Centers for Medicare and Medicaid Services (CMS) Finalize New Conditions of Participation for Home Health Agencies

On January 13, 2017 CMS published the final rule which revises the Medicare and Medicaid Program: Conditions of Participation (CoP) for home health agencies that have been in existence since the inception of the Medicare program. In 1997 CMS proposed changes to the HHA CoPs but failed to finalize the rule. Instead in 1999 they finalized the portions of that proposed rule which applied to OASIS regulations only.

The new CoPs are effective beginning July 13, 2017 with the exception of a new standard for the development of performance improvement projects which has an implementation date beginning January 13, 2018.

A summary of the major changes is listed below:

1. Revisions to the organization of the CoPs with changes to the citation numbers.
2. Changes to definitions and additions of new definitions.
3. A change in the HHA organizational structure with the removal of “subunits” as a classification effective July 13, 2017. Current subunits must operate as a stand-alone HHA or be approved as a branch.
4. Removal of the definition for bylaws as well as the requirement for the governing body to adopt and periodically review written bylaws.
5. Deletion of standard §484.16 which eliminates the need for a group of professional personnel, referred to as the Professional Advisory Group (PAG) or Professional Advisory Committee (PAC) by most agencies.
6. Significant changes to the standards in condition §484.50 Patient rights which also include specified timeframes for when the verbal and written notices must be provided to the patient and or patient-selected representative.
7. Revised 484.60(b)(4) to permit any nurse or other qualified practitioner acting in accordance with state licensure requirements to receive and document verbal orders from a physician. The previous standard limited the documentation of verbal orders to a registered nurse or qualified therapist.
8. Added a new standard §484.60(e) which requires patients to be provided with written instructions specified in the standard.
9. Creation of a new condition §484.65 which requires the development of a home health agency wide, data-driven quality assessment and performance improvement (QAPI) program.
10. Creation of a new condition §484.70 which requires the development of an infection prevention and control program.
11. Deleted the separate standard §484.52 Evaluation of agency’s program and incorporated those requirements into new standards §484.65 QAPI and §484.70 Infection prevention and control.
12. Grouped the requirements for skilled nursing, therapy services and medical social services into one standard §484.75 Skilled professional services.
13. Moved the previous home health aide services standards to §484.80 which includes changes to the supervision requirements of home health aides.
14. Incorporated the Emergency Preparedness final rule published on September 16, 2016 as condition §484.102 Emergency preparedness.
15. Created a new standard §484.105(c) “Clinical manager” which requires the agency to have one or more qualified individuals in the clinical manager role. This position replaces the former “Supervising physician or registered nurse” role found in the previous regulation.
16. Added new standards for clinic records §484.110(a) Contents of the clinical record, §484.110(b) Authentication, and §484.110(e) Retrieval of clinical records. These standards include specific timeframes for submission of transfer and discharges summaries as well as requests for records.
17. Moved personnel qualifications to §484.115 and modified the specifications for the administrator and created requirements for the new clinical manager role.

The impact of these changes will vary between agencies. Those agencies who maintain an accreditation will already meet many of the standards added, however every agency will need to modify policies, procedures and practices to some degree. It is important that HHAs begin now to evaluate what changes will be required.

The Final rule can be viewed at the Federal Register website.

If you have any questions regarding the new conditions, please contact a Marcum advisor.