Billing chart: Blue Cross highlights medical, benefit policy changes

Established
15822, 15823, 67900, 67901, 67902, 67903, 67904, 67906, 67908

Experimental

Basic benefit and medical policy

Blepharoplasty and brow ptosis repair

Blepharoplasty procedures of the upper eyelid and repair of brow ptosis are safe and effective restorative procedures when performed to correct:

• Visual impairment due to dermatochalasis, blepharochalasis or blepharoptosis
• Symptomatic redundant skin weighing down on upper lashes
• Prosthetic difficulties in an anophthalmic socket
• Blepharospasm unresponsive to conservative treatment

Blepharoplasties of the lower lid are considered primarily cosmetic in nature. This service is usually performed to improve appearance or self-esteem, not to treat a specific disease state or improve function.

Inclusionary criteria have been updated, effective Sept. 1, 2023.

Inclusions:

Criteria for blepharoplasty:

This procedure is considered reconstructive and not cosmetic when one of the following solid bullets are met:

• Visual field measurement is obtainable and all the following are met:
• There is a difference of 12 degrees or more or at least 30% superior visual field difference is demonstrated between visual field testing before and after manual elevation of the upper eyelids
• The medical record should include visual field testing reports in both taped and untaped positions. Photographs should be maintained as part of the medical record, including photographs demonstrating the head held in an erect position with eyes open and focused straight ahead. Views should reveal the full-face anterior position, as well as the right and left lateral views with a straightforward gaze.
• Visual field measurement isn’t obtainable and all the following are met:
• Infants and children whose blepharoptosis is severe enough to cause a functional visual impairment.
• While it may not be possible to obtain visual field measurements, documentation and photographs reflective of the lid obstruction should be maintained as part of the medical record.
• To relieve eye symptoms associated with blepharospasm when other treatments have failed or are contraindicated (such as an injection of Botulinum Toxin A).
• Correction of an anophthalmic socket when one of the following are met:
• There is documented difficulties with a prosthesis due to lid position.
• A margin reflex distance of 2.5 mm or less.
• A palpebral fissure height on down-gaze of 1 mm or less.

Criteria for repair of brow ptosis (browplasty) and blepharoptosis:

This procedure is considered reconstructive and not cosmetic if all the following criteria are met:

• There is a difference of 12 degrees or more or at least 30% superior visual field difference is demonstrated between visual field testing before and after manual elevation of the upper eyelids.
• The medical record should include visual fieldtesting reports in both taped and untaped positions. Photographs should be maintained as part of the medical record. Views should reveal the full-face anterior position, as well as the right and left lateral views with a straightforward gaze.

Clinical review of these procedures is usually required. Providers should consult the plan to determine whether photographs should be forwarded with the request. Photos should be maintained in the record in the event they’re requested for later review.

Exclusions:

• Lower lid blepharoplasty is considered cosmetic.
• Blepharoplasty/ptosis repair or brow lift surgery to improve the appearance when no functional impairment exists is considered cosmetic.

30469

Basic benefit and medical policy

Low-dose radiofrequency for nasal valve

Low-dose, temperature-controlled radiofrequency intranasal tissue remodeling as a treatment of nasal airway obstruction is considered experimental. The positive affect on clinical outcomes hasn’t been definitively demonstrated, effective Sept. 1, 2023.

Inclusionary and exclusionary guidelines:

Not applicable

38204,38205, 38206, 38207, 38208, 38209, 38210, 38211, 38212, 38213, 38214, 38215, 38230, 38232, 38240, 38241, 38242, 38243, 81265, 81266, 81267, 81268, 81370, 81371, 81372, 81373, 81374, 81375, 81376, 81377, 81378, 81379, 81380, 81381, 81382, 81383, 86812, 86813, 86816, 86817, 86821, S2140, S2142, S2150

Basic benefit and medical policy

HCT for acute lymphoblastic leukemia

The safety and effectiveness of hematopoietic cell transplantation for acute lymphoblastic leukemia have been established. It may be considered a useful therapeutic option for individuals who meet specific selection criteria.

