State Law

Colorado Code Of Regs-3 CCR 702-4 Series 4-2

07/31/2023 Colorado Regulation 4-2-64

Concerning Mental Health Parity In Health Benefit Plans

Medication Assisted Treatment-Prior Auth., Step Therapy Override

See bold text below:

Section 1 Authority

This emergency regulation is promulgated and adopted by the Commissioner of Insurance under the authority of §§ 10-1-109, 10-16-104(5.5)(b) and 10-16-109, C.R.S.

Section 2 Scope and Purpose

The purpose of this regulation is to establish the requirements, process, and form to be utilized by carriers to ensure compliance with § 10-16-104(5.5), C.R.S., and the Mental Health Parity and Addiction Equity Act of 2008. It replaces Emergency Regulation 19-E-04 in its entirety.

Section 3 Applicability

This regulation applies to all carriers marketing and issuing or renewing health benefit plans in the individual, small group and large group markets in Colorado on or after the effective date of this regulation. This includes all health benefit plans subject to the individual and group laws of Colorado, including non-grandfathered plans, short-term limited duration health insurance policies, and student health insurance coverage. This regulation does not apply to limited benefit plans, as defined in § 10-16-102(32)(b), C.R.S., and exclusions for coverage of specific mandated benefits as found at § 10-16-104(1.4), C.R.S.

Section 4 Definitions

A. “Aggregate lifetime dollar limit” means, for the purposes of this regulation, a dollar limitation on the total amount of specified benefits that may be paid under a health benefit plan for any coverage unit.

B. “Annual dollar limit” means, for the purposes of this regulation, a dollar limitation on the total amount of specified benefits that may be paid in a 12-month period under a health benefit plan for any coverage unit.

C. “Autism spectrum disorder” shall have the same meaning as defined at § 10-16-104(1.4)(a)(III), C.R.S.

D. “Behavioral health benefits” means, for the purposes of this regulation, the benefits supplied for items or services for behavioral health conditions.

E. “Behavioral, mental health, and substance use disorder” shall have the same meaning as defined at § 10-16-104(5.5)(d), C.R.S.

F. “Carrier” shall have the same meaning as found at § 10-16-102(8), C.R.S.

G. “FDA” means, for the purposes of this regulation, the Food and Drug Administration in the United States Department of Health and Human Services.

H. “Financial requirements” means, for the purposes of this regulation, the deductibles, copayments, coinsurance, or out-of-pocket maximums imposed under a health benefit plan. Financial requirements do not include aggregate lifetime or annual dollar limits.

I. “Health benefit plan” shall have the same meaning as found at § 10-16-102(32), C.R.S.

J. “Medical/surgical benefits” means, for the purposes of this regulation, the benefits supplied for items or services for medical conditions or surgical procedures, not including behavioral, mental health, and substance use disorder benefits.

K. “Mental health benefits” means, for the purposes of this regulation, the benefits supplied for items or services for mental health conditions.

L. “MHPAEA” shall have the same meaning as found at § 10-16-102(43.5) C.R.S.

M. “Prior authorization” shall have the same meaning as found at § 10-16-112.5(7)(d), C.R.S.

N. “SERFF” means, for the purposes of this regulation, the NAIC System for Electronic Rate and Form Filing.

O. “Short-term limited duration health insurance policy” and “short-term policy” shall have the same meaning as found at § 10-16-102(60), C.R.S.

P. “Student health insurance coverage” and “student health policy” shall have the same meaning as found at § 10-16-102(65), C.R.S.

Q. “Substance use disorder benefits” means, for the purposes of this regulation, the benefits
supplied for items or services for substance use disorders.

R. “Treatment limitations” means, for the purposes of this regulation, the limits applied based on the frequency of treatment, number of visits, days of coverage, days in a waiting period, or other limits on the scope or duration of treatment. Treatment limitations include both quantitative treatment limitations, which are expressed numerically (such as fifty (50) outpatient visits per year), and non-quantitative treatment limitations, which otherwise limit the scope or duration of benefits for treatment under a plan or coverage. This term does not include any permanent exclusion of all benefits for a particular condition or disorder.

Section 5 Required Coverage

A. Preventive Care and Access to Coverage

1. Carriers that offer behavioral, mental health, and substance use disorder treatment must
cover the following:

a. An unhealthy alcohol use screening for adults, which must be provided without deductibles, copayments or coinsurance;

b. A preventive screening for depression in adolescents and adults, which must beprovided without deductibles, copayments or coinsurance; and

c. Perinatal maternal counseling for persons at risk, which must be provided without
deductibles, copayments or coinsurance.

d. These benefits may be provided by a primary care provider, behavioral health care provider as defined at § 25-1.5-502(1.3), C.R.S., or mental health professional licensed or certified pursuant to Article 245 of Title 12.

2. Effective January 1, 2020, carriers that provide coverage for an annual physical
examination as a preventive health care service shall include coverage for behavioral health screenings using a validated screening tool for behavioral health, which coverage and reimbursement is no less extensive than the coverage and reimbursement for the annual physical examination.

B. Court-Ordered Treatment

1. Carriers shall provide coverage for court-ordered medically necessary services for
behavioral, mental health, and substance use disorder, as specified in § 10-16-104.7, C.R.S., for substance use disorders and § 10-16-104.8, C.R.S., for behavioral and mental health treatment.

