april 2018 policy update bulletin - oxhp.com · apr. 1, 2018 trogarzo (ibalizumab-uiyk) is proven...
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UnitedHealthcare respects the expertise of the physicians, health care professionals, and their staff who participate in our network. Our goal is to
support you and your patients in making the most informed decisions regarding the choice of quality and cost-effective care, and to support practice
staff with a simple and predictable administrative experience. The Policy Update Bulletin was developed to share important information regarding
Oxford® Medical and Administrative Policy.*
*Where information in this bulletin conflicts with applicable state and/or federal law, UnitedHealthcare follows such applicable federal and/or state law
April 2018
policy update bulletin Medical & Administrative Policy Updates
2 Oxford® Policy Update Bulletin: April 2018
Oxford® Medical and Administrative Policy Updates
Overview
Oxford
Tips for using the Policy Update Bulletin:
From the table of contents, click the policy title to be
directed to the corresponding policy update summary.
From the policy updates table, click the policy title to view a
complete copy of a new, updated, or revised policy.
Policy Update Classifications
New
New clinical coverage criteria and/or documentation review
requirements have been adopted for a health service (e.g., test, drug,
device or procedure)
Updated
An existing policy has been reviewed and changes have not been made
to the clinical coverage criteria or documentation review requirements;
however, items such as the clinical evidence, FDA information, and/or
list(s) of applicable codes may have been updated
Revised
An existing policy has been reviewed and revisions have been made to
the clinical coverage criteria and/or documentation review requirements
Replaced
An existing policy has been replaced with a new or different policy
Retired
The health service(s) addressed in the policy are no longer being
managed or are considered to be proven/medically necessary and are
therefore not excluded as unproven/not medically necessary services,
unless coverage guidelines or criteria are otherwise documented in
another policy
Note: The absence of a policy does not automatically indicate or imply
coverage. As always, coverage for a health service must be determined
in accordance with the member’s benefit plan and any applicable
federal or state regulatory requirements. Additionally, UnitedHealthcare
reserves the right to review the clinical evidence supporting the safety
and effectiveness of a medical technology prior to rendering a coverage
determination.
This bulletin provides complete details on Oxford® Clinical,
Administrative and Reimbursement Policy updates. The inclusion of
a health service (e.g., test, drug, device or procedure) in this
bulletin indicates only that UnitedHealthcare has recently adopted a
new policy and/or updated, revised, replaced or retired an existing
policy; it does not imply that Oxford® provides coverage for the
health service. In the event of an inconsistency or conflict between
the information provided in this bulletin and the posted policy, the
provisions of the posted policy will prevail. Note that most benefit
plan documents exclude from benefit coverage health services
identified as investigational or unproven/not medically necessary.
Physicians and other health care professionals may not seek or
collect payment from a member for services not covered by the
applicable benefit plan unless first obtaining the member’s written
consent, acknowledging that the service is not covered by the
benefit plan and that they will be billed directly for the service.
A complete library of Oxford® Medical and
Administrative Policies is available at
OxfordHealth.com > Providers > Tools & Resources >
Medical Information > Medical and Administrative Policies.
3 Oxford® Policy Update Bulletin: April 2018
Oxford® Medical and Administrative Policy Updates
In This Issue
Oxford
Clinical Policy Updates Page
NEW
Trogarzo™ (Ibalizumab-Uiyk) - Effective Apr. 1, 2018 ........................................................................................................................................... 7
UPDATED
Assisted Administration of Clotting Factors and Coagulant Blood Products - Effective Apr. 1, 2018 .............................................................................. 7 Bone or Soft Tissue Healing and Fusion Enhancement Products - Effective Apr. 1, 2018 ............................................................................................ 7 Carrier Testing for Genetic Diseases - Effective May 1, 2018 .................................................................................................................................. 8 Clotting Factors and Coagulant Blood Products - Effective Apr. 1, 2018 ................................................................................................................... 8 Collagen Crosslinks and Biochemical Markers of Bone Turnover - Effective Apr. 1, 2018 ............................................................................................ 8 Eloctate™ (Antihemophilic Factor (Recombinant), FC Fusion Protein) for Connecticut Lines of Business - Effective Apr. 1, 2018 ..................................... 8 Exondys 51™ (Eteplirsen) - Effective Apr. 1, 2018 ................................................................................................................................................ 8 Infliximab (Remicade®, Inflectra™, Renflexis™) - Effective Apr. 1, 2018.................................................................................................................. 8 Manipulation Under Anesthesia - Effective May 1, 2018 ......................................................................................................................................... 8 Maximum Dosage - Effective Apr. 1, 2018 ........................................................................................................................................................... 9 Platelet Derived Growth Factors for Treatment of Wounds - Effective Apr. 1, 2018 .................................................................................................... 9 Rituxan® (Rituximab) - Effective Apr. 1, 2018 ...................................................................................................................................................... 9 Routine Foot Care - Effective Apr. 1, 2018 ........................................................................................................................................................... 9 Simponi Aria® (Golimumab) Injection for Intravenous Infusion - Effective Apr. 1, 2018 ............................................................................................. 9 Spinraza™ (Nusinersen) - Effective Apr. 1, 2018 .................................................................................................................................................. 9 Stelara® (Ustekinumab) - Effective Apr. 1, 2018 ................................................................................................................................................. 10 White Blood Cell Colony Stimulating Factors - Effective Apr. 1, 2018 ..................................................................................................................... 10
REVISED
17-Alpha-Hydroxyprogesterone Caproate (Makena™ and 17P) - Effective May 1, 2018 ........................................................................................... 10 Buprenorphine (Probuphine® & Sublocade™) - Effective Apr. 1, 2018 ................................................................................................................... 11 Buprenorphine (Probuphine® & Sublocade™) - Effective Jul. 1, 2018..................................................................................................................... 16 Drug Coverage Criteria - New and Therapeutic Equivalent Medications - Effective Apr. 1, 2018 ................................................................................ 19 Drug Coverage Criteria - New and Therapeutic Equivalent Medications - Effective May 1, 2018 ................................................................................ 19 Drug Coverage Guidelines - Effective Apr. 1, 2018 .............................................................................................................................................. 20
o [CAR-T (Chimeric Antigen Receptor) Cell Therapy] ........................................................................................................................................ 20 o Inflectra (Infliximab) ................................................................................................................................................................................. 20 o Renflexis (Infliximab) ................................................................................................................................................................................ 20 o Sublocade (Buprenorphine Extended-Release) .............................................................................................................................................. 20 o Trogarzo (Ibalizumab) ............................................................................................................................................................................... 20
4 Oxford® Policy Update Bulletin: April 2018
Oxford® Medical and Administrative Policy Updates
In This Issue
Oxford
Drug Coverage Guidelines - Effective May 1, 2018 .............................................................................................................................................. 21 o Atralin (Tretinoin) ..................................................................................................................................................................................... 21 o Aubagio (Teriflunomide) ............................................................................................................................................................................ 21 o Avita (Tretinoin) ....................................................................................................................................................................................... 21 o Avonex (Interferon Beta 1a) ....................................................................................................................................................................... 21 o Betaseron (Interferon Beta 1b) ................................................................................................................................................................... 21 o Biktarvy (Bictegravir/Emtricitabine/Tenofovir Alafenamide) ............................................................................................................................ 21 o Bonjesta (Doxylamine/Pyridoxine) .............................................................................................................................................................. 21 o Bosulif (Bosutinib) ..................................................................................................................................................................................... 21 o Cayston (Aztreonam for Inhalation Solution) ................................................................................................................................................ 21 o Cloderm 0.1% Cream (Clocortolone) ........................................................................................................................................................... 21 o Copaxone (Glatiramer Acetate) ................................................................................................................................................................... 21 o Copaxone (Glatiramer Acetate) 40mg .......................................................................................................................................................... 21 o Cosentyx (Secukinumab) ........................................................................................................................................................................... 22 o Cordran 0.05% Cream (Clurandrenolide) ..................................................................................................................................................... 22 o Cordran 0.05% Lotion (Flurandrenolide) ...................................................................................................................................................... 22 o Cordran Ointment (Flurandrenolide) ............................................................................................................................................................ 22 o Cultivate (Fluticasone Propionate 0.05%) ..................................................................................................................................................... 22 o Decadron (Dexamethasone) ....................................................................................................................................................................... 22 o Desonate 0.05% Gel (Desonide) ................................................................................................................................................................. 22 o Egrifta (Tesamorelin) ................................................................................................................................................................................. 22 o Enbrel (Etanercept) ................................................................................................................................................................................... 22 o Endari (L-Glutamine) ................................................................................................................................................................................. 22 o Extavia (Interferon B-1b) ........................................................................................................................................................................... 22 o Fabior (Tazarotene) ................................................................................................................................................................................... 22 o Firvanq (Vancomycin Hydrochloride) ........................................................................................................................................................... 22 o Gilenya (Fingolimod) ................................................................................................................................................................................. 22 o Glatopa (Glatiramer 20mg [Generic Copaxone]) ........................................................................................................................................... 22 o Halog 0.1% Cream (Halcinonide) ................................................................................................................................................................ 23 o Halog 0.1% Ointment (Halcinonide) ............................................................................................................................................................ 23 o Intrarosa (Prasterone) ............................................................................................................................................................................... 23 o Keveyis (Dichlorphena-Mide) ...................................................................................................................................................................... 23 o Lonhala Magnair (Glycopyrrolate) ................................................................................................................................................................ 23 o Luxturna (Voretigene Neparvovecrzyl) ......................................................................................................................................................... 23 o Mytesi (Crofelemer) .................................................................................................................................................................................. 23 o Nityr (Nitisinone) ...................................................................................................................................................................................... 23 o Plegridy Pen & Prefilled Syringe (Peginterferon Beta-1a) ................................................................................................................................ 23 o Pulmozyme® (Dornase Alfa) ....................................................................................................................................................................... 23 o Rebif (Interferon Beta-1a) .......................................................................................................................................................................... 23 o Retin-A (Tretinoin) (Brand Only) ................................................................................................................................................................. 23
5 Oxford® Policy Update Bulletin: April 2018
Oxford® Medical and Administrative Policy Updates
In This Issue
Oxford
o Retin-A (Tretinoin) (Brand and Generic) ....................................................................................................................................................... 23 o Retin-A Micro (Tretinoin) ............................................................................................................................................................................ 24 o Retin-A Micro Pump (Tretinoin) (Brand and Generic) ..................................................................................................................................... 24 o Rubraca (Rucaparib).................................................................................................................................................................................. 24 o Selzentry ................................................................................................................................................................................................. 24 o Segluromet (Ertugliflozin/Metformin HCL) .................................................................................................................................................... 24 o Siliq (Brodalumab) .................................................................................................................................................................................... 24 o Soliqua .................................................................................................................................................................................................... 24 o Taltz (Ixekizumab) .................................................................................................................................................................................... 24 o Taperdex Pak 6-Day & 12-Day (Dexamethasone) .......................................................................................................................................... 24 o Tazorac (Taxarotene) ................................................................................................................................................................................ 24 o Tecfidera (Dimethyl Fumarate) ................................................................................................................................................................... 24 o Tremfya (Guselkumab) .............................................................................................................................................................................. 24 o Tretin-X 0.075% Cream (Tretinoin) ............................................................................................................................................................. 24 o Tretin-X 0.0375% Cream (Tretinoin) ........................................................................................................................................................... 25 o Tretin-X Kit (Tretinoin) .............................................................................................................................................................................. 25 o Tretinoin (Generic Retin-A) Cream .............................................................................................................................................................. 25 o Tretinoin (Generic Retin-A) Gel ................................................................................................................................................................... 25 o Ultravate ................................................................................................................................................................................................. 25 o Xeljanz (Tofacitinib) .................................................................................................................................................................................. 25 o Xeljanz XR ............................................................................................................................................................................................... 25
Hearing Aids and Devices Including Wearable, Bone-Anchored and Semi-Implantable - Effective May 1, 2018 ........................................................... 25 Implantable Beta-Emitting Microspheres for Treatment of Malignant Tumors - Effective May 1, 2018 ........................................................................ 27 Lemtrada (Alemtuzumab) - Effective May 1, 2018 .............................................................................................................................................. 28 Maximum Dosage - Effective May 1, 2018 ......................................................................................................................................................... 30 Molecular Oncology Testing for Cancer Diagnosis, Prognosis, and Treatment Decisions - Effective Apr. 1, 2018 .......................................................... 30 Office Based Program - Effective May 1, 2018 .................................................................................................................................................... 35 Omnibus Codes - Effective May 1, 2018 ............................................................................................................................................................ 36 Radiopharma-ceuticals and Contrast Media - Effective May 1, 2018 ...................................................................................................................... 37 Trogarzo™ (Ibalizumab-Uiyk) - Effective Jul. 1, 2018 .......................................................................................................................................... 38
RETIRED
Thermal Capsulorrhaphy/ Thermal Shrinkage Therapy - Effective Apr. 1, 2018 ....................................................................................................... 38
Administrative Policy Updates
REVISED
Precertification Exemptions for Outpatient Services - Effective Apr. 1, 2018 ........................................................................................................... 39
6 Oxford® Policy Update Bulletin: April 2018
Oxford® Medical and Administrative Policy Updates
In This Issue
Oxford
Reimbursement Policy Updates
UPDATED
Ambulance - Effective May 7, 2018 ................................................................................................................................................................... 40 From - To Date Policy - Effective May 1, 2018 .................................................................................................................................................... 40 Once in a Lifetime Procedures - Effective May 1, 2018......................................................................................................................................... 40 One or More Sessions - Effective Apr. 16, 2018 .................................................................................................................................................. 40 Procedure and Place of Service - Effective Apr. 16, 2018 ..................................................................................................................................... 40 Time Span Codes - Effective Apr. 16, 2018 ........................................................................................................................................................ 40
REVISED
Ambulance - Effective May 1, 2018 ................................................................................................................................................................... 40 Maximum Frequency Per Day Policy - Effective May 1, 2018 ................................................................................................................................ 43 Prolonged Services - Effective May 1, 2018 ........................................................................................................................................................ 49 Same Day/Same Service Policy (CES) - Effective May 1, 2018 ............................................................................................................................. 51 Time Span Codes - Effective May 1, 2018 .......................................................................................................................................................... 54
7 Oxford® Policy Update Bulletin: April 2018
Clinical Policy Updates
Oxford
Policy Title Effective Date Coverage Rationale
NEW
Trogarzo™ (Ibalizumab-Uiyk)
Apr. 1, 2018 Trogarzo (ibalizumab-uiyk) is proven and/or medically necessary for1 the treatment of multi-drug resistant human immunodeficiency virus (HIV) in patients who meet ALL of the following criteria:
For initial therapy, all of the following: o Both of the following:
Diagnosis of HIV-1 infection
Physician attestation that the patient has multi-drug resistant HIV-1 infection and
o Physician confirms that the patient has been prescribed an optimized backround antiretroviral regimen, containing at least one antiretroviral agent that demonstrates full viral sensitivity/susceptibility; and
o Ibalizumab initial and maintenance dosing is in accordance with the US Food and Drug Administration prescribing information: A single loading dose of 2,000mg intravenously (IV) followed by a maintenance dose of 800mg IV every two weeks thereafter; and
o Initial authorization is for no more than 6 months. For continuation therapy, all of the following:
o Patient has previously received treatment with ibalizumab; and o Physician confirms that the patient has achieved a clinically significant viral response to ibalizumab therapy;
and o Physician confirms that the patient will continue to take an optimized backround antiretroviral regimen, in
combination with ibalizumab; and o Ibalizumab maintenance dosing is in accordance with the US Food and Drug Administration prescribing
information; and
o Authorization is for no more than 12 months.