Inclusionary criteria have been clarified, effective Sept. 1, 2023.

Inclusionary and exclusionary guidelines:

Childhood acute lymphoblastic leukemia

Inclusions:

• Autologous or allogeneic hematopoietic cell transplantation to treat childhood acute lymphoblastic leukemia, or ALL, in first complete remission^a but at high risk^b of relapse.
• Autologous or allogeneic cell transplantation to treat childhood ALL in second or greater remission or refractory ALL.
• Allogeneic hematopoietic cell transplantation to treat relapsing ALL after a prior autologous HCT.
• Reduced-intensity conditioning allogeneic hematopoietic cell transplantation as a treatment of ALL in children who are in complete^a first or second remission and who, for medical reasons, would be unable to tolerate a standard myeloablative conditioning regimen.

^aDefined by bone marrow biopsy/aspirate demonstrating < 5% blasts

^bChildhood high risk factors for relapse
Adverse prognostic factors and factors associated with high risk of relapse in children include the following:

• Age younger than 1 year or older than 9  
• White blood cell count at presentation above 50,000/μL
• Hypodiploidy (<45 chromosomes)
• Translocation involving chromosomes 9 and 22 (t[9;22]), also known as BCR-ABL fusion
• Translocation involving chromosomes 4 and 11 (t[4;11]) aka MLL-AF4 fusion
• Pre-B or T-lineage immunophenotype
• Central nervous system involvement
• Poor response to initial therapy including poor response to prednisone prophase
• Poor treatment response to induction therapy at six weeks with high-risk having ≥ 0.01% minimal residual disease measured by flow cytometry

Exclusions:

• All other conditions not listed above

Adult acute lymphoblastic leukemia

Inclusions:

• Autologous hematopoietic cell transplantation to treat adult ALL in first complete remission^a but at high risk^b of relapse
• Allogeneic hematopoietic cell transplantation to treat adult ALL in first complete remission^a for any risk level
• Allogeneic hematopoietic cell transplantation to treat adult ALL in second or greater remissions, or in adults with relapsed or refractory ALL
• Allogeneic hematopoietic cell transplantation to treat relapsing ALL after a prior autologous HCT
• Reduced-intensity conditioning allogeneic hematopoietic cell transplantation as a treatment of ALL in adults who are in complete^a first or second remission and who, for medical reasons, would be unable to tolerate a standard myeloablative conditioning regimen

^aDefined by bone marrow biopsy/aspirate demonstrating < 5% blasts

^bAdult high risk factors for relapse
Individual with any of the following may be considered at high-risk for relapse:

• Older than 35 years
• Leukocytosis at presentation of greater than 30,000/μl (B-cell lineage) or greater than 10,000/μl (T-cell lineage)
• “Poor prognosis” genetic abnormalities like the Philadelphia chromosome (t[9;22])
• Extramedullary disease
• Time to attain complete remission longer than four weeks

Exclusions:

• Autologous hematopoietic cell transplantation to treat adult ALL in second or greater remission or those with refractory disease

38204, 38205, 38207, 38208, 38209, 38210, 38211, 38212, 38213, 38214, 38215, 38230, 38240, 38242, 38243, 81267, 81268, 81370, 81371, 81372, 81373, 81374, 81375, 81376, 81377, 81378, 81379, 81380, 81381, 81382, 81383, 86812, 86813, 86816, 86817, 86821, S2140, S2142, S2150

Basic benefit and medical policy

BMT – HCT for genetic diseases and acquired anemias, allogeneic

The safety and effectiveness of allogeneic hematopoietic cell transplantation for specified genetic diseases and acquired anemias have been established. It may be considered a useful therapeutic or diagnostic option when indicated.

Inclusionary and exclusionary criteria have been updated, effective Sept. 1, 2023.

Inclusions:

Allogeneic hematopoietic cell transplantation is considered established for select individuals as listed below.

The conditioning regimens for the following diseases may include myeloablative conditioning, reduced intensity conditioning or non-myeloablative conditioning as determined by the treating provider/transplant center.

