View
9
Download
0
Category
Preview:
Citation preview
MEDICAL POLICY – 6.01.502
Single Photon Emission Computed Tomography (SPECT)
for Non-cardiac Indications
Effective Date: Oct. 1, 2019
Last Revised: Sept. 5, 2019
Replaces: N/A
RELATED MEDICAL POLICIES:
6.01.54 Dopamine Transporter Imaging with Single-photon Emission Computed
Tomography
Select a hyperlink below to be directed to that section.
POLICY CRITERIA | DOCUMENTATION REQUIREMENTS | CODING
RELATED INFORMATION | EVIDENCE REVIEW | REFERENCES | HISTORY
∞ Clicking this icon returns you to the hyperlinks menu above.
Introduction
SPECT is a type of nuclear imaging test that uses a radioactive dye, also called a tracer, and a
special camera to create a three-dimensional (3-D) image of the organs in the body. The images
created by tracking the dye in the blood stream can show areas of increased/decreased blood
flow and progressive changes in the body. SPECT is proposed to help diagnose or monitor
certain tumors, bone disorders, and heart problems.
SPECT imaging of the brain for mental health disorders is used as a research tool in clinical trials.
Research has not shown the utility of SPECT brain imaging for differential diagnosis or for
assessing or predicting an individual’s risk of getting a mental health disorder.
Dopamine transporter imaging with single-photon emission computed tomography (DAT-
SPECT) is addressed in another policy (see Related Medical Policies).
Note: The Introduction section is for your general knowledge and is not to be taken as policy coverage criteria. The
rest of the policy uses specific words and concepts familiar to medical professionals. It is intended for
providers. A provider can be a person, such as a doctor, nurse, psychologist, or dentist. A provider also can
be a place where medical care is given, like a hospital, clinic, or lab. This policy informs them about when a
service may be covered.
https://www.lifewisewa.com/medicalpolicies/6.01.54.pdfhttps://www.lifewisewa.com/medicalpolicies/6.01.54.pdf
Page | 2 of 12 ∞
Policy Coverage Criteria
Procedure Medical Necessity
SPECT scan SPECT scans may be considered medically necessary for any of
the following non-cardiac conditions or symptoms:
• Brain tumor recurrence versus radiation necrosis
• Liver hemangioma versus tumor identification
• Localization of abscess, suspected or known localized infection
vs. inflammation
• Assessment of osteomyelitis (bone vs. soft tissue infection)
• Lymphoma evaluation (tumor vs. necrosis)
• Neuroendocrine tumors (carcinoid, pheocromoctyoma, thyroid
carcinoma, adrenal gland tumors) [OctreoScan™ or MIBG]
• Parathyroid disease
• Renal function and renal scarring evaluation
(Dimercaptosuccinic acid [DMSA] scan)
• Seizure foci localization for patients with intractable epilepsy (in
place of positron emission tomography [PET])
• Vertebral abnormalities evaluation (such as spondylosis,
spondylolisthesis, or stress fractures not visible on x-ray)
SPECT scan SPECT scans are considered not medically necessary for any of
the following conditions or symptoms:
• Cerebrovascular accident (also called CVA, stroke, or brain
attack)
• Subarachnoid hemorrhage
• Transient ischemic attack (TIA)
Procedure Investigational
SPECT scan SPECT scans are considered investigational for all other non-
cardiac conditions, including any of the following:
• Attention deficit hyperactivity disorder (ADHD)
• Autism spectrum disorders
• Colorectal cancer (eg, with CEA-Scan, IMMU-4)
• Head trauma – evaluation of brain morphology
Page | 3 of 12 ∞
Procedure Investigational • Mental health disorders (diagnosis, prediction, response to
medication)
• Movement disorder evaluation
• Prostate cancer (eg, with ProstaScint®)
• Unclassified dementia evaluation (eg, Alzheimer disease)
Documentation Requirements
The medical records submitted for review should document that medical necessity
criteria are met. Include history and physical supporting that patient has ANY of the
following symptoms or conditions:
• Brain tumors, to differentiate between recurrent tumor versus radiation changes, infection
• Liver hemangioma, to further define the mass
• Localization of abscess, infection, or inflammation
• Lymphoma evaluation
• Neuroendocrine tumors
• Parathyroid disease
• Renal function and renal scarring evaluation (dimercaptosuccinic acid [DMSA] scan)
• Patients with intractable epilepsy, when seizure focus cannot be localized
• Evaluation of vertebral abnormalities (such as spondylosis, spondylolysis, spondylolisthesis,
degenerative joint disease/arthritis of the facet joints, stress fractures)
Coding
Code Description
HCPCS A9507 Indium in-111 capromab pendetide, diagnostic, per study dose, up to 10 millicuries
Note: CPT codes, descriptions and materials are copyrighted by the American Medical Association (AMA). HCPCS codes,
descriptions and materials are copyrighted by Centers for Medicare Services (CMS).
Related Information
Page | 4 of 12 ∞
Definition of Terms
Abscess: A mass filled with pus (made up of dead white blood cells and dead tissue, bacteria,
and blood serum) that collects anywhere in the body as a result of the body's response to an
infection.
Adenoma: A noncancerous (benign) epithelial tumor that may affect various organs in the body.
The adenoma often comes from or resembles glandular tissue, though some grow in
nonglandular areas.
Autism spectrum disorders : Refers to a group of disorders defined as delays in the
development of socialization and communication skills often accompanied by cognitive and
language delays.
Carcinoid tumors: Carcinoid tumors are slow growing and usually start in the gastrointestinal
tract (anywhere between the stomach and the rectum) or the lung. These tumors make and
release (secrete) large amounts of hormones, including cortisol, histamine, insulin and serotonin.
Carcinoid tumors are a type of neuroendocrine tumor.
Liver hemangioma: A noncancerous tumor (mass) that forms in or on the liver. It is made up of
small blood vessels. Liver hemangiomas are more common in women than men.
Lymphoma: A cancer of the white blood cells (lymphocytes) of the body’s immune system. It
develops in the lymph nodes and lymphatic system.
