MEDICAL POLICY

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Electrical Stimulation Devices

Number 1.01.507*

Effective Date March 10, 2015

Revision Date(s) 03/10/15; 06/09/14; 05/12/14; 02/11/13; 03/13/12; 06/13/11; 06/08/10; 08/11/09; 05/13/08; 06/12/07; 07/11/06; 09/13/05; 02/08/05; 12/14/04; 09/14/04; 07/13/04; 06/08/04; 01/13/04; 10/16/03; 05/13/03; 04/15/03; 09/10/02

Replaces 1.01.09; 1.01.27, 1.01.504; and 1.04.03

*Medicare has a policy.

Policy

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Services Eligible for Reimbursement

Use of a Neuromuscular electrical stimulator (NMES) via an open loop system including but not limited to the RS 4m and RS 2m, may be considered medically necessary for disuse atrophy when the nerve supply to the muscle is intact and the patient has any of the following non-neurological causes for disuse atrophy:

  • Previous casting or splinting of a limb
  • Contractures due to burn scarring or recent hip replacement surgery (up until the time physical therapy begins)
  • Previous major knee surgery, when there is a failure to respond to physical therapy.

NOTE: Functional neuromuscular electrical stimulators (closed loop systems) are addressed in a separate policy. (See Related Policies)

Services Not Eligible for Reimbursement

  • Electrical stimulation is considered investigational for the treatment of osteoarthritis or rheumatoid arthritis. (HCPCS E0762)
  • Galvanic stimulation is considered investigational in the treatment of chronic pain.
  • Microcurrent Stimulation Devices are considered investigational.
  • Neuromuscular electrical stimulators (NMES) are considered investigational when used for general muscle strengthening in healthy individuals, for cardiac conditioning, or for the treatment of denervated muscles.
  • Sympathetic Stimulation Devices are considered investigational.
  • Transcutaneous electrical modulation pain reprocessing (TEMPR) or scrambler therapy is considered investigational. (HCPCS 0278T)

Related Policies

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2.01.57

Electrostimulation and Electromagnetic Therapy for Treating Wounds

7.01.29

Percutaneous Electrical Nerve Stimulation (PENS) and Percutaneous Neuromodulation Therapy (PNT)

7.01.125

Occipital Nerve Stimulation

7.01.522

Gastric Electrical Stimulation

7.01.529

Electrical Bone Growth Stimulation of the Appendicular Skeleton

7.01.546

Spinal Cord Stimulation

7.01.553

Posterior Tibial Nerve Stimulation (PTNS) for Voiding Dysfunction

8.01.58

Cranial Electrotherapy Stimulation (CES) and Auricular Electrostimulation

8.03.01

Functional Neuromuscular Electrical Stimulation

Policy Guidelines

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A conductive garment (E0731) may be needed when a member meets criteria for treatment with a neuromuscular electrical stimulation device (NMES) and has one of the following medical indications:

  • The treatment site is large and using a large number of standard electrodes is impractical,
  • There are multiple large treatment sites on the body that make using standard electrodes impractical,
  • The treatment site is hard to reach using standard electrodes and lead wires,
  • The member has a skin sensitivity that precludes use of standard electrodes, adhesive tape or lead wires

Definition of Terms

  • Conductive garment – a form fitted garment with integrated conductive fibers that are separated from the patient’s skin by a layer of fabric
  • Disuse atrophy – gradual wasting or deterioration of a muscle when not used or subjected to prolonged inactivity such as when an arm is in a cast for a long time. (see muscle atrophy)
  • Muscle atrophy - muscle wasting or tissue loss that occurs when a muscle is no longer as active as usual. When muscles are no longer used movement and strength decline causing weakness.
  • Neurogenic atrophy - this most severe type of muscle atrophy occurs when a nerve that connects to the muscle is injured or has a disease. This type of muscle atrophy tends to occur suddenly when compared to disuse atrophy that is more gradual.