Hemoglobinopathies

• Sickle cell anemia for children or young adults
• Homozygous beta-thalassemia (i.e., thalassemia major)

Bone marrow failure syndromes

• Aplastic anemia including hereditary (including Fanconi anemia, dyskeratosis congenita, Shwachman-Diamond syndrome, Diamond-Blackfan syndrome) or acquired (e.g., secondary to drug or toxin exposure) forms.

Primary immunodeficiencies

• Absent or defective T-cell function
• Absent or defective natural killer function
• Absent or defective neutrophil function

The following diseases are examples of the above:

• Lymphocyte Immunodeficiencies
• Adenosine deaminase deficiency
• Artemis deficiency
• Calcium channel deficiency
• CD 40 ligand deficiency
• Cernunnos/X-linked lymphoproliferative disease deficiency
• CHARGE syndrome with immune deficiency
• Common gamma chain deficiency
• Deficiencies in CD45, CD3, CD8
• DiGeorge syndrome
• DNA ligase IV deficiency syndrome
• Interleukin-7 receptor alpha deficiency
• Janus-associated kinase 3 deficiency
• Major histocompatibility class II deficiency
• Omenn syndrome
• Purine nucleoside phosphorylase deficiency
• Recombinase-activating gene 1/2 deficiency
• Reticular dysgenesis
• Severe combined immunodeficiency
• Winged helix deficiency
• Wiskott-Aldrich syndrome
• X-linked lymphoproliferative disease
• Zeta-chain-associated protein-70 deficiency

• Phagocytic deficiencies
• Chédiak-Higashi syndrome
• Chronic granulomatous disease
• Griscelli syndrome, type 2
• Hemophagocytic lymphohistiocytosis
• Interferon-gamma receptor deficiencies
• Kostmann syndrome
• Leukocyte adhesion deficiency
• Severe congenital neutropenias
• Shwachman-Diamond syndrome

• Other immunodeficiencies
• Autoimmune lymphoproliferative syndrome
• Cartilage hair hypoplasia
• CD25 deficiency
• Hyper IgD and IgE syndromes
• Immunodeficiency, centromeric instability, and facial dysmorphism syndrome
• Immunodysregulation polyendocrinopathy enteropathy X-linked syndrome
• Nuclear factor-κ B (NF-κB) essential modulator deficiency
• NF-κB inhibitor, NF-κB-α deficiency
• Nijmegen breakage syndrome

Inherited metabolic disease

• Lysosomal and peroxisomal storage disorders except for Hunter, Sanfilippo and Morquio syndromes

The following diseases are examples of the above:

• Hurler
• Maroteaux-Lamy
• Sly syndromes
• Childhood onset cerebral X-linked adrenoleukodystrophy
• Globoid-cell leukodystrophy
• Metachromatic leukodystrophy
• Alpha-mannosidosis
• Aspartylglucosaminuria
• Fucosidosis
• Gaucher types 1 and 3
• Farber lipogranulomatosis
• Galactosialidosis
• GM1
• Gangliosidosis
• Mucolipidosis II (I-cell disease)
• Multiple sulfatase deficiency
• Niemann-Pick
• Neuronal ceroid lipofuscinosis
• Sialidosis
• Wolman disease

Genetic disorders affecting skeletal tissue

• Infantile malignant osteopetrosis (Albers-Schönberg disease or marble bone disease)

Exclusions:

Allogeneic HCT hasn’t been effective in treating:

• Hunter syndrome
• Sanfilippo syndrome
• Morquio syndrome

58679, 58825, 58970, 58974, 76948, 89250, 89254, 89258, 89259, 89268, 89335, 89337, 89342, 89343, 89346, 89352, 89353, 89356

Experimental
89398, 89344, 89354, 89335

Basic benefit and medical policy

Infertility related to cancer treatment

Preservation of fertility (including collection of oocytes and spermatozoa; cryopreservation, storage and thawing of embryos, oocytes and spermatozoa) may be considered established for individuals diagnosed with cancer and at risk for treatment-related infertility when criteria are met.