Movement disorders: A group of diseases that includes abnormally slow movement
(bradykinesia), rigidity, tremor at rest, and postural instability.
Neuroendocrine tumors: A diverse group of tumors that form from cells of the hormone and
nervous systems. They may be found in the intestine and also occur in the thyroid, lung and
other parts of the body.
Transient ischemic attack (TIA): A temporary lack of adequate blood and oxygen (ischemia) to
the brain. The neurological signs and symptoms are similar to a brain attack (stroke), but go
away within a short period of time. This may also be referred to as a mini-stroke.
Evidence Review
Page | 5 of 12 ∞
Background
SPECT is an imaging modality that provides information about the functional level of a particular
body part. It requires the injection of a low-level radioactive isotope (chemical tracer) into the
bloodstream. Images then reflect how the tracer is processed by the body. This is in contrast to
structural information provided by CT, MRI or ultrasound. Scans are made with a device that
detects radioactivity in the body. A SPECT tomograph generates detailed information as the
radiotracers used with a SPECT attach to elements appropriate for obtaining specific
information. An example of this is how antibodies attach to specific types of tumors. A
radiotracer can be attached to an antibody that will then bind to a tumor, which is then
identified and located by a SPECT scan.
SPECT provides information about the cellular or level of chemical activity within an organ or
system, including structural information about that system. This process can show areas of
increased activity, such as inflammation seen in an abscess. Patterns of distribution can then be
correlated with particular diseases. The selection of a radiotracer and imaging protocol is
specific to the disease process being investigated. SPECT cameras can image large areas of the
body as the emitted radiation from the radiotracers travel through the body.
Information obtained by SPECT complements or confirms data obtained by other forms of
testing and may provide additional information in some situations. For many conditions, SPECT
has been found to be as useful as PET, even though PET images tend to be of higher quality
than those of SPECT, SPECT tends to be more available. Both PET and SPECT can diagnose
disease prior to the onset of clinical symptoms or structural manifestations of disease as they
provide information regarding the functional level of a body system.
Abscess/Infection
Labeled white blood cells are infused prior to SPECT imaging of the suspected clinical site of
infection. This infusion helps with localization of tissue inflammation.1
Autism Spectrum Disorders
Autism spectrum disorders can be difficult to diagnose due to the variety and severity of the
presentation of symptoms. The American Academy of Neurology Practice Guideline states the
following: "There is no evidence to support a role for functional neuroimaging studies in the
clinical diagnosis of autism at the present time"25
Page | 6 of 12 ∞
Surgical Repair
SPECT can be useful in distinguishing between tumor regrowth and radiation necrosis in
patients with cerebral metastases.2
Cerebrovascular Disease (CVA, stroke, brain attack, TIA)
The use of SPECT has become outdated for the evaluation and management of cerebrovascular
disease, including cerebrovascular accidents (CVA or stroke), subarachnoid hemorrhages, and
transient ischemic attacks (TIA). Newer imaging techniques are more common such as
computed tomography angiography (CTA) and magnetic resonance angiography (MRA).3-5
Epilepsy Seizure Foci
Ictal SPECT may be applicable for patients being considered for surgery to treat intractable
epilepsy, when seizure focus cannot be localized by EEG, video-EEG, or MRI. Effective surgical
treatment of patients with intractable epilepsy is dependent on accurate localization of the
epileptic focus and precise delineation of the eliptogenic region. Ictal SPECT uses the
physiologic increase in regional cerebral blood flow during seizures to localize the epileptogenic
region. This testing aids in identifying the source or sources of the seizures as well as assess
brain function. SPECT may offer a safe and accurate alternative to quantitative MRI or PET for
the pre-surgical ictal detection of seizure focus. It should be performed in a hospital setting.6,7
Kidney (renal)
Using Technetium-99m labeled dimercaptosuccinic acid (DSMA) for diagnostic imaging may be
useful to evaluate kidney function and identify scarring that may be the result of frequent
infections.8,9 The National Institute for Health and Clinical Excellence 2007 guideline
recommends DMSA scanning when the diagnosis cannot be confirmed by Doppler ultrasound.10
The American Urological Association 2010 Clinical Practice Guideline recommends DMSA scan
when a renal ultrasound is abnormal in children with vesicoureteral reflux to detect the presence
of any renal scarring.11
Page | 7 of 12 ∞
Liver Hemangioma versus Primary Hepatoma or Metastases
Technetium-labeled red blood cells are infused prior to SPECT imaging of the liver. There is risk
of hemorrhage in a percutaneous biopsy of liver hemangiomas, so non-invasive methods of
testing are useful for differentiating between the blood pool of an hepatic hemangioma from
other solid hepatic masses. Review articles and published studies support SPECT as an
appropriate diagnostic tool to differentiate between hepatic lesions versus hemangiomas.12
Lymphoma
SPECT scans may be useful to distinguish tumor from radiation necrosis in the chest and
abdomen. An initial study can be compared with a follow-up study after the completion of
treatment. SPECT is not appropriate for initial staging of lymphoma.13
Mental Health Disorders
SPECT imaging of the brain for mental health disorders is used as a research tool in clinical trials.
