Clinical UM Guideline

This document defines private duty nursing (PDN) in the home and the conditions under which it would be considered medically necessary. PDN refers to intermittent and temporary, complex skilled nursing care on an hourly basis in the home by a Registered Nurse (RN) or a Licensed Practical Nurse (LPN)/Licensed Vocational Nurse (LVN). PDN care includes assessment, monitoring, skilled nursing care, and caregiver/family training to assist with transition of care from a more acute setting to home.

Note: Please see the following related documents for additional information:

• CG-DME-47 Noninvasive Home Ventilator Therapy for Respiratory Failure
• CG-MED-19 Custodial Care
• CG-MED-23 Home Health
• CG-MED-71 Chronic Wound Care in the Home or Outpatient Setting
• CG-REHAB-07 Skilled Nursing and Skilled Rehabilitation Services (Outpatient)

Note: Benefit language supersedes this document. PDN service is not a covered benefit under all member contracts/certificates. Please see the text in the footnote of this document regarding Federal and State mandates and contract language, as these requirements or documents may specifically address the topic of PDN.

Medically Necessary:

I. Initial private duty nursing services are medically necessary when both (section A and section B below) are demonstrated in the clinical record:

Section A (Criteria A.1-A.6 must all be met):

1. The services must be skilled and not custodial in nature [See CG-REHAB-07 Skilled Nursing and Skilled Rehabilitation Services (Outpatient) and CG-MED-19 Custodial Care]; and
2. The attending physician must certify the medical necessity of private duty nursing; and
3. The attending physician must approve a written treatment plan with short and long term goals specified; and
4. Services must require the professional proficiency and skills of an RN or LPN/LVN. The decision to use an RN or LPN/LVN is dependent on the type of services required. Private duty nursing performed by an LPN/LVN must be under the supervision of an RN following a plan of care developed by the physician in collaboration with the individual, family/caregiver and private duty nursing; and
5. Services must be performed on a part-time or intermittent visiting basis, according to the defined treatment plan and under the direction of a physician in order to ensure the safety of the individual and to achieve the medically desired result; and
6. The service must be appropriate with regard to standards of good medical practice and not solely for convenience;
   and

Section B (Criterion B.1 and at least one of criteria B.2, B.3, or B.4 below must be met):

1. Private duty nursing is medically necessary for individuals with an unstable condition when all the following criteria are met:
   1. The individual’s condition must be unstable and require frequent nursing assessments and changes in the plan of care. Instability of the individual’s condition means that an individual’s condition changes frequently or rapidly, so that constant monitoring or frequent adjustments of treatment regimens are required. It must be determined that these needs could not be met through a skilled nursing visit, but could be met through private duty nursing; and
   2. The physician has ordered nursing for constant monitoring and evaluation of the individual’s condition on an ongoing basis and makes any necessary adjustment to the treatment regimen; and
   3. The nursing and other adjunctive therapy progress notes indicate that such interventions or adjustments have been made at least monthly and as necessary;
      and
2. Private duty nursing is medically necessary for individuals with respiratory disorder, including but not limited to one of the following:
   1. Dependence on mechanical ventilation; or
   2. Tracheostomy care requiring deep suctioning at least every 4 hours;
      or
3. Private duty nursing is medically necessary for individuals receiving enteral feeding when one of the following is met:
   1. Initial caregiver training for individuals receiving continuous tube feeding (for example, continuous nasogastric (NG), gastrostomy tube (GT), or jejunostomy feedings) until documentation of caregiver competence; or
   2. Enteral feeding (for example, continuous NG, GT, or jejunostomy feedings) complicated by frequent regurgitation, with or without aspiration;
      or
4. Private duty nursing is medically necessary for individuals with a seizure disorder manifested by prolonged seizures, requiring emergent administration of anticonvulsant medication.

II. Continuation of private duty nursing services are considered medically necessary when the following criteria are met:

1. A weekly written progress summary with measurable long-term and short-term goals and a plan of care are required to determine if the individual has reached their optimal level of recovery and a caregiver has been taught to assume care (the frequency of these updates should be at least monthly, at the discretion of the case manager); and
2. Documentation of Section B.1 and at least one of criteria B.2, B.3, or B.4 continues to be met.

III. Private duty nursing for the purpose of caregiver training is considered medically necessary when the following criteria are met:

1. Private duty nursing is appropriate for short-term training for a caregiver of an individual with complex medical needs with the intent of having caregivers assume this role when the individual’s medical condition becomes stable; and
2. The primary caregiver accepts ongoing 24-hour responsibility for the health and welfare of the member.

Not Medically Necessary:

Private duty nursing in the home is considered not medically necessary when it is provided for one or more of the following:

1. Solely for convenience;
2. A stable medical condition;
3. Services to allow the individual’s family to work or to provide respite for the family;
4. Custodial care (See CG-MED 19 – Custodial Care).

The following are examples of services that do not require the skills of a nurse and therefore are considered to be not medically necessary in the home setting unless there is documentation of comorbidities and complications that require individual consideration.

