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Conditions of Participation

Final Rule


Policy Corner

The biggest news affecting both home health-care agencies and clients in 2017 came from the 30 revisions the Centers for Medicare and Medicaid Services (CMS) made to Conditions of Participation (CoPs) for Medicare and Medicaid health care services.  For a summary of all the changes, see New Changes to Conditions of Participation below. To see the full final rule visit Medicare and Medicaid Program: Conditions of Participation for Home Health Agencies. The implementation of some changes, such as those involving Emergency Preparedness, began in November 2017. All others were effective starting January 13, 2018. 


Here are some important changes requiring your attention and/or participation:

  1. Clarification of court-appointed legal vs. patient-selected representative:
    • A legal representative, such as a guardian, makes health care decisions on behalf of the patient
    • A patient-selected representative participates in making decisions related to the patient’s care or well-being. This may be, but not limited to, a family member or an advocate for the patient
    • To the extent possible, the patient decides the role of either type of representative
    • The client, caregiver, nurse, and representative will collaborate to plan your care
  2. Notice of privacy rights:

    • The patient and the representative (if any) have the right to be informed of the patient’s rights in a language and manner the individual understands

    • The agency must protect and promote the exercise of these rights

  3. New timelines stipulated for notice of rights, transfer and discharge policies, OASIS (Outcome and Assessment Information Set) privacy notices:

    1. During initial evaluation visit and prior to the start of care:

      • Agencies must provide clients and representatives a written notice of patient’s rights, transfer and discharge policies, OASIS privacy notice, and obtain signatures confirming receipt of the notice of rights and responsibilities.

      • Provide contact information for the agency’s administrator

      • Determine eligibility for home care services

    2. By the end of the second visit from a skilled professional:

      • Client must receive a verbal notice of the patient’s rights and responsibilities in a language and manner the individual understands and free of charge

    3. Within four business days after the initial evaluation visit:

      • Patient-selected representative must receive written notice of the patient’s rights and responsibilities and transfer and discharge policies

      • Patient can opt out of sharing notice with his/her representative

  4. Infection prevention and control (client/caregiver/representative teaching and education requirements):

    Agencies must implement infection control program that includes:
    • A method for identifying infectious and communicable disease problems

    • A plan for the appropriate actions that are expected to result in improvement and disease prevention

    • Education of staff, patients, and caregivers

  5. Emergency Preparedness: Agencies must:

    • Establish an Emergency plan that must be reviewed and updated annually

    • Conduct emergency risk assessments and base policies and procedures on those risks

    •  Develop and maintain a Communication plan. Among other requirements, the communication preparedness plan must include all of the following:

      •  Names and contact information for the following:

        • Staff

        • Entities providing services under arrangement

        •  Patients’ physicians

        • Volunteers

      •  Contact information for the following:

        • Federal, State, tribal, regional, or local emergency preparedness staff.

        • Other sources of assistance.

    •  Develop and maintain an emergency preparedness Training and testing Program that includes staff, clients, caregivers, and representatives participating in annual emergency preparedness drills and table-top clinically-relevant scenario exercises

  6. Comprehensive Assessments Timelines:

    • Initial Assessment visit must be held either within 48 hours of referral, or within 48 hours of client’s return home, or on the physician-ordered start of care date

    • The comprehensive assessment must be completed in a timely manner, consistent with patient’s immediate needs, but no later than 5 calendar days

    • Content of the assessment must accurately reflect client’s health, psychosocial, functional, and cognitive status

    • The comprehensive assessment must be updated as warranted by patient’s condition, … but not less frequently than the last five days of every 60 days from the start of care, within 48 hours of patient’s return home from a hospital admission of 24 hours or more, or at discharge

It goes without saying that these CoP changes are designed to enhance timely and quality care delivery. Notably, they require greater decision-making involvement and education of the client/caregiver/client’s representative in the delivery of care than before.  Our employees, especially our nurses, need your cooperation and collaboration in complying with these new rules as they conduct home visits with you.



