Commercial

Medical Policy

Notification

Not Medically Necessary Services and Obsolete or Unreliable Diagnostic Tests

Notification Issue Date:

This version of the policy will become effective 05/06/2019. The following medical device was added to the policy: home uterine activity monitoring devices. The following HCPCS code has been added to the policy:

S9001 Home uterine monitor with or without associated nursing services (Not Medically Necessary)

Title:

Not Medically Necessary Services and Obsolete or Unreliable Diagnostic Tests

Policy #:

00.01.24j

Policy

Not medically necessary services and obsolete or unreliable diagnostic tests are considered not medically necessary and, therefore, not covered because the available published peer-reviewed literature does not support their use in the diagnosis or treatment of illness or injury.

DIAGNOSTIC LAB TESTS

The following diagnostic tests are considered obsolete or unreliable and have been replaced by more advanced testing procedures:

Amylase, blood isoenzymes, electrophoretic
Animal inoculation, small animal; with observation
Animal inoculation, small animal; with observation and dissection
Bendien's test for cancer and tuberculosis
Bolen test for cancer (Bolen clot retraction test)
Calcium, feces, 24-hour quantitative
Calcium saturation clotting time
Capillary fragility test (Rumpel-Leede)
Cephalin flocculation
Chromium, blood
Chymotrypsin, duodenal contents
Circulation time, one test
Colloidal gold
Congo red, blood
Gastric analysis, pepsin
Gastric analysis, tubeless
Guanase, blood
Hair analysis
Hormones, adrenocorticotropin quantitative animal tests
Hormones, adrenocorticotropin quantitative bioassay
Rehfuss test for gastric acidity
Serum seromucoid assay for cancer and other diseases
Skin test, actinomycosis
Skin test, brucellosis
Skin test, cat scratch fever (cat scratch disease; Bartonella infection)
Skin test, lymphopathia venereum
Skin test, psittacosis
Skin test, trichinosis
Starch, feces, screening
Thymol turbidity, blood
Zinc sulphate turbidity, blood

MEDICAL SERVICES

The following medical services are considered obsolete or unreliable due to having limited clinical usefulness, and as such are not appropriate with regard to generally accepted standards of medical practice within the medical community:

Adrenal tissue transplant to the brain
Arthroscopic electrothermal joint repair or thermal capsulorrhaphy or electrothermal capsulorrhaphy or thermal or electrothermal shrinkage
Cardiointegram (CIG)
Continuous noninvasive glucose monitoring using the Glucowatch
Electron beam computed tomography (EBCT)
Fabric wrapping of abdominal aortic aneurysms
Home uterine activity monitoring (HUAM) devices
Intracardiac phonocardiogram
Intragastric hypothermia (Gastric freezing)
Phonocardiogram with or without electrocardiogram (ECG) lead, with or without indirect carotid artery and/or jugular vein tracing, and/or apex cardiogram
Transtympanic micropressure device
Vectorcardiogram (VCG), with or without electrocardiogram (ECG); with or without tracing

PHARMACEUTICAL PRODUCTS

Pharmaceutical products are considered not medically necessary when the approved authorization has been rescinded by the US Food and Drug Administration (FDA) for a specific approved condition or diagnosis or the product has been withdrawn from the market based on having limited clinical usefulness, and as such are not appropriate with regard to generally accepted standards of medical practice within the medical community:

Single-agent belantamab mafodotin-blmf (Blenrep)
Hydroxyprogesterone caproate (Makena and compounded or generic products) to reduce the risk of preterm birth
Melphalan flufenamide (Pepaxto)
Olaratumab (Lartruvo)

Guidelines

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, not medically necessary services and obsolete or unreliable diagnostic tests are not eligible for payment under the medical benefits of the Company's products because these tests and services are considered not medically necessary and, therefore, not covered.

Description

Obsolete or unreliable diagnostic tests are tests that are no longer routinely used and, in some instances, are outdated and found to be of little clinical value. Some of these tests have been replaced with improved technology. The not medically necessary medical services included in this policy are services or treatments that are rarely performed and lack scientific or statistical evidence in peer-reviewed literature to document their effectiveness. These services are not appropriate with regard to generally accepted standards of medical practice within the medical community due to having limited clinical usefulness.

PHARMACEUTICAL PRODUCTS

BELANTAMAB MAFODOTIN-BLMF (BLENREP)

On August 5, 2020, Belantamab mafodotin-blmf (Blenrep) was approved by the U.S. Food and Drug Administration (FDA) for the treatment of adults with relapsed or refractory multiple myeloma who have received at least four prior therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent.

On November 22, 2022, GlaxoSmithKline initiated the process for withdrawal of the biologics license application (BLA) for this biologic, at the request of the FDA. Belantamab mafodotin-blmf (Blenrep) was granted accelerated approval based on the primary endpoint of overall response rate (ORR) from the DREAMM-2 study, with full approval contingent on confirmed clinical benefit from the DREAMM-3 randomized Phase 3 trial. However, this confirmatory trial did not meet its primary endpoint of superior progression-free survival (PFS).

HYDROXYPROGESTERONE CAPROATE (MAKENA)

On February 3, 2011, hydroxyprogesterone caproate (Makena) received an Orphan Drug designation from the FDA after showing the drug's efficacy in decreasing the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth. Hydroxyprogesterone caproate (Makena) is administered weekly by a healthcare provider through an intramuscular injection in the upper quadrant of the gluteus maximus (available in vials), or a subcutaneous injection in the back of either upper arm (available as an auto-injector). In February 2018, the FDA approved hydroxyprogesterone caproate (Makena) subcutaneous auto-injector.

On April 6, 2023, the FDA announced the final decision to withdraw approval of Makena and its generic compound for decreasing the risk of preterm birth. Mekena was FDA approved under accelerated approval pathway in 2011, based on a determination that the sponsor had demonstrated a drug effect on an intermediate clinical endpoint that was reasonably likely to predict clinical benefit. However, the Phase 3 confirmatory trial (PROLONG 2020) failed to verify the clinical benefit of Makena for neonatal outcomes or preventing preterm birth. On March 7, 2023, Covis Pharma initiated the process for withdrawal of the New Drug Application (NDA) for this drug, in response to the FDA's Obstetrics, Reproductive and Urologic Drugs Advisory Committee (ORUDAC) vote (14-1) in October 2022 recommending that the drug be pulled from the market due to the results from the confirmatory trial.

MEPHALAN FLUFENAMIDE (PEPAXTO)

On December 7, 2022, the FDA requested that the marketing authorization for melphalan flufenamide (Pepaxto) be withdrawn from the United States market following confirmatory findings from the Phase 3 OCEAN trial (NCT03151811), according to a press release from Oncopeptides AB.

Data from the OCEAN 3 trial indicated the hazard ratio for overall survival by independent review committee in the intent-to-treat population was 1.104 (95% confidence interval [CI], 0.846–1.441), with notable differences in survival findings for both melphalan flufenamide in the experimental arm and pomalidomide (Pomalyst) in the comparator arm across a number of patient subgroups. Other findings from the OCEAN trial indicated that melphalan flufenamide yielded a progression-free survival that was 42% higher than pomalidomide by investigator and independent review committee (IRC) assessment (HR,0.817; 95% CI, 0.659–1.012; P=0.064; HR, 0.790; 95% CI, 0.639–0.976). Additionally, the overall response rate was 32.1% versus 26.5% in the melphalan flufenamide and pomalidomide arms, respectively.

OLARATUMAB (LARTRUVO)

On October 19, 2016, the FDA approved the BLA for LARTRUVO (olaratumab) injection (Eli Lilly and Co.), indicated, in combination with doxorubicin, for the treatment of adult patients with soft tissue sarcoma with a histologic subtype for which an anthracycline-containing regimen is appropriate and that is not amenable to curative treatment with radiotherapy or surgery, under the Agency's accelerated approval regulations.

