WORKSHOP ON COMPLIANCE
REVISED HOSPICE
CONDITIONS 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 !
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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?
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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; Nondiscrimination; 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
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?
418.56 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 & 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
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?
The Right Services from the Right
People
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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
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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
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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: HospiceRun In-Patient Unit [IPU] 418.110
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Staffing
Rooming
Pain management and pharmacist role
Restraints
Take care to distinguish the respite
situation from the acute medical situation
The Medical Record
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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
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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
• 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?
Breakout to Work on Your QAPI
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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 !
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Intake
Communication and Coordination
Assessment
Nursing Facility patients
Documentation Changes
Outcomes by QAPI, begin at the Start!
IDT/IDG Changes
Training, including Credentialing