New Changes to Conditions of Participation

CMS provided the following summary of the Final Rule:

  1. Revised the definition of “representative” at §484.2 for additional clarity.
  2. Revised §484.50(a)(1) to clarify that it is the patient’s legal representative that must be informed of the patient rights information prior to the start of care.
  3. Revised §484.50(a)(1)(i) to require that an HHA must provide each patient with written notice regarding the HHA’s transfer and discharge policies. This requirement was originally proposed at 484.50(d).
  4. Re-designated proposed §484.50(a)(1)(ii) as §484.50(a)(3).
  5. Re-designated proposed §484.50(a)(2) as §484.50(a)(1)(ii) and removed the requirement that HHA administrators are expected to receive patient questions.
  6. Re-designated proposed §484.50(a)(3) as §484.50(a)(1)(iii).
  7. Re-designated proposed §484.50(a)(4) as §484.50(a)(2), and clarified that a signature confirming receipt of the notice of patient rights is only required from a patient or a patient’s legal representative.
  8. Revised §484.50(a)(3), requiring that the HHA must provide verbal notice of the patient’s rights no later than the completion of the second visit from a skilled professional.
  9. Added new §484.50(a)(4), requiring that the HHA provide a written notice of the patient’s rights and the HHA’s discharge and transfer policies to a patient-selected representative within 4 business days after the initial evaluation visit.
  10. Revised 484.50(b) to replace the term “incompetence” wherever it appears with the more precise term “lack legal capacity to make health care decisions.”
  11. Revised §484.50(c)(4)(i) to clarify that patients have the right to participate in and be informed about all assessments, rather than just the comprehensive assessment.
  12. Removed the requirement at §484.50(c)(4)(iii) regarding providing a copy of the plan of care to each patient.
  13. Revised §484.50(c)(10) to require HHAs to provide contact information for a defined group of federally-funded and state-funded entities.
  14. Revised §484.50(d) to remove the requirement for HHAs to provide patients with information regarding HHA admission policies and clarified that the “transfer and discharge policies” are those set forth in paragraphs (1) through (7) of this standard.
  15. Revised §484.50(d)(1) to clarify that HHAs are responsible for making arrangements for a safe and appropriate transfer.
  16. Revised §484.50(d)(3) to clarify that discharge is appropriate when the physician and the HHA both agree that the patient has achieved the measurable outcomes and goals established in the individualized plan of care.
  17. Revised §484.50(e)(1)(i) to clarify that the subject matter about which patients may make complaints is not limited to those subjects specified in the regulation. HHAs must investigate all such complaints.
  18. Revised §484.50(e)(1)(iii) to specify that HHAs must take action to prevent retaliation while a patient complaint is being investigated.
  19. Revised §484.50(e)(2) to specify that circumstances of mistreatment, neglect, abuse, or misappropriation of patient property must be reported in accordance with the requirements of state law.
  20. Added a requirement at §484.55(c)(6)(i) and (ii) that the comprehensive assessment must include information about caregiver willingness and ability to provide care, and availability and schedules.
  21. Added a requirement at §484.60 that patient and caregiver receive education and training including written instructions outlining medication schedule/instructions, visit schedule and any other pertinent instruction related to the patients care and treatments that the HHA will provide, specific to the patient’s care needs.
  22. Moved proposed §484.60(a)(3) to §484.60(a)(2)(xii), making it applicable to all patients, and removed the terms “low,” “medium,” and “high.”
  23. Revised §484.60(b)(1) to permit drugs, services, and treatment to be ordered by any physician, not just the one responsible for the patient’s plan of care.
  24. Revised §484.60(b)(4) to permit any nurse acting in accordance with state licensure requirements to receive verbal orders from a physician.
  25. Added requirements at §484.60(d)(1) and (2) that HHAs 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.
  26. Re-designated proposed §484.60(d)(1) through (3) as §484.60(d)(3) through (5).
  27. Added a requirement at §484.60(e), Written information to the patient.
  28. Revised §484.65 to require that QAPI program indicators include the use of emergent care services.
  29. Revised §484.75(b)(7) to require skilled professionals to communicate with all physicians involved in the plan of care.
  30. Revised §484.80(b)(3)(xiii) by withdrawing part of the provision under home health aide training requirements for aides to recognize and report changes in pressure ulcers.


An administrator of a Home Health Agency (HHA) who begins working for an HHA after the effective date of this final rule, even if he or she was previously employed as an administrator for a different HHA, is required to be a licensed physician, a registered nurse, or hold an undergraduate degree. A registered nurse would include a nurse practitioner or other advance practice nurse. Additionally, an administrator who begins working for an HHA after the effective date of this final rule is required to have experience in health service administration, with at least one year of supervisory or administrative experience in home health care or a related health-care program.