Description

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Neuromuscular electrical stimulation (NMES) involves the use of a device which transmits an electrical impulse via electrodes attached to the skin over a specific muscle group(s). The two broad categories of NMES are:

  1. Muscle stimulation when the patient is in a resting state to treat muscle atrophy.
  2. Muscle stimulation used to enhance functional activity of neurologically impaired patients.

Neuromuscular Electrical Stimulation Devices (NMES)

These devices, through multiple channels, attempt to stimulate motor nerves and alternately causes contraction and relaxation of muscles, unlike a TENS device which is intended to alter the perception of pain. NMES are used to prevent or retard disuse atrophy, relax muscle spasm, increase blood circulation, maintain or increase range of motion, and re-educate muscles.

This policy address the use of open loop neuromuscular systems which are used for simple tasks such as muscle strengthening alone, and typically in healthy individuals with intact neural control.

Functional neuromuscular stimulators are closed loop systems, which provide feedback information on muscle force and joint position, thus allowing constant modification of stimulation parameters which are required for complex activities such as walking. (These are addressed in a separate policy, see Related Policies)

The RS 4m and RS 2m muscle stimulator are examples of devices that delivers neuromuscular electric stimulation.

Transcutaneous Electrical Modulation Pain Reprocessing (TEMPR) (CPT 0278T)

Scrambler Therapy/Calmare® device is also known as transcutaneous electrical modulation pain reprocessing (TEMPR). It is an electrocutaneous nerve stimulation device. It uses a biophysical rather than a biochemical approach. A “no-pain” message is transmitted to the nerve via disposable surface electrodes applied to the skin in the region of the patient’s pain. The perception of pain is cancelled when the no-pain message replaces that of pain, by using the same pathway through the surface electrodes in a non-invasive way. Regardless of pain intensity, a patient’s pain can be completely removed for immediate relief. Maximum benefit is achieved through follow-up treatments. The patient may be able to go for extended periods of time between subsequent treatments while experiencing significant pain control and relief. The period of time between treatments depends on the underlying cause and severity of the pain in addition to other factors. Treatment utilizing the Calmare® medical device is restricted to allopathic physicians and other qualified licensed healthcare professionals under their direct supervision who are certified in its use and application and are familiar with the principles, clinical applications, side effects and hazards associated with transdermal pain modulation.

Galvanic Stimulation Devices

Galvanic stimulation is characterized by high voltage, pulsed stimulation and is used primarily for local edema reduction through muscle pumping and polarity effect. Edema is comprised of negatively charged plasma proteins, which leak into the interstitial space. The theory of galvanic stimulation is that by placing a negative electrode over the edematous site and a positive electrode at a distant site, the monophasic high voltage stimulus applies an electrical potential which disperses the negatively charged proteins away from the edematous site, thereby helping to reduce edema.

Microcurrent Stimulation Devices (MENS)

MENS is characterized by subsensory current that acts on the body’s naturally occurring electrical impulses in an effort to decrease pain and facilitate the healing process. MENS differs from TENs in that it uses a significantly reduced level of electrical stimulation. TENS blocks pain, while MENS acts on the naturally occurring electrical impulses to decrease pain by stimulating the healing process.

Sympathetic Stimulation Devices

Sympathetic therapy describes a type of electrical stimulation of the peripheral nerves that is designed to stimulate the sympathetic nervous system in an effort to “normalize” the autonomic nervous system and alleviate chronic pain. Unlike TENS or interferential electrical stimulation, sympathetic therapy is not designed to treat local pain, but is designed to induce a systemic effect on sympathetically induced pain.

Sympathetic therapy uses four intersecting channels of various frequencies with bilateral electrode placement on the feet, legs, arms, and hands. Based on the location of the patient’s pain and treatment protocols supplied by the manufacturers, electrodes are placed in various locations on the lower legs and feet or the hands and arms. Electrical current is then induced with beat frequencies between 0 and 1000Hz. Treatment may include daily one-hour treatments in the physician’s office, followed by home treatments if the initial treatment is effective.

