A few weeks ago, CMS released a draft version of Interpretive Guidelines for the new Conditions of Participation. This gives us a bit more insight into some of the regulations but not as much as many in the industry had hoped. The final version has not been released yet so there was a request to push back the requirements for an additional six months to allow agencies time to prepare. That request was denied by CMS and the Conditions of Participation will be effective January 13, 2018 as planned. CMS did make a concession that Civil Monetary Penalties will not be assessed on agencies who are taking steps to be compliant “unless there is an identified Immediate Jeopardy situation.” We posted an article earlier this year covering the nitty and gritty of the new CoPs. With the interpretive guidelines out, we took another dive to help you stay clear of the reefs.

Notice of Rights

Surveyors will be looking to see confirmation that patients and representatives have received verbal and written notification of rights in a language/manner that the patient and representative understand. If documentation shows that the patient does not have a good understanding of English, then there should be evidence that information was provided through competent bilingual staff, interpreters, or technology and/or telephonic interpretation services. There is a listing of “Auxiliary Aids and Services” in §484.50(f) of the guidelines that can assist agencies with alternative communication methods.

Participation and Consent

It will be more important than ever to ensure that clinicians are documenting patient input into their treatment plan. Documentation should show a collaboration between the client and the clinician as the treatment plan evolves and new interventions and goals are conceived. Make sure clinical staff is documenting patient agreement with the treatment plan and any changes.

Refusal of Services

Patients always have the right to refuse services for any reason. This has not changed. What has been cleared up is the clinician’s responsibility to ensure that the patient is educated about risks and potential adverse outcomes that could result from missing planned services. Documentation should reflect this education as well as physician communication, investigation into the patient’s refusal and interventions planned to ensure cooperation with the plan of care going forward. Discharge can be considered for those patients who repeatedly refuse services despite efforts by staff to get patient participation. Again, ensure that the clinical record demonstrates all steps taken.

Discharge for Cause

Make sure that the clinical record and policy and procedures include five essential elements for discharging for cause: (1) Identification of the problems encountered, (2) assessment of the situation, (3) communication with HHA management and the physician responsible for the plan of care, (4) a plan to resolve the issues, (5) results of the plan implementation.

Patient Complaints

Ensure that you have processes for recording, tracking, and investigation of complaints. These processes must be incorporated into your policies and procedures and communicated to all staff. Investigation of complaints should be included in the agency Quality Assurance Performance Improvement (QAPI) program. Surveyors will be looking for documentation of the complaint, the investigation, actions to remove risks to the patient, any findings, and changes to agency policy going forward if needed.

Initial Assessment Visit

If skilled nursing is involved in care, then a Registered Nurse must perform the initial assessment visit. If the case is therapy only, a Physical Therapist or Speech Language Pathologist may perform the assessment visit. As always, the initial assessment visit must be made within 48 hours of the referral or the patient’s return home or on the start of care date ordered by the physician. Agencies who schedule the initial assessment visit outside of these timeframes will be considered out of compliance with timely initiation of care.

Content of the Comprehensive Assessment

The definition of psychosocial status is clarified to be a combination of mental health and functional capacity within the community. Documentation must include identification of the patient’s personal relationships and living environment and assessment of how those elements could affect service delivery and participation.

New content includes assessment and documentation of the patient’s strengths, goals, and care preferences. Examples of patient strengths include “awareness of disease status, knowledge of medications, motivation/ability to perform self-care, and/or implement a therapeutic exercise program, understanding of dietary regimen for disease management, vocational interests/hobbies, interpersonal relationships and supports, and financial stability.” Goals must be patient-specific and developed in collaboration with the patient, the physician, and members of the clinical care team.

All client medication lists must be reviewed by an agency nurse for side effects and drug interactions, including for therapy only cases. Agency policy outlines reporting concerns to the physician.

Plan of Care

Services defined in the plan of care must follow accepted standards of practice. “Accepted standards of practice include guidelines or recommendations issued by nationally recognized organizations with expertise in the field”. The National Guideline Clearinghouse by the Agency for Health Research and Quality (AHRQ) is referenced as a resource for clinical practice guidelines.

The original Conditions of Participation made it appear that every time a verbal order was created, a new plan of care would need to be developed and signed by the physician. The interpretive guidelines have clarified that agencies are required to develop the plan of care and sent it to be reviewed and signed by the physician at the start of care and at least every 60 days or when a significant change in condition occurs.

Please see §484.60(a)(2) for the 16 items that must be included in the plan of care. Item number XII is noteworthy as it is a new addition. Plans of care after the implementation date 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.” For agencies using the CMS-485 form, this can be added to Orders for Discipline and Treatments (field 21). As re-hospitalization continues to be an issue for most home health agencies, CMS has ensured hospitalization risk will be assessed by including it in the mandatory plan of care content.

An item of concern is found in the guidelines for §484.60(c)(1). It states that “the signature and date of the review by the responsible physician verifies the interval between health care plan reviews.” This could prove problematic for agencies who have a significant period of time from the start of the episode and the date the physician signs the order. It would be a good idea to streamline processes to generate the plan of care more quickly and follow up with physicians who take a long time to sign orders.

Verbal Orders

The verbal order regulation has been updated to allow a nurse or other qualified practitioner to document verbal orders according to state licensure requirements. This means LPNs, whose state nurse practice act does not require verbal order co-signature, will not be required to have orders co-signed after January 13, 2018. Check your state’s nurse practice act before removing co-signature restrictions.

And just a reminder that clinicians documenting verbal orders must include the time that they received the order from the physician. Agencies should begin having clinicians note the time as soon as possible to identify and educate non-compliant clinicians going forward and ensure total participation by the implementation date.

Coordination of Care

Patient physicians who give orders that directly relate to home health services are considered involved in the plan of care. Agencies are responsible for ensuring that all physicians involved in the plan of care are communicated with and that their orders are integrated into the plan of care.

Clinicians are responsible to ensure that schedules are coordinated to ensure maximum treatment effectiveness. Consideration should be made to the type and amount of services a patient is receiving in a day to minimize patient discomfort or fatigue. Inter-disciplinary communication is documented to provide evidence of collaboration to ensure progress toward goals is optimized.

Written Information to the Patient

In addition to rights and responsibilities, discharge and transfer policies, privacy notices, and agency contact information, make sure all patients receive:

  • a visit schedule with frequencies of all disciplines included,
  • their medication list with name, dose, frequency and which medications will be administered by agency personnel,
  • any treatments to be administered,
  • any other pertinent instructions related to the patient’s home health care, and
  • the name and contact information for the agency Clinical Manager.

Quality Assessment and Performance Improvement (QAPI)

Enforcement of the QAPI portion of the regulations is delayed to July 13, 2018 but agencies are expected to begin the foundation work as soon as possible to be ready to comply by the deadline. As talked about in the prior article, the Governing Body of the agency has the responsibility to drive the QAPI program and ensure that the focus is relevant to the agency and that there is evidence of improvement as a result of the program or a reasonable explanation of why improvement was unable to be achieved. Relevance is determined by either high risk, high volume, or problem-prone areas. Patient outcomes, adverse events and infection control are among the data to be considered.

It is expected that skilled professional staff will participate in the agency’s QAPI program. Ensure that staff is involved in the program and that documentation reflects that participation as well as inservice training.

Infection and Control

All clinical staff is to be educated on and follow good infection control practice. Review your policies and procedures to confirm they are in line with the Center for Disease Control and Prevention (CDC) guidelines on hand hygiene, environmental cleaning and disinfection, injection and medication safety, appropriate use of personal protective equipment, minimizing potential exposures, and reprocessing of reusable medical equipment between each patient and when soiled.

Home Health Aide Training and Competency

Ensure Home Health Aides are educated and assessed as competent in communication skills and recognizing and reporting changes in skin condition. These are additional training guidelines to the annual Aide training requirements.

Review the skills listed in §484.80(c) and make sure that those designated as requiring observation are assessed appropriately. All skills must be evaluated either by observation or written exam annually.

Emergency Preparedness

Refer to our recent article on this subject for specific information. The Emergency Preparedness portion of the regulation went into effect on November 15, 2017.

Discharge Summary

The elements that a surveyor will be looking for in a discharge summary are spelled out in the guidelines for §484.110(a)(6). Ensure your discharge summary is sent to the primary care physician within 5 business days of discharge and includes these 9 elements: (1) Admission and discharge dates, (2) Physician responsible for the home health plan of care, (3) Reason for admission to home health, (4) Type of services provided and frequency of services, (5) Laboratory data, (6) Medications the patient is on at the time of discharge, (7) Patient’s discharge condition, (8) Patient outcomes in meeting the goals in the plan of care, and (9) Patient and family post-discharge instructions.

In Conclusion

It all comes down to care coordination, patient participation and documentation. The home health industry has shifted away from the traditional model of clinicians driving care and services to a much more patient-centered approach. Agencies unable to adjust to this new paradigm will inevitably be subject to more deficiencies and a very bleak future. And while CMS has given the industry a one-year reprieve on Civil Monetary Penalties concerning new Condition level deficiencies, you can be sure that surveyors will still be giving deficiencies and taking note of agencies who do not appear to be well prepared for the new Conditions of Participation. So spare yourself a bigger headache down the road and put in the legwork to position your agency for success now.