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Obsolete and Unreliable Tests and Procedures

Number: 0438



Policy
  1. Aetna considers the following tests experimental and investigational because the Centers for Medicare & Medicaid Services (CMS) has determined that these diagnostic tests are obsolete or unreliable, have been replaced by more advanced procedures, or they are not recommended by professional specialty societies (e.g., the American College of Cardiology and the American Heart Association):

    • Amylase, blood isoenzymes, electrophoretic
    • Bendien's test for cancer and tuberculosis
    • Bolen's test for cancer
    • Cardiointegram (or omnicardiogram)
    • Calcium saturation clotting time
    • Calcium, feces, 24-hour quantitative
    • Capillary fragility test (Rumpel-Leede)
    • Cephalin flocculation
    • Chromium, blood
    • Chymotrypsin, duodenal content
    • Circulation time, one test
    • Colloidal gold
    • Congo red, blood
    • Gastric analysis, pepsin
    • Gastric analysis, tubeless
    • Guanase, blood
    • Hormones, adrenocorticotropin quantitative animal tests
    • Hormones, adrenocorticotropin quantitative bioassay
    • Lupus erythematosus (LE) cell test (also known as LE prep, LE phenomenon or LE Cell Prep)
    • Mechanical fragility test, red blood cells
    • Rehfuss test for gastric acidity
    • Serum glutamate dehydrogenase 
    • Serum mucoprotein (seromucoid) assay for cancer and other diseases.
    • Skin test, actinomycosis
    • Skin test, brucellosis
    • Skin test, cat scratch fever
    • Skin test, lymphopathia venerum
    • Skin test, psittacosis
    • Skin test, trichinosis
    • Starch, feces, screening
    • Thymol turbidity, blood
    • Zinc sulphate turbidity, blood.
       
  2. Aetna considers the following procedures experimental and investigational because they are obsolete:

    • Colectomy to treat epilepsy
    • Contrast or chain urethrocystography
    • Cystotomy or cystostomy, with cryosurgery, fulguration and/or insertion of radioactive material
    • Cystourethroscopy with insertion of radioactive substance
    • Diethylstilbestrol to improve pregnancy outcomes
    • Displacement therapy (Proetz type)
    • Gastric bubble for morbid obesity (See CPB 0157 - Obesity Surgery)
    • Gastric freezing for peptic ulcer disease (See CPB 0527 - Intragastric Hypothermia)
    • Heart catheterization by left ventricular puncture
    • Incisional biopsy of the prostate
    • Mammary artery ligation for coronary artery disease
    • Optic nerve decompression surgery for non-arteritic anterior ischemic optic neuropathy (See CPB 0415- Optic Nerve Decompression Surgery)
    • Paraffin oil injection
    • Prostatotomy for external drainage of prostate abscess
    • Quinidine for suppressing recurrences of atrial fibrillation
    • Radiation therapy for acne
    • Supplemental oxygen for healthy premature baby
Background

This policy includes tests and procedures that have been deemed obsolete by the Centers for Medicare and Medicaid Services, McKesson Corporation ClaimCheck and other authorities.  Obsolete tests and procedures are those that are outdated and are no longer standard of care.

Transrectal ultrasound-guided core needle biopsy has replaced incisional biopsy of the prostate for diagnosis of prostate cancer.  In the core needle biopsy procedure, a needle is inserted into the wall of the rectum into the prostate gland and a core sample is removed for pathological analysis.  Alternatively, the needle may be inserted through the perineum to the prostate gland.  Typically, about a dozen cores of the prostate are taken.

Prostate abscesses may occur as a complication of prostatitis.  Treatment involves appropriate antibiotics and drainage.  Transurethral evacuation or transperineal aspiration have replaced a prostatotomy as the standard method of drainage of a prostatic abscess. 

For many years, contrast or chain urethrocystography was used to evaluate the lower urinary tract.  This procedure has been replaced by ultrasonography for imaging of the urethrovesical anatomy due to the radiation exposure from contrast or chain urethrocystography and due to the less invasive nature of ultrasonography.

Heart catheterization by left ventricular puncture has been made obsolete by catheterization through the femoral artery or through an upper extremity artery using percutaneous access methods.  Right heart catheterization now is commonly performed from the femoral, internal jugular, or subclavian veins.

Cystourethroscopy has replaced cystotomy or cystostomy for cryosurgery or fulguration of bladder lesions.  Although cystourethroscopy can be used to deliver radioactive substances to the bladder (intravesical brachytherapy), current evidence-based guidelines do not recommend brachytherapy as an established treatment for bladder cancer.