Policy Title Effective Date Summary of Changes
UPDATED
Assisted Administration of
Clotting Factors and Coagulant
Blood Products
Apr. 1, 2018 Updated list of applicable HCPCS codes to reflect quarterly code edits; revised description for J7188 and J7205
Bone or Soft Tissue Healing and Fusion Enhancement Products
Apr. 1, 2018 Updated coverage rationale; replaced language indicating: o “[The listed services] are proven and medically necessary” with “[the listed services] are proven and/or
medically necessary” o “[The listed services] are unproven and not medically necessary” with “[the listed services] are unproven
and/or not medically necessary”
Updated supporting information to reflect the most current clinical evidence and references
8 Oxford® Policy Update Bulletin: April 2018
Clinical Policy Updates
Oxford
Policy Title Effective Date Summary of Changes
UPDATED
Carrier Testing for Genetic Diseases
May 1, 2018 Updated list of applicable CPT codes; removed 81161
Clotting Factors and Coagulant Blood Products
Apr. 1, 2018 Updated list of applicable HCPCS codes to reflect quarterly code edits; revised description for J7188 and J7205
Collagen Crosslinks and Biochemical
Markers of Bone Turnover
Apr. 1, 2018 Updated non-coverage rationale; replaced language indicating “serum or urine collagen crosslinks or biochemical markers are unproven and not medically necessary” with “serum or urine collagen crosslinks or biochemical
markers are unproven and/or not medically necessary” Updated supporting information to reflect the most current clinical evidence, FDA information, and references
Eloctate™ (Antihemophilic Factor (Recombinant), FC Fusion Protein) for Connecticut Lines
of Business
Apr. 1, 2018 Updated list of applicable HCPCS codes to reflect quarterly code edits; revised description for J7205
Exondys 51™ (Eteplirsen)
Apr. 1, 2018 Updated coverage rationale; reformatted/clarified coverage criterion addressing applicable diagnosis and treating physician
Infliximab (Remicade®, Inflectra™,
Renflexis™)
Apr. 1, 2018 Updated list of applicable HCPCS codes to reflect quarterly code edits: o Added Q5103 and Q5104 o Removed Q5102 and corresponding modifiers ZB (Pfizer) and ZC (Merck)
Updated supporting information to reflect the most current clinical evidence and references
Manipulation Under Anesthesia
May 1, 2018 Updated coverage rationale; replaced language indicating: o “[The listed service] is proven and medically necessary” with “[the listed service] is proven and/or medically
necessary” o “[The listed services] are unproven and not medically necessary” with “[the listed services] are unproven
and/or not medically necessary” Updated and reformatted list of applicable ICD-10 diagnosis codes:
o Transferred content to embedded Excel file format o Removed M72.0, S32.110A, S32.120A, S32.130A, S32.314A, S32.315A, S32.316A, S32.414A, S32.415A,
S32.416A ,S32.424A, S32.425A, S32.426A, S32.434A, S32.435A, S32.436A, S32.444A, S32.445A, S32.446A, S32.454A, S32.455A, S32.456A, S32.464A, S32.465A, S32.466A, S32.474A, S32.475A, S32.476A, S32.484A, S32.485A, S32.486A, and S34.3XXA
Updated supporting information to reflect the most current clinical evidence and references
9 Oxford® Policy Update Bulletin: April 2018
Clinical Policy Updates
Oxford
Policy Title Effective Date Summary of Changes
UPDATED
Maximum Dosage Apr. 1, 2018 Updated coverage rationale; modified HCPCS code based maximum dosage information to reflect quarterly code edits for: Inflectra (infliximab-dyyb)
o Added Q5013 o Removed Q5102 Renflexis (infliximab-abda)
o Added Q5104 o Removed Q5102
Updated list of applicable HCPCS codes to reflect quarterly code edits: o Added Q5103 and Q5104
o Removed Q5102
Platelet Derived Growth Factors for Treatment of Wounds
Apr. 1, 2018 Updated coverage rationale; replaced language indicating: o “[The listed service] is proven and medically necessary” with “[the listed service] is proven and/or medically
necessary” o “[The listed service] is unproven and not medically necessary” with “[the listed service] is unproven and/or
not medically necessary” Updated supporting information to reflect the most current clinical evidence, FDA information, and references
Rituxan® (Rituximab)
Apr. 1, 2018 Updated coverage rationale; added language to clarify: o This policy refers only to Rituxan (rituximab) injection for intravenous infusion o For Rituxan Hycela (rituximab/hyaluronidase human), refer to policy titled Injectable Chemotherapy Drugs:
Application of NCCN Clinical Practice Guidelines Updated supporting information to reflect the most current references
o Replaced reference to “MCG™ Care Guidelines, 21st edition, 2017” with “MCG™ Care Guidelines, 22nd edition, 2018”
Routine Foot Care Apr. 1, 2018 Updated list of applicable HCPCS codes to reflect quarterly code edits; added K0903
Simponi Aria® (Golimumab)
Injection for Intravenous Infusion
Apr. 1, 2018 Updated supporting information to reflect the most current clinical evidence and references; no change to coverage rationale or lists of applicable codes
o Replaced reference to “MCG™ Care Guidelines, Ambulatory Care, 21st edition” with “MCG™ Care Guidelines, Ambulatory Care, 22nd edition”
Spinraza™ (Nusinersen)
Apr. 1, 2018 Updated coverage rationale: o Reformatted/clarified coverage criterion addressing applicable diagnosis and treating physician o Replaced references to “Hammersmith Infant Neurological Exam (HINE)” with “Hammersmith Infant
Neurological Exam Part 2 (HINE-2)” Updated supporting information to reflect the most current clinical evidence and references
10 Oxford® Policy Update Bulletin: April 2018
Clinical Policy Updates
Oxford
Policy Title Effective Date Summary of Changes
UPDATED
Stelara® (Ustekinumab)
Apr. 1, 2018 Updated supporting information to reflect the most current FDA information and references; no change to coverage rationale or lists of applicable codes
White Blood Cell
Colony Stimulating Factors
Apr. 1, 2018 Updated list of applicable HCPCS codes to reflect quarterly code edits; revised description for Q5101
Policy Title Effective Date Summary of Changes Coverage Rationale
REVISED
17-Alpha-Hydroxyprogestero
ne Caproate (Makena™ and 17P)
May 1, 2018
Revised coverage rationale; added language to indicate:
o This policy provides coverage information about the use of injectable (both intramuscular and subcutaneous) 17-alpha-hydroxyprogesterone
caproate
o Subcutaneous injection of 17P is proven and medically necessary for prevention of spontaneous preterm birth when the criteria listed in the policy are met
o Subcutaneous injection of
17P is unproven and not medically necessary for: Prevention of
spontaneous preterm
birth with any of the following:
- Short cervix with or without cerclage and no prior preterm birth
- Current mutli-fetal pregnancy (twins or greater)
- Previous medically
This policy provides coverage information about the use of injectable (both intramuscular and subcutaneous) 17-alpha-hydroxyprogesterone caproate,
commonly called 17P, may also be referred to as 17-OHP, 17-OHPC, 17Pc, Makena™, 17-alpha hydroxyprogesterone, hydroxyprogesterone, hydroxy-progesterone, and hydroxy progesterone. Hereafter, it will be referred to as 17P. Note: Oral and intravaginal formulations of progesterone are not addressed
in this policy and should be obtained through the member’s pharmacy
benefit. Intramuscular and subcutaneous injection of 17P is proven and medically necessary for the prevention of spontaneous preterm birth when ALL of the following criteria are met: Current singleton pregnancy; and History of a prior spontaneous preterm birth of a singleton pregnancy;
and Treatment is initiated between 16 weeks, 0 days of gestation and 26
weeks, 6 days of gestation; and Administration is to continue weekly until week 37 (through 36 weeks, 6
days) of gestation or delivery, whichever occurs first.
Intramuscular and subcutaneous injection of 17P is unproven and not medically necessary for: Prevention of spontaneous preterm birth with any of the following:
o Short cervix with or without cerclage and no prior preterm birth; o Current multi-fetal pregnancy (twins or greater); o Previous medically indicated preterm birth
Initiation of 17P after 26 weeks, 6 days of gestation
11 Oxford® Policy Update Bulletin: April 2018
Clinical Policy Updates
Oxford
Policy Title Effective Date Summary of Changes Coverage Rationale
REVISED
17-Alpha-Hydroxyprogesterone Caproate
(Makena™ and 17P) (continued)
May 1, 2018 indicated preterm birth
Initiation of 17P after 26
weeks, 6 days of gestation
o Oral and intravaginal
formulations of progesterone should be obtained through the member’s pharmacy benefit
Updated supporting information to reflect the most current clinical evidence and references
Although there are ongoing clinical trials to broaden the indications for the use of 17P, at this time uses as indicated above are considered unproven and not medically necessary.
*Additional Information Regarding Compounded 17P: The active ingredient in the compounded 17P and Makena is hydroxyprogesterone
caproate. Both have castor oil as an inactive ingredient. The compounded version can be made with an alternate oil base in the event of patient hypersensitivity to castor oil. Makena has the additional inactive ingredients of benzyl benzoate (1ml and 5ml vials) and benzyl alcohol (a preservative, in
the 5ml vial only). Based on the active ingredient, compounded preservative-free 17P is considered clinically interchangeable with Makena. Compounding pharmacies must comply with United States Pharmacopeia (USP) Chapter 797, which sets standards for the compounding, transportation, and storage of compounded sterile products (CSP).1 The
Pharmacy Compounding Accreditation Board will verify that the pharmacy is adhering to these standards.2
*Note: The FDA has stated that approved drug products provide a greater assurance of safety and effectiveness than do compounded products. Please refer to the U.S. Food and Drug Administration (FDA) section of the policy for additional information.
Buprenorphine (Probuphine® & Sublocade™)
Apr. 1, 2018
Notice of Revision: The following summary of changes has been modified. Revisions to the original policy update announcement are outlined in red below. Please take note of the additional updates to be
implemented on Apr. 1, 2018.
Changed policy title; previously
titled Probuphine® (Buprenorphine)
Revised conditions of coverage/precertification requirements; added language
to indicate precertification is not required for Sublocade however
This policy provides information about the use of buprenorphine formulations administered by either the subcutaneous (SC) or by subdermal implant. This policy refers to the following buprenorphine products: Probuphine® Sublocade™
Probuphine (buprenorphine) subdermal implant is proven and/or
medically necessary for the maintenance treatment of opioid dependence in patients who meet ALL of the following criteria:
Patient has achieved and sustained prolonged clinical stability on transmucosal buprenorphine; and
Patient is currently maintained on a dose of 8mg per day or less of oral, sublingual or transmucosal buprenorphine product equivalent [e.g., Subutex 8 mg or less, Suboxone (or generic equivalent) 8 mg/2 mg or
less, Bunavail 4.2 mg/0.7 mg or less, or Zubsolv 5.7 mg/1.4 mg or less]; and
12 Oxford® Policy Update Bulletin: April 2018
Clinical Policy Updates
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Policy Title Effective Date Summary of Changes Coverage Rationale
REVISED
Buprenorphine (Probuphine® & Sublocade™)
(continued)
Apr. 1, 2018
it is strongly recommended o While no penalty will be
imposed for failure to
request a pre-service review, if one is not requested, a medical necessity review will
be conducted post-service to determine coverage
o It is the referring physician’s responsibility to provide
medical documentation to demonstrate clinical necessity for the medication
o Beginning July 1, 2018, precertification will be required
Revised coverage rationale: o Added language to indicate:
This policy provides information about the use of buprenorphine formulations administered by either
the subcutaneous (SC) or by subdermal implant and refers to the following buprenorphine products: - Probuphine®
- Sublocade™
Buprenorphine extended-release injection (e.g., Sublocade) is proven and/or medically necessary for the
treatment of moderate to severe opioid use disorder in patients who
Patient has been on a stable oral, sublingual or transmucosal buprenorphine dose for six months or longer without any need for supplemental dosing or adjustments; and
Prescriber meets DATA 2000 requirements and has been assigned a unique identification number specific to the prescription of medication assisted therapy (DEA-X); and
Prescriber and/or the healthcare provider performing insertion has successfully completed a live training program specific to Probuphine insertion; and
Submission of medical records (e.g., chart notes, laboratory values)
documenting one of the following: o Initial therapy with Probuphine when meeting all of the following:
Patient has a viable site for implant on the upper arm (inner side of the upper arm about 8-10 cm (3-4 inches) above the medial epicondyle of the humerus in the sulcus between the biceps and triceps muscle).
Patient will not be receiving supplemental oral, sublingual or transmucosal buprenorphine.
Patient has not had an opioid-positive urine drug screen within the previous ninety days prior to insertion.*
or o Continuation therapy with Probuphine when meeting all of the
following:
Patient has only had one Probuphine implant and has a viable, unused site in the contralateral arm.
Patient has not, nor will receive supplemental oral, sublingual, or transmucosal buprenorphine.
Probuphine is not being inserted into a previously used arm or insertion site.
Probuphine is only to be used in a maximum of 2 insertions (once
in each arm). Patient shows no evidence of tampering, extraction, or attempted
removal of the previous Probuphine implant. Patient has not had an opioid-positive urine drug screen since
starting Probuphine therapy.*
*Note: Patients screening positive for opioid use outside of an opioid dependence treatment regimen is evidence that the patient has not achieved or is no longer in sustained, prolonged, clinical stability with
13 Oxford® Policy Update Bulletin: April 2018
Clinical Policy Updates
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Policy Title Effective Date Summary of Changes Coverage Rationale
REVISED
Buprenorphine (Probuphine® & Sublocade™)
(continued)
Apr. 1, 2018
meet all of the following criteria:
Initial Therapy
- Patient is currently maintained on a 8mg to 24mg per day
dose of oral, sublingual, or transmucosal buprenorphine product equivalent for at least 7 days prior to initiation of
extended-release buprenorphine injection; and
- Patient has not, nor
will receive supplemental, oral, sublingual, or
transmucosal buprenorphine; and
- Prescriber meets DATA 2000 requirements and has been assigned a
unique identification number specifc to the prescription of
medication assisted therapy (DEA-X); and
- Sublocade dosing is
in accordance with the U. S. Food and Drug Administration approved labeling: 300mg subcutaneously
their treatment program. Use of Probuphine is not indicated in this population. Patients should use sublingual or transmucosal buprenorphine until the patient can achieve sustained, prolonged, clinical
stability on a low-to-moderate dose (i.e., doses of no more than 8 mg per day of Subutex or Suboxone sublingual tablet or generic equivalent).
