CONTRACEPTIVES. Page. Office. 1 Please refer to the Member's specific certificate. 2 Religious exemptions may apply.

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1 CLINICAL POLICY CONTRACEPTIVES Policy Number: PHARMACY T0 Effective Date: March 1, 2016 Table of Contents CONDITIONS OF COVERAGE... BENEFIT CONSIDERATIONS COVERAGE RATIONALE... DEFINITIONS. APPLICABLE CODES... REFERENCES... POLICY HISTORY/REVISION INFORMATION... Page Related Policies: Drug Coverage Criteria - New and Therapeutic Equivalent Medications Preventive Care Services The services described in Oxford policies are subject to the terms, conditions and limitations of the Member's contract or certificate. Unless otherwise stated, Oxford policies do not apply to Medicare Advantage enrollees. Oxford reserves the right, in its sole discretion, to modify policies as necessary without prior written notice unless otherwise required by Oxford's administrative procedures or applicable state law. The term Oxford includes Oxford Health Plans, LLC and all of its subsidiaries as appropriate for these policies. Certain policies may not be applicable to Self-Funded Members and certain insured products. Refer to the Member's plan of benefits or Certificate of Coverage to determine whether coverage is provided or if there are any exclusions or benefit limitations applicable to any of these policies. If there is a difference between any policy and the Member s plan of benefits or Certificate of Coverage, the plan of benefits or Certificate of Coverage will govern. CONDITIONS OF COVERAGE Applicable Lines of Business/Products This policy applies to Oxford Commercial plan membership Benefit Type Pharmacy 1,2 General Benefits Package 1 Referral Required No (Does not apply to non-gatekeeper products) Authorization Required (Precertification always required for inpatient admission) No Precertification with Medical Director No Review Required Applicable Site(s) of Service (If site of service is not listed, Medical Director review is required) Special Considerations Office 1 Please refer to the Member's specific certificate of coverage, contract and/or prescription drug rider as applicable. 2 Religious exemptions may apply. 1

2 BENEFIT CONSIDERATIONS Before using this guideline, please check the member specific benefit plan document and any federal or state mandates, if applicable. Essential Health Benefits for Individual and Small Group: For plan years beginning on or after January 1, 2014, the Affordable Care Act of 2010 (ACA) requires fully insured non-grandfathered individual and small group plans (inside and outside of Exchanges) to provide coverage for ten categories of Essential Health Benefits ( EHBs ). Large group plans (both self-funded and fully insured), and small group ASO plans, are not subject to the requirement to offer coverage for EHBs. However, if such plans choose to provide coverage for benefits which are deemed EHBs (such as maternity benefits), the ACA requires all dollar limits on those benefits to be removed on all Grandfathered and Non-Grandfathered plans. The determination of which benefits constitute EHBs is made on a state by state basis. As such, when using this guideline, it is important to refer to the member specific benefit document to determine benefit coverage. Note: For additional information regarding preventive contraceptive coverage, refer to the policy titled Preventive Care Services. COVERAGE RATIONALE Under the health care reform law, health plans must cover Food and Drug Administration (FDA) approved contraception methods for women without cost-sharing (copayment, coinsurance or deductible) when the method(s) is provided by a network provider. According to the United States Preventive Services Task Force (USPSTF), reasonable cost controlling techniques such as tiering, exclusions and step therapy can be utilized to implement this coverage. Coverage for Prescription Contraceptives Select prescription contraceptives will be covered under the pharmacy benefit without cost-share when the item is purchased from a network pharmacy. Oxford has determined that contraceptives with the same progestin are equivalent to each other. Therefore, each unique progestin contraceptive medication will be represented in Tier 1. Contraceptives in Tier 1 will be available without cost-share to the member. Oral contraceptives that have the same unique active progestin as a tier 1 contraceptive but are multisource brands, (select) single source brands or generics for products where Oxford has a brand over generic strategy (and the brand is in Tier 1) will be in Tier 2 or 3 and a cost-share will apply to the member. Notes: Hormonal contraceptives currently excluded from benefit coverage will remain excluded since they contain the same or modified version of an active ingredient and are therapeutically equivalent to a covered product. Refer to Drug Coverage Criteria - New and Therapeutic Medications for additional information. Injectable contraceptives provided in a network physician s office are covered under the member s medical benefit (i.e.; Depo Provera 150 mg, Depo-Subq Provera 104, and Lunelle). Contraceptive Procedures/Appliances/Devices The following contraceptive procedures/appliances/devices are covered under the member s medical benefit when provided by a network provider. The provider must have an appropriate specialty (OB/GYN, Certified Nurse Midwife, Family Practitioner) to be eligible to perform the service. Office contraceptive procedures/ appliances/devices include: 2

