Isolated Small Bowel Transplant
The following language is added to the policy:
A small bowel transplant using cadaveric intestine may be considered medically necessary in adult and pediatric patients with intestinal failure (characterized by loss of absorption and the inability to maintain protein-energy, fluid, electrolyte, or micronutrient balance), who have established long-term dependency on total parenteral nutrition (TPN) and are developing or have developed severe complications due to TPN.
A small bowel transplant using a living donor may be considered medically necessary only when a cadaveric intestine is not available for transplantation in a patient who meets the criteria noted above for a cadaveric intestinal transplant.
A small bowel transplant using living donors is considered not medically necessary in all other situations and not covered.
Transcutaneous Electrical Nerve Stimulation
Criteria is added to the policy to determine medical necessity:
A form-fitting conductive garment may be considered medically necessary only when:
a) It has received permission or approval for marketing by the FDA; and
b) It has been prescribed by a physician for use in delivering covered TENS or NMES treatment; and
c) One of the medical indications outlined below is met:
-The patient cannot manage without the conductive garment because there is such a large area or so many sites to be stimulated and the stimulation would have to be delivered so frequently that it is not feasible to use conventional electrodes, adhesive tapes and lead wires;
-The patient cannot manage without the conductive garment for the treatment of chronic intractable pain because the areas or sites to be stimulated are inaccessible with the use of conventional electrodes, adhesive tapes and lead wires;
-The patient has a documented medical condition such as skin problems that preclude the application of conventional electrodes, adhesive tapes and lead wires;
-The patient requires electrical stimulation beneath a cast either to treat disuse atrophy, where the nerve supply to the muscle is intact, or to treat chronic intractable pain; or
-The patient has a medical need for rehabilitation strengthening (pursuant to a written plan of rehabilitation) following an injury where the nerve supply to the muscle is intact.
d) Coverage will not be provided for a form-fitting conductive garment when the above criteria have not been met, as this is considered not medically necessary.
Stereotactic Radiosurgery and Charged-Particle Radiation Therapy
Charged-Particle (Proton or Helium Ion) Radiation Therapy
Coverage will not be provided for other applications of charged-particle irradiation, including but not limited to use of proton beam therapy for non-small-cell lung cancer (NSCLC) at any stage or for recurrence, as they are considered investigational.
Negative Pressure Wound Therapy in the Outpatient Setting
New language is added to monitor the appropriate usage of negative pressure wound therapy in the outpatient setting. Coverage will be provided for negative pressure wound therapy in the outpatient setting when medically necessary.
Initiation of Negative Pressure Wound Therapy (NPWT):
1. An initial 2-week therapeutic trial using a negative pressure wound therapy (NPWT) system, as part of a comprehensive wound care program that includes controlling factors such diabetes, nutrition, relief of pressure, etc., may be considered medically necessary in the following indications:
a) Chronic (> 90 days) stage III or IV pressure ulcers that have failed to heal despite optimal wound care when there is high-volume drainage that interferes with healing and/or when standard dressings cannot be maintained due to anatomic factors, or
b) Traumatic or surgical wounds where there has been a failure of immediate or delayed primary closure and there is exposed bone, cartilage, tendon, or foreign material within the wound AND no contraindications to use are present, or
c) Wounds in patients with underlying clinical conditions which are known to negatively impact wound healing which are non-healing (at least 30 days) despite optimal wound care. (Examples of underlying conditions include, but are not limited to diabetes, malnutrition, small vessel disease, and morbid obesity. Malnutrition, while a risk factor, must be addressed simultaneously with the negative pressure wound therapy.
2. Contraindications to the use of NPWT systems include the following conditions as noted by a November 2009 FDA alert and will be considered not medically necessary: necrotic tissue with eschar, untreated osteomyelitis, nonenteric and unexplored fistulas, malignancy in the wound, exposed nerve, exposed anastomotic site, and exposed organ.
3. Negative pressure therapy systems should be used as part of a comprehensive wound care program that includes attention to other factors that impact wound healing such as diabetes control, nutritional status, relief of pressure, etc.
4. Continuation of the NPWT system, as part of a comprehensive wound care program, may be considered medically necessary following an initial 2-week therapeutic trial or a subsequent treatment period if the treatment has resulted in documented objective improvements in the wound. Objective improvements in the wound should include the development and presence of healthy granulation tissue, progressive wound contracture and decreasing depth, and/or the commencement of epithelial spread from the wound margins.
5. Continuation of healing during use of the NPWT system should be monitored on a frequency not less than every 14 days.
6. Continuation of the NPWT system is considered not medically necessary when any of the following occurs:
a) The therapeutic trial or subsequent treatment period has not resulted in documented objective improvement in the wound, OR
b) The wound has developed evidence of wound complications contraindicating continued NPWT, OR
c) The wound has healed to an extent that either grafting can be performed or the wound can be anticipated to heal completely with other wound care treatments.
