WORKSHOP ON COMPLIANCE REVISED HOSPICE CONDITIONS OF PARTICIPATION

WORKSHOP ON COMPLIANCEREVISED HOSPICECONDITIONS OF PARTICIPATION Deborah Randall, Esq. law@deborahrandallconsulting.com

The Workshop Goals • Understand the compliance background to the new COPs: “the times we work in” • Learn recent regulatory enforcement activities affecting Hospice =brief overview • Comprehend The Hospice COPs content, a “timeline” approach and a structural approach • Analyse a “case study”

Compliance Reviewers • State Survey and Certification Agencies; CHAP; JCAHO • State Medicaid Fraud Control Units (MFUCUs) & Medicaid Inspector Generals (IG) • Federal Office of the Inspector General (OIG) & Fiscal Intermediaries/MACs • State Consumer Protection Agencies

The Numbers Game • 18.7%= 1 yr. increase in Medicare costs • 28% = Residents in nursing homes receiving hospice care in 2005 • FY 2007, MFCUs recovered > $1.1 billion in penalties & obtained 1,205 convictions. More than 800 exclusions,based on referrals made to OIG by MFCUs.

Medicare Program Integrity • Will use the Resubmission of the Form 885s; Every 3 years • No Certainty providers will stay in system • Resurveying possible

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”

Failures in COPs affect Billing • Relationships with referral sources are inevitable in hospice (physicians, nursing homes, hospitals) must be free of fraudulent kickbacks or inducements. The new COPs require relationships and documentation… • Federal and State OIG say billing care that came from kickback = False Claim • OIG says billing “false” certifications = FCA COPs suggest > documentation at admission

Hospice Fraud and Abuse Cases • Odyssey HealthCare paid the US $12.9 million to settle a qui tam false claims case. Records did not support terminality. • Home Hospice of No.Texas paid $½ million;misinformed MDs of patient data • Faith Hospice paid $½+ million =ineligible care.

Under-serving Medicare Patients • Can be a compliance issue • Could be suggested by care plans not followed or differences in care between nursing home based patients and private home based patients • Can result in an action by OIG under the Civil Money Penalties Act, for money and to exclude you from the program

THE LESSON OF DME INDUSTRY OF SMALL COMPANIES A DECENTRALIZED, HOME BASED SERVICE PHYSICIANS ORDERING SERVICE THEY DID NOT MONITOR CLOSELY MAJOR INCREASE in Medicare Spending (Power Wheelchairs; FL and TX) RESULT = Proposed Competitive Bidding

Growth without Monitoring • US v.Palavyan–paying for referrals So.CA • People v.Gilles homecare worker sentenced to prison for false, undelivered “services” to disabled persons • Aging Care HomeHealth: kickbacks to MDs and patients ;contracting violations with physicians

Brief Update on Hospice • Reimbursement under review at MedPAC • OIG WorkPlan continues examination of hospice care to nursing home patients • Quality of Care initiatives and concerns • Program Integrity initiatives: line item of claim for specific professional services • Hospice investigations • CMS’s PSC actions with hospices

WHEW! WHAT NOW?? • Understand the new COPs as written • Put the new COPs in a timeline for actual care • See COPs as a structural improvement • Understand that it is a Team Approach ASK: CAN I DO IT?

I CAN DO IT ! • Intake • Communication and Coordination • Assessment • Nursing Facility patients • Documentation Changes • Outcomes by QAPI • IDT/IDG Changes • Training

418.52 = PATIENT’S RIGHTS • Patient= Right to be informed Hospice= Protect and promote Notice: at assessment, before care Spoken and written; understood in language Advanced directives/State law; signed

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

418.52 = PATIENT’S RIGHTS • Exercise; Property; Grievances about care or disrespect of property; Non-discrimination; Exercise by guardian or State-recognized patient representative • Hospice must immediately investigate and resolve: “anyone furnishing services on behalf of hospice”, with established procedures, report to authorities in 5 days

Compliance Response • Who owns this COP and what do they do? • When is this COP applicable • Where do the documents demonstrating compliance reside in the Company • How do we assure this COP is compliant [Training, audits, patient discussions, grievance process, other ideas??] • Why? What external impact from failure?

418.54 Assessments of Patients • Patient-specific • Need for hospice care • Need for physical, psychosocial, emotional and spiritual care • All aspects of terminal illness-palliation and management • Initial w/in 48 hrs or less of Notice of Election-Patient’s right to request sooner!

Assessments of Patients • Comprehensive:5 days of NOE; q.15 days 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. May be an amalgam of documents;may collapse Initial and Comprehensive

Assessment of Patients:Update • IDT and “collaboration of the attending” How do you document; how do you prove • Progress toward desired outcomes; response to care; did you ask patients? • Uniform data outcomes measures across all patients • Data systematic, retrievable for individual care planning and larger QAPI work

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” and “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 documentpatient’s understanding, involvement and agreement w care planning

418.56 Care Plan [CP] Content • Assessment Needs & Goals in CP • Needs & GoalsInterventions;Services Patient/Caregiver Education& Training on their Role in CP • Interventions Updated Assessment; IDG review of CP; sharing with non-hospice care providers

THEME: Coordination and Communication In 418.56(e)- System of Communication and Integration that: • IDG does its job • Care provided is based on all needs and assessments • Information is shared among hospice care providers and contractors • Information shared w non-hospice care providers

The Right Services from the Right People • 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”