Buprenorphine extended-release injection (e.g., Sublocade) is proven and/or medically necessary for the treatment of moderate to severe opioid use disorder in patients who meet ALL of the following criteria:
For initial therapy, all of the following: o Patient is currently maintained on a 8mg to 24mg per day dose of
oral, sublingual, or transmucosal buprenorphine product equivalent for at least 7 days prior to initiation of extended-release buprenorphine injection; and
o Patient has not, nor will receive supplemental, oral, sublingual, or
transmucosal buprenorphine; and o Prescriber meets DATA 2000 requirements and has been assigned a
unique identification number specific to the prescription of medication assisted therapy (DEA-X); and
o Sublocade dosing for is in accordance with the U. S. Food and Drug Administration approved labeling: 300mg subcutaneously monthly for the first 2 months, followed by a maintenance dose of 100 mg
monthly. Dosing may be increased to 300mg monthly; and o Initial authorization will be for no more than 6 months.
or For continuation therapy, all of the following:
o Patient has experienced a treatment success to buprenorphine extended-release therapy; and
o Patient has not, nor will receive supplemental, oral, sublingual, or
transmucosal buprenorphine; and o Prescriber meets DATA 2000 requirements and has been assigned a
unique identification number specific to the prescription of medication assisted therapy (DEA-X); and
o Sublocade dosing is in accordance with the U. S. Food and Drug Administration approved labeling: Maintenance dose of 100 mg
monthly. Dosing may be increased to 300mg monthly; and o Continuation authorization will be for no more than 12 months.
14 Oxford® Policy Update Bulletin: April 2018
Clinical Policy Updates
Oxford
Policy Title Effective Date Summary of Changes Coverage Rationale
REVISED
Buprenorphine (Probuphine® & Sublocade™)
(continued)
Apr. 1, 2018
monthly for the first 2 months, followed by a maintenance
dose of 100 mg monthly; dosing may be increased to
300mg monthly; and - Initial authorization
will be for no more than 6 months
Continuation Therapy - Patient has
experienced
treatment success to buprenorphine extended-release therapy; and
- Patient has not, nor will receive supplemental, oral,
sublingual, or transmucosal buprenorphine; and
- Prescriber meets DATA 2000 requirements and
has been assigned a unique identification number specifc to
the prescription of medication assisted therapy (DEA-X); and
- Sublocade dosing for is in accordance with the U. S. Food and Drug Administration approved labeling: maintenance dose of
Buprenorphine extended-release injection is unproven and/or not medically necessary for pain management.
Probuphine is unproven and/or not medically necessary for: Patients who have not achieved and sustained prolonged clinical stability
and tolerance to opioids for at least six months.
Patients who are maintained on sublingual or transmucosal buprenorphine at doses greater than 8 mg per day.
Patients who are recently tapered to a lower dose of sublingual or transmucosal buprenorphine for the sole purpose of transitioning to
Probuphine. Patients who are new entrants to opioid dependence treatment. Patients who have already had one insertion in each arm. Patient who do not have viable sites for insertion in the upper arm. Patients who have an opioid-positive urine drug screen within the
previous ninety days.
Patient is currently being treated for chronic pain requiring opioids.
15 Oxford® Policy Update Bulletin: April 2018
Clinical Policy Updates
Oxford
Policy Title Effective Date Summary of Changes Coverage Rationale
REVISED
Buprenorphine (Probuphine® & Sublocade™)
(continued)
Apr. 1, 2018
100 mg monthly; dosing may be increased to 300mg
monthly; and - Continuation
authorization will be
for no more than 12 months
o Replaced language indicating:
“Probuphine (buprenorphine) subdermal implant is proven and medically necessary for the maintenance treatment
of opioid dependence” with “Probuphine
(buprenorphine) subdermal implant is proven and/or medically necessary for the maintenance treatment
of opioid dependence” “Probuphine is unproven
and not medically necessary for pain management” with “Buprenorphine
extended-release
injection is unproven and/or not medically necessary for pain management”
“Probuphine is unproven and not medically
necessary for [the listed indications]” with “Probuphine is unproven
16 Oxford® Policy Update Bulletin: April 2018
Clinical Policy Updates
Oxford
Policy Title Effective Date Summary of Changes Coverage Rationale
REVISED
Buprenorphine (Probuphine® & Sublocade™)
(continued)
Apr. 1, 2018 and/or not medically necessary for [the listed indications]”
Updated list of applicable HCPCS codes; added J3490
Updated supporting information
to reflect the most current background information, clinical evidence, FDA information, and references
Buprenorphine (Probuphine® & Sublocade™)
Jul. 1, 2018
Revised conditions of coverage/precertification requirements to indicate precertification with review by a Medical Director or their designee is required for Sublocade
This policy provides information about the use of buprenorphine formulations administered by either the subcutaneous (SC) or by subdermal implant. This policy refers to the following buprenorphine products: Probuphine® Sublocade™ Probuphine (buprenorphine) subdermal implant is proven and/or
medically necessary for the maintenance treatment of opioid dependence in patients who meet ALL of the following criteria:
Patient has achieved and sustained prolonged clinical stability on transmucosal buprenorphine; and
Patient is currently maintained on a dose of 8mg per day or less of oral, sublingual or transmucosal buprenorphine product equivalent [e.g.,
Subutex 8 mg or less, Suboxone (or generic equivalent) 8 mg/2 mg or less, Bunavail 4.2 mg/0.7 mg or less, or Zubsolv 5.7 mg/1.4 mg or less]; and
Patient has been on a stable oral, sublingual or transmucosal buprenorphine dose for six months or longer without any need for supplemental dosing or adjustments; and
Prescriber meets DATA 2000 requirements and has been assigned a
unique identification number specific to the prescription of medication assisted therapy (DEA-X); and
Prescriber and/or the healthcare provider performing insertion has successfully completed a live training program specific to Probuphine insertion; and
Submission of medical records (e.g., chart notes, laboratory values) documenting one of the following:
o Initial therapy with Probuphine when meeting all of the following:
Patient has a viable site for implant on the upper arm (inner side
17 Oxford® Policy Update Bulletin: April 2018
Clinical Policy Updates
Oxford
Policy Title Effective Date Summary of Changes Coverage Rationale
REVISED
Buprenorphine (Probuphine® & Sublocade™)
(continued)
Jul. 1, 2018
of the upper arm about 8-10 cm (3-4 inches) above the medial epicondyle of the humerus in the sulcus between the biceps and triceps muscle).
Patient will not be receiving supplemental oral, sublingual or transmucosal buprenorphine.
Patient has not had an opioid-positive urine drug screen within
the previous ninety days prior to insertion.* or
o Continuation therapy with Probuphine when meeting all of the following:
Patient has only had one Probuphine implant and has a viable, unused site in the contralateral arm.
Patient has not, nor will receive supplemental oral, sublingual, or transmucosal buprenorphine.
Probuphine is not being inserted into a previously used arm or insertion site.
Probuphine is only to be used in a maximum of 2 insertions (once in each arm).
Patient shows no evidence of tampering, extraction, or attempted removal of the previous Probuphine implant.
Patient has not had an opioid-positive urine drug screen since starting Probuphine therapy.*
*Note: Patients screening positive for opioid use outside of an opioid dependence treatment regimen is evidence that the patient has not achieved or is no longer in sustained, prolonged, clinical stability with their treatment program. Use of Probuphine is not indicated in this population. Patients should use sublingual or transmucosal buprenorphine until the patient can achieve sustained, prolonged, clinical
stability on a low-to-moderate dose (i.e., doses of no more than 8 mg
per day of Subutex or Suboxone sublingual tablet or generic equivalent). Buprenorphine extended-release injection (e.g., Sublocade) is proven and/or medically necessary for the treatment of moderate to severe opioid use disorder in patients who meet ALL of the following criteria:
For initial therapy, all of the following: o Patient is currently maintained on a 8mg to 24mg per day dose of
oral, sublingual, or transmucosal buprenorphine product equivalent
18 Oxford® Policy Update Bulletin: April 2018
Clinical Policy Updates
Oxford
Policy Title Effective Date Summary of Changes Coverage Rationale
REVISED
Buprenorphine (Probuphine® & Sublocade™)
(continued)
Jul. 1, 2018
for at least 7 days prior to initiation of extended-release buprenorphine injection; and
o Patient has not, nor will receive supplemental, oral, sublingual, or
transmucosal buprenorphine; and o Prescriber meets DATA 2000 requirements and has been assigned a
unique identification number specific to the prescription of
medication assisted therapy (DEA-X); and o Sublocade dosing for is in accordance with the U. S. Food and Drug
Administration approved labeling: 300mg subcutaneously monthly for the first 2 months, followed by a maintenance dose of 100 mg
monthly. Dosing may be increased to 300mg monthly; and o Initial authorization will be for no more than 6 months.
or For continuation therapy, all of the following::
o Patient has experienced a treatment success to buprenorphine extended-release therapy; and
o Patient has not, nor will receive supplemental, oral, sublingual, or transmucosal buprenorphine; and
o Prescriber meets DATA 2000 requirements and has been assigned a unique identification number specific to the prescription of medication assisted therapy (DEA-X); and
o Sublocade dosing is in accordance with the U. S. Food and Drug Administration approved labeling: Maintenance dose of 100 mg
monthly. Dosing may be increased to 300mg monthly; and o Continuation authorization will be for no more than 12 months.
Buprenorphine extended-release injection is unproven and/or not medically necessary for pain management.
Probuphine is unproven and/or not medically necessary for:
Patients who have not achieved and sustained prolonged clinical stability and tolerance to opioids for at least six months.
Patients who are maintained on sublingual or transmucosal buprenorphine at doses greater than 8 mg per day.
Patients who are recently tapered to a lower dose of sublingual or transmucosal buprenorphine for the sole purpose of transitioning to
Probuphine. Patients who are new entrants to opioid dependence treatment. Patients who have already had one insertion in each arm.
19 Oxford® Policy Update Bulletin: April 2018
Clinical Policy Updates
Oxford
Policy Title Effective Date Summary of Changes Coverage Rationale
REVISED
Buprenorphine (Probuphine® & Sublocade™)
(continued)
Jul. 1, 2018 Patient who do not have viable sites for insertion in the upper arm. Patients who have an opioid-positive urine drug screen within the
previous ninety days.
Patient is currently being treated for chronic pain requiring opioids.
Drug Coverage
Criteria - New and Therapeutic Equivalent Medications
Apr. 1, 2018 Notice of Revision: The following
summary of changes has been modified. Revisions to the original policy update announcement are outlined in red below. Please take note of the additional updates to be
implemented on Apr. 1, 2018. Revised list of medications
requiring precertification through the pharmacy benefit manager (PBM): o Added Impoyz, Noctiva, and
Steglujan o Removed Baxdela Tablet,
Flolipid, and QVAR Redihaler o Updated formulary
alternatives for Acetaminophen/Caffeine/
Dihydrocodeine Bitartrate 325/30/16 mg, and Motofen
Refer to the policy for complete details on Drug Coverage Criteria - New and
Therapeutic Equivalent Medications.
Drug Coverage Criteria - New and Therapeutic
Equivalent Medications
May 1, 2018 Revised list of medications requiring precertification through the pharmacy benefit manager
(PBM): o Added Biktarvy, Bonjesta,
Decadron, Firvanq, Lonhala
Magnair, Segluromet, and Taperdex Pak 6-day & 12-day
o Removed Intrarosa and Nityr
Refer to the policy for complete details on Drug Coverage Criteria - New and Therapeutic Equivalent Medications.
20 Oxford® Policy Update Bulletin: April 2018
Clinical Policy Updates
Oxford
Policy Title Effective Date Drug/Medication Status Summary of Changes
REVISED
Drug Coverage Guidelines
Apr. 1, 2018 [CAR-T (Chimeric Antigen Receptor) Cell Therapy]
Kymriah (Tisagenlecleucel)
Yescarta
(Axicabtagene Ciloleucel)
Updated Updated list of applicable HCPCS codes to reflect quarterly code edits; added Q2041
Inflectra (Infliximab) Updated Updated list of applicable HCPCS codes to reflect quarterly code edits:
o Added Q5103 o Removed Q5102-ZB
Renflexis (Infliximab) Updated Updated list of applicable HCPCS codes to reflect quarterly code edits: o Added Q5104 o Removed Q5102-ZC
Sublocade (Buprenorphine Extended-Release)
New Notice of Revision: The following summary of changes has been modified. Revisions to the original policy update announcement are outlined in red below. Please take note of the amended guidelines to be implemented on
Apr. 1, 2018. Added language to indicate precertification is required through the
Pharmacy Benefit Manager (PBM) Added language to indicate precertification is not required however it is
strongly recommended o While no penalty will be imposed for failure to request a pre-service
review, if you do not request one, a medical necessity review will be conducted post-service to determine coverage
o It is the referring physician’s responsibility to provide medical documentation to demonstrate clinical necessity for the medication
o Beginning July 1, 2018, precertification will be required
Added precertification guidelines; refer to Precertification Guidelines: Buprenorphine (Probuphine® & Sublocade™) for complete details
Trogarzo (Ibalizumab) New Added precertification guidelines; refer to the following policies for
complete details: o Precertification Guidelines:
Trogarzo (Ibalizumab) Review at Launch for New to Market Medications Specialty Medication Administration – Site of Care Review
Guidelines
21 Oxford® Policy Update Bulletin: April 2018
Clinical Policy Updates
Oxford
Policy Title Effective Date Drug/Medication Status Summary of Changes
REVISED
Drug Coverage Guidelines
May 1, 2018 Revised New Jersey Formulary Regulations; refer to Prior Authorization/Notification Guidelines: Prior Authorization/Notification Non-Formulary (i.e., Tier 3 or higher) Copay Adjustment - New Jersey for complete details
Atralin (Tretinoin) Updated Updated prior authorization/notification guidelines; refer to Prior
Authorization/Notification Guidelines: Atralin (Tretinoin) for complete
details
Aubagio (Teriflunomide) Updated Updated prior authorization/notification guidelines; refer to Prior Authorization/Notification Guidelines: Aubagio for complete details
Avita (Tretinoin) Updated Updated prior authorization/notification guidelines; refer to Prior
Authorization/Notification Guidelines: Avita (Tretinoin) for complete details
Avonex (Interferon Beta 1a)
Updated Updated prior authorization/notification guidelines; refer to Prior Authorization/Notification Guidelines: Avonex for complete details
Betaseron (Interferon Beta 1b)
Updated Updated prior authorization/notification guidelines; refer to Prior Authorization/Notification Guidelines: Betaseron for complete details
Biktarvy (Bictegravir/ Emtricitabine/Tenofovir
Alafenamide)
New Added language to indicate precertification is required through the Pharmacy Benefit Manager (PBM)
Added therapeutic equivalent guidelines; refer to Therapeutic Equivalent Guidelines: Drug Coverage Criteria - New and Therapeutic Equivalent
Medications for complete details
Bonjesta (Doxylamine/Pyridoxine)
New Added language to indicate precertification is required through the Pharmacy Benefit Manager (PBM)
Added therapeutic equivalent guidelines; refer to Therapeutic Equivalent Guidelines: Drug Coverage Criteria - New and Therapeutic Equivalent
Medications for complete details
Bosulif (Bosutinib) Revised Revised prior authorization/notification guidelines; refer to Prior Authorization/Notification Guidelines: Bosutinib (Bosulif) for complete details
Revised step therapy guidelines; refer to Step Therapy Guidelines:
Bosutinib (bosulif) for complete details
Cayston (Aztreonam for Inhalation Solution)
Updated Updated prior authorization/notification guidelines; refer to Prior Authorization/Notification Guidelines: Cayston for complete details
Cloderm 0.1% Cream (Clocortolone)
Updated Updated step therapy guidelines; refer to Step Therapy Guidelines: Cloderm for complete details
Copaxone (Glatiramer Acetate)
Updated Updated prior authorization/notification guidelines; refer to Prior Authorization/Notification Guidelines: Copaxone for complete details
Copaxone (Glatiramer Acetate) 40mg
Updated Updated prior authorization/notification guidelines; refer to Prior Authorization/Notification Guidelines: Copaxone for complete details
22 Oxford® Policy Update Bulletin: April 2018
Clinical Policy Updates
Oxford
Policy Title Effective Date Drug/Medication Status Summary of Changes
REVISED
Drug Coverage Guidelines (continued)
May 1, 2018 Cosentyx (Secukinumab) Revised Revised step therapy guidelines; refer to Step Therapy Guidelines: Cosentyx for complete details
Cordran 0.05% Cream (Clurandrenolide)
Updated Updated step therapy guidelines; refer to Step Therapy Guidelines: Cordran for complete details
Cordran 0.05% Lotion (Flurandrenolide)
Updated Updated step therapy guidelines; refer to Step Therapy Guidelines: Cordran for complete details
Cordran Ointment (Flurandrenolide)
Updated Updated step therapy guidelines; refer to Step Therapy Guidelines: Cordran Ointment for complete details
Cultivate (Fluticasone Propionate 0.05%)
Updated Updated step therapy guidelines; refer to Step Therapy Guidelines: Cultivate for complete details
Decadron
(Dexamethasone)
New Added language to indicate precertification is required through the
Pharmacy Benefit Manager (PBM) Added therapeutic equivalent guidelines; refer to Therapeutic Equivalent
Guidelines: Drug Coverage Criteria - New and Therapeutic Equivalent Medications for complete details
Desonate 0.05% Gel
(Desonide)
Updated Updated step therapy guidelines; refer to Step Therapy Guidelines:
Desonate for complete details
Egrifta (Tesamorelin) Updated Updated prior authorization/notification guidelines; refer to Prior Authorization/Notification Guidelines: Egrifta (Tesamorelin) for complete details
Enbrel (Etanercept) Revised Revised step therapy guidelines; refer to Step Therapy Guidelines:
Enbrel for complete details
Endari (L-Glutamine) Revised Revised prior authorization/medical necessity guidelines; refer to Prior Authorization/Medical Necessity Guidelines: Endari for complete details
Extavia (Interferon B-
1b)
Updated Updated prior authorization/notification guidelines; refer to Prior
Authorization/Notification Guidelines: Extavia for complete details
Fabior (Tazarotene) Updated Updated prior authorization/notification guidelines; refer to Prior Authorization/Notification Guidelines: Fabior (Tazarotene) for complete details
Firvanq (Vancomycin
Hydrochloride)
New Added language to indicate precertification is required through the
Pharmacy Benefit Manager (PBM) Added therapeutic equivalent guidelines; refer to Therapeutic Equivalent
Guidelines: Drug Coverage Criteria - New and Therapeutic Equivalent Medications for complete details
Gilenya (Fingolimod) Updated Updated prior authorization/notification guidelines; refer to Prior
Authorization/Notification Guidelines: Gilenya for complete details
Glatopa (Glatiramer 20mg [Generic Copaxone])
Updated Updated prior authorization/notification guidelines; refer to Prior Authorization/Notification Guidelines: Glatopa for complete details
23 Oxford® Policy Update Bulletin: April 2018
Clinical Policy Updates
Oxford
Policy Title Effective Date Drug/Medication Status Summary of Changes
REVISED
Drug Coverage Guidelines (continued)
May 1, 2018 Halog 0.1% Cream (Halcinonide)
Updated Updated step therapy guidelines; refer to Step Therapy Guidelines: Halog for complete details
Halog 0.1% Ointment (Halcinonide)
Updated Updated step therapy guidelines; refer to Step Therapy Guidelines: Halog for complete details
Intrarosa (Prasterone) Revised Revised coverage criteria/precertification requirements to indicate precertification is no longer required
Removed therapeutic equivalent guidelines and corresponding reference
link to policy titled Drug Coverage Criteria - New and Therapeutic Equivalent Medications
Keveyis (Dichlorphena-Mide)
Updated Updated prior authorization/notification guidelines; refer to Prior Authorization/Notification Guidelines: Keveyis for complete details
Lonhala Magnair
(Glycopyrrolate)
New Added language to indicate precertification is required through the
Pharmacy Benefit Manager (PBM) Added therapeutic equivalent guidelines; refer to Therapeutic Equivalent
Guidelines: Drug Coverage Criteria - New and Therapeutic Equivalent Medications for complete details
Luxturna (Voretigene
Neparvovecrzyl)
Revised Revised coverage criteria/precertification requirements to indicate
precertification is required through Oxford’s Medical Management Removed reference link to policy titled Review at Launch for New to
Market Medications
Mytesi (Crofelemer) Updated Updated prior authorization/notification guidelines; refer to Prior Authorization/Notification Guidelines: Mytesi for complete details
Nityr (Nitisinone) Revised Removed therapeutic equivalent guidelines and corresponding reference link to policy titled Drug Coverage Criteria - New and Therapeutic Equivalent Medications
Plegridy Pen & Prefilled Syringe (Peginterferon
Beta-1a)
Updated Updated prior authorization/notification guidelines; refer to Prior Authorization/Notification Guidelines: Plegridy for complete details
Pulmozyme® (Dornase
Alfa)
Updated Updated prior authorization/notification guidelines; refer to Prior
Authorization/Notification Guidelines: Pulmozyme (Dornase Alfa) for complete details
Rebif (Interferon Beta-
1a)
Updated Updated prior authorization/notification guidelines; refer to Prior
Authorization/Notification Guidelines: Rebif for complete details
Retin-A (Tretinoin) (Brand Only)
Updated Updated prior authorization/notification guidelines; refer to Prior Authorization/Notification Guidelines: Retin-A and Retin-A Micro (Tretinoin) for complete details
Retin-A (Tretinoin) (Brand and Generic)
Updated Updated prior authorization/notification guidelines; refer to Prior Authorization/Notification Guidelines: Retin-A and Retin-A Micro (Tretinoin) for complete details
24 Oxford® Policy Update Bulletin: April 2018
Clinical Policy Updates
Oxford
Policy Title Effective Date Drug/Medication Status Summary of Changes
REVISED
Drug Coverage Guidelines (continued)
May 1, 2018 Retin-A Micro (Tretinoin) Updated Updated prior authorization/notification guidelines; refer to Prior Authorization/Notification Guidelines: Retin-A and Retin-A Micro (Tretinoin) for complete details
Retin-A Micro Pump (Tretinoin) (Brand and Generic)
Updated Updated prior authorization/notification guidelines; refer to Prior Authorization/Notification Guidelines: Retin-A and Retin-A Micro (Tretinoin) for complete details
Rubraca (Rucaparib) Updated Updated prior authorization/notification guidelines; refer to Prior
Authorization/Notification Guidelines: Rubraca for complete details
Selzentry Updated Updated prior authorization/notification guidelines; refer to Prior Authorization/Notification Guidelines: Selzentry for complete details
Segluromet (Ertugliflozin/Metformin
HCL)
New Added language to indicate precertification is required through the Pharmacy Benefit Manager (PBM)
Added therapeutic equivalent guidelines; refer to Therapeutic Equivalent Guidelines: Drug Coverage Criteria - New and Therapeutic Equivalent Medications for complete details
Siliq (Brodalumab) Revised Revised prior authorization/medical necessity guidelines; refer to Prior Authorization/Medical Necessity Guidelines: Siliq for complete details
Soliqua Updated Updated prior authorization/medical necessity guidelines; refer to Prior Authorization/Medical Necessity Guidelines: Soliqua for complete details
Taltz (Ixekizumab) Revised Revised prior authorization/medical necessity guidelines; refer to Prior Authorization/Medical Necessity Guidelines: Taltz for complete details
Taperdex Pak 6-Day & 12-Day (Dexamethasone)
New Added language to indicate precertification is required through the Pharmacy Benefit Manager (PBM)
Added therapeutic equivalent guidelines; refer to Therapeutic Equivalent Guidelines: Drug Coverage Criteria - New and Therapeutic Equivalent Medications for complete details
Tazorac (Taxarotene) Updated Updated prior authorization/notification guidelines; refer to Prior Authorization/Notification Guidelines: Tazorac (Taxarotene) for complete details
Tecfidera (Dimethyl Fumarate)
Updated Updated prior authorization/notification guidelines; refer to Prior Authorization/Notification Guidelines: Tecfidera for complete details
Tremfya (Guselkumab) Revised Added prior authorization/notification guidelines; refer to Prior Authorization/Notification Guidelines: Tremfya
Removed prior authorization/medical necessity guidelines and corresponding reference link to policy titled Prior Authorization/ Medical Necessity Guidelines: Tremfya
Tretin-X 0.075% Cream (Tretinoin)
Updated Updated prior authorization/notification guidelines; refer to Prior Authorization/Notification Guidelines: Tretin-X (Tretinoin) for complete details
25 Oxford® Policy Update Bulletin: April 2018
Clinical Policy Updates
Oxford
Policy Title Effective Date Drug/Medication Status Summary of Changes
REVISED
Drug Coverage Guidelines (continued)
May 1, 2018 Tretin-X 0.0375% Cream (Tretinoin)
Updated Updated prior authorization/notification guidelines; refer to Prior Authorization/Notification Guidelines: Tretin-X (Tretinoin) for complete details
Tretin-X Kit (Tretinoin) Updated Updated prior authorization/notification guidelines; refer to Prior Authorization/Notification Guidelines: Tretin-X (Tretinoin) for complete details
Tretinoin (Generic Retin-
A) Cream
Updated Updated prior authorization/notification guidelines; refer to Prior
Authorization/Notification Guidelines: Retin-A and Retin-A Micro (Tretinoin) for complete details
Tretinoin (Generic Retin-A) Gel
Updated Updated prior authorization/notification guidelines; refer to Prior Authorization/Notification Guidelines: Retin-A and Retin-A Micro (Tretinoin) for complete details
Ultravate Updated Updated prior authorization/medical necessity guidelines; refer to Prior Authorization/Medical Necessity Guidelines: Ultravate for complete details
Xeljanz (Tofacitinib) Revised Revised prior authorization/notification guidelines; refer to Prior Authorization/Notification Guidelines: Xeljanz for complete details
Revised step therapy guidelines; refer to Step Therapy Guidelines: Xeljanz for complete details
Xeljanz XR Revised Revised prior authorization/notification guidelines; refer to Prior Authorization/Notification Guidelines: Xeljanz XR for complete details
Revised step therapy guidelines; refer to Step Therapy Guidelines: Xeljanz XR for complete details
Policy Title Effective Date Summary of Changes Coverage Rationale
REVISED
Hearing Aids and Devices Including Wearable, Bone-
Anchored and
Semi-Implantable
May 1, 2018
Revised coverage rationale: o Replaced language
indicating:
“[The listed services] are
proven and medically necessary” with “[the listed services] are proven and/or medically necessary”
“[The listed services] are unproven and not
medically necessary” with “[the listed
Wearable Hearing Aids (Including Non-Implantable Bone Conduction Hearing Aids Utilizing a Headband)
Hearing Aids required for the correction of a hearing impairment (a
reduction in the ability to perceive sound which may range from slight to complete deafness) are proven and/or medically necessary.
Bilateral or unilateral bone-anchored Hearing Aids utilizing a headband (without osseointegration) are proven and/or medically necessary for hearing loss in a patient who is not a candidate for an air-conduction Hearing Aid and when used according to U.S. Food and Drug Administration (FDA) labeled indications, contraindications, warnings and precautions. See the FDA section of the policy for more information.
26 Oxford® Policy Update Bulletin: April 2018
Clinical Policy Updates
Oxford
Policy Title Effective Date Summary of Changes Coverage Rationale
REVISED
Hearing Aids and Devices Including Wearable, Bone-
Anchored and Semi-Implantable (continued)
May 1, 2018
services] are unproven and/or not medically necessary”
o Removed language indicating unilateral or bilateral fully or partially
implantable bone-anchored Hearing Aids are proven and medically necessary for sensorineural hearing loss in
both ears when both of the following criteria are present: The poorer ear is not a
candidate for an air-conduction Hearing Aid
due to a speech reception threshold of 70
dB or more OR a word discrimination score of less than 60%; and
The better hearing ear has a speech reception
threshold of 35 dB or less and a speech discrimination score of 60% or more
Modified definition of “Degree of Hearing Loss”
Updated supporting information
to reflect the most current clinical evidence, FDA information, and references
Semi-Implantable Electromagnetic Hearing Aids (SEHA)
A semi-implantable electromagnetic Hearing Aid is proven and/or medically necessary for Sensorineural Hearing Loss in a patient who is not a candidate for an air-conduction Hearing Aid and when used according to U.S. Food and Drug Administration (FDA) labeled
indications, contraindications, warnings and precautions. See the FDA section of the policy for more information. Bone Anchored Hearing Aids
Implantable Bone-Anchored Hearing Aid (BAHA) for Sensorineural Hearing Loss
A unilateral fully or partially implantable bone-anchored Hearing Aid is proven and/or medically necessary for Sensorineural Hearing Loss in one ear in a patient who is not a candidate for an air-conduction Hearing Aid and when used according to U.S. Food and Drug Administration (FDA) labeled indications, contraindications,
warnings and precautions. See the FDA section of the policy for more
information. Implantable Bone-Anchored Hearing Aid (BAHA) for Conductive or Mixed Hearing Loss
A unilateral fully or partially implantable bone-anchored Hearing Aid is proven and/or medically necessary for Conductive or Mixed Hearing Loss in one or both ears in a patient who is not a candidate
for an air-conduction Hearing Aid and when used according to U.S. Food and Drug Administration (FDA) labeled indications, contraindications, warnings and precautions. See the FDA section of the policy for more information.
Bilateral fully or partially implantable bone-anchored Hearing Aids are proven and/or medically necessary for Conductive or Mixed
Hearing Loss in both ears in a patient who is not a candidate for an air-conduction Hearing Aid and when used according to U.S. Food and Drug Administration (FDA) labeled indications, contraindications, warnings and precautions. See the FDA section of the policy for more information.
27 Oxford® Policy Update Bulletin: April 2018
Clinical Policy Updates
Oxford
Policy Title Effective Date Summary of Changes Coverage Rationale
REVISED
Hearing Aids and Devices Including Wearable, Bone-
Anchored and Semi-Implantable (continued)
May 1, 2018 Totally Implanted Middle Ear Hearing Systems
Totally implanted middle ear hearing systems are unproven and/or not medically necessary for hearing loss. There is inadequate evidence demonstrating the efficacy of totally implanted middle ear hearing systems for treating hearing loss or deafness. Well-
designed studies with larger patient populations and longer follow-up are required to demonstrate the safety and benefits of these devices. Intraoral Bone Conduction Hearing Aids
An intraoral bone conduction Hearing Aid is unproven and/or not medically necessary for treating hearing loss. There is insufficient evidence to support the use of an intraoral bone conduction Hearing Aid to treat hearing loss. The quality of the studies was low due to small study populations, short follow-up, and lack of
randomization and appropriate control groups. Future studies with larger populations of patients wearing the device for longer periods are needed to evaluate hearing benefits and device safety.
Laser or Light Based Hearing Aids
Laser or light based Hearing Aids (e.g., Earlens Contact Hearing Device) are unproven and/or not medically necessary for treating hearing loss. The evidence assessing the effectiveness of this device is limited. Additional
studies with larger populations and long-term follow-up are needed to evaluate improvement of hearing with Hearing Aids that use light to transmit sound.
