Medical Necessity and Experimental and Investigational Form

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Medical Necessity and Experimental and Investigational - Medical Policy Updated Revision Effective: October 1, 2025 Policy Number:

UM407POL

Approval Date:

Line(s) of Business:

Commercial
Medicare Advantage
Medicaid (BeHealthy)

 Line of Business

Commercial:

• Refer to the Description and Policy Guidelines sections in this medical policy.

Medicaid – BeHealthy:

• Refer to the Description and Policy Guidelines sections in this medical policy.

Medicare:

• Refer to the Description and Policy Guidelines sections in this medical policy.

Description

Medically Necessary

A. Health New England defines certain services which are reasonably calculated by a provider to prevent, diagnose, evaluate, and treat conditions (illness, injury, disease) as Medically Necessary or as a Medical Necessity. The service must meet ALL of the following in order to be Medically Necessary:

• Service is clinically appropriate, in terms of type, frequency, extent, site and duration, and considered effective for the patient’s illness, injury, or disease; AND

• Service is based on the following:

o Credible scientific evidence published in peer reviewed medical literature recognized by the relevant medical community, o Specialty Society recommendations, o Views of physician experts practicing in relevant clinical area; AND

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• Service is not more costly than an alternative service or sequence of services, which is 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; AND

• Service is not primarily for the convenience of the patient, physician, or other health care provider; AND

• Service is substantiated by submitted clinical records.

B. Health New England uses clinical criteria to decide if some services or procedures are Medically Necessary.
You can access HNE Medical Policy criteria on Health New England Website or use the following link:

   https://healthnewengland.org/Providers/Resources

MassHealth definition of Medical Necessity

In accordance with 130 CMR 450.204 and the Accountable Care Partnership Plan Contract or the MassHealth Accountable Organization Program, Medically Necessary services are those services:

1. That are reasonably calculated to prevent, diagnose, prevent the worsening of, alleviate, correct, or cure conditions in the member that endanger life, cause suffering or pain, cause physical deformity or malfunction, threaten to cause or to aggravate a handicap, or result in illness or infirmity; and achieve age-appropriate growth and development; and attain, maintain, or regain functional capacity; AND

2. For which there is no other medical service or site of service, comparable in effect, available, and suitable for the member requesting the service, that is more conservative or less costly to the MassHealth agency. Services that are less costly to the MassHealth agency include, but are not limited to, health care reasonably known by the provider, or identified by the MassHealth agency pursuant to a prior-authorization request, to be available to the member through sources described in 130 CMR 450.317(C), 503.007: Potential Sources of Health Care, or 517.007: Utilization of Potential Benefits;

   Medically necessary services must be of a quality that meets professionally recognized standards of health care, and must be substantiated by records including evidence of such medical necessity and quality. A provider must make those records, including medical records, available to the MassHealth agency upon request. (See42 U.S.C. 1396a(a)(30) and 42 CFR 440.230 and 440.260.)

   Codes that MassHealth has deemed as non-payable may be reviewed for medical necessity for MassHealth members under the age of 21 at the request of a provider.

   CMS definition of Medical Necessity

   According to CMS, medically necessary services or supplies:

   • Are proper and needed for the diagnosis, direct care or treatment of the medical condition.

   • Meet the standards of good medical practice in the local area and are not mainly for the convenience of patient or provider.

   Not Medically Necessary

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Health New England defines Not Medically Necessary as:

• Services that are based on the following:

o Credible scientific evidence published in peer reviewed medical literature recognized by the relevant medical community, o Specialty Society recommendations, o Views of physician experts practicing in relevant clinical area; BUT

• The services are not clinically appropriate, in terms of type, frequency, extent, site and duration, and considered effective for the patient’s illness, injury, or disease; OR

• The services are either more costly than an alternative service or sequence of services, which is 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; OR

• The services are primarily for the convenience of the patient, physician, or other health care provider.

Experimental and Investigational

A. Health New England defines Experimental and Investigational as:

• Medical, surgical, diagnostic, psychiatric, substance use disorder or other health care technologies, services, procedures, supplies, treatments, devices, biologic products or drug therapies that:

o Have not been demonstrated to be safe and effective for diagnosing or treating the condition or illness for which its use is proposed, through credible scientific evidence published in peer reviewed medical literature recognized by the relevant medical community, nor strongly endorsed by Specialty Society Recommendations; AND/OR o Have not been approved by the U.S. Food and Drug Administration (FDA) or other appropriate regulatory agency to be lawfully marketed for the proposed use; AND/OR o Have been the subject of review or approval by an Institutional Review Board for the proposed use.

B. A list on non-covered services can be found here:

https://healthnewengland.org/Portals/_default/Shared%20Documents/providers/Non-Covered- Services.pdf

Policy Guidelines

I. Procedure

A. Health New England will use the following resources to determine medical necessity and standard of care:

1. InterQual Level of Care (LOC) Criteria
2. InterQual “CP: Procedures” Criteria

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3. Medical and Pharmacy Policy Committee (MPPC)
4. CMS LCDs and NCDs

5. MassHealth Guidelines for Medical Necessity Determination

6. Hayes Knowledge Center
7. HNE Clinical Review Criteria
8. Peer Review Recommendation
9. Clinical Care Advisory Committee (CCAC)

10. Behavioral Health Advisory Committee (BHAC)

    B. Health New England’s Medical and Pharmacy Policy Committee (MPPC) is responsible for systematically evaluating the following:

11. New healthcare technologies

12. New application of existing technologies

13. New uses of certain existing healthcare diagnostic and therapeutic technologies

14. Pharmaceuticals

15. Medical devices

16. Medical/surgical/behavioral health services and procedures

    C. The MPPC uses evidence-based information for reviews, including established peer-reviewed scientific data, which focuses on recently developed technologies and evolving applications of established modalities, particularly those that are most relevant to the clinical care of our members.
    The process is intended to afford all members with access to safe, high quality, cost-effective care.

    D. When the MPPC determines a service, procedure, or device is experimental, unproven, or investigational, it is not eligible for payment.

    E. Category III codes are temporary codes created to describe emerging technology, services, and procedures. These codes allow for data collection and evaluation of clinical efficacy and do not conform to the requirements for Category I codes. Creation of these codes by the AMA neither implies nor endorses clinical efficacy, safety or applicability to clinical practice. Unless otherwise covered in a separate medical policy or by mandated coverage, all Category III services will be considered experimental and investigational.

    F. Health New England will defer to Medicare and Medicaid coverage policies when applicable.

    References

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Mass.gov 130 CMR 450.204 Administrative and Billing Regulations 130 CMR 450 (mass.gov)

Title XVIII of the Social Security Act, section 1862 (a)(1)(A) https://www.ssa.gov/OP_Home/ssact/title18/1862.htm

Policy Implementation

Approved by the Medical and Pharmacy Policy Committee

Kate McIntosh MD MBA

Chief Medical Officer

Saad Usmani MD MBA

Medical Director

Date Update 07/1/2012 Initial Policy Date 07/2023 Format updated with no significant change 11/2023 Updated to include E&I information 01/2024 Added Lines of Business section 08/2024 Medicaid definition of Medical Necessity updated. References updated. Formatting changes. 1/2025 Updated MassHealth definition of Medical Necessity. Updated References. 06/2025 Experimental and Investigational definition revised. Under Policy Guidelines, added InterQual “CP: Procedures” Criteria as IA2.

Medical Criteria Disclaimer

Property of Health New England. All rights reserved. The treating physician or primary care provider must submit to Health New England the clinical evidence that the patient meets the criteria for the treatment, testing or surgical procedure. Without this documentation and information, Health New England will not be able to properly review the request for prior authorization. The clinical review criteria reflect how Health New England determines whether certain services or supplies are medically necessary. Health New England established the clinical review criteria based upon a review of currently available clinical information (including clinical outcome studies in the peer-reviewed published medical literature, regulatory status of the technology, evidence-based guidelines of public health and health research agencies, evidence-based guidelines and positions of leading national health professional organizations, views of physicians practicing in relevant clinical areas, and other relevant factors). Health New England expressly reserves the right to revise these conclusions as clinical information changes and welcomes further relevant information. Each benefit program defines which services are covered. The conclusion that a particular service or supply is medically necessary does not constitute a representation or warranty that this service or supply is covered and/or paid for by Health New England, as some programs exclude coverage for services or supplies that Health New England considers medically necessary. If there is a discrepancy between this guideline and a member's benefits program, the benefits program will govern. In addition, coverage may be mandated by applicable legal requirements of a state, the Federal Government or the Centers for Medicare & Medicaid Services (CMS) for Medicare and Medicaid members. All

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coding and web site links are accurate at time of publication. Health New England has adopted the herein policy in providing management, administrative and other services to its Health Plan.