Credentialing • 418.2 Definitions: Bereavement counselor, dietary counselor, physician, physician designee, licensed professional • 418.56: RN IDG coordinator; members of IDG team=Physician does not include NP • 418.62 Licensed Professional Services, persons must participate in QAPI and training • 418.114: Specifics in disciplines; MSW issue • 418.112(f):NF staff must be oriented to hospice

Credentialing • Hospice Aide training and supervision requirements 418.76 • IDG pharmacy specialist 418.106(a) confers on all drug planning in care plan-How realistic?? • Hospice doing or referring laboratory tests: --if doing, must be licensed & meet CLIA --if referring, the laboratory must be certified in specialties and subspecialities 418.116

Linking Credentials to Services • Licensed professionals: both direct other workers and are supervised. How? • If they are “under arrangements” how will performance and quality be accounted for? • Must do the “authorizing” of services: How is this authority established? • Must participate** “actively” under “current professional standards and practice”

Training • Who and by whom • How do we document • What indicators • Who “owns” this process • How do we centralize training and the evidence of training

Medical Social Services • COPs continue to require the service to be supervised by a physician • Changes in level of social worker who can work without supervision and who can be a supervisor 418.114 • Significant issue for staff availability • “Grandfathering” very limited

Hospice Aide Supervision • In-person by an RN in the home every 14 days • In-person to observe the aide perform 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?

Background Checks • You are not “credentialed” if your behavior or background do not meet standards • 418.114(d) criminal background checks on all who do patient care or affect the patient record/billing. State law as guidance. • Affirmative obligation to come forward? • OIG and GAO exclusions list more than criminal activities; all claims unbillable • Uncredentialed = below quality = ?FCA

Compliance Response • Who owns these COPs; what do they do? • When are these COP applicable • Where do the documents demonstrating compliance reside in the Company • How do we assure COPs are compliant [Training, audits, patient discussions, grievance process, other ideas??] • Why? What external impact from failure?

What are Hospice Core Services • ??? • Who can provide a hospice core service? Answer: W-2 employee Physician under contract Specialized nursing or infrequently used specialty under contract Peak service demands: if rural, under contract if not “routine” • Can you go without core services? Others?

The Role of the “Hospice Physician” in the COPs • Medical Director; “designee” by Hospice • IDG physician • Nurse practitioner • Physician consultant • Attending physician • Nursing facility physician counterpart for hospice patient residing in NF • Physician in hospice controlled in-patient unit

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 • Allowing numerous physicians to fulfill the MDir role “would likely result in inconsistent care and decreased accountability”.

Physician • 418.2 definition (Medicare Act,) and 410.20; employee or contractor; 418.64(a) core service • on IDG-helps create care plan, IDG reassessments; responsible for management and palliation of condition; if attending unavailable, must meet medical needs of patient • supervised by the Medical Director; MDir is responsible for the overall medical care provided by the hospice • can be NP but not in IDG/care plan creation • must assess physical restraints; order drugs

Attending Physician [AP] • Hospice cannot control this function YET • Hospice must “collaborate” with AP • Hospice must communicate and coordinate with AP • Hospice must obtain AP certification for Medicare entitlement and coverage • Hospice must provide information to AP about the condition of the patient

Compliance Response • Who owns these COPs; what do they do? • When are these COP applicable • Where do the documents demonstrating compliance reside in the Company • How do we assure COPs are compliant [Training, audits, physician discussions, grievance process, other ideas??] • Why? What external impact from failure?

Drugs,Biologicals,DME • 418.106 contains many revised standards for Hospice and the IDG

Special Requirements: Patients Residing in Nursing Facilities[NF] • How is this different from Hospice Patients receiving in-patient level of care under Hospice Benefit: Compliance plan policy • How are SNFs different from NFs…or are they? Is Assisted Living = NF residency? • What is the role of the NF staff member? • How do we measure quality care in the NF setting where we don’t control everything?

418.112: Patients Residing in Nursing Facilities • Written arrangement now necessary • 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, uncertain how to make this “work”

Special Requirements: Patients Residing in Nursing Facilities • NF’s responsibility to continue to provide services as before /room&board&support • Core services remain = the hospice employee/physician contractor directly • Use of the NF personnel • Plan of Care planning, sharing, identification to each provider, consistency • Specific IDG member deals w NF coord’n

Nursing Facility Contracts • Offer to provide bereavement services to facility staff goes in contract 418.112(c)

Special Requirements: Patients Residing in Nursing Facilities • Who drafts and presents the contract? • Who “minds” the contract to ensure compliance with its terms? • How are conflicts resolved and accountability ensured? • Dialogue between Hospice MDir and NF MDir or other “attending-like” NF physician • One contract or individual patient-specific?

Special Requirements: Hospice-Run In-Patient Unit [IPU] 418.110 • Staffing • Rooming • Pain management and pharmacist role • Restraints • Take care to distinguish the respite situation from the acute medical situation

The Medical Record • What does it consist of: 418.104 • Where is it kept • Who can enter it or change/alter notes • How is it kept confidential and secure • Can patient/family review it • What about after death? • What signatures can be electronic

Staffing between IPU and Respite • The 24 hour nursing rule is now changed • The nursing level depends upon the patient acuity level 418.108(b) • This could result in needs fluctuations within a single facility • Compliance capability must exist to track and maintain the right staffing level

WORKSHOP ON COMPLIANCE REVISED HOSPICE CONDITIONS OF PARTICIPATION