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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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Page 1: Webinar Handouts · 2019. 6. 26. · Webinar Handouts California Association for Health Services at Home Medicare Conditions of Participation (CoPs) • 484.10* Patient Rights •

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

Page 2: Webinar Handouts · 2019. 6. 26. · Webinar Handouts California Association for Health Services at Home Medicare Conditions of Participation (CoPs) • 484.10* Patient Rights •

Webinar Handouts

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

Page 3: Webinar Handouts · 2019. 6. 26. · Webinar Handouts California Association for Health Services at Home Medicare Conditions of Participation (CoPs) • 484.10* Patient Rights •

Webinar Handouts

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

Page 4: Webinar Handouts · 2019. 6. 26. · Webinar Handouts California Association for Health Services at Home Medicare Conditions of Participation (CoPs) • 484.10* Patient Rights •

Webinar Handouts

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

Page 5: Webinar Handouts · 2019. 6. 26. · Webinar Handouts California Association for Health Services at Home Medicare Conditions of Participation (CoPs) • 484.10* Patient Rights •

Webinar Handouts

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

Page 6: Webinar Handouts · 2019. 6. 26. · Webinar Handouts California Association for Health Services at Home Medicare Conditions of Participation (CoPs) • 484.10* Patient Rights •

Webinar Handouts

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

Page 7: Webinar Handouts · 2019. 6. 26. · Webinar Handouts California Association for Health Services at Home Medicare Conditions of Participation (CoPs) • 484.10* Patient Rights •

Webinar Handouts

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

Page 8: Webinar Handouts · 2019. 6. 26. · Webinar Handouts California Association for Health Services at Home Medicare Conditions of Participation (CoPs) • 484.10* Patient Rights •

Webinar Handouts

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

Page 9: Webinar Handouts · 2019. 6. 26. · Webinar Handouts California Association for Health Services at Home Medicare Conditions of Participation (CoPs) • 484.10* Patient Rights •

Webinar Handouts

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

Page 10: Webinar Handouts · 2019. 6. 26. · Webinar Handouts California Association for Health Services at Home Medicare Conditions of Participation (CoPs) • 484.10* Patient Rights •

Webinar Handouts

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!”

Page 11: Webinar Handouts · 2019. 6. 26. · Webinar Handouts California Association for Health Services at Home Medicare Conditions of Participation (CoPs) • 484.10* Patient Rights •

Webinar Handouts

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

Page 12: Webinar Handouts · 2019. 6. 26. · Webinar Handouts California Association for Health Services at Home Medicare Conditions of Participation (CoPs) • 484.10* Patient Rights •

Webinar Handouts

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

Page 13: Webinar Handouts · 2019. 6. 26. · Webinar Handouts California Association for Health Services at Home Medicare Conditions of Participation (CoPs) • 484.10* Patient Rights •

Webinar Handouts

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

Page 14: Webinar Handouts · 2019. 6. 26. · Webinar Handouts California Association for Health Services at Home Medicare Conditions of Participation (CoPs) • 484.10* Patient Rights •

Webinar Handouts

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!!!!

Page 15: Webinar Handouts · 2019. 6. 26. · Webinar Handouts California Association for Health Services at Home Medicare Conditions of Participation (CoPs) • 484.10* Patient Rights •

Webinar Handouts

California Association for Health Services at Home

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

Page 16: Webinar Handouts · 2019. 6. 26. · Webinar Handouts California Association for Health Services at Home Medicare Conditions of Participation (CoPs) • 484.10* Patient Rights •

Webinar Handouts

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)

Page 17: Webinar Handouts · 2019. 6. 26. · Webinar Handouts California Association for Health Services at Home Medicare Conditions of Participation (CoPs) • 484.10* Patient Rights •

Webinar Handouts

California Association for Health Services at Home

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

Page 18: Webinar Handouts · 2019. 6. 26. · Webinar Handouts California Association for Health Services at Home Medicare Conditions of Participation (CoPs) • 484.10* Patient Rights •

Webinar Handouts

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

Page 19: Webinar Handouts · 2019. 6. 26. · Webinar Handouts California Association for Health Services at Home Medicare Conditions of Participation (CoPs) • 484.10* Patient Rights •

Webinar Handouts

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

Page 20: Webinar Handouts · 2019. 6. 26. · Webinar Handouts California Association for Health Services at Home Medicare Conditions of Participation (CoPs) • 484.10* Patient Rights •

Webinar Handouts

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

Page 21: Webinar Handouts · 2019. 6. 26. · Webinar Handouts California Association for Health Services at Home Medicare Conditions of Participation (CoPs) • 484.10* Patient Rights •

Webinar Handouts

California Association for Health Services at Home

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


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