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MP 1.01.15

Oscillatory Devices for the Treatment of Cystic Fibrosis and Other Respiratory Disorders

Medical Policy    
Durable Medical Equipment
Original Policy Date
Last Review Status/Date
Reviewed with literature search/2:2013
  Return to Medical Policy Index


Our medical policies are designed for informational purposes only and are not an authorization, or an explanation of benefits, or a contract.  Receipt of benefits is subject to satisfaction of all terms and conditions of the coverage.  Medical technology is constantly changing, and we reserve the right to review and update our policies periodically.


Oscillatory devices are used as alternatives to the standard daily percussion and postural drainage(P/PD) method of airway clearance for patients with cystic fibrosis. There are several types of devicesincluding high-frequency chest compression with an inflatable vest and oscillating positive expiratory pressure devices, such as the Flutter and Acapella devices. Oscillatory devices are also proposed for other respiratory conditions such as diffuse bronchiectasis and chronic obstructive pulmonary disorder(COPD).

Oscillatory devices are designed to move mucus and clear airways; the oscillatory component can be intra- or extra-thoracic. Some of the devices require the active participation of the patient. These include oscillating positive expiratory pressure devices, such as Flutter and Acapella, in which the patient exhales multiple times through a device. The Flutter device is a small pipe-shaped, easily portable handheld device, with a mouthpiece at one end. It contains a high-density stainless steel ball that rests in a plastic circular cone. During exhalation, the steel ball moves up and down, creating oscillations in expiratory pressure and airflow. When the oscillation frequency approximates the resonance frequency of the pulmonary system, vibration of the airways occurs, resulting in loosening of mucus. The Acapella deviceis similar in concept but uses a counterweighted plug and magnet to create air flow oscillation. Other airway clearance techniques require active patient participation. For example, autogenic drainage
and active cycle of breathing technique both involve a combination of breathing exercises performed by the patient. Positive expiratory pressure (PEP) therapy requires patients to exhale through a resistor to produce positive expiratory pressures during a prolonged period of exhalation. It is hypothesized that the positive pressure supports the small airway such that the expiratory airflow can better mobilize secretions. In contrast, high-frequency chest wall oscillation (HFCWO) devices (e.g., the Vest Airway Clearance System, formerly known as the ABI Vest or the ThAIRapy Bronchial Drainage System) are passive oscillatory devices designed to provide airway clearance without the active participation of the patient. The Vest Airway Clearance System provides high-frequency chest compression using an inflatable vest and an air-pulse generator. Large-bore tubing connects the vest to the air-pulse generator. The air-pulse generator creates pressure pulses that cause the vest to inflate and deflate against the thorax, creating high-frequency chest wall oscillation and mobilization of pulmonary secretions.

The Percussionaire device delivers intrapulmonary percussive ventilation (IPV) and is another type of passive oscillatory device. This device combines internal thoracic percussion through rapid minibursts of inhaled air and continuous therapeutic aerosol delivered through a nebulizer.
All of the above techniques can be used as alternatives to daily percussion and postural drainage (P/PD),also known as chest physical therapy or chest physiotherapy, in patients with cystic fibrosis. P/PD needs to be administered by a physical therapist or another trained adult in the home, typically a parent if the patient is a child. The necessity for regular therapy can be particularly burdensome for adolescents or adults who wish to lead independent lifestyles. Oscillatory devices can also potentially be used by patients with other respiratory disorders to promote bronchial secretion drainage and clearance, such as diffuse bronchiectasis and chronic obstructive pulmonary disorder (COPD). This policy addresses outpatient use of oscillatory devices. Inpatient device use e.g., in the immediate post-surgical period, is not included in the policy.

Regulatory Status
Several oscillatory devices have been cleared for marketing by the U.S. Food and Drug Administration
(FDA) through the 510(k) process including the following:
- The Bird IPV® Noncontinuous Ventilator (Percussionaire Corp) in 1989.
- Flutter® Mucus Clearance Device in 1994. The Flutter® device is currently marketed in the
United States by Axcan.
- The ThAIRapy Bronchial Drainage System in 1998. Since that time, updated versions of the
device were cleared by the FDA—most recently a fifth generation device. The device is now
known as the Vest Airway Clearance System, and it is manufactured by Hill-Rom.
- The Acapella® device (DHD Healthcare) in 1999.
- The RC Cornet Mucus Clearing Device (PARI Respiratory Equipment) in 1999.

