Posted on Friday, July 21, 2017 6:08 PM

Part 1: Introduction to Home Health CoPs

CMS developed Home Health Conditions of Participation (CoPs) that organizations must meet in order to begin and continue participating in Medicare and Medicaid programs. These health and safety standards are the foundation for improving quality and protecting the health and safety of the beneficiaries being cared for. CMS also ensures that the standards of accrediting organizations, such as Joint Commission, CHAP and ACHC (which are recognized by CMS through a process called “deeming”) meet or exceed the Medicare standards set forth in the CoPs.

The CoPs have existed in their current state for over 30 years. A revision to the CoP’s rule was initially proposed in 1997, but was never finalized, despite a resurgence in 2006. Finally, with a renewed effort starting in 2014, the CoPs have been finalized, with the final rule being published in the Federal Register on 1/13/2017. The final CoP Rule has an effective implementation date of 1/13/2018.

The new Home Health CoPs are designed to develop a more continuous, integrated delivery of care across home health; based on patient centered assessment, planning of care, delivery of services and quality assessment and performance improvement. The CoPs also take into consideration safeguarding patient rights.

The new Home Health CoPs incorporate structural changes as well. These changes include:

1. Renaming and Renumbering
Included across three sections:
1. A – General Provisions 484.1 – 484.2
2. B – Patient Care (Administration) 484.40 – 484.80
3. C – Organizational Environment (Furnishing Services) 484.100 – 484.115.

In addition, several standards have been combined or incorporated into new CoPs and two new CoPs have been added. Each will be covered in detail.

Lastly, changes to the new CoPs also include the elimination of some standards.

Part 2: Subpart A – General Provisions

It is important to understand Subpart A – General Provisions and any changes included with the finalization of the new CoPs to better prepare your organization for the transition.

Subpart A – General Provisions has been reorganized to better clarify the basis and scope of this section of the CoPs. Part 484.1 is based on sections 1861(o) and 1891 of the Act, which establish the conditions that a home health agency must meet in order to participate in the Medicare program. Part 484.1 is also based on section 1861(z) of the Act, which specifies the institutional planning standards that home health agencies must meet. These provisions serve as the basis for survey activities for the purposes of determining whether an agency meets the requirements for participation in Medicare.

With the revision of the Home Health CoPs several new definitions were added, some were revised and others were eliminated. First, the definitions that were modified will be outlined.

The definition for “branch office”, which means an approved location or site from which a home health agency provides services within a geographic area the parent home health agency provides services was modified by adding the requirement of the parent agency to offer more than just the sharing of services. The definition now includes the parent agency to provide supervision and administrative control of branches on a daily basis to the extent the branch depends on the parent agency’s supervision and administrative control to meet the CoPs, and would not be able to do so independently. The definition no longer requires the branch office to be “sufficiently close”. The parent agency must be available to meet the needs of any situation and respond to issues that could arise with respect to patient care and/or the administration of the agency. A violation of a CoP in one branch office is a violation for the entire home health agency. 

Minor changes are also noted in the language of the current definitions for “clinical note,” “parent home health agency,” “proprietary agency,” and “subdivision.”  

Current definitions of the terms bylaws, supervision, progress notes and sub-units were eliminated.  As it relates to sub-units, on the effective date of the new CoPs, any existing subunits, which already operate under their own provider number, will be considered distinct HHAs and will be required to independently meet all CoPs, including having an independent governing body and administrator. Subject to state-specific laws and regulations, this federal regulatory change will permit a subunit to apply to become a branch of its existing parent HHA, if the parent provides “. . . direct support and administrative control” of the branch. The State Survey Agency and CMS Regional Office will continue to be responsible for approving home health agency applications for a branch office, in accordance with current CMS guidance as set forth in various survey and certification letters and the section of the State Operations Manual. No new subunits will be approved upon implementation of this regulation, only “branch offices.”

Several new definitions were added to the CoPs: 

“In advance” means the home health agency staff must complete the specified task before any hands on patient-care or patient education takes place.

“Quality Indicator” references a specific, valid and reliable measure of access, care outcomes or satisfaction, or a measure of a process of care.

“Representative” means the patient’s legal representative, such as a guardian, who makes health care decisions on the patient’s behalf, or a patient-selected representative who participates in making decisions related to the patient’s well-being, including but not limited to a family member or an advocate for the patient.

“Supervised practical training” means training in a practicum laboratory or other setting in which the trainee demonstrates knowledge while providing the covered services to an individual under the direct supervision of a registered nurse or a licensed practical nurse who is under the supervision of a registered nurse.

“Verbal Order” is a physician’s order that is spoken to appropriate personnel and put into writing to document and as well as establish or revise the patient’s plan of care.

Part 3: Subpart B – Patient Care

This section will highlight the requirements surrounding OASIS data collection and submission, although there are minimal changes to these specific conditions regarding OASIS.  CoP 484.55 Comprehensive Assessment of Patients will also be outlined in this section.

The objective of this section is to identify requirements related to 484.40, 484.45 and 484.55.

