Related Practices & Jurisdictions
Monday, January 31, 2022
In acknowledgment to calls for greater accuracy in the decree biologic industry, 2021 connected a civic trend of added accompaniment licensing and adjustment of Pharmacy Benefit Managers (“PBMs”). In the aftermost year, laws acute PBMs to access PBM, Third Party Administrator (“TPA”) or Health Care Benefit Manager (“HCBM”) licenses/registrations from accompaniment regulators were anesthetized or became able in at atomic eighteen states. In accession to the new licensing requirements, abundant states additionally adopted requirements acclimation added aspects of PBM operations.
The eighteen states that anesthetized a PBM licensing/registration affirmation (or had one become effective) in 2021 include:
Alabama – SB 227 (effective 07/01/2021)
Alabama – Rule and Adjustment 482-1-164-.01 (effective 01/01/2022)
Delaware – HB 219 (effective 10/26/2021)
Georgia – Rule and Adjustment 120-2-97-.01 (effective 01/01/2021)
Hawaii – SB 1096 (effective 06/28/2021)
Indiana – HB 1405 (effective 04/29/2021)
Kentucky – Rules and Adjustment 806 KAR 9:360 (amendment able 07/06/2021)
Maine – Rule and Adjustment Chapter 210 (effective 02/14/2021)
Maryland – HB 601 (effective 01/01/2022)
Maryland – Bulletin 21-07 (effective 03/04/2021)
Minnesota – Allowance Code 62W.11 (amendment able 07/01/2021)
Mississippi – Rules and Regulations R30-3001-4501 (amendment able 12/30/2021)
Missouri – Rule and Adjustment 20 CSR 200-22.010 (effective 10/30/2021)
Montana – SB 395 (effective 01/01/2022)
Montana – Rule and Adjustment anachronous October 12, 2021 (effective 10/12/2021)
New Hampshire – Bulletin 21-001-AB (effective 01/04/2021)
New Hampshire – Bulletin 21-104-AB (effective 12/17/2021)
New Mexico – Rules and Adjustment 126.96.36.199 (effective 03/01/2021)
North Carolina – SB 257 (effective 10/01/2021)
Oklahoma – HB 2677 (effective 05/04/2021)
South Carolina – Bulletin 2021-08 (effective 12/01/2021)
Washington – Allowance Code 48.200.010 (effective 01/01/2022)
Washington – Rules and Regulations 284-180-110 (effective 01/01/2022)
The aloft states all prohibit an article from acting as a PBM after aboriginal acceptable accountant or registered with the adapted accompaniment ascendancy (e.g., the state’s allowance department, accompaniment pharmacy board, etc.). The specific appliance requirements for licensure or allotment alter by state. However, applications generally crave acquiescence of the afterward abstracts and information:
Organizational advice about the appellant entity, including abstracts such as the applicant’s Articles of Incorporation and Bylaws
A Certificate of Good Standing (or its equivalent) from the applicant’s accompaniment of abode and the accompaniment in which the appellant is applying for a license
The able abilities of the applicant’s principals
Background advice of the appellant article and assertive of its principals apropos bent history, authoritative actions, banking issues and civilian litigation
Financial statements assuming that the appellant is financially sound
A aggressiveness band and/or affidavit of assertive allowance coverages
A abundant business plan
Form affairs with payers and/or pharmacies
In accession to the new licensing and allotment requirements referenced above, abundant states additionally afresh adopted requirements acclimation assertive aspects of PBM operations. Common operational issues addressed by those new requirements include:
Prohibited agreement and binding accoutrement in agreements amid PBMs and their apprenticed payers and/or pharmacies
Minimum standards for, and restrictions on, the use of best acceptable amount (“MAC”) pricing
A pharmacy’s appropriate to address a affirmation assurance and a PBM’s appropriate to alter a accomplished affirmation determination
Pharmacy arrangement capability standards and accommodation for arrangement participation
Pharmacy auditing rights and protections
As a aftereffect of the cogent contempo access in the cardinal of states that are currently licensing and acclimation PBMs, it is important for PBMs to affirm that they are in acquiescence with the licensing/registration and operational requirements of the states in which they are active.
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© Polsinelli PC, Polsinelli LLP in CaliforniaNational Law Review, Volume XII, Cardinal 31
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