Are You Ready To Comply With The Four New Conditions Of Participation For Home Health Agencies? | Brouse McDowell | Ohio Law Firm

Are You Ready To Comply With The Four New Conditions Of Participation For Home Health Agencies?

By Laura F. Fryan & Laura F. Fryan on February 09, 2017

In addition to four new conditions of participation (CoPs), the Centers for Medicare & Medicaid Services (CMS) revised and re-organized the existing CoPs. The CoPs have not been updated for almost two decades, so on January 9th CMS finalized an overhaul of the CoPs.  The changes are effective on July 13, 2017, so home health agencies have six months to comply. The following is a complete overview of the revised CoPs and what you need to know about the new requirements.

The CoPs can be broadly separated into patient care requirements and administrative requirements:

Patient Care

1. Release of patient information (§ 484.40)

This section, which requires an agency and its agents to ensure the confidentiality of all patient-identifiable information in the clinical record, including the OASIS data, is the same as former section § 484.11.

2. Reporting OASIS information (§ 484.45)

CMS removed the requirement that an agency transmit data using electronic communications software that provides a direct telephone connection from the home health agency to the state agency or CMS OASIS contractor. Now, OASIS data must be transmitted in accordance with current CMS transmission policy.  This requires home health agencies to transmit data using electronic communications software that complies with the Federal Information Processing Standard.

3. Patient rights (§ 484.50)

The home health agency must provide the following information to the patient and/or the patient’s legal representative during the initial evaluation, in advance of providing care to the patient:

  • Written notice of the patient's rights and responsibilities and the agency’s transfer and discharge policies.
  • Contact information for the agency’s administrator, including the administrator's name, business address, and business phone number in order to receive complaints.
  • An OASIS privacy notice to all patients for whom the OASIS data is collected.

The home health agency must also:

  • Obtain the patient's or legal representative's signature confirming that he or she has received a copy of the notice of rights and responsibilities.
  • Provide verbal notice of the patient's rights and responsibilities in the individual's primary or preferred language and in a manner the individual understands, free of charge, with the use of a competent interpreter if necessary, no later than the completion of the second visit.
  • Provide written notice of the patient's rights and responsibilities and the agency’s transfer and discharge policies to a patient-selected representative within 4 business days of the initial evaluation visit. The home health agency may only transfer or discharge the patient in certain enumerated circumstances.
  • Provide the names, addresses, and telephone numbers of the following federally-funded and state-funded entities that serve the area where the patient resides:
    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.

This section also contains a list of the patient’s rights, billing/payment information that must be provided to the patient, and how the agency should investigate complaints.

4. Comprehensive assessment of patients (§ 484.55)

This section has largely been reorganized rather than revised. It retains the requirements for a patient-specific comprehensive assessment, verification of a patient's eligibility for the Medicare home health benefit, and all requirements related to the initial assessment visit. The key changes to this section are:

  • Additional required components of the comprehensive assessment, which include: the patient's current health, psychosocial, functional, and cognitive status; the patient's strengths, goals, and care preferences, including the patient's progress toward achievement of the goals identified by the patient and the measurable outcomes identified by the HHA; the patient's continuing need for home care; and caregiver willingness and ability to provide care, and availability and schedules.
  • Allowance for a physician-ordered resumption of care date. Adding the physician ordered resumption of care date as an alternative to the fixed 48 hour time frame for a post-hospital reassessment allows physicians to specify a resumption of care date that is tailored to the particular needs and preferences of each patient.

5. Care planning, coordination of services, and quality of care (§ 484.60) (NEW)

This new section specifies that the home health agency must provide the patient a plan of care that would set out the care and services necessary to meet the patient-specific needs identified in the comprehensive assessment, and the outcomes that the agency anticipates would occur as a result of developing and implementing the individualized plan of care. Key requirements in this section include:

  • The individualized plan of care must be reviewed and revised by the physician who was responsible for the home health agency’s plan of care and the home health agency as frequently as the patient's condition or needs require, but no less frequently than every 60 days, beginning with the start of care date.
  • The agency must ensure that each patient and caregiver, if applicable, receive ongoing training and education regarding the care and services identified in the plan of care that the patient and caregiver are expected to implement.
  • The agency must ensure that each patient and caregiver receives any training necessary for a timely discharge. A discharge or transfer summary is also required.
  • The agency must assure communication with all physicians involved in the plan of care, and integrate orders from all physicians involved in the plan of care to assure the coordination of all services and interventions provided to the patient.

