Non-Quantitative Treatment Limitation Parity Testing (Medical Necessity Criteria) Form

Clinical Policy: Non-Quantitative Treatment Limitation Parity Testing of Medical Necessity Criteria and Clinical Coverage Guidelines
Reference Number: CP.FC.45 Last Review Date 1/2026

POLICY STATEMENT:
The Company will ensure that any benefit limitations for mental health or substance use disorder (MH/SUD) benefits are comparable to those for medical/surgical benefits and will not impose less favorable benefit limitations on MH/SUD benefits compared to medical/surgical benefits, including with respect to annual and lifetime dollar limits, financial requirements, or treatment limitations.

PURPOSE:
Provide an overview of the processes, strategies, evidentiary standards, and factors that are comparable and no more stringently applied, as specified in each step for Mental Health/Substance Use Disorder Benefits as Medical/Surgical Benefits.

SCOPE:
This policy applies to the Medical Necessity Criteria and Clinical Coverage Guidelines within Population Health and Clinical Operations (including medical/surgical and behavioral health operations)

DEFINITIONS:
Medical/Surgical Benefits: Benefits for items or services for medical conditions or surgical procedures as defined under the state plan, to include long term care services.

Mental Health and Substance Use Disorder (MH/SUD) Benefits: Benefits for items or services that treat or otherwise address mental health conditions or substance use disorders as defined under the state plan, to include long term care services.

Parity: For purposes of MHPAEA, parity means that MH/SUD benefits are not administered more stringently than their corresponding M/S benefits. Parity also generally refers to the concept of promoting health equity in the provision of MH/SUD insurance coverage when compared to medical/surgical insurance coverage. Parity also is used to describe MHPAEA law, along with similar state requirements and URAC Accreditation standards.

Treatment Limitations: Defined by MHPAEA as including limits on the frequency of treatment, number of visits, days of coverage, days in a waiting period, or other similar limits on the scope or duration of treatment.

Non-Quantitative Treatment Limitations: Benefit limits that cannot be represented numerically. Examples include medical management standards, such as medical necessity

CLINICAL POLICY
CP.FC.45 Non-Quantitative Treatment Limitation Parity Testing of Medical Necessity Criteria and Clinical Coverage Guidelines 2 criteria, prior authorization, concurrent review, retrospective review, outlier management, fail- first requirements, or practice guideline selection; network admission standards, such as reimbursement rates, geographic restrictions, specialty requirements or exclusions, facility type requirement, or network tiers; prescription benefit tiers, such as generic vs. brand name or high cost vs. low cost; and out-of-network standards.

Medically necessary or medical necessity shall mean health care services that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing, or treating an illness, injury, disease, or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice;
2. Clinically appropriate, in terms of type, frequency, extent, site, and duration, and considered effective for the patient's illness, injury, or disease; and

3. Not primarily for the convenience of the patient, physician, or other health care provider, and not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient's illness, injury, or disease.

   Medically necessary health care services may not include experimental and/or investigational technologies or carve-out days.

   Generally accepted standards of medical practice means standards that are based upon credible scientific evidence published in peer‐reviewed medical literature recognized by the medical community at large or otherwise consistent with the standards set forth in policy issues involving clinical judgment.

   Experimental and/or investigational technologies are defined as any drugs, procedures, treatments, devices, supplies, and other health care services (“Service”) that are any of the following:

4. It is currently the subject of active and credible evaluation (e.g., clinical trials or research) to determine: a. Clinical efficacy, or b. Therapeutic value or beneficial effects on health outcomes, or c. Benefits beyond any established medical based alternatives.

5. It does not have final clearance from applicable governmental regulatory bodies (such as the US Food and Drug Administration "FDA") and unrestricted market approval for use in the treatment of a specified medical condition or the condition for which authorization of the Service is requested and is the subject of an active and credible evaluation.
6. The most recent peer-reviewed scientific studies published or accepted for publication by nationally recognized medical journals do not conclude, or are inconclusive in finding, that the Service is safe and effective for the treatment of the condition for which authorization of the Service is requested.

CLINICAL POLICY
CP.FC.45 Non-Quantitative Treatment Limitation Parity Testing of Medical Necessity Criteria and Clinical Coverage Guidelines 3 Not medically necessary and not investigational: evaluations and clinical recommendations that are assessed according to the scientific quality of the supporting evidence and rationale (e.g., national medical associations, independent panels, or technology assessment organizations). A service is considered not medically necessary and not investigational when:

1. There are no studies of the service described in recent, published peer-reviewed medical literature, or
2. There are no active or ongoing credible evaluations being undertaken of the service which has previously been considered not medically necessary, or
3. There is conclusive evidence in published peer-reviewed medical literature that the service is not effective, or
4. There are no peer-reviewed scientific studies published or accepted for publication by nationally recognized medical journals that demonstrate the safety and efficacy of the use of the service, or

5. It is contraindicated.

   Carve-out Days are defined as non-medically necessary inpatient hospital days that occur during an approved admission (i.e., the inpatient stay was prolonged unnecessarily). Examples of circumstances giving rise to a carve-out day(s) include, but are not limited to:

6. A day in which a member/enrollee meets concurrent inpatient criteria, and needs a service during the stay (e.g., imaging, surgery, etc.), but the service is not performed on the earliest possible date for reasons unrelated to the member’s/enrollee’s clinical condition (e.g., MRI machine is down, operating room time is not available or patient is bumped off schedule, a specialist did not come in to perform a consult, etc.);
7. A day that is solely “social” in nature (e.g., the member’s/enrollee’s is waiting for foster placement, discharge instructions, etc.);
8. A day at the end of a stay in which discharge criteria are met but the member’s/enrollee’s is not discharged (due to, e.g., a transportation problem, DME not delivered to the home, staff too busy to discharge the member, provider did not come in to write discharge order, the member’s/enrollee’s is waiting for a SNF placement, etc.).

9. A day of care that is, or appears to be, necessitated by quality of care issues or largely preventable issues [e.g., complication due to wrong medication dose, central line-associated blood stream infections (which can include PICC lines and both tunneled and non-tunneled central lines), ventriculitis or meningitis in a patient with a reservoir who is receiving taps in place of a shunt and who is 2000 grams or greater in weight; infections with resistant hospital flora such as MRSA (methicillin resistant Staphylococcus aureus) or VRE (vancomycin resistant enterococcus), etc.].

   Concurrent Review Request: Is a Service Authorization Request by an Enrollee, or a provider on Enrollee’s behalf, for home health care services following an inpatient admission, for inpatient Substance Use Disorder treatment or for continued, extended or more of an authorized service than what is currently authorized by the Plan.

   Prior-Authorization Request – Is a Service Authorization Request by the Enrollee, or a provider on the Enrollee’s behalf, for coverage of a new service, whether for a new authorization period or within an existing authorization period, before such service is provided to the Enrollee.

CLINICAL POLICY
CP.FC.45 Non-Quantitative Treatment Limitation Parity Testing of Medical Necessity Criteria and Clinical Coverage Guidelines 4

POLICY:
Fidelis is committed to ensuring compliance with the Mental Health Parity and Addiction Equity Act (“MHPAEA” or “parity”). Fidelis has adopted parity compliance non-quantitative treatment limitation (NQTL) testing policies and procedures for prior authorization, concurrent review, and retrospective review. All UM policies and procedures described in this policy also comply with NQTL policies adopted by Fidelis. Moreover, Fidelis tracks appropriate outcomes measures and associated statistical data on a regular basis to demonstrate parity compliant performance for each NQTL.

