579 Form

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Pharmacy Medical Policy Compounded Medications Table of Contents
Authorization Information
Coverage Criteria
Appendix
Policy History
References

Policy Number: 579 BCBSA Reference Number: None Related Policies Compound Medications Exclusion Drug List #705 Opioid and Opioid Combination Medication Management #102 Proton Pump Inhibitors prn #030 Sexual Dysfunction Diagnosis and Therapy #078

Prior Authorization Information

Policy ☒ Prior Authorization ☐ Step Therapy ☐ Quality Care Dosing ☐ Administrative Reviewing Department Pharmacy Operations: Tel: 1-800-366-7778 Fax: 1-800-583-6289 To request for coverage: Providers may call, fax, or mail the attached form (Formulary Exception/Prior Authorization form) to the address below.
Blue Cross Blue Shield of Massachusetts Pharmacy Operations Department 25 Technology Place Hingham, MA 02043
Tel: 1-800-366-7778 Fax: 1-800-583-6289

Individual Consideration for the atypical patient: Policy for requests that do not meet clinical criteria of this policy, see section labeled Individual Consideration
Policy Last Updated 11/2025 Pharmacy (Rx) or Medical (MED) benefit coverage ☒ Rx ☒ MED Policy applies to Commercial members with BCBSMA formulary:
• Managed Care (HMO/POS) • PPO/EPO
• Indemnity
• MEDEX with Rx plans • Managed Blue for Seniors Policy does NOT apply to: • Medicare Advantage
Provider Documentation Requirements: Documentation from the provider to support a reason preventing trial of formulary alternative(s) must include the name and strength of alternatives tried and failed (if alternatives were tried, including dates if available) and specifics regarding the treatment failure. Documentation to support clinical basis preventing switch to formulary alternative should also provide specifics around clinical reason. We may also use prescription claims records to establish prior use of formulary alternatives or to show if step therapy criteria has been met. We will require the provider to share additional information when prescription claims data is either not available or the medication fill history fails to establish use of preferred formulary medications or

2 that step therapy criteria has been met. Other documentation requirements, if any, are outlined in prior authorization criteria.
See Appendix for additional information.

Clinical Guideline Coverage Criteria: Compounded Medications INITIAL APPROVAL
Coverage may be considered MEDICALLY NECESSARY, including those submitted with HCPCS/CPT codes like J7999, when ALL the following criteria are met. Diagnosis Various Applicable Medications Compounded medications Approval Length 6 months • Regulatory authorization for facility or personnel to compound prescriptions does not support clinical safety and effectiveness evidence for a compounded product. We will no longer pay for Bulk chemicals in compounded medications. As an exception, if there is a medical need for a bulk ingredient to be added to compound, it will require Prior Authorization as stated below. Covered compounded medications that require a prescription will be processed at your highest pharmacy benefit tier, regardless of the ingredients in the medication. Our Exclusion list is subject to change. • As of 1/1/2021 there is a $300 total cost limit for all compound medications. This will be applied on a per claim basis. If the Compound needs to exceed the $300 limit, the criteria below must be met.

1. A diagnosis as an ICD 9 or 10 code is provided AND
2. History of treatment failures to two (2) prescription alternatives (by prescription claims history), or documented contraindication alternative medication AND
3. Documentation of patient’s medical records stating the clinical diagnosis and confirmatory laboratory and or other tests for the clinical diagnosis AND
4. Submission of at least two (2) peer reviewed published studies in the medical and/or scientific literature, reviewed by an independent panel of experts, that provides evidence for the prescription’s intended clinical indication and use, route of administration, dose, and dose frequency, for single or multiple drugs to be compounded, in a population age of the intended patient, demonstrating safety, efficacy and outcomes comparable or superior to existing therapy
   AND
5. Excluding pharmaceutical aids and bulk powders, with attestation that the resulting compounded product is not a copy or similar to a commercially available product, or a product or product formulation withdrawn from the market (voluntarily or by regulatory action) due to safety or efficacy concerns,
   AND

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6. A copy of the prescription which includes a complete list of ingredients AND

