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The 2017 Home Health Conditions of Participation Overview: Annotated Requirements for Survey Readiness 

The 2017 Home Health Conditions of Participation Overview: Annotated Requirements


This is a summary of the 2017 Home Health Conditions of Participation including all Conditions and the associated enforcement Standards for each that have been abridged to allow expeditions overview.


Note: Survey enforcement will not be necessarily based on the exact text of the rules supplemented by CMS interpretive guidelines.


The interpretive guidelines have not been published at this time.


In a few areas the actual text of the rule is directly referred instead of an interpretation. The complete text of these rules was published in the January 13, 2017 Federal Register Pages 4578-4590.


Key Focus Areas for Survey Readiness:

484.2 Definitions: Branch Office, Clinical Note, In Advance, Parent Home Health Agency, Primary Home Health Agency, Proprietary Agency, Public Agency, Representative, Subdivision, Summary Report, Supervised Practical Training, Verbal Order. (See Actual Regs Text)


484.40 Release of Patient Identifiable OASIS Information Ensure confidentiality of all patient data.


484.45 Reporting OASIS Information


a: Encoding and Transmitting OASIS Data Encode and transmit within 30 days of completing assessment.


b: Accuracy of Encoded OASIS Data Accurately reflect patient’s condition at time of assessment.


c: Transmittal of OASIS Data Successfully transmit test data to QIES System or CMS OASIS Contractor in proper format. Transmission compliant with Federal Information Processing Standard. Include branch identification number as applicable.


d: Data Format Encode and transmit data using CMS required record layout, edit specifications, and data dictionary.


484.50 Patient Rights


a: Notice of Rights Provide to patient and representative during initial evaluation visit before providing care.


  • Include rights, transfer and discharge policy, and be understandable to patient with limited English and assessable to those with disabilities.

  • Include contact info for HHA administrator: name, business address and phone number to receive complaints.

  • Include OASIS Privacy Notice.

  • Obtain patient or legal representative’s signature confirming receipt of Notice of Rights.

  • Provide verbal notice in primary or preferred language using free interpreter if needed no later the completion of 2nd skilled visit.

  • Provide written notice of rights, transfer and discharge policy to patient selected representative within 4 business days of initial evaluation visit.

b: Exercise of Rights If patient legally lacking capacity, rights exercised by legally appointed person.


  • If not legally lacking capacity, rights may be exercised by patient’s representative.

  • If lacking legal capacity, patient may exercise those rights allowed by court order.


c: Rights of the Patient Respect for property, free from abuse, make complaints, participate/be informed/consent/refuse: assessments, care, plan of care, disciplines furnishing care, patient identified goals, risks and benefits, factors impacting treatment, changes in care.


  • Right to receive all services in plan of care, access to confidential clinical record, payments and non-covered charges expected from Federal sources, charges before care is initiated, and changes to these payments and charges, written notice of non-covered or reduction/termination of care, advised of toll-free home health telephone hot-line, names/addresses/telephone numbers of AoA, CIL, P&A, Aging and Disability Resource Center, QIO, and be free from reprisal for exercising rights, Informed of right to access auxiliary aids and language services and how to access them.


d: Transfer and Discharge Right to be informed of transfer and discharge policies and only transfer or discharge: when necessary for patient’s welfare and agreed to by responsible physician.


  • Agency must arrange safe and appropriate transfer.

  • Also when patient or payer will no longer pay, HHA and responsible physician agree goals achieved and no longer need HH care, patient refuses services or elects transfer/discharge, patient or others in home is disruptive, abusive, uncooperative so that operations are seriously impaired.

  • But only after advice to patient, representative, aftercare physician, efforts to resolve problem, contact info for other sources of care, documentation.

  • Transfer or discharge also when person dies or HHA ceases to operate.


e: Investigation of Complaints Must investigate complaints: treatment, mistreatment, abuse, misappropriation and injures.


  • Document investigation and resolution.

  • Take action to prevent further problems including reprisals during investigation.

  • Staff must immediately report violations to HHA and authorities in accordance with State law.


f: Accessibility Provide plain and timely information in manner accessible to patient.


  • For persons with disabilities, information on the provision of auxiliary aids to the individual per ADA and 504 of Rehab Act.

  • For persons with limited English proficiency information, information on no cost language services.


484.55 Comprehensive Assessment of Patients


a: Initial Assessment Visit RN initial assessment visit for Medicare eligibility for HH benefit including homebound status within 48 hours of referral or return home or physician ordered start of care date.