PROCEDURE:
Benefit Classifications and Coverage
When applying parity requirements Fidelis Care UM will utilize the following, in scope, benefit classifications as defined by the Centers for Medicare & Medicaid Services (CMS):
• Inpatient

• Outpatient

• Emergency care

• Prescription Drug -Please refer to Pharmacy Policy Non-Quantitative Treatment Limitation Parity Testing of Medical Necessity Criteria Reference Number 4.084

Benefits/Services to which Medical Necessity and Clinical Coverage Guidelines Applies:
A. Clinical policies include medical, behavioral health, medical pharmacy benefits, durable medical equipment and devices. These policies include but are not limited to:
• New and emerging technologies
• New uses for existing technologies
• Clinical guidelines for the evaluation and treatment of specific conditions
• Criteria used in the authorization of drugs included on a Plan prior authorization list
• Clinical/medical criteria or information used in pre- or post-service review

B. Benefit/Service(s) to which the medical necessity applies. Medical necessity applies to the following services as a component of the application of prior authorization, concurrent review, retrospective review, outlier review, and appeals (which are analyzed as separate NQTLs).

I. INPATIENT (In-Network):
a. MEDICAL/SURGICAL BENEFITS:
• Inpatient Hospitalizations from the emergency room
• Post stabilization services
• Inpatient Rehabilitation (including Medical Rehab, Long Term Acute Care, Sub Acute Rehab, and Skilled Nursing Facility Care)
• Inpatient Hospitalizations at facilities reimbursed per diem

CLINICAL POLICY
CP.FC.45 Non-Quantitative Treatment Limitation Parity Testing of Medical Necessity Criteria and Clinical Coverage Guidelines 5 b. MENTAL HEALTH/ SUBSTANCE USE DISORDER BENEFITS:
• Inpatient substance use treatment after the initial 28 days of OASAS licensed inpatient detoxification, inpatient rehabilitation, or inpatient residential treatment services.
• Certain inpatient mental health treatment is subject to concurrent review determined by specific number triggers for utilization review in alignment with OMH best practice guidelines for utilization review and thus subject to Medical Necessity Criteria and Clinical Coverage Guidelines.
• Fidelis Care does not require or conduct prior authorization of inpatient mental health treatment for the initial 14 days of care for members aged 17 and under.

II. INPATIENT (Out-of-Network):
a. MEDICAL/SURGICAL BENEFITS: Same as inpatient in-network.
b. MENTAL HEALTH/ SUBSTANCE USE DISORDER BENEFITS: Same as inpatient in-network except out of state facilities require authorization and are subject to concurrent review and thus Medical Necessity Criteria and Clinical Coverage Guidelines.

III. OUTPATIENT (In-Network):
a. MEDICAL/SURGICAL BENEFITS:
Prior authorization and thus Medical Necessity Criteria and Clinical Coverage Guidelines is required on the following outpatient benefits:
Certain Outpatient medical/surgical treatment (Bariatric surgery, Blepharoplasty, Breast Reconstruction, skin surgery and other dermatological procedures, ear repair and ear piercing, eyelid and ocular surgery, abdominoplasty, lipectomy, panniculectomy, reduction mammoplasty, facial cosmetic, septoplasty, rhinoplasty, vascular procedures including vein stripping, ligation, ablation, and sclerotherapy, orthopedic and spinal surgical procedures, sinusplasty, vertevroplasty, esophageal sphincter augmentation).

Certain Outpatient and DME Services: diagnostic testing (sleep studies, breast cancer testing, other genetic testing, wireless capsule endoscopy, HIV resistance testing, and gastroenterology procedures); certain Durable Medical Equipment referenced in the Authorization Grids (see references); Home Health Care, Hospice, Imaging studies, radiology services, other therapies (phototherapy, oxygen therapy, pain management codes, radiation therapy, continuous glucose monitoring, speech therapy, occupational therapy, and physical therapy), adult day health care/AIDS adult day health care, new technology/experimental treatments, and certain dental and vision services require prior authorization.

Concurrent review applies to certain services that require prior authorization and/or are subject to concurrent review after an initial number of visits not requiring prior authorization are delivered and thus subject to Medical Necessity Criteria and Clinical Coverage Guidelines.These services include the following:

CLINICAL POLICY
CP.FC.45 Non-Quantitative Treatment Limitation Parity Testing of Medical Necessity Criteria and Clinical Coverage Guidelines 6 ▪ Certain Outpatient and DME Services: Certain Durable Medical Equipment and Supplies (such as Zoll Lifevest, CPAP, BiPAP, hyperbaric oxygen treatment, supplies for continuous glucose monitoring); Ongoing maintenance of purchased therapeutic devices and maintenance, rental extensions of therapeutic devices and ongoing supplies need for therapeutic treatment or device utilization, Home Health Care, Hospice, outpatient physical, occupation, and speech therapies Other therapies (phototherapy, oxygen therapy, pain management codes, radiation therapy, continuous glucose monitoring), adult day health care/AIDS adult day health care.

b. MENTAL HEALTH/ SUBSTANCE USE DISORDER BENEFITS: Prior authorization and/or concurrent review and thus Medical Necessity Criteria and Clinical Coverage Guidelines applies to certain outpatient mental health treatment, such as outpatient electroconvulsive therapy, partial hospitalization, intensive outpatient treatment, Applied Behavioral Analysis (ABA), and Children’s Services including Child and Family Treatment and Support Services (CFTSS). Certain outpatient mental health treatment is subject to concurrent review determined by specific triggers for utilization review defined with OMH Best Practice Guidelines and/or provider factors (outlier on quality or utilization standards) and thus subject to Medical Necessity Criteria and Clinical Coverage Guidelines.

IV. OUTPATIENT (Out-of-Network):
a. MEDICAL/SURGICAL BENEFITS: Any outpatient out of network care or service is subject to prior authorization and concurrent review and thus subject to Medical Necessity Criteria and Clinical Coverage Guidelines.
b. MENTAL HEALTH/ SUBSTANCE USE DISORDER BENEFITS: Any outpatient, out-of-network care or service is subject to prior authorization and concurrent review and thus subject to Medical Necessity Criteria and Clinical Coverage Guidelines.

V. EMERGENCY: Emergency services are not subject to Medical Necessity Criteria and Clinical Coverage Guidelines

        a.   MEDICAL/SURGICAL BENEFITS: N/A 
        b.   MENTAL HEALTH/ SUBSTANCE USE DISORDER BENEFITS: N/A

VI. PRESCRIPTION DRUG: Please refer to Pharmacy Policy Non-Quantitative Treatment Limitation Parity Testing of Medical Necessity Criteria Reference Number 4.084

Step 1: Describe the NQTL’s Requirements and Associated Procedures
N/A (proceed to steps 3-6)

CLINICAL POLICY
CP.FC.45 Non-Quantitative Treatment Limitation Parity Testing of Medical Necessity Criteria and Clinical Coverage Guidelines 7 Inpatient: M/S: N/A MH/SUD: N/A

Outpatient: M/S: N/A MH/SUD: N/A

Emergency:
M/S: N/A MH/SUD: N/A

Prescription Drug: Please refer to Pharmacy Policy Non-Quantitative Treatment Limitation Parity Testing of Medical Necessity Criteria Reference Number 4.084

Step 2: Describe the reason for applying the NQTL
N/A (proceed to steps 3-6)

Inpatient: M/S: N/A MH/SUD: N/A

Outpatient: M/S: N/A MH/SUD: N/A

Emergency:
M/S: N/A MH/SUD: N/A

Prescription Drug: Please refer to Pharmacy Policy Non-Quantitative Treatment Limitation Parity Testing of Medical Necessity Criteria Reference Number 4.084

Step 3: Identify and describe evidentiary standards and other evidence relied upon Instructions: ▪ Provide the comparative analysis demonstrating that the evidentiary standard(s) and other evidence relied upon in the creation the medical necessity criteria for MH/SUD benefits are comparable to and applied no more stringently than the evidentiary standard(s) and other evidence relied upon in the creation the medical necessity criteria for medical/surgical benefits. Describe evidentiary standards and evidence considered, but rejected. ▪ Evidentiary standards include all evidence or guidelines the plan or issuer considers in designing and applying its medical necessity criteria, such as recognized medical

CLINICAL POLICY
CP.FC.45 Non-Quantitative Treatment Limitation Parity Testing of Medical Necessity Criteria and Clinical Coverage Guidelines 8 literature, professional standards and protocols (including comparative effectiveness studies and clinical trials), published research studies, treatment guidelines created by professional guild associations or other third-party entities, publicly available or proprietary clinical definitions, and outcome metrics from consulting or other organizations.

M/S: Fidelis uses the following evidentiary standards to make medical necessity decisions (listed in order of significance) on a case-by-case basis, based on the information provided on the member’s health status:
A. Federal law (e.g., National Coverage Determinations (NCD), Local Coverage Determinations (LCD), and Medicare Coverage Articles for programs under Federal oversight such as Medicare); B. State law/guidelines (e.g., when State requirements trump or exceed federal requirements); C. Plan-specific clinical policy (including plan-specific clinical policies in MCG® as custom content); D. Fidelis adopted Centene clinical policy (including Centene clinical policies in MCG as custom content); E. If no Plan- or Centene-specific clinical policy exists, then nationally recognized decision support tools such as MCG (formerly Milliman Care Guidelines®) criteria are used; F. In the case of no guidance from A-E, additional information that the applicable Health Plan Medical Director will consider, when available, includes:

1. Reports from peer reviewed medical literature, from which a higher level of evidence and study quality is more strongly considered in determinations;
2. Professional standards of safety and effectiveness recognized in the US for diagnosis, care, or treatment;
3. Nationally recognized drug compendia resources such as Facts & Comparisons®, DRUGDEX®, and The National Comprehensive Cancer Network® (NCCN®) Guidelines
4. Medical association publications;
5. Government-funded or independent entities that assess and report on clinical care decisions and technology such as Agency for Healthcare Research and Quality (AHRQ), Hayes Technology Assessment, , Hayes, Cochrane Reviews, National Institute for Health and Care Excellence (NICE), etc.;
6. Published expert opinions, Up-To-Date
7. Opinion of health professionals in the area of specialty involved;

8. Opinion of attending provider in case at hand.

   MH/SUD: Fidelis uses the following evidentiary standards to make medical necessity decisions (listed in order of significance) on a case-by-case basis, based on the information provided on the member’s health status:
   A. Federal law (e.g., National Coverage Determinations (NCD), Local Coverage Determinations (LCD), and Medicare Coverage Articles for programs under Federal oversight such as Medicare);

CLINICAL POLICY
CP.FC.45 Non-Quantitative Treatment Limitation Parity Testing of Medical Necessity Criteria and Clinical Coverage Guidelines 9 B. State law/guidelines (e.g., when State requirements trump or exceed federal requirements);

1. For Substance Use Disorder: The most current version of LOCADTR will be utilized for determining medical necessity for all required SUD services /levels of care that are covered by this tool:
2. Inpatient hospital detox
3. Inpatient medically supervised detox
4. Rehab services for SUD residential treatment supports.
5. Medically supervised outpatient withdrawal 5.Outpatient clinic and opioid treatment program (OTP; OASAS services). a. For Behavioral Health: The most current version of the Level of Care Utilization System (LOCUS) tool and Child and Adolescent Level of Care Utilization System for Psychiatric and Addiction Services (CALOCUS) tool will be utilized for all required mental health services. These services include:
6. Inpatient psychiatric services
7. Partial hospitalization Program (PHP)
8. Intensive Outpatient Program (IOP)
9. Outpatient clinic (OMH services): Routine outpatient mental health clinic services do not require authorization.
   b. The most current version of the New York State Guidelines (OMH) Admission, concurrent, and discharge criteria are utilized for:
10. Continuing Day Treatment (CDT)
11. Personalized Recovery Oriented Service (PROS)
12. Assertive Community Treatment Team (ACT) c. The most current version of the New York State DOH CFTSS Manual: Admission, Concurrent and Discharge criteria are utilized for Child and Family Treatment and Support Services (CFTSS) C. Plan-specific clinical policy (including plan-specific clinical policies in MCG® as custom content); a. For Health Home Care Coordination and Management:
    Criteria developed by Fidelis Care based on review of NY State and federal resources will be utilized, as no national criteria sets or State required UM criteria were found to exist. NY state eligibility requirements for Health Home enrollment are adopted as admission criteria. Fidelis Care criteria are described in the attached grid. D. Fidelis adopted Centene clinical policy (including Centene clinical policies in MCG as custom content); E. If no Plan- or Centene-specific clinical policy exists, then nationally recognized decision support tools such as MCG (formerly Milliman Care Guidelines®) criteria are used; MCG most current Edition Behavioral Health Care Guidelines will be utilized for all required mental health services for which guidelines have been developed. These services include:
13. Psychiatric Homecare

CLINICAL POLICY
CP.FC.45 Non-Quantitative Treatment Limitation Parity Testing of Medical Necessity Criteria and Clinical Coverage Guidelines 10

2. Neuropsychological Testing (NPT)
3. Applied Behavioral Analysis (ABA)
4. Electroconvulsive Therapy (ECT) F. In the case of no guidance from A-E, additional information that the applicable Health Plan Medical Director will consider, when available, includes:
5. Reports from peer reviewed medical literature, from which a higher level of evidence and study quality is more strongly considered in determinations;
6. Professional standards of safety and effectiveness recognized in the US for diagnosis, care, or treatment;
7. Nationally recognized drug compendia resources such as Facts & Comparisons®, DRUGDEX®, and The National Comprehensive Cancer Network® (NCCN®) Guidelines
8. Medical association publications;
9. Government-funded or independent entities that assess and report on clinical care decisions and technology such as Agency for Healthcare Research and Quality (AHRQ), Hayes Technology Assessment, Hayes, Cochrane Reviews, National Institute for Health and Care Excellence (NICE), etc.;
10. Published expert opinions, Up-To-Date
11. Opinion of health professionals in the area of specialty involved;

12. Opinion of attending provider in case at hand.

    Step 4: Processes and strategies used to design NQTL as written Instructions: ▪ Provide the comparative analysis demonstrating that the processes and strategies used to design the medical necessity criteria, as written, for MH/SUD benefits are comparable to and no more stringently applied than the processes and strategies used to design the medical necessity criteria as written, for medical/surgical benefits. ▪ These processes may include, but are not limited to, the composition and deliberations of decision-making staff, e.g. the number of staff members allocated, time allocated, qualifications of staff involved, breadth of sources and evidence considered, deviation from generally accepted standards of care, consultations with panels of experts, and reliance on national treatment guidelines or guidelines provided by third-party organizations.

    Inpatient: In-Network Inpatient: M/S: Fidelis’ processes and strategies used to design the medical necessity criteria, as written, for MH/SUD benefits are comparable to and no more stringently applied than the processes and strategies used to design the medical necessity criteria as written, for medical/surgical benefits. This is evidenced by the fact that the factors and evidentiary standards used to design Fidelis’ medical necessity criteria are comparable between M/S and MH/SUD services, as outlined in detail in Step 3. Furthermore, the composition of decision making staff and the qualifications of staff involved are comparable and no more stringent between M/S and MH/SUD benefits. Consultations with specialty experts is performed on a case by case basis when necessary with an external review vendor to aid in the determination.

CLINICAL POLICY
CP.FC.45 Non-Quantitative Treatment Limitation Parity Testing of Medical Necessity Criteria and Clinical Coverage Guidelines 11 Comparable Factors and Evidentiary Standards
For M/S services the following evidentiary standards are used: Federal law, state law, plan specific clinical policy, Fidelis adopted Centene clinical policy, MCG/Milliman Care Guidelines, peer review medical literature, professional standards of safety and effectiveness, nationally recognized drug compendia resources, medical association publications, government-funded or independent entities that assess and report on clinical care decisions, published expert opinions, opinions of health professional in area of specialty, opinion of attending provider.

For MH/SUD services, the following evidentiary standards are used: Level of Care Utilization System (LOCUS), MCG most current Edition Behavioral Health Care Guidelines, the New York State Guidelines (OMH), LOCADTR, criteria developed by Fidelis Care based on review of NY State and federal resources where no national criteria or state requirements are found to exist.

Notably, New York state OMH guidelines are often determinative of medical necessity criteria and clinical coverage guidelines for MH/SUD services, as the state closely regulates the provisions of MH/SUD services. As such, for many behavioral health services, OMH or state guidance is largely relied upon as an evidentiary standard for MH/SUD services. By comparison, M/S evidentiary standards for medical necessity criteria are arguably more stringent than for MH/SUD services. For instance, as detailed in Step 3 above, M/S have a hierarchy of sources that are relied upon in the design of medical necessity criteria such that Fidelis uses the listed evidentiary standards to make medical necessity decisions (listed in order of significance) on a case-by-case basis. Moreover, the types of evidentiary sources are comparable and rooted in generally accepted standards of care and nationally recognized clinical guidelines (e.g. MCG/Milliman Care Guidelines and state law are utilized in the development of medical necessity criteria for both M/S and MH/SUD services). Therefore, Fidelis’ processes and strategies used to design the medical necessity criteria, as written, for MH/SUD benefits are comparable to and no more stringently applied than the processes and strategies used to design the medical necessity criteria as written, for medical/surgical benefits.

Composition of Decision Making Staff Fidelis Care’s team of licensed Medical Directors review the criteria in place to guide medical necessity determination. The team represents a diverse background of specialties including: • Pediatrics • Emergency Medicine • Allergy and Immunology • Geriatric Medicine • Internal Medicine • General Psychiatry • Addiction Medicine • Cardiovascular Disease

CLINICAL POLICY
CP.FC.45 Non-Quantitative Treatment Limitation Parity Testing of Medical Necessity Criteria and Clinical Coverage Guidelines 12 • Family Practice • Hospice and Palliative Medicine • Plastic Surgery • Child and Adolescent Psychiatry • Physical Medicine and Rehabilitation and Pain Medicine • Endocrinology & Metabolism • Preventive Medicine

Only appropriate practitioners can make the decision to deny coverage of a requested service based on medical necessity guidelines. Practitioner types appropriate for making the following types of denial decisions include*:

Provider Type
Denial Decision

Physicians, all types
Medical, behavioral healthcare, pharmaceutical, dental, chiropractic, vision, and physical therapy denials

Doctoral-level clinical psychologists or certified addiction-medicine specialists
Some behavioral healthcare denials

Doctoral-level board-certified behavioral analysts, doctoral-level clinical psychologists, child and adolescent psychiatrist, psychiatrists, pediatricians,
Applied Behavioral Analysis denials and appeals.

Pharmacists
Pharmaceutical denials

Dentists
Dental denials

Chiropractors
Chiropractic denials

Physical therapists
Physical therapy denials

Advanced practice registered nurses (such as nurse practitioners and clinical nurse specialists)
Requests within the scope of the license, when acting as independent practitioners in accordance with the state practice act or regulation

*State mandates may alter which practitioner types are appropriate for denial decisions.

CLINICAL POLICY
CP.FC.45 Non-Quantitative Treatment Limitation Parity Testing of Medical Necessity Criteria and Clinical Coverage Guidelines 13 This is true for both MH/SUD and M/S services, and the number of staff members allocated, time allocated, and qualifications of staff involved are comparable and no more stringent for MH/SUD and M/S services. Therefore, the processes and strategies used to design the medical necessity criteria, as written, for MH/SUD benefits are comparable to and no more stringently applied than the processes and strategies used to design the medical necessity criteria as written, for medical/surgical benefits.

Utilization Management Sub-Committee The UM subcommittee is an integral part of Fidelis’ decision-making staff for medical necessity criteria. Clinical and preventative guidelines are reviewed and updated at least every two years and more frequently when updates are released by the issuing entity. Fidelis Care’s Utilization Management Sub-Committee (UMSC) reviews adopted guidelines for appropriateness and applicability to our member and provider network. The Clinical and Preventative Guidelines Report is brought to UMSC at least every two years for review. The report includes: adopted guidelines, medical source of the guideline, provider type the guideline targets and the status of guidelines (changed/unchanged). The report also includes measures for monitoring provider adherence to the adopted guidelines.

Clinical and Preventative Guidelines are reviewed at least every two years and more frequently when updates are released by the issuing entity.
a. Quality Management Department Clinical Review Staff monitor the U.S. Preventative Services Task Force (USPSTF) and National Guideline Clearing House (www.guideline.gov) for changes to adopted guidelines.

b. All updates to adopted clinical and preventative guidelines will be announced to new and Participating Providers through posting on the Fidelis Care provider portal. Network providers are advised of the guideline change and provided a link to the guideline source for reference and review.

c. Changes to adopted guidelines are reviewed and approved by, the Chief Medical Officer and Utilization Management Sub-Committee, and for the Behavioral Health Stakeholder Regional Advisory Sub-committee, prior to the distribution to network providers.
• The Utilization Management Sub-Committee, composed of the Plan’s Chief Medical Officer and Medical Directors, and statewide representation of community based practitioners. It reports to the Quality Management Committee (QMC) and meets on a quarterly basis. • The Behavioral Health Stakeholder Regional Advisory Sub- committee consists of community stakeholders, which may include Members, Caregivers, Providers, and Local and State regulatory agency representatives. Additionally, community group leaders
and advocates are also invited to become members of the subcommittee.

CLINICAL POLICY
CP.FC.45 Non-Quantitative Treatment Limitation Parity Testing of Medical Necessity Criteria and Clinical Coverage Guidelines 14 • The Children’s Stakeholder Regional Advisory Sub-committee will consist of community stakeholders which may include Members (including youth and family who have been served in the child welfare system), Providers (from the behavioral health, foster care, medically fragile, and developmentally disabled service array), Caregivers, and community leaders and advocates with familiarity with the Children’s service delivery system.

The Clinical and Preventative Guideline Report is completed at least every two years by Clinical Quality Management. This report captures results from Clinical Reviewers review of adopted guidelines. The report is posted on the Provider Portal: (https://portal.fideliscare.org/provider/) in a timely manner and includes: trending of provider adherence measure rates and status update on guideline changes.

MH/SUD: Same as inpatient in-network M/S above.

Out of Network Inpatient:
M/S: Same as inpatient in-network M/S above. MH/SUD: Same as inpatient in-network M/S above.

Outpatient: In-Network Outpatient: M/S: Same as inpatient in-network M/S above. MH/SUD: Same as inpatient in-network M/S above.

Out of Network Outpatient:
M/S: Same as inpatient in-network M/S above. MH/SUD: Same as inpatient in-network M/S above.

Emergency: M/S N/A MH/SUD: N/A

Prescription Drug: Please refer to Pharmacy Policy Non-Quantitative Treatment Limitation Parity Testing of Medical Necessity Criteria Reference 4.084 Section 1. Section 2.

Step 5: Processes in implementation of NQTL in operation Instructions: ▪ Provide the comparative analysis demonstrating that the processes and strategies used in applying the medical necessity criteria for MH/SUD benefits are comparable to and no more stringently applied than the processes and strategies used in applying the medical necessity criteria, in operation, for medical surgical benefits. ▪ Processes and strategies used in applying the medical necessity criteria may include, but are not limited to, peer clinical review, consultations with expert reviewers, clinical

CLINICAL POLICY
CP.FC.45 Non-Quantitative Treatment Limitation Parity Testing of Medical Necessity Criteria and Clinical Coverage Guidelines 15 rationale used in applying the criteria, reviewer discretion, adherence to criteria hierarchy, and the selection of information deemed reasonably necessary to make a medical necessity determination. ▪ A key indicator for determining if the medical necessity criteria has been applied comparably and no more stringently may be an examination and comparison of interrater reliability audits for MH/SUD and medical/surgical utilization reviewers.