7. The requested compounded prescription’s active pharmacologic agent(s) is/are approved to cure, mitigate, treat, or prevent disease or to affect the structure or any function of the human body consistent with the diagnosis provided in the request for coverage AND

8. IF the request is for compounded prescription(s) of proton pump inhibitors, the patient meets BOTH of the following: a. Patients age is less than 18 years . b. Patient also meets criteria outlined in Policy #030

   Appendix Criteria Documentation Provider must submit supporting documentation (e.g., chart notes, lab results or other clinical information) to show that the member has met all approval criteria. Samples Requests based exclusively on the use of samples will not meet coverage criteria for exception. Additional clinical information demonstrating medical necessity of the desired medication must be submitted by the requesting prescriber for review. Forms To request prior authorization using the Massachusetts Standard Form for Medication Prior Authorization Requests (eForm), click the link below: https://www.bluecrossma.org/medical- policies/sites/g/files/csphws2091/files/acquiadam- assets/023%20E%20Form%20medication%20prior%20auth%20instruction%20prn.pdf OR Print and fax, Massachusetts Standard Form for Medication Prior Authorization Requests #434 Individual Consideration (for Atypical Patients) Our medical policies are written for most people with a given condition. Each policy is based on peer reviewed clinical evidence. We also take into consideration the needs of atypical patient populations and diagnoses.
   If the coverage criteria outlined is unlikely to be clinically effective for the prescribed purpose, the health care provider may request an exception to cover the requested medication based on an individual’s unique clinical circumstances. This is also referred to as “individual consideration” or an “exception request.”
   Some reasons why you may need us to make an exception include: therapeutic contraindications; history of adverse effects; expected to be ineffective or likely to cause harm (physical, mental, or adverse reaction).
   To facilitate a thorough and prompt review of an exception request, we encourage the provider to include additional supporting clinical documentation with their request. This may include: • Clinical notes or supporting clinical statements; • The name and strength of formulary alternatives tried and failed (if alternatives were tried) and specifics regarding the treatment failure, if applicable; • Clinical literature from reputable peer reviewed journals; • References from nationally recognized and approved drug compendia such as American Hospital Formulary Service® Drug Information (AHFS-DI), Lexi-Drug, Clinical Pharmacology, Micromedex or Drugdex®; and • References from consensus documents and/or nationally sanctioned guidelines

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Providers may call, fax or mail relevant clinical information, including clinical references for individual patient consideration, to:

Blue Cross Blue Shield of Massachusetts Pharmacy Operations Department 25 Technology Place Hingham, MA 02043 Phone: 1-800-366-7778 Fax: 1-800-583-6289

Policy History Date Action 11/2025 Annual medical policy review. Updated formatting to standardized format. No substantial criteria changes. 1/2024 Clarified policy regarding the policy is applied at the claim level. 7/2023 Reformatted Policy. 1/2023 Updated to remove the Inclusion list and update the Exclusion list as part of our PBM transition. 1/1/2021 Updated to add $300 Cost exceeds maximum edit. 7/2019 Updated to clarify that Compounds for PPI for members under 18 may be covered when a Prior Authorization is submitted. 6/2017 Updated address for Pharmacy Operations. 1/2016 Updated to include Prior Authorization for J7999. 7/2015 Updated note section. 3/2015 Updated note to include benefit tier information. 1/1/2015 Update policy and include new criteria and remove old criteria, add new inclusion list, and add new exclusion list. 1/1/2014 Implementation of the policy.
9/2013 Pharmacy and Therapeutics Committee Review.

References

1. http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm3 39764.htm
2. The American College of Obstetrics and Gynecologists, Committee on Gynecologic Practice and the American Society for Reproductive Medicine Practice Committee: Committee Opinion Number 532 August 2012, Reaffirmed 2014. Compounded Bioidentical Menopausal Hormone Therapy.
3. Androgen Therapy in Women: A Reappraisal: An Endocrine Society Clinical Practice Guideline; J Clin Endocrinol Metab 99: 3489–3510, 2014