Network Notifications

WellSense Health Plan – New Hampshire wellsense.org

New Hampshire

Date:

September 30, 2022

Number: 75

To:

All WellSense Providers

From:

WellSense Health Plan

Subject:

September Medical Policy Network Notifications

Product:

☒ NH Medicaid ☒ NH Medicare Advantage

September Network Notifications

The following Well Sense Health Plan medical policies will be updated with revisions to clinical review

criteria and/or applicable coding included in the medical policies (excluding industry-wide code

updates and/or codes that do not require prior authorization). The revised medical policies will be

effective on December 1, 2022:

1. Clinical Review Criteria, OCA 3.201

2. Complementary and Alternative Medicine, OCA 3.194

3. Gender Affirmation Services, OCA 3.11

4. Occupational Therapy in the Outpatient Setting, OCA 3.543

5. Pelvic Floor Stimulation for the Treatment of Incontinence and/or Overactive

Bladder, OCA 3.561

6. Physical Therapy in the Outpatient Setting, OCA 3.544

7. Sacral Nerve Stimulation, OCA 3.563

8. Speech Therapy, OCA 3.542

9. Temporomandibular Joint Disorders, OCA 3.968

General Information

All Well Sense Health Plan medical policies are located on the Provider’s page at

https://www.wellsense.org/providers/nh/policies under the Policies link. If you do not have Web

WellSense Health Plan – New Hampshire wellsense.org

Network Notifications

New Hampshire

access, you may contact your provider relations representative for a copy of the policies. The

updated policies listed above will be posted on the website and available from your provider relations

representative on October 1, 2022.

Questions?

If you have any questions about this Network Notification, please contact your dedicated provider

relations consultant or call the Provider Line at 877-957-1300, option 3 (for NH Medicaid) or 866-

808-3833 (for Medicare Advantage). Well Sense Health Plan Network Notifications and

Reimbursement Policies are available online at wellsense.org.

Clinical Review Criteria

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Administrative Policy

Clinical Review Criteria

Policy Number: OCA 3.201

Version Number: 30

Version Effective Date: 11/01/22

Impacted Products

☒ All Products

☒ NH Medicaid

☒ NH Medicare Advantage

☒ MA MassHealth ACO

☒ MA MassHealth MCO

☒ MA Qualified Health Plans/Employer Choice Direct

☒ MA Senior Care Options

Note: Disclaimer and audit information is located at the end of this document.

Policy Summary

This policy defines the Plan’s process for making utilization review decisions using written clinical

review criteria based on sound and current clinical evidence. The Plan conducts all utilization review

activities in accordance with applicable policies and procedures and the Plan’s Utilization Management

(UM) Program. Plan-adopted written clinical review criteria are used to determine the medical

necessity of services that require utilization review, including medical services, surgical treatment,

pharmacotherapy and pharmacy services, behavioral health services, radiological services, dental

services, and durable medical equipment, prosthetics, orthotics and supplies (DMEPOS). In addition,

clinical review criteria are used to determine the most clinically appropriate level of care and intensity

of services to ensure the provision of medically necessary services. Plan-adopted written clinical

review criteria include the Plan’s internally developed medical and pharmacy policies, InterQual®

criteria, and clinical guidelines established by delegated management partners (for related services

provided to Plan members for applicable Plan products). All Plan-adopted written clinical review

criteria are reviewed at least annually and are developed in accordance with contractual requirements,

state and federal regulations, and guidelines from accrediting organizations, including National

Committee for Quality Assurance (NCQA). Review the Plan’s Prior Authorization/Notification

Requirements Matrix, Code Look-up Tools, medical and pharmacy policies, and the Plan’s pharmacy

formulary (available via the drug search tool or the formulary guidebook) to determine if prior

authorization is required.

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The Plan’s clinical coverage criteria and UM decision tools are applied equitably across the Plan’s

membership. However, the Plan’s Office of Clinical Affairs (OCA) UM staff (or the delegated clinical

vendor’s professional staff when the management of services is delegated to the vendor) will take into

account the member’s individual needs, circumstances, and healthcare services requested and/or

currently provided to the member to integrate healthcare for continuity, coordination, and

collaboration of services, as well as assessing the local healthcare delivery system’s ability to meet the

member’s healthcare needs, when determining the medical necessity of services. Plan guidelines

(including but not limited to appeals and/or clinical reconsiderations) comply with all applicable Plan

contract terms with providers, employers, governmental agencies, and other contracting entities.

The Plan complies with coverage guidelines for all applicable state and federally-mandated benefits.

Plan authorizations, as well as authorizations by each of the Plan’s delegated clinical vendors

conducting utilization management, are based on a comprehensive and individualized needs

assessment that addresses all member needs, including but not limited to social determinants of health

and a subsequent person-centered planning process. Plan prior authorization requirements (and those

of each of the Plan’s delegated clinical vendors) comply with parity in mental health and substance use

disorders. The Plan and the Plan’s delegated clinical vendors conducting utilization management do

NOT discriminate, arbitrarily deny, or impose stricter requirements by reducing the amount, duration,

or scope of required and medically necessary services for ANY Plan member based on the member’s

diagnosis, type of illness, health status or condition, sex, gender identity or dysphoria, or sexual

orientation.

See the member’s product-specific handbook on the Plan’s website for benefit coverage guidelines

and a summary of member rights and responsibilities, as well as the Plan’s process for receiving and

promptly resolving inquires, grievances, or appeals from a member (or an authorized representative

acting on behalf of the member). Member appeals may be related to issues that include but are not

limited to benefit coverage, the evaluation of clinical technology (including new technology and a new

indication for an established technology), and/or the application of the Plan’s clinical review criteria for

the member’s requested indication for treatment.

The Plan’s Cosmetic, Reconstructive, and Restorative Services medical policy, policy number OCA 3.69,

includes the product-specific definitions of cosmetic services and reconstructive surgery and

procedures. The product-specific definitions of experimental or investigational treatment are listed in

the Plan’s Experimental and Investigational Treatment medical policy, policy number OCA 3.12.

Product-specific definitions for medically necessary services (i.e., medical necessity) are listed in the

Plan’s Medically Necessary medical policy, policy number OCA 3.14. The Clinical Technology Evaluation

administrative policy, policy number OCA 3.13, outlines the Plan’s process for evaluating new

technology and new clinical application(s) of existing technology. Review the Plan’s applicable

reimbursement policy for payment guidelines related to clinical trials.

Policy Statement

When the Plan conducts utilization review (UR), appropriate professional utilization management (UM)

Plan staff consistently apply current, Plan-adopted written clinical review criteria, including the Plan’s

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internally developed criteria specified in internal medical policies and Plan pharmacy policies,

InterQual® criteria, and clinical guidelines established by delegated management partners (for related

services provided Plan members for applicable Plan products). Plan staff (including but not limited to

representatives from the Plan’s Accreditation, Utilization Management, Pharmacy, and Vendor

Management Departments) routinely collects and reviews documentation to verify that quality

standards are met by clinical vendors who are delegated to conduct utilization management on behalf

of Plan members, including but not limited to contractual obligations and the guidelines specified in the

Delegated Management section of this policy. When national clinical guidelines (e.g., InterQual®

criteria) are not available or not adopted by the Plan, Plan-specific criteria may be established and

documented in internally developed medical and pharmacy policies.

The development and review of the Plan’s internal clinical criteria include input from participating

practitioners and consultant specialists in the related specialties that may include but are not limited to

licensed pharmacists, community-based providers, behavioral health clinicians, and physician

specialists in neonatology, pediatrics, family medicine, internal medicine, medical/pediatric/surgical

subspecialties, and geriatrics. Practitioners with professional expertise and relevant credentials in the

clinical area being reviewed have the opportunity to advise or comment on the development, adoption,

and implementation of all UM criteria utilized by the Plan; this includes feedback from qualified

practitioners on staff at the Plan or delegated clinical vendors, outside physician consultants, provider

reviewers, participating providers in the Plan’s network, and practitioners treating Plan members. The

Plan-adopted written clinical review criteria (i.e., the Plan’s internal medical policies and pharmacy

policies, InterQual® criteria, and clinical guidelines implemented by the Plan’s delegated management

partners for related services provided Plan members by Plan product type) are objective, scientifically

derived, and evidence-based for the requested service(s) and indication(s) for treatment and are

compliant with applicable legal obligations , regulatory requirements, and national accreditation

organization standards.

The Plan’s clinical coverage criteria and UM decision tools are applied equitably across the Plan’s

membership. All Plan-adopted written clinical review criteria (including criteria specified in the Plan’s

internal medical policies and pharmacy policies, InterQual® criteria, and clinical guidelines developed

and implemented by the Plan’s delegated management partners for related services provided Plan

members by Plan product type) are clinically reviewed at least annually to verify that these clinical

guidelines are developed and implemented in accordance with generally accepted standards of

medical/clinical practice which are based on objective and credible scientific evidence published in

peer-reviewed medical literature generally recognized by the relevant medical community, relying on

controlled clinical trials. On at least an annual basis, Plan staff confirm that all clinical review criteria

utilized by the Plan (including all of the Plan’s internal medical and pharmacy policies, InterQual®

criteria, and clinical guidelines implemented by the Plan’s delegated management partners for related

services provided Plan members by Plan product type) have had an annual clinical review and the

procedures for applying those clinical review criteria are documented.

Updates to clinical review criteria are implemented as new treatments, applications, and technologies

are adopted and become components of generally accepted professional practice for behavioral

health, medical/surgical services, dental services, and/or pharmacotherapy. The Plan’s Office of

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Clinical Affairs (OCA) UM staff applies the clinical review criteria consistently; however, OCA UM staff

also takes into account the member’s individual needs and circumstances. The Plan’s Medical

Directors and/or licensed Plan pharmacists consider member-specific factors when applying clinical

criteria to a request for services. When clinical review criteria are not met for a requested treatment

such that medical necessity cannot be established for the member’s condition or indication for

treatment, OCA UM staff engages in discussions with licensed Plan pharmacists, OCA UM clinicians,

and/or Plan Medical Directors to determine if the clinical review criteria are appropriate for the

member’s circumstances or local delivery system (utilizing qualified Plan clinicians applicable for the

member’s condition and requested treatment). If the clinical review criteria are not appropriate, OCA

UM staff may make the utilization determination based on the member’s condition and other unique

circumstances. The Delegated Management section of this policy includes delegated management

guidelines applicable for the Plan’s partner clinical vendors, including Plan oversight and the

development, review, and application of the clinical vendors’ clinical review criteria.

Change Health staff analyze over 3,000 medical literature sources daily to review and update current

InterQual® clinical review criteria and to develop criteria for new technologies and new application(s) of

existing technologies. InterQual® criteria are developed and implemented in accordance with generally

accepted standards of medical/clinical practice which are based on objective and credible scientific

evidence published in peer-reviewed medical literature generally recognized by the relevant medical

community, relying on controlled clinical trials. In addition, InterQual® criteria are evaluated by an

independent clinical review panel drawn from more than 900 experts for authoritative peer review,

utilizing providers with expertise and appropriate credentials in the applicable clinical area under

consideration. Inter-rater reliability testing is conducted annually by the Plan using the Plan-adopted

InterQual® criteria sets. InterQual® criteria are revised, as necessary, throughout the year (at least

annually but may occur quarterly).

Delegated Management

The Plan’s delegated clinical vendors conduct utilization management for behavioral health services,

radiology services, pharmacy services, dental services, and durable medical equipment, prosthetics,

orthotics and supplies on behalf of Plan members (when applicable for the Plan product). Practitioners

with clinical expertise in the area being reviewed have the opportunity to advise or comment on the

development, adoption, and implementation of utilization management criteria established by the

Plan’s delegated management partners; this includes feedback from qualified practitioners on staff at

the Plan or delegated clinical vendors, outside physician consultants, provider reviewers, participating

providers in the Plan’s network, and practitioners treating Plan members.

All Plan-adopted written clinical review criteria, including clinical guidelines established by delegated

management partners, are reviewed at least annually (or more frequently when policy revisions require

more immediate implementation). Clinical review criteria utilized by the Plan’s delegated clinical

vendors are develop with oversight by the clinical vendor’s Medical Director who is an actively

practicing physician and who is responsible for the oversight of the clinical vendor’s utilization

management program. Proposed new and revised clinical guidelines are evaluated by the clinical

vendor’s expert panel, all of whom are practicing clinicians and acknowledged experts in the relevant

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fields and pertinent specialties. All clinical review criteria are developed in accordance with applicable

state and federal requirements and guidelines from applicable national accreditation organizations.

The clinical review criteria and UM decision tools from each of the Plan’s delegated clinical vendors are

applied equitably across the Plan’s membership. However, the delegated clinical vendor’s professional

staff (when the management of services is delegated to the clinical vendor) will take into account the

member’s individual needs, circumstances, and healthcare services requested and/or currently

provided to the member to integrate healthcare for continuity, coordination, and collaboration of

services, as well as assessing the local healthcare delivery system’s ability to meet the member’s

healthcare needs, when determining the medical necessity of services. Inter-rater reliability testing is

utilized by the Plan’s delegated clinical vendors to assess the consistency and adherence to clinical

review criteria. At least quarterly, the consistency with which the healthcare professionals involved in

prior authorization apply criteria in decision making is evaluated by the delegated clinical vendors using

a variety of mechanisms. The application of medical necessity criteria by Medical Directors and non-

physician reviewers are assessed to ensure consistency and accuracy in the application of the clinical

review criteria. Results are reported to the Plan.

Below are delegated management guidelines applicable for the Plan’s partner clinical vendors,

including Plan oversight and the development, review, and application of the clinical vendors’ clinical

review criteria, as specified below in items 1 through 3:

1. Plan’s Delegated Services and Partner Clinical Vendors:

When applicable for the Plan product, the following services are managed by a delegated

clinical vendor for a Plan member, as stated in items a through f:

a. Behavioral Health Services (Beacon Health Strategies, LLC):

Effective March 1, 2010, the Plan delegated management of behavioral health services to an

NCQA-accredited managed behavioral health organization (MBHO), Beacon Health

Strategies, LLC. The MBHO has its own clinical criteria policy which has been approved as

part of delegation oversight.

b. Dental Services (DentaQuest for Senior Care Options Members):

Effective June 18, 2015, the Plan delegated dental services to Dental Service of

Massachusetts, Inc. (DSM) for DentaQuest to administer the Senior Care Options (SCO)

dental benefit. This clinical vendor establishes policies for communicating criteria to

providers and the vendor has its own clinical criteria policy and procedure which has been

approved as part of delegation oversight.

c. Dental Services (Delta Dental for Qualified Health Plan Pediatric Members):

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Effective November 23, 2016, the Plan delegated dental services to Dental Service of

Massachusetts, Inc. (DSM) for Delta Dental to administer the Qualified Health Plans (QHP)

pediatric dental benefit. This clinical vendor establishes policies for communicating criteria

to providers and DSM has its own clinical criteria policy and procedures which have been

approved as part of delegation oversight.

d. Durable Medical Equipment, Prosthetics, Orthotics and Supplies (Northwood, Inc.):

Effective April 1, 2011, the Plan delegated management of durable medical equipment,

prosthetics, orthotics and supplies (DMEPOS) to a URAC-accredited DMEPOS clinical

vendor, Northwood, Inc. The Plan has retained the management of medical necessity denial

decisions and notifications. This clinical vendor has its own clinical criteria policy and

procedure which has been approved as part of delegation oversight.

e. Pharmacy Benefits Manager (Express Scripts):

Effective January 1, 2021, Express Scripts is the Plan’s pharmacy benefits manager for the

Plan’s products. Express Scripts adopts the guidelines included in this Plan’s Clinical Review

Criteria administrative policy and adheres to the Plan’s administrative UM policies and

clinical policy criteria, unless specifically delegated such as the Plan’s Medicare product

lines. Policies delegated to Express Scripts have been approved as part of delegation

oversight. Effective December 1, 2019, the Plan’s pharmacy mail order company for all of

the Plan’s Massachusetts and New Hampshire products is Cornerstone Health Solutions.

f. Radiology Services, Musculoskeletal Services, Genetic Testing, and Outpatient

Rehabilitation Services (AIM Specialty Health):

For dates of service on or after November 1, 2022, the Plan has delegated the management

of radiology services, musculoskeletal services (i.e., spine surgeries, joint surgeries, and

interventional pain management treatments), and genetic testing to an NCQA-accredited

managed care clinical vendor, AIM Specialty Health. AIM manages outpatient rehabilitation

services (i.e., physical therapy, occupational therapy, and speech therapy after the initial

evaluation) provided to Plan members for dates of services on or after December 1, 2022.

AIM develops and utilizes criteria to make utilization management decisions for requested

services, establishes policies for communicating those criteria to providers and members,

and evaluates consistency in the application of those criteria through inter-rater reliability

testing when determining medical necessity for these delegated services.

2. Clinical Vendor Clinical Review:

a. Review and Application of Clinical Vendor’s Established Clinical Review Criteria:

The Plan’s Clinical Vendor Oversight Committee conducts an annual review of each clinical

vendor that conducts delegated management for Plan members to ensure that all of the

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following guidelines are met: each clinical vendor conducts an annual review of its clinical

criteria, approving and implementing criteria that are objective, scientifically-derived, and

evidence-based for the requested service(s) and indication(s) for treatment and compliant

with applicable legal obligations; each clinical vendor completes an annual review and

approval of policies and procedures developed to ensure that the clinical vendor’s clinical

criteria are consistently applied to Plan members for a requested service. The service may

include a treatment, procedure, supply, device, biologic, or drug that will be used to prevent,

diagnose, stabilize, or treat a disease, condition, or disorder that results in health impairment

or disability, or the service allows the member to attain, maintain, or regain functional

capacity. The clinical vendor will also consider member-specific factors impacting the

member’s individual healthcare needs when applying clinical review criteria to determine if

the service is medically necessary for the requested indication. Individual consideration

includes an assessment of any member-specific factor impacting care, including one or

more of the following:

(1) Member’s condition;

(2) Member’s comorbidities;

(3) Member’s age, including the assessment of the member’s age-appropriate growth,

development, and competencies, as well as evaluation of age-related and condition-

specific healthcare needs and associated issues;

(4) Relevant past medical/surgical/behavioral health/dental/pharmacotherapy history;

(5) Complications;

(6) Progression of the member’s condition, illness, or injury;

(7) Diagnostic test results;

(8) Treatment outcomes;

(9) Treatment options;

(10) Psychosocial circumstances;

(11) Home and environmental factors impacting member’s clinical condition (e.g.,

homelessness, employment status, poverty, neighborhood);

(12) Other healthcare services requested and/or provided to the member to integrate

healthcare for continuity, coordination, and collaboration of services;

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(13) Local healthcare delivery system’s ability to meet the healthcare needs of the

member’s specific condition;

(14) Member’s reasonable accessibility to a qualified provider with appropriate credentials,

licensure, clinical expertise and/or resources in the applicable clinical area necessary

to adequately manage the member’s condition (including but not limited to

pharmacotherapy, behavioral health services, dental services, radiology services,

and/or durable medical equipment, prosthetics, orthotics and supplies);

(15) Other factors related to the member’s plan of care or health outcomes; AND/OR

(16) If applicable, verification that the requested device, therapeutic, biologic, or drug is

being prescribed/requested and will be utilized according to its FDA-approved or

compendia indication and guideline information, including intended use for the

member’s age and medical condition.

b. Clinical Vendor Review of Requested Service Without Written Clinical Review Criteria:

If written clinical review criteria have not been established for the requested service (for the

specified indication) by the Plan’s delegated management clinical vendors, these clinical

vendors will use published and applicable generally accepted, scientifically-based standards

of care and objective and credible scientific evidence published in peer-reviewed

medical/clinical literature, and/or reviewing observational studies for a request for services

for a Plan member to make medical necessity determination. If scientifically-based

standards of care are not available, observational studies from more than one (1) institution

that suggest a causal relationship between the service or treatment and health outcomes

may be used by the delegated utilization management clinical vendor to make medical

necessity determinations if these observational studies are clinically appropriate with

respect to the member’s clinical presentation. The Plan’s delegated management clinical

vendors will also consider member-specific factors impacting the member’s individual

healthcare needs to determine if the service is medically necessary for the requested

indication. The service may include a treatment, procedure, supply, device, biologic, or drug

and will be used to prevent, diagnose, stabilize, and/or treat a disease, condition, and/or

disorder that results in health impairment and/or disability, and/or the service allows the

member to attain, maintain, or regain functional capacity. Individual consideration includes

an assessment of any member-specific factors impacting care, including one or more of the

following:

(1) Member’s condition;

(2) Member’s comorbidities;

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(3) Member’s age, including the assessment of the member’s age-appropriate growth,

development, and competencies, as well as evaluation of age-related and condition-

specific healthcare needs and associated issues;

(4) Relevant past medical/surgical/behavioral health/dental/pharmacotherapy history;

(5) Complications;

(6) Progression of the member’s condition, illness, or injury;

(7) Diagnostic test results;

(8) Treatment outcomes;

(9) Treatment options;

(10) Psychosocial circumstances;

(11) Home and environmental factors impacting member’s clinical condition (e.g.,

homelessness, employment status, poverty, neighborhood);

(12) Other healthcare services requested and/or provided to the member to integrate

healthcare for continuity, coordination, and collaboration of services;

(13) Local healthcare delivery system’s ability to meet the healthcare needs of the

member’s specific condition;

(14) Member’s reasonable accessibility to a qualified provider with appropriate credentials,

licensure, clinical expertise or resources in the applicable clinical area necessary to

adequately manage the member’s condition, including but not limited to

pharmacotherapy, behavioral health services, dental services, radiology services, or

durable medical equipment (prosthetics, orthotics and supplies);

(15) Other factors related to the member’s plan of care or health outcomes; AND/OR

(16) If applicable, verification that the requested device, system, biologic, or drug is being

prescribed/requested and will be utilized according to its FDA-approved or

compendia indication and guideline information, including intended use for the

member’s age and medical condition.

c. Clinical Vendor Evaluation of New Technology:

The Plan’s partner clinical vendors evaluate new technology and new application(s) of an

established technology to develop new clinical review criteria or revise established clinical

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review criteria when clinically appropriate. The Plan’s partner clinical vendor will use

published and applicable generally accepted, scientifically-based standards of care and

objective and credible scientific evidence published in peer-reviewed medical/clinical

literature, and/or reviewing observational studies for the new technology or new

application(s) of an existing technology to establish written clinical review criteria that will

be used to make medical necessity determinations (in addition to individual consideration of

the member’s status and healthcare needs). When a requested service that does not have

established, applicable clinical review criteria, the medical necessity of the service is

determined on a case-by-case basis for individual consideration, as specified above in the

Clinical Vendor Review of Requested Service Without Written Clinical Review Criteria

section.

d. Out-of-Network Providers:

The clinical vendor will authorize a member’s care from an out-of-network provider when, as

determined by the clinical vendor, the care and necessary resources are needed by the

member are not available or are not reasonably accessible to the member.

e. Input from Practicing Practitioners:

Actively practicing practitioners with appropriate credentials and clinical expertise in the

applicable clinical area have the opportunity to submit comments on clinical review criteria

utilized by clinical vendors who are delegated to conduct utilization management on behalf

of Plan members (with feedback related to the development, ongoing management, and/or

application of those criteria). Practitioners may submit feedback through the Plan’s

Provider Information Mailbox available at Provider.Info@BMCHP-wellsense.org.

If the practitioner would like to provide input on a clinical vendor’s clinical review criteria and

have those comments considered during the criteria’s next annual review, supporting

documentation must be provided that includes position statements developed or endorsed

by nationally recognized professional associations, consensus reports or guidelines from

specialty societies, and/or standards adopted by governmental agencies (e.g., National

Institutes of Health, Agency for HealthCare Research and Quality, Center for Medicare &

Medicaid Services, Massachusetts Executive Office of Health and Human Services, or New

Hampshire Department of Health and Human Services). Published scientific evidence from

additional reputable sources may also be submitted for consideration.

Issues related to clinical review criteria that must be addressed before each clinical vendor’s

annual review will be evaluated immediately during a prior authorization request for services;

clinical vendors conducting delegated utilization will engage in individual case discussions

with qualified clinicians applicable for the member’s condition and requested treatment to

determine if the clinical review criteria are appropriate for the member’s circumstances or

care provided by a local delivery system according to the guidelines specified below in the

Application of the Plan’s Clinical Review Criteria section of this policy.

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f. Access to Clinical Review Criteria:

The Plan makes all of its clinical review criteria available to practitioners and members upon

oral or written request. Providers and member may call or fax the Plan with a request for a

copy of the specific criteria, as stated in writing in the provider manual on the Plan’s website.

This access to clinical review criteria includes applicable copyrighted commercial criteria

used by the Plan’s partner delegated clinical vendors. Participating providers are notified at

least 60 calendar days before the implement of substantive revisions to applicable coding

(excluding industry-wide code updates) and/or clinical review criteria (i.e., implementation

of new medical necessity guidelines and/or revised clinical review criteria) used by the

Plan’s partner delegated clinical vendors. The current version of clinical review criteria is

available to all providers, members, and the general public on the Plan’s extranet site.

3. Plan Oversight:

Plan staff (including but not limited to representatives from the Plan’s Accreditation, Utilization

Management, Pharmacy, and Vendor Management Departments) routinely collects and reviews

documentation to verify that quality standards are met by clinical vendors who are delegated to

conduct utilization management on behalf of Plan members. In addition, an annual review of

each clinical vendor is completed by the Plan’s Clinical Vendor Oversight Committee to ensure

that each clinical vendor complies with delegated utilization management requirements,

including but not limited to contractual obligations and the guidelines specified in this section

of this policy related to the development, review, and application of objective, scientifically-

derived, and evidence-based clinical review criteria, with individual consideration of the

member’s status (when appropriate). If established quality standards are not met, the

delegated utilization management clinical vendor develops and implements a targeted and

measurable corrective action plan that is monitored by the Plan. For services managed by

clinical vendors with whom the Plan has delegated utilization management, the Plan evaluates

member access to treating facilities and availability of qualified providers (including care from

an out-of-network provider when clinically appropriate), member satisfaction, provider

satisfaction, member and provider timely access to applicable clinical review criteria, and the

vendor’s process for evaluating recommended revisions to clinical review criteria submitted by

actively practicing practitioners with appropriate credentials and clinical expertise.

Procedure

The Plan-adopted clinical review criteria are developed and implemented in accordance with generally

accepted standards of medical/clinical practice which are based on objective and credible scientific

evidence published in peer-reviewed medical literature generally recognized by the relevant medical

community, relying on controlled clinical trials. Practitioners with clinical expertise in the area being

reviewed have the opportunity to advise or comment on the development, adoption, and

implementation of all UM criteria utilized by the Plan; this includes feedback from qualified

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practitioners on staff at the Plan or delegated clinical vendors, outside physician consultants, provider

reviewers, participating providers in the Plan’s network, and practitioners treating Plan members.

See the Policy Summary and the Delegated Management sections of this policy for guidelines related

to applicable clinical review criteria and services managed by partner clinical vendors with whom the

Plan has delegated utilization management (by Plan product), including behavioral health services,

radiology services, pharmacy benefits administration, and durable medical equipment, prosthetics,

orthotics and supplies. Review the Clinical Technology Evaluation administrative policy, policy number

OCA 3.13, for a description of the Plan’s process for evaluating new technology and the new application

of existing technology.

1. Development and Review of the Plan’s Internal Clinical Review Criteria:

The Plan’s internal clinical review criteria are specified in the Plan’s medical policies or pharmacy

policies. Internal clinical review criteria are developed, reviewed at least annually, and updated as

necessary, utilizing the following resources (as applicable) to evaluate the clinical services,

treatments, and technologies for the specified indications and the application of medical necessity

criteria, as stated below in items a through l:

a. In consultation with the Plan’s Medical Director(s) and other Plan staff, as appropriate; AND

b. With input from actively practicing specialists and/or professionals or serving as consultants

who have expertise and appropriate credentials in the applicable clinical area under

consideration, as appropriate; e.g., criteria review by board-certified physician experts in the

Plan’s service area, feedback from participants of the local network-based Provider Advisory

Committee, and/or independent medical criteria review from board-certified physician

consultants from Advanced Medical Reviews (AMR). Consultants may include but are not

limited to pharmacists, community-based providers, behavioral health clinicians, dentists,

and/or board-certified physicians actively practicing in specialties that include neonatology,

pediatrics, family medicine, internal medicine, medical/surgical subspecialties, and/or geriatrics;

AND

c. In accordance with the Plan’s definition of medical necessity (as specified in the Medically

Necessary medical policy, policy number OCA 3.14), the Plan’s definition of experimental and

investigational services (as stated in the Experimental and Investigational Treatment medical

policy, policy number OCA 3.12), and the Plan’s definition of cosmetic and reconstructive or

restorative services (as documented in the Cosmetic, Reconstructive, and Restorative Services

medical policy, policy number OCA 3.69); AND

d. Review of unbiased, evidence-based assessments of health technologies, clinical programs,

and/or healthcare services to determine the impact of intervention(s) on patient safety and

clinical outcomes; AND

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e. Review of position papers and guidelines established or endorsed by nationally recognized

medical associations, specialty societies, dental organizations, or governmental agencies,

including but not limited to practice guidelines adopted by the Plan; AND

f. Clinical studies published in peer-reviewed scientific literature evaluating the use of the clinical

service as an alternative treatment strategy to established interventions considered the

standard of care for the specified indication (considering the patient’s medical condition, age,

comorbidities, and other factors applicable to the health outcomes of the clinical technology )

to determine if the service improves the net health outcome, is cost-effective compared to the

standard of care, and if the clinical outcomes outweigh any harmful effects; AND

g. The documented, favorable health outcomes are reasonably expected to be attainable outside

of the investigational settings (i.e., in a standard clinical setting) to a degree comparable in the

published, scientifically derived and evidence-based investigations; AND

h. When applicable, the clinical technology, including drugs, biologics, devices, or other products

requiring final approval to market, has final approval for the specified indication from the

appropriate governmental body(ies) with the authority to regulate the clinical technology (e.g.,

the U.S. Food and Drug Administration); AND

i. Policies, position statements, consensus reports, and standards adopted by governmental

agencies which may include but are not limited to the National Institutes of Health (NIH),

Agency for HealthCare Research and Quality (AHRQ), U.S. Center for Disease Control and

Prevention (CDC), Center for Medicare & Medicaid Services (CMS), Massachusetts Executive

Office of Health and Human Services, or New Hampshire Department of Health and Human

Services (e.g., U.S. Preventive Services Task Force, AAP Bright Futures); AND

j. Published scientific evidence from additional reputable sources concerning the safety and

effectiveness of the clinical treatment on health outcomes (i.e., proven benefit, unproven

benefit, insufficient evidence to determine effect, or documented harm) such as industry-

standard, evidence-based guidelines and recommendations (such as those established by

InterQual®, National Institute for Health and Care Excellences, National Comprehensive Cancer

Network); AND

k. Other sources deemed necessary to evaluate the clinical technology for the specified clinical

indication and to develop the Plan’s clinical coverage criteria; AND

l. With input from actively practicing practitioners with appropriate credentials and clinical

expertise in the applicable clinical area who have the opportunity to submit comments on

clinical review criteria utilized for Plan members (with feedback related to the development,

ongoing management, and/or application of those criteria). Practitioners may submit feedback

at any time through the Plan’s Provider Information Mailbox available at

Provider.Info@BMCHP-wellsense.org. The Plan will thoroughly research recommendations and

comments submitted from providers.

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On at least an annual basis, Plan staff review all clinical review criteria utilized by the Plan and

the procedures for applying those clinical review criteria; the Plan will evaluate provider

feedback submitted by practicing practitioners when evaluating applicable clinical review

criteria. If the practitioner would like to provide input on clinical review criteria that will be

considered during the internal policy’s next annual review, it is recommended that comments

and supporting references be submitted to the Plan a few months before the applicable policy’s

scheduled annual review date (as specified in the Next Review Date section at the end of each

internal policy). Supporting documentation must include position statements developed or

endorsed by nationally recognized professional associations, consensus reports or guidelines

from specialty societies, or standards adopted by governmental agencies (e.g., National

Institutes of Health, Agency for HealthCare Research and Quality, Center for Medicare &

Medicaid Services, Massachusetts Executive Office of Health and Human Services, or New

Hampshire Department of Health and Human Services). Published scientific evidence from

additional reputable sources may also be submitted for consideration.

Issues related to clinical review criteria that must be addressed before the policy’s annual

review date will be evaluated immediately during a prior authorization request for services; OCA

UM staff will engage in individual case discussions with licensed Plan pharmacists, OCA UM

clinicians, and/or Plan Medical Directors (utilizing qualified Plan clinicians applicable for the

member’s condition and requested treatment) to determine if the clinical review criteria are

appropriate for the member’s circumstances or care provided by a local delivery system

according to the guidelines specified below in the Application of the Plan’s Clinical Review

Criteria section of this policy.

Providers may email feedback on the Plan’s internal medical policies to the Medical Policy

Mailbox at medical.policy@bmchp-wellsense.org. It is important to include the medical policy

title and policy number with the comments so Plan staff can thoroughly research the issue. An

integral component of the Plan’s annual medical policy review process is to evaluate provider

comments and recommendations.

2. Application of Plan’s Internal Clinical Review Criteria and Plan-Adopted InterQual®

Criteria:

Review the Policy Summary and the Delegated Management sections (rather than this section of

the policy) for guidelines related to clinical review criteria and services managed by partner clinical

vendors with whom the Plan has delegated utilization management by Plan product. Application of

the Plan’s clinical review criteria (including internal clinical review criteria and InterQual® criteria)

follows the procedure specified below in items a through g:

a. The Plan’s Office of Clinical Affairs (OCA) includes OCA UM staff, Plan licensed pharmacists,

and Plan Medical Directors who apply applicable Plan clinical review criteria consistently when

determining the medical necessity of healthcare services. The Plan’s OCA UM staff includes

both the Pharmacy UM staff and UM staff. Reporting to the Director of Pharmacy, the

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Pharmacy UM staff reviews requests for pharmacotherapy or directs requests to a partner

clinical vendor for delegated utilization management. Reporting to the Directors of Utilization

Management, UM staff reviews medical/surgical/behavioral health requests for service or

directs requests to a partner clinical vendor for delegated utilization management according to

guidelines in both item (1) and item (2):

(1) The Plan’s OCA UM staff applies clinical review criteria consistently for all Plan members

according to the standards specified in this policy (e.g., requests for transplant services),

as well as complying with the Plan’s out-of-network guidelines and product-specific

requirements outlined in the Out-of-Network Services medical policy, policy number OCA

3.18. When standard clinical criteria are not met, qualified OCA UM staff also considers

member-specific factors impacting the member’s individual healthcare needs to

determine if the service is medically necessary for the requested indication. The service

may include a treatment, procedure, supply, device, biologic, or drug and will be used to

prevent, diagnose, stabilize, and/or treat a disease, condition, and/or disorder that results

in health impairment and/or disability, and/or the service allows the member to attain,

maintain, or regain functional capacity. Individual consideration includes an assessment of

any member-specific factors impacting care, including one or more of the following:

(a) Member’s condition;

(b) Member’s comorbidities;

development, and competencies, as well as evaluation of age-related and condition-

specific healthcare needs and associated issues;

(d) Relevant past medical/surgical/behavioral health/dental/pharmacotherapy history;

(e) Complications;

(f) Progression of the member’s condition, illness, or injury;

(g) Diagnostic test results;

(h) Treatment outcomes;

(i) Treatment options;

(j) Psychosocial circumstances;

(k) Home and environmental factors impacting member’s clinical condition (e.g.,

homelessness, employment status, poverty, neighborhood);

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(l) Other healthcare services requested and/or provided to the member to integrate

healthcare for continuity, coordination, and collaboration of services;

(m) Local healthcare delivery system’s ability to meet the healthcare needs of the

member’s specific condition;

(n) Member’s reasonable accessibility to a qualified provider with appropriate

credentials, licensure, clinical expertise or resources in the applicable clinical area

necessary to adequately manage the member’s condition, including but not limited

to pharmacotherapy, behavioral health services, dental services, radiology services,

or durable medical equipment (prosthetics, orthotics and supplies);

(o) Other factors related to the member’s plan of care or health outcomes; AND/OR

(p) If applicable, verification that the requested device, system, biologic, or drug is being

prescribed/requested and will be utilized according to its FDA-approved or

compendia indication and guideline information, including intended use for the

member’s age and medical condition; AND

(2) When clinical review criteria are NOT met for a specified service such that medical

necessity cannot be established, OCA UM staff will engage in individual case discussions

with licensed Plan pharmacists, OCA UM clinicians, and/or Plan Medical Directors (utilizing

qualified Plan clinicians applicable for the member’s condition and requested treatment)

to determine if the clinical review criteria are appropriate for the member’s circumstances

or care provided by a local delivery system. If the clinical review criteria are not

appropriate, OCA UM staff may make the utilization determination based on the

member’s condition and other unique circumstances; AND

b. OCA UM staff considers the following characteristics of the healthcare delivery system listed in

items (1) through (4) to assess the local healthcare delivery system’s ability to meet the

member’s healthcare needs when applying clinical review criteria to each request:

(1) Availability and member access to acute and subacute care facilities, including but not

limited to acute care inpatient hospitals (with access to inpatient and outpatient specialty

hospital services such as major burn care, transplantation, specialty pediatric care,

specialty outpatient centers for HIV/AIDS, sickle cell disease, hemophilia, craniofacial and

congenital anomalies), surgi-centers, rehabilitation facilities, transitional care facilities,

skilled nursing facilities (SNF), home health agencies, and hospice programs, as applicable

for the member’s clinical needs; AND

(2) Member’s reasonable accessibility to a qualified provider with appropriate credentials and

clinical expertise in the applicable clinical area necessary to adequately treat the

member’s condition; AND

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Note: The Plan will authorize a member’s care from an out-of-network provider when, as

determined by the Plan, the care needed by the member is not available or is not

reasonably accessible to the member.

(3) Covered benefits for acute and subacute care facilities, including but not limited to acute

care inpatient hospitals, surgi-centers, rehabilitation facilities, transitional care facilities,

SNF, or home health agencies, as applicable for the member’s clinical needs; AND

(4) The ability of acute and subacute care facilities, including but not limited to acute care

inpatient hospitals, surgi-centers, rehabilitation facilities, transitional care facilities, SNF,

or home health agencies, to provide the following services, as specified below in BOTH

items (a) and (b):

(a) Provide the recommended medically necessary services to the member within the

estimated amount, frequency, and duration of treatment (including the estimated

length of stay, when applicable); medically necessary services required by the

member and provided by the facility/treating provider may include routine

medical/surgical services, highly specialized healthcare services (such as transplant

services or cancer care), rehabilitative care, habilitative services, and/or support

services after hospital discharge; AND

(b) Provide the medically necessary clinical support to the Plan member after the

member’s hospital discharge and/or transition to a less intense clinical setting or to

home, as applicable for the member’s treatment plan; AND

c. When an OCA UM staff member is unable to authorize care by establishing medical necessity,

the OCA UM staff will forward the request and documentation to the appropriate Medical

Director or licensed Plan pharmacist for a determination (utilizing qualified Plan clinicians

applicable for the member’s condition and requested treatment); AND

d. When medical necessity cannot be established through existing clinical review criteria, the

Plan’s Medical Directors and/or licensed Plan pharmacists consider alternate methods of

determining medical necessity, as defined in the Medically Necessary medical policy, policy

number OCA 3.14. If Plan-adopted written clinical review criteria have not been established for

the requested service for the specified indication, the Plan’s Medical Directors and/or licensed

Plan pharmacists will use published and applicable generally accepted, scientifically-based

standards of care to determine medical necessity. If scientifically-based standards of care are

not available, observational studies from more than one (1) institution that suggest a causal

relationship between the service or treatment and health outcomes may be used by the Plan’s

Medical Directors and/or licensed Plan pharmacists to make medical necessity determinations

if these observational studies are clinically appropriate with respect to the member’s clinical

presentation. The Plan’s Medical Directors and/or licensed Plan pharmacists also consider

member-specific factors when applying clinical criteria, evaluating standards of care and

credible scientific evidence published in peer-reviewed medical/clinical literature, and/or

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reviewing observational studies for a request for services for a Plan member to make medical

necessity determinations; AND

e. The Medical Policy, Criteria, and Technology Assessment Committee (MPCTAC), Pharmacy

and Therapeutics (P&T) Committee, Utilization Management Committee (UMC), and other

applicable committees meet annually or more frequently as needed to review and/or and

authorize all clinical review criteria used by the Plan along with the policies and procedures for

application; AND

f. OCA UM staff training and annual inter-rater reliability testing are conducted to review the

application of internal clinical review criteria (including criteria in the Plan’s internal medical

policies and internal pharmacy policies) and Plan-adopted InterQual® criteria to ensure the

consistency of medical necessity determinations among the OCA UM staff, Plan pharmacists,

and Plan Medical Directors (according to the definitions of inter-rater reliability, OCA Staff, and

OCA UM Staff in the Definitions section of this policy); AND

g. The Plan makes all of its clinical review criteria available to practitioners, members, regulatory

agencies, and accreditation organizations, upon oral or written request. Providers and member

may call or fax the Plan with a request for a copy of the specific criteria, as stated in writing in

the Plan‘s provider manual and Plan’s website. This access to clinical review criteria includes

applicable copyrighted commercial criteria such as those used by the Plan’s partner delegated

clinical vendors and Plan-adopted InterQual® criteria.

The current version of clinical review criteria included in the Plan’s internal medical policies and

internal pharmacy policies are available to all providers, members, and the general public on the

Plan’s extranet site. Participating providers receive network notifications via email at least 60

calendar days before the effective date of material changes to internal clinical review criteria

and/or coding (excluding industry-wide code updates and administrative changes) or when new

versions of InterQual® criteria are adopted by the Plan. Copies of internal medical policies with

material changes to clinical review criteria and/or coding are included these provider network

notifications (sent at least 60 calendar days before the effective date); updated internal

medical policies will be available at the Plan’s website on the effective date of the revisions.

Providers may email feedback on the Plan’s medical policies to the Medical Policy Mailbox at

medical.policy@bmchp-wellsense.org. It is important to include the medical policy title and

policy number with the comments so Plan staff can thoroughly research the issue. An integral

component of the Plan’s annual medical policy review process is to evaluate provider comments

and recommendations.

The Plan will submit material revisions to its medical necessity guidelines, including clinical

review criteria and related utilization management protocols, to the Massachusetts Office of

Patient Protection, Massachusetts Executive Office of Health and Human Services (EOHHS),

New Hampshire Department of Health and Human Services (DHHS), and the Centers for

Medicare & Medicaid Services (CMS) at least 60 calendar days before the effective date of

these material revisions (or another timeframe specified by the organization) when these

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changes may impact services provided to the organization’s enrollees; a designated contact

person must be provided in writing to the Medical Policy, Criteria, and Technology Assessment

Committee (MPCTAC) by the organization or its designee.

Internal pharmacy policy revisions are communicated to providers 60 calendar days before the

effective date of the revisions. Pharmacy policies for the Plan’s NH Medicaid product are

submitted to DHHS for review and approval prior to implementation. Once approved,

pharmacy policies are available on the Plan’s website 30 calendar days before the effective

date. For Medicaid and commercial lines of business, providers may email feedback on the

Plan’s pharmacy policies at pharma[email protected], or provide feedback as part of

the UM process during Peer to Peer discussions with the Plan’s clinical staff. During the annual

pharmacy policy review process, the Plan evaluates provider feedback and recommendations.

Pharmacy policies for Medicaid and commercial products are approved by the Plan’s Pharmacy

& Therapeutics (P&T) Committee. For MA Senior Care Options (SCO) and NH Medicare

Advantage products, the pharmacy policies are approved by the Centers for Medicare &

Medicaid Services. Pharmacy utilization management functions and the P&T Committee

responsibilities are delegated to the Pharmacy Benefit Manager for MA SCO and NH Medicare

Advantage products.

Responsibility and Accountability

See the Policy Summary and Delegated Management sections of this policy for guidelines related to

clinical review criteria and services managed by clinical vendors with whom the Plan has delegated

utilization management (by Plan product), including behavioral health services, radiology services,

dental services, pharmacy benefits administration, and durable medical equipment, prosthetics,

orthotics and supplies. Responsibility and accountability related to the development, implementation,

and monitoring of the Plan’s internal clinical review criteria (included in the Plan’s medical policies and

internal pharmacy policies) are specified below in items 1 through 4:

1. The Utilization Management Committee (UMC), chaired by the Director of UM Program

Oversight and Member Appeals and Grievances, oversees and is accountable for the adoption,

development, review, update, and implementation of the Plan’s clinical review criteria.

Generally, the Plan adopts nationally developed and accepted criteria (e.g., InterQual®). When

national criteria are not available or not utilized by the Plan, Plan-specific criteria may be

developed that are objective, scientifically derived, and evidence-based, with input from

participating practitioners and consistent with applicable legal, regulatory, and national

accreditation organization standards.

2. The Medical Policy, Criteria, and Technology Assessment Committee (MPCTAC) is responsible

for developing and approving medical policies, and the Pharmacy and Therapeutics (P&T)

Committee is responsible for developing and approving pharmaceutical coverage policies.

3. The Directors of OCA (including but not limited to the Directors of Utilization Management and

the Director of Pharmacy), Chief Medical Officer, Plan Medical Directors, Plan pharmacists, and

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other OCA UM staff use the Plan’s clinical review criteria in accordance with applicable Plan

policies and procedures.

4. The Directors of OCA, including but not limited to the Directors of Utilization Management and

the Director of Pharmacy, or their designee(s) are responsible for ensuring OCA UM staff

training, evaluating, and monitoring. The Chief Medical Officer or designee is responsible for

ensuring Medical Director training, evaluation, and monitoring to ensure consistent application

of clinical review criteria and medical necessity determinations.

Variations

The Plan uses guidance from the Centers for Medicare & Medicaid Services (CMS) for medical

necessity and coverage determinations for the Plan’s Senior Care Options (SCO) members and New

Hampshire Medicare Advantage HMO members, including but not limited to national coverage

determinations (NCDs), local coverage determinations (LCDs), local coverage articles (LCAs), and

documentation included in Medicare manuals. Verify CMS guidelines in effect on the date of the prior

authorization request. When there is no guidance from CMS for the requested service, Plan-adopted

clinical review criteria will be used to determine the medical necessity of the service.

Definitions

Clinical Review Criteria (Definition for MassHealth and Senior Care Options Products):

Criteria used to determine the most clinically appropriate and necessary level of care and intensity of

services to ensure the provision of medically necessary services. Medical necessity guidelines

established by the Plan will be no more restrictive than the applicable contractual MassHealth ACO and

MCO definition of Medically Necessary or Medical Necessity and the same services furnished to

members under MassHealth fee-for-service, as specified in the Plan’s Medically Necessary medical

policy, policy number OCA 3.14. Any new or amended pre-authorization requirement or restriction shall

NOT be implemented unless the Plan’s and/or partner clinical vendor’s respective website has been

updated to clearly reflect the new or amended requirement or restriction.

Clinical Review Criteria (Definition for Qualified Health Plans/ConnectorCare/Employer

Choice Direct Definition Products): In accordance with 958 CMR 3.020, clinical review criteria are

the written screening procedures, decisions, abstracts, clinical protocols and/or practice guidelines

used by the Plan to determine the medical necessity and appropriateness of health care services.

Utilization review criteria shall be up to date and applied consistently by the Plan or the Plan’s partner

clinical vendor and made easily accessible to members, providers, and the general public on the Plan’s

website; or, in the alternative, on the Plan’s partner clinical vendor’s website so long as the Plan

provides a link on its website to the vendor’s website; provided, however, that the Plan shall not be

required to disclose licensed, proprietary criteria purchased by the Plan or partner clinical vendor on its

website, but must disclose such criteria to a provider or subscriber upon request. Review the Plan’s

Medically Necessary medical policy, policy number OCA 3.14, for the product-specific definition of

medically necessary treatment. Any new or amended pre-authorization requirement or restriction shall

NOT be implemented unless the Plan’s and/or partner clinical vendor’s respective website has been

updated to clearly reflect the new or amended requirement or restriction.

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Clinical Review Criteria (Definition for New Hampshire Medicaid Product): A set of medical

decision standards employed in the utilization review process in order to ensure members receive

appropriate care, at an appropriate time, in an appropriate setting by an appropriate provider and at an

appropriate level of care. Criteria are consistent with an efficient and effective utilization of resources

available to recipients. Medical necessity guidelines established by the Plan will be no more restrictive

than the contractual definition of Medically Necessary for the New Hampshire Department of Health

and Human Services (DHHS) and the same services furnished in the New Hampshire DHHS fee-for-

service Medicaid program, as specified in the Plan’s Medically Necessary medical policy, policy number

OCA 3.14. Any new or amended pre-authorization requirement or restriction shall NOT be

implemented unless the Plan’s and/or partner clinical vendor’s respective website has been updated to

clearly reflect the new or amended requirement or restriction.

Inter-Rater Reliability (IRR): A performance measurement tool used to compare and evaluate the

level of consistency in healthcare determinations between two (2) or more medical and behavioral

health utilization management (UM) clinicians. The tool is used to minimize variation in the application

of clinical review criteria and identify potentially avoidable utilization target areas that need

improvement and evaluate the ability to identify quality of care issues.

Office of Clinical Affairs (OCA) Staff: Plan staff members within the OCA that include but are not

limited to OCA Utilization Management (UM) staff, Plan licensed pharmacists, Plan Medical Directors,

and the Chief Medical Officer. The Directors of OCA, including the Directors of Utilization

Management and the Director of Pharmacy, or their designees are responsible for ensuring OCA UM

staff training, evaluating, and monitoring. The Plan’s OCA UM staff, Plan licensed pharmacists, and

Plan Medical Directors consistently use applicable Plan clinical review criteria when determining the

medical necessity of healthcare services. The Chief Medical Officer or designee is responsible for

ensuring Medical Director training, evaluation, and monitoring to ensure consistent application of

clinical review criteria and medical necessity determinations.

Office of Clinical Affairs (OCA) Utilization Management (UM) Staff: The Plan’s OCA UM staff

includes both the Pharmacy UM staff and UM staff. Reporting to the Director of Pharmacy, the

Pharmacy UM staff reviews requests for pharmacotherapy or directs requests to a partner clinical

vendor for delegated utilization management. Reporting to the Directors of Utilization Management,

appropriately qualified UM staff reviews medical, surgical, behavioral health, and/or dental requests for

service or directs requests to a partner clinical vendor for delegated utilization management.

Plan-Adopted Clinical Review Criteria: Written clinical review criteria used to determine medical

necessity, including internally developed criteria specified in Plan medical policies and Plan pharmacy

policies, InterQual® criteria utilized by the Plan, and clinical guidelines established by delegated

management partners (for related services provided Plan members for applicable Plan products).

Practitioner (Definition for the Qualified Health Plans, ConnectorCare, and Employer Choice

Direct): A professional who provides healthcare services. Practitioners are usually required to be

licensed as defined by law.

Clinical Review Criteria

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Utilization Review (UR): A set of formal techniques designed to monitor the use of, or evaluate the

clinical necessity, appropriateness, efficacy, or efficiency of, healthcare services, procedures, or

settings. Such techniques may include, but are not limited to, ambulatory review, prospective review,

second opinion, certification, concurrent review, case management, discharge planning, and/or

retrospective review.

References

American Society for Reproductive Medicine (ASRM). Practice Committee of ASRM. Definition of

experimental procedures: a committee opinion. Fertil Steril. 2013.

Centers for Medicare & Medicaid Services (CMS). EPSDT - A Guide for States: Coverage in the

Medicaid Benefit for Children and Adolescents. 2014 Jun.

Centers for Medicare & Medicaid Services (CMS). Manuals. Publication # 100-02. Medicare Benefit

Policy Manual.

Centers for Medicare & Medicaid Services (CMS). Manuals. Publication # 100-03. Medicare National

Coverage Determinations (NCD) Manual.

Centers for Medicare & Medicaid Services (CMS). Medicaid. Early and Periodic Screening, Diagnosis,

and Treatment. Medicaid.gov.

Centers for Medicare & Medicaid Services (CMS). Medicare Coverage Database (MCD).

Centers for Medicare & Medicaid Services (CMS). Transmittals.

Change Healthcare. InterQual® Overview.

Commonwealth of Massachusetts. Division of Insurance (DOI) Bulletins.

Commonwealth of Massachusetts. Mandatory Benefits Guide. Consumer Affairs and Business

Regulation.

Commonwealth of Massachusetts. MassHealth Provider Bulletins.

Commonwealth of Massachusetts. MassHealth Provider Manuals.

Commonwealth of Massachusetts. MassHealth Transmittal Letters.

Contract between the Commonwealth Health Insurance Connector Authority and Plan.

Clinical Review Criteria

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Contract between the Executive Office of Health and Human Services (EOHHS) and the Plan to Serve

as an Accountable Care Partnership Plan for the Accountable Care Organization (ACO) Program.

Contract between the Massachusetts Executive Office of Health and Human Services (EOHHS) and

Plan.

Contract between the New Hampshire Department of Health and Human Services (DHHS) and Plan.

Hayes, a symplr Company.

Levenson JL. Psychological factors affecting other medical conditions: Clinical features, assessment,

and diagnosis. UpToDate. 2020 Nov 2.

Medicaid.gov. Early and Periodic Screening, Diagnostic, and Treatment. Centers for Medicare &

Medicaid Services.

National Committee for Quality Assurance (NCQA). HEDIS® & Performance Measurement.

National Committee for Quality Assurance (NCQA). Utilization Management Accreditation.

National Institute for Health and Care Excellence (NICE). NICE guidance.

New Hampshire Department of Health and Human Services. Billing Manuals.

New Hampshire Department of Health and Human Services. Provider Notices.

Senior Care Options Contract between the Massachusetts Executive Office of Health and Human

Services (EOHHS) and Plan and Medicare Advantage Special Needs Plan Contract between the

Centers for Medicare & Medicaid Services (CMS) and the Plan.

U. S. Food and Drug Administration (FDA). Device Labeling.

U. S. Food and Drug Administration (FDA). Drug Approvals and Databases.

U. S. Food and Drug Administration (FDA). Medical Device Databases.

Next Review Date

06/01/23

Authorizing Entity

MPCTAC

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Appendix

Appendix: Policy History

Other Applicable Policies

Administrative Policy - Clinical Technology Evaluation, policy number OCA 3.13

Administrative Policy - Inter Rater Reliability, policy number OCA 3.216

Administrative Policy - Mental Health Parity Administrative Policy - Assurance of Parity between Medical

and Behavioral Health Benefits, policy number BH1

Medical Policy - Clinical Trials, policy number OCA 3.192

Medical Policy - Cosmetic, Reconstructive, and Restorative Services, policy number OCA 3.69

Medical Policy - Experimental and Investigational Treatment, policy number OCA 3.12

Medical Policy - Medically Necessary, policy number OCA 3.14

Medical Policy - Out-of-Network Services, policy number OCA 3.18

Reimbursement Policy - Clinical Trials, policy number 4.134

Reimbursement Policy - Clinical Trials, policy number SCO 4.134

Reimbursement Policy - Clinical Trials, policy number WS 4.12

Reimbursement Policy - Early Intervention, policy number 4.3

Reimbursement Policy - Early and Periodic Screening, Diagnosis and Treatment (EPSDT), policy

number WS 4.15

Reimbursement Policy - General Billing and Coding Guidelines, policy number 4.31

Reimbursement Policy - General Billing and Coding Guidelines, policy number SCO 4.31

Reimbursement Policy - General Billing and Coding Guidelines, policy number WS 4.17

Reimbursement Policy - General Clinical Editing and Payment Accuracy Review Guidelines, policy

number 4.108

Reimbursement Policy - General Clinical Editing and Payment Accuracy Review Guidelines, policy

number SCO 4.108

Reimbursement Policy - General Clinical Editing and Payment Accuracy Review Guidelines, policy

number WS 4.18

Reimbursement Policy - Hospital, policy number WS 4.21

Reimbursement Policy - Inpatient Hospital, policy number 4.110

Reimbursement Policy - Inpatient Hospital, policy number SCO 4.110

Reimbursement Policy - Non-Participating Provider, policy number WS 4.5

Reimbursement Policy - Non-Reimbursed Codes, policy number 4.38

Reimbursement Policy - Non-Reimbursed Codes, policy number WS 4.38

Reimbursement Policy - Outpatient Hospital, policy number 4.17

Reimbursement Policy - Outpatient Hospital, policy number SCO 4.17

Reimbursement Policy - Physician and Non-Physician Practitioner Services, policy number 4.608

Reimbursement Policy - Physician and Non-Physician Practitioner Services, policy number SCO 4.608

Reimbursement Policy - Physician and Non-Physician Practitioner Services, policy number WS 4.28

Reimbursement Policy - Provider Preventable Conditions and Serious Reportable Events, policy number

4.610

Reimbursement Policy - Provider Preventable Conditions and Serious Reportable Events, policy number

SCO 4.610

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Reimbursement Policy - Provider Preventable Conditions and Serious Reportable Events, policy number

WS 4.29

Reference to Applicable Laws and Regulations

42 CFR 405.1060. Code of Federal Regulations. Applicability of National Coverage Determinations.

42 CFR 422.205. Code of Federal Regulations. Public Health, Centers for Medicare & Medicaid

Services. Medicare Advantage Program. Provider Antidiscrimination Rules.

42 CFR 438.100. Code of Federal Regulations. Public Health, Centers for Medicare & Medicaid

Services. Managed Care. Enrollee Rights and Protections. Enroll Rights.

42 CFR §438.210. Code of Federal Regulations. Public Health. Centers for Medicare & Medicaid

Services. Medical Assistance Programs. Managed Care. Coverage and Authorization of Services.

42 CFR Parts 438, 440, 456, and 457. Code of Federal Register. Vol. 81. No. 61. Medicaid and

Children's Health Insurance Programs; Mental Health Parity and Addiction Equity Act of 2008; the

Application of Mental Health Parity Requirements to Coverage Offered by Medicaid Managed Care

Organizations, the Children's Health Insurance Program (CHIP), and Alternative Benefit Plans.

Centers for Medicare & Medicaid Services (CMS). 2016 Mar 30.

42 CFR §440.210. Code of Federal Regulations. Public Health. Centers for Medicare & Medicaid

Services. Medical Assistance Programs. Medical Assistance Programs. Required Services for the

Categorically Needy.

42 CFR §441.56. Code of Federal Regulations. Public Health. Centers for Medicare & Medicaid

Services. Medical Assistance Programs. Medical Assistance Programs. Requirements and Limits

Applicable to Specific Services. Early and Periodic Screening, Diagnosis, and Treatment (EPSDT) of

Individuals Under Age 21. Required Activities.

42 USC § 18001. United States Code. Patient Protection and Affordable Care Act. 2010.

78 FR 48164-69. Federal Register. Centers for Medicare & Medicaid Services (CMS). Medicare

Program. Revised Process for Making National Coverage Determinations. 2013 Aug 7.

114.3 CMR 17.00. Code of Massachusetts Regulations. Division of Health Care Finance and Policy.

Medicine.

130 CMR. Code of Massachusetts Regulations. Division of Medical Assistance.

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130 CMR 410.00. Code of Massachusetts Regulations. Division of Medical Assistance. Outpatient

Hospital Services.

130 CMR 415.000. Code of Massachusetts Regulations. Division of Medical Assistance. Acute Inpatient

Hospital Services.

130 CMR 433.00. Code of Massachusetts Regulations. Division of Medical Assistance. Physician

Services.

130 CMR 440.00. Division of Medical Assistance. Code of Massachusetts Regulations. Early

Intervention Program Services.

130 CMR 450.000. Code of Massachusetts Regulations. Division of Medical Assistance. Administrative

and Billing Regulations.

130 CMR 450.117(J). Code of Massachusetts Regulations. Division of Medical Assistance. Administrative

and Billing Regulations. Managed Care Participation. Compliance with Mental Health Parity Law.

130 CMR 450.204. Code of Massachusetts Regulations. Division of Medical Assistance. Administrative

and Billing Regulations. Medically Necessary.

211 CMR 52.00. Code of Massachusetts Regulations. Division of Insurance. Managed Care Consumer

Protections and Accreditation of Carriers.

211 CMR 52.02. Code of Massachusetts Regulations. Division of Insurance. Managed Care Consumer

Protections and Accreditation of Carriers. Definitions. Clinical Review Criteria.

211 CMR 52.02. Code of Massachusetts Regulations. Division of Insurance. Managed Care Consumer

Protections and Accreditation of Carriers. Definitions. Medical Necessity or Medically Necessary.

211 CMR 52.02. Code of Massachusetts Regulations. Division of Insurance. Managed Care Consumer

Protections and Accreditation of Carriers. Definitions. Utilization Review.

958 CMR 3.020. Code of Massachusetts Regulations. Health Insurance Consumer Protection.

Definitions. Clinical Review Criteria.

958 CMR 3.020. Code of Massachusetts Regulations. Health Insurance Consumer Protection.

Definitions. Utilization Review.

958 CMR 3.020. Code of Massachusetts Regulations. Health Insurance Consumer Protection.

Definitions. Medical Necessity or Medically Necessary.

958 CMR 3.020. Code of Massachusetts Regulations. Health Insurance Consumer Protection.

Definitions. Utilization Review.

Clinical Review Criteria

27 of 33

958 CMR 3.101. Code of Massachusetts Regulations. Health Insurance Consumer Protection.

Definitions. Carrier’s Medical Necessity Guidelines.

958 CMR 3.400. Code of Massachusetts Regulations. Health Insurance Consumer Protection.

External Review.

Commonwealth of Massachusetts. Chapter 207 of the Acts of 2010 - An Act Relative to Insurance

Coverage for Autism.

Commonwealth of Massachusetts. Mandatory Benefits Guide. Consumer Affairs and Business

Regulation.

Commonwealth of Massachusetts. Massachusetts General Laws Mandating that Certain Health

Benefits Be Provided By Commercial Insurers, Blue Cross and Blue Shield and Health Maintenance

Organizations. Regulatory Citations. 2017 Oct 24.

Commonwealth of Massachusetts. MassHealth Provider Regulations.

He-W 500. New Hampshire Code of Administrative Rules. Medical Assistance.

He-W 530. New Hampshire Code of Administrative Rules. Medical Assistance. Service Limits, Co-

Payments, and Non-Covered Services.

He-W 530.01(e). New Hampshire Code of Administrative Rules. Medical Assistance. Service Limits,

Co-Payments, and Non-Covered Services. Definitions. Medically Necessary.

He-W 530.05(b)(4). New Hampshire Code of Administrative Rules. Medical Assistance. Non-Covered

Services. Experimental or Investigational Procedures.

He-W 531. New Hampshire Code of Administrative Rules. Medical Assistance. Physician Services.

He-W 531.01(a). New Hampshire Code of Administrative Rules. Medical Assistance. Physician Services.

Cosmetic Purpose.

He-W 543. New Hampshire Code of Administrative Rules. Medical Assistance. Hospital Services.

He-W 546. New Hampshire Code of Administrative Rules. Medical Assistance. Early and Periodic

Screening, Diagnosis and Treatment Service.

MGL c 233. Massachusetts General Laws. An Act Relative to HIV-Associated Lipodystrophy Syndrome

Treatment.

MGL c 1760. Massachusetts General Laws. Health Insurance Consumer Protections.

Clinical Review Criteria

28 of 33

The Mental Health Parity and Addiction Equity Act of 2008 (MHPAEA). The Center for Consumer

Information & Insurance Oversight. Centers for Medicare and Medicaid Services (CMS).

Newborns’ and Mothers Health Protection Act of 1996 (NMHPA). The Center for Consumer

Information & Insurance Oversight. Centers for Medicare and Medicaid Services (CMS).

New Hampshire Department of Health and Human Services (DHHS). Certified Administrative Rules.

RSA 417-D:2-b. New Hampshire Revised Statutes Annotated. Women’s Health Care. Reconstructive

Surgery.

RSA Chapter 420-E. New Hampshire Revised Statutes. Insurance. Licensure of Medical Utilization

Review Entitles.

Social Security Act. Title XIX. 1902(a)(43), 1905(a)(4)(B), 1905(r). Grants to States for Medical

Assistance Programs. Early and Periodic Screening, Diagnosis, and Treatment (EPSDT).

Social Security Act. Title XXI. State Children’s Health Insurance Program.

U.S. Women's Health and Cancer Right Act of 1998.

Disclaimer Information:

Plan refers to Boston Medical Center Health Plan, Inc. which operates under the trade name WellSense Health Plan. Medical

Policies are the Plan’s guidelines for determining the medical necessity of certain services or supplies for purposes of

determining coverage. These Policies may also describe when a service or supply is considered experimental or

investigational, or cosmetic. In making coverage decisions, the Plan uses these guidelines and other Plan Policies, as well as

the Member’s benefit document, and when appropriate, coordinates with the Member’s health care Providers to consider the

individual Member’s health care needs.

Plan Policies are developed in accordance with applicable state and federal laws and regulations, and accrediting organization

standards (including NCQA). Medical Policies are also developed, as appropriate, with consideration of the medical necessity

definitions in various Plan products, review of current literature, consultation with practicing Providers in the Plan’s service

area who are medical experts in the particular field, and adherence to FDA and other government agency policies. Applicable

state or federal mandates, as well as the Member’s benefit document, take precedence over these guidelines. Policies are

reviewed and updated on an annual basis, or more frequently as needed. Treating providers are solely responsible for the

medical advice and treatment of Members.

The use of this Policy is neither a guarantee of payment nor a final prediction of how a specific claim(s) will be adjudicated.

Reimbursement is based on many factors, including member eligibility and benefits on the date of service; medical necessity;

utilization management guidelines (when applicable); coordination of benefits; adherence with applicable Plan policies and

procedures; clinical coding criteria; claim editing logic; and the applicable Plan – Provider agreement.

Clinical Review Criteria

29 of 33

Appendix: Policy History

Original

Approval Date

Original Effective

Date* and Version

Policy Owner

Original Policy

Approved by

Regulatory Approval:

08/01/08

MH Review: 02/19/10

Internal Approval:

07/24/07 and 08/13/07

08/13/07

Version 1

Director of Medical Policy as

Chair of Medical Policy,

Criteria, and Technology

Assessment Committee

(MPCTAC)

Utilization

Management

Committee (UMC)

*Effective date for MA QHP commercial product: 01/01/12.

*Effective date for New Hampshire Medicaid product: 01/01/13.

*Effective date for MA Senior Care Options product: 01/01/16.

*Effective date for New Hampshire Medicare Advantage HMO product: 01/01/22.

Note: Policy title was Clinical Criteria until 07/31/17. Policy title changed to Clinical Review Criteria as of

08/01/17.

Policy Revisions History

Review Date

Summary of Revisions

Revision Effective

Date and Version

Number

Approved by

04/22/08

Typos and formatting corrected. Removed

bullet stating Chief Medical Officer conducts

review on all criteria annually.

Version 2

04/22/08: UMC

05/07/08

Added authority for plan pharmacists to

render pharmacy denials.

Version 3

05/20/08: UMC

06/19/08: Quality

Improvement

Committee (QIC)

08/20/09

Changed titles within Health Services, minor

typos and formatting, updated references,

changed definition for clinical criteria.

Version 4

09/22/09: UMC

09/23/09: QIC

07/21/10

Updated names, departments and references,

extra definition for medically necessary was

removed.

Version 5

07/21/10: MPCTAC

08/25/10: QIC

07/01/11

Added medically necessary definition and

language for Commercial product.

Version 6

07/22/11: MPCTAC

08/24/11: QIC

07/01/12

References updated, moved Purpose section

of policy to the beginning of the document

and added reference for the Plan’s Prior

Authorization/ Notification Requirements

matrix. Referenced the Plan’s Medically

Necessary policy for a definition of medically

necessary for each member type and deleted

Version 7

07/18/12: MPCTAC

08/15/12: MPCTAC

Clinical Review Criteria

30 of 33

medically necessary definitions from this

policy. Added language regarding delegated

management in Policy Statement section.

Added reference to Physician Reviewers in

policy. Changed definition title from “Clinical

Criteria” to “Clinical Review Criteria.”

08/15/12

Off cycle review for New Hampshire Medicaid

product. Revised the Purpose, Definitions,

Policy Statement, reformatted Procedure,

updated references for all Plan products.

Version 8

08/17/12: MPCTAC

09/13/12: QIC

9/01/12

Added language to clarify the Plan’s UR

process that includes the evaluation of

member’s circumstances and local delivery

system, when clinically appropriate.

Version 9

09/19/12: MPCTAC

09/26/12: QIC

06/01/13

Review for effective date 07/18/13. Revised

title of chair for the Utilization Management

Committee.

07/18/13

Version 10

06/19/13: MPCTAC

07/18/13: QIC

06/01/14

Review for effective date 10/01/14. Updated

Purpose, Policy Statement, Delegated

Management, Procedure, Responsibility and

Accountability, Definitions, and References

sections.

10/01/14

Version 11

06/09/14: MPCTAC

07/09/14: QIC

06/01/15

Review for effective date 07/08/15.

Removed Commonwealth Care,

Commonwealth Choice, and Employer Choice

from the list of applicable products because

the products are no longer available.

Administrative changes made to Purpose,

Policy Statement, Delegated Management,

and Procedure sections.

07/08/15

Version 12

06/17/15: MPCTAC

07/08/15: QIC

09/01/15

Review for effective date 10/14/15. Added

reference to eviCore healthcare in the

Delegated Management section. Updated list

of applicable products, including the removal

of Common-wealth Care, Commonwealth

Choice, and Employer Choice because the

products are no longer available.

10/14/15

Version 13

09/16/15: MPCTAC

10/14/15: QIC

06/01/16

Review for effective date 07/13/16. Updated

with administrative changes to the Delegated

Management, References, and References to

Applicable Laws and Regulations sections.

07/13/16

Version 14

06/15/16: MPCTAC

07/13/16: QIC

05/01/17

Review for effective date 06/01/17.

Administrative changes made to the policy

title and the Purpose, Policy Statement,

Responsibility and Accountability, Definitions,

References, and Reference to Applicable

Laws and Regulations sections to clarify the

Plan’s clinical criteria review process and the

06/01/17

Version 15

05/17/17: MPCTAC

Clinical Review Criteria

31 of 33

use of these clinical criteria in utilization

review activities.

08/31/17

Updated the definition of Clinical Review

Criteria (for Massachusetts products) to

include requirements for the medical

necessity guidelines applicable for the

Accountable Care Organization (ACO).

Updated Product Applicability and Reference

sections to incorporate ACO.

08/31/17

Version 16

08/31/17: MPCTAC

(electronic vote)

06/01/18

Review for effective date 07/01/18.

Administrative changes made to the Policy

Statement, Procedure, Responsibility and

Accountability, References, Other Applicable

Policies, and Reference to Applicable Laws

and Regulations sections.

07/01/18

Version 17

06/20/18: MPCTAC

09/01/18

Review for effective date 12/01/18.

Administrative changes made to the Purpose

and Policy Summary sections. Updated

criteria in the Procedure section (clarifying

the existing process).

12/01/18

Version 18

09/19/18: MPCTAC

11/01/18

Review for effective date 12/01/18.

Administrative changes made to the Policy

Statement, Delegated Management, and

Procedure sections to clarify the existing

process available for practitioners to submit

comments related to clinical review criteria.

12/01/18

Version 19

11/21/18: MPCTAC

06/01/19

Review for effective date 07/01/19.

Administrative changes made to the Policy

Summary (formerly Purpose section), Policy

Statement, Delegated Management,

Procedure, Definitions, Responsibility and

Accountability, References, and Reference to

Applicable Laws and Regulations sections to

clarify the existing process.

07/01/19

Version 20

06/19/19: MPCTAC

12/01/19

Review for effective date 01/01/20.

Administrative changes made to the

Delegated Management and Procedure

sections.

01/01/20

Version 21

12/18/19: MPCTAC

06/01/20

Review for effective date 07/01/20.

Administrative changes made to the Policy

Summary, Procedure, References, and

Reference to Applicable Laws and

Regulations sections.

07/01/20

Version 22

06/17/20: MPCTAC

12/01/20

Review for effective date 01/01/21.

Administrative changes made to the

Delegated Management, Responsibility and

Accountability, and Definitions sections.

01/01/21

Version 23

12/16/20: MPCTAC

Clinical Review Criteria

32 of 33

12/22/20

Review for effective date 01/01/21 (replacing

version 23). Updated documentation related

to the Plan’s Pharmacy Manager, Express

Scripts, in the Delegated Management

section.

01/01/21

Version 24

12/23/20: MPCTAC

(electronic vote)

06/01/21

Review for effective date 07/01/21. Clarified

current guidelines with administrative

changes made to the Policy Summary, Policy

Statement, Delegated Management, and

Procedure sections to clarify existing

guidelines. Updated References section.

07/01/21

Version 25

06/16/21: MPCTAC

08/01/21

Review for effective date 09/01/21.

Administrative changes made to the Policy

Summary, Policy Statement, Definitions,

References, Other Applicable Policies, and

Reference to Applicable Laws and

Regulations sections to clarify current

guidelines.

09/01/21

Version 26

08/13/21: MPCTAC

(electronic vote)

11/01/21

Review for effective date 12/01/21. Added NH

Medicare Advantage HMO as an applicable

product effective 01/01/22. Administrative

changes made to the Policy Summary and

Policy Statement sections. Added the

Variations section.

12/01/21

Version 27

11/17/21: MPCTAC

07/01/22

Review for effective date 08/01/22.

Administrative changes made to the Policy

Summary, Policy Statement, Delegated

Management, Procedure, Responsibility and

Accountability, Definitions, and Other

Applicable Policies sections.

08/0/122

Version 28

07/25/22: MPCTAC

(electronic vote)

08/01/22

Review for effective date 11/01/22. Revised

the list of the Plan’s delegated services and

partner clinical vendors in the Delegated

Management section. eviCore healthcare

served as the Plan’s delegated vendor for

radiology services from 03/15/20 to 10/31/22.

Effective 11/01/22, the Plan will delegate the

management of radiology services,

musculoskeletal services (i.e., spine surgeries,

joint surgeries, and interventional pain

management treatments), genetic testing,

and outpatient rehabilitation services (i.e.,

physical therapy, occupational therapy, and

speech therapy after the initial evaluation) to

AIM Specialty Health.

11/01/22

Version 29

Version 29 NOT

implemented and

replaced with

Version 30 as of

11/01/22

08/26/22: MPCTAC

(electronic vote)

09/01/22

Review for effective date 11/01/22. Revised

the effective date of AIM’s management of

outpatient rehabilitation services from

11/01/22

Version 30

09/23/22: MPCTAC

(electronic vote)

Clinical Review Criteria

33 of 33

11/01/22 to 12/01/22 in the Delegated

Management section. All other policy

revisions approved for Version 29 are

implemented in Version 30 as of 11/01/22.

Policy added to the Other Applicable Policies

section.

Complementary and Alternative Medicine

1 of 10

Medical Policy

Complementary and Alternative Medicine

Policy Number: OCA 3.194

Version Number: 22

Version Effective Date: 12/01/22

Impacted Products

☐ All Products

☐ NH Medicaid

☒ NH Medicare Advantage

☒ MA MassHealth ACO

☒ MA MassHealth MCO

☐ MA Qualified Health Plans/Employer Choice Direct

☒ MA Senior Care Options

Note: Disclaimer and audit information is located at the end of this document.

Policy Summary

The Plan considers complementary and alternative medicine (CAM) NOT medically necessary unless

the service (including indication for treatment) is covered for the member. Prior authorization from

AIM Specialty Health is required for outpatient rehabilitation services.

Clinical Criteria

The member’s product-specific benefit documents will determine coverage for CAM services, as

specified below in items 1 and 2:

1. The Plan considers CAM services NOT medically necessary for Plan members, except as

covered in the member’s applicable benefit documents.

2. There may be separate medical policies that address the treatment of specific conditions or

procedures that supersede this policy. See the Plan’s Prior Authorization/Notification

Requirements matrix available at the Plan’s website for prior authorization guidelines by service

type.

Complementary and Alternative Medicine

2 of 10

Limitations and Exclusions

The Plan considers CAM to NOT be medically necessary due to insufficient scientific evidence

demonstrating the clinical validity and clinical utility of treatment unless the service (including

indication for treatment) is covered for the member. CAM include but are not limited to any of the

following services:

1. Whole medicine systems (e.g., homeopathic and naturopathic medicine, traditional Chinese

medicine such as Ayurveda).

2. Mind body medicine to improve the mind's ability to affect bodily function and symptoms (e.g.,

biofeedback except for treatment of urinary incontinence, hypnotherapy/hypnosis, meditation,

prayer, mental healing, therapies that use creative outlets such as art, music, or dance).

3. Substances found in nature (e.g., herbal products, vitamins, dietary supplements).

4. Manipulative and body based practices (e.g., massage, myotherapy, craniosacral therapy,

osteopathic manipulation, hippotherapy, yoga, reflexology).

5. Energy medicine (e.g., Reiki, therapeutic touch, pulsed fields, magnetic fields, electromagnetic,

or alternating-current or direct-current field).

Variations

The Plan uses guidance from the Centers for Medicare & Medicaid Services (CMS) for medical

necessity and coverage determinations for Senior Care Options (SCO) members and NH Medicare

Advantage HMO members, including but not limited to national coverage determinations (NCDs), local

coverage determinations (LCDs), local coverage articles (LCAs), and documentation included in

Medicare manuals. At the time of the Plan’s most recent policy review, there was no applicable clinical

policies by CMS. Verify CMS guidelines in effect on the date of the prior authorization request for the

service and indication for treatment. When there is no guidance from CMS for the requested service,

plan-adopted clinical review criteria will be used to determine the medical necessity of the service.

Applicable Coding

The Plan utilizes up-to-date, industry-standard Current Procedural Terminology (CPT) codes, Health

Care Common Procedure Coding System (HCPCS) codes, and International Statistical Classification

of Diseases and Related Health Problems, 10th revision (ICD-10) diagnosis codes in the Plan’s medical

policies. Since these codes may be updated at different intervals than the medical policy review cycle,

the list of applicable codes included in a policy is informational only and may not be all

inclusive. Applicable codes are subject to change without prior notification and do not guarantee

member coverage or provider reimbursement. Review the Plan’s reimbursement policies for Plan

billing guidelines. Providers are responsible for obtaining prior authorization for the services specified

in the Clinical Criteria section and Limitations and Exclusions section of a medical policy, even if an

Complementary and Alternative Medicine

3 of 10

applicable code appropriately describing the service is not included in the policy’s Applicable Coding

section. Providers are expected to report all services using the most up-to-date, industry-standard

procedures and diagnosis codes at the time of the service.

CPT/HCPCS Codes

Description: Service is considered NOT medically necessary, except as

specified in the member’s applicable benefit document

90880

Hypnotherapy

Plan note: Code is NOT payable for the Senior Care Options product.

M0075

Cellular therapy

Plan note: Code is NOT payable for the Senior Care Options and NH Medicare

Advantage HMO products.

References

American Chronic Pain Association (ACPA). ACPA Resource Guide to Chronic Pain management, An

Integrated Guide to Medical, Interventional, Behavioral Pharmacologic and Rehabilitation Therapies.

Feinberg S (ed.) American Chronic Pain Association Inc., Rocklin, California. 2019.

American College of Chest Physicians (ACCP). Deng GE, Rausch SM, Jones LW, Gulati A, Kumar NB,

Greenlee H, Pietanza MC, Cassileth BR. Complementary therapies and integrative medicine in lung

cancer: diagnosis and management of lung cancer, 3rd ed: ACCP evidence-based clinical practice

guidelines. Chest. 2013 May;143(5 Suppl):e420S-36S. doi: 10.1378/chest.12-2364. PMID: 23649450.

American College of Physicians (ACP). Qaseem A, Wilt TJ, McLean RM, Forciea MA; Clinical Guidelines

Committee of the American College of Physicians. Noninvasive Treatments for Acute, Subacute and

Chronic Low Back Pain: A Clinical Guideline from the ACP. Ann Intern Med. 2017 Apr 4;166(7):514-30.

doi: 10.7326/M16-2367. Epub 2017 Feb 14. PMID: 28192789.

American Society of Anesthesiologists (ASA), American Society of Regional Anesthesia and Pain

Medicine (ASRA). Rosenquist RW, Benzon HT, Connis RT, De Leon-Casasola OA, Glass D, Korevaar

WC, Cynwyd B, Mekhail NA, Merrill DG, NIckinovich DG, Rathnmell JP, Nai-Mei Sang C, Simon DL; ASA

Task Force on Chronic Pain Management. Practice guidelines for chronic pain management: an

updated report by the ASA Task Force on Chronic Pain Management and the ASRA. Anesthesiology.

2010 Apr;112(4):810-33. doi: 10.1097/ALN.0b013e3181c43103. PMID: 20124882.

Centers for Medicare & Medicaid Services (CMS). Manuals. Publication # 100-02. Medicare Benefit

Policy Manual.

Centers for Medicare & Medicaid Services (CMS). Manuals. Publication # 100-03. Medicare National

Coverage Determinations (NCD) Manual.

    
 
Complementary and Alternative Medicine 
 
4 of 10 
 
 
Centers for Medicare & Medicaid Services (CMS). Medicare Coverage Database (MCD). 
 
Centers for Medicare & Medicaid Services (CMS). Transmittals. 
 
Chou R, Deyo R, Friedly J, Skelly A, Hashimoto R, Weimer M, Fu R, Dana T, Kraegel P, Griffin J, Grusing 
S, Brodt E.  Noninvasive Treatments for Low Back Pain. Comparative Effectiveness Review No. 169. 
(Prepared by the Pacific Northwest Evidence-based Practice Center under Contract No. 290-2012-
00014-I.) AHRQ Publication No. 16-EHC004-EF. Rockville, MD: Agency for Healthcare Research and 
Quality. 2016 Feb. 
 
Chou R, Deyo R, Friedly J, Skelly A, Hashimoto R, Weimer M, Fu R, Dana T, Kraegel P, Griffin J, Grusing 
S, Brodt ED. Nonpharmacologic Therapies for Low Back Pain: A Systematic Review for an American 
College of Physicians Clinical Practice Guideline. Ann Intern Med. 2017 Apr 4;166(7):493-505. doi: 
10.7326/M16-2459. Epub 2017 Feb 14. PMID: 28192793. 
 
Commonwealth of Massachusetts. Division of Insurance (DOI) Bulletins. 
Commonwealth of Massachusetts. MassHealth Provider Bulletins. 
 
Commonwealth of Massachusetts. MassHealth Provider Manuals. 
 
Commonwealth of Massachusetts. MassHealth Transmittal Letters. 
 
Greenlee H, Balneaves LG, Carlson LE, Cohen M, Deng G, Hershman D, Mumber M, Perlmutter J, 
Seely D, Sen A, Zick SM, Tripathy D; Society for Integrative Oncology. Clinical practice guidelines on 
the use of integrative therapies as supportive care in patients treated for breast cancer. J Natl Cancer 
Inst Monogr. 2014 Nov;2014(50):346-58. doi: 10.1093/jnci monographs/lgu041. Review. Erratum in: J 
Natl Cancer Inst Monogr. 2015 May;2015(51):98. PMID: 25749602. 
  
Institute for Clinical Systems Improvement (ICSI). Pain: Assessment, Non-Opioid Treatment 
Approaches and Opioid Management. Eighth Edition. Version 2. 2017 Aug.  
 
Levy SE, Hyman SL. Complementary and alternative medicine treatments for children with autism 
spectrum disorders. Child Adolesc Psychiatr Clin N Am. 2015 Jan;24(1):117-43. doi: 
10.1016/j.chc.2014.09.004. Epub 2014 Oct 3. PMID: 25455579. 
 
National Academies of Sciences, Engineering, and Medicine. 2017. Pain management and the opioid 
epidemic: Balancing societal and individual benefits and risks of prescription opioid use. 2017 Jul 13. 
Washington, DC: The National Academies Press. doi: https://doi.org/10.17226/24781. 
 
National Cancer Institute. National Institutes of Health (NIH). Complementary and Alternative 
Medicine. 2019 Sep 30. 
 

Complementary and Alternative Medicine

5 of 10

National Center for Complementary and Integrative Health (NCCIH). National Institutes of Health

(NIH). Acupuncture. 2017 Sep 24.

National Center for Complementary and Integrative Health (NCCIH). National Institutes of Health

(NIH). Acupuncture: In Depth. 2017 Feb 21.

National Center for Complementary and Integrative Health (NCCIH). National Institutes of Health

(NIH). Complementary, Alternative, or Integrative Health: What’s In a Name? 2019 Apr 2.

New Hampshire Department of Health and Human Services. Billing Manuals.