The National Institute of Mental Health (NIMH) made the following statement in their brochure
titled “Neuroimaging and Mental Illness: A window into the brain”:
No scientific studies to date have shown that a brain scan by itself can be used for
diagnosing a mental illness or to learn about a person’s risk for disease. Brain scans alone
cannot be used to diagnose a mental disorder, such as autism, anxiety, depression,
schizophrenia, or bipolar disorder. Other types of tests are needed for a mental illness to be
properly diagnosed.14,15
Mild Cognitive Impairment (MCI) Conversion to Alzheimer’s Disease (AD)
The utility of SPECT to predict conversion from mild cognitive impairment (MCI) to Alzheimer’s
disease (AD) is limited.16,17 A technology assessment of SPECT for dementia and AD by the
Institute for Clinical Effectiveness and Health Policy concluded: “SPECT has not clearly
demonstrated its usefulness in assessing patients with dementia, and it has no precise
indications for diagnosis, evaluation of prognosis or monitoring response to treatment.”18
Controlled studies of SPECT in AD show the sensitivity of this testing varies from 50 to 95%. The
Page | 8 of 12 ∞
American Academy of Neurology does not recommend SPECT for routine use in the differential
diagnosis of dementia.19
Neuroendocrine Tumors
SPECT for the diagnosis and staging of neuroendocrine tumors may be done using a
monoclonal antibody (OctreoScan™) or I-131 meta-iodobenzyl-guanidine (MIBG) because
carcinoids and other neuroendocrine tumors have somatostatin receptors and can be imaged
with somatostain analogs tagged with an appropriate radioisotope.20, 21
Parathyroid Disease
Guidelines on parathyroid scintigraphy from the Society of Nuclear Medicine22 state that there is
a developing consensus that SPECT and SPECT/CT are most useful for improving the precision of
anatomic localization. The Parathyroid Task Group of the EANM21 state that the use of SPECT/CT
has a major role for obtaining anatomical details on ectopic foci. However, its use as a routine
procedure before target surgery is still investigational. Preliminary data suggest that SPECT/CT
has lower sensitivity in the neck area compared to pinhole imaging.22-24
Prostate Cancer
ProstaScint, a monoclonal antibody combined with radioactive indium-111, is used to detect
prostate cancer. It is injected into the body and then a gamma camera is used to locate prostate
cancer cells. There is little evidence demonstrating improvements in health outcomes following
ProstaScint scans. One study showed 60% progression-free survival (PFS) of 60% for those study
participants with a negative scan and 74% for those with a positive scan. The researchers of the
study concluded that the individuals with positive scans did not have a statistically significant
difference in PFS than those with a negative scan result.26 Pucar concluded that “ProstaScint has
not added benefit over other imaging modalities in evaluating post-radical prostatectomy
recurrence, due to its low sensitivity for detecting local recurrences and bone metastases.”27
The American College of Radiology (ACR) states: “The reliability and usefulness of indium-111
radiolabeled capromab pendetide (a first-generation monoclonal antibody against prostate-
specific membrane antigen [PSMA]) scan as a method to stage prostate cancer remains
Page | 9 of 12 ∞
unproven.”28 They also note that the optimal use of the scan remains to be determined as the
scans are difficult to interpret and are costly to perform.29
Spondylolysis and Stress Fractures
SPECT scans may be useful in evaluating chronic back or neck pain that is atypical, that may be
caused by spondylolysis or stress fractures that are undiagnosed by conventional imaging. Bone
SPECT may provide diagnostic information in cases of low back pain that is not available with
routine imaging. One study of 34 patients with chronic low back pain compared findings from
radiography, computed tomography (CT) and bone scintigraphy with SPECT. The majority of
lesions (89%) seen on SPECT corresponded to identifiable disease on CT.30 SPECT was also
found to be more sensitive than planar bone scintigraphy in identifying patients with painful
defects in the pars interarticularis compared to radiographic evidence of spondolysis and/or
spondylolisthesis in 19 adult patients studied. 31 Bencardino et al (2016) in the Expert Panel on
Musculoskeletal Imaging. American College of Radiology Appropriateness Criteria states: “planar
scintigraphy combined with SPECT is more accurate in diagnosing stress injuries than planar
scintigraphy alone.”32
Vertebral Abnormalities
SPECT scans may be useful in evaluating chronic back or neck pain that is atypical, that may be
caused by spondylolysis or stress fractures that are undiagnosed by conventional imaging
studies.30,31
References
1. Bybel B, Brunken RC, DiFilippo FP, Neumann DR, Wu G, Cerqueira MD. SPECT/CT imaging: clinical utility of an emerging
technology. Radiographics. 2008 Jul-Aug;28(4):1097-113. PMID 18635631
2. Serizawa T, Saeki N, Higuchi Y et al. Diagnostic value of thallium-201 chloride single-photon emission computerized
tomography in differentiating tumor recurrence from radiation injury after gamma knife surgery for metastatic brain tumors. J
Neurosurg 2005; 102 (Suppl):266-271. PMID 15662823
3. Lewis DH. Functional brain imaging with cerebral perfusion SPECT in cerebrovascular disease, epilepsy, and trauma. Neurosurg
Clin N Am. 1997 Jul;8(3):337-344. PMID9188542
Page | 10 of 12 ∞
4. Ueda T et al. Outcome in acute stroke with successful intra-arterial thrombolysis and predictive value of initial single photon
emission-computed tomography. J Cereb Blood Flow Metab. 1999 Jan;19(1):99-108. PMID 9886360
5. Lewis DH et al. Brain SPECT and the effect of cerebral angioplasty in delayed ischemia due to vasospasm. J Nuc Med, Oct.
1992; Vol. 33, No. 10:1789-1796. PMID 1403146
6. von Oertzen TJ, Mormann F, Urbach H, et al. Prospective use of subtraction ictal SPECT coregistered to MRI (SISCOM) in
presurgical evaluation of epilepsy. Epilepsia. 2011; 52(12):2239-2248. PMID 22136078
7. Kumar A, Chugani HT. The role of radionuclide imaging in epilepsy, Part 1: Sporadic temporal and extratemporal lobe epilepsy.
J Nucl Med. 2013 Oct;54(10):1775-1781. PMID 23970368
8. Even-Sapir E, Gutman M, Lerman H et al. Kidney allografts and remaining contralateral donor kidneys before and after
transplantation: assessment by quantitative (99m) TC-DMSA SPECT. J Nucl Med 2002; 43(5):584-588. PMID 11994518
9. Mullerad M, Kastin A, Issaq E et al. The value of quantitative 99M technetium dimercaptosuccinic acid renal scintigraphy for
predicting postoperative renal insufficiency in patients undergoing nephrectomy. J Urol 2003; 169(1):24-27. PMID 12478094
10. National Institute for Health and Care Excellence. Clinical Guideline[CG54] Urinary tract infection in under 16s: diagnosis and
management. Published date: August 2007. Last updated: October 2018. Available at:
https://www.nice.org.uk/guidance/cg54 Accessed September 2019.