3 Insertion and removal of an intrauterine device (IUD), and other FDA approved contraceptive devices (i.e.; implant, and cervical caps, etc). Diaphragms Note: Diaphragms are also covered under the pharmacy benefit if purchased at a network pharmacy. Services to place/remove/inject covered FDA approved emergency contraceptive methods (i.e.; Plan B One Step one, ella, etc). Sterilization procedures for women (i.e., tubal ligation). Note: For additional information regarding preventive contraceptive coverage, refer to the policy titled Preventive Care Services. Exclusions: Contraceptive and contraceptive counseling coverage excludes: Abortions or abortifacient drugs (i.e.; Mifiprex [mifeprestone]). Male contraception and sterilization. These services are not part of the United States Preventive Services Task Force (USPSTF) requirements. Standard coverage and cost share guidelines apply to these services. Please refer to the Member's specific certificate of coverage, contract and/or prescription drug rider as applicable. Religious employers may request a contract without coverage for contraceptives that are contrary to the religious employer s bona fide religious tenets. Refer to the Definitions section for state specific definitions of religious employer, which employers must meet in addition to the definition of religious employer under the Patient Protection and Affordable Care Act (PPACA). Exception: New York Large and Small Groups; each enrollee that is part of a group that has requested a contract without contraceptive coverage for religious tenets has the right to directly purchase such coverage. DEFINITIONS Contraceptives: Chemical, physical or barrier methods or devices used to prevent conception. Religious employer PPACA: An organization that is organized and operates as a nonprofit entity and is referred to in section 6033(a)(3)(A)(i) or (iii) of the Internal Revenue Code of 1986, as amended. Religious employer - NJ: An employer that is a church, convention or association of churches or any group or entity that is operated, supervised or controlled by or in connection with a church or a convention or association of churches as defined in 26 U.S.C. s.3121(w)(3)(a), and that qualifies as a tax-exempt organization under 26 U.S.C. s.504(c)(3). Religious employer - CT: An employer that is a "qualified church-controlled organization" as defined in 26 USC 3121 or a church-affiliated organization. Religious employer - NY: An employer for which each of the following is true: The inculcation of religious values is the purpose of the entity. (b) The entity primarily employs persons who share the religious tenets of the entity. The entity serves primarily persons who share the religious tents of the entity. The entity is a nonprofit organization as described in Section 6033(a)(2)(A)i or iii, of the Internal revenue Code of 1986, as amended. APPLICABLE CODES The Current Procedural Terminology (CPT ) codes and Healthcare Common Procedure Coding System (HCPCS) codes listed in this policy are for reference purposes only. Listing of a service code in this policy does not imply that the service described by this code is a covered or non- 3