2. Nothing in this Section 5.B. prohibits a carrier from using appropriate disease management or utilization review protocols, as long as the protocols are no more stringent or restrictive than medical/surgical disease management or utilization review protocols.

Medication Assisted Treatment-Prior Authorization; Step Therapy Override

C. For policies issued or renewed on or after January 1, 2020, carriers shall not impose the following for medication-assisted treatment of substance use disorders:

1. Any prior authorization requirements on any FDA-approved medication on the carrier’s
formulary;

2. Any step therapy or fail-first requirements as a prerequisite for coverage of a prescription medication approved by the FDA on the carrier’s formulary;

3. Place fewer than one (1) covered prescription medication approved by the FDA on the lowest tier of the drug formulary developed and maintained by the carrier, including any coverage administered by a pharmacy benefit manager on behalf of a carrier; or

4. Exclude coverage for any FDA-approved prescription medication on the carrier’s formulary and any associated counseling or wraparound services solely on the basis the medications and services were court-ordered.

D. A carrier offering a managed care plan that does not cover services provided by an out-ofnetwork provider may provide that the benefits required by this Section 5 are covered benefits if the services are rendered by a provider who is designated by or affiliated with the managed care plan only if the same requirement applies for services for a physical illness. A carrier is not required to cover out-of-network care at one hundred percent (100%) or without any cost share to the covered person.

E. If a health benefit plan applies different levels of financial requirements to different tiers of
prescription drug benefits based on reasonable factors determined in accordance with the rules in Section 9, relating to requirements for nonquantitative treatment limitations, and without regard to whether a drug is generally prescribed with respect to medical/surgical benefits or with respect to behavioral, mental health, or substance use disorder benefits, the health benefit plan satisfies the parity requirements with respect to prescription drug benefits. Reasonable factors include cost, efficacy, generic versus brand name, and mail order versus pharmacy pick-up.

Section 6 Allowed Classifications

A. Carriers shall use the following six (6) classifications of benefits in determining the appropriate behavioral, mental health, and substance use disorder benefits:

1. Inpatient In-Network;

2. Inpatient Out-of-Network;

3. Outpatient In-Network, except that carriers may use the following sub-classifications:

a. Office visits (such as physician visits); and

b. All other outpatient services (such as outpatient surgery, facility charges for day treatment centers, laboratory charges, or other medical items);

4. Outpatient Out-of-Network, except that carriers may use the following sub-classifications:

a. Office visits (such as physician visits); and

b. All other outpatient services (such as outpatient surgery, facility charges for day treatment centers, laboratory charges, or other medical items);

5. Emergency room; and

6. Pharmacy

B. Multiple In-Network Tiers

1. If a carrier provides benefits through multiple tiers of in-network providers (such as an innetwork tier of preferred providers with more generous cost-sharing to members than a
separate in-network tier of participating providers), the carrier may divide its benefits
furnished on an in-network basis into sub-classifications that reflect network tiers, if the
tiering is based on reasonable factors determined in accordance with the rules in Section
9 of this regulation and without regard to whether a provider provides services with
respect to medical/surgical benefits or behavioral, mental health, and substance use
disorder benefits.

2. After the sub-classifications are established, the carrier shall not impose any financial
requirement or treatment limitation on behavioral, mental health, and substance use
disorder benefits in any sub-classification that is more restrictive than the predominant
financial requirement or treatment limitation that applies to substantially all
medical/surgical benefits in the sub-classification using the methodology as required by

Section 7 of this regulation.

C. Carriers shall not use any other type of sub-classification, including but not limited to intermediate services, intensive care or any other sub-classification.

D. Carriers shall not sub-classify between primary care providers and specialists in the outpatient classifications.

Section 7 Calculation of Substantially All and Predominant Benefits

A. Carriers shall not impose any financial requirement or quantitative treatment limitation to
behavioral, mental health, or substance use disorders in any classification that is more restrictive than the predominant financial requirement or treatment limitation than what is applied to substantially all medical/surgical benefits in the same classification.

B. Calculation of Substantially All and Predominant Level Tests

1. Carriers shall use a reasonable and credible method to determine the claims costs
associated with the medical/surgical benefits that are subject to a financial requirement or
quantitative treatment limitation. The method utilized by the carrier shall conform with
Actuarial Standards of Practice.

2. Carriers shall not consider claims costs associated with behavioral, mental health, or
substance use disorder benefits in the calculation.

3. Carriers shall consider all claims applying to the deductible and out-of-pocket maximum
when calculating the deductible and out-of-pocket applicability in determining if the
deductible and out-of-pocket apply to substantially all of the claims.

C. Carriers shall not use any financial requirement unless the carrier can provide verification that the following conditions have been met:

1. “Substantially All” Test

Carriers shall not apply any type of financial requirement or quantitative treatment
limitation to behavioral, mental health, or substance use disorder benefits unless the
financial requirement applies to substantially all medical/surgical benefits in a permitted
classification, which consists of no less than two-thirds (2/3) of the expected
medical/surgical claims for any given classification of benefits.

