C.R.S. Section 10-16-1401
Definitions

As used in this part 14, unless the context otherwise requires:

(1)

“Advisory council” means the Colorado prescription drug affordability advisory council created in section 10-16-1409.

(2)

“Affordability review” means an affordability review of a prescription drug performed by the board pursuant to section 10-16-1406.

(3)

“All-payer health claims database” means the all-payer health claims database described in section 25.5-1-204.

(4)

“Authorized generic drug” has the meaning set forth in 42 CFR 447.502.

(5)

“Biological product” has the meaning set forth in 42 U.S.C. sec. 262 (i)(1).

(6)

“Biosimilar drug” means a prescription drug that is produced or distributed in accordance with a biological product license issued pursuant to 42 U.S.C. sec. 262 (k)(3).

(7)

“Board” means the Colorado prescription drug affordability review board created in section 10-16-1402.

(7.5)

“Board activity” means:

(a)

Selecting prescription drugs for an affordability review pursuant to section 10-16-1406 (2);

(b)

Determining whether a prescription drug is unaffordable pursuant to section 10-16-1406 (3);

(c)

Selecting prescription drugs for which the board establishes an upper payment limit pursuant to section 10-16-1407; and

(d)

Establishing an upper payment limit for a prescription drug pursuant to section 10-16-1407.

(8)

“Brand-name drug” means a prescription drug that is produced or distributed in accordance with an original new drug application approved pursuant to 21 U.S.C. sec. 355. “Brand-name drug” does not include an authorized generic drug.

(9)

“Carrier” has the meaning set forth in section 10-16-102 (8).

(10)

“Conflict of interest” means an association, including a financial or personal association, that has the potential to bias or appear to bias an individual’s decisions in matters related to the board or the advisory council or the conduct of the activities of the board or the advisory council. “Conflict of interest” includes any instance in which a board member; an advisory council member; a staff member; a contractor of the division, on behalf of the board; or an immediate family member of a board member, an advisory council member, a staff member, or a contractor of the division, on behalf of the board, has received or could receive:

(a)

A financial benefit of any amount derived from the results or findings of a study or determination that is reached by or for the board; or

(b)

A financial benefit from an individual or company that owns or manufactures a prescription drug, service, or item that is being or will be studied by the board.

(11)

“Financial benefit” means honoraria, fees, stock, or any other form of compensation, including increases to the value of existing stock holdings.

(12)

“Generic drug” means:

(a)

A prescription drug that is marketed or distributed in accordance with an abbreviated new drug application approved pursuant to 21 U.S.C. sec. 355 (j);

(b)

An authorized generic drug; or

(c)

A prescription drug that was introduced for retail sale before 1962 that was not originally marketed under a new drug application.

(13)

“Health benefit plan” has the meaning set forth in section 10-16-102 (32).

(14)

“Inflation” means the annual percentage change in the United States department of labor’s bureau of labor statistics consumer price index for Denver-Aurora-Lakewood for all items paid by all urban consumers, or its applicable predecessor or successor index.

(15)

Intentionally left blank —Ed.

(a)

“Large employer” means any person, firm, corporation, partnership, or association that:

(I)

Is actively engaged in business;

(II)

Employed an average of more than one hundred eligible employees on business days during the immediately preceding calendar year, except as provided in subsection (15)(c) of this section; and

(III)

Was not formed primarily for the purpose of purchasing insurance.

(b)

For purposes of determining whether an employer is a “large employer”, the number of eligible employees is calculated using the method set forth in 26 U.S.C. sec. 4980H (c)(2)(E).

(c)

In the case of an employer that was not in existence throughout the preceding calendar quarter, the determination of whether the employer is a large employer is based on the average number of employees that the employer is reasonably expected to employ on business days in the current calendar year.

(16)

“Manufacturer” means a person that:

(a)

Engages in the manufacture of a prescription drug that is sold to purchasers located in this state; or

(b)

Intentionally left blank —Ed.

(I)

Enters into a lease or other contractual agreement with a manufacturer to market and distribute a prescription drug in this state under the person’s own name; and

(II)

Sets or changes the wholesale acquisition cost of the prescription drug in this state.