Implantable Beta-Emitting
Microspheres for Treatment of
Malignant Tumors
May 1, 2018
Revised coverage rationale: o Replaced references to
“yttrium-90 (90Y) microsphere
radioembolization” with “transarterial radioembolization (TARE) using yttrium-90 (90Y) microspheres”
o Replaced language indicating:
“[The listed service] is
Transarterial radioembolization (TARE) using yttrium-90 (90Y) microspheres is proven and/or medically necessary for the following
indications: Unresectable metastatic liver tumors from primary colorectal cancer
(CRC) Unresectable metastatic liver tumors from neuroendocrine tumors Unresectable primary hepatocellular carcinoma (HCC) Unresectable intrahepatic cholangiocarcinoma Transarterial radioembolization (TARE) using yttrium-90 (90Y) microspheres is unproven and/or not medically necessary for all
other indications.
28 Oxford® Policy Update Bulletin: April 2018
Clinical Policy Updates
Oxford
Policy Title Effective Date Summary of Changes Coverage Rationale
REVISED
Implantable Beta-Emitting Microspheres for
Treatment of Malignant Tumors (continued)
May 1, 2018 proven and medically necessary” with “[the listed service] is proven
and/or medically necessary”
“[The listed service] is
unproven and not medically necessary” with “[the listed service] is unproven and/or not
medically necessary” Updated supporting information
to reflect the most current FDA information
Limited evidence suggests that treatment with intrahepatic microsphere radiation (IMR) might shrink tumors and relieve symptoms in some patients, sometimes enough to render some inoperable tumors operable. However,
limited available evidence has not shown improved survival. In addition, the treatment's potential impact on quality of life has not been studied. No studies have yet compared the effects of IMR therapy with alternative
treatments, such as chemoembolization. Randomized controlled trials are needed to determine the clinical utility of this treatment.
Lemtrada (Alemtuzumab)
May 1, 2018
Revised coverage rationale: o Replaced language
indicating:
“Lemtrada (alemtuzumab) is proven and medically necessary for treatment of relapsing-remitting multiple sclerosis when
all of the [listed] criteria are met” with “Lemtrada (alemtuzumab) is proven and medically necessary for treatment of relapsing forms of
multiple sclerosis when
all of the [listed] criteria are met”
“Alemtuzumab is unproven for the treatment of [the listed conditions]” with “alemtuzumab is
unproven and not medically necessary for
Lemtrada (alemtuzumab) is proven and medically necessary for treatment of relapsing forms of multiple sclerosis when ALL of the following criteria are met:
Diagnosis of relapsing forms of multiple sclerosis (MS) (e.g., relapsing-remitting MS, secondary-progressive MS with relapses, progressive-relapsing MS with relapses); and
One of the following: o Treatment-naïve to alemtuzumab:
Member has history of failure following a trial for at least 4 weeks
or history of intolerance to at least two of the following: - interferon β-1a (Avonex® or Rebif®)) - interferon β-1b (Betaseron® or Extavia®) - glatiramer acetate (Copaxone® or Glatopa®) - dimethyl fumarate (Tecfidera®) - teriflunomide (Aubagio®)
- fingolimod (Gilenya®)
- peginterferon beta-1a (Plegridy™) - natalizumab (Tysabri®) - daclizumab (Zinbryta™) - ocrelizumab (Ocrevus®) and
Member has not been previously treated with alemtuzumab; and Member is not receiving alemtuzumab in combination with
another disease modifying agent for multiple sclerosis (e.g., interferon beta preparations, glatiramer acetate, natalizumab,
29 Oxford® Policy Update Bulletin: April 2018
Clinical Policy Updates
Oxford
Policy Title Effective Date Summary of Changes Coverage Rationale
REVISED
Lemtrada (Alemtuzumab) (continued)
May 1, 2018
the treatment of [the listed conditions]”
o Updated coverage criteria for
proven and medically necessary indications; replaced criterion requiring:
“Diagnosis of relapsing-remitting multiple sclerosis (RRMS)” with “diagnosis of relapsing
forms of multiple sclerosis (MS) (e.g., relapsing-remitting MS, secondary-progressive MS with relapses, progressive-relapsing MS
with relapses)” “Patient has history of
failure following a trial for at least 4 weeks or history of intolerance or contraindication to two of the [listed drug
products]” with “patient has history of failure following a trial for at least 4 weeks or history of intolerance to at least two of the [listed drug
products]”
- Updated list of drugs products requiring history of trial and failure or intolerance; added reference to brand
name “Glatopa®” for glatiramer acetate
Updated supporting information
fingolimod, teriflunomide, etc.); and Initial dosing is administered: 12 mg intravenously daily for 5
consecutive days; and
Regimen is administered only once within 12 months or
o Treatment-experienced with alemtuzumab:
Member has previously received treatment with alemtuzumab; and
Member is not receiving alemtuzumab in combination with another disease modifying agent for multiple sclerosis (e.g.,
interferon beta preparations, glatiramer acetate, natalizumab, fingolimod, teriflunomide, etc.); and
Retreatment dosing is administered: 12 mg intravenously daily for 3 consecutive days; and
Regimen is administered only once within 12 months
Coverage of Lemtrada is limited up to two treatment courses (5 day initial and 3 day end course). Requests for additional doses/courses beyond two
courses will not be approved. Alemtuzumab is unproven and not medically necessary for the treatment of: Rheumatoid arthritis
Autoimmune neutropenia Autoimmune hemolytic anemia Pure red cell aplasia Immune thrombocytopenic purpura Evan's syndrome Autoimmune pancytopenia
30 Oxford® Policy Update Bulletin: April 2018
Clinical Policy Updates
Oxford
Policy Title Effective Date Summary of Changes Coverage Rationale
REVISED
Lemtrada (Alemtuzumab) (continued)
May 1, 2018 to reflect the most current clinical evidence, FDA information, and references
Maximum Dosage May 1, 2018 Revised coverage rationale: o Updated maximum allowed
quantities for National Drug Code (NDC) billing for Herceptin (trastuzumab); added: NCD 50242-0132-01
How Supplied: 150 mg powder for reconstitution
Maximum Allowed: 3 vials
NCD 50242-0333-01 How Supplied: 420 mg
powder for reconstitution
Maximum Allowed: 3 vials
Updated list of applicable NDCs; added 50242-0132-01 and 50242-0333-01
Updated supporting information
to reflect the most current references
Refer to the policy for complete details on Maximum Dosage guidelines.
Molecular Oncology Testing for Cancer Diagnosis,
Prognosis, and Treatment Decisions
Apr. 1, 2018
Notice of Revision: The following summary of changes has been modified. Revisions to the original
policy update announcement are outlined in red below. Please take note of the additional updates to be
implemented on Apr. 1, 2018. Revised coverage rationale:
o Updated list of unproven/not medically necessary gene expression profiling assays
for colorectal cancer (CRC)
Gene Expression Tests for Breast Cancer Treatment
The use of one of the following gene expression tests is considered proven and/or medically necessary to make a treatment decision
regarding adjuvant chemotherapy in females or males with non-metastatic breast cancer when all of the following criteria are met. However, the use of more than one gene expression test for the same tumor in an individual with breast cancer is unproven and/or
not medically necessary. Gene Expression Tests for High Risk Breast Cancer
Gene expression tests for high risk breast cancer, including
31 Oxford® Policy Update Bulletin: April 2018
Clinical Policy Updates
Oxford
Policy Title Effective Date Summary of Changes Coverage Rationale
REVISED
Molecular Oncology Testing for Cancer Diagnosis,
Prognosis, and Treatment Decisions
(continued)
Apr. 1, 2018
risk assessment or management; removed “fecal DNA testing, i.e.,
ColonSentry” o Replaced language
indicating:
“[The listed services] are proven and medically necessary” with “[the listed services] are
proven and/or medically necessary”
“[The listed services] are unproven and not medically necessary” with “[the listed
services] are unproven and/or not medically
necessary” o Replaced reference to
“patient” with “individual” Updated list of applicable CPT
codes; added 0012M*, 0013M*,
81520, and 81521 (*quarterly code edit)
Updated supporting information to reflect the most current references
MammaPrint (also referred to as the "Amsterdam Signature" or "70-Gene Signature"), are considered proven and/or medically necessary to assess distant recurrence of disease in individuals with recently
diagnosed non-metastatic breast cancer when ALL the following criteria are met: High clinical risk of recurrence based on at least one of the following
criteria: o Lymph node positive (pN1-2); or o Tumor size greater than 2 cm; or o Poorly differentiated or undifferentiated histology (grade 3) AND
tumor size greater than 1 cm; and Hormone receptor-positive (estrogen receptor positive, progesterone
receptor positive or both); and HER2 receptor negative; and Adjuvant chemotherapy is not precluded due to any other factor (e.g.,
advanced age and/or significant co-morbidities); and
Individual and treating physician have had a discussion prior to testing regarding the potential results of the test and determined to use the
results to guide therapy.
MammaPrint is considered unproven and/or not medically necessary for all other indications. Gene Expression Tests for Intermediate and Low Risk Breast Cancer
Oncotype Dx Breast, Prosigna PAM-50 Breast Cancer Prognostic Gene
Signature Assay, EndoPredict and the Breast Cancer Index gene expression tests for intermediate and low risk breast cancer are considered proven and/or medically necessary to assess use of adjuvant chemotherapy in individuals with recently diagnosed non-
metastatic breast cancer when all of the following criteria are met: Lymph node negative (pN0) or axillary lymph node micrometastasis less
than 2mm (pN1mi); and
Hormone receptor positive (estrogen receptor positive, progesterone receptor positive or both); and
HER2 receptor negative; and Adjuvant chemotherapy is not precluded due to any other factor (e.g.,
advanced age and/or significant co-morbidities); and Individual and treating physician have had a discussion prior to testing
regarding the potential results of the test and determined to use the
32 Oxford® Policy Update Bulletin: April 2018
Clinical Policy Updates
Oxford
Policy Title Effective Date Summary of Changes Coverage Rationale
REVISED
Molecular Oncology Testing for Cancer Diagnosis,
Prognosis, and Treatment Decisions
(continued)
Apr. 1, 2018
results to guide therapy.
Oncotype Dx Breast, Prosigna PAM-50 Breast Cancer Prognostic Gene
Signature Assay, EndoPredict, and the Breast Cancer Index are considered unproven and/or not medically necessary for all other indications.
Gene expression profiling assays for breast cancer treatment other than those previously described as covered are considered unproven and/or not medically necessary, including but not limited to:
BluePrint (also referred to as "80-gene profile") Breast Cancer Gene Expression Ratio (also known as Theros H/I) BreastNext BreastOncPX BreastPRS Insight DX Breast Cancer Profile
Mammostrat NexCourse Breast IHC4
NuvoSelect eRx 200-Gene Assay Oncotype DX DCIS SYMPHONY Genomic Breast Cancer Profile TargetPrint TheraPrint
The 41-gene signature assay The 76-gene "Rotterdam signature" assay To date, the majority of the available studies fail to provide sufficient evidence that gene expression profiling is useful for managing the treatment of breast cancer and leads to improved health outcomes (i.e., clinical utility).
Well-designed randomized controlled trials (RCTs) are needed to determine
the clinical utility of gene expression profiling as a technique of managing the treatment of breast cancer compared with traditional clinical factors to guide medical management and improve clinical outcomes. Gene Expression Profiling to Identify the Tissue of Origin for Cancers of Unknown Primary Site
To identify the tissue of origin for cancers of unknown primary site, gene expression profiling assays are considered unproven and/or not medically necessary for all indications, including but not limited
33 Oxford® Policy Update Bulletin: April 2018
Clinical Policy Updates
Oxford
Policy Title Effective Date Summary of Changes Coverage Rationale
REVISED
Molecular Oncology Testing for Cancer Diagnosis,
Prognosis, and Treatment Decisions
(continued)
Apr. 1, 2018
to: ResponseDX: Tissue of Origin Test CancerTYPE ID Test
Rosetta Cancer Origin Test (miRview mets and miRview mets2 tests) ProOnc TumorSourceDX Test
To date, the majority of the available studies fail to provide sufficient evidence that gene expression profiling to identify the tissue of origin for cancers lead to improved health outcomes (i.e., clinical utility). Well-designed randomized controlled trials (RCTs) are needed to determine the
clinical utility of gene expression profiling to identify the tissue of origin for cancers of unknown primary site compared with traditional clinicopathologic factors to guide medical management and improve clinical outcomes. Gene Expression Profiling of Melanoma
In cutaneous and uveal melanoma, gene expression profiling assays are considered unproven and/or not medically necessary for all
indications, including but not limited to: DecisionDx-Melanoma test
DecisionDx-UM To date, the majority of the available studies fail to provide sufficient evidence that gene expression profiling of melanoma leads to improved health outcomes (i.e., clinical utility). Well-designed randomized controlled trials (RCTs) are needed to determine the clinical utility of gene expression
profiling of melanoma compared with traditional clinical factors to guide medical management and improve clinical outcomes. Gene Expression Profiling as a Technique for Colorectal Cancer (CRC) Risk Assessment or Management
In colorectal cancer (CRC) risk assessment or management, gene expression profiling assays are considered unproven and/or not medically necessary, including but not limited to: Oncotype DX Colon Cancer Assay
Colorectal Cancer DSA GeneFx Colon OncoDefender-CRC To date, the majority of the available studies fail to provide sufficient
34 Oxford® Policy Update Bulletin: April 2018
Clinical Policy Updates
Oxford
Policy Title Effective Date Summary of Changes Coverage Rationale
REVISED
Molecular Oncology Testing for Cancer Diagnosis,
Prognosis, and Treatment Decisions
(continued)
Apr. 1, 2018
evidence that gene expression profiling as a technique for colorectal cancer (CRC) risk assessment or management lead to improved health outcomes (i.e., clinical utility). Well-designed randomized controlled trials (RCTs) are
needed to determine the clinical utility of gene expression profiling as a technique for colorectal cancer (CRC) risk assessment or management compared with traditional clinical factors to guide medical management and
improve clinical outcomes. Gene Expression Profile Tests for Evaluation or Management of Multiple Myeloma
Gene expression profile tests for evaluation or management of multiple myeloma are considered unproven and/or not medically
necessary, including but not limited to: MyPRS/MyPRS Plus To date, the majority of the available studies fail to provide sufficient evidence that gene expression profile tests for evaluation or management of
multiple myeloma lead to improved health outcomes or to manage treatment decisions (i.e., clinical utility). Well-designed randomized controlled trials
(RCTs) are needed to determine the clinical utility of gene expression profile tests for evaluation or management of multiple myeloma compared with traditional clinical factors to guide medical management and improve clinical outcomes. Gene Expression Profile Tests for the Screening, Detection and Management of Prostate Cancer
Gene-based tests for the screening, detection and management of
prostate cancer are considered unproven and/or not medically necessary, including but not limited to:
Oncotype DX Prostate Cancer Assay TMPRSS2 fusion gene Prolaris Prostate Cancer Test Decipher Prostate Cancer Classifier
To date, the majority of the available studies fail to provide sufficient evidence that gene-based tests for the screening, detection and management of prostate cancer lead to improved health outcomes or to manage treatment decisions (i.e., clinical utility). Well-designed randomized controlled trials (RCTs) are needed to determine the clinical utility of gene-
35 Oxford® Policy Update Bulletin: April 2018
Clinical Policy Updates
Oxford
Policy Title Effective Date Summary of Changes Coverage Rationale
REVISED
Molecular Oncology Testing for Cancer Diagnosis,
Prognosis, and Treatment Decisions
(continued)
Apr. 1, 2018 based tests for the screening, detection and management of prostate cancer compared with traditional clinical factors to guide medical management and improve clinical outcomes.