The OASIS is a key component of Medicare’s partnership with the home care industry to foster and monitor improved home health care outcomes and is an integral part of the revised Conditions of Participation for Medicare-certified home health agencies. Conditions 484.40 and 484.45 and the associated standards cover the release of patient identifiable information, including OASIS information and the reporting of OASIS information.

The Home Health Condition of Participation 484.40 (previously 484.11) – Release of patient identifiable outcome and assessment information set (OASIS) information has not changed with the revision and renumbering of the CoPs. The condition states the home health agency and any agent acting on the behalf of the agency in accordance with a written contract must ensure the confidentiality of all patient identifiable information contained in the clinical record, including OASIS data, and may not release patient identifiable information to the public. 

484.45 (previously 484.20) Reporting of OASIS information requires home health agencies to electronically report all OASIS data collected in accordance with CoP 484.55, Comprehensive Assessment of Patients.  The four standards associated with CoP 484.45 include:

a) Standard encoding and transmitting OASIS data. Home health agencies must encode and electronically submit each completed OASIS assessment to the CMS system within 30 days of completing the assessment.
b) Standard accuracy of encoded OASIS data. The encoded OASIS data must accurately reflect the patient’s status at the time of the assessment.
c) Standard transmittal of OASIS data. The home health agency must:
1. Transmit the data for all completed assessments to the CMS collection site using electronic communications software that complies with the Federal Information Processing Standards. The reference to telephone connection has been removed from this standard.
2. Successfully transmit test data to the QIES ASAP System or to the CMS contractor.
3. Transmit data that includes the CMS-assigned branch ID as applicable.
d) Standard data format. The home health agency must encode and transmit data using the software available from CMS or other software that conforms to the CMS standard electronic record layout, edit specifications, data dictionary, and that includes the current OASIS data set.

The Home Health Condition of Participation 484.55 Comprehensive Assessment of Patients states each patient must receive, and the home health agency must provide, a patient-specific comprehensive assessment. For those patients that are Medicare Beneficiaries, the agency must verify the patient’s eligibility for the Medicare home health benefit, including homebound status, both at the time of the initial assessment and the comprehensive assessment.

The standards associated with this CoP are:

a) Initial assessments of patients
b) Completion of the comprehensive assessment
c) Contents of the comprehensive assessment
d) Update of the comprehensive assessment

The requirements regarding initial assessments of the patients and the timing of this assessment has not changed. The same holds true for the completion of the comprehensive assessment. The contents of the comprehensive assessment, a new standard that incorporates elements from the current CoP including drug regimen review, incorporation of the OASIS data set and adds several new items.  This standard states the comprehensive assessment must accurately reflect the patient’s status and at a minimum must include the following information:

• The patient’s current health, psychosocial, functional and cognitive status. This evaluation is to assist the home health agency in using this information in developing and implementing a patient-specific plan of care and so that agencies can potentially identify unmet patient needs that may need additional follow-up by another health care provider.  The intent of the evaluation of the cognitive status is to determine the extent in which the patient will be able to understand, remember and participate in the development and implementation of their own plan of care.  In general, it is felt there may be crossover between these items and items within the OASIS, although the items in the OASIS assessment may not always be sufficient for all patients.
• The patient’s strengths, goals and care preferences including information that may be used to demonstrate the patients progress towards goals and measurable outcomes identified by the home health agency.
• The continued need for home care services.
• The patient’s medical, nursing, rehabilitative, social and discharge needs
• Full medication review to identify any potential adverse effects or drug reactions, identify ineffective drug therapy, significant side effects and/or drug interactions, duplicate drug therapy and non-compliance with drug regimen.
• The comprehensive assessment must contain the patient’s primary caregiver, if any, and other available supports willingness and ability to provide care and their availability and schedules.
• The patient’s representative/s, if any.
• Incorporation of the current version of the OASIS data set for all time points.

The last standard for this CoP is the requirement to update of the comprehensive assessment. The comprehensive assessment must be updated and revised (including the incorporation of the OASIS data set) as frequently as the patient’s condition warrants due to a major decline or improvement in the patient’s health status, but not less frequently than the last 5 days of every 60-day period starting with the start of care date unless there is a beneficiary elected transfer, a significant change in the patient’s condition, or a discharge and return to the home health agency within the 60-day period. 

The comprehensive assessment must also be updated within 48-hours of a patient’s return to the home from a hospital admission of 24-hours or greater for anything other than diagnostic testing or on a physician’s ordered resumption of care. Lastly, it must be updated on discharge.

Part 4: Subpart B – Patient Rights

This is the second section covering Subpart B – Patient Care.  It will focus on the CoPs regarding Patient Rights.

484.50 Condition: Patient Rights states that the patient and their representative, if any, have the right to be informed of all patient rights in a language and manner the individual understands. The home health agency must protect and promote the exercise of these rights.

