Medical Necessity Criteria Form

Page 1 of 8 Clinical Policy: Medical Necessity Criteria Reference Number: CP.FC.05

Last Review Date: 07/25 Revision Log All LOB except Medicare

See Important Reminder at the end of this policy for important regulatory and legal information.

Description
Medical necessity criteria and related definitions.

Note: This policy may not be referenced in denial letters as the criteria for adverse determinations. The denial notification must reference the specific medical necessity criterion used to make the denial decision

Policy/Criteria Fidelis Care will use the following guidelines to make medical necessity decisions (listed in order of significance) on a case-by-case basis, based on the information provided on the
member/enrollee’s health status:

A. Federal law for federal programs such as Medicare (e.g., National Coverage Determinations (NCD), Local Coverage Determinations (LCD), and Medicare Coverage Articles) or state law/guidelines (e.g., when state requirements trump federal requirements, such as for Medicaid, or exceed federal requirements);*

B. State law/guidelines (e.g., when State requirements trump or exceed federal requirements);

1. For Behavioral Health: Level of Care Utilization System for Psychiatric and Addiction Services (LOCUS) tool and Child and Adolescent Level of Care Utilization System for Psychiatric and Addiction Services (CALOCUS) tool
2. For Substance Use Disorder: Level of Care for Alcohol and Drug Treatment Referral (LOCADTR) 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 (not in order of significance):
3. Reports from peer reviewed medical literature, from which a higher level of evidence and study quality is more strongly considered in determinations;
4. Professional standards of safety and effectiveness recognized in the US for diagnosis, care, or treatment;
5. Nationally recognized drug compendia resources such as Facts & Comparisons®, DRUGDEX®, and The National Comprehensive Cancer Network® (NCCN®) Guidelines
6. Medical association publications; such as those from American Society of Addiction Medicine, American College of Obstetricians and Gynecologists, etc.;

CLINICAL POLICY Medical Necessity Criteria Reference Number: CP.FC.05 Page 2 of 8

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; including in UpToDate
7. Opinion of health professionals in the area of specialty involved;

8. Opinion of attending provider in case at hand.

   • Note: Federal law may affect state and federal programs (e.g. Women’s Health and Cancer Rights Act, Affordable Care Act), superseding any other criteria. However, this is taken into consideration in corporate clinical policies and state regulations.

   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 allowed to make denial decisions: 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 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.

   Definitions
   Unless defined differently by the member/enrollees’ Benefit Plan Contract or the applicable provider agreement, the Health Plan uses the following definitions:

   A. 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:

9. In accordance with generally accepted standards of medical practice;

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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. For further information, please refer to CP.MP.36, Experimental Technologies.

   B. 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.

   C. 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; b. Therapeutic value or beneficial effects on health outcomes; 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.

   D. 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:

7. There are no studies of the service described in recent, published peer-reviewed medical literature;
8. There are no active or ongoing credible evaluations being undertaken of the service which has previously been considered not medically necessary;
9. There is conclusive evidence in published peer-reviewed medical literature that the service is not effective;
10. 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;

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5. It is contraindicated.

   E. In relation to inpatient stays, 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.].

   F. The terms “never events,” “serious reportable events,” and “non-reimbursable serious hospital-acquired conditions” all refer to serious adverse events occurring in facilities that are largely preventable and of concern to both the public and to health care providers. Based on the benefit plan contract, the event and services resulting directly from a never event may not be a covered benefit and/or may be non-reimbursable. Examples of such events include:

10. Death/disability associated with intravascular air embolism
11. Death/disability associated with hypoglycemia
12. Stage 3 or 4 pressure ulcers after admission
13. Death/disability associated with electric shock
14. Death/disability associated with a burn incurred within facility
15. Various surgical site infections, i.e., following coronary artery bypass graft, bariatric surgery, or certain orthopedic procedures, etc.
16. Death caused by self-inflicted injurious behavior if any of the following apply: a. While in a health care setting; b. Within 7 days of discharge from inpatient services; c. Within 7 days of discharge from emergency department (ED); d. While receiving or within 7 days of discharge from the following behavioral health care services: Day Treatment/Partial Hospitalization Program (PHP)/Intensive Outpatient Program (IOP), Residential, Group Home, and Transitional Supportive Living;
17. Homicide of any individual served receiving care, treatment, and services while on site at the organization or while under the care or supervision of the organization;