Related Policies


Use of the Flutter® valve or Acapella® device may be considered medically necessary in patients with hypersecretory lung disease (i.e., produce excessive mucus) who have difficulty clearing the secretions and recurrent disease exacerbations.

High-frequency chest wall compression devices and intrapulmonary percussive ventilation (IPV) devices may be considered medically necessary in patients with cystic fibrosis or chronic diffuse bronchiectasis as determined by specific criteria (see Policy Guidelines) (including chest computed tomography [CT] scan) when standard chest physiotherapy has failed OR standard chest physiotherapy is unavailable or not tolerated. In considering the chest wall compression and IPV devices, there should be demonstrated need for airway clearance. There should also be documented failure of standard treatments, i.e., the patient has frequent severe exacerbations of respiratory distress involving inability to clear mucus despite standard treatment (chest physiotherapy and, if appropriate, use of the Flutter® device), or valid reasons why standard chest physiotherapy cannot be performed, such as inability of the caregiver to perform it.

High-frequency chest wall compression devices and intrapulmonary percussive ventilation devices are considered not medically necessary as an alternative to chest physical therapy in patients with cystic fibrosis or chronic bronchiectasis in any other clinical situations; there are no clinical data to show that these devices provide any additional health benefit compared to conventional chest physical therapy in situations other than those specified here.

Other applications of high-frequency chest wall compression devices and intrapulmonary percussive ventilation devices, including, but not limited to, their use as an adjunct to chest physical therapy or their use in other lung diseases, such as chronic obstructive pulmonary disease, are considered investigational.

Policy Guidelines

For this policy, chronic diffuse bronchiectasis is defined by daily productive cough for at least 6 continuous months or more than 2 times per year exacerbations requiring antibiotic therapy and confirmed by high-resolution or spiral chest computed tomography scan.

For the chest wall compression devices, a trial period to determine patient and family compliance may beconsidered. Those who appear to benefit most from the compression devices are adolescents and adults due to lifestyle factors in which manual P/PD may essentially not be available.

A trial period may also be helpful because patients’ responses to the various types of devices can be variable; the types of devices should be considered as alternative, and not equivalent, devices.

Benefit Application
BlueCard/National Account Issues

Oscillatory devices such as the Flutter® device, the Vest™ Airway Clearance System, and Percussionaire IPV® device have been primarily investigated as an alternative (not adjunct) to conventional chest physical therapy. Since the published clinical data do not suggest that these devices are associated with an increased health benefit, their use primarily represents a convenience to the patient, and it is on this basis that they are considered not medically necessary (unless conventional chest physical therapy has failed or is unavailable).


This policy was originally created in 1997 and was updated regularly with searches of the MEDLINE database. The most recent literature search was performed for the period December 2011 through January 7, 2013. Following is a summary of the literature to date:

Cystic Fibrosis
In 2009, a Cochrane review was published that evaluated the evidence on oscillating devices for the treatment of cystic fibrosis. (1)Investigators identified 30 randomized controlled trials (RCTs) with 708 patients that compared oscillatory devices to another recognized airway clearance technique. Eleven studies used a parallel design and 19 were crossover studies. Ten of the included studies were
published as abstracts only. The majority, 16, were conducted in the United States. Sample sizes of individual studies ranged from 5 to 166, with a median of 20 participants. There were 16 studies using the Flutter device as a comparison, 11 using high-frequency chest wall oscillation, 5 using intrapulmonary percussive ventilation, and 2 using Cornet. No studies were identified that compared Acapella to another treatment. Study duration ranged from 1 week to 1 year; 21 of the studies were of less than 3 months’ duration and 10 lasted less than 1 week. Outcomes included pulmonary function, sputum weight and volume, hospitalization rate, and quality-of-life measures. Findings of the studies could not be pooled due to the variety of devices used, outcome measures and lengths of follow-up. The authors concluded that there is a lack of evidence supporting any one airway clearance technique or device over another and that there is a need for adequately powered randomized controlled studies with long-term follow-up.

Findings from selected randomized controlled trials included in the Cochrane review are described below:

Oermann and colleagues conducted a pilot study of 24 patients with cystic fibrosis who were randomly assigned to receive either the Vest Airway Clearance System or the Flutter device for 4 weeks followed by crossover to the other group. (2) Spirometry, lung volume measures, quality of life, and patient satisfaction were measured after each 4-week treatment period. The only significant difference between the groups was patient satisfaction; 50% of the participants preferred the Vest Airway Clearance System,
while 37% preferred the Flutter device.