2. “Predominant Level” Test

Once the carrier has determined that the financial requirement or quantitative treatment
limitation applies to at least two-thirds (2/3) of the benefits, it shall not apply any specific
level of financial requirement or quantitative treatment limitation to any behavioral, mental
health, or substance use disorder benefit unless the financial requirement applies to more
than one-half (1/2) of the expected claims for any given classification of benefits.

Section 8 Financial Requirements and Quantitative Treatment Limitations

A. Carriers shall not impose any financial requirement or quantitative treatment limitation on
behavioral, mental health, or substance use disorder benefits that it does not impose on
medical/surgical benefits.

B. Carriers shall not impose annual maximums on the number of visits or dollar amounts for
behavioral, mental health, or substance use disorder benefits.

C. Carriers shall not impose any financial requirement or quantitative treatment limitation on
behavioral, mental health, or substance use disorder benefits, unless the financial requirement or quantitative treatment limitation applies to substantially all of the medical/surgical benefits in a permitted benefit classification, as shown in Section 6 of this regulation.

D. Carriers shall not impose a level of financial requirement or quantitative treatment limitation on behavioral, mental health, or substance use disorder benefits, unless the level of financial requirement or treatment limitation predominantly applies to medical/surgical benefits, as shown in Section 7 of this regulation.

E. If a carrier determines that no one specific level of financial requirement or quantitative treatment level applies to more than one-half (1/2) of the expected claims for the classification, the carrier must use the least restrictive (lowest) amount that makes up one-half (1/2) of the expected claims.

For example, if a carrier applies five (5) copayments in a particular classification of benefits, the carrier may use any combination of copayments to comprise this requirement. If the carrier utilizes the top three (3) copayments, the carrier shall use the lowest copayment of the three (3) as the behavioral, mental health, and substance use disorder copayment for that benefit classification.

F. Carriers shall use a combined deductible for behavioral, mental health, and substance use
disorder and medical/surgical benefits.

G. Carriers shall use a combined out-of-pocket for behavioral, mental health, and substance use disorder and medical/surgical benefits.

H. Nothing in this section shall prohibit a carrier from:

1. Providing some benefits that are subject to the deductible and other benefits that are not
subject to the deductible within the same classification; or

2. Applying, separately, a deductible or out-of-pocket maximum that differs between the innetwork and out-of-network benefit levels, as long as the same deductible or out-ofpocket applies to behavioral, mental health, or substance use disorder benefits that applies to medical/surgical benefits.

Section 9 Non-Quantitative Treatment Limitations

A. Carriers shall not impose a non-quantitative treatment limitation with respect to behavioral, mental health, and substance use disorder services in any classification unless, under the terms of the coverage as written and in operation, any processes, strategies, evidentiary standards, or other factors used in applying the non-quantitative treatment limitation to behavioral, mental health, or substance use disorder services are comparable to, and are applied no more stringently than, the processes strategies, evidentiary standards, or other factors used in applying the limitation with respect to medical/surgical benefits in the classification.

B. Examples of non-quantitative treatment limitations include, but are not limited to:
1. Medical management standards limiting or excluding benefits based on:

a. Medical necessity or medical appropriateness; or

b. Whether the treatment is experimental or investigational.

2. Step therapy or fail-first protocols;

3. Exclusions based on failure to complete a course of treatment;

4. Restrictions based on:

a. Geographic location;

b. Facility type;

c. Provider specialty; and

d. Other criteria that limit the scope or duration of benefits.

5. Formulary design for prescription drugs;

6. Network tier design (when the plan has multiple network tiers); and

7. Standards for provider admission to a network, including reimbursement rates.

C. Allowable Non-Quantitative Treatment Limitations

Carriers may utilize the following non-exhaustive standards when applying non-quantitative
treatment limitations:

1. Medical management standards may be used, as long as the criteria are comparable, and applied no more stringently than for behavioral, mental health, and substance use disorder benefits than for medical/surgical benefits;

2. Formulary design may be used, as long as the criteria used for behavioral, mental health,
and substance use disorder benefits are comparable, and applied no more stringently
than for medical/surgical benefits; and

3. Network design may be used, as long as the criteria used for behavioral, mental health,
and substance use disorder benefits are comparable, and applied no more stringently
than for medical/surgical benefits that comply with state network adequacy requirements.

D. Examples of Non-Quantitative Treatment Limitation Violations

1. Carriers shall not use the following medical management standards when applying
limitations to behavioral, mental health, and substance use disorder benefits:

a. The carrier routinely approves a number of days without a treatment plan for
medical/surgical inpatient services, but approves, on a routine basis, a lesser number of days without a treatment plan for behavioral, mental health, and substance use disorders.

b. The carrier applies concurrent review to inpatient stays with various lengths of stay due to the medical condition, but reviews all behavioral, mental health, and substance use disorder inpatient stays using a more restrictive review criteria, reviewing the stay more frequently in all cases than commonly used for medical/surgical benefits.

c. Location of Services

(1) The carrier allows for out-of-state treatment of medical/surgical services, but does not permit out-of-state treatment for behavioral, mental health, and substance use disorder services; or

(2) Permits access to a non-network hospital for medical/surgical services, but does not permit access to a non-network hospital for behavioral, mental health, and substance use disorders, when the plan covers nonnetwork services.

d. The carrier does not apply a payment reduction penalty to outpatient medical/surgical services that do not have prior authorization, but applies a penalty to all outpatient behavioral, mental health, and substance use disorder benefits when no prior authorization has been obtained.

e. Employee Assistance Programs (Group Plans Only)

The carrier requires that the member utilize the available Employee Assistance Program benefits prior to utilizing the behavioral, mental health, and substance use disorder benefits under the group plan. The carrier does not require the member to utilize the Employee Assistance Program for any medical/surgical benefits prior to utilizing the group plan.