Pulsed Electrical and Electromagnetic Stimulation Devices

Pulsed electrical and electromagnetic stimulation are being investigated to improve functional status and relieve pain related to osteoarthritis (OA) and rheumatoid arthritis (RA) unresponsive to other standard therapies. Electrical stimulation is provided by an electronic device that noninvasively delivers a subsensory low-voltage, monophasic electrical field to the target site of pain. Pulsed electromagnetic fields are delivered via treatment coils that are placed over the skin. Combined magnetic fields deliver a time-varying magnetic field by superimposing the time-varying magnetic field onto an additional static magnetic field.

In basic research studies, pulsed electrical stimulation has been shown to alter chondrocyte-related gene expression in vitro and to have regenerative effects in animal models of cartilage injury. Therefore, pulsed electrical stimulation is proposed to be similar to bone stimulator therapy for fracture nonunion. Electrical bone growth stimulation of the appendicular skeleton is addressed in a separate policy. (See Related Policies).

Scope

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Medical policies are systematically developed guidelines that serve as a resource for Company staff when determining coverage for specific medical procedures, drugs or devices. Coverage for medical services is subject to the limits and conditions of the member benefit plan. Members and their providers should consult the member benefit booklet or contact a customer service representative to determine whether there are any benefit limitations applicable to this service or supply. This medical policy does not apply to Medicare Advantage.

Benefit Application

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N/A

Rationale

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This policy was originally developed in 2002 and has undergone annual review and was updated as needed since that time.

Sympathetic Therapy

In 2002 Guido and colleagues studied 20 individuals with chronic pain and peripheral neuropathies treated daily with Dynatron STS for 28 days. Pain was reported as moderate to severe by 11 of 15 individuals prior to treatment, with a decrease in pain reported by six of the individuals at conclusion of the treatment. The author did not report on the reason why five of the 20 individuals did not provide self-reports of pain severity. The 15 individuals who remained in the study, the authors reported the mean cumulative VAS scores for multiple locations of pain decreased from 107.8 to 45.3. However, drawing conclusions concerning the efficacy of Dynatron STS for the management of chronic, intractable pain is limited due to the small participant population, lack of a randomized control group, placebo effects and lack of data on pain severity in a quarter of the subjects. There is a lack of peer-reviewed literature concerning the efficacy of sympathetic therapy in terms of pain relief or for another indication.

Microcurrent Stimulation

Bertolucci and Grey (1995) compared the efficacy of MENS therapy to mid-laser and laser placebo treatment of 48 individuals with TMJ pain. There was a difference in pain and functional outcomes between laser and MENS therapy with laser being slightly higher; however, the difference was not statistically significant. There was no data to suggest whether the effect was durable and whether the effects continued with repeated use.

There is a lack of large controlled clinical trials testing the clinical effectiveness of microcurrent electrical nerve stimulation against placebo devices. Therefore, this treatment remains investigational

Galvanic Stimulation

A 2009 Cochrane review of electrotherapy concluded that the evidence was of low quality and more studies are needed to reliably establish effectiveness.

Pulsed Electrical Stimulation

A review of the literature has not found adequate evidence to indicate that the use of pulsed electrical or electromagnetic stimulation for the treatment of arthritis will result in improvements in health outcomes. A well-conducted meta-analysis from 2013 identified 7 randomized sham-controlled trials on treatment of osteoarthritis of the knee. There was some evidence of an improvement in function but no evidence of an improvement in pain. These conclusions are limited by methodologic limitations and inconsistency of the study results. No published studies for rheumatoid arthritis were identified. This evidence remains insufficient to evaluate the effect of this treatment on health outcomes. Additional study with a larger number of subjects is needed. Therefore, pulsed electrical or electromagnetic stimulation is considered investigational for the treatment of osteoarthritis and rheumatoid arthritis.

Regulatory status

  • The BioniCare Bio-1000™ stimulator is a device that has received U.S. Food and Drug Administration (FDA) 510(k) marketing clearances to deliver pulsed electrical stimulation for the treatment of osteoarthritis of the knee and rheumatoid arthritis of the hand. The FDA found the device to be substantially equivalent to transcutaneous electrical nerve stimulation (TENS) devices. The BioniCare system is contraindicated in patients with demand-type pacemakers and may interfere with other electronic devices.
  • Calmare® Pain Therapy Medical Device is U.S. FDA 510(k)-cleared and European CE mark-certified for the treatment of oncologic and neuropathic pain through biophysical stimulation. The Device has five separate channels, convenient dial selectors with five corresponding channel meters, indicator lights and an LCD display to monitor operation. http://www.calmarett.com/.
  • The OrthoCor™ Active Knee System (OrthoCor Medical) uses pulsed electromagnetic field energy at a radio frequency of 27.12 MHz to treat pain. The OrthoCor Knee System received marketing clearance from the FDA in 2009 and is classified as a shortwave diathermy device for use other than applying therapeutic deep heat (K091996, K092044). It is indicated for adjunctive use in the palliative treatment of postoperative pain and edema in superficial soft tissue and for the treatment of muscle and joint aches and pain associated with overexertion, strains, sprains, and arthritis. The system includes single-use packs (pods) that deliver hot or cold and are supplied in packets of 15. The predicate devices are the OrthoCor (K091640) and Ivivi Torino II™ (K070541).
  • The SofPulse™ (also Torino II, 912-M10, and Roma3™, Ivivi Health Sciences) received marketing clearance in 2008 as short-wave diathermy devices that apply electromagnetic energy at a radio frequency of 27.12 MHz (K070541). They are indicated for adjunctive use in the palliative treatment of postoperative pain and edema in superficial soft tissue. Palermo is another name for a device marketed by Ivivi Health Sciences.
  • The Magnetofield (F& B International, Italy) and Elettronica Pagani (Energy Plus Roland Series, Italy) devices provide pulsed electromagnetic field therapy. They are currently marketed in Europe.

Medicare National Coverage

Treatment of Muscle Atrophy

Coverage of NMES to treat muscle atrophy is limited to the treatment of disuse atrophy where nerve supply to the muscle is intact, including brain, spinal cord and peripheral nerves, and other non-neurological reasons for disuse atrophy. Some examples would be casting or splinting of a limb, contracture due to scarring of soft tissue as in burn lesions, and hip replacement surgery (until orthotic training begins).

References

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  1. Guido EH. Effects of sympathetic therapy on chronic pain in peripheral neuropathy subjects. Am J Pain Manage 2002; 12(1):31-4.
  2. Stevens JE, Mizner RL, Snyder-Mackler L. Neuromuscular electrical stimulation for quadriceps muscle strengthening after bilateral total knee arthroplasty. J Orthop Sports Phys Ther 2004; 34(1):21-29. PMID 14964588Brosseau, LU, Pelland, LU, Casimiro, LY, Robinson, VI, Tugwell, PE, Wells, GE. Electrical stimulation for the treatment of rheumatoid arthritis. Cochrane Database Syst Rev. 2002(2):CD003687. PMID: 12076504
  3. Bertolucci LE, Grey T. Clinical comparative study of microcurrent electrical stimulation to mid-laser and placebo treatment in degenerative joint disease of the temporomandibular joint. Cranio. 1995; 13(2):116-120. PMID 8697497
  4. Hayes, Inc. Hayes Search & Summary. CALMARE® Pain Therapy Treatment. Lansdale, PA: Hayes, Inc.; February, 2012.
  5. Negm A, Lorbergs A, Macintyre NJ. Efficacy of low frequency pulsed subsensory threshold electrical stimulation vs placebo on pain and physical function in people with knee osteoarthritis: systematic review with meta-analysis. Osteoarthritis Cartilage. Sep 2013;21(9):1281-1289. PMID 23973142
  6. Fary RE, Carroll GJ, Briffa TG et al. The effectiveness of pulsed electrical stimulation in the management of osteoarthritis of the knee: results of a double-blind, randomized, placebo-controlled, repeated-measures trial. Arthritis Rheum 2011; 63(5):1333-42. PMID 21312188
  7. Garland D, Holt P, Harrington JT et al. A 3-month, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of a highly optimized, capacitively coupled, pulsed electrical stimulator in patients with osteoarthritis of the knee. Osteoarthritis Cartilage 2007; 15(6):630-637. PMID 17303443
  8. Ozguclu E, Cetin A, Cetin M, et al. Additional effect of pulsed electromagnetic field therapy on knee osteoarthritis treatment: a randomized, placebo-controlled study. Clin Rheumatol. Aug 2010;29(8):927-931. PMID 20473540
  9. Zizic TM, Hoffman KC, Holt PA et al. The treatment of osteoarthritis of the knee with pulsed electrical stimulation. J Rheumatol 1995; 22(9):1757-1761. PMID 8523357
  10. Nelson FR, Zvirbulis R, Pilla AA. Non-invasive electromagnetic field therapy produces rapid and substantial pain reduction in early knee osteoarthritis: a randomized double-blind pilot study. Rheumatol Int 2013; 3(8):2169-2173. PMID 22451021
  11. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). TENS or PENS in the treatment of chronic and postoperative pain. TEC Assessments 1996; Volume 11, Tab 21.
  12. Centers for Medicare and Medicaid Services (CMS) Neuromuscular Electrical Stimulator (NMES) 160.12. NCD Manual Chap 1, rev. 173, September, 2014. Available at: http://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/ncd103c1_part2.pdf. Accessed February, 2015.
  13. Blue Cross Blue Shield Association. Medical Policy Reference Manual. Electrical Stimulation for the Treatment of Arthritis. Policy No. 1.01.27, 2014.