Topographic Genotyping
Topographic genotyping is unproven and/or not medically necessary. Examples of such tests include, but are not limited to, the following: PathFinder TG To date, the majority of the available studies fail to provide sufficient evidence that topographic genotyping lead to improved health outcomes (i.e., clinical utility). Well-designed randomized controlled trials (RCTs) are
needed to determine the clinical utility of topographic genotyping compared with traditional clinical factors to guide medical management and improve clinical outcomes. Multi-Gene Cancer Panels for Diagnosis, Prognosis and Treatment Decisions (Molecular Profiling)
Molecular profiling of tumors using a multi-gene cancer panel of up to 50 genes is considered proven and/or medically necessary for individuals with metastatic non-small cell lung cancer (NSCLC).
Use of more than one gene multi-gene cancer panel for the same individual with non-small cell lung cancer is unproven and/or not medically necessary. Multi-gene cancer panels are considered unproven and/or not
medically necessary for all other indications.
Multi-gene cancer panels of greater than 50 genes are considered unproven and/or not medically necessary for all indications.
Office Based Program
May 1, 2018
Revised conditions of coverage/precertification requirements; added language pertaining to CPT codes 36473,
36475 and 36478 to indicate: o Medical director review is
requierd regardless of the
Introduction
In an effort to minimize out-of-pocket costs for Oxford members and to improve cost efficiencies for the overall health care system, we are implementing prior authorization guidelines that aim to encourage more cost-effective sites of service for certain outpatient surgical procedures, when medically appropriate.
36 Oxford® Policy Update Bulletin: April 2018
Clinical Policy Updates
Oxford
Policy Title Effective Date Summary of Changes Coverage Rationale
REVISED
Office Based Program (continued)
May 1, 2018 site of service o Precertification is required
under the member's General
Benefits package when performed in the office of a participating provider
o For Commercial plans, precertification is not required, but is encouraged for out-of-network services
performed in the office that are covered under the member's General Benefits package; if precertification is not obtained, Oxford may review for medical necessity
after the service is rendered
These prior authorization requirements apply to participating providers that are providing services to members enrolled on Oxford commercial plans that require services to be medically necessary, including being cost-effective.
Refer to the member specific benefit plan document to determine if medical necessity applies. Coverage Rationale
With the exception of the qualifying conditions below, certain elective procedures should be performed in an Office setting. The following will be taken into account to determine whether the elective procedure is being performed in a cost effective setting:
Member’s benefit plan Geographic availability of an in network provider Office capability (i.e., appropriate equipment) Significant member comorbidities Certain Qualifying Conditions
Some patients may require more complex care due to certain medical factors or functional limitations and it may be appropriate to have the procedure in an outpatient hospital setting or ambulatory surgery center. (Not an all-
inclusive list). Patient unable to cooperate with procedure due to mental status, severe
anxiety, or extreme pain sensitivity Failed office based procedure attempt due to body habitus, abnormal
anatomy, or technical difficulties Bleeding disorder that would cause a significant risk of morbidity
Allergy to local anesthetic Potential Documentation Requirements
Physician office notes Elective Procedures List
Prior authorization is required for the following procedures if not performed in an office setting (see Applicable Codes section of the policy).
Omnibus Codes
May 1, 2018
Removed coverage guidelines for collagen cross-linking of cornea analysis (CPT code 0402T); this
Refer to the policy for complete details on the coverage guidelines for Omnibus Codes.
37 Oxford® Policy Update Bulletin: April 2018
Clinical Policy Updates
Oxford
Policy Title Effective Date Summary of Changes Coverage Rationale
REVISED
Omnibus Codes
May 1, 2018 service no longer requires clinical review
Radiopharma-
ceuticals and Contrast Media
May 1, 2018
Revised coverage rationale/
reimbursement guidelines; updated list of nuclear medicine
procedure codes allowed with the following radiopharmaceuticals: o A9512: Removed 78016-
78018, 78291, 78483,
78607, 78631-78634, and 78636-78649
o A9516: Removed 78015-78018
o A9524: Removed 78452, 78482, and 78483
o A9528, A9528, and
A9531: Removed 78803 o A9538: Removed 78301-
78305 o A9539: Removed 78428,
78445, and 78579-78598 o A9540: Removed 78579-
78597 o A9547: Removed 78805-
78807 o A9548: Removed 78800 o A9551: Removed 78800
and 78803
o A9554: Removed 78707
o A9556: Removed 78801-78807
o A9558: Removed 78580-78597
o A9562: Removed 78700 o A9567: Removed 78580,
78581, and 78583-78597
o A9572: Removed 78017 and 78018
Refer to the policy for complete details on the coverage guidelines for
Radiopharmaceuticals and Contrast Media.
38 Oxford® Policy Update Bulletin: April 2018
Clinical Policy Updates
Oxford
Policy Title Effective Date Summary of Changes Coverage Rationale
REVISED
Trogarzo™ (Ibalizumab-Uiyk)
Jul. 1, 2018 Updated list of related policies; removed reference link to policy titled Review at Launch for New
to Market Medications Revised conditions of
coverage/precertification
requirements to indicate precertification with review by a Medical Director or their designee is required
Trogarzo (ibalizumab-uiyk) is proven and/or medically necessary for the treatment of multi-drug resistant human immunodeficiency virus (HIV) in patients who meet ALL of the following criteria:
For initial therapy, all of the following:
o Both of the following:
Diagnosis of HIV-1 infection Physician attestation that the patient has multi-drug resistant
HIV-1 infection and
o Physician confirms that the patient has been prescribed an optimized backround antiretroviral regimen, containing at least one antiretroviral agent that demonstrates full viral sensitivity/susceptibility; and
o Ibalizumab initial and maintenance dosing is in accordance with the US Food and Drug Administration prescribing information: A single
loading dose of 2,000mg intravenously (IV) followed by a maintenance dose of 800mg IV every two weeks thereafter; and
o Initial authorization is for no more than 6 months. For continuation therapy, all of the following:
o Patient has previously received treatment with ibalizumab; and o Physician confirms that the patient has achieved a clinically
significant viral response to ibalizumab therapy; and o Physician confirms that the patient will continue to take an optimized
backround antiretroviral regimen, in combination with ibalizumab; and
o Ibalizumab maintenance dosing is in accordance with the US Food and Drug Administration prescribing information; and
o Authorization is for no more than 12 months.
Policy Title Effective Date Summary of Changes
RETIRED
Thermal Capsulorrhaphy/ Thermal Shrinkage Therapy
Apr. 1, 2018 Policy retired; thermal shrinkage therapy of joint capsules, ligaments, and tendons no longer requires clinical review
39 Oxford® Policy Update Bulletin: April 2018
Administrative Policy Updates
Oxford
Policy Title Effective Date Summary of Changes Administrative Guidelines
REVISED
Precertification Exemptions for Outpatient Services
Apr. 1, 2018 Notice of Revision: The following summary of changes has been modified. Revisions to the original
policy update announcement are outlined in red below. Please take note of the additional updates to be
implemented on Apr. 1, 2018. Revised list of applicable CPT
codes for Pathology and
Laboratory services that do not require precertification in the office or outpatient setting: o Added 0035U*, 0036U*,
0037U*, 0038U*, 0039U*, 0040U*, 0041U*, 0042U*,
0043U*, and 0044U* (*quarterly code edits)
o Removed 81520 and 81521 (refer to the policy titled Molecular Oncology Testing for Cancer Diagnosis, Prognosis, and Treatment
Decisions for applicable coverage guidelines)
Refer to the policy for complete details on Precertification Exemptions for Outpatient Services.
40 Oxford® Policy Update Bulletin: April 2018
Reimbursement Policy Updates
Oxford
Policy Title Effective Date Summary of Changes
UPDATED
Ambulance May 7, 2018 Updated Ambulance Bundled Code List (attachment file listing CPT/HCPCS codes that are not separately reimbursed when reported with an ambulance transportation code) to reflect quarterly code edits; added HCPCS codes Q5103 and Q5104
From - To Date Policy
May 1, 2018 Updated policy application guidelines; added language to clarify this policy applies to services reported using the 1500 Health Insurance Claim Form (a/k/a CMS-1500) or its electronic equivalent or its successor form
Updated From - To Policy Exceptions List (attachment file listing CPT/HCPCS codes for services exempt from this policy) to reflect quarterly code edits; added HCPCS codes K0903, Q2041, Q5103, and Q5104
Once in a Lifetime Procedures
May 1, 2018 Updated policy application guidelines; added language to clarify this policy applies to: o Services reported using the 1500 Health Insurance Claim Form (a/k/a CMS-1500) or its electronic equivalent
or its successor form o All products
Updated list of applicable modifier codes; revised description for 58 Reformatted Once in a Lifetime Procedures Policy List (attachment file listing codes for procedures that are
reimbursed once per member lifetime); transferred content to embedded Excel file format
One or More
Sessions
Apr. 16, 2018 Updated One or More Sessions Policy List (attachment file listing procedure codes with a defined treatment or
monitoring period) to reflect quarterly code edits; removed CPT codes 93293, 93294, 93295, 93296, 93297, 93298, and 93299
Procedure and
Place of Service
Apr. 16, 2018 Updated Procedure and Place of Service List [attachment file listing applicable procedure codes with
corresponding place of service (POS) codes] to reflect quarterly code edits: o Added CPT codes 99155, 99156, and 99157 with corresponding POS codes 21, 22, 23, 24, 26, 31, 34, 41,
42, 51, 52, 53, 56, and 61 o Added CPT code 99600 and HCPCS codes G0299, G0300, G0490, S9208, S9209, S9211, S9212, S9213,
S9214, S9335, S9339, S9590, T1021, and T1022 with corresponding POS codes 4, 9, 12, 13, 14, 16, 33, and 55
Time Span Codes Apr. 16, 2018 Updated Time Span Codes List (attachment file listing Time Span Codes and their designations) to reflect
quarterly code edits; added HCPCS codes A4595 and K0553
Policy Title Effective Date Summary of Changes Reimbursement Guidelines
REVISED
Ambulance
May 1, 2018
Revised policy application guidelines to indicate this policy applies to: o Services reported using the
1500 Health Insurance Claim
Form (a/k/a CMS-1500) or
Ambulance Providers and Suppliers
Oxford considers only an Ambulance Provider or Supplier as eligible for reimbursement of ambulance services reported with Healthcare Common Procedure Coding System (HCPCS) codes A0021 and A0225-A0999. Other provider specialties, e.g., emergency room physicians, should report
41 Oxford® Policy Update Bulletin: April 2018
Reimbursement Policy Updates
Oxford
Policy Title Effective Date Summary of Changes Reimbursement Guidelines
REVISED
Ambulance (continued)
May 1, 2018
its electronic equivalent or its successor form
o All products and all network
and non-network Ambulance Providers or Suppliers, including, but not limited to,
non-network authorized and percent of charge contract Ambulance Providers or Suppliers
Revised reimburesment guidelines: Ambulance Providers and Suppliers o Removed reference link to
the attachment file titled
Ambulance Services Code List
Origin and Destination Modifiers o Added language to indicate
single digit alpha characters used to designate an origin
and destination are: D = Diagnostic or
therapeutic site other than P or H when these are used as origin codes
E = Residential,
domiciliary, custodial
facility (other than 1819 facility)
G = Hospital based ESRD facility
H = Hospital I = Site of transfer (e.g.
airport or helicopter pad) between modes of ambulance transport
the Current Procedural Terminology (CPT®) and/or HCPCS codes that specifically and accurately describe the services and procedures outside of the HCPCS code A0021 and A0225-A0999 range.
Oxford will not reimburse non-ambulance providers or suppliers for rendering ambulance services.
Origin and Destination Modifiers
For ambulance transportation claims, Oxford has adopted the Centers for Medicare and Medicaid Services (CMS) guidelines that require an Ambulance Provider or Supplier to report an origin and destination modifier for each trip provided.
Each ambulance modifier is comprised of a single digit alpha character identifying the origin of the transport in the first position, and a single digit alpha character identifying the destination of the transport in the second position. Example: RH (residence to hospital). Single digit alpha characters
used to designate an origin and destination are listed below: D = Diagnostic or therapeutic site other than P or H when these are used
as origin codes E = Residential, domiciliary, custodial facility (other than 1819 facility) G = Hospital based ESRD facility H = Hospital I = Site of transfer (e.g. airport or helicopter pad) between modes of
ambulance transport
J = Freestanding ESRD facility N = Skilled nursing facility P = Physician’s office R = Residence
S = Scene of accident or acute event X = Intermediate stop at physician’s office on way to hospital
(destination code only)
In alignment with CMS, Oxford will reimburse a code on the Ambulance Transportation Codes List only when reported with a two-digit ambulance modifier on the Ambulance Modifiers List. Ambulance transportation services reported without a valid two-digit ambulance modifier will be denied. When “X” (Intermediate stop at physician's office en route to the
hospital) is present within the 2 digit modifier combination, “X” must be
42 Oxford® Policy Update Bulletin: April 2018
Reimbursement Policy Updates
Oxford
Policy Title Effective Date Summary of Changes Reimbursement Guidelines
REVISED
Ambulance (continued)
May 1, 2018
J = Freestanding ESRD facility
N = Skilled nursing
facility P = Physician’s office R = Residence
S = Scene of accident or acute event
X = Intermediate stop at physician’s office on way
to hospital (destination code only)
Advanced Life Support, Level 2 (ALS2) Ambulance Transportation o Removed language
indicating: ALS2 Criteria 1 and
Criteria 2 Codes are not considered included in the ALS2 ambulance transport and will be allowed separately
In alignment with CMS, UnitedHealthcare will only reimburse an ALS2 ambulance transport (HCPCS code A0433) when criteria for an ALS2
ambulance transport (as
defined) is met Ambulance Providers or
Suppliers are required to report CPT or HCPCS codes which would satisfy criteria (1) or (2)
when reporting A0433 Ambulance transport
services that do not
in the second digit position preceded by a valid origin digit in the first position. If “X” is the first digit of the two digit modifier combination, the ambulance transportation code will be denied.
