Obsolete and Unreliable Tests and Procedures

Number: 0438

Policy

1. CMS designated obsolete tests and procedures

   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for Medicare & Medicaid Services (CMS) has determined that these diagnostic tests are obsolete or unreliable, have been replaced by more advanced procedures, or they are not recommended by professional specialty societies (e.g., the American College of Cardiology and the American Heart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
   • Counterimmunoelectrophoresis, each antigen
   • 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. Other obsolete tests and procedures

   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
   • Radical parametrectomy after “cut-through” hysterectomy in low-risk early-stage cervical cancer
   • Renal decapsulation for the treatment of anuria
   • 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.

Counterimmunoelectrophoresis is a laboratory technique using an electrical field across a diffusion medium that measures binding of an antibody to an antigen. In clinical medicine, it has been replaced by newer, less labor-intensive immunoassay techniques including enzyme-linked immunosorbent assay (ELISA).

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.

Renal Decapsulation for the Treatment of Anuria:

Drager and colleagues (2017) stated that in the early 20th century, Harrison first performed renal decapsulation in anuric children with scarlet fever and observed improvement in renal function post-operatively.  The pathophysiological explanation was seen in intra-parenchymal renal pressure due to edema which was improved by surgical decapsulation.  The technique of decapsulation was simple excision after incision and blunt dissection of the renal parenchyma.  Renal decapsulation then became a procedure commonly used for many indications in inflammatory renal conditions; indications were renal angioneurosis, hydronephrosis, toxic, bacterial and chronic nephritis, renal abscess and even eclampsia.  The authors concluded that with the beginning of the antibiotic era, renal decapsulation became obsolete and has disappeared from the urological spectrum completely.

Radical Parametrectomy after “Cut-Through” Hysterectomy in Low-Risk Early-Stage Cervical Cancer:

Pareja and colleagues (2018) identified predictive factors in patients with a diagnosis of early-stage cervical cancer after simple hysterectomy in order to avoid a radical parametrectomy.  A retrospective review was performed of all patients who underwent radical parametrectomy and bilateral pelvic lymphadenectomy at MD Anderson Cancer Center and at the Instituto de Cancerologia Las Americas in Medellin, Colombia from December 1999 to September 2017.  These researchers sought to determine the outcomes in patients diagnosed with low-risk factors (squamous, adenocarcinoma or adeno-squamous lesions less than 2-cm in size, and invading less than 10 mm) undergoing radical parametrectomy and pelvic lymphadenectomy.  A total of 30 patients were included in the study.  The median age was 40.4years (range of 26 to 60) and median body mass index (BMI) was 26.4kg/m2 (range of 17.7 to 40.0).  A total 22 patients had tumors less than 1 cm and 8 had tumors between 1 and 2 cm.  A total of 6 (33 %) of 18 patients had evidence of lymph-vascular invasion (LVSI).  No radical parametrectomy specimen had residual tumor, involvement of the parametrium, vaginal margin positivity, or lymph node metastasis.  None of the patients received adjuvant therapy.  After a median follow-up of 99 months (range of 6 to 160) only 1 patient recurred.  The authors concluded that radical parametrectomy may be avoided in patients with low-risk early-stage cervical cancer detected after a simple hysterectomy; rates of residual disease (parametrial or vaginal) and the need for adjuvant treatments or recurrences were very low.

The above policy is based on the following references: