Suction Pumps

Number: 0503

Table Of Contents

Policy
Applicable CPT / HCPCS / ICD-10 Codes
Background
References


Policy

Scope of Policy

This Clinical Policy Bulletin addresses suction pumps.

  1. Medical Necessity

    Aetna considers the following suction pumps and associated supplies medically necessary:

    1. Respiratory Suction Pump

      1. Home model respiratory suction machines as durable medical equipment for members who have difficulty raising and clearing secretions secondary to any of the following conditions:

        1. Cancer or surgery of the throat or mouth; or
        2. Dysfunction of the swallowing muscles; or
        3. Tracheostomy; or
        4. Unconsciousness or obtunded state.

        Aetna considers respiratory suction pumps experimental, investigational, or unproven for all other indications because of insufficient evidence of effectiveness for other indications.

      2. Tracheal suction catheters and sterile water/saline as supplies for suction pumps.

        1. Closed system catheters when all of the following are met:

          1. The member has a tracheostomy; and
          2. The member requires the use of a medically necessary respiratory suction pump, as described above, for tracheostomy suctioning; and
          3. The member requires the use of a medically necessary ventilator.
        2. Tracheal suction catheters other than closed system catheters when all of the following are met:

          1. The member has a tracheostomy; and
          2. The member requires the use of a medically necessary respiratory suction pump, as described above, for tracheostomy suctioning.
        3. More than three tracheal suction catheters other than closed system per day are considered not medically necessary for tracheostomy suctioning.

          1. In most cases, in the home setting, sterile catheters are considered medically necessary only for tracheostomy suctioning.
          2. Three suction catheters per day are considered medically necessary for tracheostomy suctioning, unless additional documentation is provided. When a tracheal suction catheter is used in the oropharynx, which is not sterile, the catheter can be re-used if properly cleansed and/or disinfected. In this situation the medical necessity for more than 3 catheters per week would require additional documentation.
        4. An oral interface used with a respiratory suction pump is considered not medically necessary because it is not used to remove secretions for the indications described above.
        5. Sterile saline solution when used to clear a suction catheter after tracheostomy suctioning. It is not usually considered medically necessary for oropharyngeal suctioning.
    2. The following supplies for use with a suction pump:

      1. Disposable or non-disposable canister used with suction pump;
      2. Oropharyngeal suction catheters;
      3. Tubing used with suction pump.

      When a suction pump is used for tracheal suctioning, other supplies (e.g., basins, cups, gloves, solutions, etc.) included with the tracheal care kit are considered medically necessary. When a suction pump is used for oropharyngeal suctioning, these other supplies are not considered medically necessary.

    3. Gastric Suction Pump

      1. Use of a gastric suction pump and related supplies for members who are unable to empty gastric secretions through normal gastrointestinal functions. A gastric suction pump is used to remove gastrointestinal fluids under continuous or intermittent suction via a tube. Gastric suction pumps are considered experimental, investigational, or unproven for all other indications.
      2. Supplies (tubing, tape, dressings, etc.) for use with a medically necessary gastric suction pump.
    4. Wound Suction Pumps

      1. Use of suction on wounds only in those clinical scenarios where the quantity of exudate exceeds the capacity of conservative measures such as surgical dressings and wound fillers to contain it. However, wound suction to remove exudate can be accomplished with the use of disposable, suction devices, which are considered supplies, or with portable home model suction pumps, which are considered DME.
      2. Supplies (dressings, tubing, etc.) when they are used with a medically necessary portable home model suction pump for use on wounds.

      Note: When a disposable suction device alternative exists, it is not considered medically necessary to use a portable home model suction pump for use on wounds. Note: Disposable suction devices are not covered under plans that exclude supplies.

  2. Experimental, Investigational, or Unproven

    Aetna considers subcutaneous peritoneal ascites pump (e.g., the alfa-pump System) experimental, investigational, or unproven for the management of ascites; and other indications including prevention of multidrug-resistant bacterial infections, repair of hernia, and treatment of hepato-cellular carcinoma because its effectiveness for these indications has not been established.

  3. Policy Limitations and Exclusions 

    Saline used for tracheal lavage is considered a supply, and is not covered under plans that exclude supplies.

    All items used with any suction pump, such as tracheal suction catheters, sterile water, saline used for suctioning, dressings, gastric tubes, etc. (not all-inclusive) are considered to be supplies for durable medical equipment.

    Disposable wound suction devices and related supplies are considered supplies and are not considered DME; they are not covered under plans that exclude supplies.