11. American Urological Association. Clinical Practice Guideline. Management and screening of primary vesicoureteral reflux.
Reviewed 2017. Available at: http://www.auanet.org/guidelines/vesicoureteral-reflux-(2010-reviewed-and-validity-
confirmed-2017) Accessed September 2019.
12. Jacobson AF, Teefey SA. Cavernous hemangiomas of the liver. Association of sonographic appearance and results of Tc-99m
labeled red blood cell SPECT. Clin Nucl Med. 1994;19(2):96-99. PMID 8187411
13. Bockisch A, Freudenberg LS, et al. Hybrid imaging by SPECT/CT and PET/CT: proven outcomes in cancer imaging. Semin Nucl
Med. 2009 Jul;39(4):276-289. PMID 19497404
14. American Psychiatric Association. Practice Guideline for the Psychiatric Evaluation of Adults, Third Edition. August 2015.
Available at: https://www.psychiatry.org/psychiatrists/practice/clinical-practice-guidelines Accessed September 2019.
15. Farah MJ, Gillihan SJ. The Puzzle of Neuroimaging and Psychiatric Diagnosis: Technology and Nosology in an Evolving
Discipline. AJOB neuroscience. 2012;3(4):31-41. PMID 23505613
16. Devanand DP, Van Heertum RL, Kegeles LS, et al. (99m)Tc hexamethyl-propylene-aminoxime single-photon emission computed
tomography prediction of conversion from mild cognitive impairment to Alzheimer disease. Am J Geriatr Psychiatry.
2010;18(11):959-972. PMID 20808143
17. McNeill R, Sare GM, Manoharan M, et al. Accuracy of single-photon emission computed tomography in differentiating
frontotemporal dementia from Alzheimer’s disease. J Neurol Neurosurg Psychiatry. 2007;78(4):350-355. PMID 17158559
18. Ferrante, D. SPECT for the diagnosis and assessment of dementia and Alzheimer’s disease (summary). Report ITB No. 14.
Buenos Aires, Argentina: Institute for Clinical Effectiveness and Health Policy (ICES); 2004.
19. Knopman DS, DeKosky ST, et al. Practice parameter: Diagnosis of dementia (an evidence-based review). Report of the Quality
Standards Subcommitte of the American Academy of Neurology. Neurology. 2001;56 (9): 1143-1153
20. Schillaci O, Scopinaro F, Angeletti S, et al. SPECT improves accuracy of somatostatin receptor scintigraphy in abdominal
carcinoid tumors. J Nuclear Med. 1996;37(9):1452-1456. PMID 8790191
21. Schillaci O, Corleto VD, Annibale B, et al. Single photon emission computed tomography procedure improves accuracy of
somatostatin receptor scintigraphy in gastro-entero pancreatic tumours. Ital J Gastroenterol Hepatol. 1999 Oct; 31 Suppl
2():S186-189. PMID 10604127
22. Greenspan BS, Brown ML, Dillehay GL, et al. The Society of Nuclear Medicine Procedure Guideline for Parathyroid Scintigraphy.
Version 3.0. Reston, VA: Society of Nuclear Medicine; June 2004.
https://www.nice.org.uk/guidance/cg54http://www.auanet.org/guidelines/vesicoureteral-reflux-(2010-reviewed-and-validity-confirmed-2017)http://www.auanet.org/guidelines/vesicoureteral-reflux-(2010-reviewed-and-validity-confirmed-2017)https://www.psychiatry.org/psychiatrists/practice/clinical-practice-guidelines
Page | 11 of 12 ∞
23. Hindié E, Ugar O, Fuster D, et al; Parathyroid Task Group of the EANM. 2009 EANM parathyroid guidelines. Eur J Nucl Med Mol
Imaging. 2009:36(7):1201-1216. PMID 19471928
24. Tunninen V, Varjo P, Schildt J, et al. Comparison of five parathyroid scintigraphic protocols. Int J Mol Imaging.
2013;2013:921260. PMID 23431436
25. Filipek PS, Accardo PJ, Ashwal S, et al. Practice parameter: screening and diagnosis of autism: report of the Quality Standards
Subcommittee of the American Academy of Neurology and the Child Neurology Society. Neurology. 2000; 55(4):468-479.
PMID: 10953176
26. Koontz BF, Mouraviev V, Johnson JL, et al. Use of local (111) in-capromab pendetide scan results to predict outcome after
salvage radiotherapy for prostate cancer. Int J Radiat Oncol Biol Phys. 2008; 71(2):358-361.
27. Pucar D, Sella T, Schöder H. The role of imaging in the detection of prostate cancer local recurrence after radiation therapy and
surgery. Curr Opin Urol. 2008; 18(1):87-97.
28. American College of Radiology. ACR Appropriateness Criteria®. Post-treatment Follow-up of Prostate Cancer (Revised 2017).
Available at: https://acsearch.acr.org/docs/69369/Narrative/ Accessed September 2019.
29. American College of Radiology. ACR Appropriateness Criteria®. Prostate Cancer — Pretreatment Detection, Staging, and
Surveillance (Revised 2016). Available at: https://acsearch.acr.org/docs/69371/Narrative/ Accessed September 2019.
30. Ryan PJ et al. Chronic low back pain: Comparison of bone SPECT with radiography and CT. Radiology 1992, Vol. 182:849-854.
PMID 1531544
31. Collier BD et al. Painful spondylolysis of spondylolisthesis studied by radiography and single photon emission computed
tomography. Radiology 1985, Vol. 154:207-211. PMID 3155479
32. Bencardino, JT, Stone TJ, Roberts CC, et al.Expert Panel on Musculoskeletal Imaging. ACR Appropriateness Criteria Stress
(fatigue/insufficiency) fracture, including sacrum, excluding other vertebrae.. J Am Coll Radiol 2017; 14 (5S): S293-S306. PMID:
28473086. https://acsearch.acr.org/docs/69435/Narrative/ Accessed September 2019.
