HIGHMARK COMMERCIAL MEDICAL POLICY - PENNSYLVANIA

 
 
Medical Policy:
Z-103-002
Topic:
Coverage with Evidence Development
Section:
Miscellaneous
Effective Date:
March 4, 2021
Issued Date:
May 2, 2022
Last Revision Date:
March 2022
Annual Review:
March 2022
 
 

This medical policy describes Coverage with Evidence Development (CED) for commercial members. 

In order to accelerate the emergence of high-quality affordable health care, Highmark will implement a “coverage with evidence development” (“CED”) medical policy and process. This policy will provide coverage for new technologies, procedures or services that are considered experimental and/or investigational under current Highmark medical policy, but which (a) have already gained all necessary regulatory approvals; (b) demonstrate results in the peer-reviewed clinical literature; (c) can reasonably be projected to achieve significant cost savings with equal or better clinical outcomes as compared with existing procedures/services; (d) have demonstrated benefits for the member in other pilots or trials; (e) improved a member’s access to care; and (f) could reasonably be implemented for use in a wider population of members by various and multiple clinicians.

Policy Position

A. Eligibility

  • Referrals may come from the VITAL12 program, from a qualified study principal within the Highmark provider network or from internal Highmark staff.
  • CED participation requires that Highmark members participate in a designated study or program and comply with program eligibility criteria and all applicable study protocols. Notwithstanding the foregoing, if contract or benefit exclusions prohibit such participation, such members are CED ineligible even if they may meet other criteria.
  • Highmark’s CED medical policy and process is entirely voluntary and non-obligatory for participant and/or provider participation.  Unless otherwise covered under Highmark medical policy and terms of coverage, Highmark is not obliged to cover any technology if it has not established a CED medical policy for that technology using the CED process set forth below.  

B. CED Process:

  • Referrals for CED consideration will go through a formal proposal review process outlined below in this policy.
  • Highmark staff and/or a designee(s) will conduct a preliminary review and determine whether the proposal fulfills the requirements described below. If the proposal meets the requirements set forth below in Highmark and/or a designee(s)’ sole determination, the proposal will then move forward to the CED review committee for its determination.
  • CED requests that do not meet these requirements will not be considered and shall not move forward to the CED review committee. This decision is considered final and non-appealable.
  • If the CED review committee approves a CED study, Highmark shall issue a written approval, which shall include any limitations in coverage. The approval shall be for two years from the date the CED review committee approves the proposal.
  • The CED Review Committee shall be responsible for monitoring the conduct of the study or program and making periodic reports to Highmark’s Vice President Executive Medical Director and/or a designee(s) at least annually, or more frequently as determined by the CED review committee. Such monitoring will include determining when it is necessary and appropriate to terminate a CED study.
  • Upon termination of a CED study, Highmark will consider the results of the study in determining whether to develop a new policy or modify existing medical policy.
  • In reviewing a technology, the CED review committee may consider the following:
  • A request is received from within the Highmark provider network for coverage of a technology associated with  high-quality research or a quality improvement clinical study that potentially meets the criteria for CED;
  • A Highmark Medical Director and/or a designee(s) identifies a technology associated with a high quality research or quality improvement clinical study that potentially meets the criteria for CED; and
  • Highmark receives a proposal from a study principal for consideration of a technology for CED based on it satisfying the CED criteria.

C. Required Proposal

To gain approval for coverage of a CED-eligible procedure and/or service, eligible providers shall be required to submit a proposal that includes all of the following:

  • Direct prior experience with the CED-eligible procedure and/or service;
  • A well-defined value proposition for the patient, provider, and payer as well as the potential economic impact to the healthcare system if successful;
  • Specific patient inclusion/exclusion criteria the provider would use to determine appropriate candidates for the requested CED-eligible procedures;
  • Specific clinical outcomes expected to be achieved  for eligible individuals that receive  the CED-approved procedure or service;
  • Specific methodology for measuring, monitoring, and documenting the clinical outcomes they expect to achieve;
  • The provider’s experience performing the CED-eligible procedure/service;
  • The names and credentials of all of the individual practitioners  who will be performing the CED-eligible procedure/service;
  • Letter of support from any facility at which the procedure and/or service is expected to be delivered, including commitment to provide the necessary equipment and therapeutics to accomplish the procedure and/or service; and
  • An attestation that all providers and facilities involved the CED-eligible proposal are willing and able to enter into a contractual agreement Highmark Inc. for the CED-eligible procedure/service.  