Inpatient: In-Network Inpatient:

M/S:
M/S Operations Measure #1: Fidelis reviews all policies and procedures, including the medical necessity policies outlined in this NQTL, at least yearly in order to ensure the processes and strategies used in applying the medical necessity criteria for MH/SUD benefits are comparable to and no more stringently applied than the processes and strategies used in applying the medical necessity criteria, in operation, for medical surgical benefits. Fidelis accomplishes this through committee review. Fidelis’ clinical policy committee reports up to the UM sub committee (UM subcommittee is described above in Step 4). The process by which this review is conducted is detailed as follows:

Physical Health Policy Creation A. Attendance at the Monthly Centene Clinical Policy Committee 1.Participate in monthly meeting for CPC for policy reviews via Zoom 2.Complete pre-CPC meeting survey via email 3.Complete Post CPC meeting survey via email B. Fidelis review of Policies (new policies and updates) 1.Clinical Policy Workgroup reviews new or updating Centene Policies a. Make recommendations to Utilization Management Sub- Committee (UMSC) i. Accept as is ii. Reject due to state requirements/benefits/provider contracts iii. Modify due to State requirements/benefits/provider contracts and create new Fidelis policy iv. Accept, but convert to payment policy b. Prepare materials for UMSC i. Provide Policy ii. Provide brief description iii. Participate in quarterly UMSC meeting via Zoom c. Notify Clinical policy workgroup of UMSC decision i. Work with Policy Production team on timing of upload into MCG ii. Determine implementation date for clinical reviews d. Submit policy to Communications by the 15th of the month to publish on fideliscare.org e. Post policy on Medical Director wiki

CLINICAL POLICY
CP.FC.45 Non-Quantitative Treatment Limitation Parity Testing of Medical Necessity Criteria and Clinical Coverage Guidelines 16 2.Clinical Policy determines Fidelis policy is needed a. Modification of existing Centene Policy including State specific regulatory or contractual requirements b. Develop De Novo policy i. New benefit requires policy ii. New and emerging technologies iii. New uses for existing technologies iv. Coverage issues relating to new and existing technologies v. Clinical guidelines for the evaluation and treatment of specific conditions
vi. Clinical/medical criteria or information used in pre- or post-service review vii. Lack of clear criteria for review noted by RNs and/or MDs c. Prepare materials for UMSC i. Provide Policy ii. Provide brief description iii. Participate in quarterly UMSC meeting via Zoom d. Notify Clinical policy workgroup of UMSC decision i. Work with Policy Production team on timing of upload into MCG ii. Determine implementation date for clinical reviews e. Submit policy to Communications by the 15th of the month to publish on fideliscare.org f. Post policy on Medical Director wiki 3.Annual review of Policies a. Perform review of all Centene and Fidelis policies, and provide necessary updates. b. Notify UMSC of updates c. Notify Clinical policy workgroup of UMSC decision i. Work with Policy Production team on timing of upload into MCG ii. Determine implementation date for clinical reviews d. Submit policy to Communications by the 15th of the month to publish on fideliscare.org e. Post policy on Medical Director wiki 4.Upload Fidelis policies (New and updates) on Centene SharePoint site: https://cnet.centene.com/sites/PPLS/SitePages/ClinicalHome.aspx C. Review new policy request or policy change request submitted by provider(s) 1.Work with provider as to why the request is necessary 2.Request evidence to support the request 3.Appoint Clinical Policy Workgroup Subcommittee to review the request 4.Subcommittee makes recommendations to Clinical Policy Workgroup D. Work with Provider Relations to determine if prior notification of 30 days is required

CLINICAL POLICY
CP.FC.45 Non-Quantitative Treatment Limitation Parity Testing of Medical Necessity Criteria and Clinical Coverage Guidelines 17 E. Work with Coding and Configuration to make necessary changes in Claims/Facets 1.Submit tickets for changes through request central if needed F. For policies that are recommended to convert to payment policies, work with Payment Integrity team to modify clinical policy to payment policy. G. Keep Policy tracker updated

Clinical Policy Committee The Clinical Policy Committee ensures that clinical policies provide a guide to medical necessity, are reviewed and approved by appropriately qualified physicians, and are available to all Centene Health Plans.

Clinical policies provide a guide to medical necessity. Benefit determinations should be based in all cases on the applicable contract provisions governing plan benefits (“Benefit Plan Contract”) and applicable state and federal requirements, as well as applicable plan- level administrative policies and procedures. To the extent there are any conflicts between these policies and the Benefit Plan Contract provisions, the Benefit Plan Contract provisions will control.

Clinical policies reflect current scientific research and evidence-based clinical standards.
Clinical policies are not intended to dictate to providers how to practice medicine. Providers are expected to exercise professional medical judgment in providing the most appropriate care and are solely responsible for the medical advice and treatment given to members. All clinical policies are available to providers in compliance with all federal, statutory and regulatory requirements and upon request. I. Purpose A. The Centene Corporate Chief Medical Officer (CMO) or his/her designee is responsible for establishing and maintaining a Clinical Policy Committee (CPC) composed of physicians and other medical and operational representatives as
appropriate from Corporate Medical Management and each Plan to assist in the identification of need, development, revision, and/or review of clinical policy. All corporate clinical policies require approval by the CPC. Physicians participating in the CPC shall be board-certified and shall be licensed in good standing in at least one state.
B. Clinical policies include medical, and durable medical equipment and devices. These policies include but are not limited to:

1. New and emerging technologies
2. New uses for existing technologies
3. Coverage issues relating to new and existing technologies
4. Clinical guidelines for the evaluation and treatment of specific conditions
5. Clinical/medical criteria or information used in pre- or post-service review C. The CMO or designee performs an annual review of all existing corporate clinical policies to determine continued applicability and appropriateness. In connection with this annual review, the CMO or designee is responsible for identifying which policies

CLINICAL POLICY
CP.FC.45 Non-Quantitative Treatment Limitation Parity Testing of Medical Necessity Criteria and Clinical Coverage Guidelines 18 require revisions. The CMO or designee shall send any such policies to the CPC to oversee the revision process and for subsequent re-approval.

II. Membership The CMO or designee recruits and replaces, as needed, CPC members to maintain a committee that includes: A. Voting members:

1. One Medical Director from each Plan (at minimum);
2. Senior Corporate Medical Directors B. Non-voting members:
3. One representative from each Plan’s medical operations department
4. Corporate clinical policy leadership
5. Corporate Medical Management Staff C. Ad hoc advisors
6. Representatives from Centene subsidiaries
7. Internal legal counsel
8. Plan compliance directors

9. Outside experts and/or relevant interested parties depending upon the specialty area or special needs of the clinical policy.

   III. Committee Maintenance and Oversight A. The CMO or designee acts as the chairperson for meetings and activities performed by the CPC (Committee Chair). The Corporate Director of Clinical Policy reports to the Committee Chair. B. The Corporate Director of Clinical Policy oversees the Clinical Policy Department which is tasked with the following responsibilities in connection with the development and approval of clinical policies:

10. Coordinating research and development of clinical policies, which includes: a. Prioritizing all inquiries for new corporate policies and maintaining an electronic log of all requests for research and new policies with the requestor and subject of review.
    Highest priority is given to inquires based on open medical management cases such as pending authorizaitons or appeals cases. Response to these requests typically occurs within 24 hours. Priority then continues based on requests originating from providers or members, needs identified through financial analysis, followed by inquiries by vendors and technologies identified through trade publications.
    b. Conducting prelimary review of topics as follows: i. A critical appraisal of the current published medical literature from peer- reviewed publications including systematic reviews, randomized controlled trials, cohort studies, case control studies, and diagnostic test studies with statistically sound methods. ii. Evidence-based guidelines developed by national organizations and recognized authorities.