33. Centers for Medicare & Medicaid Services. National Coverage Decision (NCD) for Single Photon Emission Computed
Tomography (SPECT) (220.12). 2002. https://www.cms.gov/medicare-coverage-database/details/ncd-
details.aspx?NCDId=271&ncdver=1&DocID=220.12&bc=gAAAAAgAAAAAAA%3d%3d& Accessed September 2019.
History
Date Comments 09/01/16 New policy, approved August 9, 2016. Add to Medicine section. SPECT may be
considered medically necessary when criteria are met for select non-cardiac
indications. SPECT is not medically necessary for cerebrovascular indications. SPECT is
investigational when criteria are not met.
06/01/17 Annual review, approved May 23, 2017. Policy reorganized for clarity; no change in
policy statements.
07/01/18 Annual Review, approved June 12, 2018. Policy updated with literature search through
April 2018, References 10, 11,18, 19, 26-29 added. Added assessment of osteomyelitis
to medical necessity criteria. Deleted degenerative joint disease/arthritis of the facet
joints from the vertebral abnormalities medical necessity criteria.
https://acsearch.acr.org/docs/69369/Narrative/https://acsearch.acr.org/docs/69371/Narrative/https://acsearch.acr.org/docs/69435/Narrative/https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=271&ncdver=1&DocID=220.12&bc=gAAAAAgAAAAAAA%3d%3d&https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=271&ncdver=1&DocID=220.12&bc=gAAAAAgAAAAAAA%3d%3d&
Page | 12 of 12 ∞
Date Comments 10/01/19 Annual Review, approved September 5, 2019. Policy updated with literature search
through August 2019. References 32 and 33 added. Minor edits made for clarity.
Otherwise, policy statements unchanged. Added HCPCS code A9507, removed CPT
code 78607.
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). ©2019 Premera
All Rights Reserved.
Scope: Medical policies are systematically developed guidelines that serve as a resource for Company staff when
determining coverage for specific medical procedures, drugs or devices. Coverage for medical services is 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 any benefit limitations
applicable to this service or supply. This medical policy does not apply to Medicare Advantage.
Discrimination is Against the Law
LifeWise Health Plan of Washington complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. LifeWise does not exclude people or treat them differently because of race, color, national origin, age, disability or sex.
LifeWise: • 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 LifeWise 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 - Complaints and Appeals PO Box 91102, Seattle, WA 98111 Toll free 855-332-6396, Fax 425-918-5592, TTY 800-842-5357 Email AppealsDepartmentInquiries@LifeWiseHealth.com
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.
Getting Help in Other Languages
This Notice has Important Information. This notice may have important information about your application or coverage through LifeWise Health Plan of Washington. There may be key dates in this notice. You may need to take action by certain deadlines to keep your health coverage or help with costs. You have the right to get this information and help in your language at no cost. Call 800-592-6804 (TTY: 800-842-5357).
አማሪኛ (Amharic): ይህ ማስታወቂያ አስፈላጊ መረጃ ይዟል። ይህ ማስታወቂያ ስለ ማመልከቻዎ ወይም የ LifeWise Health Plan of Washington ሽፋን አስፈላጊ መረጃ ሊኖረው ይችላል። በዚህ ማስታወቂያ ውስጥ ቁልፍ ቀኖች ሊኖሩ ይችላሉ። የጤናን ሽፋንዎን ለመጠበቅና በአከፋፈል እርዳታ ለማግኘት በተውሰኑ የጊዜ ገደቦች እርምጃ መውሰድ ይገባዎት ይሆናል። ይህን መረጃ እንዲያገኙ እና ያለምንም ክፍያ በቋንቋዎ እርዳታ እንዲያገኙ መብት አለዎት።በስልክ ቁጥር 800-592-6804 (TTY: 800-842-5357) ይደውሉ።
Oromoo (Cushite): Beeksisni kun odeeffannoo barbaachisaa qaba. Beeksisti kun sagantaa yookan karaa LifeWise Health Plan of Washington tiin tajaajila keessan ilaalchisee odeeffannoo barbaachisaa qabaachuu danda’a. Guyyaawwan murteessaa ta’an beeksisa kana keessatti ilaalaa. Tarii kaffaltiidhaan deeggaramuuf yookan tajaajila fayyaa keessaniif guyyaa dhumaa irratti wanti raawwattan jiraachuu danda’a. Kaffaltii irraa bilisa haala ta’een afaan keessaniin odeeffannoo argachuu fi deeggarsa argachuuf mirga ni qabaattu. Lakkoofsa bilbilaa 800-592-6804 (TTY: 800-842-5357) tii bilbilaa.
Français (French): Cet avis a d'importantes informations. Cet avis peut avoir d'importantes informations sur votre demande ou la couverture par l'intermédiaire de LifeWise Health Plan of Washington. Le présent avis peut contenir des dates clés. Vous devrez peut-être prendre des mesures par certains délais pour maintenir votre couverture de santé ou d'aide avec les coûts. Vous avez le droit d'obtenir cette information et de l’aide dans votre langue à aucun coût. Appelez le 800-592-6804 (TTY: 800-842-5357).
Kreyòl ayisyen (Creole): Avi sila a gen Enfòmasyon Enpòtan ladann. Avi sila a kapab genyen enfòmasyon enpòtan konsènan aplikasyon w lan oswa konsènan kouvèti asirans lan atravè LifeWise Health Plan of Washington. Kapab genyen dat ki enpòtan nan avi sila a. Ou ka gen pou pran kèk aksyon avan sèten dat limit pou ka kenbe kouvèti asirans sante w la oswa pou yo ka ede w avèk depans yo. Se dwa w pou resevwa enfòmasyon sa a ak asistans nan lang ou pale a, san ou pa gen pou peye pou sa. Rele nan 800-592-6804 (TTY: 800-842-5357).