Inclusionary and exclusionary criteria have been updated, effective Sept. 1, 2023.

Inclusions:

• Preservation of fertility in a post-pubertal biological female or a post-pubertal biological male may be considered established when:
• The individual is diagnosed with cancer, and the cancer treatment will result in irreversible infertility, such as with:
• Gonadotoxic chemotherapy
• Radiation therapy of the pelvis, lower abdomen or total body
• Surgical removal of ovaries or testicles

Procedures that may be considered established in fertility preservation:

• Collection of mature oocytes and spermatozoa
• Cryopreservation of embryos, mature oocytes and spermatozoa
• Storage of embryos, mature oocytes and spermatozoa for up to two years
• Thawing of embryos, mature oocytes and spermatozoa within two years of the procurement
• Culture of oocytes
• Ovarian transposition (in anticipation of pelvic or lower abdominal radiation)
• Embryo transfer, back to the member, within two years from cryopreservation

Exclusions:

• Storage of sperm, oocytes or embryos for longer than two years
• Co-culture of embryos
• Post-menopausal females
• Individuals who have undergone elective sterilization (vasectomy, tubal sterilization), with or without reversal
• Request for fertility preservation that doesn’t meet inclusion criteria
• Other assisted reproductive techniques, unless the member has additional benefit coverage for these services.
• Cryopreservation of ovarian tissue, immature oocytes and testicular tissue in post-pubertal biological males
• Cryopreservation of testicular tissue in pre-pubertal biologic males

80145, 80230, 80280, 80299,** 83520**

Experimental
84999**

Basic benefit and medical policy

Measurement of serum and anti-drug antibody levels

Measurement of biologic agent drug levels and, if low, anti-drug antibody levels in individuals with inflammatory bowel disease, or IBD, is established.

Measurement of antidrug antibodies in other individuals being treated with a biologic agent, either alone or as a combination test, which includes the measurement of serum TNF blocking agent levels, is considered experimental. The use of these tests hasn’t been clinically proven to improve patient clinical outcomes or alter patient management.

The medical policy statement and inclusionary and exclusionary criteria have been updated, effective Sept. 1, 2023.

Inclusions:

Biologic agent drug levels are established in individuals who meet all the following:

• Diagnosed with inflammatory bowel disease
• Being treated with either Adalimumab, Infliximab, Ustekinumab and Vedolizumab
• Being monitored for their response to the agent by biologic agent drug level

If the biologic agent drug level is below the therapeutic range, testing for the anti-drug antibody level is established.

Exclusions:

• Any condition other than inflammatory bowel disease

81513, 81514, 87510- 87512, 87480- 87482, 87660, 87661

Experimental:
0352U

Basic benefit and medical policy

Testing for diagnosis of vaginitis

Nucleic acid amplification test or polymerase chain reaction, known as PCR, testing and multitarget PCR testing, when limited to known pathogenic species, is considered established for the diagnosis of vaginitis (BV, candidiasis, trichomonas) in symptomatic individuals, effective Sept. 1, 2023.

Inclusions: 

The following are considered established for the management of vaginitis:

• Nucleic acid amplification test or PCR testing and multitarget PCR testing, when limited to known pathogenic species, is considered established for the diagnosis of vaginitis (BV, candidiasis, trichomonas) in symptomatic individuals.

Exclusions:

• All other tests for vaginitis not addressed above are considered experimental.

89253

Basic benefit and medical policy

*89253 removed from Physician Office Laboratory List

Procedure code *89253 was removed from the Physician Office Laboratory List. This procedure can no longer be performed in a physician’s office.

97129, 97130

Basic benefit and medical policy

Cognitive rehabilitation

The safety and effectiveness of cognitive rehabilitation (as a distinct and definable component of the rehabilitation process) have been established. It may be considered a useful therapeutic option in the rehabilitation of patients meeting specific selection criteria.

Exclusionary criteria have been updated, effective Sept. 1, 2023.

Group variations:

Be sure to check individual contract, certificate and rider for specific coverage information.