For rehab only services, initial assessment may be made by rehab professional.


b: Completion of the Comprehensive Assessment Completed timely no later than 5 calendar days from SoC.


c: Content of the Comprehensive Assessment Current health, psychosocial, functional and cognitive status, patient strengths, goals and care preferences, including measures of progress and measurable outcomes.


  • The patient's continuing need for homecare.

  • Patient’s medical, nursing, rehab, social and discharge planning needs.

  • Review of all meds to identify potential adverse effects, drug reactions, ineffective drug therapy, significant side effects and drug interactions, duplicative therapy and noncompliance.

  • Identify primary caregiver(s) and other supports including willingness/ability, availability and schedules, the patient’s representative.

  • Incorporate current OASIS.


d: Update of the Comprehensive Assessment Updated as often as frequently as patient condition warrants due to major decline or improvement but no less than last 5 days of every 60 day episode unless beneficiary elected transfer, significant change in condition, discharge and return in same 60-day episode.


  • Also within 48 hours of patient return from hospital admission of 24 hours or more except for diagnostic tests (or physician ordered resumption date).

  • And at discharge.


484.60 Care Planning Coordination of Services, and Quality of Care


a: Plan of Care Individualized plan of care


  • with all pertinent diagnoses,

  • mental/psychosocial/cognitive status,

  • services/supplies/equipment needed,

  • frequency and duration of visits,

  • prognosis,

  • rehab potential,

  • functional limitations,

  • activities permitted,

  • nutritional requirements,

  • all meds and treatments,

  • safety measures to prevent injury,

  • patient’s risk of ER visits or hospital readmission with interventions needed to address risks,

  • patient and caregiver education for timely discharge,

  • patient-specific interventions and education/measurable outcomes/goals identified by HHA and patient,

  • info on advanced directives,

  • additional items HHA or physician may choose to include,

  • all patient care orders including verbal orders.


b: Conformance to Physician Orders Drugs,


  • services and treatments administered only as ordered by physician,

  • influenza and pneumococcal vaccines per agency policy developed in consultation with physician and after no contraindications,

  • verbal orders accepted only by authorized personnel,

  • verbal orders must be documented in clinical record, signed, dated, and timed.

  • Verbal orders must be authenticated and dated by physician in accordance with state law/regs/agency policies.


c: Review and Revision to Plan of Care Physician must revise plan of care as frequently as patient’s care requires and no less than every 60 days.


  • HHA must promptly advise physician of changes that suggest objectives are not being achieved and POC must be altered.

  • Revisions, including those related to plans for discharge, must be communicated to patient, representative, caregiver, and all physicians issuing orders.


d: Coordination of Care HHA must assure communication with all physicians involved in PoC and integrate all physician orders and services, coordinate care delivery, ensure patients and caregivers get appropriate training including that necessary for discharge.


e: Written Information to Patient HHA must provide patient and caregiver written instructions on: visit schedule, patient medication schedule, treatments, pertinent instructions and name/contact information for Clinical Manager.


484.65 Quality Assessment and Performance Improvement


a: Program Scope Capable of showing measurable improvement in outcomes, patient safety, and quality of care.


b: Program Data HHA must use QI data including OASIS measures to monitor effectiveness, safety, quality, identify opportunities for improvement. Frequency and detail of data collection must be approved by HHA governing body.


c: Program Activities Must focus on high risk, high volume, or problem-prone areas, consider incidence/prevalence/severity and lead to immediate corrective action on any problem threatening health and safety of patient. Must track adverse events, analyze causes, and track performance to ensure sustained improvement.


d: Performance Improvement Projects Effective 1/13/18 conduct PIPs reflecting scope, complexity and past performance of HHA and document projects, reason for conducting, and measurable progress.


e: Executive Responsibilities HHA Governing Body responsible for ensuring an HHA-wide, ongoing QAP addressing quality and patient safety, all improvements evaluated for effectiveness, clear expectations established/implemented/maintained and findings of fraud or waste are appropriately addressed.


484.70 Infection Prevention and Control


a: Prevention HHA must follow accepted standards, precautions, and control infections and communicable diseases.


b: Control Maintain a coordinated agency-wide surveillance, identification, control and investigation integral with QAPI. Have method to identify problems, plan for appropriate actions.


c: Education HHA must provide infection control education for patients, staff, and caregivers.


484.75 Skilled Professional Services


a: Provision of Services by Skilled Professionals Services authorized, delivered and supervised only by those qualified under these rules and who practice per HHA policies and procedures.


b: Responsibilities of Skilled Professionals Ongoing interdisciplinary assessment of patient, development/evaluation of PoC with patient, representative, caregiver.