Coding

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Codes

Number

Description

CPT

64550

Application of surface (transcutaneous) neurostimulator

 

97014

Application of modality to one or more areas; electrical stimulation, unattended

 

0278T

Transcutaneous electrical modulation pain reprocessing (e.g., scrambler therapy), each treatment session (includes placement of electrodes)

HCPCS

E0745

Neuromuscular stimulator, electronic shock unit

 

E0762

Transcutaneous electrical joint stimulation device system, includes all accessories

 

E1399

Durable medical equipment, miscellaneous (Determine if an alternative HCPCS Level II or a CPT code better describes the service being reported. This code should be used only if a more specific code is unavailable.)

 

G0283

Electrical stimulation (unattended), to one or more areas for indication(s) other than wound care, as part of a therapy plan of care

Type of Service

Durable Medical Equipment

 

Place of Service

Home
Inpatient/
Outpatient

 

Appendix

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N/A

History

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Date

Reason

09/10/02

Add to Durable Medical Equipment Section - New Policy. Replaces 1.01.13 H-Wave Electrical Stimulation; 1.01.104 (1.01.09) Transcutaneous Electrical Nerve Stimulator (TENS); 1.04.03 Sympathetic Therapy for the Treatment of Pain; 7.01.29 Percutaneous Electrical Nerve Stimulation (PENS)

04/15/03

Replace Policy - Policy reviewed with references added.

05/13/03

Replace Policy - Policy section revised for clarification only.

10/16/03

Replace Policy - Interferential Stimulation Devices description updated; references added. No change to policy statement.

01/13/04

Replace Policy - TMJ as investigational for TENS was added. This is consistent with TMJ policy.

06/08/04

Replace Policy - Policy reviewed; No change to policy statement.

07/13/04

Replace Policy - Description of PENS revised; information on percutaneous neuromodulation included; policy statement revised to indicate that percutaneous neuromodulation considered investigational. No change in policy statement regarding PENS.

09/01/04

Replace Policy - Policy renumbered from PR.1.01.107. No date changes.

09/14/04

Replace Policy - Policy statement revised by adding pulsed electrical stimulation with the BioniCare® to be considered investigational as a treatment for osteoarthritis. Rationale Section updated.

12/14/04

Replace Policy - Description of TENS revised; information on dementia added; reference added; Medicare policy language on TENS added. No change to policy statement.

02/08/05

Replace Policy - RS-4i Sequential Stimulator information added. No change to policy statement.

05/31/05

Update only to web - HCPCS codes added only—no other changes and not presented to MPC.

09/13/05

Replace Policy - Interferential Stimulation and PENS/ PNT added to Rationale section. References updated; no change to policy statement.

02/06/06

Codes updated - No other changes.

