services fall into one of the DHS categories.

39 COMMON QUESTIONS The Stark Law requires that a medical director s compensation not exceed fair market value. What is fair market value?

40 The Stark Law defines fair market value as the value in arm s length transactions, consistent with the general market value. General market value means the compensation that would be included in a service agreement as the result of bona fide bargaining between wellinformed parties to an agreement who are not otherwise in a position to generate business for the other party at the time of the agreement.

41 Prior regulations had included a safe harbor for establishing fair market value by comparison to either the average hourly rate for emergency room physicians or the hourly rate based on salary surveys for physicians in the same specialty. In December, 2007, those safe harbors were eliminated, although the fair market value requirement remains in place.

42 COMMON QUESTIONS What are the penalties for violating the Stark Law?

43 Regulators may impose a broad range of penalties for violations of the Stark Law. Civil penalties include: a) repayment of all amounts billed to the Medicare and Medicaid program that violate the Stark Law; b) civil monetary penalties up to $100,000 if an arrangement is found to have as its principal purpose the intent to ensure physician referrals; or c) exclusion from the Medicare and Medicaid programs. d) filing a Medicare or Medicaid claim in violation of the Stark Law constitutes a false claim, which could trigger liability under the federal False Claims Act.

44 COMMON QUESTIONS If a provider commits an error and violates Stark Law without intent to do so, will it be penalized?

45 Yes. Stark is a strict liability law and may be violated regardless of the physician s good intentions to benefit patient care or improve patient access to health care resources. Penalties for violations of the Stark Law may be greatly increased if the intent of the arrangement is to secure patient referrals in violation of the federal Antikickback Statute or the federal False Claims Act.

46 OIG Risk Area: Hospice Services in Nursing Facilities

47 Who is Eligible For Hospice Care? Resident must be certified as being terminally ill --which means that either the person s attending physician or the hospice medical director must specify that the individual s prognosis is for a life expectancy of 6 months or less if the terminal illness runs its normal course.

48 What is Hospice Care? Hospice care is a set of comprehensive (core and non-core) services identified and coordinated by a hospice interdisciplinary group to provide for the physical, psychosocial, spiritual, and emotional needs of a terminally ill patient and/or family members, as delineated in a specific patient plan of care.

49 Interdisciplinary Group Doctor RN Social Worker Pastoral or other counselor Also check state regulations, which may require additional members on the IDG team. May also see: hospice aids, bereavement counselors, volunteers, PT, OT, ST, ancillary services such as music, massage, pet therapy and others.

50 Core Services: Substantially all Core Services must be provided directly by hospice employees: Physician (may be contracted) Nursing Medical Social Counseling Bereavement Dietary Spiritual

51 Non Core Services: May Be Provided Under Contract (for example with the nursing facility) PT, OT, ST Hospice Aid Homemaker Volunteers

52 Levels of Care and Approx. Rate Paid/Day: Routine ($140) Continuous Care ($830) Respite ($145) In Patient ($635)

53 OIG Background: Identified hospice in NFs high potential for fraud and abuse Special Fraud Alert 1998 Comp. Guidance Hospices 1999 Comp. Guidance NFs 2008 Revised Hospice Medicare Conditions of Participation (CoPs) 12/2008 OIG Work Plan 2009

54 OIG Risk Areas: Free nursing services offered by the hospice for non-hospice patients. Room and board payments in excess of those paid to the facility at the Medicaid rate. Inflated payments to the facility for performing hospice services to the hospice s patients.

55 Risk Areas Continued: A hospice offering free goods, or goods below market value, to a nursing facility to induce the facility to refer patients to the hospice. A hospice paying amounts to the nursing facility for additional services that Medicaid considers to be included in its room and board payment to the hospice.

56 Risk Areas Continued: A hospice paying room and board payments to the nursing facility in excess of what the nursing facility would have received directly from Medicaid had the patient not been enrolled in hospice. Any additional payments must represent the FMV of additional services actually provided that are not included in the daily rate.

57 Risk Areas Continued: A hospice paying above fair-market value for additional services that Medicaid does not consider to be included in its room and board payment to the nursing facility. A hospice referring its patients to a nursing facility to induce the nursing facility to refer its patients to the hospice.

58 Risk Areas Continued: A hospice providing free or below fair market value care to nursing facility patients, for whom the nursing facility is receiving Medicare payment und the SNF benefit, with the expectation that after the patient exhausts the SNF benefit, the patient will receive hospice services from that hospice.