App and colleagues performed a randomized trial with a crossover design comparing the Flutter device and autogenic drainage in 14 patients with cystic fibrosis. (3) Patients received therapy with either autogenic drainage or the Flutter device and then crossed over to the alternate treatment. At the beginning and end of each 4-week interval, pulmonary function was measured before and after an acute
30-minute therapy. At the end of the session, the weight and viscoelasticity of the sputum wereevaluated. No significant changes in pulmonary function or sputum volume were noted throughout the study. Sputum viscoelasticity was lower in those receiving Flutter therapy, potentially allowing it to be cleared more easily by cough and airflow mechanisms.

Newhouse and colleagues reported on the results of a randomized trial with crossover design that
compared the results of the Percussionaire device and the Flutter device in 8 patients with cystic fibrosis.(4) Each regimen was randomly administered to each patient on 3 separate days during 3 successiveweeks. Post-treatment pulmonary function tests were obtained at 1 and 4 hours after each treatmentregimen. The weight of sputum samples collected over 4 hours after treatment was also recorded. Therewas no difference in sputum quantity with any method studied. Results of pulmonary function tests were
inconsistent in this small trial.

In a randomized trial, McIlwaine and colleagues compared positive expiratory pressure (PEP) and the Flutter device in 40 children with cystic fibrosis. (5) Participants were randomly assigned tphysiotherapy with PEP or the Flutter device for 1 year. Clinical status, pulmonary function, and compliance were measured at regular intervals throughout the year. In the PEP group the pulmonary
function remained relatively stable, while in the Flutter group, there was a greater mean annual rate of decline in forced vital capacity. This difference did not become apparent until 6 to 9 months into the study, underlining the importance of long-term results.

Varekojis and colleagues compared high-frequency chest wall compression using the Vest and intrapulmonary percussive ventilation using the Percussionaire device to percussion and postural drainage (P/PD) in 24 hospitalized patients with cystic fibrosis. (6) Patients used each modality for 2 days in a randomized order over a 6-day period. While wet sputum weights from use of the Percussionaire device were significantly greater than the Vest, there was no significant difference in any of the modalities in dry sputum weights. In addition, patients found use of each of the devices to be equally acceptable when questioned about comfort, convenience, effectiveness, and ease of use.

Several additional RCTs have been published since the 2009 Cochrane review. Similar to the earlier trials, these tended to be underpowered due to small sample sizes and/or high dropout rates and did not find clear advantages of one oscillatory device over another. Details on representative recent studies are
as follows:

Pryor and colleagues evaluated patients aged 16 years and older with cystic fibrosis from a single center in the U.K. (7) The 75 patients were randomly assigned to receive 1 of 5 treatments for 1 year (15 per group): the Cornet device, the Flutter device, PEP, active cycle of breathing technique or autogenic drainage. Sixty-five of 75 (87%) patients completed the study, and these were included in the analysis.
Mean forced expiratory volume in one second (FEV1) values at 12 months, the primary outcome, were 1.90 +/- 0.89 in the Cornet group (n=14), 2.43 +/- 0.94 in the Flutter group (n=12), 2.02 +/- 1.17 in the PEP group (n=13), 1.94 +/- 0.80 in the active cycle of breathing group (n=13), and 2.64 +/- 1.22 in the autogenic drainage group (n=13). The difference among the 5 groups was not statistically significant for FEV1 or any other lung function variable; however, this study had a small number of patients per group. Sontag and colleagues conducted a multicenter randomized trial with 166 adults and children with cystic fibrosis. (8) Patients were assigned to receive treatment with P/PD (n=58), the Flutter device (n=51), or the Vest (n=57). Investigators planned to evaluate participants on a quarterly basis for 3 years. However, dropout rates were high and consequently the trial ended early; 35 (60%), 16 (31%), and 5 (9%) patients withdrew from the postural drainage, Flutter, and Vest groups, respectively. Fifteen patients withdrew in the first 60 days (11 of these on the day of randomization) and the remainder after 60 days. The most common reasons for withdrawal after 60 days were moved or lost to follow-up (n=13), and lack of time (n=7). At study termination, patients had a final assessment; the length of participation
ranged from 1.3 to 2.8 years. An intention-to-treat (ITT) analysis found no significant differences between treatment groups in the modeled rate of decline for FEV1 predicted or forced vital capacity (FVC, %)predicted. The small sample size and high dropout rate greatly limit the conclusions that might be drawn from this study.


