iStent Trabecular Micro Bypass Stent
Transcript Of iStent Trabecular Micro Bypass Stent
iStent Trabecular Micro Bypass Stent
State(s): Idaho
Montana Oregon Washington Other:
LOB(s): Commercial
Medicare
Medicaid
Enterprise Policy
Clinical Guidelines are written when necessary to provide guidance to providers and members in order to outline and clarify coverage criteria in accordance with the terms of the Member’s policy. This Clinical Guideline only applies to PacificSource Health Plans, PacificSource Community Health Plans, and PacificSource Community Solutions in Idaho, Montana, Oregon, and Washington. Because of the changing nature of medicine, this list is subject to revision and update without notice. This document is designed for informational purposes only and is not an authorization or contract. Coverage determination are made on a case-by-case basis and subject to the terms, conditions, limitations, and exclusions of the Member’s policy. Member policies differ in benefits and to the extent a conflict exists between the Clinical Guideline and the Member’s policy, the Member’s policy language shall control. Clinical Guidelines do not constitute medical advice nor guarantee coverage.
Background
Surgical procedures for glaucoma aim to reduce intraocular pressure (IOP) resulting from impaired aqueous humor drainage in the trabecular meshwork and/or Schlemm’s canal when medical therapy has failed to adequately control the IOP.
The most common surgical procedure for lowering IOP in glaucoma is a trabeculectomy (guarded filtration surgery), which creates a hole in the sclera to let the aqueous fluid drain into the outer cyst or bleb.
The iStent Trabecular Micro-Bypass Stent System creates a permanent opening from the anterior chamber into Schlemm’s canal to improve aqueous humor outflow past the trabecular meshwork, thereby reducing IOP.
Criteria
Commercial
Prior Authorization is Required.
iStent Trabecular Micro-Bypass Stent System may be consider medically necessary when ALL of the following criteria have been met:
• patient is an adult
• diagnosis of mild to moderate open-angle glaucoma
• currently treated with ocular hypotensive medication
• procedure is in conjunction with cataract surgery for the reduction of intraocular pressure (IOP)
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Use of the iStent® Trabecular Micro-Bypass Stent System for all other conditions, including patients with glaucoma when intraocular pressure is adequately controlled by medications, does not meet PacificSource medical criteria for coverage and is considered experimental/investigational/unproven.
Medicaid
PacificSource Community Solutions follows this policy in accordance with Guideline Note 184 of the OHP Prioritized List of Health Services for coverage of iStent Trabecular Micro-Bypass Stent.
Medicare
PacificSource Medicare follows Local Coverage Determination L35490 for Category III Codes.
Coding Information
0191T Insertion of anterior segment aqueous drainage device, w/o extraocular reservoir; internal approach, into the trabecular meshwork 0253T Insertion of anterior segment aqueous drainage device, without extraocular reservoir; internal approach, into the suprachoroidal space
0376T each additional device insertion (List in separately in addition to code for primary procedure)
References
American Glaucoma Society (AGS): (2012) Position Statement on New Glaucoma Surgical Procedure. Accessed on April 23, 2014, November 30, 2017, October 31, 2018, October 2, 2019, 7/20/2020 https://www.americanglaucomasociety.net/about/statements
Fea, AM et al. (2014) Prospective unmasked randomized evaluation of the iStent inject® versus two ocular hypotensive agents in patients with primary open-angle glaucoma. Clin Ophthalmol. 2014; 8: 875–882. November 30, 2017, October 31, 2018, 10/2/2019, 7/20/2020 http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4019628/
Hayes Health Technology Brief: iStent Trabecular Micro-Bypass Stent (Glaukos Corp.) in Combination with Cataract Surgery for Treatment of Primary Open-Angle Glaucoma. Lansdale PA: Hayes, Inc. Winifred S. Hayes, Inc. March 17, 2016. Annual review March 30, 2018, Sep 17, 2019
Samuelson, TW et al. (2011) Randomized evaluation of the trabecular micro-bypass stent with phacoemulsification in patients with glaucoma and cataract. Ophthalmology. 2011 Mar;118(3):459-67. Accessed November 30, 2017, October 31, 2018, October 2, 2019, 7/20/2020 http://www.ncbi.nlm.nih.gov/pubmed/20828829
Appendix
Policy Number:
Page 2 of 3
Effective: 8/1/2020
Next review: 8/1/2021
Policy type: Enterprise
Author(s):
Depts: Health Services
Applicable regulation(s): [Applicable Regulation(s)]
Page 3 of 3
State(s): Idaho
Montana Oregon Washington Other:
LOB(s): Commercial
Medicare
Medicaid
Enterprise Policy
Clinical Guidelines are written when necessary to provide guidance to providers and members in order to outline and clarify coverage criteria in accordance with the terms of the Member’s policy. This Clinical Guideline only applies to PacificSource Health Plans, PacificSource Community Health Plans, and PacificSource Community Solutions in Idaho, Montana, Oregon, and Washington. Because of the changing nature of medicine, this list is subject to revision and update without notice. This document is designed for informational purposes only and is not an authorization or contract. Coverage determination are made on a case-by-case basis and subject to the terms, conditions, limitations, and exclusions of the Member’s policy. Member policies differ in benefits and to the extent a conflict exists between the Clinical Guideline and the Member’s policy, the Member’s policy language shall control. Clinical Guidelines do not constitute medical advice nor guarantee coverage.