The standard method of sinus irrigation in sinusitis involves placement of an instrument into the sinus and flushing the sinus with sterile water.  This procedure is typically performed with local anesthesia (i.e., novocaine).  The Proetz procedure (saline irrigation combined with suctioning) is an older method of sinus irrigation.  With the patient in the supine position and the head hyperextended, the nose and nasopharynx are partially filled with a saline solution to which a topical decongestant may be added.  Suction is then applied to one nostril while the other is occluded in order to remove the irrigating solution along with the secretions.  These steps may be repeated in order to achieve irrigation and drainage of the sinuses.  The effectiveness of this procedure in improving clinical outcomes of sinusitis and its advantages over the current standard method of sinus irrigation are not well documented in the peer-reviewed published medical literature.

Kadish and colleagues (2001) noted that cardiointegram (CIG)/omnicardiogram is a technique intended to detect abnormalities in the standard 12-lead electrocardiogram (ECG) that are beyond the standard, routine interpretation in patients at risk of cardiac ischemia.  This additional technology consists of a microcomputer that receives output from a standard ECG and transforms it to produce a graphical representation of heart electrophysiological signals.  This procedure is mainly used as a substitute for exercise tolerance testing with thallium imaging in patients for whom a resting ECG may be inadequate to identify changes compatible with coronary artery disease.  These findings are based on theoretical assumption that poor exercise tolerance is related to electrophysiological signals; but this test does not consider the impact of other symptoms or blood flow.  The American College of Cardiology and the American Heart Association do not recommend this test.

Gu et al (2005) stated that mechanical fragility of red blood cells (RBCs) is a critical variable for the hemolysis testing of many important clinical devices, such as pumps, valves, and cannulae, and gas exchange devices.  Unfortunately, no standardized test for RBC mechanical fragility is currently well accepted.  Although many test devices have been proposed for the study of mechanical fragility of RBCs, no one has ever shown that their results have any relevance to a blood pump.  Thus, the fundamental objective of this study was to determine if one or more test devices could be validated as calibrators to document the fragility of the test blood used for any particular test blood.  These investigators compared 5 mechanical fragility test systems to each other and to a Biopump, with respect to hemolysis.  All 5 devices seem to measure the same parameter; the hemo-resistometer most closely matched the pump test results, but the stainless steel bead test may be the most practical for routine calibration purposes.

The Canadian Agency for Drugs and Technologies in Health's report on "Re-assessment of health technologies: Obsolescence and waste" (Joshi et al, 2009) noted that the National Library of Medicine listed examples of health care technologies that were found “to be ineffective or harmful after being widely diffused".  Some of these obsolete technolgies include the following (not an all-inclusive list):

  • Colectomy to treat epilepsy
  • Diethylstilbestrol to improve pregnancy outcomes
  • Gastric bubble for morbid obesity
  • Gastric freezing for peptic ulcer disease
  • Mammary artery ligation for coronary artery disease
  • Optic nerve decompression surgery for non-arteritic anterior ischemic optic neuropathy
  • Quinidine for suppressing recurrences of atrial fibrillation
  • Radiation therapy for acne
  • Supplemental oxygen for healthy premature baby.

Conn (1994) stated that the lupus erythematosus (LE) cell test (also known as LE prep, LE phenomenon; CPT No. 85544, LE Cell Prep) is a diagnostic test for systemic lupus erythematosus (SLE) that is based on an in-vitro immunologic reaction between the patient's autoantibodies to nuclear antigens and damaged nuclei in the testing medium.  It is subject to numerous experimental variables and dependent on subjective interpretation.  The author concluded that it should be abandoned in favor of more definitive, quantitative immunologic tests for this condition.

An UpToDate review on “Diagnosis and differential diagnosis of systemic lupus erythematosus in adults” (Wallace, 2015) states that “Previously, most clinicians relied for the diagnosis of lupus upon the classification criteria that were developed by the American Rheumatism Association (ARA, now the ACR).  The criteria were established by cluster analyses, primarily in academic centers and primarily in Caucasian patients.  The patient is classified with SLE using the ACR criteria if four or more of the manifestations are present, either serially or simultaneously, during any interval of observations.  A positive LE cell test, used in older criteria, was replaced by the presence of antiphospholipid antibodies”.