Many of the old standards from the current CoPs regarding Patient Rights have been reorganized and revised and even expanded upon. In addition, some new standards have been added. Overall, given the number of changes, patient rights is like a new CoP. The patient rights CoP is divided into six separate standards:  Notice of Rights, Exercise of Rights, Rights of the Patient (significantly modified), Transfer and Discharge (new standard), Investigation of Complaints (new standard) and Accessibility (new standard).  Each standard will be discussed in detail.

a) Standard – Notice of Rights requires a home health agency to provide the patient and the patient’s legal representative the following information on the initial evaluation visit, prior to providing care to the patient:
1. Written notice of the patient’s rights and responsibilities,
2. The agencies transfer and discharge policies
3. The home health agency Administrator’s contact information
4. An OASIS privacy notice

The patient and any legal representative of the patient has the right to be informed of the patient’s rights in a manner they understand. The written notification must be presented in a manner that is understandable by individuals that have a limited English proficiency and accessible to those with disabilities. Receipt of the written notifications must be confirmed by patient or the patient’s legal representative. Also, by the completion of the second visit by a skilled professional, the patient must be provided with a verbal notice in the patient’s primary or preferred language and in a manner or format they understand. The agency may use an interpreter if necessary, although the patient can’t be charged for this service. Lastly, any patient designated representative must be presented the written notifications of the patient’s rights and responsibilities, including the agency transfer and discharge policies within 4 business days of the initial evaluation visit.

b) Standard – Exercise of Rights. Due to concerns across various state regulations with regards to the definition of “incompetent” this term has been removed. The revised CoPs state if the patient “has been ajudged to lack the legal capacity to make health care decisions as established by state law”. If this is the case, and the court has appointed an individual to act on the person’s behalf, this individual may exercise the patient’s rights. In the event an agency is caring for a patient that has been ajudged to lack the legal capacity to make health care decisions, a copy of the court order should be obtained to verify the authority of the legal representative and for further reference.
c) Standard – Rights of the patient is not a new standard. It has had significant revisions, so seems like a new standard. Each listed in the standard will be discussed in brief with all new and revised language highlighted. Patients have the right to his or her property and person to be treated with respect.

Be free from verbal, mental, sexual and physical abuse, including injuries of unknown source, neglect and misappropriation of personal property. This is a new requirement within this standard, as the previous CoPs did not expressly address this right.

The right to make complaints regarding care or lack thereof. In addition, the patient has the right to be advised of the state toll free home health hotline, it’s phone number, contact information and hours of operation and it purpose to receive complaints and questions regarding local home health agencies.

The patient also has the right to participate in, be informed and consent to or refuse care and or any treatments with respect to the completion of the comprehensive assessment as well as all other assessments. The same rights apply to the creation of the plan of care and any revisions in the plan of care including the disciplines seeing the patient and the frequency of their visits and the expected outcomes of the goals and interventions being planned, along with risks and benefits of the care. The patient has the right to receive all services outlined in the plan of care. Overall the patient’s involvement in the plan of care is a significant focus.

In addition to the above rights the patient has a right to a confidential medical record. Revisions were made to this standard regarding access to and/or the release of information to conform with HIPAA Privacy regulations.

A patient has always had the right to be advised of payment for services from federal payors or the patient themselves. This standard has been revised slightly, although home health agencies have always been responsible to inform the patient of any potential liability for services they receive. The new standard does require that the home health agency provide, in writing to the patient, notification of any services the home health agency believes may not be covered or in advance of reducing and/or terminating the patient’s care.

The patient also has the right to be advised of the state toll-free hotline number, contact information and the hours of operation and the purpose of receiving complaints or answering questions regarding area home health agencies. In addition to providing this information, a new standard states home health agencies are now required to provide the names, addresses, and contact information on the following federally and state funded agencies in the patient’s area: 1. Agency on Aging 2. Center for Independent Living, 3. Protection and Advocacy Agency, 4. Aging and Disability Resource Center, and 5. Quality Improvement Organization.

The patient also has the right to be free of any discrimination or reprisal for exercising any of his/her rights.

Lastly, a new standard outlines the patient’s rights to access auxiliary aides and language and must be informed on how to access these services.

Every patient being cared for in home health has always had rights. The newly revised CoPs enhance those rights for the protection of the patient.

Part 5: Conclusion of CoP 484.50

The remainder of 484.50, which includes the new standards of Transfer and Discharge, Investigation of Complaints and Accessibility will be highlighted in this section. 

The first standard is transfer and discharge. The revised standard defines the circumstances for when a home health agency is allowed to transfer or discharge a patient. This includes the following:

1. When a transfer or discharge is necessary for the welfare of the patient
2. The payor and/or patient will no longer pay for the care or services
3. The patient’s physician and the agency agree the patient has achieved the desired outcomes or measurable goals as stated in the plan of care
4. The patient refuses services
5. When the home health agency determines, based on written policy the patient can be discharged for cause
6. Patient death
7. If the home health agency closes

Because transfers and discharges are now governed by this new standard, agencies must have policies and procedures in place to reflect this standard. A key consideration related to this standard is the patient’s right to refuse care – which is not a new right.  If a patient refuses services or care, this does not automatically mean the patient should be discharged. The agency needs to consider if the care and services the patient is refusing will compromise the home health agency from delivering safe and effective care to the extent the agency can no longer meet the patient’s needs.   The agency will need policy and procedures in place to assist in the management when refusal of services and care becomes a discharge and ensure documentation supports the decision-making process.