Several small RCTs were identified that included patients with bronchiectasis. Thompson and colleaguescompared the Flutter device to the active cycle of breathing technique in 17 patients. (9) There were nosignificant between-group differences in outcomes e.g., peak expiratory flow rate, spirometric tests, andquality of life. In a 2007 cross-over study with 36 patients, Eaton and colleagues compared the Flutter device, the active cycle of breathing technique and active cycle of breathing plus postural drainage, inrandom order. (10) Total sputum weight was highest after active cycle of breathing plus posturaldrainage; patient preference was highest for use of the Flutter device. In a study of 20 patients with acuteexacerbation of bronchiectasis during antibiotic therapy, Patterson et al. found no difference in changes inlung function with the “usual” airway clearance approach compared to Acapella. (11)

Chronic Obstructive Pulmonary Disease (COPD)
At least 2 systematic reviews of studies on airway clearance techniques in patients with COPD have beenpublished. (12, 13) Both reviews addressed a variety of techniques i.e., they were not limited to studieson oscillatory devices. The 2011 review by Ides and colleagues identified 6 studies evaluating positive expiratory pressure in COPD patients, 4 of which used oscillatory devices (Flutter or Cornet), and 1 study on high-frequency chest wall oscillation. (12) Sample sizes in individual studies ranged from 10 to 50 patients; the study with the largest sample size was published in German. The Ides review did not pool study findings but the authors commented that the evidence on techniques such as oscillating PEP is poor due to a lack of appropriate trials. The 2012 Cochrane review on airway clearance techniques for
COPD did not specifically discuss the number of studies or the results of studies on oscillatory devices. (13) In 2011, Chakrovorty and colleagues in the United Kingdom published a randomized cross-over study evaluating use of high-frequency chest wall oscillation (HFCWO) in patients with moderate to severe COPD and mucus hypersecretion. (14) Patients received HFCWO or conventional treatment, in random
order, for 4 weeks, with a 2-week wash-out period between treatments. Thirty patients enrolled in the study and 22 (73%) completed the trial; 8 patients withdrew due to COPD exacerbations. The primary outcome was quality of life; this was measured with the St. George’s Respiratory Questionnaire (SGRQ). Only 1 out of 4 dimensions of the SGRQ (the symptom dimension) improved after HFCWO compared to
before treatment, with a decrease in the mean score from 72 to 64 (p=0.02). None of the 4 dimensions of the SGRQ improved after conventional treatment. There were no significant differences in secondary outcomes such as FEV1 or FVC after either treatment compared to before treatment. The study was limited by the relatively high drop-out rate and lack of intention-to-treat analysis.

Ongoing clinical trials
Long-term study, comparing Vest therapy to Positive Expiratory Pressure (PEP) therapy in the treatment of cystic fibrosis (NCT00817180) (15): This open-label RCT is comparing the safety and efficacy of highfrequency chest wall oscillation using the Vest System to PEP. The study includes patients age 6 years and older with cystic fibrosis, and estimated enrollment is 1,707 individuals. The primary outcome
measure is the difference between groups in the number of respiratory exacerbations during 1 year. The study is being conducted in Canada and is sponsored by the University of British Columbia.

Clinical Input Received Through Physician Specialty Societies and Academic Medical Centers
In response to requests, input was received from 2 academic medical centers while this policy was under review in December 2008. While the various physician specialty societies and academic medical centers may collaborate with and make recommendations during this process, through the provision of appropriate reviewers, input received does not represent an endorsement or position statement by the
physician specialty societies or academic medical centers, unless otherwise noted. The reviewers indicated that the available studies demonstrate that these devices are comparable to chest physiotherapy for both cystic fibrosis and bronchiectasis.

Oscillatory devices are designed to move mucus and clear airways. In patients with cystic fibrosis, it is difficult to reach scientific conclusions regarding the relative efficacy of oscillatory therapies compared to standard treatment with daily percussion and postural drainage. However, findings from randomized controlled trials, combined with clinical input, suggest that oscillatory devices may be comparable to chest physical therapy for cystic fibrosis patients in some situations. The available evidence and clinical input also suggest that oscillatory devices may be appropriate for treating diffuse bronchiectasis in similar situations. Thus, these devices may be considered medically necessary when chest physical therapy has failed or is unavailable or not tolerated by the patient. The sparse data do not suggest that any one oscillatory device is superior to another for cystic fibrosis or bronchiectasis. The Flutter® device, autogenic drainage, and positive expiratory pressure are simple devices or maneuvers that can be learned by most patients. In contrast, intrapulmonary percussive ventilation or high-frequency chest wall compression, e.g., with the Vest Airway Clearance System are more complex devices.
The use of high-frequency chest wall compression and intrapulmonary percussive ventilation devices in other chronic pulmonary diseases, such as COPD, is considered investigational due to insufficient evidence on the impact of treatment on health outcomes.

Practice Guidelines and Position Statements
The 2006 guidelines from the American College of Chest Physicians recommend (level of evidence; low) that in patients with cystic fibrosis, devices designed to oscillate gas in the airway, either directly or by compressing the chest wall, can be considered as an alternative to chest physiotherapy. (16)

In April 2009, the Cystic Fibrosis Foundation published guidelines on airway clearance therapies based
on a systematic review of evidence. (17) They recommend airway clearance therapies for all patients
with cystic fibrosis but state that no therapy has been demonstrated to be superior to others (level of
evidence, fair; net benefit, moderate; grade of recommendation, B). They also issued a consensus
recommendation that the prescribing of airway clearance therapies should be individualized based on
factors such as age and patient preference.

Medicare National Coverage
No national coverage determination.

1. Morrison L, Agnew J. Oscillating devices for airway clearance in people with cystic fibrosis. Cochrane
Database Syst Rev 2009; (1):CD006842.
2. Oermann CM, Sockrider MM, Giles D et al. Comparison of high-frequency chest wall oscillation and
oscillating positive expiratory pressure in the home management of cystic fibrosis: a pilot study.
Pediatr Pulmonol 2001; 32(5):372-7.
3. App EM, Kieselmann R, Reinhardt D et al. Sputum rheology changes in cystic fibrosis lung disease
following two different types of physiotherapy: Flutter vs autogenic drainage. Chest 1998;
4. Newhouse PA, White F, Marks JH et al. The intrapulmonary percussive ventilator and Flutter device
compared to standard chest physiotherapy in patients with cystic fibrosis. Clin Pediatr (Phila)
1998; 37(7):427-32.
5. McIlwaine PM, Wong LT, Peacock D et al. Long-term comparative trial of positive expiratory pressure
versus oscillating positive expiratory pressure (Flutter) physiotherapy in the treatment of cystic
fibrosis. J Pediatr 2001; 138(6):845-50.
6. Varekojis SM, Douce FH, Flucke RL et al. A comparison of the therapeutic effectiveness of and
preference for postural drainage and percussion, intrapulmonary percussive ventilation, and highfrequency
chest wall compression in hospitalized cystic fibrosis patients. Respir Care 2003;
7. Pryor JA, Tannenbaum E, Scott SF et al. Beyond postural drainage and percussion: Airway clearance
in people with cystic fibrosis. J Cyst Fibros 2010; 9(3):187-92.
8. Sontag MK, Quittner AL, Modi AC et al. Lessons learned from a randomized trial of airway secretion
clearance techniques in cystic fibrosis. Pediatr Pulmonol 2010; 45(3):291-300.                                              9. Thompson CS, Harrison S, Ashley J et al. Randomized crossover study of the Flutter device and the
active cycle of breathing technique in non-cystic fibrosis bronchiectasis. Thorax 2002; 57(5):446-8.
10. Eaton T, Young P, Zeng I et al. A randomized evaluation of the acute efficacy, acceptability and
tolerability of Flutter and active cycle of breathing with and without postural drainage in non-cystic
fibrosis bronchiectasis. Chron Respir Dis 2007; 4(1):23-30.
11. Patterson JE, Hewitt O, Kent L et al. Acapella versus ‘usual airway clearance’ during acute
exacerbation in bronchiectasis: a randomized crossover trial. Chron Respir Dis 2007; 4(2):67-74.
12. Ides K, Vissers D, De BL et al. Airway clearance in COPD: need for a breath of fresh air? A
systematic review. COPD 2011; 8(3):196-205.
13. Osadnik CR, McDonald CF, Jones AP et al. Airway clearance techniques for chronic obstructive
pulmonary disease. Cochrane Database Syst Rev 2012; 3:CD008328.
14. Chakravorty I, Chahal K, Austin G. A pilot study of the impact of high-frequency chest wall oscillation
in chronic obstructive pulmonary disease patients with mucus hypersecretion. Int J Chron
Obstruct Pulmon Dis 2011; 6:693-9.
15. Sponsored by the University of British Columbia. Long-term study, comparing Vest therapy to
Positive Expiratory Pressure (PEP) therapy in the treatment of cystic fibrosis (NCT00817180).
Available online at: Last accessed January, 2013.
16. McCool FD, Rosen MJ. Nonpharmacologic airway clearance therapies: ACCP evidence-based
clinical practice guidelines. Chest 2006; 129(1 suppl):250S-59S.
17. Flume PA, Robinson KA, O’Sullivan BP et al. Cystic fibrosis pulmonary guidelines: airway clearance
therapies. Respirat Care 2009; 54(4):522-37.





CPT  No Code 
ICD-9 Procedure  93.18  Breathing exercise 
ICD-9 Diagnosis  277.00-277.09 Cystic Fibrosis NOS
  494.0, 494.1 Bronchiectasis without and with acute exacerbations, respectively
HCPCS  E0483  High frequency chest wall oscillation air-pulse generator system (includes hoses and vest), each 
  A7025  High frequency chest wall oscillation system vest, replacement for use with patient-owned equipment, each 
  A7026  High frequency chest wall oscillation system hose, replacement for use with patient-owned equipment, each 
  E0481  Intrapulmonary percussive ventilation system and related accessories 
  E0484 Oscillatory positive expiratory pressure device, non-electric, any type
  S8185  Flutter device 
ICD-10-CM (effective 10/1/14) E84.0-E84.9 Cystic fibrosis code range
   J47.1-J47.9 Broncheictasis code range
ICD-10-PCS (effective 10/1/14)   ICD-10-PCS codes are only used for inpatient services. There are no ICD-10-PCS codes for devices and there is no is no specific ICD-10-PCS code for this therapy.
   F07C6ZZ Physical rehabilitation and diagnostic audiology, rehabilitation, motor treatment, respiratory system- whole body, therapeutic exercise
Type of Service  Pulmonary 
Place of Service  Home 



Acapella Device
Cystic Fibrosis, Oscillatory Devices
High Frequency Chest Compression
Intrapulmonary Percussive Ventilation (IPV)
IPV (Intrapulmonary Percussive Ventilation)
Oscillatory Devices for Cystic Fibrosis
ThAIRapy Vest

Policy History
Date Action Reason
11/01/97 Add to DME Section New policy
07/12/02 Replace policy Policy reviewed and updated, no change in policy statement
10/09/03 Replace policy Literature review updated, expanded policy title, Medicare policy and new HCPCS codes added; policy statement unchanged
04/16/04 Replace policy Policy updated with literature review. Acapella device added (similar to Flutter device); no change in policy statement
4/1/05 Replace policy Policy updated with literature review; no changes in policy statement.
10/10/2006 Replace policy Policy updated with literature review through August 2006; policy statement unchanged. References 14-16 added and reference 17 is renumbered.
12/11/08 Replace policy  Policy updated with literature review; reference numbers 17 – 21 added. Clinical input reviewed. Policy statements changed to indicate high-frequency chest wall compression devices may be medically necessary in cystic fibrosis and chronic bronchiectasis when specific criteria are met and that flutter valves and Acapella device may be considered medically necessary in some cases of hypersecretory chronic lung diseases. Chest wall compression devices remain investigational for other conditions such as COPD.
02/11/10 Replace policy Policy updated with literature review; Policy statements changed to indicate intrapulmonary percussive devices may be medically necessary in cystic fibrosis and chronic bronchiectasis when specific criteria are met. (Same as criteria for high-frequency chest wall compression devices). Rational re-written; reference numbers 1 and 11 added, others renumbered/removed.
2/10/11 Replace policy Policy updated with literature review. References 7 and 8 added. No changes to policy statements.
2/09/12 Replace policy Policy updated with literature review. References 12, 13 and 14 added. No changes to policy statements.
02/14/13 Replace Policy Policy updated with literature review through December 18, 2012. References 13 and 14 added; other references renumbered or removed.