Di Benedetto et al (2002) noted that injection of foreign materials, such as paraffin oil, is an old and obsolete procedure.  The authors described previous uses for this procedure that had been used since the 19th century and the treatment of patients affected by such a disease.

Onate Celdran et al (2012) reported a rare case of penile paraffinoma caused by the subcutaneous or intra-urethral injection of foreign substances containing long-chain saturated hydrocarbons.  These were injected in order to increase the penis size which generated a chronic granulomatous inflammatory reaction.  These investigators presented the case of a 32-year old Bulgarian male who presented with a 2-year history of elastic, slightly painful penis swelling after subcutaneous liquid paraffin injection.  The proposed treatment was excision of the affected tissue and penile reconstruction in a 2-stage procedure.  The operative procedure was successful and the patient had good aesthetic and functional results.  Paraffin and other materials injected into the penis can produce many complications.  Foreign body granuloma, skin necrosis, penile deformity, chronic and unhealed ulcer, painful erection, and the inability to achieve a satisfactory sexual relationship are some of the resulting complications.  Intra-lesional or systemic steroids have been used in primary sclerosing lipogranuloma resulting in the disappearance of the granuloma, but in the authors’ opinion the treatment of choice should be radical excision, and, if necessary, secondary reconstruction of the penis.  The authors concluded that injection of foreign substances to enhance penis size is currently an unjustifiable practice.  However, it is still carried out, especially in Eastern Europe and Asia.  In most cases surgical treatment is needed to treat the complications and the best modality seems to be radical excision together with follow-up.

