The Centers for Medicare & Medicaid Services (CMS) have issued new Conditions of Participation (CoP) for home health agencies (HHA) that are effective January 13, 2018.  The CoP were originally scheduled to take effect on July 13, 2017; a final rule delaying the effective date until January 13, 2018 was issued this past summer. CMS recently issued draft Interpretive Guidelines that help to clarify some of the new standards.

The CoP are the minimum health and safety standards an HHA must meet in order to participate in Medicare and Medicaid. Connecticut has its own regulations governing the licensure of HHAs, so Connecticut HHAs that participate in Medicare and Medicaid must comply with both the CoP and state law. Where the federal and state requirements govern the same subject matter, the HHA must adhere to the more stringent requirement.

To comply with the new CoP, Connecticut HHAs may need to provide additional staff training, revise their patient disclosures and take other actions that require lead time. HHAs in the state should ensure that they have taken appropriate steps so that they can be in compliance on the effective date.

We’ve summarized three significant provisions in the new federal standards that differ in important respects from the Connecticut regulations:

Patient Transfers and Discharges

• Under the new CoP (42 CFR §484.50(d)), patients may be transferred or discharged only for one of the seven exclusive reasons listed in the CoP. These reasons include a transfer or discharge for “cause” when the behavior of the patient (or other person in the patient’s home) is so disruptive, abusive or uncooperative that it seriously impairs the delivery of care. The CoP impose additional obligations on the HHA if the reason for the transfer or discharge is for “cause,” including having a policy in place for the purpose of addressing discharge for “cause” that meets the requirements of the CoP, and making efforts to resolve the problems presented by the behavior. The draft Interpretive Guidelines provide that the clinical record must reflect the HHA’s plan to resolve the issues and the results of the plan implementation, but notes that when staff are threatened or endangered, the HHA may be required to take immediate actions to discharge or transfer the patient without taking measures to resolve the issue.The Connecticut regulations (Regs. Conn. State Agencies §19-13-D72(a)(3)) provide a non-exclusive list of reasons why a patient might be discharged, so Connecticut HHAs should be particularly mindful of the new limitations. Any discharge or transfer on or after January 13, 2018 will need to fit into one of the categories listed in the CoP and, according to CMS, those categories do not include discharges because the HHA experiences a staffing shortage. Further, while Connecticut requires its HHAs to conduct a case review prior to any premature discharge, the new standard requiring an attempt to resolve the problems presented by a patient’s difficult behavior may necessitate more effort on the part of the HHA (except in cases where staff are threatened or endangered).

Administration

• The new CoP replace the current role of the “supervising physician or registered nurse” with a new role of “clinical manager” who is responsible for the oversight of all patient care services and personnel (42 CFR §484.105(c)). The CoP list five specific duties of the clinical manager: (1) making patient and personnel assignments; (2) coordinating patient care; (3) coordinating referrals; (4) assuring that patient needs are continually assessed; and (5) assuring the development, implementation and updates of the individualized plan of care.

The clinical manager must be a physician; physical or occupational therapist; speech-language pathologist; audiologist; social worker; or registered nurse. According to CMS, the duties of the clinical manager cannot be delegated among other personnel. However, an HHA may choose to have more than one clinical manager.

HHAs in Connecticut must be prepared to designate one or more clinical managers who will be responsible for all of the duties specified in the CoP by January 13, 2018. Since Connecticut requires its HHAs to employ a supervisor of clinical services (Reg. §19-13-D68(e)), HHAs in the state might consider whether this individual could also be named the “clinical manager” tasked with the responsibilities outlined in the new CoP.

Quality Assessment and Performance Improvement

• The new CoP revise the requirements for quality assessment and performance improvement (QAPI) (42 CFR §484.65). For example, HHAs must measure, analyze and track quality indicators, including adverse patient events, and other aspects of performance to enable them to assess their services and operations. The QAPI program must be capable of showing measurable improvement, must be individualized to the HHA and must include, at a minimum, those areas that are high-risk, high-volume or problem-prone.In some respects, the new CoP impose stricter requirements on HHAs than do the Connecticut regulations (Reg. §19-13-D76). For example, the new CMS program is more data-driven and HHAs must focus on problem areas. In other respects, the Connecticut rules governing quality assessment are stricter. For example, unlike the new CoP, Connecticut requires its HHAs to prepare an annual written report on the clinical competence of each direct service staff member who is employed by or under contract with the HHA.