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9. Homicide of a staff member, visitor, or vendor while on site at the organization or while providing care or supervision to individuals served;
10. Any intrapartum maternal death;
11. Severe maternal morbidity (leading to permanent harm or severe harm);
12. Sexual abuse/assault of any individual served receiving care, treatment, and services while on site at the organization or while under the care or supervision of the organization;
13. Sexual abuse/assault of a staff member, visitor, or vendor while on site at the organization or while providing care or supervision to individuals served;
14. Physical assault (leading to death, permanent harm, or severe harm) of any individual served receiving care, treatment, and services while on site at the organization or while under the care or supervision of the organization;
15. Physical assault (leading to death, permanent harm, or severe harm) of a staff member, visitor, or vendor while on site at the organization or while providing care or supervision to individuals served;
16. Surgery or other invasive procedure performed at the wrong site, on the wrong patient, or that is the wrong (unintended) procedure for a patient regardless of the type of procedure or the magnitude of the outcome;
17. Discharge of an infant to the wrong family;
18. Abduction of any individual served receiving care, treatment, and services;
19. Any elopement (that is, unauthorized departure) of an individual served from a staffed around-the-clock care setting (including the ED), leading to death, permanent harm, or severe harm to the individual served;
20. Administration of blood or blood products having unintended ABO and non-ABO (Rh, Duffy, Kell, Lewis, and other clinically important blood groups) incompatibilities,
    hemolytic transfusion reactions, or transfusions resulting in death, permanent harm, or severe harm;
21. Unintended retention of a foreign object in a patient after an invasive procedure, including surgery;
22. Severe neonatal hyperbilirubinemia (bilirubin >30 milligrams/deciliter);
23. Fluoroscopy resulting in permanent tissue injury when clinical and technical optimization were not implemented and/or recognized practice parameters were not followed;
24. Any delivery of radiotherapy to the wrong individual served, wrong body region, unintended procedure, or >25% above the planned radiotherapy dose
25. Fire, flame, or unanticipated smoke, heat, or flashes occurring during direct care of the individual served caused by equipment operated and used by the organization. To be considered a sentinel event, equipment must be in use at the time of the event; staff do not need to be present;
26. Fall in a staffed-around-the-clock care setting or fall in a care setting not staffed around the clock during a time when staff are present resulting in any of the following: a. Any fracture; b. Surgery, casting, or traction; c. Required consult/management or comfort care for a neurological (for example, skull fracture, subdural or intracranial hemorrhage) or internal (for example, rib fracture, small liver laceration) injury; d. A patient with coagulopathy who receives blood products as a result of the fall

CLINICAL POLICY Medical Necessity Criteria Reference Number: CP.FC.05 Page 6 of 8 e. Death or permanent harm as a result of injuries sustained from the fall (not from physiologic events causing the fall); G. NY State clinical review criteria that issuers and their utilization review agents must use when conducting utilization review for mental health services: Insurance Law § 4902(a)(12) and Public Health Law § 4902(1)(j) provide that when conducting utilization review for purposes of determining coverage for a mental health condition, issuers and their utilization review agents must use evidence-based and peer reviewed clinical review criteria that is appropriate to the age of the patient. The clinical review criteria must also be deemed appropriate and approved for such use by the Commissioner of OMH, in consultation with the Commissioner of Health (DOH), and the Superintendent of Financial Services. When making coverage determinations related to the treatment of mental health conditions for adults, OMH strongly encourages issuers and their utilization review agents to use the most recent version of the Level of Care Utilization System for Psychiatric and Addiction Services (LOCUS) tool. When making coverage determinations related to treatment of mental health conditions for children and adolescents OMH strongly encourages issuers and their utilization review agents to use the most recent version of the Child and Adolescent Level of Care Utilization System for Psychiatric and Addiction Services (CALOCUS) tool. Issuers and their utilization review agents who use LOCUS and CALOCUS will not be required to demonstrate to OMH that the criteria is recognized as evidence-based, peer-reviewed, and appropriate to the age of the patients to whom it is intended to apply. Further, OMH will prioritize and expedite its review of submissions for issuers and their utilization review agents who use LOCUS and CALOCUS.

Background Fidelis Care clinical policies are intended to be reflective of current scientific research and clinical practice and judgment . They are developed with oversight of board-certified physicians and practitioners, reviewed on an annual basis for appropriateness and approved by the Fidelis Care Clinical Policy Committee. The Clinical Policy Committee is composed of physicians and other medical and operational representatives, as appropriate, from Fidelis Care to assist in the identification of need, development, revision, and/or review of clinical policy. 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

MCG criteria are proprietary and cannot be publicly published and/or distributed. On an individual member/enrollee basis, the specific criteria document used to make a medical necessity determination can be made available upon request. The member/enrollee or the provider can request the criteria from the plan by telephone or in writing. For Medicare line of business, the criteria are available to both members/enrollees and providers on fideliscare.org

CLINICAL POLICY Medical Necessity Criteria Reference Number: CP.FC.05 Page 7 of 8 Licensee and any recipient thereunder shall use the Clinical Content in accordance with the terms and conditions of the license agreement.