New Hampshire Department of Health and Human Services. Provider Notices.

Office of Patient Centered Care and Cultural Transformation (OPCC&CT). Complementary and

Integrative Health (CIH) Resource Guide. Version 2. Last Update: 2017 Oct.

U.S. Department of Veterans Affairs (VA), Department of Defense (DoD). VA/DoD Clinical Practice

Guideline for Diagnosis and Treatment of Low Back Pain. Version 2.0 – 2017.

U.S. Department of Veterans Affairs. Department of Defense (DoD). VA/DoD Clinical Practice

Guideline for the Management of Chronic Multisymptom Illness CMI 2014.

U.S. National Library of Medicine. National Institutes of Health. Collection Development Manual.

Complementary and Alternative Medicine. 2018 Mar 26.

Yuan QL, Guo TM, Liu L, Sun F, Zhang YG. Traditional Chinese medicine for neck pain and low back

pain: a systematic review and meta-analysis. PLoS One. 2015 Feb 24;10(2):e0117146. doi:

10.1371/journal.pone.0117146. eCollection 2015. PMID: 25710765.

Next Review Date

02/01/23

Authorizing Entity

MPCTAC

Appendix

Appendix: Policy History

Disclaimer Information:

Plan refers to Boston Medical Center Health Plan, Inc. which operates under the trade name WellSense Health Plan. Medical

Policies are the Plan’s guidelines for determining the medical necessity of certain services or supplies for purposes of

determining coverage. These Policies may also describe when a service or supply is considered experimental or

Complementary and Alternative Medicine

6 of 10

investigational, or cosmetic. In making coverage decisions, the Plan uses these guidelines and other Plan Policies, as well as

the Member’s benefit document, and when appropriate, coordinates with the Member’s health care Providers to consider the

individual Member’s health care needs.

Plan Policies are developed in accordance with applicable state and federal laws and regulations, and accrediting organization

standards (including NCQA). Medical Policies are also developed, as appropriate, with consideration of the medical necessity

definitions in various Plan products, review of current literature, consultation with practicing Providers in the Plan’s service

area who are medical experts in the particular field, and adherence to FDA and other government agency policies. Applicable

state or federal mandates, as well as the Member’s benefit document, take precedence over these guidelines. Policies are

reviewed and updated on an annual basis, or more frequently as needed. Treating providers are solely responsible for the

medical advice and treatment of Members.

The use of this Policy is neither a guarantee of payment nor a final prediction of how a specific claim(s) will be adjudicated.

Reimbursement is based on many factors, including member eligibility and benefits on the date of service; medical necessity;

utilization management guidelines (when applicable); coordination of benefits; adherence with applicable Plan policies and

procedures; clinical coding criteria; claim editing logic; and the applicable Plan – Provider agreement.

Complementary and Alternative Medicine

7 of 10

Appendix: Policy History

Original

Approval Date

Original Effective

Date* and Version

Policy Owner

Original Policy

Approved by

Regulatory Approval: N/A

Internal Approval:

07/28/09: Medical Policy, Criteria, and

Technology Assessment Committee

(MPCTAC)

08/26/09: Quality Improvement

Committee (QIC)

11/01/09

Version 1

Director of

Medical Policy as

Chair of

MPCTAC

MPCTAC and QIC

*Effective Date for QHP Commercial Product: 01/01/12

*Effective Date for Senior Care Options Product: 01/01/16

*Effective Date for NH Medicare Advantage HMO Product: 01/01/22

Policy title was Complementary and Alternative Medicine, Including Acupuncture Treatment until 06/30/19. As of

07/01/19, policy title changed to Complementary and Alternative Medicine, Including Acupuncture. As of

01/01/22, policy title changed to Complementary and Alternative Medicine.

Policy Revisions History

Review

Date

Summary of Revisions

Revision Effective

Date and Version

Number

Approved by

07/01/10

Removed osteopathic manipulation from the list

of CAM services. Changed the “non-covered”

language to “not medically necessary,” added

massage by a massage therapist and updated

references.

Version 2

07/21/10: MPCTAC

08/25/10: QIC

07/01/11

Updated references and added commercial

language.

Version 3

07/22/11: MPCTAC

08/24/11: QIC

07/01/12

Updated references, added language to

Applicable Code section and added applicable

code list. Updated Summary section and

Applicable Code section to specify that

acupuncture is considered a medically necessary

service for Commonwealth Care and

MassHealth members when used for substance

abuse detoxification, as managed and

authorized by Beacon Health Strategies.

Included statement that acupuncture is not a

covered service for Commercial members and

Version 4

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08/22/12: QIC

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added a reference to the Medically Necessary

policy in the Summary section.

05/01/13

Review for effective date 09/01/13. Updated

Summary section and applicable code list.

Referenced Reimbursement Guidelines:

Chiropractic Services (Spinal Manipulation),

policy number 4.114. Medical Policy Statement

section revised without changing criteria.

Hippotherapy added to applicable code list, and

the reference to the Hippotherapy policy

deleted from Medical Policy Statement section

(since Hippotherapy policy will be retired

effective 09/01/13). Renumbered policy from

OCA: 3.193 to OCA: 3.194.

09/01/13

Version 5

05/15/13: MPCTAC

06/20/13: QIC

05/01/14

Review for effective date 07/01/14. Updated

Summary section. Added acupuncture services

in the Description of Item or Service and Clinical

Background Information sections. Revised

language in Medical Policy Statement section

and Limitations section without changing

criteria. Updated references. Revised policy

title.

07/01/14

Version 6

05/21/14: MPCTAC

06/11/14: QIC

01/01/15

Review for effective date 03/01/15. Updated

Medical Policy Statement section to clarify

guidelines without changing criteria. Updated

references.

03/01/15

Version 7

01/21/15: MPCTAC

02/11/15: QIC

04/01/15

Review for effective date 06/01/15. Removed

Commonwealth Care, Commonwealth Choice,

and Employer Choice from the list of applicable

products because the products are no longer

available. Administrative changes made to the

Applicable Coding section, but no changes

made to the code list. Updated Summary and

References sections.

06/01/15

Version 8

04/15/15: MPCTAC

05/13/15: QIC

11/25/15

Review for effective date 01/01/16. Updated

template with list of applicable products and

notes. Administrative changes made to the

Summary, Medical Policy Statement, and

Limitations section without revising criteria.

Revised language in the Applicable Coding

section.

01/01/16

Version 9

11/18/15: MPCTAC

11/25/15: MPCTAC

(electronic vote)

12/09/15: QIC

04/01/16

Review for effective date 06/01/16. Updated

the Clinical Background Information,

References, and Reference to Applicable Laws

and Regulations sections.

06/01/16

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04/01/17

Review for effective date 05/08/17.

Administrative changes made to the Medical

Policy Statement and Applicable Coding

sections (without changing the code list or

criteria). Updated Definitions, Clinical

Background Information, References, and

Reference to Applicable Laws and Regulations

sections.

05/08/17

Version 11

04/19/17: MPCTAC

02/01/18

Review for effective date 03/01/18. Updated

Description of Item or Service and Other

Applicable Policies sections.

03/01/18

Version 12

02/21/18: MPCTAC

05/01/18

Review for effective date 06/01/18.

Administrative changes made to the Limitations

sections. Updated Plan notes in the Applicable

Coding section without changing the code list.

Removed QHP/ConnectorCare/Employer

Choice Direct from the list of applicable

products for this policy. Updated Policy

Summary, Definitions, References, and Other

Applicable Policies sections.

06/01/18

Version 13

05/16/18: MPCTAC

03/01/19

Review for effective date 04/01/19.

Administrative changes made to the Description

of Item or Service, Limitations, Applicable

Coding (with Plan notes added), References,

and Other Applicable Policies sections.

04/01/19

Version 14

03/20/19: MPCTAC

04/01/19

Review for effective date 05/01/19.

Administrative changes made to the Policy

Summary, Description of Item or Service,

Medical Policy Statement, and Limitations

sections. Revised the policy title. Removed

non-payable code listed as not medical

necessary (administrative change) and updated

Plan notes in the Applicable Coding section.

05/01/19

Version 15

04/18/19: MPCTAC

(electronic vote)

12/01/19

Review for effective date 01/01/20.

Administrative changes made to Plan notes in

the Applicable Coding section, References

section, and Reference to Applicable Laws and

Regulations section.

01/01/20

Version 16

12/18/19: MPCTAC

04/01/20

Review for effective date 07/01/20.

Administrative changes made to the Policy

Summary, Clinical Background Information,

References, and Reference to Applicable Laws

and Regulations sections. Revised the Plan

notes in the Applicable Coding section. Add a

prior authorization requirement for acupuncture

07/01/20

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04/15/20:

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for Senior Care Options members in the Medical

Policy Statement and Limitations sections.

12/01/20

Review for effective date 01/01/21.

Administrative changes made to the Description

of Item or Service, Medical Policy Statement,

Applicable Coding, and References sections.

01/01/21

Version 18

12/16/20: MPCTAC

11/01/21

Review for effective date 12/01/21. Adopted

new medical policy template; removed

administrative sections, the Medical Policy

Statement section renamed the Clinical Criteria

section, and the Limitations section renamed

the Limitations and Exclusions section. Added

NH Medicare Advantage HMO as an applicable

product effective 01/01/22. Administrative

changes made to the Policy Summary, Clinical

Criteria, Limitations and Exclusions, Applicable

Coding, and References sections.

01/01/22

Version 19

11/17/21: MPCTAC

12/01/21

Review for effective date 01/01/22. Removed

acupuncture references. Review the Plan’s

Acupuncture medical policy, policy number OCA

3.17, rather than this policy for acupuncture

services as of 01/01/22.

01/01/22

Version 20

12/15/21: MPCTAC

08/01/22

Review for effective date 11/01/22.

Administrative changes made to the Policy

Summary, Clinical Criteria, and Limitations and

Exclusions sections. Revised coding in the

Applicable Coding section.

11/01/22

Version 21

Version 21 NOT

implemented; Version

20 effective 01/01/22

to 11/30/22

08/26/22: MPCTAC

(electronic vote)

09/01/22

Review for effective date 12/01/22. The

effective date of AIM Specialty Health’s

management of outpatient rehabilitation

services changed from 11/01/22 to 12/01/22.

Administrative changes made to the Policy

Summary, Clinical Criteria, and Limitations and

Exclusions sections. Revised coding in the

Applicable Coding section.

12/01/22

Version 22

09/23/22: MPCTAC

(electronic vote)

Gender Affirmation Services

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Medical Policy

Gender Affirmation Services

Policy Number: OCA 3.11

Version Number: 22

Version Effective Date: 12/01/22

Impacted Products

☒ All Products

☒ NH Medicaid

☒ NH Medicare Advantage

☒ MA MassHealth ACO

☒ MA MassHealth MCO

☒ MA Qualified Health Plans/Employer Choice Direct

☒ MA Senior Care Options

Note: Disclaimer and audit information is located at the end of this document.

Policy Summary

Gender affirmation surgeries and permanent hair removal require prior authorization and are

considered medically necessary for a member seeking treatment for gender dysphoria when Plan

medical criteria are met. Gender affirmation surgeries may include one (1) or more surgical procedures

and are part of a complex treatment plan involving medical, surgical, and behavioral health

interventions to achieve the desired outcomes for the individual.

Voice therapy is considered medically necessary as a treatment option for gender dysphoria when AIM

clinical appropriateness guidelines are met; prior authorization from AIM Specialty Health is required.

The Plan and the Plan’s delegated clinical vendors conducting utilization management do NOT

discriminate, arbitrarily deny, and/or impose stricter requirements by reducing the amount, duration,

and/or scope of required and medically necessary services for ANY Plan member based on the

member’s diagnosis, type of illness, health status or condition, sex, gender identity/gender dysphoria,

and/or sexual orientation. The full range of medical and/or surgical treatment options available to

individuals diagnosed with gender dysphoria may include, but are not limited to, those listed in

professional medical publications such as the current version of WPATH Standards of Care for Health

and Transsexual, Transgender and Gender-Nonconforming People.

Breast reconstruction used for the treatment of members with persistent, well-documented gender

dysphoria may include the medically necessary surgical removal of breast implants and/or the

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replacement of breast implants after implant explantation (including when the implant was initially

inserted as a component of a gender affirmation surgery); review the criteria in the Breast

Reconstruction medical policy, policy number OCA 3.43, rather than the criteria included in this policy.

Feminizing/masculinizing hormonal therapy and/or gender affirmation surgeries may limit the

member’s fertility. Infertility services are covered for some Plan products. Review the Plan’s Infertility

Services medical policy, policy number OCA 3.725.

Clinical Criteria

Applicable criteria must be met for gender affirmation services in item I for gender affirmation surgery

and permanent hair removal and/or item II for gender affirmation services that require Plan Medical

Director review.