Inclusions:

Cognitive rehabilitation is an established procedure when used as an adjunctive treatment of cognitive deficits (e.g., attention, language, memory, reasoning, executive functions, problem-solving and visual processing) when all the following criteria are met:

1. The cognitive deficits have been acquired as a result of neurologic impairment due to traumatic brain injury or stroke.
2. Services must be provided by a qualified licensed professional and must be prescribed by the attending physician as part of the written care plan.
3. There must be documentation of potential for improvements based on the patient’s pre-injury function.
4. Patients must be able to actively participate in the program. The patient must have sufficient cognitive function to understand and participate in the program as well as adequate language expression and comprehension (e.g., the patient shouldn’t have severe aphasia).

The member is expected to make significant cognitive improvement (e.g., the member isn’t in a vegetative or custodial state).

Exclusions:

Excluded diagnoses include, but aren’t limited to:

• Mental retardation
• Multiple sclerosis
• Cerebral palsy
• Encephalopathy
• S/P brain surgery
• Dementia (e.g., from Alzheimer’s disease, HIV-infection or Parkinson’s disease)
• Cognitive decline chronic obstructive pulmonary disease
• Behavioral or psychiatric disorders such as attention-deficit/hyperactivity disorder and schizophrenia
• Pervasive developmental disorders
• Post-acute cognitive sequelae of SARS-CoV-2 infection
• Autism spectrum disorders
• Seizure disorders
• Cognitive deficits due to brain tumor or previous treatment for cancer

J1741

Basic benefit and medical policy

Caldolor (ibuprofen injection)

Effective May 11, 2023, Caldolor (ibuprofen injection) is covered for the following FDA-approved indications:

Caldolor is a nonsteroidal anti-inflammatory drug indicated in adults and pediatric patients age 3 months and older for the:

• Management of mild to moderate pain and the management of moderate to severe pain as an adjunct to opioid analgesics
• Reduction of fever

Dosage and administration:

• Pediatric (pain and fever) age 3 months to less than 6 months: 10 mg/kg intravenously over 10 minutes up to a maximum single dose of 100 mg

J3490

Basic benefit and medical policy

Abilify Asimtufii (aripiprazole)

Abilify Asimtufii (aripiprazole) is considered established when criteria are met, effective April 27, 2023.

Abilify Asimtufii (aripiprazole) is an atypical antipsychotic indicated:

• For the treatment of schizophrenia in adults
• As maintenance monotherapy treatment of bipolar I disorder in adults

Dosage and administration:

• For patients naïve to aripiprazole, establish tolerability with oral aripiprazole before initiating treatment with Abilify Asimtufii (aripiprazole).
• Administered by intramuscular injection in the gluteal muscle by a health care professional. Don’t administer by any other route. 
• Recommended dosage is 960 mg administered once every two months as a single injection. Dose can be reduced to 720 mg in patients with adverse reactions.
• Missed doses: Dosage adjustment may be required.
• Known CYP2D6 poor metabolizers: Recommended dosage is 720 mg administered once every two months as a single injection.

Dosage forms and strengths:

Extended-release injectable suspension: 960 mg/3.2 mL and 720 mg/2.4 mL single-dose pre-filled syringes

Abilify Asimtufii (aripiprazole) isn’t a benefit for URMBT.

J3490

Basic benefit and medical policy

Roctavian (valoctocogene roxaparvovec-rvox)

Roctavian (valoctocogene roxaparvovec-rvox) is considered established, effective June 29, 2023.
Coverage of Roctavian (valoctocogene roxaparvovec-rvox) is provided when all the following are met:

• FDA-approved age
• Prescribed by or in consultation with a specialist who works in a hemophilia treatment center
• Diagnosis of severe hemophilia A with factor VIII level < 1% IU/dL
• Must not have detectable pre-existing immunity to the AAV5 capsid as measured by AAV5 transduction inhibition or AAV5 total antibodies
• Must not have a history of factor VIII inhibitors and results for a modified Nijmegen-Bethesda assay of less than 0.6 Bethesda units (BU) on two consecutive occasions at least one week apart within the past 12 months must be submitted to the plan
• Must have been treated with or exposed to factor VIII concentrates or cryoprecipitate for a minimum of 150 exposure days
• Must be treatment experienced with Hemlibra for at least six months and experienced treatment failure, defined as any of the following:
• Spontaneous soft tissue bleeding event
• Micro-bleeding into a joint
• Ongoing joint pain of a known target joint B

