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Chapter 1369

Benefits Related to Prescription Drugs and Devices and Related Services

Subchapter A. Coverage of Prescription Drugs in General

1369.001 Definitions 1369.002 Applicability of Subchapter 1369.003 Exception 1369.004 Coverage Required 1369.0041 Certain Payments and Refills 1369.005 Rules

Subchapter B. Requirements Affecting Coverage of Specific Prescription Drugs or Cost Sharing

1369.051 Definitions 1369.052 Applicability of Subchapter 1369.053 Exception 1369.054 Notice and Disclosure of Certain Information Required 1369.0541 Modification of Drug Coverage under Plan 1369.0542 Effect of Reductions in Out-of-Pocket Expenses on Cost Sharing 1369.0545 Step Therapy Protocols 1369.0546 Step Therapy Protocol Exception Requests 1369.0547 Step Therapy Protocols for Prescription Drugs to Treat Serious Mental Illnesses 1369.055 Continuation of Coverage Required; Other Drugs Not Precluded 1369.056 Adverse Determination 1369.057 Rules

Subchapter B-1. Transparency Requirements for Certain Individual Health Benefit Plans

1369.076 Definitions 1369.077 Applicability of Subchapter 1369.078 Formulary Information on Internet Website 1369.079 Formulary Disclosure Requirements 1369.080 Formulary Information Provided by Toll-Free Telephone Number

Subchapter B-2. Disclosure of Certain Prescription Drug Information Specified by Drug Formulary

1369.091 Definitions 1369.092 Applicability of Subchapter 1369.093 Exceptions to Applicability of Subchapter 1369.094 Disclosure of Prescription Drug Information

Subchapter C. Coverage of Prescription Contraceptive Drugs and Devices and Related Services

1369.101 Definitions 1369.102 Applicability of Subchapter 1369.103 Exception 1369.1031 Certain Coverage Required 1369.104 Exclusion or Limitation Prohibited 1369.105 Certain Cost-Sharing Provisions Prohibited 1369.106 Certain Waiting Periods Prohibited 1369.107 Prohibited Conduct 1369.108 Exemption for Entities Associated with Religious Organization 1369.109 Enforcement

Subchapter D. Pharmacy Benefit Cards

1369.151 Applicability of Subchapter 1369.152 Exception 1369.153 Information Required on Identification Card 1369.154 Rules

Subchapter E. Coverage for Orally Administered Anticancer Medications

1369.201 Definitions 1369.202 Applicability of Subchapter 1369.203 Exception 1369.204 Required Coverage for Orally Administered Anticancer Medications

Subchapter E-1. Coverage of Prescription Drugs for Stage-Four Advanced, Metastatic Cancer

1369.211 Definitions 1369.212 Applicability of Subchapter 1369.213 Prohibited Conduct

Subchapter E-2. Coverage for Chimeric Antigen Receptor T-Cell Therapy

1369.221 Applicability of Subchapter 1369.222 Exceptions to Applicability of Subchapter 1369.223 Coverage Requirements 1369.224 Rules

Subchapter F. Audits of Pharmacists and Pharmacies

1369.251 Definitions 1369.252 Exceptions to Applicability of Subchapter 1369.253 Conflict with Other Laws 1369.254 Audit of Pharmacist or Pharmacy; Notice; General Provisions 1369.255 Completion of Audit 1369.256 Audit Requiring Professional Judgment 1369.257 Access to Pharmacy Area 1369.258 Validation Using Certain Records Authorized 1369.2581 Audit Discrepancies; Wholesale Invoices 1369.259 Limitations on Payment Adjustments and Recoupment; Use of Extrapolation Prohibited 1369.260 Clerical or Recordkeeping Error; Fraud Allegation 1369.261 Access to Previous Audit Reports; Uniform Audit Standards 1369.262 Compensation of Auditor 1369.263 Conclusion of Audit; Summary; Preliminary Audit Report 1369.264 Final Audit Report 1369.265 Certain Audits Exempt from Deadlines 1369.266 Recoupment and Interest Charged After Audit 1369.267 Waiver Prohibited 1369.268 Remedies Not Exclusive 1369.269 Enforcement; Rules 1369.270 Legislative Declaration