CLINICAL POLICY
CP.FC.45 Non-Quantitative Treatment Limitation Parity Testing of Medical Necessity Criteria and Clinical Coverage Guidelines 19 iii. Opinions and assessments by nationally recognized medical associations including physician specialty societies, consensus panels, or other nationally recognized research or technology assessment organizations such as Hayes, UpToDate, or ECRI.
iv. Reports and publications of government agencies such as the Food and Drug, Administration (FDA), Centers for Disease Control (CDC), or National Institutes of Health (NIH).
v. External review organization recommendations. c. Conveying the findings of the preliminary review to the requestor within the priority-based time frame. In cases of open medical management decisions, the requestor will use the information provided by the clinical policy staff and the specifics of the particular case to render a decision. Preliminary review findings are saved in an electronic file for future policy development. d. For topics identified through medical management needs, if two requests for the same topic are submitted, a formal medical policy may be developed.
Requests identified through financial analysis will follow this policy development process.
i. The clinical policy staff utilizes the preliminary research to draft a policy.
Relevant CPT, HCPCS and ICD-10 codes are identified and included in the policy. A review of historical handling and/or payment of the policy topic is also conducted to share with the CPC as appropriate. ii. Opinions from external physicians are solicited as appropriate, including behavioral health physicians. The policy is sent for CPC review and approval.
iii. Subsequent to each new policy approval, the clinical policy staff sends a notice to all medical directors and medical management leadership to inform them of new policies that have been approved by the CPC.
iv. The completed policies are reviewed annually or updated more frequently as dictated by current medical literature, medical director or other relevant staff requests and appeals analysis.
v. Completed policies are posted on CNET and in Adobe Experience Manager for access by internal staff and for plans to link to plan websites for providers. e. Communication of these policies to provider networks is arranged by the plan marketing or provider network department.

2. Coordinating activities of the CPC including, but not limited to, the review, revision, approval, and maintenance processes of all corporate clinical policies.
   This includes scheduling meetings, sending necessary agendas and attachments, documenting meeting minutes, clinical policy reference number assignment, and the maintenance of such documents in electronic files and within the organizational internal database.
3. Generating reports reflecting CPC activity on a quarterly basis, or more frequently as needed, for the Committee Chair.
4. Notifying all relevant persons/departments and health plans regarding approved policies and related materials through email, including:

CLINICAL POLICY
CP.FC.45 Non-Quantitative Treatment Limitation Parity Testing of Medical Necessity Criteria and Clinical Coverage Guidelines 20 a. Claim support service teams for dissemination to IS and claims. The clinical policy team offers direction/coordination for any system needs to support the clinical policy.
b. Corporate Medical Management VPs and Corporate medical auditing and training teams for dissemination and auditing. c. CPC members, plan medical management VPs and directors, and other health plan contacts for dissemination to their plan UM personnel. This includes notification to plan respresentatives for inclusion in the plan UM or QI committee responsible for plan level policy approval. Marketing and/or provider relations are included for appropriate provider notification of policy changes.

5. Facilitating training, as needed, with the corporate Medical Management Training Department.

   IV. Meeting Frequency A. CPC meetings are held, at minimum, on a quarterly basis. Frequency is dependent upon clinical policy revision cycles and/or clinical policy need (as determined by the CMO or designee). B. Meetings may be held in a physical location or through the use of alternative media as determined by the participation of members from remote locations or by the urgency of the clinical policy. Such media include video, telephonic conference call, or email.

   V. Committee Member Activities and Responsibilities: A. Identification of new subjects to consider for clinical policy development can occur in the following ways:

6. Through UM authorization requests;
7. New technologies identified through trade publications;
8. Inquiries from providers and vendors;
9. Review of appeals cases;
10. Suggestion of the Medical Policy Governance Team; B. Review of clinical policies which includes:
11. New clinical policy drafts;
12. Policies due for scheduled review;
13. Updates or revisions to existing policies outside of the scheduled review due to advances or changes in standards of care, new information, missing information or content error;
14. Updates regarding the status of any policies under review;

15. Policy and prioritization requests for new clinical policies;

    M/S Operations Measure #2: Fidelis reviews the meeting minutes of the clinical policy committee and the UM sub committee on a quarterly basis in order to ensure the processes and strategies used in applying the medical necessity criteria for MH/SUD benefits are comparable to and no more stringently applied than the processes and strategies used in applying the medical necessity criteria, in operation, for medical surgical benefits.

CLINICAL POLICY
CP.FC.45 Non-Quantitative Treatment Limitation Parity Testing of Medical Necessity Criteria and Clinical Coverage Guidelines 21 MH/SUD: MH/SUD Operations Measure #1: Fidelis reviews all policies and procedures, including the medical necessity policies outlined in this NQTL, at least yearly in order to ensure the processes and strategies used in applying the medical necessity criteria for MH/SUD benefits are comparable to and no more stringently applied than the processes and strategies used in applying the medical necessity criteria, in operation, for medical surgical benefits. Fidelis accomplishes this through committee review. Fidelis’ clinical policy committee reports up to the UM sub committee (UM subcommittee is described above in Step 4). The process by which this review is conducted for behavioral health is detailed as follows:

Behavioral Health (BH) Clinical Policies A. Attendance at the Centene Quarterly Behavioral Health Clinical Policy Committee B. BH Policy Committee review of Policies (new policies and updates) 1.BH Policy Committee review of Centene Policies (new policies and updates)
a. Make recommendations to Utilization Management Sub-Committee (UMSC) i. Accept as is ii. Reject due to state requirements/benefits/provider contracts iii. Modify due to State requirements/benefits/provider contracts and create new Fidelis policy iv. Accept, but convert to payment policy b. Prepare materials for UMSC i. Provide Policy ii. Provide brief description c. Notify BH Policy Committee of UMSC decision i. Work with Policy Production team on timing of upload into MCG ii. Determine implementation date for clinical reviews d. Submit policy to Communications by the 15th of the month to publish on fideliscare.org e. Post policy on Medical Director wiki 2.BH Policy Committee determines Fidelis policy is needed a. Modification of existing Centene Policy including State specific regulatory or contractual requirements b. If applicable, Develop De Novo policy
i. New benefit requires policy ii. New and emerging technologies iii. New uses for existing technologies iv. Coverage issues relating to new and existing technologies v. Clinical guidelines for the evaluation and treatment of specific conditions
vi. Clinical/medical criteria or information used in pre- or post-service review vii. Lack of clear criteria for review noted by CMs and/or MDs c. Prepare materials for UMSC i. Provide Policy

CLINICAL POLICY
CP.FC.45 Non-Quantitative Treatment Limitation Parity Testing of Medical Necessity Criteria and Clinical Coverage Guidelines 22 ii. Provide brief description d. Notify BH Policy Committee of UMSC decision i. If applicable, work with Policy Production team on timing of upload into MCG ii. Determine implementation date for clinical reviews e. Submit policy to Communications by the 15th of the month to publish on fideliscare.org f. Post policy on Medical Director wiki 3.Annual review of Policies a. Perform review of all Centene and Fidelis BH policies, and provide necessary updates. b. Notify UMSC of updates c. Notify BH Policy Committee of UMSC decision i. If applicable, work with Policy Production team on timing of upload into MCG ii. If applicable, determine implementation date for clinical reviews d. Submit policy to Communications by the 15th of the month to publish on fideliscare.org e. Post policy on Medical Director wiki 4.Upload Fidelis policies (New and updates) on Centene SharePoint site: https://cnet.centene.com/sites/PPLS/SitePages/ClinicalHome.aspx 5.Submit tickets for changes through request central if needed C. Review new policy request or policy change request submitted by provider(s) a. Work with provider as to why the request is necessary b. Request evidence to support the request c. Appoint Clinical Policy Workgroup Subcommittee to review the request d. Subcommittee makes recommendations to Clinical Policy Workgroup D. If applicable, work with Provider Relations to determine if prior notification of 30 days is required E. If applicable, work with Coding and Configuration to make necessary changes in Claims/Facets.
F. For policies that are recommended to convert to payment policies, work with Payment Integrity team to modify clinical policy to payment policy. G. Keep Policy tracker updated

Clinical Policy Committee The Clinical Policy Committee ensures that clinical policies provide a guide to medical necessity, are reviewed and approved by appropriately qualified physicians, and are available to all Centene Health Plans.

