3 Colo. Code Regs. § 702-9-4.1

Current through Register Vol. 47, No. 22, November 25, 2024

Section 3 CCR 702-9-4.1 - Upper Payment Limit Methodology

A.Authority

The statutory authority for this part 4.1 is sections 10-16-1407, 10-16-1412(2), and 10-16-1403(5), C.R.S.

B.Scope and Purpose

The purpose of this part 4.1 is to establish the methodology required pursuant to section 10-16-1407, C.R.S., for the Board to establish upper payment limits for prescription drugs it has determined to be unaffordable pursuant to section 10-16-1406, C.R.S., and part 3 of these rules.

C.Methodology to Establish Upper Payment Limits

1. Number of Upper Payment Limits on Prescription Drugs: The Board may establish an upper Payment limit for any prescription drug for which the Board has performed an affordability review pursuant to section 10-16-1406, C.R.S., and part 3 of the Board's rules and determined that the use of the prescription drug is unaffordable for Colorado consumers.

a. The Board may not establish more than twelve upper payment limits each calendar year from 2022 through 2024. If the Board finds a need to establish upper payment limits for more than twelve prescription drugs in the 2023 and 2024 calendar years, the Board may establish an additional six upper payment limits during that calendar year.

b. Beginning in 2025, the Board may establish any number of upper payment limits.

2. Upper Payment Limit Methodology: In establishing an upper payment limit, the Board shall review the following factors to determine an upper payment limit for a prescription drug, in accordance with section 10-16-1407(2) -(4), C.R.S.

a. Prescription Drug Costs: To approximate prescription drug costs, the Board may consider one or more price and cost metrics as an estimation of the cost of administering or dispensing the prescription drug, the cost of distributing the prescription drug, and other relevant costs. Price and cost metrics include but are not limited to:

i. Wholesale Acquisition Cost,

ii. Average Sales Price,

iii. National Average Drug Acquisition Cost as reported by the Center for Medicare and Medicaid Services,

iv. Out-of-pocket amounts,

v. Carrier paid amounts,

vi. Retail discount amounts,

vii. Public health care program fee schedules,

viii. Estimates of manufacturer net-cost and net-sales amounts,

ix. Medicare's Maximum Fair Price, and

x. Cost information voluntarily provided by a wholesaler, pharmacist, or provider.

b. Drug Shortage List: The Board will consider the status of the prescription drug on the Drug Shortage List published by the Drug Shortage Program within the Food and Drug Administration and the American Society of Health System Pharmacists. The Board's consideration may include:

i. Whether the prescription drug is listed on the Drug Shortage List on the day the Board adopts an upper payment limit for the prescription drug, as well as whether the prescription drug is subject to a resolved or discontinued shortage.

ii. If the prescription drug is listed on the Drug Shortage List, the Board may consider:

(1) Availability and estimated shortage duration,

(2) Shortage reason,

(3) Therapeutic classification, and

(4) Other related information.

c. Impact to Older Adults and Persons with Disabilities: The upper payment limit methodology must consider the impact of the upper payment limit methodology to older adults and persons with disabilities and shall not place a lower value on their lives.

i. Impact to Older Adults- the Board will consider the following metrics for individuals 65 years and older: to the extent such information is readily available in the APCD:

(1) To the extent such information is available in the APCD:

(a) Utilization of the prescription drug,

(b) Cost of the prescription drug, and

(c) Insurance coverage type for individuals utilizing the prescription drug; and

(2) Qualitative or quantitative analyses and information submitted by stakeholders with lived experience or expertise of the prescription drug's impact to older adults. The Board will not consider any analyses or information submitted that utilizes a cost-per-QALY or similar measure that discounts the value of life because of an individual's disability or age.

ii. Impact to Persons with Disabilities: The Board will consider the following metrics for persons with disabilities:

(1) Therapeutic classification of the prescription drug, including the prescription drug's therapeutic purpose and any conditions or diseases the prescription drug may treat,

(2) To the extent it is known that any conditions or diseases the prescription drug may treat are considered disabilities, or to the extent it is known the drug treats a condition or disease causes disabilities, and to the extent such information is available in the APCD, the Board may consider:

