Webinar Handouts
California Association for Health Services at Home
THE MEDICARE CONDITIONS OF
PARTICIPATION & INTERPRETIVE
GUIDELINES
Webinar
PART 7
Mary Lou Connolly
Medicare Conditions of Participation
(CoPs)
• Federal Register: August 1989
• Fifteen Amendments
• Revised CoPs proposed: 1997-Only change
enacted=OASIS
• Minimum health and safety standards that
HHAs must comply with in order to qualify
for reimbursement under the Medicare
Program
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California Association for Health Services at Home
Medicare Conditions of Participation
(CoPs)
• 484.10* Patient Rights
• 484.11 OASIS Release of Information
• 484.12* Compliance with Laws & Professional
Standards
• 484.14* Organization, Services &
Administration
• 484.16 Group of Professional Personnel
CoPs • 484.18* Acceptance of Patients, Plan of Care,
Medical Supervision
• 484.20 Reporting OASIS Information
• 484.30* Skilled Nursing
• 484.32* Therapy Services
• 484.34 Medical Social Service
• 484.38 Qualifying to Furnish Outpatient PT or ST Services
CoPs • 484.36* Home Health Aide
• 484.48* Clinical Records
• 484.52 Program Evaluation
• 484.55* Comprehensive Assessment of
Patients (OASIS)
*Conditions addressed in a standard survey:
used to be 7; now 9
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California Association for Health Services at Home
Conditions for Review
• ALL 15
• If a HHA is out of compliance with even ONE
Condition:
• A new agency would likely NOT be certified
• An existing one would expect surveyors back
for another survey in 45-60 days
Medicare CoP Document
• Handout includes the CoPs & Interpretive
Guidelines with Revised Survey Protocols
• Source: State Operations Manual (SOM)
SOM
• Guides surveyors in how to conduct survey
per CMS direction
• Appendices include all the entities that are
surveyed
• Home health care is in Appendix B-
rev.2/11/11
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California Association for Health Services at Home
CMS Website
• www.cms.hhs.gov/
• Regulations & Guidance
• Under “Guidance”, click on Manuals
• Under “Manuals”, click on Internet Only
Manuals (IOM)
• Then go to 100-07, State Operations Manual
(SOM) Appendix B- Guidance to Surveyors:
Home Health Agencies
CoPs & Interpretive Guidelines
• CoPs are mostly in numerical order and each
has a G-tag/“data” tag per CMS)
• The Interpretive Guidelines tell the surveyor
exactly what to look for as evidence of
compliance
CoP Structure
• CoP 484.10 G 100 Patient Rights
– G tags for every standard under this Condition
• The number of G-Tags and Standards vary from CoP
to CoP. Being out of compliance with any G-Tag will
lead to a deficiency citation at the Condition or
Standard level
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California Association for Health Services at Home
Level of Deficiencies
• Conditions
• Standards
Survey Process Change
• Previous:
�Standard deficiencies received variable weight
based upon Interpretive Guidelines and
subjective criteria
• After May 1, 2011:
�Revised protocols
�Level 1 and Level 2 Standards identified
Level 1 Standards
• Standard survey addresses 9/15 CoPs
• “Highest priority”-each has an expected
outcome statement
• Process standards are most related to high
quality patient care
• Administrative standards are most related to
HHA ability to deliver high quality care
• Compliance with all 34 = likely in compliance
with all CoPs
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California Association for Health Services at Home
Level 1 Standards
• 484.10 Patient Rights: G107,G109
• 484.12 Compliance Federal,State, Local: G121
• 484.14 Organization, Services, Administration:
G123,G133,G143,G144
• 484.18 Acceptance, PoC, Med Supervision:
G157,G158,G159,G164,G165,G166
• 484.30 Skilled Nursing:
G170,G172,G173,G174,G175,G176,G177
Level 1 Standards
• 484.32 Therapy Services: G186,G187,G188
• 484.36 Home Health Aide: G224,G229
• 484.38 Clinical Records: G236
• 484.55 Comprehensive Assessment of
Patients: G331,G332,G334,G335,G336,G337,
G338,G340
Level 1 Standards
• When a standard level non-compliant finding
is identified in any Level 1 standard (1/34)
then surveyors will:
• Conduct Partial Extended Survey
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California Association for Health Services at Home
Level 2 Standards
• Next “highest priority” standards
• During Partial Extended Survey: surveyor
reviews at a minimum , Level 2 standards
under same Condition as Level 1 standards
out of compliance
• Can go beyond to “assist” in compliance
decision
Level 2 Standards• Patient Rights: G101,G108,G111,G114
• Compliance Federal,State,Local: G118
• Organization,Service,Administration: G124,G125,G137,G138,G139,G150
• Acceptance,PoC,Med Sup: G160,G162,G163
• Skilled Nursing: G169,G179
• Therapy: G190,G193
• HH Aide: G212,G215,G225,G226,G230,G232
• Clinical Records: G239
• Comp Assessment of Pts: G339,G341
Interpretive Guidelines and Revised
Protocols
• Tell the surveyors exactly what to look for
• When to advance from a standard survey- 9 Conditions (Level 1 standards) to a Partial Extended Survey (Level 2 standards under the same Condition)
• Provide formulas which lead to finding Conditions out of compliance thus advancing to
• Extended Survey where all Conditions are reviewed
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California Association for Health Services at Home
CoP Example: Patient Rights
• 484.10(b)(4)Standard: Exercise of Rights
G106…”patient has the right to voice
grievances…”
• Interpretive Guidelines:
• “During home visits, ask the patient, the
patient’s family or guardian if they have any
comments or concerns, or have registered any
grievances or complaints about the HHA or its
services.”