Quantity limitations, authorization period and renewal criteria:

• Quantity limit: FDA-approved dosing
• Authorization period: Three months with no renewal

This drug isn’t a benefit for URMBT.

J3490
J3590

Basic benefit and medical policy

Vyjuvek (beremagene geperpavec-svdt)

Vyjuvek (beremagene geperpavec-svdt) is considered established, effective May 19, 2023.

Coverage of Vyjuvek (beremagene geperpavec-svdt) is provided when all the following are met:

• FDA-approved age
• For the treatment of open wounds in patients with a diagnosis of dystrophic epidermolysis bullosa as confirmed by all the following:
• Skin biopsy of an induced blister with immunofluorescence mapping or transmission electron microscopy
• Genetic test results documenting mutations in the COL7A1 gene
• Patient must not have current evidence or a history of squamous cell carcinoma in the area undergoing treatment.
• Trial and failure, intolerance or a contraindication to the preferred products as specified in the Blue Cross Blue Shield of Michigan medical utilization management drug list B.

Quantity limitations, authorization period and renewal criteria:

• Quantity limit: Align with FDA-recommended dosing.
• Initial authorization period: Six months
• Renewal criteria: Clinical documentation must be provided to confirm that current criteria are met and that the medication is providing clinical benefit.

This drug isn’t a benefit for URMBT.

J9173

Basic benefit and medical policy

Imfinzi (durvalumab)

The FDA has updated the payable indications for Imfinzi (durvalumab), effective Sept. 2, 2022. The payable indications include the following:

Imfinzi is a programmed death-ligand 1 (PD-L1) blocking antibody indicated in combination with gemcitabine and cisplatin, as treatment of adult patients with locally advanced or metastatic biliary tract cancer, or BTC.

Dosage and administration:

Administer Imfinzi as an intravenous infusion over 60 minutes after dilution.

BTC:

• Weight of 30 kg and more: Administer Imfinzi 1,500 mg every three weeks in combination with chemotherapy and then 1,500 mg every four weeks as a single agent.
• Weight less than 30 kg: Administer Imfinzi 20 mg/kg every three weeks in combination with chemotherapy and then 20 mg/kg every four weeks as a single agent.

S9123, S9124

Basic benefit and medical policy

Private duty nursing

Private duty nursing may be considered established when specified criteria are met (refer to inclusionary and exclusionary guidelines).

Inclusionary and exclusionary criteria have been updated, effective June 1, 2023.

Inclusions:

All must be met:

• The PDN services must be ordered by a physician, M.D. or D.O., who is involved in the ongoing care of the patient.
• The patient must have a need for skilled nursing care. 
• The patient’s condition must be complex or medically fragile.
• The patient’s complex or fragile condition requires continuous assessment, observation and monitoring.
• The patient must be medically stable at the time of discharge from the hospital such that PDN services can be provided safely.
• At least two caregivers (family, friends, etc.) must be trained and competent to give care.
• The patient needs skilled care that exceeds the scope of intermittent care.
• The family or caregivers must provide at least eight hours of skilled care/day (a maximum of 16 hours per day of PDN care may be approved per day if medical necessity criteria are met).
• Training and teaching activities by the private duty nurse to teach the patient, family or caregivers how to manage the treatment regimen is required and considered a skilled nursing service.
• Training is no longer appropriate if, after a reasonable period of time, the patient, family or caregiver won’t or isn’t able to be trained.
• If the caregiver/family member can’t or won’t accept responsibility for the care, private duty nursing will be considered not medically necessary as the home would be deemed an unsafe environment.
• Criteria for specific conditions, if present, in addition to the medically complex and or fragile condition of the patient, one of the following must be present:
• Tracheostomy tube suctioning is necessary for secretion control and required at least twice per eight-hour shift. (Tracheostomy tube changing is skilled; tracheostomy hygiene care isn’t.)
• Management of tube drainage, complex wounds, cavities or irrigations require documentation of services on the record when they occur.
• Complex medication administration (excluding PO medications that would ordinarily be taken by self-administration) of drugs with potential for serious side effects or drug interactions require documentation and appropriate monitoring. This includes intravenous administration of drugs or nutrition.
• Tube feedings that require frequent changes in formulation or administration rate or have conditions that increase the aspiration risk requires documentation.