Background
Surgical procedures for glaucoma aim to reduce intraocular pressure (IOP) resulting from impaired aqueous humor drainage in the trabecular meshwork and/or Schlemm’s canal when medical therapy has failed to adequately control the IOP.
The most common surgical procedure for lowering IOP in glaucoma is a trabeculectomy (guarded filtration surgery), which creates a hole in the sclera to let the aqueous fluid drain into the outer cyst or bleb.
The iStent Trabecular Micro-Bypass Stent System creates a permanent opening from the anterior chamber into Schlemm’s canal to improve aqueous humor outflow past the trabecular meshwork, thereby reducing IOP.
Criteria
Commercial
Prior Authorization is Required.
iStent Trabecular Micro-Bypass Stent System may be consider medically necessary when ALL of the following criteria have been met:
• patient is an adult
• diagnosis of mild to moderate open-angle glaucoma
• currently treated with ocular hypotensive medication
• procedure is in conjunction with cataract surgery for the reduction of intraocular pressure (IOP)
Page 1 of 3
Use of the iStent® Trabecular Micro-Bypass Stent System for all other conditions, including patients with glaucoma when intraocular pressure is adequately controlled by medications, does not meet PacificSource medical criteria for coverage and is considered experimental/investigational/unproven.
Medicaid
PacificSource Community Solutions follows this policy in accordance with Guideline Note 184 of the OHP Prioritized List of Health Services for coverage of iStent Trabecular Micro-Bypass Stent.
Medicare
PacificSource Medicare follows Local Coverage Determination L35490 for Category III Codes.
Coding Information
0191T Insertion of anterior segment aqueous drainage device, w/o extraocular reservoir; internal approach, into the trabecular meshwork 0253T Insertion of anterior segment aqueous drainage device, without extraocular reservoir; internal approach, into the suprachoroidal space
0376T each additional device insertion (List in separately in addition to code for primary procedure)
References
American Glaucoma Society (AGS): (2012) Position Statement on New Glaucoma Surgical Procedure. Accessed on April 23, 2014, November 30, 2017, October 31, 2018, October 2, 2019, 7/20/2020 https://www.americanglaucomasociety.net/about/statements
Fea, AM et al. (2014) Prospective unmasked randomized evaluation of the iStent inject® versus two ocular hypotensive agents in patients with primary open-angle glaucoma. Clin Ophthalmol. 2014; 8: 875–882. November 30, 2017, October 31, 2018, 10/2/2019, 7/20/2020 http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4019628/
Hayes Health Technology Brief: iStent Trabecular Micro-Bypass Stent (Glaukos Corp.) in Combination with Cataract Surgery for Treatment of Primary Open-Angle Glaucoma. Lansdale PA: Hayes, Inc. Winifred S. Hayes, Inc. March 17, 2016. Annual review March 30, 2018, Sep 17, 2019
Samuelson, TW et al. (2011) Randomized evaluation of the trabecular micro-bypass stent with phacoemulsification in patients with glaucoma and cataract. Ophthalmology. 2011 Mar;118(3):459-67. Accessed November 30, 2017, October 31, 2018, October 2, 2019, 7/20/2020 http://www.ncbi.nlm.nih.gov/pubmed/20828829
Appendix
Policy Number:
Page 2 of 3
Effective: 8/1/2020
Next review: 8/1/2021
Policy type: Enterprise
Author(s):
Depts: Health Services
Applicable regulation(s): [Applicable Regulation(s)]
Page 3 of 3