(17)

“Optional participating plan” means a self-funded health benefit plan offered in Colorado that elects to subject its purchases of or payer reimbursements for prescription drugs for its members in Colorado to the requirements of this part 14, as described in section 10-16-1407 (8).

(18)

“Practitioner” has the meaning set forth in section 12-280-103 (40).

(19)

“Prescription drug” has the meaning set forth in section 12-280-103 (42); except that the term includes only prescription drugs that are intended for human use.

(20)

“Pricing information” means information about the price of a prescription drug, including information that explains or helps explain how the price was determined.

(21)

“Small employer” has the meaning set forth in section 10-16-102 (61).

(22)

“State entity” means any agency of state government that purchases or reimburses payers for prescription drugs on behalf of the state for a person whose heath care is paid for by the state, including any agent, vendor, contractor, or other party acting on behalf of the state.

(23)

“Upper payment limit” means the maximum amount that may be paid or billed for a prescription drug that is dispensed or distributed in Colorado in any financial transaction concerning the purchase of or reimbursement for the prescription drug.

(24)

“Wholesale acquisition cost” has the meaning set forth in 42 U.S.C. sec. 1395w-3a (c)(6)(B).

(25)

“Wholesaler” has the meaning set forth in section 12-280-103 (55).

Source: Section 10-16-1401 — Definitions, https://leg.­colorado.­gov/sites/default/files/images/olls/crs2023-title-10.­pdf (accessed Oct. 20, 2023).

10‑16‑101
Short title 10‑16‑102
Definitions 10‑16‑103
Proposal of mandatory health-care coverage provisions 10‑16‑103.4
Essential health benefits - requirements - rules 10‑16‑103.5
Payment of premiums - required term in contract - rules - definition 10‑16‑103.6
Copayment-only prescription payment structures - required inclusion in health benefit plans - rules 10‑16‑104
Mandatory coverage provisions - definitions - rules - applicability 10‑16‑104.1
Prohibition on discrimination for organ transplants based solely on disability - definition 10‑16‑104.2
Coverage for contraception - rules - definitions 10‑16‑104.3
Health coverage for persons under twenty-six years of age - coverage for students who take medical leave of absence 10‑16‑104.6
Off-label use of cancer drugs 10‑16‑104.7
Substance use disorders - court-ordered treatment coverage 10‑16‑104.8
Behavioral, mental health, or substance use disorder services coverage - court-ordered 10‑16‑104.9
Geographic areas for small employers 10‑16‑105
Guaranteed issuance of health insurance coverage - individual and small employer health benefit plans 10‑16‑105.1
Guaranteed renewability - exceptions - individual and small employer health benefit plans - rules 10‑16‑105.2
Small employer health insurance availability program 10‑16‑105.3
Health benefit plans - not prohibited 10‑16‑105.6
Rate usage 10‑16‑105.7
Health benefit plan open enrollment periods - special enrollment periods - rules 10‑16‑106
Group replacement - extension of benefits 10‑16‑106.3
Uniform claims - billing codes - electronic claim forms 10‑16‑106.5
Prompt payment of claims - legislative declaration - rules 10‑16‑106.7
Assignment of health insurance benefits 10‑16‑107
Rate filing regulation - benefits ratio - rules 10‑16‑107.1
False or misleading information - penalties 10‑16‑107.2
Filing of health policies - rules 10‑16‑107.3
Health insurance policies - plain language required - rules 10‑16‑107.4
Health-care sharing plan or arrangement - required reporting and certification - noncompliance - information posted on division website - rules 10‑16‑107.5
Uniform application form - use by all carriers - rules 10‑16‑107.7
Nondiscrimination against providers 10‑16‑108
Continuation privileges 10‑16‑108.5
Fair marketing standards - rules 10‑16‑109
Rules 10‑16‑110
Fees paid by health coverage entities 10‑16‑111
Annual statements and reports - rules 10‑16‑112
Private utilization review - health-care coverage entity responsibility - definitions 10‑16‑112.5
Prior authorization for health-care services - disclosures and notice - determination deadlines - criteria - limits and exceptions - definitions - rules 10‑16‑113
Procedure for denial of benefits - internal review - rules - definitions 10‑16‑113.5
Independent external review of adverse determinations - legislative declaration - definitions - rules 10‑16‑113.7
Reporting the denial of benefits to division 10‑16‑116
Catastrophic health insurance - coverage - premium payments - reporting requirements - definitions - short title 10‑16‑118
Prohibition against preexisting condition exclusions 10‑16‑119
Requirements for excess loss or stop-loss health insurance used in conjunction with self-insured employer benefit plans under the federal “Employee Retirement Income Security Act” - data collection 2013-18 - rules 10‑16‑119.5
Stop-loss health insurance for small employers of not more than fifty employees - requirements - definitions - rules 10‑16‑121
Required contract provisions in contracts between carriers and providers - definitions 10‑16‑121.3
Limitations on provisions in contracts between carriers and licensed health-care providers - methods of payment - fees 10‑16‑121.5
Prohibited contract provisions in contracts between carriers and providers for dental services - definition 10‑16‑121.7
Prohibited contract provisions in contracts between carriers and eye care providers - definitions 10‑16‑122
Access to prescription drugs 10‑16‑122.1
Contracts between PBMs and pharmacies - carrier submit list of PBMs - PBM registration - fees - prohibited practices - exception - rules - enforcement - short title - definitions 10‑16‑122.3
Pharmacy benefit management firm payments - retroactive reduction prohibited - enforcement - rules - definitions 10‑16‑122.4
Pharmacy benefits - formulary change prohibition - exceptions - enforcement - definition - rules 10‑16‑122.5
Pharmacy benefit manager - audit of pharmacies - time limits on on-site audits - enforcement - rules 10‑16‑122.6
Pharmacy benefit managers - contracts with pharmacies - maximum allowable cost pricing - enforcement - rules 10‑16‑122.7
Disclosures between pharmacists and patients - carrier and PBM prohibitions - enforcement - short title - legislative declaration - preemption by federal law - rules 10‑16‑122.9
Prescription drug benefits - real-time access to benefit information - enforcement - definitions - rules 10‑16‑123
Telehealth - definitions 10‑16‑124
Prescription information cards - legislative declaration 10‑16‑124.5
Prior authorization form - drug benefits - rules of commissioner - definitions - repeal 10‑16‑124.7
Opioid analgesics with abuse-deterrent properties - study - definitions 10‑16‑124.8
Colorado consortium for prescription drug abuse prevention - create process for recovery - report 10‑16‑125
Reimbursement to nurses 10‑16‑126
Fee-for-service dental plans 10‑16‑127
Coinsurance and deductibles 10‑16‑128
Annual report to general assembly 10‑16‑129
Health savings accounts 10‑16‑130
Disclosure of rate increases to public entities - legislative declaration - definitions 10‑16‑133
Health carrier information disclosure - website - insurance producer fees and disclosure requirements - legislative declaration - rules 10‑16‑134
Health-care transparency - information required - website - definition 10‑16‑135
Health coverage plan information cards - rules - standardization - contents 10‑16‑137
Policy forms - explanation of benefits - standardization of forms - rules 10‑16‑138
Pathology services - direct billing required 10‑16‑139
Access to care - rules - definitions 10‑16‑140
Grace periods - premium payments - rules 10‑16‑141
Medication synchronization services - cost sharing for partial refills - dispensing fees 10‑16‑142
Physical rehabilitation services - copayments and coinsurance - research 10‑16‑143.5
Pharmacy reimbursement - substance use disorders - injections - patient counseling 10‑16‑144
Health-care services provided by pharmacists 10‑16‑145
Step therapy - limitations - exceptions - definitions - rules 10‑16‑145.5
Step therapy - prior authorization - prohibited - stage four advanced metastatic cancer - opioid prescription - definitions 10‑16‑146
Periodic updates to provider directory 10‑16‑147
Parity reporting - commissioner - carriers - rules - examination of complaints 10‑16‑148
Medication-assisted treatment - limitations on carriers - rules 10‑16‑150
Primary care payment reform collaborative - created - powers and duties - report - definition - repeal 10‑16‑151
Cost sharing in prescription insulin drugs - limits - definition - rules 10‑16‑152
HIV prevention and treatment medication - limitations on carriers - step therapy - prior authorization - study - repeal 10‑16‑153
Coverage for opiate antagonists provided by a hospital - definition 10‑16‑154
Disclosures - physical therapists - occupational therapists - chiropractors - acupuncturists - patients - carrier prohibitions - enforcement 10‑16‑155
Actuarial reviews of proposed health-care legislation - division to contract with third parties - required considerations - confidentiality - limits on expenditures - repeal 10‑16‑155.5
Actuarial review of doula services - report - definition 10‑16‑156
Prescription drugs - rebates - consumer cost reduction - point of sale - study - report - rules - definitions 10‑16‑157
Alternative payment model parameters - parameters to include an aligned quality measure set - primary care providers - requirement for carriers to submit alternative payment models to the division - legislative declaration - report - rules - definitions 10‑16‑158
Treatment of sexually transmitted infection - cost sharing - rules - definition 10‑16‑159
Coverage for sterilization services - cost sharing 10‑16‑160
Cost sharing - prescription epinephrine - limits - rules - definition 10‑16‑161
Calculation of contribution to out-of-pocket and cost-sharing requirements - exception - definitions - rules 10‑16‑162
Prohibition on discrimination for coverage based solely on natural medicine consumption - definitions 10‑16‑163
Contracts - health benefit plans - pharmacy benefit managers - policyholders - transparency requirements - rules - definitions 10‑16‑164
Hospital facility fee report - data collection 10‑16‑165
Dental coverage plans - dental loss ratio - rules - definitions 10‑16‑166
Prohibition on using the body mass index or ideal body weight - medical necessity criteria - rules 10‑16‑201
Form and content of individual sickness and accident insurance policies 10‑16‑202
Required provisions in individual sickness and accident policies 10‑16‑203
Optional provisions in individual sickness and accident insurance policies 10‑16‑204
Inapplicable or inconsistent provisions in individual policies of sickness and accident insurance 10‑16‑205
Order of certain policy provisions in individual policies of sickness and accident insurance 10‑16‑206
Third-party ownership of individual sickness and accident insurance policies 10‑16‑207
Requirements of other jurisdictions 10‑16‑208
Conforming to statute 10‑16‑209
Application for policy 10‑16‑210
Notice - waiver 10‑16‑211
Age limit 10‑16‑212
Exemption from attachment and execution 10‑16‑213
Industrial sickness and accident insurance 10‑16‑214
Group sickness and accident insurance 10‑16‑215
Blanket sickness and accident insurance 10‑16‑216
Examinations 10‑16‑216.5
Hearing procedure and judicial review - violations - penalty 10‑16‑217
Application of part 1 of this article and part 2 10‑16‑218
Judicial review 10‑16‑219
Benefits for care in tax-supported institutions - behavioral health disorders - mental health disorders - intellectual and developmental disabilities 10‑16‑220
Minimum standards for sickness and accident plans 10‑16‑221
Statewide health care review committee - creation - membership - duties - repeal 10‑16‑222
Termination of policies 10‑16‑301
Legislative declaration 10‑16‑302
Incorporation and organization - exemptions 10‑16‑303
Filing of articles of incorporation 10‑16‑304
Contents of articles 10‑16‑305
Directors 10‑16‑306
Contracts - benefits for long-term care insurance 10‑16‑307
Authority to do business 10‑16‑308
Automatic extension of certificate 10‑16‑309
Requirements for certificate of authority 10‑16‑310
Surplus - guarantee fund deposit - regulations 10‑16‑311
Group benefits for depositors of banks - benefits for subscribers in public institutions 10‑16‑312
Contracts with other organizations 10‑16‑314
Payment for examinations of corporations 10‑16‑315
Revocation of certificate - appeal 10‑16‑316
Complaints 10‑16‑317
Exemption of direct payment methods 10‑16‑317.5
Assignment of benefits 10‑16‑318
Prospective reimbursement 10‑16‑319
Effective date 10‑16‑320
Investment of funds 10‑16‑321
Medicare supplement benefit standards 10‑16‑322
Filing of health policies 10‑16‑324
Conversion of corporation to a stock insurance company 10‑16‑325
Termination of health policies 10‑16‑401
Establishment of health maintenance organizations 10‑16‑402
Issuance of certificate of authority - denial 10‑16‑403
Powers of health maintenance organizations 10‑16‑404
Governing body 10‑16‑405
Fiduciary responsibilities 10‑16‑406
Evidence of coverage - rules 10‑16‑407
Information to enrollees 10‑16‑408
Open enrollment 10‑16‑409
Complaint system 10‑16‑410
Investments 10‑16‑411
Protection against insolvency 10‑16‑412
Statutory deposit 10‑16‑413
Prohibited practices 10‑16‑413.5
Return to home - legislative declaration - definitions 10‑16‑414
Regulation of agents 10‑16‑415
Powers of insurers and nonprofit hospital, medical-surgical, and health service corporations 10‑16‑416
Examination 10‑16‑417
Suspension or revocation of certificate of authority 10‑16‑418
Rehabilitation, liquidation, or conservation of health maintenance organization 10‑16‑419
Administrative procedures 10‑16‑420
Penalties and enforcement 10‑16‑421
Statutory construction and relationship to other laws 10‑16‑421.5
Acquisition of control of or merger of a health maintenance organization 10‑16‑422
Filings and reports as public documents 10‑16‑423
Confidentiality of health information 10‑16‑424
Commissioner’s authority to contract 10‑16‑425
Applicability of provisions 10‑16‑426
Medicare supplement benefit standards 10‑16‑427
Contractual relations 10‑16‑429
Termination of contract 10‑16‑501
Legislative declaration 10‑16‑502
Establishment of prepaid dental care plan organizations 10‑16‑503
Application for certificate of authority 10‑16‑504
Issuance of certificate of authority 10‑16‑505
Guarantee fund deposit 10‑16‑506
Reserve requirement - exception 10‑16‑507
Enrollee coverage by prepaid dental care plan organizations - form filing requirements 10‑16‑508
Examination of prepaid dental care plan organization 10‑16‑509
Operational expenses 10‑16‑510
Suspension or revocation of certificate of authority 10‑16‑511
Rehabilitation, liquidation, or conservation of prepaid dental care plan organization 10‑16‑512
Other laws applicable 10‑16‑601
Legislative declaration 10‑16‑602
Definitions 10‑16‑603
Independent medical examinations - governing standard 10‑16‑604
Financial interest in future care of patient prohibited 10‑16‑605
Independence of examiners 10‑16‑606
Applicability 10‑16‑701
Short title 10‑16‑702
Legislative declaration 10‑16‑703
Applicability 10‑16‑704
Network adequacy - required disclosures - balance billing - rules - legislative declaration - definitions 10‑16‑705
Requirements for carriers and participating providers - definitions 10‑16‑705.5
Participating provider networks - definitions - selection standards - informal reconsideration - enforcement - legislative declaration 10‑16‑705.7
Timely credentialing of physicians by carriers - notice of receipt required - notice of incomplete applications required - delegated credentialing agreements - discrepancies - denials of claims prohibited - disclosures - recredentialing - enforcement - rules - definitions 10‑16‑706
Intermediaries 10‑16‑707
Enforcement 10‑16‑708
Rule-making authority of commissioner 10‑16‑709
Evaluation - nonparticipating health-care providers - legislative declaration - rules 10‑16‑710
Reporting to commissioner - medication-assisted treatment - rules 10‑16‑1001
Legislative declaration 10‑16‑1002
Definitions 10‑16‑1003
Privacy of health information 10‑16‑1004
Health-care coverage cooperatives - establishment - fees 10‑16‑1005
Issuance of certificate of authority by commissioner for cooperative to purchase health-care coverage 10‑16‑1006
Authority to deny application for, revoke, or suspend certificate of authority 10‑16‑1007
Prohibition on cooperatives transacting insurance business 10‑16‑1008
Administrative structure of cooperatives - board of directors - officers - employees 10‑16‑1009
Powers, duties, and responsibilities of cooperatives 10‑16‑1010
Marketing requirements of cooperatives 10‑16‑1013
Violations of article by persons involved with operations of cooperatives - enforcement - penalties 10‑16‑1014
Technical assistance to authorized cooperatives from division of insurance 10‑16‑1015
Health-care cooperatives - rule-making authority 10‑16‑1016
State innovation waiver - authority to apply 10‑16‑1101
Short title 10‑16‑1102
Legislative declaration 10‑16‑1103
Definitions 10‑16‑1104
Commissioner powers and duties - rules - study and report 10‑16‑1105
Reinsurance program - creation - enterprise status - subject to waiver or funding approval - operation - payment parameters - calculation of reinsurance payments - eligible carrier requests - definition 10‑16‑1106
Accounting - reports - audits 10‑16‑1107
Funding for reinsurance program - sources - permitted uses - reinsurance program cash fund - calculation of total funding for program 10‑16‑1109
State innovation waiver - federal funding - Colorado reinsurance program 10‑16‑1110
Repeal of part - notice to revisor of statutes 10‑16‑1201
Short title 10‑16‑1202
Legislative declaration 10‑16‑1203
Definitions 10‑16‑1204
Health insurance affordability enterprise - creation - powers and duties - assess and allocate health insurance affordability fee and special assessment 10‑16‑1205
Health insurance affordability fee - special assessment on hospitals - allocation of revenues 10‑16‑1206
Health insurance affordability cash fund - creation 10‑16‑1207
Health insurance affordability board - creation - membership - powers and duties - subject to open meetings and public records laws - commissioner rules 10‑16‑1208
Limitation on authority - public option 10‑16‑1301
Short title 10‑16‑1302
Legislative declaration - intent 10‑16‑1303
Definitions 10‑16‑1304
Standardized health benefit plan - established - components - rules - independent analysis - repeal 10‑16‑1305
Standardized health benefit plan - carriers required to offer - premium rates - rules 10‑16‑1305.5
Rate filings 10‑16‑1306
Failure to meet premium rate requirements - notice - public hearing - rules 10‑16‑1307
Advisory board - members - rules 10‑16‑1308
Federal waiver - commissioner application - use of money 10‑16‑1309
Standardized plan - cost shift 10‑16‑1310
Reports required - repeal 10‑16‑1311
State measurement for accountable, responsive, and transparent (SMART) government act report 10‑16‑1312
Rules 10‑16‑1313
Severability 10‑16‑1401
Definitions 10‑16‑1402
Colorado prescription drug affordability review board - created - membership - terms - conflicts of interest 10‑16‑1403
Colorado prescription drug affordability review board - powers and duties - rules 10‑16‑1404
Colorado prescription drug affordability review board meetings - required to be public - exceptions 10‑16‑1405
Colorado prescription drug affordability review board - reports from carriers and pharmacy benefit management firms required - confidential materials 10‑16‑1406
Colorado prescription drug affordability review board - affordability reviews of prescription drugs - repeal 10‑16‑1407
Colorado prescription drug affordability review board - upper payment limits for certain prescription drugs - rules - severability 10‑16‑1408
Colorado prescription drug affordability review board - judicial review 10‑16‑1409
Colorado prescription drug affordability advisory council - created - membership - powers and duties 10‑16‑1410
Use of savings - report - rules 10‑16‑1411
Unlawful acts - enforcement - penalties 10‑16‑1412
Notice of withdrawal of prescription drugs with upper payment limits required - rules - penalty 10‑16‑1413
Optional participating plans - notice of election to participate required 10‑16‑1414
Reports 10‑16‑1415
Exemption - prescription drugs derived from cannabis 10‑16‑1416
Repeal of part 10‑16‑1501
Short title 10‑16‑1502
Legislative declaration 10‑16‑1503
Definitions 10‑16‑1504
Applicability - exclusions 10‑16‑1505
Prohibition on 340B discrimination 10‑16‑1506
Enforcement - rules
Green check means up to date. Up to date

Current through Fall 2024

§ 10-16-1401’s source at colorado​.gov