On May 24, NYDFS on pharmacy benefit manager licensure standards.
NYDFS proposed rules to establish Pharmacy benefits manager (PBM) requirements.
Amended NY INS 11-450 (benefits); added NY INS 11-453 (PBM assessments), NY INS 11-454 (filings and license requirements), and NY INS 11-455 (reporting and records).
Provided redline version of proposed amendments to NY INS 11-450 (benefits bureau).
PBM Assessments
Added new NY INS 11-453 (Regulation 223) to establish PBM assessment standards.
Defined assessment process for NYDFS operating expenses related to PBM regulation.
Assessment is equal to the total operating cost and is assessed for all registered PBMs.
Total operating costs are divided pro rata among registrants and licensees based on their share of the aggregate number of claims processed for pharmacies in the State.
Licenses/registrations may be suspended, revoked, or terminated for noncompliance.
Established a special assessment process in the event the Superintendent determines that expenses associated with a specific exam are best allocated solely to specific PBM.
PBM Licensing
Created NY INS 11-454 (Regulation 224) on PBM licensure application requirements.
Set licensing process and defined required application information; filed electronically.
Must pay the NYDFS Superintendent a non-refundable license application fee of $24k.
Required licensees to be compliant with cybersecurity requirements in NY LEG 23-500.
Reporting and Record Retention
Also created NY INS 11-455 (Regulation 225) on PBM reporting and record retention.
Records and indices must be maintained in durable medium; defined required records.
Disclosure requirements defined; set forth annual reporting requirements to PBMs.
Pharmacy Benefit Definitions
Proposed amendment to NY INS 11-450 (Regulation 219) amended definition section.
To include additional definitions for certain terms and words used in the new rules.
Consultation
Comments on amended and proposed regulations are due in 60 days on Jul. 24, 2023.
On Nov. 15, 2023, NYDFS published notice of adoption of rulemaking in State register.
In Nov. 2023, NYDFS issued FAQ, guidance for pharmacy benefit managers, #192706.
Regulators
NYDFS
Entity Types
Ins
Reference
NY SR Vol. XLV Is. 46, RF DFS-21-23-00002-A, 11/15/2023; PR, Info, Nt, RF, 10/31/2023; RF, 10/30/2023; NY SR Vol. 45 No. 21, RF DFS-21-23-00002-P, 5/24/2023; Citation: NY INS 11-450; NY LEG 23-500;