6. Quality assessment and performance improvement (QAPI) (§ 484.65)

This section replaces two current CoPs with the new QAPI program that has five standards:

  • Program scope. The QAPI program will show measurable improvement in indicators for which there was evidence that the improvement led to improved health outcomes, safety, and quality of care for patients. Home health agencies will have to measure, analyze, and track quality indicators, including adverse patient events, as well as other indicators of performance so that the agency can adequately assess its processes, services, and operations.
  • Program data. The tools, collected data, and associated quality measures will be used by a home health agency to monitor the effectiveness and safety of its services, as well as the quality of its care. The home health agency’s governing body is responsible for approving the frequency of, and level of detail to be used in data collection.
  • Program activities. A home health agency’s QAPI program activities must focus on high risk, high volume, or problem-prone areas of service, and to consider the incidence, prevalence, and severity of problems in those areas. The home health agency must also track incidents and adverse patient events.
  • Performance improvement projects. A home health agency’s performance improvement projects must be conducted at least annually and the agency must document the QAPI projects undertaken, the reasons for conducting these projects, and the measurable progress achieved.
  • Executive responsibilities. The governing body of a home health agency is responsible for the QAPI program.

7. Infection Prevention and Control (§ 484.70) (NEW)

This new CoP requires home health agencies to follow infection prevention and control best practices, maintain a coordinated agency-wide program for the surveillance, identification, prevention, control, and investigation of infectious and communicable diseases, and provide education on “current best practices” to staff, patients, and caregivers.

8. Skilled professional services (§ 484.75) (NEW)

This new CoP sets forth requirements for skilled professional services. Skilled professional services include physician services, skilled nursing services, physical therapy, speech-language pathology services, occupational therapy, and medical social work services. Such skilled professionals must participate in coordinating all aspects of care and participate in the home health agency’s QAPI program and any in-service training.

One of the key requirements is the supervision of skilled professional assistants. An RN must supervise the care provided by nurses such as licensed vocational nurses and licensed practical nurses. All rehabilitative therapy assistant services must be provided under the supervision of a physical therapist or occupational therapist. Also, all medical social services must be provided under the overall supervision of a Master of Social Work.

9. Home health aide services (§ 484.80)

This CoP specifies the requirements for an individual to be considered a qualified home health aide as well as the required training, evaluation, and supervision.


1. Compliance with federal, state, and local laws and regulations (§ 484.100)

This CoP states the obvious, that a home health agency must be in compliance with all Federal, State and local laws related to the health and safety of patients, and that its services must be furnished in accordance with accepted professional standards and principles. The CoP also reiterates the same ownership disclosure requirements that have always been required.

2. Organization and administration (§ 484.105)

This CoP describes the role of a home health agency’s governing body and administrator. The key changes in this section are:

  • The addition of a clinical manager role. The clinical manager must be a qualified licensed physician or registered nurse who is responsible for the oversight of all personnel and all patient care services. The supervision of home health agency personnel includes assigning personnel as well as developing personnel qualifications and policies. 
  • New requirements regarding the “parent-branch relationship.” A parent home health agency must demonstrate that it can monitor all services provided in its entire service area, furnished by any branch offices, to ensure compliance with the CoPs. Branch locations must be reported to the state survey agency at the time of an agency’s initial certification request, at each survey, and at the time any proposed additions or deletions are made.

3. Clinical records (§ 484.110)

This CoP retains and clarifies most of the long-standing clinical record requirements. Key changes include:

  • All records must be authenticated.
  • Clinical records must be retained for five (5) years after the discharge of the patient, unless state law stipulates a longer period of time. A home health agency’s policies must provide for retention of records even if the HHA discontinues operations and the state agency must be notified as to where the agency's clinical records will be maintained.
  • A patient's clinical records (whether hard copy or electronic) must be made available to a patient or appropriately authorized individuals or entities upon request at the next home health visit or within four (4) business days, whichever is earlier.

4. Personnel qualifications (§ 484.115) (NEW)

This CoP retains the current personnel qualifications for the following professions: audiologist, home health aide, licensed practical nurse, occupational therapist, occupational therapy assistant, physical therapist, physical therapist assistant, physician, registered nurse, social work assistant, and social worker. The new provisions in this CoP are:

  • The term “practical (vocational) nurse” has been replaced with the more widely used and accepted term, “licensed practical nurse.”
  • A home health agency administrator must be a licensed physician, a registered nurse, or hold an undergraduate degree, with at least one (1) year of supervisory or administrative experience in home health care or a related health care program. Current home health administrators are grandfathered in.
  • A speech-language pathologist (SLP) must have a master's or doctoral degree in speech-language pathology and be licensed as a speech-language pathologist by the state in which he or she furnishes these services.

In addition to the changes above, CMS made minor changes to definitions and eliminated some definitions. One conspicuous change is that CMS eliminated the concept of sub-units. The rationale is that the only difference between a sub-unit and an independent home health agency is that a sub-unit may share the same governing body, administrator, and group of professional personnel with its parent. CMS currently requires that sub-units meet the CoPs independent of the parent agency, so there is little distinction between a sub-unit and an independent agency. Existing sub-units, which already operate under their own provider number, will now be considered distinct home health agencies and will be required to independently meet all CoPs without sharing a governing body or administrator.

Home health agencies are highly scrutinized and remain a high risk for fraud. The sooner agencies can begin implementing changes needed to comply with the new and revised CoPs, the better situated they will be in 2017. While CMS intended to streamline some of the requirements for home health agencies and provide flexibility, home health agencies have even more requirements now for patient care and administration. 

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