2. Carriers shall not use the following pharmacy benefits when applying limitations to
behavioral, mental health, and substance use disorder benefits:

a. Carrier formulary design for coverage of prescription drugs for medical/surgical conditions is based on FDA approval, clinical studies, peer-reviewed medical literature,  recommendations of experts with necessary training and experience and other medical decision criteria which are routinely provided, whereas the exclusion of behavioral, mental health, and substance use disorder drugs is only based on the side effects reported as a part of clinical studies.

b. A carrier regularly provides coverage for medical/surgical prescription drugs on all four (4) tiers of a four (4) tier formulary design, but places all drugs for the treatment of behavioral, mental health, and substance use disorders on the two (2) highest tiers, without regard to it being generic, preferred brand name or nonpreferred brand name.

3. Carriers shall not use the following network designs when applying limitations to
behavioral, mental health, and substance use disorder benefits:

a. The carrier regularly allows licensed non-M.D. providers into the network while not permitting a licensed non-M.D. provider into the network who primarily treats behavioral, mental health, or substance use disorders.

b. The carrier regularly negotiates with a medical/surgical provider based on the rates for behavioral, mental health, and substance use disorder providers.

Section 10 Denial of Benefits for Behavioral, Mental Health or Substance Use Disorders

A. Carriers shall provide consumers with written notice of the denial when denying benefits for the treatment of behavioral, mental health, or substance use disorders that explicitly provides the reason for denial.

B. Carriers shall provide the following language on any adverse determination of benefits for
behavioral, mental health, or substance use disorders on the notification required by § 10-16-113, C.R.S.:

“This plan is subject to the protections provided under the Mental Health Parity and Addiction Equity Act (MHPAEA). Coverage provided for mental health and substance use disorders must be comparable to services covered under the medical benefits available on this plan. If you believe that your rights under MHPAEA have been violated, you may contact the Office of the Ombudsperson for Behavioral Health Access to Care at 303-866-2789 or at
CDHS_Ombudsman_BH@state.co.us, or the Division, at Colorado Division of Insurance,
Consumer Services, 1560 Broadway, Ste. 850, Denver, CO 80202, dora_insurance@state.co.us or 303-894-7490 or 800-930-3745 (in-state, toll-free).
You may also request a copy of the medical necessity criteria for any behavioral, mental health, or substance use disorder benefits, and it will be provided to you at no additional cost.”

Section 11 Annual Reporting to the Commissioner

A. As part of their annual health benefit plan filings, carriers shall provide the annual compliance documents as shown in Appendices A through J of this regulation.

B. Timing and Format of Filings

1. Carriers offering plans in the non-grandfathered individual and small group markets shall
submit fully completed documents as shown in Appendices A through J of this regulation
by the date designated by the Division for annual filings.

2. Carriers offering plans in the non-grandfathered large group, student health policy and
short-term limited duration policy lines of business shall submit fully completed
documents as shown in Appendices A through J of this regulation no later than March 1
of each year and prior to the submission of any rates, as applicable, for an upcoming plan
year.

3. Carriers offering plans in the non-grandfathered large group markets shall submit fully
completed documents as shown in Appendices A through J of this regulation no later
than March 1 of each year and prior to the submission of any rates for the upcoming plan
year.

4. Carriers shall submit the completed documents as shown in Appendices A through J of
this regulation in SERFF as an “Annual MHPAEA Compliance Statement” filing. This
filing shall be submitted separately from any rate, form, annual certification, binder or
network adequacy filing.

5. Carriers shall use “On Approval” for the “Implementation Date” in SERFF.

6. Carriers shall use “File and Use” for the “Requested Filing Mode” in SERFF.

7. Carriers shall provide a filing description, including the plan year the filing will support.

C. Carrier Attestation of Other Benefit Categories

Carriers shall attest to the following using the attestation form in Appendix A:

Note, Appendix A may be accessed at https://www.sos.state.co.us/CCR/GenerateRulePdf.do?ruleVersionId=8922&fileName=3%20CCR%20702-4%20Series%204-2

1. The plan applies the same deductible for medical/surgical and behavioral, mental health,
and substance use disorders;

2. The plan applies the same out-of-pocket for medical/surgical and behavioral, mental
health, and substance use disorders;

3. The plan uses the same benefits for emergency room benefits, including all ancillary
services provided as part of the emergency room benefits, for medical/surgical and
behavioral, mental health, and substance use disorders;

4. The plan utilizes the same copayment, coinsurance or deductible structure for prescription drug benefits for medical/surgical and behavioral, mental health, and substance use disorders;

5. The plan utilizes the same copayment, coinsurance or deductible structure for autism
spectrum disorders as it does for medical/surgical diagnoses for the following services:

a. Evaluation and assessment services;

b. Habilitative benefits, including occupational therapy, physical therapy and speech
therapy;

c. Rehabilitative benefits, including occupational therapy, physical therapy and
speech therapy;

d. Pharmacy care and medication, as required by Section 6.A.6. of this regulation;

e. Psychiatric care; and

f. Psychological care, including family counseling.

6. The carrier utilizes the same penalties for failure to obtain prior authorization for
behavioral, mental health, and substance use disorders as it does for medical/surgical
procedures.

7. The form shall be signed by the president, vice president, assistant vice president,
corporate secretary, assistant corporate secretary, chief executive officer, chief financial
officer, chief operating officer, general counsel or other person, with documentation
showing that the person has been appointed a company officer by the board of directors.

D. Financial Requirements/Non-Quantitative Treatment Limitations Reporting

1. Carriers shall provide the “Medical Management Evaluation” found in Appendix B of this
regulation.

Note, Appendix B may be accessed at https://www.sos.state.co.us/CCR/GenerateRulePdf.do?ruleVersionId=8922&fileName=3%20CCR%20702-4%20Series%204-2

2. Carriers shall provide the “Non-Quantitative Treatment Limitation Verifications” found in
Appendix C of this regulation.

Note, Appendix C may be accessed at https://www.sos.state.co.us/CCR/GenerateRulePdf.do?ruleVersionId=8922&fileName=3%20CCR%20702-4%20Series%204-2

a. Carriers shall provide data for the twelve (12) month period immediately preceding the filing date (i.e. if filing in June, carriers should use June through May to compile the data).

b. Carriers shall only list fully adjudicated claims. Carriers shall include any denied
claims at the time of filing, with the appropriate denial reason.

c. Carriers shall use claim lines to calculate the number of claims.

d. Carriers shall use the primary diagnosis, if the entire claim is processed based on the primary diagnosis. Otherwise, carriers shall use the diagnosis code assigned to the individual claim line.

e. Carriers shall display the top nine (9) denial reasons for each category.

f. Carriers shall utilize the place of service of the claim. If the claim indicates inpatient as the place of service, but contains emergency room services, the claim shall be classified as inpatient.

g. For prior authorizations and concurrent review, carriers shall use the decision date.

3. Carriers shall provide the “Quantitative Treatment Limitation Classifications” calculations,
contained in Appendix D of this regulation. Carriers shall provide the required calculations
as follows:

Note, Appendix D may be accessed at https://www.sos.state.co.us/CCR/GenerateRulePdf.do?ruleVersionId=8922&fileName=3%20CCR%20702-4%20Series%204-2

a. For plan years beginning on or after January 1, 2020, for individual and small group plans, carriers shall provide the required calculations for plans identified by the Division.

b. For large group, student health policies and short-term limited duration policies, carriers shall provide the required calculations for the top ten (10) plan designs or top twenty percent (20%) of plan designs by premium volume, whichever is greater.

c. Carriers shall provide the estimated claims payments made by the carrier for each of the benefits specified and provide the classification of each of the benefits as either inpatient or outpatient. If the carrier subclassifies the outpatient benefits, the carrier shall specify which of the outpatient benefits is considered an “office visit” or is included in the “all other outpatient services” category.

d. If the carrier utilizes multiple in-network tiers, the carrier shall supply two (2) versions of the “Quantitative Treatment Limitation Classifications” worksheet, identifying the tier the template applies to.

f. Carriers shall not include any behavioral, mental health, or substance use disorder benefits in the financial requirements calculations, including applied behavioral analysis therapy for autism spectrum disorders.

4. Carriers shall supply data for the immediately preceding calendar year no later than June
1st of the following year that demonstrates parity compliance for adverse determinations
regarding claims for behavioral, mental health, or substance use disorders and includes
the total number of adverse determinations for the following:

a. Processed claim counts for covered medical/surgical, behavioral, mental health, and substance use disorder claims shall be provided as follows:

(1) Claims by medical/surgical, behavioral health, mental health or substance use disorder, utilizing the primary diagnosis and service codes for each claim; and

(2) By classification, as shown in Section 6 of this regulation.

b. Non-duplicate claim service line denial counts for medical/surgical, behavioral, mental health, and substance use disorder claims for other than eligibility denials shall be provided as follows:

(1) Reasons for the claim denials, as well as the percent of total claims denied for other than eligibility reasons;

(2) Claims by medical/surgical, behavioral health, mental health or substance use disorder, utilizing the primary diagnosis and service codes for each claim; and

(3) By classification, as shown in Section 6 of this regulation.

c. Approved prior authorization counts for medical/surgical, behavioral health, mental health and substance use disorders shall be provided as follows:

(1) By medical/surgical, behavioral health, mental health, or substance use disorders; and

(2) By classification, as shown in Section 6 of this regulation.

d. Denied prior authorization counts for medical/surgical, behavioral health, mental health and substance use disorders shall be provided as follows:

(1) By medical/surgical, behavioral health, mental health or substance use disorders;

(2) By classification, as shown in Section 6 of this regulation; and

(3) By reason for denial for the medical/surgical, behavioral health, mental health or substance use disorders.