  4. Related Policies


Table:

CPT Codes / HCPCS Codes / ICD-10 Codes

Code Code Description

CPT codes not covered for indications listed in the CPB:

0870T Implantation of subcutaneous peritoneal ascites pump system, percutaneous, including pump-pocket creation, insertion of tunneled indwelling bladder and peritoneal catheters with pump connections, including all imaging and initial programming, when performed
0871T Replacement of a subcutaneous peritoneal ascites pump, including reconnection between pump and indwelling bladder and peritoneal catheters, including initial programming and imaging, when performed
0872T Replacement of indwelling bladder and peritoneal catheters, including tunneling of catheter(s) and connection with previously implanted peritoneal ascites pump, including imaging and programming, when performed
0873T Revision of a subcutaneously implanted peritoneal ascites pump system, any component (ascites pump, associated peritoneal catheter, associated bladder catheter), including imaging and programming, when performed
0874T Removal of a peritoneal ascites pump system, including implanted peritoneal ascites pump and indwelling bladder and peritoneal catheters
0875T Programming of subcutaneously implanted peritoneal ascites pump system by physician or other qualified health care professional

HCPCS codes covered if selection criteria are met:

A4216 Sterile water, saline and/or dextrose, diluent/flush, 10 ml
A4217 Sterile water/saline, 500 ml
A4605 Tracheal suction catheter, closed system, each
A4624 Tracheal suction catheter, any type other than closed system, each
A4628 Oropharyngeal suction catheter, each
A4927 Gloves, non-sterile, per 100
A7000 Canister, disposable, used with suction pump, each
A7001 Canister, non-disposable, used with suction pump, each
A7002 Tubing, used with suction pump, each
A9272 Wound suction, disposable, including dressing, all accessories and components, any type, each
E0600 Respiratory suction pump, home model, portable or stationary, electric
E2000 Gastric suction pump, home model, portable or stationary, electric
K0743 Suction pump, home model, portable, for use on wounds
K0744 Absorptive wound dressing for use with suction pump, home model, portable, pad size 16 square inches or less
K0745 Absorptive wound dressing for use with suction pump, home model, portable, pad size more than 16 square inches but less than or equal to 48 square inches
K0746 Absorptive wound dressing for use with suction pump, home model, portable, pad size greater than 48 square inches

Other HCPCS codes related to the CPB:

A4481 Tracheostoma filter, any type, any size, each
A4623 Tracheostomy, inner cannula
A4629 Tracheostomy care kit for established tracheostomy
A7047 Oral interface used with respiratory suction pump, each
A7501 - A7527 Tracheostomy supplies

ICD-10 codes covered if selection criteria are met:

C03.0 - C06.9
C09.0 - C14.8
Malignant neoplasm of gum, oral cavity and pharynx
D00.00 - D00.08 Carcinoma in situ of lip, oral cavity, and pharynx
D00.1 Carcinoma in situ of esophagus
D10.0 - D11.9
D13.0
Benign neoplasm of mouth, pharynx, oral cavity, major salivary glands and esophagus
J39.0 - J39.2 Other diseases of pharynx
K31.84 Gastroparesis
R13.0 - R13.19 Aphagia and dysphagia
R40.0 - R40.4 Somnolence, stupor and coma
Z93.0 Tracheostomy status

ICD-10 codes not covered for indications listed in the CPB:

C22.0 Liver cell carcinoma
K40.00 - K46.9 Hernia
R18.0 - R18.8 Ascites

Background

A portable home model suction pump is a light-weight, compact, electric aspirator designed for upper respiratory, oral pharyngeal and tracheal suction for use in the home.  Use of the device does not require technical or professional supervision. A stationary home model respiratory suction pump is an electric aspirator designed for oropharyngeal and tracheal suction.

A portable or stationary home model gastric suction pump is an electric aspirator designed to remove gastrointestinal secretions. 

A closed system tracheal suction catheter is a type of suction catheter that is protected by an outer sheath. It is connected to the ventilator circuit of a person on mechanical ventilation and left in place. Suctioning is accomplished without disconnection from ventilation. 

A tracheal suction catheter is a long, flexible catheter. 

An oropharyngeal catheter is a short, rigid (usually) plastic catheter of durable construction. 

Wound suction is provided with an integrated system of components. This system contains a pump and dressing sets. It does not include a separate collection canister, a defining component of Negative Pressure Wound Therapy (NPWT). Instead, exudate is retained in the dressing materials. Wound suction systems that do not contain all of the required components are not classified as wound suction systems.

A portable home model suction pump for use on wounds describes a suction pump for wounds which provides controlled subatmospheric pressure that is designed for use with dressings, without a canister. 

An absorptive wound dressing for use with a portable home model suction pump describes an allowance for dressing sets which are used in conjunction with a stationary or portable suction pump but not used with a canister. Each of these absorptive wound dressings is used for a single, complete dressing change, and contains all necessary components, including but not limited to non-adherent porous dressing, drainage tubing, and an occlusive dressing which creates a seal around the wound site for maintaining sub-atmospheric pressure at the wound. These dressing sets are selected based upon wound size using the smallest size necessary to cover the wound. For multiple wounds located close together, a single large dressing must be used rather than multiple smaller dressing sets if it is possible to fit the wounds under a single larger dressing set. 

A disposable wound suction including dressing and accessories describes a disposable wound suction device. Suction is developed through the use of any type of mechanism. This device includes all components, accessories and dressings.

Subcutaneous Peritoneal Ascites Pump (e.g., the Alfa-Pump System) for the Management of Ascites

Fotopoulou et al (2019) noted that malignant ascites (MA) is a therapeutic dilemma significantly impairing patients' quality of life (QOL).  The Sequana Medical (Gent, Belgium) alfa-pump (AP) System, a subcutaneous, externally rechargeable, implantable device, continually draining ascites via the urinary bladder, has been well-established in liver cirrhosis, but not yet in MA.  In a retrospective, multi-center study, these researchers examined the use of the AP System in reducing the need for large volume paracentesis (LVP) in cancer patients.  The AP System was evaluated for its ability to reduce LVP and cross-correlated with adverse events (AE), survival, and retrospective physician-reported QOL.  A total of 17 patients with median age of 63 years (range of 18 to 81 years), 70.6 % female, across 7 primary tumor types were analyzed.  Median duration of implantation of the AP System was 60 mins (range of 30 to 270 mins) and median post-implantation hospital stay was 4 days (range of 2 to 24 days).  A total of 12 protocol-defined AE occurred in 5 patients (29.4 %): 4 kidney failures, 4 pump/catheter-related blockages, 3 infections/peritonitis, and 1 wound dehiscence.  Median ascitic volume (AV) pumped daily was 303.6 ml/day (range of 5.6 to 989.3 ml/day), and median total AV drained was 28 L (range of 1 to 638.6 L).  Median patient post-AP-survival was 111 days (range of 10 to 715 days) and median pump survival was 89 days (range of 0 to 715 days).  Median number of paracenteses was 4 (range of 1 to 15) per patient pre-implant versus 1 (range of 0 to 1) post-implant (p = 0.005); 71 % of patients were reported to have an improvement of at least 1 physician reported QOL-parameters.  The authors concluded that in this retrospective analysis, the AP System appeared to be relatively safe and effective in palliating patients with MA, while seemingly improving their QOL.  Its implantation was rather straight-forward and minimally invasive, resulting in reduced necessity of repetitive ascitic drainages; therefore, its broader implementation in oncology services should be further examined in prospective and comparative clinical trials to establish its value.  These researcher noted that a prospective study is currently in planning to compare standard practice techniques with the AP System including comparative analysis of cost-effectiveness, prospective evaluation of QOL, impact on patients nutritional as well as metabolic status and overall well-being.

The authors stated that this analysis had several drawbacks.  First, the retrospective design on a multi-center level had as a consequence the lack of completeness of the requested data, especially in a population that had in its majority deceased.  This applied especially in the QOL evaluation, which was just a retrospective estimation of the treating physicians and hence required further examination.  Second, the small sample, especially per cancer type, resulted in only assumptive hypothesis regarding the value of the pump on all patients with MA; thus, more targeted and focused studies are needed to resolve the issues, challenges, and effectiveness of the pump in particular cancer types.  Third, the lack of cost estimates in relation to the standard treatment.  These investigators stated that future studies will need to focus on the costing’s comparison of the relatively pricey AP System compared to the simple ascitic drainage; and whether this is being adequately counter-balanced with the gain from the reduced hospitalization times, potential positive effect on electrolyte disbalances, nutritional status of the treated patients, etc.