Ambulance Transportation Code List Ambulance Modifiers List Services Included in Ambulance Transportation
Per CMS, services including, but not limited to oxygen, drugs, extra attendants, supplies, EKG, and night differential are not paid separately when reported as part of an ambulance transportation service. In addition, the ambulance must have customary patient care equipment and first aid supplies, including reusable devices and equipment such as backboards,
neckboards and inflatable leg and arm splints. These are all considered part of the general ambulance service and payment for them is included in the payment rate for the transport. In alignment with CMS, Oxford will not reimburse codes on the Ambulance
Bundled Codes list when provided by the Same Ambulance Provider or Supplier for the same patient on the same date of service as a code on the
Ambulance Transportation Codes list. This applies to network providers only. Ambulance Transportation Code List Ambulance Bundled Code List Advanced Life Support, Level 2 (ALS2) Ambulance Transportation
There are marked differences in resources necessary to furnish the various levels of ground ambulance services. According to CMS, Basic Life Support (BLS) ambulances must be staffed by at least two people, at least one of
whom must be certified as an emergency medical technician (EMT) by the State or local authority where the services are being furnished and be legally
authorized to operate all lifesaving and life-sustaining equipment on board the vehicle. All Advanced Life Support (ALS) vehicles must be staffed by at least two people, at least one of whom must be certified by the State or local authority as an EMT-Intermediate or an EMT-Paramedic. In addition, Advanced Life Support, level 1 (ALS1) must include the provision of an ALS
Assessment or at least one ALS Intervention. CMS defines Advanced Life Support, level 2 (ALS2) as transportation by ground ambulance vehicle and the provision of medically necessary supplies and services including (1) at least three separate administrations of one or
43 Oxford® Policy Update Bulletin: April 2018
Reimbursement Policy Updates
Oxford
Policy Title Effective Date Summary of Changes Reimbursement Guidelines
REVISED
Ambulance (continued)
May 1, 2018 include the services described in criteria 1 or 2 should be reported
with a more appropriate ambulance transport code
o Removed reference links to attachment files titled ALS2 Criteria 1 Codes List and ALS2 Criteria 2 Codes List
o Added language to indicate in alignment with CMS, reimbursement is based on the level of service provided, not on the vehicle used
Updated Questions & Answers
(Q&A); removed Q&A #2 pertaining to reimbursement of
HCPCS code A0433 (ALS2) Removed attachment files titled:
o Ambulance Services Code List
o ALS2 Criteria 1 Codes List
o ALS2 Criteria 2 Codes List
more medications by intravenous push/bolus or by continuous infusion (excluding crystalloid fluids) or (2) ground ambulance transport, medically necessary supplies and services, and the provision of at least one of the
ALS2 procedures listed below: Manual defibrillation/cardioversion Endotracheal intubation
Central venous line Cardiac pacing Chest decompression Surgical airway or
Intraosseous line In alignment with CMS, reimbursement is based on the level of service provided, not on the vehicle used. Refer to the Definitions section of the policy for more information on
ambulance transport.
Maximum Frequency Per Day Policy
May 1, 2018
Updated Questions & Answers (Q&A): o Q#1: Replaced reference to
“network home health services and supplies/home
health agencies, anesthesia
management, and ambulance providers” with “DME network home health services and home health agencies, anesthesia management, and ambulance providers”
o Q#2: Replaced reference to “service” with “service, drug
MFD Determination: Part I
The following criteria are first used to determine the MFD values for codes to
which these criteria are applicable: The service is classified as bilateral (CMS Indicators 1 or 3) on the
Centers for Medicare & Medicaid Services (CMS) National Physician Fee
Schedule (NPFS) or the term 'bilateral' is included in the code descriptor. For the majority of these codes, the MFD value is 1. There are some codes that describe more than one anatomical site or vertebral level that
can be treated bilaterally where the MFD value may be more than 1. Where the CPT or HCPCS code description/verbiage references reporting
the code once per day, the MFD value is 1. The service is anatomically or clinically limited with regard to the number
of times it may be performed, in which case the MFD value is established at that value.
44 Oxford® Policy Update Bulletin: April 2018
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Policy Title Effective Date Summary of Changes Reimbursement Guidelines
REVISED
Maximum Frequency Per Day Policy
(continued)
May 1, 2018
or supply” o A#3: Modified language to
clarify bilateral eligible
procedures may also be billed with modifiers RT and LT, but must be reported on
two separate lines with 1 unit each
o A#10: Replaced reference to example CPT code “80301”
with “80305” o A#14: Modified language
pertaining MFD value assignment example
Revised Maximum Frequency Per Day Code List (attachment file
designating the maximum frequency per day value
assignments for CDT, CPT, and HCPCS codes): o Added 0001U, 0001M,
0002M, 0002U, 0003M, 0003U, 0004M, 0004U,
0005U, 0006M, 0006U, 0007M, 0007U, 0008M, 0008U, 0009M, 0009U, 0010U, 0011M, 0011U, 0012U, 0013U, 0014U, 0015U, 0016U, 0017U,
0018U, 0019U, 0020U,
0021U, 0022U, 0023U, 0024U, 0025U, 0026U, 0027U, 0028U, 0029U, 0030U, 0031U, 0032U, 0033U, and 0034U
o Revised value assignments
for 81521, 81520, 85660, 86794, 90744, 94669, 97811, 97814, A4253,
The CPT or HCPCS code description/verbiage indicates the number of times the service can be performed, in which case the MFD value is set at that value.
CMS Durable Medical Equipment Medicare Administrative Contractor (DMEMAC) Local Coverage Determination (LCD) assigns an MFD value in which case the MFD value is set at that value.
Where the criteria above have not defined an MFD value, the CMS Medically Unlikely Edits (MUE) value, where available, will be utilized to establish an MFD value.
Where no other definitive value has been established based on the
criteria above, drug HCPCS codes will have an MFD value of 999 which indicates they are exempt from the MFD policy.
Where no other definitive value has been established based on the criteria above, unlisted CPT and HCPCS codes will have an MFD value of 999 which indicates they are exempt from the MFD policy.
Where no other definitive value has been established based on the
criteria above, new CPT codes released by the American Medical Association and new HCPCS codes released by CMS since the last MFD
value update (not covered by any of the above criteria), will have an MFD value of 100.
MFD Determination: Part II
When none of the criteria listed in Part I apply to a code, data analysis is conducted to establish MFD values according to common billing patterns. When a code has 50 or more claim occurrences in a data set, the MFD
values are determined through claim data analysis and are set at the 100th percentile (i.e., the highest number of units billed for that CPT or HCPCS code in the data set). If the 100th percentile exceeds the 98th percentile by a factor of four, the MFD will be set at the 98th percentile.
When a code has less than 50 claim occurrences in a data set, the MFD values will be set at the default of 100 until the next annual analysis.
In any case where, in Oxford's judgment, the 98th percentile does not
account for the clinical circumstances of the services billed, the MFD for a code may be increased so as to capture only obvious billing submission and data entry errors.
The MFD per Day Policy List (refer to the Attachments section of the policy) contains the most current MFD values.
45 Oxford® Policy Update Bulletin: April 2018
Reimbursement Policy Updates
Oxford
Policy Title Effective Date Summary of Changes Reimbursement Guidelines
REVISED
Maximum Frequency Per Day Policy
(continued)
May 1, 2018
A4259, A4321, A4331, A4333, A4334, A4336, A4349, A4353, A4360,
A4366, A4369, A4371, A4373, A4387, A4388, A4390, A4391, A4393,
A4394, A4395, A4396, A4405, A4406, A4408, A4409, A4411, A4412, A4414, A4415, A4417,
A4418, A4420, A4422, A4424, A4425, A4427, A4428, A4430, A4431, A4433, A4434, A4601, A4619, A6411, A6412, K0554, L8032, S8930, and
S9999 o Removed 36400, 36405,
36406, 36410, 36415, 36416, 36420, 36425, 76801, 76802, 76805, 76810, 76811, 76812, 76813, 76814, 76818,
76819, 76820, 76821, 76825, 76826, 76827, 76828, E0424, E045, E0430, E0431, E0433, E0434, E0435, E0439, E0440, E0441, E0442, E0443, and
E0444
Revised list of Codes Restricting Modifiers LT and RT (attachment file listing codes that allow up to the MFD limit with "bilateral" or "unilateral or bilateral" in the description or where the concept
of laterality does not apply); added 0001U, 0001M, 0002M, 0002U, 0003M, 0003U, 0004M,
The MFD values apply whether a physician, hospital, ambulatory surgical center, or other health care professional submits one CPT or HCPCS code with multiple units on a single claim line or multiple claim lines with one or
more unit(s) on each line. It is common coding practice for some CPT and HCPCS codes to be submitted with multiple units. However, when reporting the same CPT or HCPCS code on multiple and/or separate claim lines, the
claim line may be classified as a duplicate service and/or may be subject to additional Oxford reimbursement policies. Services provided are reimbursable services up to and including the MFD
value for an individual CPT or HCPCS code. In some instances, a modifier may be necessary for correct coding and corresponding reimbursement purposes. See Q&A #3, 4 and 5 of the Questions & Answers section of the policy. Modifiers LT and RT Restrictions
Bilateral payment via the use of modifiers LT or RT is inappropriate for
procedures, services, and supplies where the concept of laterality does not apply. Oxford will pay up to the maximum frequency per day value for codes
with "bilateral" or "unilateral or bilateral" in description or for codes where the concept of laterality does not apply, whether submitted with or without modifiers LT and/or RT by the same individual physician, hospital, ambulatory surgical center, or other healthcare professional on the same date of service for the same member. Use of modifiers LT and/or RT on the codes identified in the "Codes Restricting Modifiers LT and RT" list will be
considered informational only. Refer to the Attachments section of the policy for a list of Codes Restricting Modifiers LT and RT
There may be situations where a physician, hospital, ambulatory surgical center, or other healthcare professional reports units accurately and those
units exceed the established MFD value. In such cases, Oxford will consider additional reimbursement if reported with an appropriate modifier such as modifier 59, 76, 91, XE, XS or XU. Medical records are not required to be submitted with the claim when modifiers 59, 76, 91, XE, XS or XU are appropriately reported. Documentation within the medical record should reflect the number of units being reported and should support the use of the modifier.
46 Oxford® Policy Update Bulletin: April 2018
Reimbursement Policy Updates
Oxford
Policy Title Effective Date Summary of Changes Reimbursement Guidelines
REVISED
Maximum Frequency Per Day Policy
(continued)
May 1, 2018
0004U, 0005U, 0006M, 0006U, 0007M, 0007U, 0008M, 0008U, 0009M, 0009U, 0010U, 0011M,
0011U, 0012U, 0013U, 0014U, 0015U, 0016U, 0017U, 0018U, 0019U, 0020U, 0021U, 0022U,
0023U, 0024U, 0025U, 0026U, 0027U, 0028U, 0029U, 0030U, 0031U, 0032U, 0033U, and 0034U
Medically Unlikely Edit Adjudication Indicator (MAI) 2
CMS has identified CPT/HCPCS codes where the units of service (UOS) on the same date of service in excess of the MUE value would be considered impossible because it is contrary to statute, regulation or sub-regulatory guidance. Therefore, Oxford will not allow units in excess of the MFD value to
be reimbursed for CPT/HCPCS codes assigned an MAI indicator of “2”. Per CMS guidelines, no modifier override will be allowed nor will the MFD value be overridden by supplying documentation for adjustment requests.
CMS MUE File
Modifier Description
59
Distinct Procedural Service Under certain circumstances, it may be necessary to indicate
that a procedure or service was distinct or independent from other non-E/M services performed on the same day. Modifier 59 is used to identify procedures or services, other than E/M services, that are not normally reported together but are
appropriate under the circumstances. Documentation must support a different session, different procedure or surgery, different size or organ system, separate incision or excision,
separate lesion, or separate injury (or area of injury in extensive injuries) not ordinarily encountered or performed on the same day by the same individual. However, when another already established modifier is appropriate it should be used rather than modifier 59. Only if no more descriptive modifier is available and the use of modifier 59 best explains the circumstances should modifier 59 be used.
Note: Modifier 59 should not be appended to an E/M service. To report a separate and distinct E/M service performed on the same date, see modifier 25.
76
Repeat Procedure or Service by Same Physician or
Other Qualified Health Care Professional It may be necessary to indicate that a procedure or service was repeated subsequent to the original procedure or service. This circumstance may be reported by adding modifier 76 to the repeated procedure or service.
Note: This modifier should not be appended to an E/M service. To report a separate and distinct E/M service
47 Oxford® Policy Update Bulletin: April 2018
Reimbursement Policy Updates
Oxford
Policy Title Effective Date Summary of Changes Reimbursement Guidelines
REVISED
Maximum Frequency Per Day Policy
(continued)
May 1, 2018
performed on the same date, see modifier 25. It is also inappropriate to use modifier 76 to indicate repeat
laboratory services. Modifiers 59 or 91 should be used to indicate repeat or distinct laboratory services, as appropriate according to the AMA and CMS. Separate consideration for reimbursement will not be given to laboratory codes reported with modifier 76.
91
Repeat Clinical Diagnostic Laboratory Test
In the course of treatment of the patient, it may be necessary to repeat the same laboratory test on the same day to obtain subsequent (multiple) test results. Under these circumstances, the laboratory test performed can be identified by its usual procedure number and the addition of modifier 91.
Note: This modifier may not be used when tests are rerun to confirm initial results; due to testing problems with specimens or equipment; or for any other reason when a
normal, one-time, reportable result is all that is required. This modifier may not be used when other code(s) describe a series of test results (e.g., glucose tolerance tests, evocative/suppression testing). This modifier may only be used for laboratory test(s) performed more than once on the same day on the same patient.
XE
Separate Encounter
A service that is distinct because it occurred during a separate encounter.
XS
Separate Structure
A service that is distinct because it was performed on a separate organ/structure.
XU
Unusual Non-Overlapping Service
The use of a service that is distinct because it does not overlap usual components of the main service.
Anatomic Modifier
E1 Upper left eyelid
E2 Lower left eyelid
E3 Upper right eyelid
48 Oxford® Policy Update Bulletin: April 2018
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Oxford
Policy Title Effective Date Summary of Changes Reimbursement Guidelines
REVISED
Maximum Frequency Per Day Policy
(continued)
May 1, 2018
E4 Lower right eyelid
F1 Left hand, second digit
F2 Left hand, third digit
F3 Left hand, fourth digit
F4 Left hand, fifth digit
F5 Right hand, thumb
F6 Right hand, second digit
F7 Right hand, third digit
F8 Right hand, fourth digit
F9 Right hand, fifth digit
FA Left hand, thumb
LC Left circumflex coronary artery
LD Left anterior descending coronary artery
LM Left main coronary artery
LT Left side
RC Right coronary artery
RI Ramus intermedius coronary artery
RT Right side
T1 Left foot, second digit
T2 Left foot, third digit
T3 Left foot, fourth digit
T4 Left foot, fifth digit
T5 Right foot, great toe
T6 Right foot, second digit
T7 Right foot, third digit
T8 Right foot, fourth digit
T9 Right foot, fifth digit
TA Left foot, great toe
49 Oxford® Policy Update Bulletin: April 2018
Reimbursement Policy Updates
Oxford
Policy Title Effective Date Summary of Changes Reimbursement Guidelines
REVISED
Prolonged Services
May 1, 2018
Updated policy application guidelines; added language to clarify this policy applies to
services reported using the 1500 Health Insurance Claim Form (a/k/a CMS-1500) or its
electronic equivalent or its successor form
Updated policy overview: o Replaced reference to
“Complex Chronic Care Management (CCM)” with “Care Management (CM)”
o Updated list of applicable CM codes; added CPT codes 99484, 99490, and 99492-
99494 Revised reimbursement
guidelines; added language to indicate: o Oxford will reimburse HCPCS
codes G0513 and G0514 when reported with E/M
codes in which time is a factor in determining level of service
o CPT/HCPCS codes 99359, G0513, and G0514 are considered add-on codes and
should not be reported
without the appropriate primary code
o Prolonged Services without Direct Patient Contact (CPT codes 99358–99359) will not be separately reimbursed
when reported with CM CPT codes 99484, 99490, 99492, 99493, and 99494
Oxford reimburses Prolonged Services when reported with E/M codes in which time is a factor in determining level of service in accordance with CPT guidelines.
Physicians or other health care professionals should report only Prolonged Services beyond the typical duration of the service on a given date, even if the time spent by the physician or other care professional is not continuous.
