Amendments to Regulation 1411 Pharmacy Benefits Manager Registration

NOTE: This Bulletin is intended solely for informational purposes. It is not intended to set forth legal rights, duties, or privileges, nor is it intended to provide legal advice. Readers should consult applicable statutes and rules and contact the Delaware Department of Insurance if additional information is needed. ♦INSURANCE.DELAWARE.GOV♦ 1351 W. NORTH ST., SUITE 101, DOVER, DELAWARE 19904-2465 (302) 674-7300 DOVER♦ (302) 259-7554 GEORGETOWN♦ (302) 577-5280 WILMINGTON Page | 1 TRINIDAD NAVARRO COMMISSIONER STATE OF DELAWARE DEPARTMENT OF INSURANCE TO: RE: DATED: DOMESTIC AND FOREIGN INSURERS BULLETIN NO. 136 ALL PHARMACY BENEFITS MANAGERS AMENDMENTS TO REGULATION 1411 PHARMACY BENEFITS MANAGER REGISTRATION January 13, 2023 REVISED: January 20, 2023 On October 1, 2022, the Department published in the Register of Regulations its proposal to amend Regulation 1411 to implement House Bill 219 (“HB 219”) of the 151st General Assembly. The adoption of the amendments was published at 26 DE Reg. 594 (01/01/2023) and is effective January 11, 2023. See https://regulations.delaware.gov/register/january2023/final/26%20DE%20Reg%20594%2001-01- 23.htm. The purpose of Domestic and Foreign Bulletin No. 136 as revised is to remove reference to “Carriers” and replace with “Pharmacy benefits managers.” The January 13, 2023 version of this bulletin advised registered pharmacy benefits managers of reporting due dates, the location of PBM-specific forms, and how to request approval of claim adjudication fees and pharmacy accreditation standards or certification requirements as follows: Report due dates: • Annual Network Adequacy Report - May 1. • Quarterly Reporting - January 15, April 15, July 15, and October 15. o The 1st report is due to the Department on April 15, 2023. ▪ Aggregate-only quarterly information will be required through January 15, 2024. Pharmacy benefits managers shall submit “individual” level data, in addition to aggregate data, beginning with the April 15, 2024 report. Reports shall be submitted electronically to doipbm@delaware.gov. NOTE: This Bulletin is intended solely for informational purposes. It is not intended to set forth legal rights, duties, or privileges, nor is it intended to provide legal advice. Readers should consult applicable statutes and rules and contact the Delaware Department of Insurance if additional information is needed. ♦INSURANCE.DELAWARE.GOV♦ 1351 W. NORTH ST., SUITE 101, DOVER, DELAWARE 19904-2465 (302) 674-7300 DOVER♦ (302) 259-7554 GEORGETOWN♦ (302) 577-5280 WILMINGTON Page | 2 Forms: • Maximum Allowable Cost (MAC) Appeal forms: o Pharmacist/Appellant MAC Appeal form: https://insurance.delaware.gov/wpcontent/uploads/sites/15/2023/01/Pharmacist-MAC-Appeal-form-2.pdf o PBM/Respondent MAC Appeal form: https://insurance.delaware.gov/wpcontent/uploads/sites/15/2023/01/Respondent-MAC-Appeal-form.pdf • Quarterly Report form: https://view.officeapps.live.com/op/view.aspx?src=https%3A%2F%2Finsurance.delawar e.gov%2Fwp-content%2Fuploads%2Fsites%2F15%2F2023%2F01%2FDE-Quarterly- PBM-Itemized-Aggregate-Financial-report.xlsx&wdOrigin=BROWSELINK o Quarterly PBM Attestation form: https://insurance.delaware.gov/wpcontent/uploads/sites/15/2023/01/Delaware-Quarterly-PBM-Attestation.pdf • Mailing address/contact update form: https://insurance.delaware.gov/wpcontent/uploads/sites/15/2023/01/PBM-Address-Change-form.pdf • PBM Name Change form: https://insurance.delaware.gov/wpcontent/uploads/sites/15/2023/01/PBM-Name-Change-Application.pdf • The Department does not provide a Network Adequacy Reporting Form. A PBM may submit its Network Adequacy report in its own form; however, the report must include all the information required by 18 DE Admin. Code 1411-10.0. Approval of Claim Adjudication Fees and Pharmacy Accreditation Standards or Certification Requirements: All fees which are charged to Delaware pharmacies related to the adjudication of a claim, and any pharmacy accreditation standard or certification requirement that is inconsistent with, more stringent than, or in addition to the requirements of the Board of Pharmacy, must be submitted for review and approval by the Commissioner. Requests for review and approval related to claim adjudication fees or pharmacy accreditation standards/certification requirements shall be submitted electronically to doipbm@delaware.gov and shall include all of the information required by 18 DE Admin. Code 1411-12.2 and 1411-12.3, respectively. Additional information related to PBMs is available at https://insurance.delaware.gov/divisions/berg/#pbm. Questions, comments or requests for clarification about this Bulletin should be emailed to doipbm@delaware.gov. This Bulletin shall be effective immediately and shall remain in effect unless withdrawn or superseded by subsequent law, regulation or bulletin. NOTE: This Bulletin is intended solely for informational purposes. It is not intended to set forth legal rights, duties, or privileges, nor is it intended to provide legal advice. Readers should consult applicable statutes and rules and contact the Delaware Department of Insurance if additional information is needed. ♦INSURANCE.DELAWARE.GOV♦ 1351 W. NORTH ST., SUITE 101, DOVER, DELAWARE 19904-2465 (302) 674-7300 DOVER♦ (302) 259-7554 GEORGETOWN♦ (302) 577-5280 WILMINGTON Page | 3 ______________________________________ Trinidad Navarro Delaware Insurance Commissioner