In a prospective, open-label, multi-center study (the MOSAIC Trial), Bendel et al (2020) examined the feasibility, procedural outcomes, and safety aspects of implantation of the AP System for the management of refractory ascites by interventional radiology (IR) methods.  This study included 29 patients (mean age of 60.0 ± 9.9 years; range of 32 to 72 years, 17 [56.7 %] men) with cirrhotic refractory ascites who received an AP System implanted by IR.  The fully subcutaneous AP System consists of a pump and 2 silicone catheters, whose distal ends were inserted in the peritoneum and the bladder, respectively.  The device moves ascites from the peritoneum to the bladder, reducing the requirement of paracentesis.  Pumped volume and speed could be customized as required.  The implant procedure was carried out under general or local anesthesia.  Both catheters were placed under ultrasound (US) guidance.  The pump was inserted in a subcutaneous pocket on the upper abdomen.  Incidence and severity of procedure-related serious AEs up to 3 months after implantation were recorded.  Technical success was achieved in 29 (100 %) IR implant procedures.  The pump was usually implanted on the right abdomen (76.7 %).  In 5 patients, deviation from the “instructions for use” was needed; AEs (requirement of additional incisions, post-operative bleed) occurred in 3 patients.  At 3 months following implantation, 3 possibly procedure-related serious AEs (ascites leakage, bacterial peritonitis, and post-operative bleeding) had occurred.  Two explantation (2/29; 6.8 %) (cellulitis, pump pocket infection) and 4 re-interventions (pump or catheter replacement) were required, corresponding to an AE incidence rate of 9/29 (31.0 %).  The authors concluded that placement of the AP System using IR methods was both feasible and technically successful. Moreover, these researchers stated that future development of this device as well as the outcome of this study will aid in minimizing AEs going forward.

The authors stated that drawbacks of this trial included restricted outcome data, with short follow-up interval (3 months) and limited demonstration of safety owing to the small sample size (n = 29).  There were no comparisons or controls, further limiting the conclusions that may be drawn at this point.  These researchers stated that further investigation of the AP System in larger patient cohorts is needed.

Weil-Verhoeven et al (2022) stated that refractory ascites (RA) is a frequent and life-threatening complication of cirrhosis.  In selected patients with RA, trans-jugular intrahepatic portosystemic shunt (TIPS) placement and liver transplantation (LTx) are currently considered the best therapeutic alternatives to repeated LVP.  In patients with a contraindication to TIPS or LT, the AP System has been developed to lower the need for iterative paracentesis, and consequently to improve the QOL and nutritional status.  These investigators reported recent data on the technical progress made since the 1st implantation, the effectiveness and tolerance of the device, the position of the pump in the therapeutic armamentarium for RA, and the grey areas that remain to be clarified regarding the optimal selection of patients who are potential candidates for this treatment.  Moreover, these researchers stated that the concerns related to the cost of the device, the surgical procedure of implantation, as well as the potential complications that could occur are not fully resolved yet; however, the implantation technique could evolve towards a "minimally invasive" approach, with a view to lowering the risks and improving the cost-effectiveness of the implantation.  These investigators noted that patient information and active participation of the patient are 2 prerequisites for successful management.  They stated that additional studies, especially real-world data from large heterogeneous populations with long-term follow-up, are needed to clarify some unresolved issues, notably concerning the acceptable limits of liver and kidney function, age, forms of albumin compensation, or cost-effectiveness.  There are currently several ongoing observational studies that would hopefully provide a more complete picture of the advantages and disadvantages of this innovative device.

Furthermore, these researchers stated the alfa-pump offers interesting perspectives that warrant further evaluation:

  • Percutaneous treatment of hepato-cellular carcinoma (HCC): By reducing the quantity of ascites, the AP System renders the percutaneous treatment of HCC possible. To-date, this was reported in only 1 case report; however, this therapeutic approach warrants further investigation.
  • Cure of hernia: A retrospective study of European multi-center data recently showed that patients who had concomitant umbilical or inguinal hernia repair and AP System placement had a shorter hospital stay, fewer complications, and better survival without paracentesis than patients undergoing emergency hernia surgery.  Hernia surgery concomitant with the implantation of the AP System allowed the patient to undergo programmed surgery and to avoid the usual post-operative drainage, since the pump achieved ascites control.  However, these data must be confirmed prospectively before this “concomitant” approach can be recommended.  In the current state of knowledge, experts discourage concomitant repair of hernias.
  • Prevention of multidrug-resistant bacterial infections: Due to the decrease in hospitalizations for paracentesis, patients with the AP System may be less exposed to nosocomial bacterial infections, which mainly involve multi-drug resistant bacteria.  This may be of interest for patients who are candidates for LTx.  However, this potential benefit has not yet been examined in the long-term, and must be balanced against the risk of infections related to the procedure.

Lan et al (2024) noted that in recent years, advances have been made for treating ascites in patients with cirrhosis.  Recent studies have indicated that several treatments that have been used for a long time in the management of portal hypertension may have beneficial effects that were not previously identified.  Long-term albumin infusion may improve survival in patients with cirrhosis and ascites while beta-blockers may reduce ascites occurrence.  TIPS placement may also improve survival in selected patients in addition to the control with ascites.  Low-flow ascites pump insertion (e.g., the AP System) can be another option for some patients with intractable ascites.  These investigators reviewed the latest data related to the management of ascites occurring in cirrhosis.  There are still unanswered questions, such as the optimal use of albumin as a long-term therapy, the place of beta-blockers, and the best timing for TIPS placement to improve the natural history of ascites, as well as the optimal stent diameter to reduce the risk of shunt-related side-effects.  Moreover, these researchers stated that several safety issues limit the use of the AP System in clinical practice.  Of note, no compensatory albumin infusion is made in this setting, and acute kidney injury (AKI) occurred in 30 % of patients, while serum creatinine increased by a mean of 23 μmol/L after low‐flow ascites pump insertion.  Other severe side effects, such as urinary tract infection (UTI) and bacterial peritonitis, occurred in 20 % to 27 % of the patients.  Long‐term antibiotic therapy appeared to be sufficient for the prevention of septic complications.  With these findings in mind, it does not appear advisable to consider low‐flow ascites pump insertion in patients with pre-existing renal dysfunction or in those who have just recovered from a UTI or from bacterial peritonitis.  Another unsettled issue is whether albumin infusions could prevent kidney injury.  In line with this issue, a recent study indicated that clinical complications in patients with RA related to performing low‐volume drainage without albumin infusion were associated with the daily volume drained, a complication occurring more frequently when more than 1.5 L of ascites was drained per day.  These researchers stated that criteria allowing the appropriate selection of patients who are candidates for the AP system are also needed; these issues should be addressed in future studies.

Furthermore, an UpToDate review on “Ascites in adults with cirrhosis: Diuretic-resistant ascites” (Runyon, 2024) lists low-flow ascites pump (e.g., alfapump) as an experimental treatment.


References

The above policy is based on the following references:

  1. American Association for Respiratory Care (AARC). Suctioning of the patient in the home. AARC Clinical Practice Guidelines. Respir Care. 1999;44(1):91-98.
  2. Bendel EC, Sniderman K, Shaw C, et al. Feasibility and procedural safety of alfapump system implantation by IR: Experience from the MOSAIC Study, a multicenter, open-label prospective study in cirrhotic patients with refractory ascites. J Vasc Interv Radiol. 2020;31(8):1256-1262.
  3. Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD) for Durable Medical Equipment Reference List (280.1). Baltimore, MD: CMS; effective July 5, 2005.
  4. Fotopoulou C, Berg T, Hausen A, et al. Continuous low flow ascites drainage through the urinary bladder via the Alfapump system in palliative patients with malignant ascites. BMC Palliat Care. 2019;18(1):109.
  5. Lan T, Chen M, Tang C, Deltenre P. Recent developments in the management of ascites in cirrhosis. United European Gastroenterol J. 2024;12(2):261-272.
  6. NHIC, Corp. Suction pumps. Local Coverage Article No. A52519. Durable Medical Equipment Medicare Administrative Contractor (DME MAC) Jurisdication A. Hingham, MA: NHIC; effective October 1, 2015.
  7. NHIC, Corp. Suction pumps. Local Coverage Determination No. L33612. Durable Medical Equipment Medicare Administrative Contractor (DME MAC) Jurisdiction A. Hingham, MA: NHIC; revised October 1, 2015.
  8. Runyon BA. Ascites in adults with cirrhosis: Diuretic-resistant ascites. UpToDate Inc., Waltham, MA. Last reviewed April 2024.
  9. Senol YC, Li J, Orscelik A, et al. Comparative analysis of syringes versus pump devices in benchtop aspiration thrombectomy models: A systematic review and meta-analysis. Interv Neuroradiol. 2023 Dec 27 [Online ahead of print].
  10. Thompson L. Suctioning adults with an artificial airway: A systematic review. Systematic Review; 9. Adelaide, SA: Joanna Briggs Institute for Evidence Based Nursing and Midwifery; 2000.
  11. Weil-Verhoeven D, Di Martino V, Stirnimann G, et al. Alfapump® implantable device in management of refractory ascites: An update. World J Hepatol. 2022;14(7):1344-1356.
  12. Woollons S. Ambulatory suction equipment for home use. Prof Nur. 1996;11(6):373-374, 376.