Clinical policies provide a guide to medical necessity. Benefit determinations should be based in all cases on the applicable contract provisions governing plan benefits (“Benefit Plan Contract”) and applicable state and federal requirements, as well as applicable plan-

CLINICAL POLICY
CP.FC.45 Non-Quantitative Treatment Limitation Parity Testing of Medical Necessity Criteria and Clinical Coverage Guidelines 23 level administrative policies and procedures. To the extent there are any conflicts between these policies and the Benefit Plan Contract provisions, the Benefit Plan Contract provisions will control.

Clinical policies reflect current scientific research and evidence-based clinical standards.
Clinical policies are not intended to dictate to providers how to practice medicine. Providers are expected to exercise professional medical judgment in providing the most appropriate care and are solely responsible for the medical advice and treatment given to members. All clinical policies are available to providers in compliance with all federal, statutory and regulatory requirements and upon request. I. Purpose A. The Centene Corporate Chief Medical Officer (CMO) or his/her designee is responsible for establishing and maintaining a Clinical Policy Committee (CPC) composed of physicians and other medical and operational representatives as appropriate from Corporate Medical Management and each Plan to assist in the identification of need, development, revision, and/or review of clinical policy. All corporate clinical policies require approval by the CPC. Physicians participating in the CPC shall be board-certified and shall be licensed in good standing in at least one state.
B. Clinical policies include medical, and durable medical equipment and devices. These policies include but are not limited to: A. New and emerging technologies B. New uses for existing technologies C. Coverage issues relating to new and existing technologies D. Clinical guidelines for the evaluation and treatment of specific conditions
E. Clinical/medical criteria or information used in pre- or post-service review C. The CMO or designee performs an annual review of all existing corporate clinical policies to determine continued applicability and appropriateness. In connection with this annual review, the CMO or designee is responsible for identifying which policies require revisions. The CMO or designee shall send any such policies to the CPC to oversee the revision process and for subsequent re-approval.

II. Membership The CMO or designee recruits and replaces, as needed, CPC members to maintain a committee that includes: A. Voting members:

1. One Medical Director from each Plan (at minimum);
2. Senior Corporate Medical Directors B. Non-voting members:
3. One representative from each Plan’s medical operations department
4. Corporate clinical policy leadership
5. Corporate Medical Management Staff C. Ad hoc advisors
6. Representatives from Centene subsidiaries
7. Internal legal counsel

CLINICAL POLICY
CP.FC.45 Non-Quantitative Treatment Limitation Parity Testing of Medical Necessity Criteria and Clinical Coverage Guidelines 24

3. Plan compliance directors

4. Outside experts and/or relevant interested parties depending upon the specialty area or special needs of the clinical policy.

   III. Committee Maintenance and Oversight A. The CMO or designee acts as the chairperson for meetings and activities performed by the CPC (Committee Chair). The Corporate Director of Clinical Policy reports to the Committee Chair. B. The Corporate Director of Clinical Policy oversees the Clinical Policy Department which is tasked with the following responsibilities in connection with the development and approval of clinical policies:

5. Coordinating research and development of clinical policies, which includes: • Prioritizing all inquiries for new corporate policies and maintaining an electronic log of all requests for research and new policies with the requestor and subject of review.
   • Highest priority is given to inquires based on open medical management cases such as pending authorizaitons or appeals cases.
   Response to these requests typically occurs within 24 hours. Priority then continues based on requests originating from providers or members, needs identified through financial analysis, followed by inquiries by vendors and technologies identified through trade publications.
   • Conducting prelimary review of topics as follows: • A critical appraisal of the current published medical literature from peer-reviewed publications including systematic reviews, randomized controlled trials, cohort studies, case control studies, and diagnostic test studies with statistically sound methods. • Evidence-based guidelines developed by national organizations and recognized authorities. • Opinions and assessments by nationally recognized medical associations including physician specialty societies, consensus panels, or other nationally recognized research or technology assessment organizations such as Hayes, UpToDate, or ECRI.
   • Reports and publications of government agencies such as the Food and Drug, Administration (FDA), Centers for Disease Control (CDC), or National Institutes of Health (NIH).
   • External review organization recommendations. • Conveying the findings of the preliminary review to the requestor within the priority-based time frame. In cases of open medical management decisions, the requestor will use the information provided by the clinical policy staff and the specifics of the particular case to render a decision.

CLINICAL POLICY
CP.FC.45 Non-Quantitative Treatment Limitation Parity Testing of Medical Necessity Criteria and Clinical Coverage Guidelines 25 Preliminary review findings are saved in an electronic file for future policy development. For topics identified through medical management needs, if two requests for the same topic are submitted, a formal medical policy may be developed. Requests identified through financial analysis will follow this policy development process.
• The clinical policy staff utilizes the preliminary research to draft a policy. Relevant CPT, HCPCS and ICD-10 codes are identified and included in the policy. A review of historical handling and/or payment of the policy topic is also conducted to share with the CPC as appropriate. • Opinions from external physicians are solicited as appropriate, including behavioral health physicians. The policy is sent for CPC review and approval.
• Subsequent to each new policy approval, the clinical policy staff sends a notice to all medical directors and medical management leadership to inform them of new policies that have been approved by the CPC.
• The completed policies are reviewed annually or updated more frequently as dictated by current medical literature, medical director or other relevant staff requests and appeals analysis.
• Completed policies are posted on CNET and in Adobe Experience Manager for access by internal staff and for plans to link to plan websites for providers. E. Communication of these policies to provider networks is arranged by the

   plan marketing or provider network department.

F. Coordinating activities of the CPC including, but not limited to, the review, revision, approval, and maintenance processes of all corporate clinical policies. This includes scheduling meetings, sending necessary agendas and attachments, documenting meeting minutes, clinical policy reference number assignment, and the maintenance of such documents in electronic files and within the organizational internal database. G. Generating reports reflecting CPC activity on a quarterly basis, or more frequently as needed, for the Committee Chair.
H. Notifying all relevant persons/departments and health plans regarding approved policies and related materials through email, including: • Claim support service teams for dissemination to IS and claims.
The clinical policy team offers direction/coordination for any system needs to support the clinical policy.
• Corporate Medical Management VPs and Corporate medical auditing and training teams for dissemination and auditing. • CPC members, plan medical management VPs and directors, and other health plan contacts for dissemination to their plan UM personnel. This includes notification to plan respresentatives for

CLINICAL POLICY
CP.FC.45 Non-Quantitative Treatment Limitation Parity Testing of Medical Necessity Criteria and Clinical Coverage Guidelines 26 inclusion in the plan UM or QI committee responsible for plan level policy approval. Marketing and/or provider relations are included for appropriate provider notification of policy changes.
i.Facilitating training, as needed, with the corporate Medical Management Training Department.

IV. Meeting Frequency A. CPC meetings are held, at minimum, on a quarterly basis. Frequency is dependent upon clinical policy revision cycles and/or clinical policy need (as determined by the CMO or designee). B. Meetings may be held in a physical location or through the use of alternative media as determined by the participation of members from remote locations or by the urgency of the clinical policy. Such media include video, telephonic conference call, or email.

V. Committee Member Activities and Responsibilities: A. Identification of new subjects to consider for clinical policy development can occur in the following ways:

1. Through UM authorization requests;
2. New technologies identified through trade publications;
3. Inquiries from providers and vendors;
4. Review of appeals cases;

5. Suggestion of the Medical Policy Governance Team; B. Review of clinical policies which includes:
   1.New clinical policy drafts; 2.Policies due for scheduled review; 3.Updates or revisions to existing policies outside of the scheduled review due to advances or changes in standards of care, new information, missing information or content error; 4.Updates regarding the status of any policies under review; 5.Policy and prioritization requests for new clinical policies;

   MH/SUD Operations Measure #2: Fidelis reviews the meeting minutes of the clinical policy committee on a quarterly basis and the UM sub committee on an as-needed basis (when BH Clinical Polices are reviewed) in order to ensure the processes and strategies used in applying the medical necessity criteria for MH/SUD benefits are comparable to and no more stringently applied than the processes and strategies used in applying the medical necessity criteria, in operation, for medical surgical benefits.