As defined by the standard – Investigating Complaints, home health agencies now must receive and investigate complaints from the patient, the patient representative and the patient’s caregivers and/or family. Included but not limited to are any complaints related to the treatment of care delivered or care that is failed to be delivered or delivered inconsistently or inappropriately.  In addition, any mistreatment, neglect, or verbal, mental, physical, or sexual abuse including injuries of an unknown source and/or misappropriation of the patient’s property by anyone furnishing services on behalf of the home health agency.

The complaint must be documented by the home health agency and must include the steps taken to investigate and resolve the complaint. The agency must also take actions to prevent further violations or retaliations against the complainant while the investigation is underway. This could include actions such as reassigning staff and or suspending staff.

If an employee suspects maltreatment, neglect or abuse of any kind, injuries from an unknown source, or misappropriation of the patient’s property it is the employee’s responsibility to report their suspicions immediately to their supervisor and/or the home health agency per their agency policies. The agency has a responsibility to report any suspicions on behalf of the employee to the appropriate state agencies as indicated.

Accessibility is the requirement for agencies to provide information in plain language and in a manner that is accessible and timely. This includes providing accessible websites and auxiliary aides in accordance with the Americans with Disabilities Act as well as the Rehabilitation Act.  If the patient and or patient representative has limited English proficiency, oral interpreters and written translations must be provided.  

Ensuring all employees are properly educated on the implications of each of the above standards is necessary. Those caring for patients have a responsibility to understand these requirements to ensure the safe and effective care that is compliant with all regulations for each patient.

Part 6: Emergency Preparedness

Emergency Preparedness requirements set forth in the newly revised CoPs mirrors the Federal mandate that goes into effect in November of 2017 for most other Medicare certified providers.  Included in the Standards for this CoP is an Emergency Plan, Emergency Preparedness Policy and Procedures, a Communication Plan, Training and Testing and provisions for those home health agencies that are part of an integrated health system.

Home Health agencies are required to have an emergency plan that must be in place and reviewed and updated at least annually.  The plan must be based on a facility and community-based risk assessment using an all hazards approach.  It must also include strategies for addressing emergency events as outlined in the risk assessment.  Also addressed is the patient populations, including what services the home health agency has the ability to provide during an emergency and the continuity of care during this period of time.  Included in the plan is the process for cooperation and collaboration with all emergency preparedness officials.

Emergency Preparedness Policies and Procedures are also required.  They too must be reviewed and updated at least annually.  The policies and procedures must define how an agency handles patients during a disaster that must be addressed in the comprehensive assessment for each patient. Procedures must also include the notification of local and state officials regarding patients needing evacuation and on how services will be delivered when there is an interruption of services due to an emergency.  The home health agency is also required to report to local and state officials any on-duty staff and patients they are unable to contact and have a process for using volunteers or other staff to accommodate a surge needs during an emergency.  The patient’s confidentiality and PHI is of the upmost importance and the agency must address how it will be protected during an emergency.

The communication plan is required and must be reviewed and updated at least annually.  Contact information for staff, contracted entities or individuals providing services to the home health agency, all patient’s physicians, volunteers and all emergency preparedness staff and any other sources of assistance.  The agency must have both a primary and secondary means of communicating with staff and emergency preparedness personnel.  The communication plan must also outline the manner in which the agency will implement a process for the sharing of patient information to ensure continuity of all care.

Home health agencies are required to implement a training and testing program covering all aspects of the Emergency Preparedness requirements. This program must be reviewed and updated at least annually. The training must be provided at least annually to all staff, volunteers and any individuals providing services to the agency and all training provided must be documented. At least annually, the agency must conduct Emergency Preparedness testing and participate in a full-scale community based Emergency Preparedness exercise. If there is no community-based Emergency Preparedness exercise to participate in, the agency must test within their facility.  A second community or facility based exercise must also be conducted.  The second event can be a table top exercise including group discussion and led by a facilitator. 

Lastly, home health agencies that are a part of an integrated health system that includes other Medicare certified providers, has the option of participating with the system’s emergency preparedness plan.  If the home health agency chooses to participate with the system, they must ensure the agency’s patient population and services are considered and incorporated into the overall plan.

Part 7 – Organization and Administrative Services and the Clinical Record

This section will cover Organization and Administrative Services and the Clinical Record as outlined in the new Conditions of Participation. 

CoP 484.105 Organization and Administrative Services requires agencies to organize, manage and administer all services in a manner which maintains the “highest level of practicable functional capacity” and provide “optimal care” in accordance with each patient’s plan of care.

Home Health agencies are not allowed to delegate administrative and supervisory functions to other home health agencies or organizations.

Each home health agency is required to place, in writing, their organizational structure, including the lines of authority and all services provided.   The agencies operating and capital budgets must be prepared under the direction of the agencies governing body.   It is also required to have a budget and planning committee which includes representatives of the governing body, administrative staff and medical staff if the agency has medical staff.  The same committee must review and if necessary revise the plan at least annually under the direction of the governing body.