G107(L1): HHA Must Investigate
• Expected outcome: patient complaints are
investigated, resolved and documented
• Agency compliance is described in Probes
including interview and documentation
Complaint Investigation
1. How does the HHA receive & investigate
complaints?
2. Who is responsible?
3. Review documentation
4. Ask the patient if s/he had a complaint &
how it was handled
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California Association for Health Services at Home
Self-Survey
• Use the Interpretive Guidelines (the surveyors’
instructions from CMS) to ensure your HHA is
in compliance with the CoPs
• Prioritize:
�Start with Level 1 Standards
�Review Level 2 Standards
�Review all Conditions and Standards
*484.10 G100 Patient Rights
• G101 (L2) Patient has the right to be informed
of rights & to exercise rights
• G102 The HHA is required to inform all
patients of their rights before beginning care
• Document your notification of the patient
(signed consent form)
Patient Rights Overview
• Family/guardian may exercise rights for patient, if incompetent (note on consent form)
• Right to have property treated with respect, voice grievance without reprisal
• Be advised in advance of care, changes to care & participate in care planning before changes occur (G109-L1). Expected Outcome: patients are involved in developing their PoC
• Receive information on Advance Directives, confidentiality of medical records, record & OASIS disclosure policies
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California Association for Health Services at Home
484.10(e) G114(L2) Liability for
Payment
• Patient must be informed in advance of what
Medicare is expected to pay for care
• This Standard (and the Lutvin vs. Thompson
lawsuit settlement) is the basis for the revised
Home Health Advanced Beneficiary Notice
(HHABN)
HHABN Triggering Events
• Initiation of non-covered
care
• Reduction in services not in
original plan of care
• Termination of Medicare
coverage:
� Normal end of service use
CMS-10123, no HHABN
� Care continues, no
Medicare, use HHABN
Reduction Clarification
• PoC includes reduction in
service – no HHABN
• Change of orders for
reduced services – HHABN,
Box 3
• Recert with reduced orders
– HHABN, Box 3
• Patient in hospital, care on
hold – no HHABN
• Patient request – no HHABN
• “Honey, please don’t come
here so often!”
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California Association for Health Services at Home
HHABN Notice of Non-Coverage
• The revised forms and detailed explanations
of the forms are posted:
• www.cms.hhs.gov/BNI/06_FFSEDNotices.asp
G116 Hotline Information
• The number itself needs to be easy to locate
• Hours of operation
• Purposes: receive questions or complaints
about HHAs and questions about advance
directives
484.11 Release of Patient Identifiable
OASIS Information
• G310 HHA and agent acting on behalf of
agency must ensure confidentiality of all
patient identifiable information contained in
the clinical record, including OASIS data and
may not release patient identifiable OASIS
information to the public
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California Association for Health Services at Home
484.11 Guidelines• G310
• Must have P&Ps limiting access to OASIS data
to only those persons agency designates
• If agency contracts with a vendor for
transmission of data- must have a written
contract that addresses confidentiality
• Agency must have processes in place to limit
access to data , ex: secure passwords
*484.12 G117 Compliance CoP
• G118 (L2)Compliance with Federal, State
and Local Laws
• Disclosure and Ownership Information
• G121 (L1) Accepted Professional
Standards and Principles
• Compliance with everything!
Disclosure of Ownership
• G120
• Owners, officers, directors & agents of the
HHA must be disclosed on initial certification
& when anything changes including agency
name & address
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California Association for Health Services at Home
Accepted Professional Standards
• G121(L1)
• Agency & staff must comply with accepted
professional standards & principles including
agency’s own P&Ps
G121 (L1)
• G 121(L1)- EO: all care providers follow
parameters defined by State practice acts,
Fed, State laws and regulations, ex: CDC
guidelines for infection control
• New probe: are there examples of care
provision not in compliance…accepted
professional standards or HHA P&Ps,ex:
wound care, wound assessment…
• Remember: stricter standard prevails
*484.14 G122 (L1) Organization, Services &
Administration
• G123 (L1) Organization, services furnished,
control & lines of authority for delegation of
responsibility down to patient care level
clearly set out in writing
• Look for current org chart that matches staff
response in interviews
• List positions vs. names
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California Association for Health Services at Home
Supervision & Services
• G124(L2) Administrative and supervisory
functions may not be delegated to another
agency
• G125(L2) All services not furnished directly are
monitored and controlled by HHA
G127 Services: Part Time, Intermittent
& Skilled
• RN & at least one other service (PT, OT, SLP,
MSW & CHHA) are available, one service must
be provided entirely by agency employees:
� On a visiting basis
� In patient’s place of residence
� Services not provided directly may be by
provided by arrangement
G128 Governing Body
• Governing Body assumes full legal authority
and responsibility for the agency
• Most often is composed of owners but may
include others of owners choosing
• Must be involved!!!!