  • Provide services ordered by physician PoC,

  • patient/caregiver/family counselling,

  • patient/caregiver education,

  • preparing clinical notes,

  • communication with all PoC physicians,

  • participation in QAPI and in-service training.


c: Supervision of Skilled Professional Assistants Nursing supervised by RN, Rehab supervised by OT/PT, Medical Social Services by Social Worker.


484.80 Home Health Aide Services


a: Home Health Aide Qualifications Successful completion of HH Aide or nurse aide training and competency program or State Licensing Program. No lapse in paid practice for 24 months without completing new program.


b: Content and Duration of Home Health Aide Classroom and Supervised Practical Training Must include classroom and supervised practical training under supervision of RN for 75 hours, minimum 16 hours of classroom before 16 hours of supervised practical training.


Program must address:


  • communication skills,

  • observation/reporting/documentation,

  • reading/recording of temp/pulse/respiration,

  • basic infection prevention/control, body function and changes needing reporting,

  • maintenance of clean/safe/healthy environment,

  • recognizing emergencies and procedures,

  • physical/emotional and developmental needs including respect for patient privacy and property,

  • safe techniques for personal hygiene and grooming,

  • safe transfer techniques,

  • normal range of motion and positioning,

  • adequate nutrition and fluid intake,

  • recognizing and reporting skin changes,

  • other tasks permitted under State Law.

  • HHA responsible for training and documentation.


c: Competency Evaluation Must complete competency evaluation by written exam and observation by RN. HHA must maintain documentation.


d: In-Service Training HH Aide 12 hours required every 12 months.


e: Qualification for Instructors Conducting Classroom and Supervised Practical Training RN with 2yrs experience and 1 in HHA


f: Eligible Training and Competency Evaluation Organizations.


  • Agency in compliance, and within 2 years did not permit unqualified HH Aides,

  • not subject to extended survey for substandard care,

  • not assessed civil monetary penalty of $5000 or more,

  • no compliance deficiencies endangering health and safety and no government-appointed temporary management,

  • not terminated, no penalty of $5000 or more for standards,

  • not subject to payment suspension,

  • no been closed or patients transferred by State,

  • not excluded from participating in Federal healthcare programs.


g: Home Health Aide Assignments and Duties Assigned by RN or skilled professional, with written instructions, services ordered by physician, in POC, permitted under State law, consistent with training.


Duties include:


  • hands-on personal care,

  • simple procedures extending skilled care,

  • assistance with ambulation or exercises and self-administered drugs.

  • Must be part of interdisciplinary team,

  • report changes to skilled staff,

  • complete appropriate records.


h: Supervision of Home Health Aides Onsite skilled visit every 14 days.


  • If area of concern skilled staff must observe and annual on-site to observe each aide.

  • If patient not receiving skilled care, must do skilled observation every 60 days.

  • If problem in observation, HHA must do competency evaluation.

  • Supervision must include:

    • furnishing care in safe and effective manner,

    • following PoC on assigned tasks,

    • maintain communication with patient, representative, caregiver, family members,

    • demonstrate competency on assigned tasks,

    • comply with infection prevention and control,

    • report changes in patient condition,

    • honor patient rights.


  • If HHA provides HH Aide under arrangements, must also ensure overall quality of care by aide, supervise aide services, ensure aides meet training/competency requirements.


i: Individuals Furnishing Medicaid Personal Care Aide-Only Services Under a Medicaid PC Benefit. If aide services under Medicaid Personal Care, must meet State requirements and demonstrate competency in services provided.


484.100 Compliance with Federal, State, and Local Laws and Regulations Related to the Health Safety of Patients


a: Disclosure of Ownership and Management Information Meet 420 subpart C and disclose at certification request, for each survey, and change in ownership or management:


  • names and addresses of all persons with ownership or controlling interest,

  • each person who is an officer, director, agent, or managing employee,

  • the name and business address of the corporation, association or company responsible for management,

  • the names and addresses of the CEO and Board Chair.


b: Licensing HHA, branches, and all persons furnishing services must be licensed, certified or registered by State licensing authority.


c: Laboratory Services If HHA does laboratory services, must be in compliance with regs at Part 493.


If HHA refers specimens to a lab, the referral lab must be certified in appropriate specialties per Part 493.


484.102 Emergency Preparedness


a: Emergency Plan HHA must develop and maintain emergency preparedness plan, reviewed and updated annually. Plan must include:


  • community and facility-based,

  • all hazards based risk assessment,

  • strategies for events in risk assessment,

  • patient population including type of services provided in emergency,

  • continuity of operations,

  • delegations of authority, and succession.