(a) Utilization of the prescription drug,

(b) Cost of the prescription drug, and

(c) Insurance coverage type for individuals utilizing the prescription drug; and

(3) Qualitative or quantitative analyses and information submitted by stakeholders with lived experience or expertise of the prescription drug's impact to persons with disabilities. The Board will not consider any analyses or information submitted that utilizes a cost-per-QALY or similar measure that discounts the value of life because of an individual's disability or age.

d. Reasonable Pharmacy Fees: An upper payment limit established by the Board does not preclude a pharmacist or pharmacy (as defined by section 12-280-103(43), C.R.S.) licensed by the State Board of Pharmacy to charge reasonable fees, to be paid by the providing health benefit plan of the consumer, for dispensing or delivering a prescription drug for which the Board has established an upper payment limit.

e. Research and Methods that Employ a Dollars-Per-Quality Adjusted Life Year (QALY): The Board shall not consider research or methods that employ a dollars-per-QALY or similar measure in estimating impact to older adults and persons with disabilities, or in any other upper payment limit methodology considerations.

f. Stakeholder Input: The Board shall receive stakeholder information submitted through an upper payment limit rulemaking, containing information relevant to any of these considerations that the Board may take into account in establishing an upper payment limit.

D.Process for Establishing Upper Payment Limits

1. Process: The Board will establish upper payment limits through rulemaking, as required by section 10-16-1406(1)(a)(II), C.R.S., and in compliance with section 24-4-103, C.R.S. The Board will select drugs for which to establish an upper payment limit and initiate a rulemaking for a rule establishing an upper payment limit for the prescription drug. An upper payment limit may apply to multiple NDCs that are indicated for the prescription drug.

a. If the Board has determined a prescription drug to be unaffordable pursuant to section 10-16-1406, C.R.S, the Board may choose to establish an upper payment limit for that prescription drug. The Board will select drugs for which to establish an upper payment limit and initiate a rulemaking for a rule establishing an upper payment limit for the prescription drug.

b. The Board may terminate a rulemaking to establish a specific upper payment limit for a prescription drug.

2. Consumer Notice: The Board's initiation of a public rulemaking pursuant to section 24-4-103, C.R.S., shall constitute notification to consumers of the Board's decision to establish an upper payment limit as required by section 10-16-1407(6), C.R.S.

3. Effective Date: rules establishing upper payment limits promulgated by the Board will identify an effective date for the upper payment limit as required by section 10-16-1407(5), C.R.S.

4. Unit: The Board will identify the unit to which the upper payment limit applies for the prescription drug.

E.Prescription Drug Availability Inquiries and Reporting

1. Withdrawal Information from Manufacturers:

a. Inquiry process:

i. For any upper payment limit established, the Board shall inquire of manufacturers:

(1) Whether the manufacturer is able to make the prescription drug available for sale in the State of Colorado, and

(2) The rationale for the manufacturer's response.

ii. Manufacturers shall have 30 days to respond.

b. Notification to Consumers: If the Board receives notification that a manufacturer intends to withdraw a prescription drug for which the Board has established an upper payment limit from the sale or distribution within Colorado, the Board will notify consumers within ten days, as required by section 10-16-1412(2), C.R.S.

2. Reporting to the General Assembly: The Board shall submit the manufacturer's inquiry response annually to the Health and Human Services Committee of the Senate and the Health and Insurance Committee of the House of Representatives, or to any successor committees.

F.Confidentiality

A person submitting information for the Board's consideration pursuant to this part 4 shall clearly designate the specific information it deems to be confidential, trade secret or proprietary. The Board may also determine that information submitted to it is confidential, trade secret, or proprietary. The Board will not disclose confidential, trade-secret, or proprietary information in an open meeting or its public meeting materials. The Board may seek additional information regarding whether the information is confidential, trade-secret, or proprietary from the person submitting the information or, to the extent the Board is able to determine who created the document or information, the person who created the document or information. To the extent the information submitted to the Board contains confidential information, the Board will consider such information in executive session and will not disclose the information publicly pursuant to sections 10-16-1404(3), and 10-16-1407(7), C.R.S.

3 CCR 702-9-4.1

45 CR 05, March 10, 2022, effective 3/30/2022

45 CR 18, September 25, 2022, effective 10/15/2022

45 CR 24, December 25, 2022, effective 1/14/2023

46 CR 03, February 10, 2022, effective 3/17/2023

46 CR 20, October 25, 2023, effective 11/14/2023