59 Risk Areas Continued: A hospice providing staff at its expense to the nursing facility.

60 OIG Recommendations: 1. Facilities should develop policies and procedures that prohibit the facility from requesting, requiring, or accepting : free or below fair market value goods or services as an inducement to refer patients to a particular hospice; room and board payments in amounts in excess of what the facility would have received directly from Medicaid had the patient not been enrolled in hospice;

61 Cont. above fair market value for additional non-core services that Medicaid does not consider to be included in its room and board payments to nursing homes; referrals from a hospice as an inducement to refer nursing home residents to the hospice;

62 the hospice to provide free or below fair market value care to nursing home residents, for whom the nursing home is receiving payment under the Medicare SNF benefit, with the expectation that after the patient exhausts the SNF benefit, the patient will receive hospice services from that hospice; the hospice to provide staff at the hospice s expense to the nursing home to perform duties that otherwise would be performed by the nursing home.

63 OIG Recommendations: 2. Facilities should structure their relationships (contracts) with hospice providers to fit within a recognized safe harbor under the Anti-Kickback Statute (such as the personal services and management contracts safe harbor).

64 Specifically, what are we being asked to measure or monitor? 1. Are nursing home residents who may meet hospice eligibility requirements being provided with information allowing them a choice between local hospice providers? 2. Can the nursing facility support its decision (if one has been made) to limit the number of hospice providers permitted in the facility?

65 3. Are there written agreements in place with each hospice provider, and do these written agreements fall within the personal services and management services safe harbor? 4.Is there any financial or legal relationship between the medical director or the hospice and the nursing facility or its medical director?

66 5. Does the nursing facility have an appropriate process in place for making and documenting reasonable, consistent, and objective determinations of fair market value of the services they are providing to or receiving from the hospice? 6. Are room and board payments being made to the facility by the hospice in excess of what the facility would have received directly from Medicaid if the patient had not elected hospice?

67 7. Is the nursing facility allowing hospice employees to provide free services to non-hospice patients or their family members? 8.Is the nursing facility making referrals to the hospice with the expectation that it will result in reciprocal referrals from the hospice?

68 9. Is the facility permitting the hospice access to resident records that are not either 1) current patients of the hospice, or 2) residents who have specifically requested and authorized review by the hospice for hospice eligibility? 10.Is the nursing facility permitting a hospice to solicit residents who have either not been referred to hospice by their physician or who are currently under the care of another hospice provider?

69 11. Is the nursing facility accepting additional payments from the hospice for goods or services that Medicaid determines are included in the amount received for room and board? 12. Is the hospice providing substantially all of the core services for each hospice patient through the hospice s own staff?

70 13. Are non-core services that are being provided by the nursing facility and not by the hospice being provided under an arrangement that provides for payment of fair market value for the services? 14. Do we have in place facility policies and procedures reflecting the guidelines set forth in items 1 13, above?

71 Where should we look to answer questions 1 14? 1. The facility s policies and procedures governing relationships and written arrangements with hospice providers and the provision of care and services to hospice patients;

72 2.Legal assessment of all contractual relationships with hospice providers as they are established, including an assessment of any relationship(s) between the hospice/medical director and the nursing facility/medical director, and any corresponding documentation of fair market value determinations;

73 3.review the number of available local hospice providers and compare this to the number of providers under arrangement with the nursing facility. Does reasonable rationale exists for limiting the number of providers permitted to provide hospice services within the facility? A review of the number of resident requests for noncontracted hospice providers, if any, should be included in this review.

74 4.Monitor regular coordinated care planning meetings to ensure core hospice services are being provided by the hospice and are reflected in the coordinated plan of care and patient record as such, and that services being provided by the nursing facility are consistent with those included in the room and board charge, or pursuant to a written agreement for additional non-core services;

75 5.Interview facility staff, hospice patients and their family members to determine if they understand the distinction between services that must be provided by the hospice and those that must/can be provided by the nursing facility, and whether they believe that services are being provided as needed and ordered;

76 6.Monitor a sample of the visits made to the facility by hospice personnel and document activities beyond the scope of providing services to designated hospice patients.

77 7.Audit a sample of billing records to ensure bills to hospice providers are supported by appropriate documentation, include only charges for room and board or additional noncore services that are consistent with the terms of the contract(s) in place with the hospice provider.

78 What do we do with the results? 1. Results should be provided to the facility s compliance officer and compliance committee for evaluation and response. 2. Policies and procedures should be modified, as appropriate, based on these findings and appropriate training or re-training provided to appropriate staff.

79 What do we do with the results? 3. Other corrective actions should be implemented as appropriate and explained to affected staff, with follow up to ensure compliance. 4. This information should be provided to the Quality Assurance Committee and to the facility/company Board of Directors or owners, including the results of the audit, any problems identified and any corrective measures implemented, along with a plan for ongoing review and monitoring of corrective actions.