   Out of Network Inpatient:
   M/S: Same as inpatient in-network.
   MH/SUD: Same as inpatient in-network.

CLINICAL POLICY
CP.FC.45 Non-Quantitative Treatment Limitation Parity Testing of Medical Necessity Criteria and Clinical Coverage Guidelines 27 Outpatient: In-Network Outpatient: M/S: Same as inpatient in-network. MH/SUD: Same as inpatient in-network.

Out of Network Outpatient:
M/S: Same as inpatient in-network. MH/SUD: Same as inpatient in-network.

Emergency: M/S: N/A MH/SUD: N/A

Prescription Drug: Please refer to Pharmacy Policy Non-Quantitative Treatment Limitation Parity Testing of Medical Necessity Criteria Reference 4.084 Section 1. Section 3.

Step 6: Summary conclusion of how plan or issuer has determined overall compliance Instructions: ▪ Based on the responses provided in the steps above, please clearly summarize the basis for the plan or issuer's conclusion that both as written and in operation, the processes, strategies, evidentiary standards, and factors used to design and apply the medical necessity criteria for MH/SUD benefits are comparable to and applied no more stringently than the processes, strategies, evidentiary standards, and factors used to design and apply the medical necessity criteria for medical/surgical benefits in each classification of benefits in which utilization review is performed involving the use of the medical necessity criteria.

Inpatient: In-Network Inpatient: M/S: As written and in operation, the processes, strategies, evidentiary standards, and factors used to design and apply the medical necessity criteria for MH/SUD benefits are comparable to and applied no more stringently than the processes, strategies, evidentiary standards, and factors used to design and apply the medical necessity criteria for medical/surgical benefits in each classification of benefits.

As Written Analysis
As demonstrated in detailed analysis in Step 4, the evidentiary standards and processes used to develop medical necessity criteria for MH/SUD and M/S services in writing are comparable and no more stringent.

For many behavioral health services, OMH or state guidance is largely relied upon as an evidentiary standard for MH/SUD services. By comparison, M/S evidentiary standards for medical necessity criteria are arguably more stringent than for MH/SUD services. For instance, as detailed in Step 3 above, M/S have a hierarchy of sources that are relied upon in the design of medical necessity criteria such that Fidelis uses the listed evidentiary standards to make medical

CLINICAL POLICY
CP.FC.45 Non-Quantitative Treatment Limitation Parity Testing of Medical Necessity Criteria and Clinical Coverage Guidelines 28 necessity decisions (listed in order of significance) on a case-by-case basis. However, the types of evidentiary sources are comparable and rooted in generally accepted standards of care and nationally recognized clinical guidelines (e.g. MCG/Milliman Care Guidelines and state law are utilized in the development of medical necessity criteria for both M/S and MH/SUD services).

In addition, only appropriate practitioners can make the decision to deny coverage of a requested service based on medical necessity guidelines. Practitioner types appropriate for making the following types of denial decisions are comparable and no more stringent for MH/SUD and M/S services. Therefore, Fidelis’ processes and strategies used to design the medical necessity criteria, as written, for MH/SUD benefits are comparable to

and no more stringently applied than the processes and strategies used to design the medical necessity criteria as written, for medical/surgical benefits.

In Operation Analysis
In addition, the operations measures outlined in Step 5 are comparable for MH/SUD and M/S services. For instance, both MH/SUD and M/S services have two operations measures which include: (1) a committee based process for regular review of medical necessity policies and clinical coverage guidelines, (2) periodic review of committee meeting minutes to ensure that processes for review of M/S and MH/SUD clinical criteria are comparable and no more stringent.

The only difference is in operations measure #1, because the committees responsible for review and adoption of the medical necessity criteria are different for behavioral health versus physical health services. For MH/SUD services, there is quarterly Behavioral Health Clinical Policy Committee that reviews new policies and updates and makes recommendations to the Utilization Management Sub-Committee (UMSC). For M/S services, there is a monthly clinical policy committee which reviews new policies and updates and makes recommendations to the UMSC.

However, the process for establishing and updating medical necessity criteria are the same for both M/S and MH/SUD services in operation. Clinical and preventative guidelines are reviewed and updated at least every two years and more frequently when updates are released by the issuing entity. Fidelis Care’s Utilization Management Sub-Committee (UMSC) reviews adopted guidelines for appropriateness and applicability to our member and provider network. The Clinical and Preventative Guidelines Report is brought to UMSC at least every two years for review. The report includes: adopted guidelines, medical source of the guideline, provider type the guideline targets and the status of guidelines (changed/unchanged). The report also includes measures for monitoring provider adherence to the adopted guidelines.

Therefore, as demonstrated in Step 4, the processes, strategies, evidentiary standards, and factors used to design the medical necessity criteria for MH/SUD benefits are comparable to and applied no more stringently than the processes, strategies, evidentiary standards, and factors used to design the medical necessity criteria for M/S services. Furthermore, as demonstrated by the operations measures in Step 5, the processes, strategies, evidentiary standards, and factors used to apply the medical necessity criteria in operation for MH/SUD benefits are comparable to and

CLINICAL POLICY
CP.FC.45 Non-Quantitative Treatment Limitation Parity Testing of Medical Necessity Criteria and Clinical Coverage Guidelines 29 applied no more stringently than the processes, strategies, evidentiary standards, and factors used to apply the medical necessity criteria in operation for M/S services.

MH/SUD: Same as inpatient in-network M/S above.

Out of Network Inpatient:
M/S: Same as inpatient in-network M/S above. MH/SUD: Same as inpatient in-network M/S above.

Outpatient: In-Network Outpatient: M/S: Same as inpatient in-network M/S above. MH/SUD: Same as inpatient in-network M/S above.

Out of Network Outpatient:
M/S: Same as inpatient in-network M/S above. MH/SUD: Same as inpatient in-network M/S above.

Emergency: M/S: N/A MH/SUD: N/A

Prescription Drug: Please refer to Pharmacy Policy Non-Quantitative Treatment Limitation Parity Testing of Medical Necessity Criteria Reference 4.084 Section 1. Section 4.

REFERENCES:
Mental Health Parity and Addiction Equity Act (MHPAEA) Final Rule (42 CFR 438, 42 CFR 440, 42 CFR 456, 42 CFR 457)
New York State Department of Financial Services 11 NYCRR PART 230 (Insurance Regulation 218).
New York State 10 NYCRR Section 98-4.4 - Mental health and substance use disorder parity compliance program.
Office of Mental Health NQTL Spreadsheet Guidance

CLINICAL POLICY
CP.FC.45 Non-Quantitative Treatment Limitation Parity Testing of Medical Necessity Criteria and Clinical Coverage Guidelines 30

REVISION LOG
REVISION:
DATE:
Annual Review. Updated hierarchy of evidence; Added Specialties in Composition of Decision Making Staff section; corrected formatting/spacing; added Children’s Home and Community Based Services to MH NY State Guidelines; Revised Section labelled IV.HARP/BH Rehabilitation and Recovery and Home and Community Based Services (HCBS) 1/2023 Annual Review. Typos corrected. As pharmacy is now at the corporate level, pharmacy references have been deleted. 1/2024 Annual Review. Updated medical directors specialties. Changed UMSC meeting as occurring “quarterly” instead of “monthly”. 1/2025 Ad Hoc Review. Definitions and formatting updated for consistency with Prior Authorization and Concurrent Review NQTLs. Definition of MH/SUD Oupatient Servies updated to include CFTSS. List of when NYS OMH guidelines are used updated to include CFTSS. Benefits/Services to which Medical Necessity and Clinical Coverage Guidelines Applies updated for consistency with most recent Medical Necessity and Clinical Coverage Guidelines Clinical Policy and Prior Authorization and Concurrent Review NQTLs. HARP HCBS/CORE removed as no authorization required for services. Table of practitioner types appropriate for making denial decisions updated for consistency with most recent table in Medical Necessity and Clinical Coverage Guidelines Clinical Policy. 11/2025 Annual Review. References reviewed. 1/2026