  • Process for cooperation and collaboration with all levels of government to maintain integrated response including HHA efforts to contact officials and collaborative and cooperative planning efforts.


b: Policies and Procedures Plans for patients and include in each patient assessment,


  • procedures to inform State and Local government of HHA patients in need of evacuation with medical, psychiatric and environmental info,

  • procedures for follow up with on-duty staff and patients to determine services needed if interrupted,

  • must inform State and Local of patients unable to contact,

  • system of medical documentation preserving information confidentially and with access,

  • use of volunteers or other emergency staffing strategies including integration with Federal and State designated health care professionals.


c: Communication Plan Communication Plan that complies with Federal, State and Local requirements updated annually that includes:


  • names and contact info for staff,

  • under arrangements services,

  • patient’s physicians, volunteers, Federal/State/Local emergency preparedness officials, other sources of assistance,

  • primary and alternate means of communicating with staff and emergency preparedness officials,

  • method for sharing information and medical documentation on patients with other health care providers,

  • means of providing information on general condition and location of patients,

  • means of providing information about HHAs needs and ability to provide assistance to Incident Command Center.


d: Training and Testing HHA must:


  • have initial emergency preparedness training of all staff, volunteers, and under arrangement providers,

  • provide training annually,

  • document training,

  • demonstrate staff knowledge of procedures.

  • HHA must conduct exercises to test plan annually,

  • participate in full-scale community based exercise or facility-based event annually unless actual emergency activated plan that year.

  • HHA must conduct an additional exercise:

    • a second full-scale community or facility-based,

    • or a tabletop exercise led by a facilitator using a narrated, clinically relevant scenario with problem statements, directed messages, or prepared questions to challenge plan.

    • HHA must analyze HHA’s response and maintain documentation.


e: Integrated Health Care Systems If part of an integrated HC system, HHA may elect to participate in the system’s drill if:


  • each part of system actively participated,

  • developed to take into account each part’s unique circumstances, patients, services,

  • and demonstrates each part actively uses and complies with the integrated program,

  • that plan complies with a documented community-based, all-hazards risk assessment, a separate risk assessment for each certified part of integrated system,

  • coordinated communication plan,

  • training and testing plan.


484.105 Organization and Administration of Services


a: Governing Body Must assume full legal authority and responsibility for HHA’s management and operation, services, fiscal operations, budget, operational plans, quality assessment, and performance improvement.


b: Administrator Must be appointed by and report to governing body,


  • responsible for all day-to-day operations,

  • assure that clinical manager is available all operating hours,

  • ensure employs qualified personnel and develops personnel qualifications and policies.

  • Designates a qualified, pre-designated person authorized in writing by the administrator and governing body to assume all responsibilities and obligations when administrator is not available.

  • Administrator or designate is available all working hours.


c: Clinical Manager One or more qualified individuals must provide clinical oversight over all patient care services and staff, including:


  • making assignments,

  • coordinating care and referrals,

  • assuring patient needs are continually assessed,

  • assuring development, implementation, and updates of PoC.


d: Parent-Branch Relationship Parent HHA must report all branch location to Single State Agency at initial certification, each survey, and proposal to add or delete a branch.


e: Services Under Arrangement HHA must ensure that all services under arrangement meet requirements, have a written agreement, maintain overall responsibility for services and manner provided.


  • Other provider may not have been denied Medicare or Medicaid enrollment,

  • been excluded or terminated from any Federal program,

  • had Medicare or Medicaid billing privileges revoked,

  • been debarred from any government program.

  • Primary HHA remains responsible for all care.


f: Services Furnished Must provide Skilled Nursing and at least one other therapeutic service, available on visiting basis, in place of residence used as patient’s home, Once service must be provided directly.


g: Outpatient Physical Therapy or Speech-Language Pathology Services If providing outpatient PT or OT, agency must meet regs under section 1861(p) of the Social Security Act.


h: Institutional Planning


  • Must be annual operating budget including all income and expenses prepared in accordance with generally accepted accounting principles.

  • There must be a 3-year capital expenditure plan for expenditures over $600,000 in capital expenditures.

  • This plan must include all plans, specifications, drawings, fees etc., thus including all components of costs even if they are spread over time.