Results from the confirmatory ANNOUNCE trial did not meet the primary endpoints of overall survival for olaratumab in combination with doxorubicin compared with doxorubicin alone in the full study population or within the leiomyosarcoma subpopulation. On February 25, 2020, the FDA issued a letter to Eli Lilly revoking the approval to manufacture and market LARTRUVO injection (BLA 761038).

References

American Academy of Orthopaedic Surgeons (AAOS). Thermal capsulorrhaphy. [AAOS Web site]. October 2007 (last reviewed September 2010). Available at: http://orthoinfo.aaos.org/topic.cfm?topic=a00034. Accessed May 18, 2023.

American Academy of Otolaryngology–Head and Neck Surgery. AAO-HNS position on micropressure therapy. 2012. Available at: https://www.entnet.org/resource/position-statement-micropressure-therapy/. Accessed May 18, 2023.

American Academy of Otolaryngology–Head and Neck Surgery. Available at: http://www.enthealth.org/conditions/menieres-disease. Accessed May 18, 2023.

American College of Obstetricians and Gynecologists; Committee on Practice Bulletins—Obstetrics. ACOG practice bulletin no. 171: Management of preterm labor. Obstet Gynecol. 2016;128:e155-164 (Interim Update).

American College of Obstetricians and Gynecologists (ACOG). Practice Bulletin No. 130: Prediction and Prevention of Preterm Birth. Obstet Gynecol. 2012;120:964-973. Reaffirmed 2016.

Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD). Fabric Wrapping of Abdominal Aneurysms (20.23). [CMS web site]. Available at:
http://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=51&ncdver=1&DocID=20.23&bc=gAAAABAAAAAA&. Accessed May 18, 2023.

Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD).20.27 Cardiointegram (CIG) as an Alternative to Stress Test or Thallium Stress Test [CMS Web site]. Available at: http://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=259&ncdver=1&DocID=20.27&bc=gAAAABAAAAAA&. Accessed May 18, 2023.

Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD). 100.6: Gastric freezing [CMS Web site]. Available at:
http://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=87&ncdver=1&DocID=100.6&bc=gAAAABAAAAAA&. Accessed May 18, 2023.

Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD). 190.6 Hair Analysis [CMS Web site]. Available at: http://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=189&ncdver=1&DocID=190.6&bc=gAAAABAAAAAA&. Accessed May 18, 2023.

Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD). 300.1: Obsolete or unreliable diagnostic tests. [CMS Web site]. 06/19/06. Available at: http://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=204&ncdver=2&DocID=300.1&bc=gAAAABAAAAAA&. Accessed May 18, 2023.

Chen S, Haen PS, Walton J, et al. The effects of thermal capsular shrinkage on the outcomes of arthroscopic stabilization for primary anterior shoulder instability. Am J Sports Med. 2005;33(5):705-711.

D’Alessandro DF, Bradley JP, Fleischli JE, Connor PM. Prospective evaluation of thermal capsulorrhaphy for shoulder instability: indications and results, two- to five-year follow-up. Am J Sports Med. 2004;32(1):21-33.

Jansen N, Van Riet RP, Meermans G, et al. Thermal capsulorrhaphy in internal shoulder impingement: a 7-year follow-up study. Acta Orthop Belg. 2012;78(3):304-308.

Gates GA, Green JD. Intermittent pressure therapy of intractable Ménière's disease using the Meniett device: a preliminary report. Laryngoscope. 2002;112(8 pt 1):1489-1493.

Gates GA, Green JD, Tucci DL, et al. The effects of transtympanic micropressure treatment in people with unilateral Ménière's disease. Arch Otolaryngol Head Neck Surg. 2004;130(6):718-725.

Gates GA, Verrall A, Green JD, Jr., et al. Meniett clinical trial: long-term follow-up. Arch Otolaryngol Head Neck Surg. 2006;132(12):1311-1316.

Grundy SM, Stone NJ, Bailey AL, et al. AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol: Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol (2018).