The MCG guideline(s) and products are not intended to be used without the judgment of a qualified health care provider with the ability to take into account the individual circumstances of each patient’s case.

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 medical necessity criteria and clinical coverage guidelines, and included medical necessity criteria in NQTL policies for prior authorization and concurrent review. All medical necessity and clinical coverage guidelines 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.

Reviews, Revisions, and Approvals Date Approval Date Policy developed 05/19 06/19 Added Note: This policy may not be referenced in denial letters as the sole criteria for adverse determinations. The denial notification must reference the specific medical necessity criterion used to make the denial decision. Added advanced practice registered nurses and doctoral-level Board- Certified Behavioral Analysts to provider type table. Added Doctoral-level board-certified behavioral analysts, doctoral-level clinical psychologists, child and adolescent psychiatrist. References reviewed and updated.
7/20 7/20 Removed Up-To-Date from list of resources to use when no guidance is available in A-E in Policy/Criteria F.5, and added to F6 under “published expert opinion.” References reviewed and updated. In F.4., added examples of medical associations, such as ASAM and ACOG. Added NY State requirement of clinical review criteria that issuers and their utilization review agents must use when conducting utilization review for mental health services, including LOCUS and CALOCUS. Updated Section F., adding “12.” referring to “various surgical site infections”, found on CMS (added reference). Added reference to CP.MP.36 Experimental Technologies. Added reference to parity compliance with NQTL.
References reviewed and updated.
6/21 6/21 Annual review completed. Definition section C. and D. replaced “or” with a semi-colon. Minor wording changes in the background with no clinical significance. References reviewed and updated. 06/22

Annual review. Included “state law/guidelines…” under A and reworded for clarity. Added a note stating Federal law may affect state and federal programs (e.g. Women’s Health and Cancer Rights Act, Affordable Care Act), superseding any other criteria, but that it is taken into consideration in corporate clinical policies and state regulations, clarified psychiatrists (child, adolescent) in provider type table. 7/23

CLINICAL POLICY Medical Necessity Criteria Reference Number: CP.FC.05 Page 8 of 8 Reviews, Revisions, and Approvals Date Approval Date Update. Clarified this policy is not to be used to make determinations for either approval or denial. Added MCG is available to members and providers on fideliscare.org 2/24

Annual review. Updated list of “Never Events” in Definition F to include the Joint Commission’s list. Removed previous never events listed in 1-4 and 6 and 11 as they are otherwise stated in the Joint Commission’s list. References reviewed and updated. 07/24

Annual review. Changed Header to “All LOB except Medicare”. Replaced all instances of “member” with “member/enrollee”. Background updated with no impact on criteria. References reviewed and updated. 07/25

References

1. Lembitz A, Clarke TJ. Clarifying "never events and introducing "always events". Patient Saf Surg. 2009;3:26. Published 2009 Dec 31. doi:10.1186/1754-9493-3-26
2. National Committee for Quality Assurance. NCQA Standards and Guidelines for the Accreditation of Health Plans 2022.
3. National Quality Forum (NQF). Serious Reportable Events in Healthcare 2011 Update: A Consensus Report, Washington, DC: NQF; 2011.
4. Steinberg EP, Tunis S, Shapiro D. Insurance coverage for experimental technologies. Health Aff (Millwood). 1995;14(4):143 to 158. doi:10.1377/hlthaff.14.4.143
5. National Academies of Sciences, Engineering, and Medicine. Essential Health Benefits: Balancing Coverage and Cost. Appendix G: Medical necessity. Institutes of Medicine. Washington, DC: The National Academies Press, 2012 https://doi.org/10.17226/13234.
6. Hospital-acquired conditions. Centers for Medicare and Medicaid. https://www.cms.gov/medicare/payment/fee-for-service-providers/hospital-aquired- conditions-hac. Accessed July 28, 2025.
7. Joint Commission. Sentinel Event Policy (SE). Sentinel Event Policy and Procedures. July 1, 2024. Accessed July28, 2025. https://www.jointcommission.org/- /media/tjc/documents/resources/patient-safety-topics/sentinel- event/2024/cambehhealthcarese20240320_153325.pdf.
8. MCG Care Guidelines, current edition
9. Centene Clinical Policy CP.CPC.05 Medical Necessity Criteria version 06/25.