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G133 (L1)Administrator
• Administrator –MD or RN appointed by Governing Body :
�Organizes & directs agency functions
�Hires qualified staff, budgets, supervises services,
�Delegates authority (in writing) to qualified alternate G137 (L2)
G138 (L2)Supervising MD or RN
• Skilled nursing & other therapeutic services
are under supervision of MD or RN (generally
an RN) - available at all times during operating
hours G139 (L2) and participates in all
activities relevant to professional services
furnished
G141 Personnel Policies
• Personnel practices & patient care are
supported by appropriate written personnel
policies
• Personnel records include qualifications &
current licensure
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California Association for Health Services at Home
G 143 (L1)Coordination of Care
• EO: …information re each patient’s health
status and PoC is communicated among all
relevant care providers, including the HH Aide
and physician
• Many new probes: focus is communication re
patient condition/changes, patient response
to interventions, calls to MDs and other
providers of care including contractors and it’s
all DOCUMENTED
Contract Personnel
• Contracts specify:
�Patients accepted by HHA
�Services to be furnished
�Contractor follows agency policies
�Responsibility for care planning
�HHA control, coordination & evaluation of contract care
�Procedure for submitting documentation
�Payment procedures
G144 (L1)
• Clinical record or minutes of case conferences
establish…coordination of patient care occurs
• Expected outcome: communication among
providers is documented(case conferences,
phone calls)
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G145 60 Day Summary
• A written summary report for each patient is
sent to the MD at least every 60 days
• Hint: Write/print the 60 day summary as part
of the 485
G147 Institutional Planning
• HHA must have overall plan & budget
• Budget must include 3 year capital
expenditure plan
• Hint: document “Capital: None”
G150 (L2) Laboratory Services
• HHA lab testing must be in compliance with
applicable regs (CLIA waiver)
• Outside labs must be certified for tests
performed
• Keep copies of outside lab CLIA certificates
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California Association for Health Services at Home
CLIA Resources
• CLIA info:
www.cms.hhs.gov/clia/
• Click: brochure for a 2 page overview of the
program &
• Categorization of tests for list of waived tests
(20+pgs)
484.16 G151 Group of Professional
Personnel• G152 Group of professional personnel: at least one MD and
one RN with appropriate representation from other
professional disciplines
• G153 Establish & annually review policies governing services
offered, admission and DC policies, medical supervision, PoCs,
Program Evaluation
• At least one member is neither an owner or employee
• G155 Meet frequently to advise agency, minutes are kept
*484.18 G156
• Acceptance of Patients
• Plan of Care
• Medical Supervision
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California Association for Health Services at Home
G157 (L1) Acceptance of Patients
• Patients are accepted based on the
reasonable expectation that: medical, nursing
& social needs can be met adequately in the
place of residence
• Expected outcome: HHA will only accept…if
the HHA can adequately meet the patient’s
medical, nursing and social needs
G158 (L1) Plan of Care
• PoC is written, followed & periodically
reviewed by the physician (MD, DO or
Podiatrist)
• May include a range of visits
• Can’t use zero in a range
G159(L1) PoC
• Includes all pertinent diagnoses, types of
services, frequency of visits……….and any
other appropriate items
• Expected outcomes:
�Pts receive appropriate services based on an
assessment of their needs and MD orders
� HHA develops a PoC specific to each patient’s
needs and containing all required elements
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California Association for Health Services at Home
G163 (L2) Periodic Review of PoC
• Reviewed as often as necessary (supplemental
orders) but at least every 60 days
G164 (L1) Altering PoC
• Agency staff promptly alert MD to any changes that suggest a need to alter POC
• EO: changes in pt status including measurements outside stated parameters, or changes that suggest the need to alter the PoC, are reported promptly to the MD…includes notifying MD of D/C when pt’s needs met
• Make certain all MD communication is documented. If serious enough to call then there should be documentation of response
G165 (L1) Conformance W/ MD Orders
• Expected outcome: HHA staff administer only
meds and treatments as ordered by the MD
• No MD order needed for flu/pneumonia
vaccines
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G166 (L1) Verbal Orders
• Verbal orders are written, signed and dated by
the RN or therapist
• EO: verbal orders are written, signed and
dated by the appropriate RN or skilled
therapist, and countersigned by the MD as
soon as possible
484.20 G320 Reporting OASIS
• Must electronically report all OASIS-C data
collected at least monthly
• G321 HHA must encode and be capable of
transmitting OASIS-C data upon completion of an
OASIS-C data set
• G322 Must accurately reflect patient’s status at
time of assessment