The Centers for Medicare & Medicaid Services (CMS) has issued final regulations (CMS-3819-F) that will make substantial changes to the Medicare home health agency Conditions of Participation (CoPs). These sweeping changes take effect July 13, 2017, and represent the most comprehensive changes to the CoPs since 1989.

The final regulations, dated January 9, 2017, include numerous new requirements relating to: nursing; therapy and aide services; supervision assessments; patients’ rights; care planning; quality improvement; clinical records; agency structure; governance; management; and other compliance hurdles for home health agencies (HHAs) that participate in Medicare and Medicaid (New York State bases its program regulations on the CoPs). The compliance burden will be significant as CMS estimates these regulatory changes will cost HHAs $293 million nationally in the first year, and $290 million each subsequent year. This comes at a time in New York when HHAs are working to address the issues related to a minimum wage increase.

Although CMS touted the final regulations as a mechanism to streamline and improve care to patients, the CoPs include numerous provisions that require significant operational, functional and structural changes to be implemented by HHAs, making it important for HHAs to carefully read the new regulations and understand the changes to the CoPs that are necessary during the compressed timeframe for implementation.

Highlighted below are several of the significant CoPs changes slated for this year.

Agency Structure

The definition of “branch office” has been modified such that a parent agency must provide supervision and administrative control of branch offices on a “daily basis,” to the extent that the branch depends upon the parent agency’s supervision and administrative functions in order to meet the CoPs. While the CoPs do not explicitly define what constitutes adequate supervision and control, the CoPs put great emphasis of oversight on branch offices by imputing violations by a branch office as violations by the HHA as a whole.

Additionally, the definition would no longer require the branch offices to be “sufficiently close” to the parent agency. Instead, the parent agency would have to be available to meet the needs of any situation and respond to issues that could arise with respect to patient care or administration of the agency.

Personnel Qualification

HHAs will need to assess their current staffing structure and employee qualifications and make any necessary changes quickly. While the personnel qualifications requirements have been reorganized within the regulations, many qualifications have remained the same, except for the following two significant changes:

Clinical Manager. Starting in July 2017, there will be a new requirement that HHAs designate a clinical manger (which can be one or more individuals). The clinical manager provides oversight of all patient-care services and personnel, including: making patient and personnel assignments, coordinating patient care, coordinating referrals, assuring that patient needs are continually assessed, and assuring the development, implementation, and updates of the individualized plan-of-care. A clinical manager must be a licensed physician, physical therapist, speech-language pathologist, occupational therapist, audiologist, social worker, or a registered nurse (including a nurse practitioner or other advanced practice nurse). The clinical manager must be available during all operating hours.

Administrator. The personnel qualifications for HHA administrators also will change. Administrators beginning employment after July 13, 2017, will need to be: (1) a licensed physician, registered nurse, or hold an undergraduate degree; and (2) have at least one year of supervisory or administrative experience in home health care or a related health care program.

Comprehensive Assessment

Caregiver Assessment. In response to comments received on the 2014 proposed regulations, the final rule requires HHAs to include information regarding caregiver willingness, ability, and availability to provide care in the comprehensive assessment. The collection of this information is designed to assess and capture a caregiver’s comfort level in carrying out tasks to ensure proper caregiver education and coordination of home care. While recognized as a best practice, and encouraged by CMS, the collection of caregiver information does not impute an affirmative obligation on HHAs to screen for caregiver depression or strain.

Emergency Department and Hospital Readmission Assessment. Reflecting the goal to reduce unnecessary hospital admissions, the final regulations impose a re-hospitalization assessment obligation for all HHA patients (the proposed rule applied the assessment to just those receiving home care immediately following discharge). As a result, all patient plans of care must include a description of the patient’s risk for emergency department visits and hospital re-admission, and all necessary interventions to address the underlying risk factors. The final regulations also eliminated the “low, medium, and high” risk assessment designations in the proposed regulations, but issued no further guidance or standardized tool for assessments, citing a desire to create HHA flexibility and innovation to reduce unnecessary emergent care visits and hospital admissions.

Record Retention and Documentation

Authentication. The CoPs require that clinical records be “appropriately authenticated, dated and timed.” CMS clarified that all record entries are subject to this standard and stressed that clinical records should “tell a linear story of the course of the patient’s care.” HHAs should stress the importance of accurate records and ensure that the time an event occurred is reflected, which will not necessarily be the same as the time of entry. While the CoPs do not contain a specific timeframe requirement for authentication, this does not relieve HHAs from compliance with any state law timeframe requirements.

Retention and Patient Requests. Clinical records must be retained for five years after the discharge of the patient. Patients also must be afforded free and timely access to their records. Clinical records must be made available within four business days of a request or at the next home visit, whichever is shorter.

OASIS Reporting Requirements

HHAs must ensure that patient identifiable OASIS data is transmitted using electronic communications software that complies with the Federal Information Processing Standard. HHAs also must ensure that patient identifiable information is kept confidential and not disclosed to the public.

This is merely a snapshot of the numerous new conditions slated to take effect in July.