4 covered health service. Coverage is determined by the member specific benefit document and applicable laws that may require coverage for a specific service. The inclusion of a code does not imply any right to reimbursement or guarantee claims payment. Other policies and coverage determination guidelines may apply. This list of codes may not be all inclusive. Applicable CPT Codes CPT Code 11976** Removal, implantable contraceptive capsules 11981** Insertion, non-biodegradable drug delivery implant 11982** Removal, non-biodegradable drug delivery implant 11983** Removal, with reinsertion, non-biodegradable drug delivery implant 58300** Insertion of IUD (service includes surgical procedure only) 58301** Removal of IUD 58565* Hysteroscopy, surgical; with bilateral fallopian tube cannulation to induce occlusion by placement of permanent implants 57170* Diaphragm or cervical cap fitting with instructions 58600* Ligation or transection of fallopian tube(s), abdominal or vaginal approach, unilateral or bilateral Ligation or transection of fallopian tube(s), abdominal or vaginal 58605* approach, postpartum, unilateral or bilateral, during same hospitalization (separate procedure) Ligation or transection of fallopian tube(s) when done at the time of 58611* cesarean delivery or intra-abdominal surgery (not a separate procedure) (List separately in addition to code for primary procedure) 58615* Occlusion of fallopian tube(s) by device (e.g., band, clip, Falope ring) vaginal or suprapubic approach 58670* Laparoscopy, surgical; with fulguration of oviducts (with or without transection) 58671* Laparoscopy, surgical; with occlusion of oviducts by device (e.g., band, clip, or Falope ring) 00940*** Anesthesia for vaginal procedures (including biopsy of labia, vagina, cervix or endometrium); not otherwise specified Anesthesia for vaginal procedures (including biopsy of labia, 00942*** vagina, cervix or endometrium); colpotomy, vaginectomy, colporrhaphy, and open urethral procedures 00950*** Anesthesia for vaginal procedures (including biopsy of labia, vagina, cervix or endometrium); culdoscopy Anesthesia for vaginal procedures (including biopsy of labia, 00952*** vagina, cervix or endometrium); hysteroscopy and/or hysterosalpingography 01960*** Anesthesia for vaginal delivery only 01961*** Anesthesia for cesarean delivery only 01965*** Anesthesia for incomplete or missed abortion procedures 01966*** Anesthesia for induced abortion procedures 01967*** 01968*** Neuraxial labor analgesia/anesthesia for planned vaginal delivery (this includes any repeat subarachnoid needle placement and drug injection and/or any necessary replacement of an epidural catheter during labor) Anesthesia for cesarean delivery following neuraxial labor analgesia/anesthesia (List separately in addition to code for primary procedure performed) CPT is a registered trademark of the American Medical Association. 4

5 Applicable HCPCS Codes HCPCS Code A4261* Cervical cap for contraceptive use A4264* Permanent implantable contraceptive intratubal occlusion device(s) and delivery system A4266* Diaphragm for contraceptive use J7297** Levonorgestrel-releasing intrauterine contraceptive system, 52 mg, 3 year duration J7298** Levonorgestrel-releasing intrauterine contraceptive system, 52 mg, 5 year duration J7300* Intrauterine copper contraceptive J7303 Contraceptive supply, hormone containing vaginal ring, each J7306** Levonorgestrel (Contraceptive) Implant System, Including Implants and Supplies J7307** Etonogestrel (contraceptive) implant system, including implant and supplies (IMPLANON TM ) Q0090** Levonorgestrel-Releasing Intrauterine Contraceptive System (SKYLA), 13.5 mg S4981** Insertion of levonorgestrel-releasing intrauterine system S4989** Contraceptive intrauterine device (e.g., Progestacert IUD), including implants and supplies CPT/HCPCS Coding Notes: *Indicates CPT/HCPCS code is payable without cost share regardless of the diagnosis code. **Indicates CPT/HCPCS code is payable without cost share only when billed with one of the diagnosis codes listed in the Applicable Diagnosis Codes grid below (except for ICD- 10 diagnosis code Z30.2). ***Indicates CPT is payable without cost share when billed with diagnosis code Z30.2 only (listed in the Applicable Diagnosis Codes grid below). ICD-9 Diagnosis Codes (Discontinued 10/01/15) The following list of codes is provided for reference purposes only. Effective October 1, 2015, the Centers for Medicare & Medicaid Services (CMS) implemented ICD-10-CM (diagnoses) and ICD- 10-PCS (inpatient procedures), replacing the ICD-9-CM diagnosis and procedure code sets. ICD-9 codes will not be accepted for services provided on or after October 1, ICD-9 Code (Discontinued 10/01/15) V25.01 Prescription of oral contraceptives V25.02 Initiation of other contraceptive measures V25.03 Encounter for emergency contraceptive counseling and prescription V25.09 Other (family planning device) V25.11 Encounter for insertion of intrauterine contraceptive device V25.12 Encounter for removal of intrauterine contraceptive device V25.13 Encounter for removal and reinsertion of intrauterine contraceptive device V25.2*** Sterilization V25.40 Contraceptive surveillance, unspecified V25.41 Contraceptive pill V25.42 Intrauterine contraceptive device V25.43 Implantable subdermal contraceptive V25.49 Other contraceptive method V25.5 Insertion of implantable subdermal contraceptive 5

6 ICD-9 Code (Discontinued 10/01/15) V25.8 Other specified contraceptive management V25.9 Unspecified contraceptive management ICD-10 Codes ICD-10-CM (diagnoses) and ICD-10-PCS (inpatient procedures) must be used to report services provided on or after October 1, ICD-10 codes will not be accepted for services provided prior to October 1, ICD-10 Code Z Encounter for initial prescription of contraceptive pills Z Encounter for prescription of emergency contraception Z Encounter for initial prescription of injectable contraceptive Z Encounter for initial prescription of intrauterine contraceptive device Z Encounter for initial prescription of other contraceptives Z Encounter for initial prescription of contraceptives, unspecified Z30.09 Encounter for other general counseling and advice on contraception Z30.2 Encounter for sterilization Z30.40 Encounter for surveillance of contraceptives, unspecified Z30.41 Encounter for surveillance of contraceptive pills Z30.42 Encounter for surveillance of injectable contraceptive Z Encounter for insertion of intrauterine contraceptive device Z Encounter for routine checking of intrauterine contraceptive device Z Encounter for removal of intrauterine contraceptive device Z Encounter for removal and reinsertion of intrauterine contraceptive device Z30.49 Encounter for surveillance of other contraceptives Z30.8 Encounter for other contraceptive management Z30.9 Encounter for contraceptive management, unspecified ICD-10 Coding Note: ***Diagnosis code Z30.2 only applies when billed with CPT codes 00940, 00942, 00950, 00952, 01960, 01961, 01965, 01966, 01967and (listed in the Applicable CPT Codes grid above). REFERENCES CFR American Medical Association. Current Procedural Terminology: CPT Professional Edition. 3. American Medical Association. Healthcare Common Procedure Coding System. Medicare's National Level II Codes HCPCS. 4. C.G.S.A 38a-503e; C.G.S.A 38a-530e (2002); PA N.Y. Ins (cc) (McKinney 2002). 6. NY INS 3221 (1)(16)(A)(1). 7. NJSA 17B: x(b). 8. CT ST 38a-530e(f). 9. Oxford Certificate of Coverage and Member Handbook. 10. ECRI Custom Hotline "Monthly Combined Injectable Contraceptives". Dated October 24,

7 11. Del.Code Ann.Tit (2002) Reversible Contraceptives. 12. LunelleTM package insert. Kalamazoo, MI: Pharmacia & Upjohn Company; Depo-Provera Contraceptive Injection package insert. Kalamazoo, MI: Pharmacia & Upjohn Company; Women s Preventive Services: Required Health Plan Coverage Guidelines: POLICY HISTORY/REVISION INFORMATION Date 08/01/ /01/2016 Action/ Removed reference link to related policy Prescription Drug Quantity Duration (QD) and Quantity Level Limitations (QLL) Reorganized conditions of coverage/special considerations Added benefit considerations language to indicate: o Before using this guideline, please check the member specific benefit plan document and any federal or state mandates, if applicable o For Essential Health Benefits for Individual and Small Group plans: For plan years beginning on or after January 1, 2014, the Affordable Care Act of 2010 (ACA) requires fully insured non-grandfathered individual and small group plans (inside and outside of Exchanges) to provide coverage for ten categories of Essential Health Benefits ( EHBs ) Large group plans (both self-funded and fully insured), and small group ASO plans, are not subject to the requirement to offer coverage for EHBs; however, if such plans choose to provide coverage for benefits which are deemed EHBs (such as maternity benefits), the ACA requires all dollar limits on those benefits to be removed on all Grandfathered and Non-Grandfathered plans The determination of which benefits constitute EHBs is made on a state by state basis; as such, when using this guideline, it is important to refer to the member specific benefit document to determine benefit coverage Updated and reorganized coverage rationale: o Removed language pertaining to contraceptive coverage prior to Aug. 1, 2012 o Added language to indicate: Contraceptive procedures/appliances/devices are covered under the member s medical benefit when provided by a network provider Diaphragms are covered under the pharmacy benefit if purchased by prescription at a network pharmacy o Removed/relocated definition of religious employer Updated definitions; added definition of: o Religious employer Patient Protection and Affordable Care Act o Religious employer Connecticut o Religious employer New Jersey o Religious employer New York Updated lists of applicable CPT and HCPCS codes; consolidated notations pertaining to cost share guidelines Updated list of applicable ICD-10 codes; added notation 7

8 indicating diagnosis code Z30.2 only applies when billed with CPT codes 00940, 00942, 00950, 00952, 01960, 01961, 01965, 01966, and Archived previous policy version PHARMACY T0 8