VII-62-008

Medical Policy:

VII-62-008

Topic:

Mechanical Stretching Devices

Section:

Ancillary Services

Effective Date:

November 25, 2024

Issued Date:

November 25, 2024

Last Revision Date:

November 2019

Annual Review:

November 2024

A variety of outpatient mechanical stretch devices have been developed to restore functioning range of motion to a joint with stiffness and limited range of motion. These outpatient devices include the following:

Low load prolonged-duration stretch devices (LLPS), also known as dynamic stretching devices, are spring-loaded devices that apply continuous stretch to the affected joint. The patient may adjust the tension of the spring but otherwise no patient intervention is required.
- These products are considered by the FDA as Class I limb orthosis devices and are exempt from 510(k) requirements.
- Several LLPS products include, but are not limited to, Dynasplint, Ultraflex, and EMPI Advance®.
Static progressive stretch (SPS) devices, also known as low intensity stretch devices, provide low to moderate stretching with a crank or rachet that progressively increases the stretch. Patients are instructed to adjust these devices intended for home use to the maximum tolerated position of end range stretch for several minutes several times per day.
- SPS devices are classified by the FDA as “Exerciser, NonMeasuring,” and are exempt from 510(k) requirements as Class I devices.
- Examples include the JAS (Joint Active Systems), Static-Pro®, Stat-A-Dyne®, AliMed® Turnbuckle Orthosis, and Aircast®.
Patient Actuated Serial Stretch Devices (PASS), also known as patient-controlled serial stretch devices or high intensity stretch devices, are used in the home primarily to address excessive scar tissue around the joint. Progressive stretch is alternated with periods of relaxation using a hydraulic pump to control the load.
- These devices are also classified by the FDA as “Exerciser, NonMeasuring” and are exempt from 510(k) requirements as Class I devices.
- Examples include the ERMI (ERMI, Inc.) line of PASS devices includes the Flexionater, Knee Flexionater, Knee Extensionater, Elbow Extensionater, and the MPJ Extensionater.

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

Policy Position Coverage is subject to the specific terms of the member's benefit plan.

I. Use of low load prolonged-duration stretch devices (LLPS) (dynamic stretch devices) may be considered MEDICALLY NECESSARY AND APPROPRIATE for restoration of joint range of motion.

II. Patient-controlled end range of motion stretching devices are considered EXPERIMENTAL/INVESTIGATIVE for all indications, including but not limited to the following, due to the lack of clinical evidence demonstrating an impact on improved health outcomes:

Static progressive stretch (SPS) devices;
Patient actuated serial stretch (PASS) devices.

E1399 E1800 E1801 E1802 E1803 E1804 E1805 E1806 E1807 E1808 E1810 E1811 E1812 E1813 E1814 E1815 E1816 E1818 E1822 E1823 E1825 E1826 E1827 E1828 E1829 E1830 E1831 E1840 E1841

Denial Statements

No additional statements.

Links

Blue Cross and Blue Shield of Minnesota medical policies apply generally to all Blue Cross and Blue Plus plans and products. Benefit plans vary in coverage and some plans may not provide coverage for certain services addressed in the medical policies. When determining coverage, reference the member’s specific benefit plan, including exclusions and limitations.

Medicaid products may provide different coverage for certain services, which may be addressed in different policies. For Minnesota Health Care Program (MHCP) policies, please consult the MHCP Provider Manual website.

Medicare products may provide different coverage for certain services, which may be addressed in different policies. For Medicare National Coverage Determinations (NCD), Local Coverage Determinations (LCD), and/or Local Coverage Articles, please consult CMS, National Government Services, or CGS websites.

Note that services with specific coverage criteria may be reviewed retrospectively to determine if criteria are being met. Retrospective denial of claims may result if criteria are not met.

Blue Cross and Blue Shield of Minnesota reserves the right to revise, update and/or add to its medical policies at any time without notice. Codes listed on this policy are included for informational purposes only and are subject to change without notice. Inclusion or exclusion of a code does not constitute or imply member coverage or provider reimbursement.

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