1. Routine services directed toward the prevention of injury or illness.
2. Administration or set-up of oral (PO) medications or both.
3. Application of eye drops or ointments and topical medications.
4. Routine administration of maintenance medications, including insulin. This applies to PO, subcutaneous (SQ), intramuscular (IM) and intravenous (IV) medications.
5. Routine enteral feedings (for example, continuous or bolus nasogastric (NG), gastrostomy tube (GT) or jejunostomy feedings).
6. Routine colostomy care.
7. Ongoing intermittent straight catheterization for chronic conditions.
8. Custodial care by an LPN/LVN or RN.
9. Emotional support, counseling or both.
10. Nasopharyngeal or nasotracheal suctioning.
11. Any duplication of care which is already provided by supply or infusion companies.

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services may be Medically Necessary when criteria are met:

When services are Not Medically Necessary:
For the procedure codes listed above when criteria are not met or for situations designated in the Clinical Indications section as not medically necessary.

PDN is defined as the provision of medically necessary, complex skilled nursing care in the home by an RN or an LPN/LVN. The purpose of PDN is to assess, monitor and provide more individualized and continuous skilled nursing care in the home on an hourly basis; to assist in the transition of care from a more acute setting to home; and to teach competent caregivers the assumption of this care when the condition of the individual is stabilized. The length and duration of PDN services is intermittent and temporary in nature and not intended to be provided on a permanent ongoing basis. Such services are normally billed at an hourly or shift rate. The PDN cannot be a member of the individual’s immediate family or anyone living in the home.

Gay and colleagues (2016) reported the results of a retrospective matched cohort study of 2783 hospitalized children receiving post discharge home health services across 19 states and 7361 matched individuals discharged without home health services between 2004-2012. The outcomes measured were subsequent hospitalizations, hospital days, and readmissions. Although the individuals that received home health services had a higher rate of complex chronic conditions, technology assistance, and neurologic impairment than the control group, 30-day readmission rates were lower in the home health group (18.3% versus 21.5%, p=0.001). At 12 months after the index admission, the home health group averaged fewer admissions (0.8 versus 1.0, p=0.001) and fewer days in the hospital (6.4 versus 6.6, p<0.001) compared with the control group. The authors concluded that children discharged with home health care experienced less hospital utilization than those with similar characteristics who did not use home health care.

The Hospital at Home model (HAH) is a primary means for treating acutely ill patients in many regions of the world, however the HAH model in the USA is not yet mainstream. In November 2020, due to the COVID-19 pandemic, Medicare issued a temporary CMS waiver that allows hospital-level reimbursement for the HAH model. Helberg and colleagues (2023) published a non-randomised, prospective, case-controlled study of 60 individuals with heart failure (HF) enrolled in HAH (n=40) versus admission to the hospital (n=20). Inclusion criteria were individuals aged 18 years or older with known HF (systolic or diastolic) that presented to their community providers or emergency departments with acute decompensated HF requiring inpatient admission. Acute decompensated HF was defined as worsening of specific HF signs including peripheral edema, pulmonary rales, increased abdominal girth, and symptoms such as dyspnea and fatigue caused by abnormal cardiac function, and supported by documentation including electrocardiography, chest X- ray, laboratory tests, or echocardiography. No participants admitted to the HF HAH program required inotropes or oxygen at the time of admission. The study results demonstrate that HAH participants had slightly longer lengths of stay (6.3 days versus 4.7 days), however, fewer adverse events (12.5% versus 35%) compared with the admission group. Participants in the HAH program were less likely to be discharged with post-acute services. Secondary outcomes of 30-day readmission and emergency department usage were similar between the groups. The authors concluded that the HAH pilot program is a safe and effective alternative to hospitalization for appropriately selected individuals presenting with acute on chronic HF.

Bi-level positive airway pressure (BPAP): A mechanical ventilation technique that keeps the airways open by delivering pressurized air at two different pressure levels. When an individual breathes in the machines deliver higher air pressure, when the individual breathes out the machine reduces the air pressure.

Continuous positive airway pressure (CPAP): A mechanical ventilation technique that keeps the airways open by delivering continuous pressurized air through an invasive or noninvasive interface.

Intubation: A surgical procedure in which a tube is placed in the trachea (airway) to keep it open so air can get to the lungs. A nasotracheal tube is inserted through the nares into the trachea. An orotracheal tube is passed through the mouth into the trachea. A tracheostomy tube is inserted through a tracheostomy.

Mechanical Ventilation: A form of life support in which a machine (ventilator) supports the work of breathing when an individual is not able to breathe enough independently.

• Invasive Mechanical Ventilation: Mechanical ventilation provided through an invasive interface such as a nasotracheal, orotracheal, or endotracheal tube.
• Noninvasive Mechanical Ventilation (NIV): The use of a face mask connected to a ventilator that pushes air into the  lungs. Forms of noninvasive ventilation include devices which may be used at home, like CPAP, or BiPAP^®.
• Additionally, the Cuirass Shell Ventilator (Lifecare Services, Inc., McHenry, IL) is another form of NIV that uses biphasic ventilation to inflate the lungs through an externally worn chest wall device.