484.110 Clinical Records


a: Contents of the Clinical Record Must contain:


  • current comprehensive assessment,

  • clinical notes,

  • PoC,

  • physician orders,

  • all interventions and responses including medications,

  • PoC goals and progress,

  • contact info for patient, representative, primary caregiver,

  • primary physician for post HH discharge,

  • completed discharge summary,

  • and completed transfer summary.


b: Authentication All entries must be legible, clear, complete, authenticated (signature and title or secure unique computer entry), dated, and timed.


c: Retention of Records Retained for 5 years after discharge or longer if by State law. Policies must provide for retention if it discontinues operation and HHA must inform State agency where those clinical records will be maintained.


d: Protection of Records Must be protected against loss or unauthorized use and comply with rules on protected health information.


e: Retrieval of Clinical Records Must be made available to patient on request free of charge at the next home health visit or within 4 business days if earlier.


484.115 Personnel Qualifications


a: Administrator If employed before 1/13/17 must be:


  • licensed physician,

  • registered nurse,

  • or 1 year of training and experience in health service administration and 1 year of supervisory experience in home health or a related health care program.


After 1/13/17 must be:


  • licensed physician,

  • registered nurse

  • or hold undergraduate degree and at least 1 year of health service administration, with at least 1 year of supervisory or administrative experience in home health or a related health services program.


b: Audiologist Meets educational and experience requirements for a Certificate of Clinical Competence by ASLHA or who meets the above educational requirements and is in the process of completing the experience requirements for certification.


c: Clinical Manager Is a licensed physician, RN, PT, SLP, OT, audiologist, social worker.


d: Home Health Aide A person who meets the requirements in the qualifications in 484.80


e: Licensed Practical (Vocational) Nurse A person who has completed a practical (vocational) nursing program, is licensed in the State, and furnishes services under RN supervision.


f: Occupational Therapist: See actual complex regs text.


  • A person licensed as an OT if State has licensure,

  • graduated from OT educational program accredited by ACOTE, AOTA, or successor to ACOTE.

  • And is eligible to take or has completed entry level certification examination for OT from NBCOT.

  • On or before 12/31/2009 is licensed OT in state

  • or where no licensure: graduated after completion of OT educational program accredited by ACOTE, its successor, or AOTA and is eligible to take or successfully completed entry level certification exam for OT by NBCOT.

  • On or before 1/1/2008, graduated after successful completion of OT program accredited by CAHEA of AMA and AOTA,

  • On or before 12/31 1977: 2 years experience as OT and satisfactory grade on OT proficiency test conducted, approved or sponsored by USPHS.

  • If educated outside the US: graduated after successful completion of OT education program equivalent to OT entry level in US by ACOTA or successor, World Federation of OT, a credentialing body approved by AOTA, successful completion of entry level certification exam for OT by NBCOT.

  • On or before 12/31/2009 is licensed or properly regulated as an OT.


g: Occupational Therapy Assistant: See actual complex regs text.


h: Physical Therapist: See actual complex regs text.


i: Physical Therapist Assistant: See actual complex regs text.


j: Physician A person who meets the qualifications and conditions specified in 1861(r) of the Act as implemented in 410.20(b) of this rule


k: Registered Nurse A graduate of an approved school of professional nursing licensed in the State.


l: Social Work Assistant A person who provides social work services under supervision of social worker and has a bachelor’s degree in social work, sociology, or field related to social work and has had 1 year of social work experience in a healthcare setting or who has had 2 years appropriate experience as a SWA and achieved a satisfactory grade on proficiency exam of USPHS except for those persons initially licensed by the State or seeking initial qualification as SWA after 12/31/1977.


m: Social Worker Person with a master’s or doctoral degree from a school of social work and 1 year of experience in a healthcare setting.


n: Speech Language Pathologist A person with a master’s or doctoral degree in SLP and either Is licensed as an SLP or in State where not licensed, successful completion of 350 hours of supervised clinical practicum or is in process of accumulating supervised clinical experience and completed not less than 9 months of full time SLP after master’s or doctoral degree in SLP or related field, and successfully completed a national exam in SLP approved by the Secretary of DHHS.

484.2 Definitions
484.40 & 45 Release of Patient Identifiable OASIS Information Ensure confidentiality of all patient data.
484.50 Patient Rights
484.55 Comprehensive Assessment of Patients
484.60 Care Planning Coordination of Services, and Quality of Care
484.65 Quality Assessment and Performance Improvement
484.70 Infection Prevention and Control
484.75 Skilled Professional Services
484.80 Home Health Aide Services
484.102 Emergency Preparedness
484.105 Organization and Administration of Services
484.110 Clinical Records
484.115 Personnel Qualifications
484.100 Compliance with Federal, State, and Local Laws and Regulations Related to the Health Safety of Patients
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