GSK press release. GSK provides an update on Blenrep (belantamab mafodotin-blmf) US marketing authorisation. November 22, 2022. Available at: https://www.gsk.com/en-gb/media/press-releases/gsk-provides-update-on-blenrep-us-marketing-authorisation/. Accessed on May 18, 2023.

Gurkov R, Filipe Mingas LB, Rader T, et al. Effect of transtympanic low-pressure therapy in patients with unilateral Ménière's disease unresponsive to betahistine: a randomised, placebo-controlled, double-blinded, clinical trial. J Laryngol Otol. 2012;126(4):356-362.

Kazandjian D. Multiple myeloma epidemiology and survival: A unique malignancy. Semin Oncol. 2016;43(6):676-681.

Kramer CM, Villines TC. Coronary artery calcium scoring (CAC): Overview and clinical utilization. Up to Date. [UpToDate Web site]. 08/23/2022. Available at: http://www.uptodate.com/home/index.html [via subscription only].

Kulkarni S, Rumberger JA, Jha S. Electron Beam CT: A Historical Review. AJR Am J Roentgenol. 2021 May;216(5):1222-1228.

Lonial S, Lee HC, Badros A, et al. Belantamab mafodotin for relapsed or refractory multiple myeloma (DREAMM-2): a two-arm, randomised, open-label, phase 2 study. Lancet Oncol. 2020;21(2):207-221.

Mattox DE, Reichert M. Meniett device for Ménière's disease: use and compliance at 3 to 5 years. Otol Neurotol. 2008;29(1):29-32.

Mohtadi NG, Hollinshead RM, Ceponis PJ, et al. A multi-centre randomized controlled trial comparing electrothermal arthroscopic capsulorrhaphy versus open inferior capsular shift for patients with shoulder instability: protocol implementation and interim performance: lessons learned from conducting a multi-centre RCT [ISRCTN68224911; NCT00251160]. Trials. 2006;7:4.

National Cancer Institute. The surveillance, epidemiology, and end results (SEER) Cancer Facts & Figures 2019. Available at: https://seer.cancer.gov/statfacts/html/mulmy.html. Accessed May 18, 2023.

National Institute for Clinical Excellence (NICE). Micropressure therapy for refractory Ménière's disease. NICE interventional procedure guidance 426. 2012: Available at: https://www.nice.org.uk/guidance/ipg426/chapter/1-Guidance. Accessed May 18, 2023.

National Institute of Child Health and Human Development. Home uterine monitors not useful for predicting premature birth. January 23, 2002. Available at: https://www.nichd.nih.gov/newsroom/releases/uterine. Accessed May 18, 2023.

Nooka AK, Kastritis E, Dimopoulos MA. Treatment options for relapsed and refractory multiple myeloma. Blood. 2015;125(20):3085-3099.

Oakes DA, McAllister DR. Failure of heat shrinkage for treatment of a posterior cruciate ligament tear. Arthroscopy. 2003;19(6):E1-E4.

Oncopeptides provides update on Pepaxto US marketing authorization. News release. Oncopeptides AB. December 7, 2022. Available at: https://bit.ly/3YcSMuG. Accessed on May 18, 2023.

Oncopeptides withdraws Pepaxto® in US, scale down organization and focus on R&D. News release. Oncopeptides AB. October 22, 2021. Available at: https://bit.ly/3B5OCIC. Accessed May 18, 2023.

Oncopeptides. Important information regarding PEPAXTO® in the United States. News release. Oncopeptides. March 1, 2022. Available at: https://bit.ly/3hq2VUE. Accessed May 18, 2023.

Reinsch N, Mahabadi AA, Lehmann N, et al. Comparison of dual-source and electron-beam CT for the assessment of coronary artery calcium scoring. Br J Radiol. 2012 Jul;85(1015):e300-6.

Russo FY, Nguyen Y, De Seta D, et al. Meniett device in Ménière disease: randomized, double-blind, placebo-controlled multicenter trial. Laryngoscope. 2017;127(2):470-475.

Siegel RL, Miller KD, Jemal A. Cancer statistics, 2020. CA: A Cancer Journal for Clinicians. 2020;70(1):7-30.

Syed MI, Rutka JA, Hendry J, et al. Positive pressure therapy for Ménière's syndrome/disease with a Meniett device: a systematic review of randomised controlled trials. Clin Otolaryngol. 2015;40(3):197-207.

Thomsen J, Sass K, Odkvist L, et al. Local overpressure treatment reduces vestibular symptoms in patients with Ménière's disease: a clinical, randomized, multicenter, double-blind, placebo-controlled study. Otol Neurotol. 2005;26(1):68-73.

Urquhart C, Currell R, Harlow F, et al. Home uterine monitoring for detecting preterm labour. Cochrane Database Syst Rev. 2017;2:CD006172.

US Preventive Services Task Force. Screening Home Uterine Activity Monitoring. January 1996. Available at: http://www.uspreventiveservicestaskforce.org. Last accessed on September 7, 2017.

US Food and Drug Administration. Makena (hydroxyprogesterone caproate injection) information. 04/06/2023. Available at: https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/makena-hydroxyprogesterone-caproate-injection-information. Accessed May 18, 2023.

US Food and Drug Administration. Federal Register. Final decision on withdrawal of MAKENA (hydroxyprogesterone caproate) and eight abbreviated new drug applications following public hearing; availability of final decision. 05/15/2023. Available at: https://www.federalregister.gov/documents/2023/05/15/2023-10264/final-decision-on-withdrawal-of-makena-hydroxyprogesterone-caproate-and-eight-abbreviated-new-drug. Accessed May 18, 2023.

US Food and Drug Administration. Federal Register. Eli Lilly and Co.; Announcement of the revocation of the biologics license for LARTRUVO. 07/17/2020. Available at: https://www.federalregister.gov/documents/2020/07/17/2020-15516/eli-lilly-and-co-announcement-of-the-revocation-of-the-biologics-license-for-lartruvo. Accessed May 18, 2023.

Virgil H. FDA requests Melphalan Flufenamide be withdrawn from US market. Dec 18, 2022. Available at: https://www.cancernetwork.com/view/fda-requests-melphalan-flufenamide-be-withdrawn-from-us-market. Accessed May 18, 2023.

Coding

CPT Procedure Code Number(s)

87003

The following code is used to represent Arthroscopic electrothermal joint repair, Thermal capsulrorrhaphy, Electrothermal capsulorrhaphy, and Thermal or electrothermal shrinkage procedures:
29999

The following code is used to represent Amylase, blood isoenzymes, electrophoretic, Bolen's test for cancer (Bolen's clot retraction test [CRT]), Colloidal gold, Chromium, blood, Chymotrypsin; duodenal contents, Gastric analysis, pepsin, Gastric analysis, tubeless, Guanase, blood, Hormones, adrenocorticotropin quantitative animal tests, Hormones, adrenocorticotropin quantitative bioassay, and Starch, Feces, Screening procedures:
84999

The following code is used to represent Calcium saturation clotting time, Capillary fragility test (Rumpel-Leede), and Circulation time, one test procedures:
85999

The following code is used to represent Skin test, Actinomycosis, Skin test, Brucellosis, Skin test, Cat scratch fever (cat scratch disease; Bartonella Infection), Skin test, Lymphopathia venereum, Skin test, Psittacosis, and Skin test, Trichinosis:
86486

The following code is used to represent Bendien's test for cancer and tuberculosis, Calcium, feces, 24-hour quantitative, and Zinc sulphate turbidity, blood tests:
89240

The following code is used to represent Rehfuss test for gastric acidity procedure:
91299

The following code is used to represent Intracardiac phonocardiogram, Phonocardiogram with or without electrocardiogram (ECG) lead, with or without indirect carotid artery and/or jugular vein tracing, and/or apex cardiogram, and Vectorcardiogram (VCG), with or without electrocardiogram (ECG); with or without tracing SER services:

