3 CCR 702-9 – Prescription Drug Affordability Board

DEPARTMENT OF REGULATORY AGENCIES PRESCRIPTION DRUG AFFORDABILITY BOARD 3 CCR 702-9 [Editor’s Notes follow the text of the rules at the end of this CCR Document.] _________________________________________________________________________ Part 1 GENERAL PROVISIONS

1.1

Authority The statutory authority for this rule includes but is not limited to section 10-16-1403(5), C.R.S. Scope and Purpose The purpose of this rule is to provide necessary definitions of terms used throughout the rules. Defined terms are capitalized where they appear in the rules, to let the reader know to refer back to these definitions. When a term is used in a conventional sense, and is not intended to be a defined term, it is not capitalized.

1.1 Definitions

“Affordability Review” means a review of a prescription drug performed by the Board pursuant to section 10-16-1406(3)-(7), C.R.S., to determine whether use of the Prescription Drug consistent with the labeling approved for Prescription Drug by the FDA or with standard medical practice is unaffordable for Colorado consumers.

“Aggrieved Person” means a Person who has suffered actual loss or injury or is being exposed to potential loss or injury to legitimate interest including, but not limited to, business and economic interests. “Board” has the same meaning as set forth in section 10-16-1401(7), C.R.S. “Board Staff” means any individual employed by the Division of Insurance providing support to and/or doing work on behalf of the Board.

“Days” means calendar days.

“Person” includes an individual, limited liability company, partnership, corporation, association, county, and public or private organization of any character other than an agency. “Prescription Drug” has the same meaning as set forth in section 10-16-1401(19), C.R.S. “Upper Payment Limit” has the same meaning as set forth in section 10-16-1401(23), C.R.S. 1 CODE OF COLORADO REGULATIONS 3 CCR 702-9 Part 2 PRESCRIPTION DRUG AFFORDABILITY BOARD APPEALS

2.1

Authority The statutory authority for this rule includes but is not limited to section 10-16-1408, C.R.S. Scope and Purpose The purpose of this rule is to establish the process and timeline for an Aggrieved Person to file an appeal under section 10-16-1408, C.R.S., to the Prescription Drug Affordability Board.

2.1 Appeals

A. Filing an Appeal. Any Aggrieved Person may appeal an initial decision by the Board to establish a specific Upper Payment Limit pursuant to section 10-16-1407, C.R.S., by filing via electronic mail to dora_ins_pdab@state.co.us, a written appeal with the Board within sixty (60) days after the Board’s initial decision to establish a specific Upper Payment Limit.

1. Any party who fails to properly file a written appeal within the time provided in these rules shall be deemed to have waived the right to an appeal.
2. The appeal may not include information not provided to the Board at or prior to the time the Board decision was made, unless the Aggrieved Person demonstrates good cause for providing new information not previously provided to the Board at or prior to the Board decision being made.
1. a. Good cause shall include newly discovered information that the Aggrieved Person could not, with reasonable diligence, have discovered and provided to the Board as part of the rulemaking record for establishing a specific upper payment limit.
2. b. An Aggrieved Person shall clearly identify new information not previously provided to the Board at or prior to the Board decision being made in its written appeal. The Board reserves the right to not consider such new information if it finds the Aggrieved Person did not demonstrate good cause.

B. Appeal. A written appeal from the Board’s initial decision to establish a specific Upper Payment Limit shall include:

1. Name of the Aggrieved Person.
2. A statement giving the basis and grounds for the appeal.
3. Citations to the rulemaking record providing support for the appeal.
4. Requested relief.

C. Appeals are limited to Initial Decisions to Establish Specific Upper Payment Limits. Nothing in this rule creates a right to an appeal from selection by the Board of a Prescription Drug for an Affordability Review, a finding regarding a Prescription Drug’s unaffordability, or selection by the Board of an unaffordable Prescription Drug to establish an Upper Payment Limit for the Prescription Drug.

2 CODE OF COLORADO REGULATIONS 3 CCR 702-9

D. Multiple Appeals. Where more than one Aggrieved Person appeals an initial decision by the Board, the Board shall consolidate all of the appeals into a single matter and consider all issues raised by the Aggrieved Person(s). The Board shall notify all Aggrieved Persons that their appeals have been consolidated.

E. Procedures for Reviewing Appeals.

1. The Board shall notify the Aggrieved Person and all persons on the rulemaking docket via electronic mail that the Board received the appeal.
2. The Board may further solicit the views of the Aggrieved Person or request a response be filed by Board Staff.
3. Within sixty (60) days of an Aggrieved Person filing an appeal or the Board consolidating the appeals of more than one Aggrieved Person, whichever is later, the Board will meet in public session to consider the appeal and issue a final written decision regarding the appeal.

F. Final Decision by the Board. Within sixty (60) days of an Aggrieved Person filing an appeal or the Board consolidating the appeals of more than one Aggrieved Person, whichever is later, the Board shall consider the appeal and issue a final decision regarding the appeal. If no appeal is filed, then the Board’s initial decision becomes a final decision pursuant to section 10-16-1408(3), C.R.S. Once the Board has a final decision, the Board shall determine whether to adopt a regulation establishing the Upper Payment Limit and may adopt, modify, or withdraw its initial decision regarding the upper payment limit including the effective date of the Upper Payment Limit.

G. Judicial Review.

1. Upon issuance of a final decision regarding the initial decision to establish a specific Upper Payment Limit, an Aggrieved Person may petition for judicial review in the district court in the city and county of Denver pursuant to section 24-4-106, C.R.S.
2. Upon adopting a regulation establishing an Upper Payment Limit, an Aggrieved Person may petition for judicial review in the district court in the city and county of Denver pursuant to section 24-4-106, C.R.S.

_________________________________________________________________________ Editor’s Notes History New rule eff. 03/30/2022.