Prolonged seizures: Continuous seizure activity that lasts 5 minutes or longer, or repetitive seizures lasting fifteen minutes.

Tracheostomy: A surgical procedure in which a hole is created in the trachea through which a tube is inserted to exchange respiratory gasses with the lungs. A tracheostomy may be temporary or permanent.

Ventilation: The process of moving respiratory gasses into and out of the lungs; also called breathing.

Ventilator: A mechanical device capable of providing pressurized air with or without supplemental oxygen and two or more of the following features: pressure support, rate support, volume support or various combinations of pressure, rate, and volume support.

Peer Reviewed Publications:

1. Borchers EL. Improving nursing documentation for private-duty home health care. J Nurs Care Qual. 1999; 13(5):24-43.
2. Donaghy B, Writght AJ. New home care choices for children with special needs. Caring. 1993; 12(12):47-50.
3. Duncan BW, Howell LJ, deLorimier AA, et al. Tracheostomy in children with emphasis on home care. J Pediatr Surg. 1992; 27(4):432-435.
4. Gay JC, Thurm CW, Hall M et al. Home health nursing care and hospital use for medically complex children. Pediatrics. 2016; 135(5).
5. Helberg J, Bensimhon D, Katsadouros V, et al. Heart failure management at home: a non- randomised prospective case–controlled trial (HeMan at Home). Open Heart 2023; 10:e002371.
6. Jessop DJ, Stein RE. Providing comprehensive health care to children with chronic illness. Pediatrics. 1994; 93(4):602-607.
7. Roemer NR. The tracheotomized child. Private duty nursing at home. Home Healthc Nurse. 1992; 10(4):28-32.
8. Sperling RL. New OSHA standards managers must know. Home Healthc Nurse Manag. 2000; 4(4):11-16.

Government Agency, Medical Society, and Other Authoritative Publications:

1. American Academy of Pediatrics Committee on Children with Disabilities. Guidelines for home care on infants, children, and adolescents with chronic disease. Pediatrics. 1995; 96(1 Pt 1):161-164.
2. American Academy of Pediatrics Section on Home Health Care. Guideline for pediatric home health care, 2nd edition. Libby RC, Imaizumi SO Editors. 2009. pp87-88.
3. Centers for Medicare and Medicaid Services. Manual. Available at: https://www.cms.gov/medicare/regulations-guidance/manuals?redirect=/Manuals/PBM/list.asp. Accessed on May 2 , 2024.
   • Home Health Agency Manual. Pub 11. Last updated May 11, 2015.
   • Skilled Nursing Facility. Pub 12. Last updated September 8, 2005.
4. The Global Initiative for Chronic Obstructive Lung Disease. Global Strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. 2024 Report. Available at: https://goldcopd.org/2024-gold-report/. Accessed on May 2, 2024.
5. State of Nevada. Department of Health and Human Services. Division of Health Care Financing and Policy. Medicaid Services Manual. Private duty nursing. Effective December 28, 2018. Available at: http://dhcfp.nv.gov/Resources/AdminSupport/Manuals/MSM/C900/Chapter900/. Accessed on May 2, 2024.
6. State of New York. Department of Health and Human Services. Division of Health Care Financing and Policy. New York State Medicaid Program private duty nursing manual policy guideline. Effective December 27, 2018. Available at: http://dhcfp.nv.gov/uploadedFiles/dhcfpnvgov/content/Resources/AdminSupport/Manuals/MSM/C900/MSM_900_18_12_28.pdf. Accessed on May 2, 2024.
7. Sterni LM, Collaco JM, Baker CD, et al. American Thoracic Society Documents. An official American Thoracic Society clinical practice guideline: pediatric chronic home invasive ventilation. Am J Respir Crit Care Med. 2016; 193(8):e16-35.
8. U.S. Food and Drug Administration (FDA). Medical Devices. CAM-10 Cuirass Shell- No. K792673. Rockville, MD: FDA. January 11, 1980. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K792673. Accessed on May 14, 2024.

1. American Thoracic Society. Mechanical Ventilation. Available at: https://www.thoracic.org/patients/patient-resources/resources/mechanical-ventilation.pdf. Accessed on May 2, 2024.
2. The Cleveland Clinic: BiPAP. Available at: https://my.clevelandclinic.org/health/treatments/24970-bipap. Accessed on May 2, 2024.
3. The Cleveland Clinic: Mechanical Ventilation, Overview. Available at: https://my.clevelandclinic.org/health/treatments/15368-mechanical-ventilation. Accessed on May 2, 2024.

Private Duty Nursing

Federal and State law, as well as contract language including definitions and specific coverage provisions/exclusions, and Medical Policy take precedence over Clinical UM Guidelines and must be considered first in determining eligibility for coverage. The member's contract benefits in effect on the date that services are rendered must be used. Clinical UM Guidelines, which address medical efficacy, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and we reserve the right to review and update Clinical UM Guidelines periodically. Clinical UM guidelines are used when the plan performs utilization review for the subject. Due to variances in utilization patterns, each plan may choose whether or not to adopt a particular Clinical UM Guideline. To determine if review is required for this Clinical UM Guideline, please contact the customer service number on the back of the member's card.