Deutsche (German): Diese Benachrichtigung enthält wichtige Informationen. Diese Benachrichtigung enthält unter Umständen wichtige Informationen bezüglich Ihres Antrags auf Krankenversicherungsschutz durch LifeWise Health Plan of Washington. Suchen Sie nach eventuellen wichtigen Terminen in dieser Benachrichtigung. Sie könnten bis zu bestimmten Stichtagen handeln müssen, um Ihren Krankenversicherungsschutz oder Hilfe mit den Kosten zu behalten. Sie haben das Recht, kostenlose Hilfe und Informationen in Ihrer Sprache zu erhalten. Rufen Sie an unter 800-592-6804 (TTY: 800-842-5357).
Hmoob (Hmong): Tsab ntawv tshaj xo no muaj cov ntshiab lus tseem ceeb. Tej zaum tsab ntawv tshaj xo no muaj cov ntsiab lus tseem ceeb txog koj daim ntawv thov kev pab los yog koj qhov kev pab cuam los ntawm LifeWise Health Plan of Washington. Tej zaum muaj cov hnub tseem ceeb uas sau rau hauv daim ntawv no. Tej zaum koj kuj yuav tau ua qee yam uas peb kom koj ua tsis pub dhau cov caij nyoog uas teev tseg rau hauv daim ntawv no mas koj thiaj yuav tau txais kev pab cuam kho mob los yog kev pab them tej nqi kho mob ntawd. Koj muaj cai kom lawv muab cov ntshiab lus no uas tau muab sau ua koj hom lus pub dawb rau koj. Hu rau 800-592-6804 (TTY: 800-842-5357).
Iloko (Ilocano): Daytoy a Pakdaar ket naglaon iti Napateg nga Impormasion. Daytoy a pakdaar mabalin nga adda ket naglaon iti napateg nga impormasion maipanggep iti apliksayonyo wenno coverage babaen iti LifeWise Health Plan of Washington. Daytoy ket mabalin dagiti importante a petsa iti daytoy
(Arabic): ةالعربي a pakdaar. Mabalin nga adda rumbeng nga aramidenyo nga addang sakbay dagiti partikular a naituding nga aldaw tapno mapagtalinaedyo ti coverage ti salun-atyo wenno tulong kadagiti gastos. Adda karbenganyo a امةھ ماتولعم اراإلشع ھذا يحوي . أو طلبك وصخصب مةمھ اتمولعم عارشإلا ھذا ويحي قد
mangala iti daytoy nga impormasion ken tulong iti bukodyo a pagsasao nga اللخ من ھاعلي لوالحص تريد التي التغطية LifeWise Health Plan of Washington. قدawan ti bayadanyo. Tumawag iti numero nga 800-592-6804 (TTY: 800-842-5357).
على اظلحفل نةعيم يخراوت في إجراء التخاذ اجتحت قدو . اإلشعار ذاھ في مھمة يخراوت ھناك تكون ةدمساعوال تالوملمعا ھذه على ولحصال لك يحق .يفكالتال دفع في دةاعسملل أو يةحصلا تكطيتغ
فةلكت أية بدتك دون تكغلب (TTY: 800-842-5357) 6804-592-800بـصل ات .
中文 (Chinese):本通知有重要的訊息。本通知可能有關於您透過 LifeWise Health Plan of Washington 提交的申請或保險的重要訊息。本通知內可能有重要日期。您可能需要在截止日期之前採取行動,以保留您的健康保險或者費用補貼。您有
權利免費以您的母語得到本訊息和幫助。請撥電話 800-592-6804 (TTY: 800-842-5357)。
037336 (07-2016)
Italiano (Italian): Questo avviso contiene informazioni importanti. Questo avviso può contenere informazioni importanti sulla tua domanda o copertura attraverso LifeWise Health Plan of Washington. Potrebbero esserci date chiave in questo avviso. Potrebbe essere necessario un tuo intervento entro una scadenza determinata per consentirti di mantenere la tua copertura o sovvenzione. Hai il diritto di ottenere queste informazioni e assistenza nella tua lingua gratuitamente. Chiama 800-592-6804 (TTY: 800-842-5357).
https://www.hhs.gov/ocr/office/file/index.htmlhttps://ocrportal.hhs.gov/ocr/portal/lobby.jsfmailto:AppealsDepartmentInquiries@LifeWiseHealth.com
้
日本語 (Japanese):この通知には重要な情報が含まれています。この通知には、 LifeWise Health Plan of Washington の申請または補償範囲に関する重要な情報が含まれている場合があります。この通知に記載されている可能性がある重要
な日付をご確認ください。健康保険や有料サポートを維持するには、特定
の期日までに行動を取らなければならない場合があります。ご希望の言語
による情報とサポートが無料で提供されます。 800-592-6804 (TTY: 800-842-5357)までお電話ください。
한국어 (Korean): 본 통지서에는 중요한 정보가 들어 있습니다 . 즉 이 통지서는 귀하의 신청에 관하여 그리고 LifeWise Health Plan of Washington 를 통한 커버리지에 관한 정보를 포함하고 있을 수 있습니다 . 본 통지서에는 핵심이 되는 날짜들이 있을 수 있습니다 . 귀하는 귀하의 건강 커버리지를 계속 유지하거나 비용을 절감하기 위해서 일정한 마감일까지 조치를 취해야 할 필요가 있을 수 있습니다 . 귀하는 이러한 정보와 도움을 귀하의 언어로 비용 부담없이 얻을 수 있는 권리가 있습니다 . 800-592-6804 (TTY: 800-842-5357) 로 전화하십시오 .