CPT Codes / HCPCS Codes / ICD-9 Codes
CPT codes not covered for indications listed in the CPB:
Lupus erythematosus (LE) cell test or the LE Cell Phenomenon test - no specific code:
30210 Displacement therapy (Proetz type)
51020 Cystotomy or cystostomy; with fulguration and/or insertion of radioactive material
51030     with cryosurgical destruction of intravesical lesion
51605 Injection procedure and placement of chain for contrast and/or chain urethrocystography
52250 Cystourethroscopy with insertion of radioactive substance, with or without biopsy or fulguration
55705 Biopsy, prostate; incisional, any approach
55720 Prostatotomy, external drainage of prostatic abscess, any approach; simple
55725     complicated
82024 Adrenocorticotropic hormone (ACTH) [animal tests]
82150 Amylase [electrophoretic]
82495 Chromium [blood]
82965 Glutamate dehydrogenase [serum]
85345 Coagulation time; Lee and White [calcium saturation clotting time]
85347     activated [calcium saturation clotting time]
85348     other methods [calcium saturation clotting time]
85547 Mechanical fragility, RBC
86185 Counterimmunoelectrophoresis, each antigen [amylase]
HCPCS codes not covered for indications listed in the CPB:
P2028 Cephalin floculation, blood
P2029 Congo red, blood
P2033 Thymol turbidity, blood
P2038 Mucoprotein, blood (seromucoid) (medical necessity procedure)
S9025 Omnicardiogram/cardiointegram
Colectomy to treat Epilepsy:
CPT codes not covered for indications listed in the CPB:
44139 Mobilization (take-down) of splenic flexure
44140 - 44147 Colectomy, partial
44150 Colectomy, total
44160 Colectomy, partial, with removal of terminal ileum with ileocolostomy
ICD-9 codes not covered for indications listed in the CPB:
345.00 - 345.91 Epilepsy and recurrent seizures
Diethylstilbestrol to improve pregnancy outcomes:
HCPCS codes not covered for indications listed:
J9165 Injection, diethylstilbestrol diphosphate, 250 mg
ICD-9 codes not covered for indications listed in the CPB:
630 - 679.14 Complications of pregnancy, childbirth, and the puerperium
V22.0 - V23.9 Supervision of pregnancy
Gastric bubble to treat morbid obesity:
There is no specific code for gastric bubble:
ICD-9 codes not covered for indications listed in the CPB::
278.01 Morbid obesity
V85.35 - V85.45 Body mass index 35.0 - 70 and over, adult
Gastric freezing for peptic ulcer disease:
HCPCS codes not covered for indications listed in the CPB:
M0100 Intragastric hypothermia using gastric freezing
ICD-9 codes not covered for indications listed in the CPB (not all-inclusive):
530.00 - 533.91 Gastric ulcer [peptic ulcer disease]
Mammary artery ligation for coronary artery disease:
CPT codes not covered for indications listed in the CPB:
37616 Ligation, major artery; chest [mammary artery]
ICD-9 codes not covered for indications listed in the CPB:
414.0 - 414.07 Coronary atherosclerosis
Optic nerve decompression surgery for non-arteritic anterior ischemic optic neuropathy:
CPT codes not covered for indications listed in the CPB:
67570 Optic nerve decompression (eg, incision or fenestration of optic nerve sheath)
ICD-9 codes not covered for indications listed in the CPB:
377.41 Ischemic optic neuropathy
Paraffin oil injection - no specific code:
Quinidine for suppressing recurrences of atrial fibrillation:
There is no specific code for Quinidine:
ICD-9 codes not covered for indications listed in the CPB:
427.31 Atrial fibrillation
Radiation Therapy for acne:
CPT codes covered for indications listed in the CPB:
77401 Radiation treatment delivery, superficial and/or ortho voltage, per day
ICD-9 codes not covered for indications listed in the CPB:
706.0 - 706.1 Acne
Supplemental oxygen for healthy premature baby:
There is no specific code to identify supplemental oxygen for a healthy premature baby:
CPT Codes / HCPCS Codes / ICD-10 Codes
Information in the [brackets] below has been added for clarification purposes.   Codes requiring a 7th character are represented by "+":
ICD-10 codes will become effective as of October 1, 2015:
CPT codes not covered for indications listed in the CPB:
Lupus erythematosus (LE) cell test or the LE Cell Phenomenon test - no specific code.:
30210 Displacement therapy (Proetz type)
51020 Cystotomy or cystostomy; with fulguration and/or insertion of radioactive material
51030     with cryosurgical destruction of intravesical lesion
51605 Injection procedure and placement of chain for contrast and/or chain urethrocystography
52250 Cystourethroscopy with insertion of radioactive substance, with or without biopsy or fulguration
55705 Biopsy, prostate; incisional, any approach
55720 Prostatotomy, external drainage of prostatic abscess, any approach; simple
55725     complicated
82024 Adrenocorticotropic hormone (ACTH) [animal tests]
82150 Amylase [electrophoretic]
82495 Chromium [blood]
82965 Glutamate dehydrogenase [serum]
85345 Coagulation time; Lee and White [calcium saturation clotting time]
85347     activated [calcium saturation clotting time]
85348     other methods [calcium saturation clotting time]
85547 Mechanical fragility, RBC
86185 Counterimmunoelectrophoresis, each antigen [amylase]
HCPCS codes not covered for indications listed in the CPB:
P2028 Cephalin floculation, blood
P2029 Congo red, blood
P2033 Thymol turbidity, blood
P2038 Mucoprotein, blood (seromucoid) (medical necessity procedure)
S9025 Omnicardiogram/cardiointegram
Colectomy to treat Epilepsy:
CPT codes not covered for indications listed in the CPB:
44139 Mobilization (take-down) of splenic flexure
44140 - 44147 Colectomy, partial
44150 Colectomy, total
44160 Colectomy, partial, with removal of terminal ileum with ileocolostomy
ICD-10 codes not covered for indications listed in the CPB:
G40.001 - G40.919 Epilepsy and recurrent seizures
Diethylstilbestrol to improve pregnancy outcomes:
HCPCS codes not covered for indications listed:
J9165 Injection, diethylstilbestrol diphosphate, 250 mg
ICD-10 codes not covered for indications listed in the CPB:
O00.0 - O9A.53 Pregnancy, childbirth, and the puerperium
Z33.1 Pregnant state, incidental
Z34.00 - Z34.93 Supervision of pregnancy
Gastric bubble to treat morbid obesity:
There is no specific code for gastric bubble:
ICD-10 codes not covered for indications listed in the CPB::
E66.01 Morbid (severe) obesity due to excess calories
Z68.35 - Z68.45 Body mass index 35.0 - 70 and over, adult
Gastric freezing for peptic ulcer disease:
HCPCS codes not covered for indications listed in the CPB:
M0100 Intragastric hypothermia using gastric freezing
ICD-10 codes not covered for indications listed in the CPB (not all-inclusive):
K27.0 - K27.9 Peptic ulcer, site unspecified
Mammary artery ligation for coronary artery disease:
CPT codes not covered for indications listed in the CPB:
37616 Ligation, major artery; chest [mammary artery]
ICD-10 codes not covered for indications listed in the CPB:
I25.10 - I25.9 Chronic ischemic heart disease
Optic nerve decompression surgery for non-arteritic anterior ischemic optic neuropathy:
CPT codes not covered for indications listed in the CPB:
67570 Optic nerve decompression (eg, incision or fenestration of optic nerve sheath)
ICD-10 codes not covered for indications listed in the CPB:
H47.011 - H47.019 Ischemic optic neuropathy
Paraffin oil injection - no specific code:
Quinidine for suppressing recurrences of atrial fibrillation:
There is no specific code for Quinidine:
ICD-10 codes not covered for indications listed in the CPB:
I48.0 Atrial fibrillation
I48.2 Chronic atrial fibrillation
I48.91 Unspecified atrial fibrillation
Radiation Therapy for acne:
CPT codes covered for indications listed in the CPB:
77401 Radiation treatment delivery, superficial and/or ortho voltage, per day
ICD-10 codes not covered for indications listed in the CPB:
L70.0 - L70.9 Acne
Supplemental oxygen for healthy premature baby:
There is no specific code to identify supplemental oxygen for a healthy premature baby:


The above policy is based on the following references:
    1. U.S. Department of Health and Human Services, Center for Medicare & Medicaid Services (CMS). Obsolete or unreliable diagnostic tests. Medicare Coverage Issues Manual §50-34. Baltimore, MD: CMS; 2002.
    2. Tietz NW. Clinical Guide to Laboratory Tests. 3rd ed. Philadelphia, PA: W.B. Saunders Co.; 1995.
    3. Henry JB. Clinical Diagnosis and Management by Laboratory Methods. 19th ed. Philadelphia, PA: W.B. Saunders Co.; 1996.
    4. Klaassen CD, Amdur MO, Doull J. Casarett and Doull's Toxicology: The Basic Science of Poisons. 3rd ed. New York, NY: Macmillan Publishing Co.; 1986.
    5. Xact Medicare Services. Procedures of questionable current usefulness (POQCU) - pathology and laboratory. Medicare Medical Policy Bulletin. No. G-33. Camp Hill, PA: Xact; May 27, 1996. Available at: http://www.xact.org/policy/g33.html. Accessed March 27, 2000.
    6. McKesson Corp. ClaimCheck V38 [online software]. San Francisco, CA; McKesson; 2006.
    7. Kadish AH, Buxton AE, Kennedy HL, et al; ACC/AHA clinical competence statement on electrocardiography and ambulatory electrocardiography: A report of the American College of Cardiology/American Heart Association/American College of Physicians-American Society of Internal Medicine Task Force on Clinical Competence (ACC/AHA Committee to Develop a Clinical Competence Statement on Electrocardiography and Ambulatory Electrocardiography). J Am Coll Cardiol. 2001;38(7):2091-2100.
    8. Gu L, Smith WA, Chatzimavroudis GP. Mechanical fragility calibration of red blood cells. ASAIO J. 2005;51(3):194-201.
    9. Centers for Medicare & Medicaid Services (CMS).  NCD for cardiointegram (CIG) as an alternative to stress test or thallium stress test. CMS Manual System. Pub. 100-3. Medicare National Coverage, Chapter 1, Part 1, Section 20.27  Baltimore, MD: CMS; last modified April 23, 2009.
    10. Joshi NP, Stahnisch FW, Noseworthy TW. Reassessment of health technologies: Obsolescence and waste. Ottawa, ON: Canadian Agency for Drugs and Technologies in Health (CADTH); December 4, 2009. Available at: http://www.cadth.ca/media/pdf/494_Reassessment_of_HT_Obsolescence_and_Waste_tr_e.pdf. Accessed May 4, 2011.
    11. Conn RB. Practice parameter -- the lupus erythematosus cell test. An obsolete test now superseded by definitive immunologic tests. Am J Clin Pathol. 1994;101(1):65-66.
    12. Di Benedetto G, Pierangeli M, Scalise A, Bertani A. Paraffin oil injection in the body: An obsolete and destructive procedure. Ann Plast Surg. 2002;49(4):391-396.
    13. Onate Celdran J, Sanchez Rodriguez C, Tomas Ros M, et al. Penile paraffinoma after subcutaneous injection of paraffin. Treatment with a two step cutaneous plasty of the penile shaft with scrotal skin. Arch Esp Urol. 2012;65(5):575-578.
    14. Wallace DJ. Diagnosis and differential diagnosis of systemic lupus erythematosus in adults. UpToDate Inc., Waltham, MA. Last reviewed march 2015.


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