Aetna considers medical supervision of peripheral vascular rehabilitation programs experimental and investigational because the value of such supervision is not well documented by the available peer-reviewed published medical literature.
Aetna considers the PADnet System and testing program experimental and investigational for evaluation of peripheral artery disease and other indications because of insufficient evidence of its effectiveness.Background
Both physical activity and medications are used to treat peripheral vascular disease. Vascular specialists agree that long daily walks are the best treatment for people with intermittent claudication, thereby increasing the distance of pain-free walking through the development of collateral circulation.
Patients whose legs hurt during physical activity often find it hard to follow a walking program. For this reason, the cardiac rehabilitation departments of some hospitals have created supervised exercise programs that offer support and encouragement. These peripheral vascular rehabilitation programs are geared to patients with various peripheral vascular disorders, including post-surgical patients (e.g., peripheral angioplasty, peripheral arterial bypass, stent) and patients with peripheral arterial disease who are not candidates for surgery. Services are provided by a multi-disciplinary team, which includes nurses, physical therapists and physicians. The usual duration of the program is 3 times a week for 12 weeks (36 visits). The goal of treatment is to improve endurance and decrease symptoms.
There is insufficient evidence in the medical literature demonstrating superior outcomes of such supervised exercise programs over exercise without supervision.
The American College of Cardiology/American Heart Association's 2005 practice guidelines for the management of patients with peripheral arterial disease (Hirsch et al, 2006) recommended a program of supervised exercise training (treadmill or track walking, a minimum of 30 to 45 mins, in sessions performed at least 3 times per week for a minimum of 12 weeks) as an initial treatment modality for patients with intermittent claudication.
On the other hand, McDermott et al (2006) reported that among patients with peripheral arterial disease, self-directed walking exercise performed at least 3 times weekly is associated with significantly less functional decline during the subsequent year. Similar trends were also seen in the subset of asymptomatic patients with peripheral arterial disease. In addition, Fabbian et al (2006) stated that a rehabilitation program performed at home at a specific velocity, just below the pain threshold speed appeared to be well-suited for hemodialysis patients with peripheral arterial disease because it induced functional improvements and vascular adaptations with low costs.
Furthermore, a Cochrane systematic evidence review (Bendermacher et al, 2006) found that supervised exercise therapy has not been proven to be better than non-supervised exercise therapy in managing patients with intermittent claudication. The Cochrane review compared the effects of supervised versus non-supervised exercise therapy on the maximal walking time or distance for individuals with this condition (Bendermacher et al, 2006). The Cochrane Peripheral Vascular Diseases Group searched their specialized register and the Cochrane Central Register of Controlled Trials (CENTRAL) database in the Cochrane library. In addition, these investigators hand-searched the reference lists of relevant articles for additional trials. There was no restriction on language of publication. Randomized and controlled clinical trials comparing supervised exercise programs with non-supervised exercise programs for people with intermittent claudication were selected. Two authors independently selected trials and extracted data. One author assessed trial quality and this was confirmed by a second author. For all continuous outcomes the authors extracted the number of participants, the mean differences, and the standard deviation. If data were available, the standardized mean difference was calculated using a fixed-effect model. These researchers identified 27 trials, of which 19 had to be excluded because the control group received no exercise therapy at all. The remaining 8 trials involved a total of 319 male and female participants with intermittent claudication. The follow-up ranged from 12 weeks to 12 months. In general, the supervised exercise regimens consisted of 3 exercise sessions per week. All trials used a treadmill walking test as one of the outcome measures. The overall quality of the included trials was good, though the trials were all small with respect to the number of participants, ranging from 20 to 59. Supervised exercise therapy showed statistically significant and clinically relevant differences in improvement of maximal treadmill walking distance compared with non-supervised exercise therapy regimens in the short-term, with an overall effect size of 0.58 (95 % confidence interval: 0.31 to 0.85) at 3 months. This translated to a difference of approximately 150 meters increase in walking distance in favor of the supervised group. However, there is a high possibility of a training effect as the supervised exercise therapy groups were trained primarily on treadmills (and the home based were not) and the outcome measures were treadmill based. The authors concluded that supervised exercise therapy is suggested to have clinically relevant benefits compared with non-supervised regimens in the short-term, which is the main prescribed exercise therapy for people with intermittent claudication. However, the clinical relevance has not been demonstrated definitely and will require additional studies with a focus on durability of outcomes and improvements in quality of life (Bendermacher et al, 2006).
In a systematic review of the clinical evidence for home-based versus center-based exercise programs for older adults, Ashworth et al (2005) has observed that home based programs for peripheral vascular disease appear to have a significantly higher long-term adherence rate than supervised center-based programs. However, this conclusion was based primarily on the one study (with the highest quality rating of the studies found) of sedentary older adults. This showed an adherence rate of 68 % in the home-based program at 2-year follow-up compared with a 36 % adherence in the center-based group.
Crowther and colleagues (2008) examined the effects of a 12-month exercise program on lower limb mobility (temporal-spatial gait parameters and gait kinematics), walking performance, peak physiological responses, and physical activity levels in individuals with symptoms of intermittent claudication due to peripheral arterial disease (PAD-IC). Participants (n = 21) with an appropriate history of PAD-IC, ankle-brachial pressure index (ABI) less than 0.9 in at least one leg and a positive Edinburgh claudication questionnaire response were prospectively recruited. Subjects were randomly allocated to either a control PAD-IC group (CPAD-IC) (n = 11) that received standard medical therapy and a treatment PAD-IC group (TPAD-IC) (n = 10), which also took part in a 12-month supervised exercise program. A further group of participants (n = 11) free of PAD (ABI greatetr than 0.9) and who were non-regular exercisers were recruited from the community to act as age and mass matched controls. Lower limb mobility was determined via 2-dimensional video motion analysis. A graded treadmill test was used to assess walking performance and peak physiological responses to exercise. Physical activity levels were measured via a 7-day pedometer recording. Differences between groups were analyzed via repeated measures analysis of variance. The 12-month supervised exercise program had no significant effect on lower limb mobility, peak physiological responses, or physical activity levels in TPAD-IC compared with CPAD-IC participants. However, the TPAD-IC participants demonstrated significantly greater walking performance (171 % improvement in pain-free walking time and 120 % improvement in maximal walking time compared with baseline). The authors concluded that these findings confirmed that a 12-month supervised exercise program will result in improved walking performance, but does not have an impact on lower limb mobility, peak physiological responses, or physical activity levels of PAD-IC patients.
Franz and co-workers (2010) evaluated the effectiveness of a 12-week, institution-based, supervised exercise rehabilitation program with atherogenic risk factor modification in improving cardiovascular profile, ambulatory function, and quality of life of patients with PAD by comparing pre- and post-program measurements. Participants were prospectively enrolled. Cardiovascular profile variables, ambulatory function tests, and quality of life questionnaires were evaluated. Of 101 institution-based program participants, 69 completed the 12-session minimum and 47 completed a post-program evaluation. Mean post-program results were significantly different from pre-program results, corresponding to improvement, for the following variables: triglyceride levels (p < 0.036), both function tests (p < 0.001 for both), 4 of 5 Walking Impairment Questionnaire measurements, and Intermittent Claudication Questionnaire score (p < 0.001). The authors concluded that this supervised exercise program improved the cardiovascular profiles, ambulatory function, and quality of life of PAD patients completing the program and is a viable adjunct to drug therapy and surgical intervention. These initial findings were skewed by the modest completion rate (68 %) and the low post-program evaluation rate (47 %).
In a review on the associations between PAD and ischemic stroke and the implications for primary and secondary prevention, Banerjee and colleagues (2010) concluded that in both primary and secondary prevention settings, PAD indicates a high-risk of future events. They noted that data on which additional preventive measures are beneficial in this patient group are lacking, but the presence of PAD does have implications for current management in both primary and secondary prevention of stroke.
In a randomized controlled trial, Saxton et al (2011) investigated the effects of upper- and lower-limb aerobic exercise training on disease-specific functional status and generic health-related quality of life (QoL) in patients with IC. The study recruited 104 patients (mean age of 68 years; range of 50 to 85) from the Sheffield Vascular Institute. Patients were randomly allocated to groups that received upper-limb (ULG) or lower-limb (LLG) aerobic exercise training, or to a non-exercise control group. Exercise was performed twice-weekly for 24 weeks at equivalent limb-specific relative exercise intensities. Main outcome measures were scores on the Walking Impairment Questionnaire (WIQ) for disease-specific functional status, the Medical Outcomes Study Short Form version 2 (SF-36v2), and European Quality of Life Visual Analog Scale (EQ-VAS) for health-related QoL. Outcomes were assessed at baseline, and at 6, 24, 48, and 72 weeks. After 6 weeks, improvements in the perceived severity of claudication (p = 0.023) and stair climbing ability (p = 0.011) versus controls were observed in the ULG, and an improvement in the general health domain of the SF-36v2 versus controls was observed in the LLG (p = 0.010). After 24 weeks, all 4 WIQ domains were improved in the ULG versus controls (p ≤ 0.05), and 3 of the 4 WIQ domains were improved in the LLG (p < 0.05). After 24 to 72 weeks of follow-up, more consistent changes in generic health-related QoL domains were apparent in the ULG. The authors concluded that these findings supported the use of alternative, relatively pain-free forms of exercise in the clinical management of patients with IC.