05/26/06

Update Scope and Disclaimer - No other changes.

07/11/06

Replace Policy - Update description to include detail of RS 4M and RS 2M muscle stimulators; no change to policy statement.

04/10/07

Cross Reference Update - No other changes.

06/12/07

Replace Policy - Policy updated with literature review; references added. No changes in policy statement. Reviewed by practicing orthopedic surgeon in May 2007.

05/13/08

Replace Policy - Policy updated with literature search. Policy statement was updated to include cranial electrostimulation therapy is considered investigational for all indications listed. The manufacturer provided many articles to be reviewed. Many of them were from the 1990s and earlier. Most of the later studies were not regarding the FDA approved labeled indications. Additional and much larger double-blinded, sham controlled studies are needed to document long-term effects of CES. References and code added to support the update.

01/13/09

Code Update - Code E0770 added, effective 1/1/09.

08/11/09

Replace Policy - Policy updated with literature search; references added. No change to policy statement.

04/13/10

Cross Reference Update - No other changes.

06/08/10

Replace Policy - Policy updated with literature search, reference added. Added medically necessary statement re: conductive garment and TENS/IF. Also included Flex IT to investigational statement.

06/13/11

Replace Policy - Policy updated with literature search, reference added. No change to policy statement.

01/25/12

HCPCS codes S8130 and S8131 added to policy.

01/26/12

CPT code 0278T added.

03/13/12

Replace policy. Policy revised by removing indications, descriptions, and rationale addressed in separate policies: 1.01.13, 1.01.24, 1.01.27, 7.01.29, and 8.01.58. Policy now addresses TENS, open loop neuromuscular electrical stimulation, galvanic, microcurrent, cranial electrostimulation and sympathetic electrical stimulation devices.

04/17/12

Related Policies updated; 7.01.546 added to replace 7.01.25 which has been deleted.

08/24/12

Update Related Policies – Change title for 7.01.106

11/20/12

Update Related Policies. Add 8.01.58.

12/19/12

Update Related Policy title for 2.01.57.

02/11/13

Replace policy. Removed information on cranial electrostimulation which is addressed in Medical Policy 8.01.58. Added policy statement on scrambler therapy.

12/30/13

Coding update. HCPCS code E0762 removed; this is addressed in policy No. 1.01.27, Electrical Stimulation for the Treatment of Arthritis. Remove Related Policy 1.01.19; it was archived effective 12/9/13.

03/21/14

Update Related Policies. Delete 7.01.106 and replace with 7.01.553.

05/12/14

Annual Review. TENS policy statements and information removed. Added references 3 and 4.

06/09/14

Interim update. HCPCS codes E0720, E0730 and E0731 are no longer reviewed and from the policy. The Policy section has been updated with removal of the policy statement related to code E0730 and the TENS unit.

03/10/15

Annual Review. Policy updated with literature search through November 2014. Added statement from medical policy 1.01.27 (that is now archived) “Electrical stimulation is considered investigational for the treatment of osteoarthritis or rheumatoid arthritis” along with the HCPCS code. Added policy 7.01.529, removed policy 1.01.27 from Related Policies section. Added information about conductive garment to the Policy Guidelines. Added Definition of Terms to Policy Guidelines. Regulatory Status section updated with additional device names. Reference 6-12, 14 added; others renumbered. Added code E0762. Policy statement added as noted. Coding update: CPT codes 64553-64590 removed as there are more specific codes listed; HCPCS codes S8130, S8131 removed as these are not being utilized; HCPCS codes E0770 and L8680 removed as these are listed on other policies to which they apply.


Disclaimer: This medical policy is a guide in evaluating the medical necessity of a particular service or treatment. The Company adopts policies after careful review of published peer-reviewed scientific literature, national guidelines and local standards of practice. Since medical technology is constantly changing, the Company reserves the right to review and update policies as appropriate. Member contracts differ in their benefits. Always consult the member benefit booklet or contact a member service representative to determine coverage for a specific medical service or supply. CPT codes, descriptions and materials are copyrighted by the American Medical Association (AMA).
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