D.  The required CED study or program characteristics include all of the following:

  • The study is feasible, and necessary resources have been identified to complete the study;
  • The study’s efforts to develop informative and necessary evidence to draw conclusions regarding the benefit of the technology are defined;
  • The study design is methodologically appropriate and the anticipated number of enrolled subjects is sufficient to answer the research question(s) being asked in the study;
  • The study is performed by an organization or individual capable of completing it successfully and within a reasonable period of time;
  • The study is in compliance with all applicable Federal regulations concerning the protection of human subjects, U.S. Department of Health & Human Services, 45 CFR 46, and is approved by an Institutional Review Board (IRB);
  • All aspects of the study are conducted according to appropriate standards of scientific integrity set by the International MPC of Medical Journal Editors (http://www.icmje.org);
  • The study has a written protocol that clearly demonstrates adherence to the standards listed here as requirements for CED;
  • The study meets all appropriate requirements of investigational research by applicable institutions;
  • The study protocol does not meet the clinical trials criteria of Highmark Medical Policies;
  • The study is a randomized controlled trial, pragmatic trial, observational study or other design appropriate to the key questions of interest; and
  • Medical technologies designated as Emergency Use Authorization (EUA) status do not meet the intent of this CED policy.
Related Policies

Refer to Medical Policy G-27, Clinical Trials, for additional information.

Refer to Medical Policy Z-67, Experimental/Investigational Services, for additional information.

Refer to Medical Policy Z-11, Definition of Medical Necessity, for additional information.


Place of Service: Inpatient/Outpatient


The policy position applies to all commercial lines of business



Links





This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical or other circumstances may warrant individual consideration, based on review of applicable medical records, as well as other regulatory, contractual and/or legal requirements.

Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect Highmark's reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.

Highmark retains the right to review and update its medical policy guidelines at its sole discretion. These guidelines are the proprietary information of Highmark. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.

Discrimination is Against the Law
The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer:

  • Provides free aids and services to people with disabilities to communicate effectively with us, such as:
    • Qualified sign language interpreters
    • Written information in other formats (large print, audio, accessible electronic formats, other formats)
  • Provides free language services to people whose primary language is not English, such as:
    • Qualified interpreters
    • Information written in other languages

If you need these services, contact the Civil Rights Coordinator.

If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295, TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.

You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:

U.S. Department of Health and Human Services
200 Independence Avenue, SW
Room 509F, HHH Building
Washington, D.C. 20201
1-800-368-1019, 800-537-7697 (TDD)

Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.

This information is issued by Highmark Blue Shield on behalf of its affiliated Blue companies, which are independent licensees of the Blue Cross Blue Shield Association.  Highmark Inc. d/b/a Highmark Blue Shield and certain of its affiliated Blue companies serve Blue Shield members in the 21 counties of central Pennsylvania. As a partner in joint operating agreements, Highmark Blue Shield also provides services in conjunction with a separate health plan in southeastern Pennsylvania.  Highmark Inc. or certain of its affiliated Blue companies also serve Blue Cross Blue Shield members in 29 counties in western Pennsylvania, 13 counties in northeastern Pennsylvania, the state of West Virginia plus Washington County, Ohio, the state of Delaware[ and [8] counties in western New York and Blue Shield members in [13] counties in northeastern New York].  All references to Highmark in this document are references to Highmark Inc. d/b/a Highmark Blue Shield and/or to one or more of its affiliated Blue companies.




Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.

Discrimination is Against the Law
The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer:

  • Provides free aids and services to people with disabilities to communicate effectively with us, such as:
  • Qualified sign language interpreters
  • Written information in other formats (large print, audio, accessible electronic formats, other formats)

  • Provides free language services to people whose primary language is not English, such as:
  • Qualified interpreters
  • Information written in other languages
    • If you need these services, contact the Civil Rights Coordinator.

    If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295 , TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.

    You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:

    U.S. Department of Health and Human Services
    200 Independence Avenue, SW
    Room 509F, HHH Building
    Washington, D.C. 20201
    1-800-368-1019, 800-537-7697 (TDD)

    Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.