On January 13, 2017 CMS published the final rule for the Conditions of Participation (CoPs) for Home Health Agencies (HHAs). According to the document, the main reason for the change is to update the regulations for home health and shift the focus of home health to increase patient participation, encourage interdisciplinary communication, and ensure better outcomes. Unless otherwise stated, most items referenced are effective July 13, 2017. While this blog will share a lot of details of what was contained in the final rule, readers are encouraged to view the final rule in its entirety available as a downloadable PDF or as a website page. In the PDF, the actual regulation begins on page 76. Preceding it are the public’s comments along with the response from CMS. I encourage you to read the commentary for additional insight into the meaning of the various aspects of the rule.

Definitions

CMS starts with clarifying the language to be used in the CoPs. Definitions of note are “Verbal Order”, clarified to be “a physician order that is spoken to appropriate personnel and later put in writing for the purposes of documenting as well as establishing or revising the patient’s plan of care. ”, and “Representative”, which is “the patient’s legal representative, such as a guardian, who makes health-care decisions on the patient’s behalf, or a patient-selected representative who participates in making decisions related to the patient’s care or well-being, including but not limited to, a family member or an advocate for the patient. The patient determines the role of the representative, to the extent possible.” Also noteworthy is the dropping of “subunit”. In fact, entities currently operating as subunits will be considered parent HHAs effective July 13, 2017 unless they apply to be branch offices if able to do so. Subunits should look into their state’s current regulations immediately to determine what options are available to them and how to proceed. If a subunit becomes a distinct HHA, it “will be required to independently meet all CoPs, including having an independent governing body and administrator”.

Patient Care – Patient Rights

Of great importance is the new guidance stating that the patient and the patient’s legal representative (if there is one) must receive the written rights and responsibilities, transfer and discharge policy, contact information for the Administrator for complaints, and the OASIS privacy notice before any services can be provided. This information needs to be understandable to the patient and/or the patient’s legal representative. The clinician performing the comprehensive assessment should obtain the signature(s) to demonstrate that the notice was received. Verbalized notice of rights and responsibilities must be provided by the completion of the second skilled visit in a language and/or manner that the patient and/or their representative understands. The HHA has four business days from the initial evaluation date to provide the patient’s selected representative (this person may be different from the legal representative) with a copy of the written rights and responsibilities as well as the agency’s transfer and discharge policy. While not explicitly stated in the regulation, in responding to public comments on the proposed rule, CMS states that “We would expect an HHA to document in the patient’s record that a patient declined to have a copy of the notice of rights provided to the representative.” Therefore, make sure that your documentation shows whether the patient has designated a representative or declined one. If a representative is chosen, indicate what information the patient wants their representative to have access to, including the date and transmission method of rights and responsibilities along with the transfer and discharge policy, if authorized.

Provisions have been added for clients who lack legal capacity to make healthcare decisions. Patients with a court-appointed representative may have that person exercise their home health rights. Patients who have not been legally declared to be unable to make their own healthcare decisions may still request a representative to exercise their rights. Agencies are advised to review court orders to determine the extent a patient may be allowed to exercise their individual rights.

The CoPs continue into detail about what home health patients have a right to. Most of these rights are familiar, such as treating patients with respect, upholding the confidentiality of the clinical record, advising of the services to be provided, and the charges the patient may be responsible for in their care. The patient has always had the right to be informed and to participate in planning care and treatment. Now the regulation explicitly states that the patient has the right to “consent or refuse care in advance of and during treatment” and delineates some of the areas where patient input would be expected adding “completion of all assessments”, “establishing and revising the plan of care”, “expected outcomes of care, including patient-identified goals, and anticipated risks and benefits”, and “any factors that could impact treatment effectiveness”. Patients must also be advised of the contact information for their local Agency on Aging, Center for Independent Living, Protection and Advocacy Agency, Aging and Disability Resource Center, and Quality Improvement Organization.

As already mentioned above, patients and their representatives (legal representative and the patient’s designated representative who could be a different individual) must be provided written information about the home health agency’s transfer and discharge policies. The CoPs outline acceptable reasons for transfer and discharge and details the steps of a discharge for cause in situations such as abusive or extremely uncooperative behavior. Patient and the patient’s representatives must additionally be provided with applicable investigation of complaints and accessibility policies. The regulation’s standard for investigation of complaints dives into a bit more detail about what should be investigated, expands notification duties to all staff, including contracted employees, and reminds agencies to take action to prevent further violations while investigating. The accessibility standard reminds agencies to provide information in a manner that can be understood by patients who may have limited language skills or disabilities.