I. The Plan considers gender affirmation services medically necessary for the treatment of gender

dysphoria, and Plan prior authorization is required for the services specified in this section. ALL

applicable Plan clinical review criteria must be met in items A through C:

A. Referral/Initial Assessment by Qualified Licensed Mental Health Professional:

There is a referral/initial assessment from a licensed qualified mental health professional that

contains ALL of the following documentation listed in items 1 through 8:

1. Gender identity resulting in a definitive diagnosis of persistent, well-documented gender

dysphoria (meeting DSM-5 criteria) for at least 6 months, history and development of

gender dysphoric feelings, and impact of stigma attached to gender nonconformity; AND

2. If living in an identity-congruent gender role, documentation of member’s experience, start

date, and if living full-time in identity-congruent gender role; AND

3. The member’s general identifying characteristics; AND

4. Results of psychosocial assessment, including any diagnoses and confirmation that other

behavioral health conditions are appropriately managed, reasonably controlled, and not

contributing to gender dysphoria); AND

5. Duration of mental health professional’s relationship with member, including type of

evaluation and therapy/counseling to date; AND

6. Written clinical rationale supporting member’s request for specific treatment(s); AND

7. Statement that mental health professional is available for coordination of care and plan of

care is in place; AND

8. Member’s psychological readiness for the requested treatment(s) with no contraindications

to treatment documented, including member’s capacity to make a fully informed decision

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and has the capacity to consent for treatment(s), and includes parental or guardian consent

(as applicable) if the member is younger than age 18 on the date of service unless the

adolescent member is emancipated at the time the service is rendered; AND

B. Member age 18 or older on the date of service; AND

C. Service-Specific Criteria:

Criteria must be met in item 1 for all gender affirmation surgical procedures and procedure

specific criteria must be met in item 2:

1. Gender Affirmation Surgical Procedures:

All criteria must be met in items a through e for any gender affirmation surgery:

a. Requests for prior authorization for each gender affirmation surgery must be submitted

by the surgeon (or the surgeon’s designee) performing the procedure and accompanied

by written clinical documentation; AND

b. Surgeon has reviewed the documentation by the qualified licensed mental health

professional (referenced above in item A), including the DSM-5 diagnosis of gender

dysphoria, and documentation from the member’s health care provider; AND

c. Surgeon has discussed risks and complications of proposed surgery and various surgical

techniques, surgeon’s own complication rates, impact on fertility, procedures for

preservation of fertility, and has obtained member’s informed consent; AND

d. If hormone therapy is a required criterion for a gender affirmation surgery (as specified

below in the procedure-specific criteria), medical records must document member

compliance with the prescribed regimen and clinical response over the course of

hormone therapy; AND

e. Member’s treating surgeon has documented that there are no contraindications to the

planned surgery, verified significant medical conditions are stable, and agrees with the

plan of care; AND

2. Procedure-Specific Criteria:

Procedure-specific criteria must be met for ANY procedure listed in items a through h:

a. Chest Procedures:

(1) Bilateral augmentation mammoplasty (with implantation of breast prostheses or

lipofilling) when the member has had 12 continuous months of clinician-supervised

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hormone therapy (unless hormone therapy is medically contraindicated for the

member), and the hormone therapy has not resulted in sufficient breast

development as self-reported by the member to the treating provider; OR

(2) Bilateral breast reduction, mastectomy, and/or chest reconstruction is requested;

b. Feminizing Genital Surgery:

ALL guidelines must be met in items (1) through (4):

(1) ANY of the procedures in items (a) through (g) will be performed:

(a) Clitoroplasty/neoclitoroplasty;

(b) Labiaplasty/neolabiaplasty;

(d) Penectomy;

(e) Urethroplasty and urethra-meatoplasty;

(f) Vaginoplasty (also known as neovaginoplasty); e.g., penile inversion

vaginoplasty, colovaginoplasty, peritoneal pulldown vaginoplasty;

(g) Vulvoplasty/neovulvoplasty; AND

(2) Member has been assessed by 2 independently licensed health professionals, one

of whom must be a licensed qualified behavioral health professional (referenced

above in item A) and the other a clinician familiar with the member’s health, with

each assessment resulting in a diagnosis of gender dysphoria meeting DSM-5

criteria. The initial diagnosis (from one professional) must have been present for

at least 6 months; AND

(3) Member has had 12 continuous months of living as the gender that is congruent

with the member’s identity. Exceptions may be provided on a case-by-case basis

should the request for prior authorization document that compliance with this

requirement would jeopardize the health, safety, and/or well-being of the member;

AND

(4) The member has had 12 continuous months of clinician-supervised hormone

therapy appropriate to the member’s gender goals, unless hormone therapy is

medically contraindicated; OR

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c. Masculinizing Genital Surgery:

ALL guidelines must be met in items (1) through (4):

(1) ANY of the procedures listed in items (a) through (i) will be performed:

(a) Hysterectomy;

(b) Metoidioplasty;

(d) Phalloplasty with implantation of penile prosthesis;

(e) Salpingectomy;

(f) Scrotoplasty with insertion of testicular implants;

(g) Urethroplasty;

(h) Vaginectomy;

(i) Vulvectomy; AND

(2) Member has been assessed by 2 independently licensed health professionals, one

of whom must be a licensed qualified behavioral health professional (referenced

above in item A) and the other a clinician familiar with the member’s health, with

each assessment resulting in a diagnosis of gender dysphoria meeting DSM-5

criteria. The initial diagnosis (from 1 professional) must have been present for at

least 6 months; AND

(3) Member has had 12 continuous months of living as the gender that is congruent

with the member’s identity. Exceptions may be provided on a case-by-case basis

should the request for PA document that compliance with this requirement would

jeopardize the health, safety, or well-being of the member; AND

(4) Member has had 12 continuous months of clinician-supervised hormone therapy

appropriate to the member’s gender goals, unless hormone therapy is medically

contraindicated; OR

d. Facial Feminization or Facial Masculinization Surgical Procedures:

ONE (1) or more of the procedures listed in items (1) through (12) will be performed:

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(1) Blepharoplasty (eyelid surgery) ONLY in conjunction with other medically

necessary facial feminization or facial masculinization procedures;

(2) Brow reconstruction/brow lift;

(3) Cheek augmentation;

(4) Forehead contouring (including forehead reshaping or forehead reduction);

(5) Genioplasty (chin augmentation, chin reconstruction, or chin

reduction/narrowing);

(6) Scalp/hairline advancement;

(7) Lateral canthopexy;

(8) Surgical lip lift;

(9) Lysis intranasal synechiae;

(10) Mandibuloplasty;

(11) Osteoplasty;

(12) Rhinoplasty and septoplasty;

(13) Rhytidectomy (facelift surgery) of the forehead, cheek, and/or neck

(platysmaplasty);

(14) Suction-assisted lipectomy in conjunction with medically necessary facial

procedures; AND/OR

(15) Tracheoplasty/tracheal shave; OR

e. Hair Removal with Laser or Electrolysis:

Electrolysis and/or laser treatments for face and neck hair removal is performed by a

licensed and qualified treating clinician and ALL criteria are met in items (1) through (5):

(1) A licensed qualified health professional recommends hair removal of the face

and/or neck as part of the member’s medically necessary treatment for gender

dysphoria; AND

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(2) A letter from the clinician performing the hair removal is submitted to the Plan and

includes attestation of the medical necessity of hair removal and a summary of the

member’s care as it relates to gender dysphoria treatment; AND

(3) Documentation submitted to the Plan includes the area size and location(s) for

permanent hair removal, the type of hair removal treatment (laser or electrolysis),

and the expected timeframe and number of treatments requested. The Plan will

authorize medically necessary requests for electrolysis and/or laser ablation

treatments for medically necessary permanent hair removal of the face and/or neck for

up to 12 calendar months from the date of the authorization request. Additional

treatments require a separate Plan authorization; AND

(4) Clinician performing the hair removal has discussed risks and complications of the

proposed procedure, including the clinician’s own complication rates, and has

obtained informed consent from the member; AND

(5) Member has had 12 continuous months of clinician-supervised hormone therapy

appropriate to the member’s gender goals unless hormone therapy is medically;

f. Hair removal for standard pre-operative preparation for genital gender affirmation

surgery:

Electrolysis and/or laser treatments for hair removal is performed by a licensed and

qualified treating provider and ALL criteria are met in items (1) through (4):

(1) Permanent hair removal is required as part of the standard pre-operative

preparation for genital affirming surgery(ies) and is recommended by the treating

surgeon, with documentation verifying that hair removal is medically necessary;

AND

(2) A letter from the clinician performing the hair removal is submitted to the Plan and

includes attestation of the medical necessity of hair removal and a summary of the

member’s care as it relates to gender dysphoria treatment; AND

(3) Documentation submitted to the Plan includes the area size and location(s) for

permanent hair removal, the type of hair removal treatment (laser or electrolysis),

expected timeframe and number of treatments requested, and the estimated date

of the genital gender affirmation surgical procedure(s). The Plan will authorize

medically necessary requests for electrolysis and/or laser ablation treatments for

medically necessary pre-operative permanent hair removal as standard preparation for

genital gender affirmation surgery for up to 18 calendar months from the date of the

authorization request. Additional treatments require a separate Plan authorization; AND

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(4) Clinician performing the hair removal has discussed risks and complications of the

proposed procedure, including the clinician’s own complication rates, and has

obtained informed consent from the member; OR

g. Gender Affirmation Procedures NOT Requiring Medically Necessary Permanent Hair

Removal of Graft Site:

The Plan will authorize medically necessary requests for gender affirmation surgery(ies)

up to 12 calendar months from the date of the authorization request; OR

h. Genital Gender Affirmation Procedures Requiring Medically Necessary Permanent Hair

Removal of Graft Site:

The Plan will authorize medically necessary requests for genital gender affirmation

procedure(s) that require pre-operative permanent hair removal as standard

preparation for surgery up to 18 calendar months from the date of the authorization

request.

II. The following requests require Plan Medical Director review:

A. Permanent hair removal in preparation for planned genital gender affirmation procedure if the

procedure has not yet been authorized by the Plan.

B. Hair removal when documentation from the member’s surgeon and/or qualified licensed health

provider(s) is within 13-18 calendar months of the prior authorization request and permanent

hair removal is NOT a medically necessary component of pre-operative preparation for genital

gender affirmation procedure(s). Additional documentation must be submitted to the Plan to

report the extenuating circumstances that necessitate an extension of the standard 12 calendar

month time limit.

C. Gender affirmation surgery for a member who does NOT meet DSM-5 definitive diagnosis of

persistent gender dysphoria (e.g., non-binary members who do not meet traditional diagnostic

criteria for gender dysphoria).

D. Gender affirmation services for a member unable to live in the chosen gender role full-time.

This includes members who identify as genders other than male or female. Treating provider

must submit documentation indicating why it would be clinically inappropriate to require the

member to meet this criterion and why this requirement should be waived.

E. Gender affirmation surgery and/or permanent hair removal for a member age 17 or younger on

the date of service. The Plan Medical Director will review the current version of WPATH

Standards of Care and member’s clinical situation, including but not limited to the amount of

time the adolescent member has been living in the gender congruent role, treatment timeframe

with hormone therapy, age of the member, and the requested intervention. Adolescent

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members may be eligible for interventions when adolescents and their parents (or guardian)

make informed decisions about treatment, and the service is a covered benefit for the Plan

member. Informed consent by a parent or guardian for treatment of an adolescent member

may not apply if the adolescent member is emancipated at the time the service is rendered (as

determined by state requirements).

F. Surgical revision of a previously performed gender affirmation surgery.

G. Laparoscopic prostatectomy as a component of gender affirmation surgical procedure(s).

H. Post-operative lodging is NOT routinely covered by the Plan; Plan Medical Director review is

required.

Limitations and Exclusions

A. External review will be available to the members enrolled in Qualified Health Plans,

ConnectorCare, or Employer Choice Direct products when the Plan determines that coverage

for treatment of gender dysphoria is NOT medically necessary or the Plan considers the

treatment experimental or investigational. The external review for Qualified Health Plans,

ConnectorCare, or Employer Choice Direct products will be based upon the Massachusetts

definition of medical necessity. (Source: The Commonwealth of Massachusetts, Health Policy

Commission, Memo: External Review for Denials of Coverage for Medical and/or Surgical

Treatment of Gender Dysphoria, July 2, 2015.)

B. Hair removal is ONLY covered when criteria are met in the Clinical Criteria section for the

method of hair removal (i.e., electrolysis and/or laser hair removal). Any other method of hair

removal or indication for treatment is NOT covered.

C. The Plan considers any services or surgical procedures used to reverse gender affirmation

surgery to NOT be medically necessary.

D. The following procedures/services in items 1 through 17 are NOT covered for the treatment of

gender dysphoria:

1. Blepharoplasty (eyelid surgery) NOT in conjunction with other facial feminization or facial

masculinization procedures used for the treatment of gender dysphoria; OR

2. Body contouring procedures, including abdominoplasty, liposuction, lipofilling, and/or

suction-assisted lipectomy UNLESS the treatment is listed as medically necessary in the

Clinical Criteria section (e.g., facial procedures for the treatment of gender dysphoria) and

ALL applicable clinical review criteria are met for the gender affirmation surgical procedure;

3. Calf augmentation (calf implants); OR

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4. Collagen injections; OR

5. Facial feminization surgery, facial masculinization surgery, facial bone reduction, or facial

implants or injections UNLESS the treatment is specified as medically necessary in the

Clinical Criteria section and applicable clinical review criteria are met for the facial

feminizing or facial masculinizing gender affirmation surgical procedure; OR

6. Gluteal augmentation (gluteal implants and/or lipofilling); OR

7. Hair transplantation or hair reconstruction (see the Clinical Criteria section for guidelines for

hairline advancement surgery); OR

8. Laryngoplasty (technique to alter the voice tract and adjust vocal range); OR

9. Lip reduction or lip enhancement (see the Clinical Criteria section for guidelines related to

lip lift); OR

10. Osteoplasty UNLESS clinical review criteria are met for the facial feminization or facial

masculinization gender affirmation surgical procedure in the Clinical Criteria section); OR

11. Otoplasty (surgical reshaping of the outer ear); OR

12. Pectoral augmentation (pectoral implants); OR

13. Removal of redundant skin including but NOT limited to panniculectomy and/or

abdominoplasty when used for the treatment of gender dysphoria UNLESS the procedure

is listed as medically necessary in the Clinical Criteria section and applicable criteria are met;

Note: Review the Plan’s medical necessity guidelines included in the Panniculectomy and

Related Redundant Skin Surgery medical policy, policy number OCA 3.722.

14. Silicone injections of the breast; OR

15. Skin resurfacing treatments including but NOT limited to chemical peels and/or

dermabrasion; OR

16. Tattooing; OR

17. Vocal cord surgery (laryngoplasty, cricothyroid approximation or shortening of the vocal

cords).

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E. Reimbursement for travel expenses is NOT covered by the Plan unless the Plan’s product-

specific criteria are met, as specified in the Non-Emergency Transportation Services medical

policy applicable for the member’s product, policy number OCA 3.191.

Variations

The Plan uses guidance from the Centers for Medicare & Medicaid Services (CMS) for medical

necessity and coverage determinations for the Plan’s Senior Care Options (SCO) members and New

Hampshire Medicare Advantage HMO members, including but not limited to national coverage

determinations (NCDs), local coverage determinations (LCDs), local coverage articles (LCAs), and

documentation included in Medicare manuals. At the time of the Plan’s most recent policy review,

NCD 140.9 states CMS has determined that no NCD is appropriate at this time for gender affirmation

surgery for Medicare beneficiaries with gender dysphoria. LCA A53793 includes billing, coding, and

treatment guidelines for gender affirmation services for gender dysphoria. Verify CMS guidelines in

effect on the date of the prior authorization request. When there is no guidance from CMS for the

requested service, Plan-adopted clinical review criteria will be used to determine the medical necessity

of the service.