WORKSHOP ON COMPLIANCE REVISED HOSPICE CONDITIONS OF PARTICIPATION Deborah Randall, Esq. [email protected]

WORKSHOP ON COMPLIANCEREVISED HOSPICE

CONDITIONS OF PARTICIPATION

Deborah Randall, Esq.

[email protected]

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; JCAHOState 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 daysSigned 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

Compliance Response







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 document patient’s understanding, involvement and agreement w care planning

418.56 Care Plan [CP] Content

• Assessment Needs & Goals in CP• Needs & GoalsInterventions;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

Compliance Response







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 subspecialities418.116

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


• How do we assure COPs are compliant



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


• How do we assure COPs are compliant

[Training, audits, physician discussions, grievance process, other ideas??]


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

Authentication of Records

• CMS now leaves this to the Hospice to design

• Uniform system, teaching for employees, and compliance maintenance audits are all necessary

QAPI as a Condition: 418.58

• Driving, not responding to, quality concerns. Baseline=>action=>measures

• Data: from intake onward; from professional organization sources

• Standards for care/quality• Hospice chooses: Quality Indicators and

mechanisms for data analysis; patient “adverse events”[“harm”] collected as data

• Available measures, not reinventing….

QAPI as a Condition

• Program activities that are “high risk, high volume or problem prone”. Prioritized.

• Number and scope of improvement projects scalable to the Company

• Governing Body central to entire process and bearing the brunt of the responsibility to ensure safe, effective, high quality care is being provided to patients 418.100(b)

QAPI as a Condition

• If you improve the indicators, do you improve the outcome?

• CMS points to transitions between care sites as important area for agreements, coordination, sharing of protocols, communication systems

• Outcome measures data must go in patient records

• CMS says look to past problems &include

QAPI as a Condition

• CMS acknowledges more effort and time needed to develop national parameters, but cites a half dozen “standards”. BIG question is how well did CMS review and understand these named standards.

• Aggregation of data based on individual hospices’ policies & procedures; small hospices might aggregate several months’

• Costs!! Surveyor understanding!!

Surveyors & QAPI

• Will access aggregated data and analysis• Will access QAPI plan, minutes and notes• Will access “individuals responsible”• Will match data w actual experiences of

employees and patients to see if QAPI is “Prevalent” throughout and “positively influencing patient care”

• Why quality measures chosen, how data consistent, used in care planning

Surveyors & QAPI - 2

• How data relates to performance improvement projects

• How projects implemented

• How data used to show if projects are effective

• State Operations Manual Interpretive Guidelines will be revised

Compliance Response







Breakout to Work on Your QAPI

• What is status

• Who is in charge

• Discussion of process and progress

• Next steps

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Fundamentals of Hospice “Organization”

• Largely unchanged

• Governing Body Directly Involved

• Room for modern health delivery systems such as electronic medical records and signatures

• The Organization wraps around the clinical timetable

• Individualization is expected

Breakout: COPs as a Timeline

• Can we fit the COPs to a timeline from first contact by referral source to discharge from care due to death, revocation, discharge or transfer?

• Can a Case Study aid in this exercise?

• I CAN DO IT as a tool?

I CAN DO IT !

• Intake• Communication and Coordination• Assessment• Nursing Facility patients• Documentation Changes• Outcomes by QAPI, begin at the Start!• IDT/IDG Changes• Training, including Credentialing

Documents

WORKSHOP ON COMPLIANCE REVISED HOSPICE CONDITIONS OF PARTICIPATION Deborah Randall, Esq. [email protected]