Patient Care – Comprehensive Assessment of Patients

One of the major changes is the allowance for the resumption of care to occur on a physician-ordered resumption of care date if it is not appropriate for the resumption to happen within 48 hours of the patient’s discharge from the hospital or facility. Additionally, all elements of the comprehensive assessment are consolidated into one standard which expands upon the existing standard’s content to include gathering more information about the patient’s psychosocial, functional and cognitive status. There is an expectation that agencies will use standardized assessments where available, though it is not explicitly stated in the CoPs. There are websites cited in the comment and response portion of this section (specifically responses 7 and 8) which could be helpful resources in your preparation efforts. Clinicians will also be required to gather information about the patient’s strengths, goals, and care preferences, the caregivers’ availability, ability and level of comfort to provide care, and any information about non-clinical patient representatives.

Patient Care – Care Planning, Coordination of Services, and Quality of Care

This section does a good job of consolidating and listing the elements expected to be in a plan of care. Most of the items are familiar, however, there are a few new and expanded-upon elements. Agencies will need to add a risk assessment for hospitalization and interventions to address the risk factors identified. Patient and caregiver education or training to help meet discharge goals is another element to be incorporated in care plan’s goals/outcomes as are patient-centered interventions and measurable outcomes collaborated on by the clinician and the patient. Advance directives information was also added. All verbal orders are to continue to be recorded in your plans of care.

Speaking of orders, there are two big changes for agencies to account for. First, when documenting verbal orders, clinicians will have to write the order, sign, date and time it. Then, the agency will need to have the physician sign and date the order to authenticate it. Yes, clinicians will need to document the time they received the verbal order from the physician. According to CMS, this is a proactive measure to ensure that patients whose clinical needs change rapidly (potentially multiple times in one day) have their orders recorded in the correct sequence. The second change is allowing LPNs to receive verbal orders in states where the code permits LPNs to do so. Check your state’s applicable practice act to verify for your state.

Revisions to the plan of care, because of a patient’s change in health status, must be communicated to the patient, their representative(s), their caregiver, and all physicians issuing orders for the plan of care. Any changes in the plans for patient discharge must be communicated to all of the above and the primary care physician or other health care professional who will be providing medical services after discharge from the agency.

Care coordination is now more clearly spelled out to include communication with all physicians involved in the plan of care, integrating orders from all physician into the plan of care, and integration of all services. This extends beyond physicians to all medical services the patient is receiving while under home health care. Care coordination is expected to involve the patient, representative(s), and caregiver as appropriate. The agency must also provide to the patient and the representative(s) the visit schedule, medication list, treatments, instructions, and the name and contact information of the agency’s clinical manager as part of their written instructions.

We are not covering the changes to the contents of the discharge summary because they are included in another rule, CMS-3317-P, which, as of this writing, has not been finalized.

Patient Care – Quality Assessment and Performance Improvement (QAPI)

The CoPs are offering more guidance as to what is expected to be present in a Performance Improvement program for an agency. While not explicitly instructing in the exact methods they want used in these programs, CMS is providing a basic framework of what will be reviewed during a survey. The good news is, agencies have a bit more time to comply with this standard. January 13, 2018 is when it is scheduled to be phased in, allowing agencies an additional six months to aggregate data and design meaningful programs. The responsibility for the QAPI program lies with the governing body of the agency. The governing body must make sure that the QAPI program has the proper complexity, selects measures relevant to improving agency outcomes, and is adequately documented to be able to demonstrate its operation.

Essentially, the QAPI program must be able to show measurable improvement in relevant health metrics such as reducing hospital readmissions, improving ambulation, etc. through measurement and analysis of the agency’s quality data. The expectation is that agencies will take a good look at their current data, see where they may be under-performing and focus on those areas to produce a meaningful program. In the words of the CoPs, “Focus on high risk, high volume, or problem-prone areas.”

Remember that thoroughly documenting your QAPI program will be vital. This means, the parameters of the program must be defined and approved by the governing body by January 13, 2018. These parameters should include the metrics to be tracked, the methods involved in analysis, how you plan on improving/preventing the designated indicator, documentation showing that you implemented your plan, follow-up data showing the effect of your intervention, and modified plans if the initial plan did not affect the data in any significant way. As always, if you find any practices that require immediate intervention, especially unsafe practices, fraud or waste, it is expected that such findings would be addressed immediately.

Note, this QAPI initiative is replacing prior standards regarding clinical record review (quarterly chart audits) and evaluation of the agency’s program.

