The Centers for Medicare & Medicaid Services (CMS) recently issued a final rule, 42 C.F.R. pt. 484, implementing significant changes to the conditions of participation (CoPs) that home health agencies (HHAs) must satisfy to participate in the Medicare and Medicaid programs.The new CoPs impose additional responsibilities on HHAs related to patient rights, patient assessment and care planning, care coordination and integration, quality assessment and performance improvement, infection control, and recordkeeping. In this alert, we provide an overview of significant provisions in the new CoPs. Except as noted below, the revised CoPs are effective on July 13, 2017.

  • Patient Rights. The HHA must inform patients of their rights in a language and format the patient can understand. The new CoPs also clarify that a patient's rights may be exercised by the patient or their representative, allow the patient to participate in and be informed about their care, and specify the circumstances under which a patient may be transferred or discharged.
  • Comprehensive Assessment of Patients. CMS retained most of the current CoPs regarding patient assessments with some modifications. HHAs must now conduct, document and update a patient-specific comprehensive assessment within five calendar days of the start of care. The comprehensive assessment must address several specific items identified in the new CoPs. For Medicare patients, HHAs must also verify the patient's eligibility for the Medicare home health benefit, including the patient's homebound status, at specified times.
  • Care Planning, Coordination of Services and Quality of Care. HHAs must provide the patient a plan of care established by a physician that sets out the services necessary to meet the patient's needs as identified in the comprehensive assessment. Notice must be provided to the patient, patient's representative, caregivers and the physician responsible for the plan of care when the plan is updated due to a change in the patient's condition. The HHA must also facilitate communication between all physicians involved in the plan of care and integrate all orders to ensure that services are well coordinated.
  • Quality Assessment and Performance Improvement. The HHA must develop, implement, evaluate, and maintain an effective, ongoing, HHA-wide, data-driven Quality Assessment and Performance Improvement (QAPI) program that is individualized to the HHA and capable of showing measurable improvement in patient outcomes, safety and care quality. The program must adhere to several specific requirements contained in the CoPs. The HHA's governing body must oversee the program. These changes are effective January 13, 2018.
  • Infection Control and Prevention. HHAs must develop an infection control and prevention program that adheres to standards of practice, is integrated into the QAPI program, provides for education of patients, caregivers and staff, and satisfies other requirements.
  • Skilled Professional Services. Skilled professional service providers (skilled nurses, physical therapists, occupational therapists, speech-language pathologists, medical social workers and physicians) performing services for HHA patients have increased responsibilities related to interdisciplinary assessment, communication, education and documentation. All skilled professional service providers must participate in the HHA's QAPI program and in HHA-sponsored training.
  • Home Health Aide Services. Home health aides have several additional training and duty requirements. All home health aides must successfully complete a training and competency program that includes several specific components listed in the CoPs. Home health aides, including those currently employed by HHAs, must also undergo a training and competency evaluation no later than July 13, 2017. Home health aides are also subject to new supervision requirements.
  • Emergency Preparedness. The HHA must have an emergency preparedness plan and training program based on a documented facility-based and community-based risk assessment utilizing an all-hazards approach. If the HHA is part of a system with multiple separately certified health care facilities, the HHA's plan may be integrated with the system's unified emergency preparedness plan.
  • Clinical Records. A HHA must maintain clinical records containing past and current information for every patient accepted by the HHA to receive services. The records must be legible, clear, complete, appropriately authenticated, dated and timed. The records must be retained for five years after the discharge of the patient, unless state law stipulates a longer period of time, even if the HHA discontinues operations.
  • Laboratory Services. If the HHA engages in laboratory testing, other than assisting a patient in self-administering a test, the testing must be conducted in compliance with CMS requirements for clinical laboratories. Additionally, the HHA may not substitute its own equipment for a patient's equipment when assisting with self-administered tests.
  • The primary takeaway from the new CoPs is that HHAs participating in the Medicare or Medicaid programs should review their current policies, procedures and practices against the new CoPs and make modifications as necessary for compliance.