MEDICAL POLICY

POLICY
RELATED POLICIES
POLICY GUIDELINES
DESCRIPTION
SCOPE
BENEFIT APPLICATION
RATIONALE
REFERENCES
CODING
APPENDIX
HISTORY

Technology Review

Number 10.01.504

Effective Date July 9, 2013

Revision Date(s) 07/08/13; 09/11/12; 12/13/11; 12/14/10; 11/10/09; 12/16/08; 06/10/08, 07/10/07; 12/12/06, 11/11/05; 12/14/04; 12/09/03; 12/10/02; 07/10/01; 10/05/99; 10/06/98; 03/12/96

Replaces N/A

Policy

The Medical Policy Committee members and Medical Directors evaluate new technology, including medical and behavioral health procedures, pharmaceuticals, and devices, to address whether the services meet contractually defined coverage criteria.

Related Policies

10.01.511

Medical Policy Guidelines and Definitions

Policy Guidelines

Technology review occurs in the context of Medical Policy Committee determinations or related to an individual member or provider request for coverage of a new technology.

  • The technology review process may include any of the following sources:
  • BCBSA Medical Policy Reference Manual
  • BCBSA Technology Evaluation Center (TEC) Assessments and other national sources of technology assessments(such as AHRQ and ICIS)
  • Company Medical Policy Manual
  • Consultation with local physicians with expertise in the field
  • Hayes, Inc. Knowledge Center and Technology Assessment Services (©1996-2012 Winifred S. Hayes, Inc.)
  • Independent external advisory group or medical specialty association recommendations
  • MCG™ - 17th edition (formerly Milliman Care Guidelines®) (MCGTM Copyright ©2013, MCG Health, LLC)
  • Published credible scientific evidence in peer-reviewed medical literature generally recognized by the relevant medical community
  • Regulatory rulings and publications, e.g., FDA status and OIC regulations
  • Up-To-Date® (Wolters Kluwer Health, ©2013, UpToDate, Inc.)

Description

The Company regularly evaluates new and developing medical and behavioral health applications of technologies, drugs and services to determine if published scientific evidence supports the safety and efficacy of the proposed services.

The Medical Policy Committee and Medical Directors use available Blue Cross Blue Shield (BCBSA) Technology Evaluation Center (TEC) assessments, Hayes, Inc. Knowledge Center and technology assessment services and other national sources of technology assessment. In addition the following may also be used:

  • A search of MEDLINE or other scientific literature databases, with an emphasis on credible scientific evidence in peer-reviewed medical literature generally recognized by the relevant medical community
  • National physician specialty recommendations
  • General internet search, including manufacturer’s website if available
  • Local medical practice patterns and medical expert opinion

The Medical Policy Committee and Medical Directors use the BCBSA TEC criteria listed below to assess new and evolving technology

The technology must have final approval from the appropriate governmental regulatory bodies.

  • This criterion applies to drugs, biological products, devices and any other product or procedure that must have final approval to market from the U.S. Food and Drug Administration or any other federal governmental body with authority to regulate the technology.
  • Any approval that is granted as an interim step in the U.S. Food and Drug Administration's or any other federal governmental body's regulatory process is not sufficient.
  • The indications for which the technology is approved need not be the same as those which Blue Cross and Blue Shield Association's Technology Evaluation Center is evaluating.

The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes.

  • The evidence should consist of well-designed and well-conducted investigations published in peer-reviewed journals. The quality of the body of studies and the consistency of the results are considered in evaluating the evidence.
  • The evidence should demonstrate that the technology can measure or alter the physiological changes related to a disease, injury, illness, or condition. In addition, there should be evidence or a convincing argument based on established medical facts that such measurement or alteration affects health outcomes.
  • Opinions and evaluations by national medical associations, consensus panels, or other technology evaluation bodies are evaluated according to the scientific quality of the supporting evidence and rationale.

The technology must improve the net health outcome.

  • The technology's beneficial effects on health outcomes should outweigh any harmful effects on health outcomes.

The technology must be as beneficial as any established alternatives.

  • The technology should improve the net health outcome as much as, or more than, established alternatives.

The improvement must be attainable outside the investigational settings.

  • When used under the usual conditions of medical practice, the technology should be reasonably expected to satisfy TEC criteria #3 and #4.

The above criteria are listed in the majority of member contracts as the threshold to define services that are investigational. A given service must meet all of the bullets listed above. Failure to meet any one of the criteria results in a designation of that service as investigational (or experimental and investigational) and therefore excluded by the member’s contract.

NOTE: A small number of member contracts may contain differing definitions of investigational services. The member benefit booklet should be consulted for the definition of investigational services for that group.

Scope

Medical policies are systematically developed guidelines that serve as a resource for Company staff when determining coverage for specific medical or behavioral health procedures, drugs or devices. Coverage for any service is always subject to the limits and conditions of the member benefit plan. Members and their providers should consult the member benefit booklet or contact a customer service representative to determine whether there are benefit limitations applicable to any given service or supply.

Benefit Application

N/A

Rationale

N/A

References

N/A

Appendix

N/A

History

Date

Reason

03/12/96

Add to Managed Care Policy Manual - Initial documentation of process

10/06/98

Revise and Update - Transfer to Premera Medical Policy Manual Introduction Section

10/05/99

Add to Administrative Section - Formatted as a Policy and removed from Introduction Section of Manual

07/10/01

Replace Policy - Scheduled review; revised for clarity.

12/10/02

Replace Policy - Policy reviewed; no criteria changes.

12/09/03

Replace Policy - Scheduled review; no criteria changes.

09/01/04

Replace Policy - Policy renumbered from PR.10.01.104. No date changes.

12/14/04

Replace Policy - Scheduled review; no criteria changes.

11/11/05

Replace Policy - Scheduled review; no criteria changes.

05/26/06

Scope and Disclaimer language update only. - No other changes.

12/12/06

Replace Policy - Scheduled review, revised for clarity. No change to the policy statement.

07/10/07

Replace Policy - Policy updated with BCBSA TEC criteria added to Description section and inclusion of information on Physician Specialty Society review board.

06/10/08

Replace Policy - Scheduled review; no criteria changes.

12/16/08

Replace Policy - Policy updated to include BCBSA and Premera policies to description section.

11/10/09

Replace Policy - Scheduled review; no criteria changes.

12/14/10

Replace Policy - Scheduled review; no criteria changes.

12/13/11

Replace Policy – Scheduled review. Policy updated with language to include behavioral health procedures, pharmaceuticals and devices, to address whether the services meet contractually defined coverage criteria.

09/11/12

Replace policy. Scheduled review; no criteria changes.

07/08/13

Replace policy. MCG™ and Up-To-Date® added as resources. Guideline description of review process reformatted. Clarification added regarding differing member contract definitions of investigational service.


Disclaimer: This medical policy is a guide in evaluating the medical necessity of a particular service or treatment. The Company adopts policies after careful review of published peer-reviewed scientific literature, national guidelines and local standards of practice. Since medical technology is constantly changing, the Company reserves the right to review and update policies as appropriate. Member contracts differ in their benefits. Always consult the member benefit booklet or contact a member service representative to determine coverage for a specific medical service or supply. CPT codes, descriptions and materials are copyrighted by the American Medical Association (AMA).
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