Patient Care – Infection Prevention and Control

While agencies have always been expected to maintain good infection prevention and control, it has its own standard now. This standard places infection control and prevention under the agency’s QAPI program. Agencies are expected to educate their staff, patients and caregivers about infection control measures and ensure all are following accepted standards of practice.

Patient Care – Skilled Professional Services

This section talks about skilled nursing, therapy and social work services. Responsibilities are combined under the title of “skilled professionals” with the added duties of developing and evaluating the plan of care in partnership with the patient, representative and caregiver and participation in the agency’s QAPI program. Supervision is briefly covered for skilled professional assistants.

Patient Care – Home Health Aide Services

The Home Health Aide standard is a section which agencies will want to review for themselves. This standard sets off with home health aide qualifications, summarizing the experience needed to meet home health aide requirements. Noteworthy is the directive that an aide can be disqualified if he/she goes for 24 consecutive months without providing aide services for pay. If that happens, the aide must repeat the program to re-qualify as a home health aide. Adjust your policies and procedures to ensure that you are paying attention to your new CNA’s job history since it will be an important factor in determining whether the aide qualifies to continue working in the same capacity.

There is substantial information about aide training and the competency evaluation. If your agency does its own training and competency programs, you need to make sure that your program remains compliant. The main update in this context is the task of “recognizing and reporting changes in skin condition” along with a few other small clarifications. Agencies are required to retain documentation of each aide’s training and competency evaluation. The competency evaluation must address each of the tasks listed in the training portion of the standard and some of the tasks must be observed while performed with a patient. There are several ways an agency can be disqualified from providing aide training or competency programs. Please review the CoPs for more information.

Aide’s annual inservice training is still set at 12 hours. In addition, there must be at least one annual onsite supervisory visit with each of the agency’s aides. All training is to be supervised by a registered nurse who has at a minimum two years of nursing experience, one of which is in home health care. Registered nurses can still assign home health aides, however, now the standard has been extended to include “other appropriate skilled professional” for cases where nursing may not be the skilled service that qualifies the patient for home health.

The frequency of onsite home health aide supervision (with or without the presence of the aide) remains at 14 days or more often if needed. The supervisory note must now include assessing whether the aide is following the patient’s care plan, whether communication with the patient and patient support people is open and effective, if the aide is competent in executing the tasks, if the aide is following infection prevention and control procedures, whether the aide is appropriately reporting changes in patient’s condition, and if the aide is honoring patient rights. If a deficiency is found during a supervisory visit, the aide must complete a new competency evaluation.

Organizational Environment – Compliance with Federal, State, and Local Laws Related to Patient Safety

To comply with this standard, have the names and addresses of all owners, officers, directors, and managing employees available to surveyors. Also, if an agency refers specimens to a laboratory for testing, the agency is responsible for ensuring that the lab is certified. Agencies may not use their own equipment in place of a patient’s equipment when assisting with self-administered tests.

Organizational Environment – Emergency Preparedness

This standard spells out how an agency would develop an effective emergency preparedness program. It is a loose framework that affords agencies the flexibility in designing their own policy based on their needs. While it is a framework, the CoPs outline specific steps which need to be addressed in each emergency preparedness policy, including maintaining emergency contact names and numbers for staff, contracted entities, patients, and community resources. Development and annual (at least) testing of the emergency plan is mandatory. The requirement for a training program to orient staff to the agency’s emergency preparedness program is stated as are the documentation requirements. Analysis of the emergency preparedness plan is expected. Specific instructions are provided for those agencies who are part of an integrated healthcare system.

Organizational Environment – Organization and Administration of Services

The governing body is more clearly defined as the entity assuming full legal authority and responsibility for all operations and management of the agency. It is expected that the governing body will have an active role in the agency’s operations and decision-making especially concerning management of staff, operations, finances, and the agency’s QAPI program.

The administrator is responsible for the day-to-day operations of the agency. The administrator, or a designee, must be available during all agency operating hours. It is the responsibility of the administrator to ensure that a clinical manager is also available during all operating hours, that all staff hired by the agency are qualified for their respective positions, and that policies and procedures are aligned with rules, regulations and agency practice.