7. Complete healing of a wound would normally be anticipated if all bone, cartilage, tendons, and foreign material were completely covered, healthy granulation were present to within 5 mm of the surface, and the wound edges were reduced to 2 cm in width or diameter.
No coverage will be provided for therapeutic trials of NPWT systems for the treatment of other acute or chronic wounds except as noted above as they are considered not medically necessary.
Transcatheter Arterial Chemoembolization (TACE) to Treat Primary or Metastatic Liver Malignancies
Transcatheter hepatic arterial chemoembolization as neoadjuvant or adjuvant therapy in hepatocellular cancer that is considered resectable is considered investigational and is not covered.
Coverage will be provided for measurement of serum tumor marker CA-125 when medically necessary.
1. Measurement of CA-125 may be considered medically necessary in patients with symptoms suggestive of ovarian cancer or in those with known ovarian cancer.
2. Measurement of CA-125 may be considered medically necessary in individual patients with other gynecologic malignancies of the endometrium, fallopian tube, or endocervix (HM), in whom baseline levels of CA-125 have been shown to be elevated.
3. Measurement of CA-125 is considered investigational in asymptomatic patients as a screening technique for ovarian cancer.
4. Measurement of serum tumor marker CA-125 is considered investigational for the diagnosis or management of any other malignancy other than those listed above.
Not Medically Necessary
Ultrasonographic Evaluation of Skin Lesions
Ultrasonographic evaluation as a technique to assess photoaging or skin rejunvenation techniques is not medically necessary and therefore not covered.
Cryosurgical Ablation and Radiofrequency Ablation
Radiofrequency Facet Joint Denervation
Radiofrequency denervation of cervical facet joints (C3-4 and below) and lumbar facet joints is considered medically necessary when criteria in the policy are met. These were updated to indicate 2 (rather than 3) positive blocks are required and information about single versus multiple level diagnostic blocks was also added. The new policy language is as follows:
A trial of controlled diagnostic medial branch blocks (2 separate positive blocks or placebo controlled series of blocks) under fluoroscopic guidance has resulted in at least a 50% reduction in pain; and the diagnostic blocks should involve the levels being considered for RF treatment. These diagnostic blocks should be targeted to the likely pain generator. Single level blocks lead to more precise diagnostic information, but multiple single level blocks require several visits and additional exposure to radiation.
Experimental/Investigative Services Radiology
Scintimammography/Breast-Specific Gamma Imaging/Molecular Breast Imaging
The following is added to the policy:
Scintimammography, breast specific gamma imaging, and molecular breast imaging in all applications including, but not limited to its use as an adjunct to mammography or in staging the axillary lymph nodes is considered investigational and not covered.
Experimental/Investigative Services Medicine
Cytoreduction and Hyperthermic Intraperitoneal Chemotherapy for the Treatment of Pseudomyxoma Peritonei and Peritoneal Carcinomatosis of Gastrointestinal Origin
The following language was added to the policy: Cytoreduction and hyperthermic intraperitoneal chemotherapy for peritoneal carcinomatosis from colorectal cancer is considered investigational and not covered.
For the treatment of pseudomyxoma peritonei it may be considered medically necessary.
Experimental/Investigative Services Surgery
Minimally Invasive Coronary Artery Bypass Graft Surgery
The following medically necessary language was added to the policy:
Minimally invasive coronary artery bypass graft surgery techniques including, but not limited to, PACAB (port access coronary artery bypass), hybrid CABG or TECAB (total endoscopic coronary artery bypass) is considered investigational and not covered.
Minimally invasive direct coronary artery bypass graft surgery (MIDCAB) may be considered medically necessary.
Periurethral Bulking Agents for the Treatment of Urinary Incontinence
The use of autologous cellular therapy (e.g., myoblasts, fibroblasts, muscle-derived stem cells or adipose-derived stem cells), autologous fat, and autologous ear chondrocytes to treat stress urinary incontinence is considered investigational and not covered.
The use of any other periurethral bulking agents, including, but not limited to Teflon®, to treat stress urinary incontinence is considered investigational and not covered.
-The use of cross-linked collagen, carbon-coated spheres, calcium hydroxylapatite, or polydimethylsiloxane may be considered medically necessary to treat stress urinary incontinence in men and women who have failed appropriate conservative therapy.
-Patients should have had inadequate response to conservative therapy or therapies; in general, these treatments should have been used for at least 3 months. Conservative therapy for stress incontinence includes pelvic floor muscle exercises and behavioral changes, such as fluid management and moderation of physical activities that provoke incontinence. Additional options include intravaginal estrogen therapy, use of a pessary, and treatment of other underlying causes of incontinence in patients amenable to these treatments.
-The use of periuretheral bulking agents to treat urge urinary incontinence is considered investigational and not covered.
Experimental/Investigative Services Therapy
Manipulation under Anesthesia
Spinal manipulation and manipulation of other joints under anesthesia involving serial treatment sessions is considered investigational and not covered.
Manipulation under anesthesia involving multiple body joints is considered investigational for treatment of chronic pain and not covered.