ລາວ (Lao): ແຈ້ງການນີ້ ນສໍ າຄັນ. ແຈ້ງການນີ້ ອາດຈະມີ ນສໍ າຄັນກ່ຽວກັບຄໍ າຮ້ອງສະ ກ ຫຼື ຄວາມຄຸ້ມຄອງປະກັນໄພຂອງທ່ານຜ່ານ LifeWise Health Plan of
Washington. ອາດຈະມີ ນທີ າຄັນໃນແຈ້ງການນ້ີ . ທ່ານອາດຈະຈໍ າເປັ ນຕ້ອງດໍ າ ເນີ ນການຕາມກໍ ານົດເວລາສະເພາະເພື່ ອຮັກສາຄວາມຄຸ້ມຄອງປະກັນສຸຂະພາບ ຫຼື ຄວາມຊ່ວຍເຫຼື ອເລ່ື ອງຄ່າໃຊ້ າຍຂອງທ່ານໄວ້ . ທ່ານມີ ດໄດ້ ບຂໍ້ ນນ້ີ ແລະ ຄວາມ ວຍເຫຼື ອເປັ ນພາສາຂອງທ່ານໂດຍບໍ່ ເສຍຄ່າ. ໃຫ້ໂທຫາ 800-592-6804
(TTY: 800-842-5357).
ភាសាែខមរ (Khmer):
ມູ ຮັ ສິ
ມູ ຂໍ້
ສໍ
ຈ່
ວັ
ມູ ຂໍ້ ມີ ໝັ
ຊ່
Română (Romanian): Prezenta notificare conține informații importante. Această notificare poate conține informații importante privind cererea sau acoperirea asigurării dumneavoastre de sănătate prin LifeWise Health Plan of Washington. Pot exista date cheie în această notificare. Este posibil să fie nevoie să acționați până la anumite termene limită pentru a vă menține acoperirea asigurării de sănătate sau asistența privitoare la costuri. Aveți dreptul de a obține gratuit aceste informații și ajutor în limba dumneavoastră. Sunați la 800-592-6804 (TTY: 800-842-5357).
Pусский (Russian): Настоящее уведомление содержит важную информацию. Это уведомление может содержать важную информацию о вашем заявлении или страховом покрытии через LifeWise Health Plan of Washington. В настоящем уведомлении могут быть указаны ключевые даты. Вам, возможно, потребуется принять меры к определенным предельным срокам для сохранения страхового покрытия или помощи с расходами. Вы имеете право на бесплатное получение этой информации и помощь на вашем языке. Звоните по телефону 800-592-6804 (TTY: 800-842-5357).
Fa’asamoa (Samoan): Atonu ua iai i lenei fa’asilasilaga ni fa’amatalaga e sili ona taua e tatau ona e malamalama i ai. O lenei fa’asilasilaga o se fesoasoani e fa’amatala atili i ai i le tulaga o le polokalame, LifeWise Health Plan of Washington, ua e tau fia maua atu i ai. Fa’amolemole, ia e iloilo fa’alelei i aso fa’apitoa olo’o iai i lenei fa’asilasilaga taua. Masalo o le’a iai ni feau e tatau ona e faia ao le’i aulia le aso ua ta’ua i lenei fa’asilasilaga ina ia e iai pea ma maua fesoasoani mai ai i le polokalame a le Malo olo’o e iai i ai. Olo’o iai iate oe le aia tatau e maua atu i lenei fa’asilasilaga ma lenei fa’matalaga i legagana e te malamalama i ai aunoa ma se togiga tupe. Vili atu i le telefoni 800-592-6804 (TTY: 800-842-5357).
Español (Spanish): Este Aviso contiene información importante. Es posible que este aviso contenga información importante acerca de su solicitud o cobertura a través de LifeWise Health Plan of Washington. Es posible que haya fechas clave en este aviso. Es posible que deba tomar alguna medida antes de
េសចកតជី ូ នដំ ងេនះមានព័ ី
ជាមានព័ ៌ ៉ ងសំ ់អពី ់ ៉ ប់ តមានយា ខាន ំ ទរមងែបបបទ ឬការរា
ជូ ត៌ ណឹ នដ
រងរបស់អន
LifeWise Health Plan of Washington ។ របែហលជាមាន កាលបរ ិ ឆ ំ ់ េចទសខានេនៅ
មានយ៉ា ំ ់ ត ងសខាន។ េសចក ំណឹងេនះរបែហល
កតាមរយៈ
ងេសចកត ី នដណងេនះ។ អករបែហលជារតវការបេញញសមតភាព ដល់ ណត់ ំ ឹ ន ូ ច ថ កំ ជូ កន ុ determinadas fechas para mantener su cobertura médica o ayuda con los អន ៃថងជាកចបាសនានា េដ ី ឹ ុ ៉ ប់ ុខភាពរបស់ ក ឬរបាក់ costos. Usted tiene derecho a recibir esta información y ayuda en su idioma ់ ់ ើមបនងរកសាទកការធានារា រងស
ក sin costo alguno. Llame al 800-592-6804 (TTY: 800-842-5357). ជ ំ យេចញៃថ កមានសិ េដាយមិ ុ ើ ូ ូ នអសលយេឡយ។ សមទ
ទធ នួ ល។ អន នួ ិ ួលព័ ៌ ិងជំ ន ុងភាសារបស ទទ តមានេនះ ន យេនៅក អន ់
800-592-6804 (TTY: 800-842-5357)។
រស័
ਅੰ
ਜਾਬੀ (Punjabi): paunawa na ito ay maaaring naglalaman ng mahalagang impormasyon ਇਸ ਨੋ ਿਟਸ ਿਵਚ ਖਾਸ ਜਾਣਕਾਰੀ ਹੈ. ਇਸ ਨੋ ਿਟਸ ਿਵਚ LifeWise Health Plan of tungkol sa iyong aplikasyon o pagsakop sa pamamagitan ng LifeWise
Health Plan of Washington. Maaaring may mga mahalagang petsa dito sa Washington ਵਲ ਤੁ ਜ ਅਤੇ ਅਰਜੀ ਬਾਰੇ ਮਹਤਵਪੂ ੋ ਸਕਦੀ ਹਾਡੀ ਕਵਰੇ ੱ ਰਨ ਜਾਣਕਾਰੀ ਹ
ពទ
paunawa. Maaring mangailangan ka na magsagawa ng hakbang sa ilang ਹੈ ੋ ਿਜਸ ਜਵਚ ਖਾਸ ਤਾਰੀਖਾ ਹੋ ਂ ਹਨ. ਜੇ ੁ ੇ ੱ ਖਣੀ ਹੋ ੇ mga itinakdang panahon upang mapanatili ang iyong pagsakop sa . ਇਸ ਨ ਸਕਦੀਆ ਕਰ ਤਸੀ ਜਸਹਤ ਕਵਰਜ ਿਰ ਵ ਜਾ ਓਸ ਦੀ ਲਾਗਤ ਜਿਵੱਚ ਮਦਦ ਦੇ ੱ ੁ ੋ ਤਾਂ ਤੁ ੰ ੂ ਤਮ ਤਾਰੀਖ਼ ਤ ਪਿਹਲਾਂ ਕੁ kalusugan o tulong na walang gastos. May karapatan ka na makakuha ng ਇਛਕ ਹ ਹਾਨ ੱ ਝ ਖਾਸ
ganitong impormasyon at tulong sa iyong wika ng walang gastos. Tumawag ਕਦਮ ਚੁਕਣ ਦੀ ਲੜ ਹੋ ਸਕਦੀ ਹ ੈ,ਤੁ ੰ ੂ ਮੁ ੱ ਚ ਤੇ ੱ ਚ ਜਾਣਕਾਰੀ ਅਤੇ ੱ ੋ ਹਾਨ ਫ਼ਤ ਿਵ ਆਪਣੀ ਭਾਸ਼ਾ ਿਵ ਮਦਦ sa 800-592-6804 (TTY: 800-842-5357). ਪ੍ਰ ੈਾਪਤ ਕਰਨ ਦਾ ਅਿਧਕਾਰ ਹ ,ਕਾਲ 800-592-6804 (TTY: 800-842-5357).
ਪੰ
Tagalog (Tagalog): Ang Paunawa na ito ay naglalaman ng mahalagang impormasyon. Ang
ไทย (Thai): ประกาศน ้ีมีข้อมลูสําคญั ประกาศน ้ีอาจมีข้อมลูที่สําคญัเกี่ยวกบัการการสมคัรหรือขอบเขตประกนั
(Farsi): فارسی فرم بارهدر ھمم اطالعات حاوی است ممکن يهمالعا اين . ميباشد ھمم اطالعات یوحا يهمالعا اين
สขุภาพของคณุผ่าน LifeWise Health Plan of Washington และอาจมีกําหนดการในประกาศ طريق از ماش ای مهبي وششپ يا و تقاضا LifeWise Health Plan of Washington به .باشدี น جهتو يهمالعا اين در ھمم ھای خيتار يا تان بيمه وششپ حقظ برای است کنمم ماش . يدماين کمک คณุอาจจะต้องดําเนินการภายในกําหนดระยะเวลาที่แน่นอนเพื่อจะรักษาการประกนัสขุภาพของคณุ
اجتياح صیاخ کارھای امانج برای صیمشخ ھای خيتار به تان، انیمدر ھای زينهھ پرداخت درหรือการช่วยเหลือที่มีค่าใช้จ่าย คณุมีสิทธิที่จะได้รับข้อมลูและความช่วยเหลือน ้ีในภาษาของคณุโดยไม่ม ีباشيد داشته . رايگان ورط به ودخ انزب به را مکک و اطالعات اين که داريد را اين حق ماش
(ค่าใช้จ่าย โทร 800-592-6804 (TTY: 800-842-5357 مارهش با اطالعات سبک برای . نماييد دريافت 800-592-6804 . اييد نم برقرار استم ) 5357-842-800 مارهباش اس تم TTY کاربران(
Polskie (Polish): To ogłoszenie może zawierać ważne informacje. To ogłoszenie może zawierać ważne informacje odnośnie Państwa wniosku lub zakresu świadczeń poprzez LifeWise Health Plan of Washington. Prosimy zwrócic uwagę na kluczowe daty, które mogą być zawarte w tym ogłoszeniu aby nie przekroczyć terminów w przypadku utrzymania polisy ubezpieczeniowej lub pomocy związanej z kosztami. Macie Państwo prawo do bezpłatnej informacji we własnym języku. Zadzwońcie pod 800-592-6804 (TTY: 800-842-5357).
Português (Portuguese): Este aviso contém informações importantes. Este aviso poderá conter informações importantes a respeito de sua aplicação ou cobertura por meio do LifeWise Health Plan of Washington. Poderão existir datas importantes neste aviso. Talvez seja necessário que você tome providências dentro de determinados prazos para manter sua cobertura de saúde ou ajuda de custos. Você tem o direito de obter esta informação e ajuda em seu idioma e sem custos. Ligue para 800-592-6804 (TTY: 800-842-5357).
Український (Ukrainian): Це повідомлення містить важливу інформацію. Це повідомлення може містити важливу інформацію про Ваше звернення щодо страхувального покриття через LifeWise Health Plan of Washington. Зверніть увагу на ключові дати, які можуть бути вказані у цьому повідомленні. Існує імовірність того, що Вам треба буде здійснити певні кроки у конкретні кінцеві строки для того, щоб зберегти Ваше медичне страхування або отримати фінансову допомогу. У Вас є право на отримання цієї інформації та допомоги безкоштовно на Вашій рідній мові. Дзвоніть за номером телефону 800-592-6804 (TTY: 800-842-5357).
Tiếng Việt (Vietnamese): Thông báo này cung cấp thông tin quan trọng. Thông báo này có thông tin quan trọng về đơn xin tham gia hoặc hợp đồng bảo hiểm của quý vị qua chương trình LifeWise Health Plan of Washington. Xin xem ngày quan trọng trong thông báo này. Quý vị có thể phải thực hiện theo thông báo đúng trong thời hạn để duy trì bảo hiểm sức khỏe hoặc được trợ giúp thêm về chi phí. Quý vị có quyền được biết thông tin này và được trợ giúp bằng ngôn ngữ của mình miễn phí. Xin gọi số 800-592-6804 (TTY: 800-842-5357).
Recommended