The home health agencies governing body has full legal authority for the operations and management of the agency.   Included is the provision of all home health services, fiscal operations, budget, operational plans and the oversite of the agencies Quality Assessment and Process Improvement program (QAPI).

The agency Administrator must be appointed by the governing body and has responsibility for running the home health agency daily operations.  When the Administrator is not available, he/she must delegate a qualified individual to assume the Administrator responsibilities. 

This designation should be made by both the Administrator and the governing body and the time allotment to do so should be outlined in the agencies policies and procedures.

Home health agencies must also have one or more qualified Clinical Managers to oversee all patient care and agency personnel.  This oversight includes all patient and personnel assignments, the coordination of patient care, the coordination of referrals, the assessment of patient needs, and to ensure the plan of care is developed, implemented and updated as needed.  The CoP does state the Clinical Manager may also be the designated qualified individual when the Administrator is not available.

The Clinical Manager must also be available during all operating hours of the agency, which is defined as all hours the agency staff is providing care and services to patients. 

With the new CoPs, the parent-branch relationship regarding home health agencies has changed.  Home health agencies are required to report all branch locations to the state survey agency when they are initially certified, when surveyed and when an agency seeks to add a branch or close a branch location.  The agency is required to provide administrative control and support over each branch location. The distance of parent-branch locations is no longer a consideration. Sub-units will no longer be recognized. Agencies will need to either close or convert sub-units to branches or free-standing home health agencies. There has been recent discussion regarding the elimination of sub-units and the parent-branch information and opinions regarding this being in the CoPs, although no proposed changes have been published at this time.

The remainder of the CoPs and standards regarding Organization and Structure contain renumbering and minor verbiage revisions or additions and will not be covered.

Clinical Records – 484.110 requires home health agencies to maintain a clinical record of past and current information of all patients receiving home health services.  The clinical record must contain accurate information on each patient and adhere to the standards of practice for accurate documentation.  The clinical record must be available to physicians and other staff that may be issuing orders for patient services.  The clinical record may also be electronic.

There are requirements with regards to the contents of the clinical record.  The patient’s current record must contain the most current comprehensive assessment, or the assessment with the most recent date.  In addition to the most current comprehensive assessment the record must also contain all assessments related to the patient’s current admission.  In addition, all clinical notes, plans of care and physician orders must be contained in the record.  All patient goals and interventions, medication administration, treatments and services and the progress towards goals and responses interventions must be included as well.  Contact information for the patient, patient representative, the primary patient caregivers, the patient’s practitioner and any other health care professionals providing care or services to the patient is also part of the clinical record. 

A discharge summary must be sent to the primary physician or practitioner and other health care professionals providing care for the patient.  The agency must send the summary within 5 days of the patients discharge from the home health agency.  This summary is not to be confused with the transfer summary, which is required to be sent within 2 business days of planned or an unplanned transfer if the patient is receiving care in a health care facility at the time the home health agency is made aware of the transfer.

All contents of the clinical record must be legible, clear, complete, appropriately authenticated, dated and timed. Authentication includes both a signature and a title. For those records that are contained in an electronic or computer record, a unique identifier is approved.  It is important to know that CMS does allow electronic signatures, but the original, signed paper documents should be retained as part of the authentication in the clinical record. 

Clinical records are required to be retained for at least 5 years, unless a specific state law requires a longer time-period. All home health agencies must have a policy in place that accounts for the process surrounding the clinical record in the event the agency closes. As part of this, they must notify the state agency as to where clinical records will be stored. All home health agencies must safeguard the clinical record from loss or unauthorized use and comply with HIPAA regulations regarding protected health information. 

Lastly, the home health agency must provide, free of charge, a copy of the patient’s clinical record if the patient makes the request.  If the request is made, the record must be made available to the patient on the next home visit or within 4 days, whichever comes first.  As with record retention, state laws may have stricter requirements surrounding this provision.

Part 8 – Comprehensive Assessment and Care Planning

This section will introduce CoP changes and additions regarding the Comprehensive Assessment – 484.55 and Care Planning – 484.60.

Each patient in home health must receive, and the home health agency must provide, a patient specific comprehensive assessment.  For patients that are Medicare beneficiaries, the home health agency must verify the patient’s eligibility for the home health Medicare benefit, including homebound status, both at the time of the initial visit and at the time of the comprehensive assessment.

The first two standards related to the comprehensive assessment have not changed with the revised CoPs. These standards include:

• The initial assessment visit
• The completion of the comprehensive assessment visit

As previous, the initial assessment must be completed within 48-hours and the comprehensive assessment must be completed within the 5-day window of start of care.  The requirement that an RN completes the comprehensive assessment except in therapy only cases is unchanged.

The contents of the comprehensive assessment visit have some additional requirements with the revised CoPs. Included in the verbiage is the requirement to include the patient’s current health, psychosocial, functional and cognitive status. Assessing a patient’s psychosocial status refers to an evaluation of the patient’s mental health, social status and functional capacity to identify areas of risk around their social and/or psychological status. This will assist the home health agency in developing and implementing a patient specific plan of care and to identify unmet patient goals that may require further follow up with another health care provider.

In addition, the patient’s strengths, goals and care preferences, including information that may be used to demonstrate the patient’s progress toward achievement of the goals identified by the patient and the measurable outcomes identified by the home health agency. Traditionally, the patient’s plan of care has focused on their deficits and the required treatment making the patient a passive recipient in their health care.  The goal now is to assure home health agencies plan for and provide patient-directed care and in accordance with the physician orders.  

It is also required to capture the patient’s primary caregiver/s, if any, and all other available supports and their willingness and ability to provide care and their availability and schedules. The patient’s representative, if any, must be identified.

Requirements regarding updating the comprehensive assessment remain intact. The comprehensive assessment must be updated:

The last 5 days of every 60 days beginning with the start of care date – unless there is:

• An elected beneficiary transfer
• Significant change in condition
• Discharge and return to the same home health agency during the 60-day episode
• Within 48-hours of return from a hospital admission of 24-hours or more for reasons other than diagnostic tests or on the physicians ordered resumption of care date
• At discharge

CoP 484.60 Care Planning, coordination of services and quality of care reference the individualized plan of care must specify the care and services necessary to meet the patient-specific needs as identified in the comprehensive assessment, including the responsible disciplines and the measurable outcomes the agency anticipates will occur with the implementation of the interventions and coordinating the plan of care.  The individualized plan of care must also specify the patient and caregiver education and the training provided specific to the needs of the patient.

Each patient must receive the home health services that are written in the individualized patient-specific plan of care that identifies the patient’s measurable outcomes and goals.

The plan of care must also include a description of patient’s risk for emergency department visits and hospital re-admission and all the necessary interventions to address the underlying risk factors. 

The patient and caregiver education to facilitate timely discharge must also be included.

Any information related to advance directives must be included on the plan of care.

There were no previous requirements removed from the plan of care.

The home health agency and clinicians providing care to patients must conform with the physician provided orders. Drugs, services and treatments are only administered as provided by the physician responsible for the patient’s care while receiving home health. When services are provided on the basis of verbal orders, these must be documented in the patient’s clinical record, signed, dated and timed. Verbal orders must be authenticated and dated by the physician in accordance with applicable state laws, as well as the agencies policies.

Review and revision of the plan of care must occur by the physician responsible for the patient’s care and the home health agency as frequently as the patient condition warrants, but no less frequently than every 60 days, beginning with the start of care date. The agency is required to notify the physician promptly with any changes in the patient’s condition or any needs that may suggest that outcomes are not being met and/or the need for altering the plan of care.

Revisions to the plan of care must be communicated as follows:

• Any revision to the plan of care due to a change in the patient’s health status must be communicated to the patient, the patient representative, if any, caregiver and the physician responsible for the patient’s care.
• Any revisions to the plans for the patient’s discharge must be communicated to the patient, the patient representative, if any, caregiver and all physicians issuing orders for the home health plan of care, and the patient’s primary care practitioner and any other health care professionals who will be responsible for providing care after the patient’s discharge from the home health agency.

The coordination of the patient’s care is very important. The home health agency must assure communication with all physicians involved in the plan of care. Orders from all physicians must be integrated into the plan of care to ensure coordination of all services and interventions provided to the patient. Agencies must also integrate all services, whether services are provided directly or under arrangement, to assure the identification of patient needs and factors that could impact patient safety and treatment effectiveness and the coordination of care provided by all disciplines.  It is important to coordinate care delivery to meet the patient’s needs and to involve the patient, the patient representative and caregivers as appropriate. A key component of the coordination of care is to make sure patients, their patient representative and caregivers receive proper education and training provided by the agency regarding the care and services identified in the plan of care.

The home health agency must provide a written copy to the patient and the patient caregiver of the visit schedule, including the frequency of planned visits by the home health agency and by individuals acting on behalf of the agency. The agency must also provide the medication schedule including medication name, dosage and frequency and which medications will be administered by the agency if any.  The written instructions must also include any treatments the patient will receive, including therapy services and any other pertinent information regarding the care they will be receiving as outlined in the patient specific plan of care.  

Lastly, the home health agency must provide to the patient, patient representative, if any and to the caregiver/s the name and contact information for the home health clinical manager.

Part 9 – Skilled Professional Services Home Health Aide Services

Changes and additions to Skilled Professional Services 484.75 and Home Health Aide Services 484.80 will be outlined in this section.

CoP 484.75 Skilled Professional Services combines and revises the previous 484.30 Skilled Nursing Services, 484.32 Therapy Services and 484.34 Medical Social Services into one CoP. The newly revised CoP now includes the following skilled professional services – skilled nursing services, physical therapy services, speech-language pathology services, occupational therapy services, physician services and medical social worker services. Any skilled professionals that provide the identified skilled services directly to patient on behalf of the home health agency, under a contract arrangement or other arrangement, must also participate in the coordination of care.

Skilled professional services are authorized and delivered, as well as supervised by healthcare professionals that meet the appropriate qualifications and who practice in accordance with the home health agency’s policies and procedures. With the revision of the CoPs, rather than focus on discipline specific tasks, broad expectations for all skilled professionals are outlined.

Skilled professionals must assume responsibility for, but not limited to the following:

• Ongoing interdisciplinary assessment of the patient
• Development and evaluation of the patient-specific plan of care in partnership with the patient and the patient representative, if there is any.
• Providing services as ordered by the physician as indicated in the plan of care
• Patient, caregiver and family counseling
• Patient and caregiver education
• Preparing clinical notes
• Communication with the physician who is responsible for the home health plan of care and other health care practitioners (as appropriate) related to the current plan of care
• Participation in the home health agency QAPI program
• Participation in agency sponsored in-service training

The supervision of skilled professionals is based on discipline. Nursing is supervised by registered nurses that meet the requirements. RNs oversee LPNs/LVNs. Rehabilitative therapy services are overseen by either an Occupational or Physical Therapist that meet the requirements. All medical social services are supervised by a Social Worker that meets all outlined requirements. The requirements for personnel is outlined in CoP 484.115.

Condition 484.80 Home Health Aide Services states that all home health aide services must be provided by individuals that meet the following qualifications. The individual must have successfully completed a training and competency evaluation program that is approved by the respective state as meeting all requirements and listed in good standing in the state nurse registry.

A home health aide or nurse aide will not be considered completed in a program if there has been a continuous 24 months or greater period-of-time where the described aide services have not been provided. For lapses of this time-period or greater, the individual must complete another training and competency program prior to delivering any services.

The home health aide training program must include both classroom training, as well as supervised practical training in a setting where the individual demonstrates their knowledge and skills while caring for a patient under the direct supervision of a registered nurse or licensed practical nurse. Classroom and practical training must include 75 hours. 16-hours of classroom training must precede a minimum of 16-hours of supervised practicum training as part of the 75 hours.

A home health aide training program must address each of the following:

• Communication skills – the ability to read, write and verbally report clinical information to patients, patient representatives and caregivers, as well as to agency staff
• Observation, reporting and documentation of the patient status and care provided
• Reading and recording vital signs – specifically temperature, pulse and respirations
• Basic infection prevention and control procedures
• Basic elements of body functioning and changes in body functions that must be reported to the aide’s supervisor
• Maintenance of a clean, safe and healthy environment
• Recognizing emergencies and the knowledge to institute emergency procedures
• The physical, emotional and developmental needs of and the way to work with the populations served by the home health agency, including the need to respect the patient, their property and privacy
• Appropriate and safe techniques for completing personal hygiene and grooming tasks that include bed bath, sponge bath, tub and/or shower bath. Also included is hair shampooing in the sink, the tub and the bed if applicable.
• Nail and skin care, oral hygiene, toileting and elimination, safe transfer techniques and ambulation, normal range of motion and positioning, recognizing and reporting skin changes and any other task the home health agency may require the aide perform as permitted under state law.

The home health agency is responsible for training the individuals on any skills not listed in the basic checklist that they may ask the aide to complete.  The agency must also maintain documentation that demonstrates the requirements of this standard have been met.

A home health aide may provide services on behalf of the home health agency only after the individual has successfully completed a competency evaluation program. Certain competencies must be evaluated by observing the aide’s performance of the task on a patient while others can be evaluated administering written or oral examinations or, after observation of the individual with a patient. The competency evaluation must be performed by a registered nurse in consultation with other skilled professionals as needed. An individual or aide is not considered competent in any skill or task rated as unsatisfactory. The aide may not complete that task without direct supervision until after receiving additional training and subsequently completing the task satisfactorily on subsequent evaluation. The aide is not considered to have successfully completed the competency evaluation if an unsatisfactory rating is identified in any of the required tasks.

As previously required, home health aides must receive 12 clock hours of in-service training annually during a 12-month period. The training in-service may also occur when the aide is delivering care to a patient. For classroom in-service training, the training must be provided by a registered nurse who possess a minimum of 2 years of nursing experience with 1 year of the experience being in home health.

Any home health agency may provide a training and competency evaluation program for aides unless within the previous 2 years met one of the listed conditions in the previous standard describing the exceptions. One new item has been added to this list that states any agency that has been excluded from participating in federal health care programs or debarred from participating in any government program can’t provide an aide training and competency evaluation program.

Home health aides are assigned to specific patients by a registered nurse or other appropriate skilled professionals, with written patient care instructions for a home health aide prepared by the appropriate skilled professional or the registered nurse.   Home health aides must be members of the interdisciplinary team, must report changes in the patient’s condition and document accordingly as outlined in the agency policies and procedures.

If a home health aide is providing services to a patient that is also receiving skilled nursing or rehabilitative services, a registered nurse or other appropriate skilled professional who is familiar with the patient, the patient’s plan of care and the written care instruction is required to make a supervisory visit to the patient’s home no less than every 14 days. The aide does not have to be in attendance when the visit is made.  The registered nurse or other appropriate skilled professional must make an annual on-site visit to the location where a patient is receiving care, to observe and assess the aide while the aide is delivering care. Aide supervision must ensure the aide is delivering care in a safe and effective manner.

For individuals only performing Medicaid personal care-aide services under a Medicaid benefit only, are required to meet state qualification requirements and demonstrate competency only in the tasks the individual is required to furnish.

Part 10 – QAPI and Infection Prevention and Control

The final section in the Home Health Conditions of Participation series will cover the new CoPs – 484.65 Quality Assessment and Performance Improvement (QAPI) and 484.70 Infection Prevention and Control.

The Quality Assessment and Performance Improvement or QAPI requires home health agencies to develop, implement, evaluate and maintain an effective ongoing, agency wide, data driven program. The agency’s governing body must ensure the program reflects the complexity of the organization and services; (including those provided under contract or arrangement); focuses on indicators that relate to positive outcomes, including hospital admissions and re-admissions. The program must also take actions that address the agency’s performance across the spectrum of care, including the prevention and reduction of medical errors. Documented evidence of the QAPI program must be kept by the home health agency, as well as the ability to demonstrate the programs operation to CMS.

The first standard for this new CoP is:

a.) Program Scope
1. The program must at least be capable of demonstrating measurable improvement in indicators for which there is evidence that there is improvement in indicators that improve health outcomes, patient safety and quality of care.

The second standard is:

b.) Program Data – the home health agency QAPI program must use quality indicator data, including measures derived from OASIS, where applicable, and other relevant data in the design of it’s program. The agency must also use the data collected to monitor the effectiveness and safety of services and quality of care, as well as identify opportunities for improvement. Lastly the frequency and detail of the data collection must be approved by the home health agency governing body.

Program Activities is the third standard in this new CoP.

The home health agency performance improvement activities must focus on high risk, high volume or problem-prone areas.  The agency must consider incidence, prevalence and the severity of the identified problems in those areas and lead to an immediate correction of any identified problem that directly or potentially threaten the health and safety of patients. The performance improvement activities must track adverse patient events, analyze their causes and implement preventative actions.

The home health agency must take actions aimed at performance improvement, and after implementing those actions, the agency must measure its successes and track performance to ensure the implemented improvements are sustained.

The timeline of home health agencies to begin conducting performance improvement projects is January 13, 2018 as detailed in the fourth standard of the CoP.

The number and scope of distinct improvement projects conducted annually must reflect the scope, complexity and past performance of the agency’s services and operations.  The agency must document the quality improvement projects undertaken, the reasons for conducting the identified projects and the measurable progress achieved on each one. A phase in was added that allows home health agencies the time necessary to collect the data prior to implementing the performance improvement projects. This allows for a full 12-month time-period between the time the final rule was published and the time agencies must begin conducting performance improvement projects.

This CoP also has language that outlines executive responsibilities. The governing body is responsible for ensuring that the ongoing program for quality improvement and safety is defined, implemented and maintained.  They are also responsible to ensure the home health agency-wide quality assessment and performance improvement efforts address priorities for improved quality of care and patient safety and that all improvement actions are evaluated for effectiveness. The governing body must make certain there are clear expectations for patient safety and they are established, implemented and maintained. 

If any evidence of fraud and abuse or waste is detected, they are appropriately addressed.

The second new CoP that is being covered – 484.70 Infection Prevention and Control requires a home health agency maintains and documents an infection prevention and control program which has a primary goal of preventing infection and communicable diseases.  Many agencies already have rigorous infection control and prevention programs in place, but with the revised CoP, this is a requirement for all home health agencies.

The standard for prevention states the home health agency must follow accepted standards of practice, including the use of standard precautions, to prevent the transmission of infections and communicable diseases.  The standard for control requires the home health agency must maintain a coordinated agency-wide program for surveillance, identification, prevention, control and investigation of infectious and communicable diseases that is an integral part of the home health agency’s QAPI program. The infection program must include a method for identifying infectious and communicable disease problems and a plan for appropriate actions that are expected to result in improvement and disease prevention.

The home health agency is also required to provide infection control education to all staff, patients and caregivers. Documentation and tracking of completed education must be maintained.

This concludes the final section of the Home Health Conditions of Participation summary.  The next 6 months are a crucial time period for agencies to begin preparing for these new requirements.

Written by Peggy Patton, Vice President of Education Services at Corridor

Addit­ional Corridor CoP Resources:

Corridor’s Free Webinar on Proposed Home Health CoPs – It’s All About Quality is Available on YouTube! Click here to view Corridor’s free webinar.

 Corridor Has the Solutions You Need to Get Prepared! Click here to save over 15% when you buy a Home Health or Hospice CoP Compliance Pack.

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About Corridor

Corridor is the nation’s preferred partner and trusted business advisor to home health and hospice providers, providing quality services and impactful results for 30 years. Focusing on key operational, regulatory and financial challenges, Corridor delivering industry-unique solutions and deep expertise in coding, clinical documentation review, compliance, billing and collections , consulting and provider staff education . At Corridor, we make the business of caring for people Better! For the most important industry updates and news that impacts home health and hospice, please make sure to sign up for our weekly newsletter to receive the latest up-to-date industry information direct to your inbox!

For additional information, please contact Corridor at 1-866-263-3795.

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