In a comparative longitudinal cohort study, Fakhry et al (2011) evaluated effects of a structured home-based exercise program on functional capacity and QoL in patients (n = 142) with IC after 1-year follow-up, and compared these results with those from a concurrent control group who received supervised exercise training (SET). Main outcome measures included the maximum (pain-free) walking distance and the ABI (at rest and post-exercise) were measured at baseline and after 6 and 12 months' follow-up. Additionally, QoL was evaluated using a self-administered questionnaire consisting of the Euroqol-5D (scale 0 to 1), rating scale (scale 0 to 100), SF-36 (scale 0 to 100), and the Vascular QoL Questionnaire (VascuQol; scale 1 to 7). Comparison of the groups was performed with adjustment for the non-randomized setting using propensity scoring. Patients with IC started the structured home-based exercise program, of whom 95 (67 %) completed 12 months' follow-up. The mean relative improvement compared with baseline was statistically significant after 12 months' follow-up for the maximum and pain-free walking distance (342 %, 95 % confidence interval [CI]: 169 to 516; p < 0.01 and 338 %, 95 % CI: 42 to 635; p = 0.03, respectively) and for the ABI post-exercise (mean change of 0.06; 95 % CI: 0.01 to 0.10; p = 0.02). For the QoL outcomes, the improvement compared with baseline was statistically significant after 12 months for the VascuQol (mean change of 0.42; 95 % CI: 0.20 to 0.65; p < 0.01) and for the SF-36 physical functioning (mean change of 5.17; 95 % CI: 0.77 to 9.56; p = 0.02). Compared with the structured home-based exercise program, patients in the control group showed significantly better results in the mean relative improvement of maximum and pain-free walking distance and change in the ABI at rest after 12 months' follow-up. The authors concluded that structured home-based exercise training is effective in improving both functional capacity and QoL in patients with IC and may be considered as a feasible and valuable alternative to SET.
The BioMedix PADnet Lab was approved by the U.S. Food and Drug Administration on October 12, 2004. PADnet (Peripheral Arterial Disease-Internet Ready) system is a non invasive cardiovascular blood flow monitor to gauge the lower extremity arterial system using pulse volume recordings and oscillometric segmental systolic blood pressures to assist in the identification of vascular disease. It uses automated means to obtain Ankle-Brachial Index/Toe-Brachial Index (ABI/TBI) values and Pulse Volume Recording (PVR) waveforms. The device is capable of sending test results instantly via the web to a vascular specialist for interpretation. Ankle-Brachial Index and Pulse Volume Recording values are used to identify the obstructive disease and determine whether medical or surgical treatment is necessary. The device uses a supplied laptop with specifications, hardware and a user interface. The PADnet is intended to be used by healthcare professionals in a hospital or clinic environment. The device is not intended for pediatric or fetal use. It is also not intended for use on or near non intact skin.
In a Cochrane review, Fokkenrood et al (2013) provided an accurate overview of studies evaluating the effects of supervised exercise programs (SETs) versus non-supervised exercise therapy on maximal walking time or distance on a treadmill for people with intermittent claudication. For this update, the Cochrane Peripheral Vascular Diseases Group Trials Search Co-ordinator searched the Specialised Register (last searched September 2012) and CENTRAL (2012, Issue 9). In addition, these investigators hand-searched the reference lists of relevant articles for additional trials. No restriction was applied to language of publication. Randomized clinical trials comparing SETs with non-supervised exercise programs (defined as walking advice or a structural home-based exercise program) for people with intermittent claudication were selected for analysis; studies with control groups, which did not receive exercise or walking advice or received usual care (maintained normal physical activity), were excluded. Two review authors independently selected trials and extracted data; 3 review authors assessed trial quality, and this was confirmed by 2 other review authors. For all continuous outcomes, these researchers extracted the number of participants, the mean differences, and the standard deviation. The 36-Item Short Form Health Survey (SF-36) outcomes were extracted to assess quality of life. Effect sizes were calculated as the difference in treatment normalized with the standard deviation (standardized mean difference) using a fixed-effect model. A total of 14 studies involving a total of 1,002 male and female participants with PAD were included in this review. Follow-up ranged from 6 weeks to 12 months. In general, supervised exercise regimens consisted of 3 exercise sessions per week. All trials used a treadmill walking test as one of the outcome measures. The overall quality of the included trials was moderate to good, although some trials were small with respect to the number of participants, ranging from 20 to 304. Supervised exercise therapy showed statistically significant improvement in maximal treadmill walking distance compared with non-supervised exercise therapy regimens, with an overall effect size of 0.69 (95 % CI: 0.51 to 0.86) and 0.48 (95 % CI: 0.32 to 0.64) at 3 and 6 months, respectively. This translated to an increase in walking distance of approximately 180 meters that favored the supervised group. Supervised exercise therapy was still beneficial for maximal and pain-free walking distances at 12 months, but it did not have a significant effect on quality of life parameters. The authors concluded that SET has statistically significant benefit on treadmill walking distance (maximal and pain-free) compared with non-supervised regimens. Moreover, they stated that the clinical relevance of this has not been demonstrated definitively; additional studies are needed that focus on quality of life or other disease-specific functional outcomes, such as walking behavior, patient satisfaction, costs, and long-term follow-up.
|CPT Codes / HCPCS Codes / ICD-9 Codes|
|CPT codes not covered for indications listed in the CPB:|
|PADnet System - no specific code:|
|93668||Peripheral arterial disease (PAD) rehabilitation, per session|
|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:|
|PADnet system - no specific code:|
|93668||Peripheral arterial disease (PAD) rehabilitation, per session|