Providers should not include the time devoted to performing separately reportable services when determining the amount of prolonged services time. For example, the time devoted to performing cardiopulmonary resuscitation (CPT code 92950) should not be included in prolonged services time. A
prolonged service of less than 30 minutes total duration on a given date is not separately reported because the work involved is included in the total work of the evaluation and management codes. Report CPT code 99354 (office or outpatient place of service codes) for
the first hour of prolonged physician or other qualified health care professional services. This code should be used only once per date, and
prolonged services must exceed 30 minutes in order to report this service.
Report CPT code 99355 (office or outpatient place of service codes) for each additional 30 minutes beyond the first 60 minutes of prolonged physician or other qualified health care professional services. Additional services must exceed 15 minutes in order to report this service.
Report CPT code 99356 (inpatient or observation place of service code)
for the first hour of prolonged physician or other qualified health care professional services. This code should be used only once per date, and prolonged services must exceed 30 minutes in order to report this service.
Report CPT code 99357 (inpatient or observation place of service code) for each additional 30 minutes beyond the first 60 minutes of prolonged
physician or other qualified health care professional services. Additional
services must exceed 15 minutes in order to report this service. Report CPT code 99358 (office, outpatient, inpatient or observation place
of service codes) for the first hour of prolonged physician or other qualified health care professional services. This code should be used only once per date, and prolonged services must exceed 30 minutes in order to report this service.
Report CPT code 99359 (office, outpatient, inpatient or observation place of service codes) for each additional 30 minutes beyond the first 60 minutes of prolonged physician or other qualified health care professional
50 Oxford® Policy Update Bulletin: April 2018
Reimbursement Policy Updates
Oxford
Policy Title Effective Date Summary of Changes Reimbursement Guidelines
REVISED
Prolonged Services (continued)
May 1, 2018
Added list of applicable/ reimbursable HCPCS codes: G0513 and G0514
services. Additional services must exceed 15 minutes in order to report this service.
Report CPT code 99415 (office or outpatient place of service codes) for
the first hour of prolonged clinical staff services of direct patient contact with physician supervision. This code should be used only once per date, and prolonged services must exceed 30 minutes in order to report this
service. Report CPT code 99416 (office or outpatient place of service codes) for
each additional 30 minutes beyond the first 60 minutes of prolonged clinical staff services of direct patient contact with physician supervision.
Additional services must exceed 15 minutes in order to report this service.
Report HCPCS code G0513 Prolonged preventive service(s) (beyond the typical service time of the primary procedure), in the office or other outpatient setting requiring direct patient contact beyond the usual service; first 30 minutes (list separately in addition to code for
preventive service) Report HCPCS code G0514 Prolonged preventive service(s) (beyond the
typical service time of the primary procedure), in the office or other outpatient setting requiring direct patient contact beyond the usual service; each additional 30 minutes (list separately in addition to code G0513 for additional 30 minutes of preventive service)
According to CPT, Prolonged Service codes 99354–99357, 99359, 99415, 99416, G0513, and G0514 are considered add-on codes and should not be reported without the appropriate primary code.
Refer to the Add-On Policy for details.
Prolonged Services for labor and delivery are not separately reimbursable services.
As described in American Congress of Obstetricians and Gynecologists (ACOG) coding guidelines, prolonged services are not reported for services that do not have a time component such as labor and delivery management. Refer to the Obstetrical Policy for more information.
In accordance with The Centers for Medicare Services (CMS), Prolonged Services without Direct Patient Contact (CPT codes
99358–99359) will not be separately reimbursed when reported with CM CPT codes 99484, 99487, 99489, 99490, 99492, 99493, and 99494, and TCM CPT codes 99495 and 99496.
51 Oxford® Policy Update Bulletin: April 2018
Reimbursement Policy Updates
Oxford
Policy Title Effective Date Summary of Changes Reimbursement Guidelines
REVISED
Same Day/Same Service Policy (CES)
May 1, 2018
Revised policy application guidelines to indicate this policy applies to:
o Services reported using the 1500 Health Insurance Claim Form (a/k/a CMS-
1500) or its electronic equivalent or its successor form
o All products and all network
and non-network physicians and other qualified health care professionals, including, but not limited to, non-network authorized and percent of charge
contract physicians and other qualified health care
professionals Revised policy overview
language; removed references to “hospital” and “ambulatory surgical center”
Revised definition of “Same Specialty Physician or Other Health Care Professional”
The Medicare Claims Processing Manual states: "Physicians in the same group practice who are in the same specialty
must bill and be paid as though they were a single physician. If more
than one evaluation and management (face-to-face) service is provided on the same day to the same patient by the same physician or more than one physician in the same specialty in the same group, only one
evaluation and management service may be reported unless the evaluation and management services are for unrelated problems. Instead of billing separately, the physicians should select a level of service representative of the combined visits and submit the appropriate code
for that level.” “Contractors pay a physician for only one hospital visit per day for the
same patient, whether the problems seen during the encounters are related or not. The inpatient hospital visit descriptors contain the phrase ‘per day’ which means that the code and the payment established for the code represent all services provided on that date. The physician should
select a code that reflects all services provided during the date of the service.”
“In a hospital inpatient situation involving one physician covering for another, if physician A sees the patient in the morning and physician B, who is covering for A, sees the same patient in the evening, contractors do not pay physician B for the second visit. The hospital visit descriptors include the phrase ‘per day’ meaning care for the day.”
“If the physicians are each responsible for a different aspect of the patient’s care, pay both visits if the physicians are in different specialties and the visits are billed with different diagnoses.”
The National Correct Coding Initiative Policy Manual states: "Procedures should be reported with the most comprehensive CPT code
that describes the services performed. Physicians must not unbundle the
services described by a HCPCS/CPT code.” “A physician should not report multiple HCPCS/CPT codes when a single
comprehensive HCPCS/CPT code describes these services." Consistent with Medicare, Oxford's Same Day/Same Service policy recognizes physicians or other health care professionals of the same group
and specialty as the same physician, physician subspecialty is not considered. According to correct coding methodology, physicians are to select the code that accurately identifies the service(s) performed. Multiple
52 Oxford® Policy Update Bulletin: April 2018
Reimbursement Policy Updates
Oxford
Policy Title Effective Date Summary of Changes Reimbursement Guidelines
REVISED
Same Day/Same Service Policy (CES)
(continued)
May 1, 2018
E/M services, when reported on the same date for the same patient by the same specialty physician, will be subject to edits used by and sourced to third party authorities. As stated above, physicians should select a level of
service representative of the combined visits and submit the appropriate code for that level. Edit Sources
Oxford sources its Same Day Same Service edits to methodologies used and recognized by third party authorities. Those methodologies can be definitive or interpretive. A definitive source is one that is based on very specific instructions from the given source. An interpreted source is one that is based on an interpretation of instructions from the identified source. Please see the
edit types section below for further explanations of these sources. The sources used to determine if a Same Day Same Service edit is appropriate are as follows: Current Procedural Terminology Book (CPT®) from the American Medical
Association (AMA);
CMS National Correct Coding Initiative (CCI) edits; CMS Policy; and
Physician specialty societies (e.g., American Academy of Orthopaedic Surgeons (AAOS), American College of Obstetricians and Gynecologists (ACOG), American College of Cardiology, and Society of Cardiovascular Interventional Radiology.
Edit Types
The following are edit types that may be applied in the Same Day Same Service Policy.
CCI Definitive: An edit sourced to specific billing guidelines from the General Correct Coding Policies contained in the National Correct Coding
Policy Manual published by CMS. For example, the Evaluation and Management Services section (chapter xi) specifically states "A physician should not report an 'initial' per diem E&M service with the same type of 'subsequent' per diem service on the same date of service." Oxford will not separately reimburse for an initial and a subsequent per diem service
on the same date, such as 99223 and 99232. CMS Definitive: An edit sourced to a specific billing guideline from CMS.
For example, the Medicare Claims Processing Manual states "If the same physician who admitted a patient to observation status also admits the patient to inpatient status from observation before the end of the date on
53 Oxford® Policy Update Bulletin: April 2018
Reimbursement Policy Updates
Oxford
Policy Title Effective Date Summary of Changes Reimbursement Guidelines
REVISED
Same Day/Same Service Policy (CES)
(continued)
May 1, 2018
which the patient was admitted to observation, pay only an initial hospital visit for the evaluation and management services provided on that date." Oxford will not separately reimburse for an initial observation
care service on the same date as an initial hospital care service, such as 99218 and 99222.
CPT Definitive: An edit sourced to specific CPT® book direction related
to the reporting of exact codes or modifiers. For example, the CPT coding book states "Do not report 94002-94004 in conjunction with Evaluation and Management services 99201-99499." Oxford will not separately reimburse for any service in the range 94002-94004 when reported with
any service in the range of 99201-99499. CCI Interpretive: CMS does not always create a comprehensive set of
edits between similar codes because of its target population and certain code sets that it does not recognize. Oxford, however, may include edits which have been created between similar codes based on an interpretation or extrapolation of the existing CCI edits. Examples of
these codes include newborn services, preventive medicine services and other CPT and HCPCS codes for which CMS has indicated the code is
invalid for Medicare. CMS Interpretive: The CMS National Correct Coding Initiative Policy
Manual cites certain specialty specific services which primarily involve evaluation and management services. When these specialty specific codes are reported, a separate evaluation and management service from
the range of CPT codes 99201-99499 should not be reported on the same date of service. Examples of these codes include general and special ophthalmologic services and general and special diagnostic and therapeutic psychiatric services.
CPT Interpretive: Based on Current Procedural Terminology (CPT) code definition, when a service is a component that is necessary to complete
the primary service, it is by definition included in the reimbursement of
that primary service. Examples of this would be codes that include words or phrases that indicate they include other services. For instance certain evaluation and management codes have descriptions that state "...admission and discharge on the same date..." By definition an initial observation care service or an initial hospital care service would be a component necessary to complete the primary service.
Significant, Separately Identifiable Evaluation and Management Service
54 Oxford® Policy Update Bulletin: April 2018
Reimbursement Policy Updates
Oxford
Policy Title Effective Date Summary of Changes Reimbursement Guidelines
REVISED
Same Day/Same Service Policy (CES)
(continued)
May 1, 2018 According to the CPT® book "It may be necessary to indicate that on the day a procedure or service identified by a CPT code was performed, the patient's condition required a significant, separately identifiable E/M service above and
beyond the other service provided or beyond the usual preoperative and postoperative care associated with the procedure that was performed. A significant, separately identifiable E/M service is defined or substantiated by
documentation that satisfies the relevant criteria for the respective E/M service to be reported (see Evaluation and Management Services Guidelines for instructions on determining level of E/M service)..."
Oxford will allow modifier 25 to indicate a significant and separately identifiable E/M service when a second physician in the same group and specialty provides a separate E/M service on the same day for an unrelated problem. However, there are instances when modifier 25 would not be appropriate to report, including but not limited to, reporting two E/M services where one is a "per day" code or reporting separate services when a more
comprehensive code exists that describes the services.
Time Span Codes
May 1, 2018
Revised Time Span Codes List (attachment file listing Time Span Codes and their designations); changed time span designation from “28 days” to “Calendar Month” for
CPT/HCPCS codes 90964, 90963, 90965, 90966, 95250, 95251, E0441, E0442, E0443, E0444, G9678, H0042, H0044, S0320, S5141, S5146, S5161, S5185, S9110, T1041, T2022,
T2023, T2030, and T2032
Time Span Codes
Oxford will reimburse a CPT or HCPCS Level II code that specifies a time
period for which it should be reported (e.g., weekly, monthly), once during that time period. The time period is based on sourcing from the AMA or CMS including: the CPT or HCPCS code description, CPT book parentheticals and other coding guidance in the CPT book, other AMA publications or CMS
publications. For example: Within the CPT book, the code description for CPT code 95250 states, “Ambulatory continuous glucose monitoring of interstitial tissue fluid via subcutaneous sensor for a minimum of 72 hours; sensor placement,
hook-up, calibration of monitor, patient training, removal of sensor, and printout of recording”. In addition to that code description, there is also a
parenthetical that provides further instructions with regard to the frequency the code can be reported. The parenthetical states, “Do not report 95250 more than once per month”. Oxford will reimburse CPT Code 95250 only once per month for the same member, for services provided by the Same Group Physician and/or Other Health Care Professional. In order to consider reimbursement for these services that may be repeated following a month with fewer than 31 days, Oxford may allow reimbursement of monthly Time
Span Codes when these codes are reported with dates of service at least 28
55 Oxford® Policy Update Bulletin: April 2018
Reimbursement Policy Updates
Oxford
Policy Title Effective Date Summary of Changes Reimbursement Guidelines
REVISED
Time Span Codes (continued)
May 1, 2018
days apart. CPT coding guidelines specify for physicians or other qualified health care
professionals to select the name of the procedure or service that accurately identifies the services performed.
Refer to Q&A #2 of the Question & Answers scetion of the policy for information on Time Span Code values and modifier usage. External Electrocardiographic Recording Services - CPT codes 93224, 93225, 93226, and 93227 Reported with Modifier 52
CPT codes 93224 – 93227 are reported for external electrocardiographic
recording services up to 48 hours by continuous rhythm recording and storage. CPT coding guidelines for codes 93224 – 93227 specify that when there are less than 12 hours of continuous recording modifier 52 (Reduced Services) should be used.
When modifier 52 is appended to CPT code 93224, 93225, 93226, or 93227, Oxford does not apply the Time Span Codes Policy for reimbursement of these codes. Instead, Oxford applies the Reduced Services policy which addresses reimbursement for codes appended with modifier 52. End-Stage Renal Disease Services (ESRD) 90951-90962
CPT codes 90951-90962 are grouped by age of the patient and the number
of face-to-face physician or other qualified health care professional visits provided per month (i.e., 1, 2-3, or 4 or more). Oxford will reimburse the single most comprehensive outpatient ESRD code submitted per age category (i.e., under 2 years of age, 2-11 years of age, 11-19 years of age, and 20 years of age and older) once per month. This aligns with CPT coding
guidance which states to report the age-specific ESRD codes should be
reported once per month for all physician or other health care professional face-to-face outpatient services. Time Span Comprehensive and Component Codes
When related Time Span Codes which share a common portion of a code description are both reported during the same time span period by the Same
Group Physicians and/or Other Health Care Professional for the same patient, the code with the most comprehensive description is the reimbursable
56 Oxford® Policy Update Bulletin: April 2018
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Policy Title Effective Date Summary of Changes Reimbursement Guidelines
REVISED
Time Span Codes (continued)
May 1, 2018
service. The other code is considered inclusive and is not a separately reimbursable service. No modifiers will override this denial.
The following example illustrates how the CPT book lists code 93268 first as it is the comprehensive code. CPT codes 93270, 93271, and 93272 are indented and each share a common component of their code description with
CPT code 93268.
CPT Code Description
93268
External patient and, when performed, auto activated electrocardiographic rhythm derived event recording with
symptom-related memory loop with remote download capability up to 30 days, 24-hour attended monitoring; includes transmission, physician review and interpretation
93270 Recording (includes connection, recording, and disconnection)
93271 Transmission and analysis
93272 Review and interpretation by a physician or other qualified health care professional
When CPT code 93270, 93271, or 93272 are reported with CPT 93268 during the same 30 day period by the Same Group Physician and/or Other Health Care Professional for the same patient, only CPT code 93268 is the
reimbursable service. The Time Span Comprehensive and Component Codes list (refer to the Attachments section of the policy) includes applicable comprehensive and related component Time Span Codes.