e. Approved concurrent review counts for medical/surgical, behavioral health, mental health and substance use disorders shall be provided as follows:

(1) By medical/surgical, behavioral health, mental health or substance use disorders;

(2) By classification, as shown in Section 6 of this regulation; and

(3) By reason for denial for the medical/surgical, behavioral health, mental health or substance use disorder.

f. Denied concurrent review counts for medical/surgical, behavioral health, mental health and substance use disorders shall be provided as follows:

(1) By medical/surgical, behavioral health, mental health or substance use disorder;

(2) By classification, as shown in Section 6 of this regulation; and

(3) By reason for denial for the medical/surgical, behavioral health, mental health or substance use disorder.

g. Paid pharmacy claim counts for medical/surgical, behavioral, mental health, and substance use disorder claims shall be provided as follows:

(1) Claims by medical/surgical, behavioral health, mental health or substance use disorder, utilizing the primary diagnosis and service codes for each claim; and

(2) By classification, as shown in Section 6 of this regulation.

h. Claim denial pharmacy claim counts for medical/surgical, behavioral, mental health, and substance use disorder claims for other than eligibility denials shall be provided as follows:

(1) Reasons for the claim denials, as well as the percent of total claims denied for other than eligibility reasons;

(2) By classification, as shown in Section 6 of this regulation; and
(3) Claims by medical/surgical, behavioral health, mental health or substance use disorder, utilizing the primary diagnosis and service codes for each claim.

i. Approved prior authorization counts for medical/surgical, behavioral health, mental health and substance use disorder pharmacy services shall be provided as follows:

(1) By medical/surgical, behavioral health, mental health, or substance use disorder; and

 

(2) By classification, as shown in Section 6 of this regulation.
j. Denied prior authorization counts for medical/surgical, behavioral health, mental health and substance use disorder pharmacy services shall be provided as follows:

(1) By medical/surgical, behavioral health, mental health or substance use disorder;

(2) By classification, as shown in Section 6 of this regulation; and

(3) By reason for denial for the medical/surgical, behavioral health, mental health or substance use disorder.

5. A qualified actuary must certify that the calculations shown in the “substantially all” and “predominant” tests of the financial requirements and quantitative treatment limitations of

Section 8 of this regulation are accurate and true to the best of the actuary’s knowledge and have been appropriately calculated in accordance with Actuarial Standards of Practice.

E. Non-Quantitative Treatment Limitations

1. Carriers shall provide responses for the following classifications for each question found
in Appendices E through J of this regulation:

a. Inpatient In-Network;

b. Inpatient Out-of-Network, if the plan has out-of-network benefits available;

c. Outpatient In-Network;

d. Outpatient Out-of-Network, if the plan has out-of-network benefits available;

e. Emergency Room Services; and

f. Pharmacy Services shall be provided separately, as shown in Appendix F of this regulation.

Note, Appendix F may be accessed at https://www.sos.state.co.us/CCR/GenerateRulePdf.do?ruleVersionId=8922&fileName=3%20CCR%20702-4%20Series%204-2

2. Carriers shall provide the narratives for the following questionnaires in the format found in
Appendices E through J of this regulation:

a. Non-Quantitative Treatment Limitations – Medical/Surgical Services Questionnaire (Appendix E):

Note, Appendix E may be accessed at https://www.sos.state.co.us/CCR/GenerateRulePdf.do?ruleVersionId=8922&fileName=3%20CCR%20702-4%20Series%204-2

(1) Carriers shall provide the processes for the development of medical necessity standards, providing the processes, strategies, evidentiary standards, and other factors used;

(2) Carriers shall provide any factors that were considered but discarded and explain why the factor was discarded;

(3) Carriers shall provide the eligibility criteria for case management services;

(4) Carriers shall provide the circumstances and method by which treatment plans must be submitted to obtain or continue coverage;

(5) Carriers shall provide how fail-first and step-therapy protocols are determined;

(6) Carriers shall provide how the concurrent review standards are determined, including how review intervals have been determined;

(7) Carriers shall provide any benefits that are contingent upon improvement within a set number of days;

(8) Carriers shall provide any penalties that may be imposed for failure to obtain prior authorization;

(9) Carriers shall list any restrictions that apply to obtaining services from a facility or provider based on geographic location;

(10) Carriers shall list any restrictions that apply to obtaining services from specific facilities or provider specialties;

(11) Carriers shall list any other limitations imposed on obtaining covered services; and

(12) Carriers shall have the chief medical officer and director of medical/surgical services certify that the information contained in the questionnaire is accurate and in compliance with this regulation.

b. Non-Quantitative Treatment Limitations – Pharmacy Services Questionnaire (Appendix F):

Note, Appendix F may be accessed at https://www.sos.state.co.us/CCR/GenerateRulePdf.do?ruleVersionId=8922&fileName=3%20CCR%20702-4%20Series%204-2

(1) Carriers shall supply specific information for medical/surgical, behavior and mental health and substance use disorders for each of the following:

(a) Carriers shall list any factors considered when establishing prior authorization for pharmacy services, including any factors considered and discarded;

(b) Carriers shall list any factors used in determining if fail-first or step-therapy is required for pharmacy services; and

(c) Carriers shall list any factors considered when tiering pharmacy drugs.