The supervising physician/registered nurse has been replaced with the clinical manager. The clinical manager can be several qualified individuals who supervise patient care services and the employees who provide them. Clinical manager(s) are ultimately responsible for coordinating patient care and referrals, assigning personnel, and ensuring continuing patient needs assessment. Plan of care development, its implementation, and updates are the most vital responsibilities of this position and the main reason that CMS settled on its necessity. According to CMS comments, “Six of the twenty most frequently cited survey deficiencies center on the need for patient care coordination and implementation, including the most frequently cited deficiency related to ensuring that each patient has a written and updated plan of care. These frequent deficiency citations indicate that patient care, as structured under the current CoPs, is not being sufficiently planned, coordinated, and implemented to ensure the highest quality care for all HHA patients at all times. As such, we believe that a new approach is needed in order to consistently achieve improved patient outcomes, and that consolidating these frequently deficient areas under the overall responsibility of a designated management position will address this need.”

The standards covering the parent-branch relationship and services under arrangement have not changed much from prior regulations except for the removal of “subunits” which I addressed earlier in this article. Agencies contracting with other entities to provide services must screen those providers to ensure that they have not been denied Medicare or Medicaid enrollment, been excluded or terminated from Medicaid or any federal healthcare program, had their Medicare or Medicaid billing privileges revoked, or been debarred from government program participation. While CMS admits that the enforcement of these items may be difficult, it expects the agencies to at least have these provisions signed by the contracted entity, check the OIG List of Excluded Individuals and Entities and/or check the System for Award Management periodically where appropriate.

Agencies must still provide skilled nursing and at least one other therapeutic service. At least one of these services must be provided directly, by the agency’s own employees. Other services may be provided under arrangement. If agencies provide outpatient therapy services, they must follow all home health standards as well as the additional standards listed in the CoPs.

For institutional planning, the annual operating budget and the capital expenditure plan have not changed. The only significant change appears to be the removal of the Professional Advisory Committee as a condition of participation replaced by the more robust documentation standards of the QAPI program and the increased responsibilities of the governing body in the accountability for the QAPI program.

Organizational Environment – Clinical Records

The clinical records standard details the information expected to be contained in the patient’s medical record. Much of this is carried over from the prior regulations. New or expanded information includes the discharge summary that is now required to be sent to the health care professional who will be following the patient within 5 business days of the discharge date and the transfer summary which is required to be sent within 2 business days of a planned transfer or 2 days of the day the agency becomes aware of an unplanned transfer if the patient is still in the facility.

There is clarification about record authentication including legibility, signature requirements (with the new time requirement on verbal orders I mention above), and clarification of electronic authentication by “a secured computer entry by a unique identifier” (like your unique user ID and password in therapyBOSS).

Retention of records has been clarified to be 5 years after the discharge date of the patient unless state law requires longer. An agency is responsible for proper record retention even if it discontinues operations. This provision must be stated in the policies and, in the event of an HHA closure, the HHA must notify the state agency (often the Department of Health) of the location of the stored records.

All records must continue to be protected and must be made available to patients free of charge upon their request. The big clarification here is that patient records are to be made available within 4 business days or at the next home visit, whichever comes first.

Organizational Environment – Personnel Qualifications

Administrators hired after July 13, 2017, will be required to be a physician, a nurse, or hold an undergraduate degree AND have at least 1 year of supervisory or administrative experience in health service administration. The old regulations said “or”.

Licensed Practical (Vocational) Nurse had a title update and the qualifications now include supervision under a qualified registered nurse. Social Work Assistant qualifications now include providing services under supervision of a qualified Social Worker.

Audiologist, Occupational Therapist, Occupational Therapy Assistant, Registered Nurse, Physical Therapist, Physical Therapist Assistant, Registered Nurse, and Social Worker remain unchanged from the prior regulations. Home Health Aides are covered earlier in this blog.

Physician qualifications are clarified as a professional acting within the scope of their license with the types of physicians specified.

A clinical manager can be a Physician, Registered Nurse, Physical Therapist, Occupational Therapist, Audiologist, Social Worker, or Speech-Language Pathologist.

Speaking of Speech-Language Pathologists, the qualifications to practice in home health are now made clearer. In order to more closely align the regulations to the Social Security Act §1861, CMS removed the reference to the American Speech-Language-Hearing Association. SLPs now must have a master’s or doctoral degree in speech-language pathology and be licensed as an SLP in the state where they are providing services. If the state does not offer a licensing program, the SLP must have completed 350 clock hours of supervised clinical practicum, performed at least 9 months of full-time speech-language pathology services after obtaining their degree and successfully completed the Secretary-approved national exam in speech-language pathology.

The End?

Thank you all for staying with me through all of this. There is a lot of information and I have served up the biggest chunks for you to chew on and think about. I encourage all agencies to read the Conditions of Participation Final Rule for themselves. Make sure you are signed up for e-mail updates from cms.gov, your fiscal intermediary, and your state agency. They all can be valuable sources of information.