Subchapter G. Standard Request Form for Prior Authorization of Prescription Drug Benefits

1369.301 Definition 1369.302 Applicability of Subchapter 1369.303 Exception 1369.304 Standard Form 1369.305 Advisory Committee on Uniform Prior Authorization Forms 1369.306 Failure to Use or Acknowledge Standard Form

Subchapter H. Maximum Allowable Cost

1369.351 Definitions 1369.352 Certain Benefits Excluded 1369.353 Criteria for Drugs on Maximum Allowable Cost Lists 1369.354 Formulation of Maximum Allowable Costs; Disclosures 1369.355 Updates 1369.356 Access to Maximum Allowable Cost Lists 1369.357 Appeal from Maximum Allowable Cost Price Determination 1369.358 Confidentiality of Maximum Allowable Cost List 1369.359 Waiver Prohibited 1369.360 Remedies Not Exclusive 1369.361 Enforcement 1369.362 Legislative Declaration

Subchapter I. Pharmacy Benefit Claim Adjudication

1369.401 Definition 1369.402 Certain Fees Prohibited

Subchapter J. Coverage Related to Prescription Drug Synchronization

1369.451 Definitions 1369.452 Applicability of Subchapter 1369.453 Applicability to Certain Medications 1369.454 Proration of Cost-Sharing Amount Required 1369.455 Proration of Dispensing Fee Prohibited 1369.456 Implementation of Certain Medication Synchronization Plans

Subchapter K. Prescription Drug Cost Transparency

1369.501 Definitions 1369.502 Pharmacy Benefit Manager Information 1369.503 Health Benefit Plan Issuer Information 1369.5035 Content of Reports 1369.504 Rules

Subchapter L. Affiliated Providers

1369.551 Definitions 1369.552 Exceptions to Applicability of Subchapter 1369.553 Transfer or Acceptance of Certain Records Prohibited 1369.554 Prohibition on Certain Communications 1369.555 Prohibition on Certain Referrals and Solicitations

Subchapter M. Contracts with Pharmacists and Pharmacies

1369.601 Definitions 1369.602 Applicability of Subchapter 1369.6021 Online Access to Pharmacy Benefit Network Contract 1369.6022 Pharmacy Benefit Network Contract: Adverse Material Changes 1369.6023 Pharmacy Benefit Network Contract: Other Modifications and Addendums 1369.6024 Pharmacy Benefit Network Contract Disclosure 1369.6025 Provider Manual Disclosure 1369.6026 Pharmacy Benefit Network Contract Fee Limitations 1369.6027 Pharmacy Benefit Network Participation Requirements Prohibited 1369.603 Reduction of Certain Claim Payment Amounts Prohibited 1369.604 Reimbursement of Affiliated and Nonaffiliated Pharmacists and Pharmacies 1369.605 Network Contract Fee Schedule 1369.606 Disclosure of Pharmacy Services Administrative Organization Contract 1369.607 Delivery of Drugs 1369.608 Professional Standards and Scope of Practice Requirements 1369.609 Retaliation Prohibited 1369.610 Waiver Prohibited

Subchapter N. Coverage of Prescription Drugs for Autoimmune Diseases and Certain Blood Disorders

1369.651 Definition 1369.652 Applicability of Subchapter 1369.653 Exceptions 1369.654 Prohibition on Multiple Prior Authorizations

Subchapter Q. Clinician-Administered Drugs

1369.761 Definitions 1369.762 Applicability of Subchapter 1369.763 Exceptions to Applicability of Subchapter 1369.764 Certain Limitations on Coverage of Clinician-Administered Drugs Prohibited