(2) Carriers shall have the chief medical officer and the director of pharmacy services certify that the information contained in the questionnaire is accurate and in compliance with this regulation.

c. Non-Quantitative Treatment Limitations – Behavioral Health/Mental Health Questionnaire (Appendix G):

Note, Appendix G may be accessed at https://www.sos.state.co.us/CCR/GenerateRulePdf.do?ruleVersionId=8922&fileName=3%20CCR%20702-4%20Series%204-2

(1) Carriers shall provide the processes for the development of medical necessity standards, providing the processes, strategies, evidentiary standards, and other factors used;

(2) Carriers shall provide any factors that were considered but discarded and explain why the factor was discarded;

(3) Carriers shall provide the eligibility criteria for case management services;

(4) Carriers shall provide the circumstances and method by which treatment plans must be submitted to obtain or continue coverage;
(5) Carriers shall provide how fail-first and step-therapy protocols are determined;

(6) Carriers shall provide how the concurrent review standards are determined, including how review intervals have been determined;

(7) Carriers shall provide any benefits that are contingent upon improvement within a set number of days;

(8) Carriers shall provide any penalties that may be imposed for failure to obtain prior authorization;

(9) Carriers shall list any restrictions that apply to obtaining services from a facility or provider based on geographic location;

(10) Carriers shall list any restrictions that apply to obtaining services from specific facilities or provider specialties;

(11) Carriers shall list any other limitations imposed on obtaining covered services; and

(12) Carriers shall have the chief medical officer and director of the behavioral health services certify that the information contained in the questionnaire is accurate and in compliance with this regulation.

d. Non-Quantitative Treatment Limitations – Substance Use Disorder Questionnaire
(Appendix H):

Note, Appendix H may be accessed at https://www.sos.state.co.us/CCR/GenerateRulePdf.do?ruleVersionId=8922&fileName=3%20CCR%20702-4%20Series%204-2

(1) Carriers shall provide the processes for the development of medical necessity standards, providing the processes, strategies, evidentiary standards, and other factors used;

(2) Carriers shall provide any factors that were considered but discarded and explain why the factor was discarded;

(3) Carriers shall provide the eligibility criteria for case management services;

(4) Carriers shall provide the circumstances and method by which treatment plans must be submitted to obtain or continue coverage;

(5) Carriers shall provide how fail-first and step-therapy protocols are determined;

(6) Carriers shall provide how the concurrent review standards are determined, including how review intervals have been determined;

(7) Carriers shall provide any benefits that are contingent upon improvement within a set number of days;

(8) Carriers shall provide any penalties that may be imposed for failure to obtain prior authorization;
(9) Carriers shall list any restrictions that apply to obtaining services from a facility or provider based on geographic location;

(10) Carriers shall list any restrictions that apply to obtaining covered services from specific facilities or provider specialties;

(11) Carriers shall list any other limitations imposed on obtaining services covered; and

(12) Carriers shall have the chief medical officer and director of the behavioral health services certify that the information contained in the questionnaire is accurate and in compliance with this regulation.

e. Non-Quantitative Treatment Limitations – Network Adequacy/Provider Credentialing and Network Admission Questionnaire (Appendix I)

Note, Appendix I may be accessed at https://www.sos.state.co.us/CCR/GenerateRulePdf.do?ruleVersionId=8922&fileName=3%20CCR%20702-4%20Series%204-2

(1) Carriers shall provide the information requested for medical/surgical, behavioral and mental health and substance use disorder services;

(2) Carriers shall provide the factors and strategies used to determine how physicians, non-physicians, and facilities are credentialed and admitted to the network; and

(3) Carriers shall have the director of network operations certify that the information contained in the questionnaire is accurate and in compliance with this regulation.

f. Non-Quantitative Treatment Limitations – Confidential Network Development Questionnaire (Appendix J)

Note, Appendix J may be accessed at https://www.sos.state.co.us/CCR/GenerateRulePdf.do?ruleVersionId=8922&fileName=3%20CCR%20702-4%20Series%204-2

(1) Carriers shall provide the factors utilized in determining the make-up of the network, including any factors that were considered but discarded;

(2) Carriers shall provide the calculations utilized in determining the required number of providers to supply the covered services without unreasonable delay; and

(3) Carriers shall provide the Division with reimbursement rates for medical/surgical, behavioral, mental health, and substance use disorder providers and facilities, as well as a description of how provider reimbursement rates are negotiated for medical/surgical, behavioral, mental health, and substance use disorder providers and facilities as specified in Appendix J of this regulation. Supplemental information required by Appendix J shall be submitted in Excel format.

Note, Appendix J may be accessed at https://www.sos.state.co.us/CCR/GenerateRulePdf.do?ruleVersionId=8922&fileName=3%20CCR%20702-4%20Series%204-2

g. Non-Quantitative Treatment Limitation – Comparative Analysis Reporting (Appendix K)

Note, Appendix K may be accessed at https://www.sos.state.co.us/CCR/GenerateRulePdf.do?ruleVersionId=8922&fileName=3%20CCR%20702-4%20Series%204-2

(1) Carriers shall provide the comparative analysis information required by Section 12 of this regulation for the following Non-Quantitative Treatment Limitations:

(a) Medical/Surgical Services;

(b) Pharmacy Services;

(c) Behavioral Health/Mental Health;

(d) Substance Use Disorder;

(e) Network Adequacy/Provider Credentialing and Network Admission; and

(f) Confidential Network Development.

(2) Carriers shall have the president, vice president, assistant vice president, corporate secretary, assistant corporate secretary, chief executive officer, chief financial officer, chief operating officer, general counsel or other person, with documentation showing that the person has been appointed a company officer by the board of directors certify that the
information contained in the comparative analyses is accurate and in compliance with this regulation.

F. The signatures required in the appendices and by this Section 11 must be an original or valid electronic signature of the person signing. Signature stamps, photocopies or a signature on behalf of the authorized signer are not acceptable. Electronic signatures shall be in compliance with § 24-71.3-101 et seq., C.R.S., and applicable regulations.

Section 12 Comparative Analysis Reporting

A. Carriers shall provide the Commissioner with a comparative analysis demonstrating that, for any non-quantitative treatment limitation, including medical necessity criteria, as written and in operation, the processes, strategies, evidentiary standards, or other factors used in applying the medical necessity criteria and each non-quantitative treatment limitation to benefits for behavioral, mental health, and substance use disorders within each classification of benefits are comparable to, and are applied no more stringently than, the processes, strategies, evidentiary standards, or other factors used in applying the medical necessity criteria and each non-quantitative treatment limitation to medical and surgical benefits within the corresponding classification of benefits.

B. Carriers, shall provide these comparative analyses results to the Commissioner, showing the following, at a minimum:

1. Identification of any factors used to determine whether a non-quantitative treatment
limitation will apply to a benefit, including any factors considered and discarded;

2. Identify and define the specific evidentiary standards used to define the factors and any
other evidence relied on in designing each non-quantitative treatment limitation;

3. Provide the comparative analyses, including any results of the analyses, performed to
determine that the processes and strategies used to design each non-quantitative
treatment limitation, as written, and the written processes and strategies used to apply to
each non-quantitative treatment limitation for benefits for behavioral, mental health, and
substance use disorders are comparable to, and are applied no more stringently than, the
processes and strategies used to design and apply to each non-quantitative treatment
limitation, as written, and the written processes and strategies used to apply to each nonquantitative treatment limitation for medical and surgical benefits;

4. Provide the comparative analyses, including the results of the analyses, performed to
determine that the processes and strategies used to apply to each non-quantitative
treatment limitation, in operation, for benefits for behavioral, mental health, and substance use disorders are comparable to, and are applied no more stringently than, the processes and strategies used to apply to each non-quantitative treatment limitation, in operation, for medical and surgical benefits; and

5. Disclose the specific findings and conclusions reached by the carrier that the results of
the analyses indicate that each health benefit plan offered by the carrier complies with §
10-16-104(5.5), C.R.S., and the MHPAEA.

Section 13 Confidentiality

A. All mental health parity filings submitted shall be considered public and shall be open to public inspection, unless the information may be considered confidential pursuant to § 24-72-204, C.R.S. The Division does not consider such items as the calculations of “substantially all” and “predominant” tests; narratives regarding any review standard the carrier may use; the attestations; or any other such documents as confidential. Carriers must submit the confidential exhibits separately in SERFF, which must be indicated as such by the confidential icon in SERFF.

Non-confidential information must be in a separate SERFF component.

B. Nothing in this section shall prohibit a carrier from redacting information in public documents that is confidential. Carriers shall submit a redacted and unredacted version of any documents.

C. The Division considers the information submitted in Appendix J as confidential, pursuant to § 24-72-204, C.R.S.

Note, Appendix J may be accessed at https://www.sos.state.co.us/CCR/GenerateRulePdf.do?ruleVersionId=8922&fileName=3%20CCR%20702-4%20Series%204-2

D. A “Confidentiality Index” must be completed if the carrier desires confidential treatment of any information submitted, as required in this regulation. The Division will evaluate the
reasonableness of any requests for confidentiality and will provide notice to the carrier if the
request for confidentiality is rejected.

Section 14 Severability

If any provision of this regulation or the application of it to any person or circumstance is for any reason held to be invalid, the remainder of this regulation shall not be affected.

Section 15 Enforcement

Noncompliance with this regulation may result, after proper notice and hearing, in the imposition of any of the sanctions made available in the Colorado statutes pertaining to the business of insurance or other laws which include the imposition of fines, issuance of cease and desist orders, and/or suspensions or revocation of license. Among others, the penalties provided for in §10-3-1108, C.R.S., may be applied.

Section 16 Effective Date

This regulation shall become effective on February 1, 2020.

Section 17 History

Emergency regulation 19-E-02 effective June 13, 2019.
Emergency regulation 19-E-04 effective October 10, 2019.
Regulation effective February 1, 2020.

See https://www.sos.state.co.us/CCR/DisplayRule.do?action=ruleinfo&ruleId=3120&deptID=18&agencyID=57&deptName=Department%20of%20Regulatory%20Agencies&agencyName=Division%20of%20Insurance&seriesNum=3%20CCR%20702-4%20Series%204-2