PDN for patients on ventilators

• For patients who are on ventilators after discharge or suffer an acute event, up to 30 days of PDN services may be authorized.
• Ventilator management: There must be documentation of the initial settings of mode of ventilation, tidal volume, respiratory rate and wave form modifications, if any, PEEP, and FIO2 at the beginning of each shift.
• Oxygen saturation must be measured continuously for ventilator patients and any changes from baseline recorded thereafter.
• Hourly observations of the patient’s clinical condition related to the ventilator management must be documented along with any changes in oxygen saturation.
• The goal is to transition ventilator care to family or caregivers once the member is stable.    When family or caregivers can provide the patient’s routine ventilator care, including weaning (when appropriate), under the direction of their health care professional, the patient is deemed stable.

Ventilator care/management isn’t considered a skilled service requiring PDN nursing.

Exclusions:

Services of a private duty nurse are considered not covered in any of the following instances:

• The PDN is acting as a nurse’s aide.
• Custodial care (bathing, feeding, exercising, homemaking, giving oral medications or acting as a companion/sitter) doesn’t qualify for PDN.
• The private duty nurse is a member of the patient’s household or if the cost of care is provided by one of the patient’s relatives (by blood, marriage or adoption).
• The PDN is for maintenance care after the patient’s condition has stabilized (including routine ostomy care, tube feeding administration and tracheostomy or ventilator management). 
• Medical and nursing documentation shows that the patient’s condition is stable/predictable or controlled, and a licensed nurse isn’t required to monitor the condition.
• Care plan indicates a licensed nurse isn’t required to be in continuous attendance.
• Care plan doesn’t require hands-on nursing interventions (Note: Observation in case an intervention is required isn’t considered skilled care.)
• The caregiver or patient’s family has demonstrated the ability to carry out the plan of care.
• If the patient’s anticipated need is indefinite, lifetime private duty nursing isn’t a benefit.
• The care is for a person without an available caregiver in the home. 
• It’s for respite care that includes (list isn’t all inclusive):
• Care during a caregiver vacation
• The convenience of the family or caregiver, so that the caregiver may attend work, school or care for other family members.
• If the caregiver or family can’t or won’t accept responsibility for the care, private duty nursing will be considered not medically necessary as the home would be deemed an unsafe environment.
• The PDN is provided outside the home (for example, school, nursing facility or assisted living facility).
• It’s a duplication or overlap of services (for example, when a person is receiving hospice care services or for the same hours of a skilled nursing home care visit).
• It’s for observational purposes only.
• The skilled nursing is provided as part-time/intermittent and not continuous care.

Documentation requirements need all of the following:

• Current plan of care signed by a physician (M.D. or D.O.) or signed by an advanced practitioner (NP, CNS or PA) in accordance with state law.
• Plan of care must reflect the patient’s current clinical condition and be updated at least every three months.
• Care plans greater than three months may indicate the patient is stable or that care is maintenance.
• A comprehensive assessment of the patient’s health status, including documentation of the skilled need and medication administration record.
• Discharge summary or recent progress note if patient is being discharged from an inpatient setting.
• Consultation notes if the patient is receiving services from subspecialist.
• Hourly documentation of the clinical information and services performed is required.

Additional documentation clarifying clinical status (such as well-child check or specialist visit notes) may be requested if clinical documentation provided doesn’t support the hours required.