93799

ICD - 10 Procedure Code Number(s)

N/A

ICD - 10 Diagnosis Code Number(s)

N/A

HCPCS Level II Code Number(s)

A4638 Replacement battery for patient-owned ear pulse generator, each
E2120 Pulse generator system for tympanic treatment of inner ear endolymphatic fluid

J1726 Injection, hydroxyprogesterone caproate, (Makena), 10 mg
J9037 Injection, belantamab mafodontin-blmf, 0.5 mg
J9247 Injection, melphalan flufenamide, 1 mg
J9285 Injection, olaratumab, 10 mg

M0100 Intragastric hypothermia using gastric freezing

M0301 Fabric wrapping of abdominal aneurysm

P2028 Cephalin flocculation, blood

P2029 Congo red, blood

P2031 Hair analysis (excluding arsenic)

P2033 Thymol turbidity, blood

P2038 Mucoprotein, blood (seromucoid)

S1030 Continuous noninvasive glucose monitoring device, purchase (for physician interpretation of data, use CPT code)

S1031 Continuous noninvasive glucose monitoring device, rental, including sensor, sensor replacement, and download to monitor (for physician interpretation of data, use CPT code)

S2103 Adrenal tissue transplant to brain

S2300 Arthroscopy, shoulder, surgical; with thermally-induced capsulorrhaphy

S8092 Electron beam computed tomography (also known as ultrafast CT, cine CT)

S9001 Home uterine monitor with or without associated nursing services

S9025 Omnicardiogram/cardiointegram

THE FOLLOWING CODE IS USED TO REPRESENT hydroxyprogesterone caproate, (Makena) TO REDUCE THE RISK OF PRETERM BIRTH:

J1729 Injection, hydroxyprogesterone caproate, not otherwise specified, 10 mg

Revenue Code Number(s)

N/A

MPMiscCodesNarrativesPub

Coding and Billing Requirements

Cross Reference

Policy History

Revisions From 01.01.24j:

07/01/2023

This version of the policy will become effective 07/01/2023. The policy title was updated to: Not Medically Necessary Services and Obsolete or Unreliable Diagnostic Tests.

The following medical service was added to the policy: electron beam computed tomography (EBCT).

Policy coverage statement was added to include pharmaceutical products. The following pharmaceutical products were added to the policy:

Single-agent belantamab mafodotin-blmf (Blenrep)
Hydroxyprogesterone caproate (Makena and generic products)
Melphalan flufenamide (Pepaxto)
Olaratumab (Lartruvo)

The following codes have been added to the policy:

J1726 Injection, hydroxyprogesterone caproate, (Makena), 10 mg

J1729 Injection, hydroxyprogesterone caproate, not otherwise specified, 10 mg

J9037 Injection, belantamab mafodontin-blmf, 0.5 mg

J9247 Injection, melphalan flufenamide, 1 mg

J9285 Injection, olaratumab, 10 mg

S8092 Electron beam computed tomography (also known as ultrafast CT, cine CT)

Revisions From 01.01.24i:

11/21/2022

This version of the policy will become effective 11/21/2022. The following medical service was added to the policy: transtympanic micropressure device. The following codes have been added to the policy: A4638,E2120.

Revisions From 00.01.24h:

06/30/2021	This policy has been reissued in accordance with the Company's annual review process.
10/07/2020	This policy has been reissued in accordance with the Company's annual review process.
05/06/2019	This version of the policy will become effective 05/06/2019. The following medical device was added to the policy: home uterine activity monitoring devices. The following HCPCS code has been added to the policy: S9001 Home uterine monitor with or without associated nursing services (Not Medically Necessary)

Revisions From 00.01.24g:

01/14/2019

This version of the policy will become effective 01/14/2019. The following medical service was added to the policy: arthroscopic electrothermal joint repair. The following codes have been added to the policy: 29999, S2300.

Effective 10/05/2017 this policy has been updated to the new policy template format.

Version Effective Date:

7/1/2023

Version Issued Date:

7/3/2023

Version Reissued Date: