MedStar Health, Inc. POLICY AND PROCEDURE MANUAL

POLICY NUMBER: MP.057.MH REVISION DATE: 07/15 ANNUAL APPROVAL DATE: 07/15 PAGE NUMBER: 1 of 7

SUBJECT: for & (COMMERCIAL ONLY) INDEX TITLE: Medical Management ORIGINAL DATE: January 2013

This policy applies to the following MedStar Health lines of business: (Check those that apply.) COMMERCIAL [ ] HMO [ ] PPO [ ] Fully [ ] Individual [ ] Marketplace [ X ] All Insured Product (Exchange) GOVERNMENT [ ] MA HMO [ ] MA PPO [ ] MA C-SNP [ ] MA D-SNP [ ] MA All PROGRAMS [ ] Medicaid OTHER [ ] Self-funded/ASO

I. POLICY

It is the policy of MedStar Health, Inc. to cover Acupuncture for nausea and vomiting when it is medically necessary (refer to CRM.015.MH Medical Necessity policy) and covered under the member’s specific benefit plan.

Due to a lack of controlled studies, MedStar Health, Inc. considers the use of acupuncture as investigational except when it is used for the treatment of post- operative nausea, induced nausea and excessive nausea and vomiting associated with pregnancy. This is based on the 1997 National Institute of Health (NIH) consensus statement endorsing the use of acupuncture for nausea.

Coverage will be considered, on a case-by-case basis, for the specific indications detailed in this policy.

All denials are based on medical necessity and appropriateness as determined by a MedStar Health, Inc. (Medical Director).

II. DEFINITIONS

N/A

III. PURPOSE

The purpose of this policy is to establish criteria for the use of acupuncture in the treatment of refractory nausea and vomiting.

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IV. SCOPE

This policy applies to various MedStar Health, Inc. departments as indicated by the Benefit and Reimbursement Committee. These include but are not limited to: Medical Management, Benefit Configuration and Claims Departments.

V. PROCEDURE

A. Medical Description

Acupuncture: acupuncture is a procedure adapted from Chinese medical practice, in which the skin is pierced at specific body sites to induce anesthesia, improve certain symptoms such as , nausea or vomiting, and to treat certain medical conditions.

Types of Acupuncture Manual – hand stimulation of the inserted needles Electro-acupuncture – application of electrodes to the acupuncture needles with low frequency electrical stimulation

Regulation of Acupuncture The U.S. Food and Drug Administration (FDA) regulates acupuncture needles and approves their use. They must be disposable, and manufacturers are required to label them for single use only.

Traditional View of Acupuncture Acupuncture has been part of traditional Chinese medicine for 3,000 years. According to the traditional practice, positive and negative energy (chi or qi) vital to health, flows just beneath the skin through 360 specific points along 14 different lines called meridians. In health, chi is in balance. An imbalance in chi causes a block in the flow of energy, resulting in a state of unhealthiness. It is believed that inserting needles into specific points in the body may bring chi back into balance and restore health.

Modern View of Acupuncture Western research suggests acupuncture may work through the nervous system by stimulating the regional release of hormones and peptides, including substance P, calcitonin gene-related peptide, enkephalin and beta-endorphins, with effects on prostaglandin synthesis. In electro-acupuncture, low frequency stimulation releases a type of endorphin that produces a slow onset, longer duration analgesia. When higher frequencies are applied, a neurochemical is produced that causes rapid onset analgesia of shorter duration. Future research trials may better define how acupuncture works and may more precisely define regimens for specific conditions, with refinements in positioning, stimulation frequencies and duration of treatment.

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POLICY NUMBER: MP.057.MH DATE: 07/15 ANNUAL APPROVAL DATE: 07/15 PAGE NUMBER: 3 of 7

There are some research studies on acupuncture of good quality from which conclusions may be drawn. Much of the historical literature however involves uncontrolled case series, variability of acupuncture approach from one subject to the next, concerns regarding adequacy of controls and other design flaws. More recent research such as the University of Maryland study on acupuncture for knee osteoarthritis provide examples of how to design high quality randomized controlled studies. Such high quality studies have received support from the National Center for Complementary and Alternative Medicine and other instituted at the NIH, and it is anticipated that the potential benefit of acupuncture for many other conditions, particularly chronic pain states will be clearly demonstrated.

Note: This policy pertains to acupuncture in the treatment for nausea as described below.

B. Specific Indications

MedStar Health, Inc. considers coverage of Acupunture treatment for only the following conditions:  Chemotherapy-induced nausea and vomiting,  Postoperative nausea and vomiting,  Nausea and vomiting in .

The following specific indications will be applied in these situations. Documented evidence of at least one (1) of the following:  History of high use of expensive anti-emetics.  Certain chemotherapy regimens associated with high incidence of nausea and vomiting.  Evidence of nausea and vomiting not adequately controlled with multimodal pharmacologic prophylaxis.  Evidence of success with previous acupuncture treatments for nausea associated with the above conditions.  Allergy or other contraindications to standard therapy.

C. Limitations

1. Members must be at least 18 years of age. 2. Provision of acupuncture is limited to appropriately credentialed and licensed physicians OR licensed or appropriately credentialed acupuncturists.

D. Information Required for Review

In order for medical necessity to be established, adequate information must be furnished by the treating physician. Necessary information includes the following: 1. Physician’s prescription or letter of medical necessity.

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POLICY NUMBER: MP.057.MH DATE: 07/15 ANNUAL APPROVAL DATE: 07/15 PAGE NUMBER: 4 of 7

2. Documentation supporting the member’s need for treatment of nausea and vomiting as described above, including :  The member’s diagnosis AND  Evidence of history of failed standard treatment for a period of three (3) months or more 3. Evidence of Credentialing and Privileges for the Practitioner

E. Review Process

1. The Medical Management Ancillary Service staff reviews the request. If the case does not meet the established criteria, it is referred to a MedStar Health, Inc. Medical Director (Medical Director). 2. If referred, the Medical Director determines if the requested service is medically necessary and appropriate. 3. The Medical Management Ancillary Service staff completes the review process and communicates the review decision according to the Timeliness of UM Decisions policy for the member’s benefit plan.

F. Variations

Medical Assistance Product Procedure is not on the Medical Assistance fee schedule; therefore this policy does not apply to this product.

CHIP (UPMC for Kids) Product Acupuncture is not covered for this product

G. Records Retention

Records Retention for documents, regardless of medium, are provided within the MedStar Health, Inc. Policy and Procedure CORP.028.MH Records Retention.

H. Codes

The following codes for treatments and procedures applicable to this policy are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

Applicable CPT Coding: CPT Code: Description:

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POLICY NUMBER: MP.057.MH DATE: 07/15 ANNUAL APPROVAL DATE: 07/15 PAGE NUMBER: 5 of 7

Acupuncture, 1 or more needles; without electrical 97810 stimulation, initial 15 minutes of personal one-on-one contact with the member Acupuncture, 1 or more needles; without electrical stimulation, each additional 15 minutes of personal 97811 one-on-one contact with the member, with re-insertion of needle(s). Acupuncture, 1 or more needles; with electrical 97813 stimulation, initial 15 minutes of personal one-on-one contact with the member Acupuncture, 1 or more needles; with electrical stimulation, each additional 15 minutes of personal 97814 one-on-one contact with the member, with re-insertion of needle(s)

I. References

Medical Literature/Clinical Information:

1. Reindl TK, Geilen W, Hartmann R, et al. Acupuncture against chemotherapy- induced nausea and vomiting in pediatric oncology. Interim results of a multicenter crossover study. support care cancer. 2006 Feb; 14(2):172-176. http://download.springer.com/static/pdf/227/art%253A10.1007%252Fs00520- 005-0846- z.pdf?auth66=1393453716_6a10609a74d43bc5da11693207053d0d&ext=.pdf 2. Ezzo J, Vickers A, Richardson MA, et al. Acupuncture-point stimulation for chemotherapy-induced nausea and vomiting,” J Clin Oncol. 2005 Oct; 23(28):7188-7198. http://jco.ascopubs.org/content/23/28/7188.full.pdf+html 3. Neri I, Allais G, Schiapparelli P, et al. Acupuncture versus pharmacological approach to reduce hyperemesis gravidarum discomfort. Minerva Ginecol., 2005, Aug; 57(4):471-475. http://www.ncbi.nlm.nih.gov/pubmed/16170293 4. Witt C, Brinkhaus B, Jena S, et al. Acupuncture in patients with osteoarthritis of the knee: A randomized trial. Lancet, 2005 Jul; 366(9480):136-143. http://ac.els- cdn.com/S0140673605668717/1-s2.0-S0140673605668717- main.pdf?_tid=440a0152-9da4-11e3-9ee4- 00000aab0f26&acdnat=1393281639_7e3e86267eb0f3d1d51335433ba4d40e 5. Linde K, Streng A, Juergens S, et al. Acupuncture for patients with migraine: a randomized controlled trial. JAMA, 2005 May 4; 293(17):2118-2125. http://jama.jamanetwork.com/article.aspx?articleid=200822 6. Berman BM, Lao L, Langenberg P, et al. Effectiveness of acupuncture as adjunctive therapy in osteoarthritis of the knee. Ann Int Med. 2004 Dec; 141(12):901-910. http://annals.org/article.aspx?articleid=718021 7. Gan T.J. Acupuncture reduces nausea and vomiting, pain after major breast surgery. In: ScienceDaily. Posted: September 22, 2004. Available at: http://www.sciencedaily.com/releases/2004/09/040922070424.htm

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8. Stener-Victorin E, Kruse-Smidje C, Jung k. Comparison between electro- acupuncture and hydrotherapy, both in combination with patient education alone, on the symptomatic treatment of osteoarthritis of the hip. Clin J Pain, 2004 May; 20(3):179-185. http://ovidsp.tx.ovid.com/sp- 3.11.0a/ovidweb.cgi?WebLinkFrameset=1&S=FMHFFPPCDIDDEPNKNCMKM DMCCGJFAA00&returnUrl=ovidweb.cgi%3f%26Full%2bText%3dL%257cS.sh. 22.23%257c0%257c00002508-200405000- 00008%26S%3dFMHFFPPCDIDDEPNKNCMKMDMCCGJFAA00&directlink=ht tp%3a%2f%2fgraphics.tx.ovid.com%2fovftpdfs%2fFPDDNCMCMDNKDI00%2ff s046%2fovft%2flive%2fgv023%2f00002508%2f00002508-200405000- 00008.pdf&filename=Comparison+Between+Electro- Acupuncture+and+Hydrotherapy%2c+Both+in+Combination+With+Patient+Edu cation+and+Patient+Education+Alone%2c+on+the+Symptomatic+Treatment+of +Osteoarthritis+of+the+Hip.&pdf_key=FPDDNCMCMDNKDI00&pdf_index=/fs0 46/ovft/live/gv023/00002508/00002508-200405000-00008 9. Vickers AJ, Rees RW, Zollman CE, et al. Acupuncture for chronic headache in primary care: large, pragmatic, randomised trial. BMJ, 2004 Mar; 328(7442):744. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC381326/pdf/bmj32800744.pdf 10. Collins KB, Thomas DJ. Acupuncture and for the management of chemotherapy-induced nausea and vomiting. J Am Acad Nurse Prac. 2004 Feb; 16(2):76-80. http://www.ncbi.nlm.nih.gov/pubmed/?term=Collins+k+%5Bau%5D+AND+acup uncture+%5Bti%5D 11. Streitberger K, Friedrich-Rust M, Bardenheuer H, et al. Effect of acupuncture compared with placebo-acupuncture at P6 as additional antiemetic prophylaxis in high-dose chemotherapy and autologous peripheral blood stem cell transplantation: A randomized controlled single-blind trial. Clin Cancer Res. 2003; 9(7):2538-2544. http://clincancerres.aacrjournals.org/content/9/7/2538.full.pdf+html 12. Carlsson C, Axemo P, Bodin A, et al. Manual acupuncture reduces hyperemesis gravidarum: a placebo-controlled, randomized, single-blind, crossover study. J Pain Symptom Manage. 2000 Oct; 20(4):273-279. http://ac.els-cdn.com/S0885392400001858/1-s2.0-S0885392400001858- main.pdf?_tid=7056384c-9daa-11e3-b178- 00000aacb361&acdnat=1393284290_37be1d89e8849bb61ba2dc2c597033a4 13. Shen J, Wenger N, Glaspy J, et al. Electroacupuncture for control of myeloablative chemotherapy-induced emesis: a randomized controlled trial. JAMA, 2000 Dec; 284(21):2755-2761. http://jama.jamanetwork.com/article.aspx?articleid=193319 14. Rotchford JK. Overview: Adverse Events of Acupuncture. Medical Acupuncture, 1999-2000 Fall-Winter;11(2) 15. McMillan C, Dundee JW, Abram WP. Enhancement of the anti-emetic action of ondansetron by transcutaneous electrical stimulation of the P6 anti-emetic point, in patients having highly emetic cytotoxic drugs. Br J Cancer, 1991 Nov; 64(5):971-972.

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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1977487/pdf/brjcancer00075- 0179.pdf 16. Dundee JW, McMillan CM. Clinical uses of P6 acupuncture. Acupunct Electrother Res. 1990; 15(3-4):211-215. http://www.ncbi.nlm.nih.gov/pubmed/1982043 17. Dundee JW, Yang J. Prolongation of the antiemetic action of P6 acupuncture by acupressure in patients having cancer chemotherapy. J Royal Society of Medicine, 1990 Jun; 83(6):360-362. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1292684/pdf/jrsocmed00135- 0022.pdf 18. Dundee JW, Ghaly RG, Fitzpatrick KT, et al. Acupuncture prophylaxis of cancer chemotherapy-induced sickness. J R Soc Med. 1989 May; 82(5):268- 271. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1292129/pdf/jrsocmed00150- 0024.pdf 19. Raustia AM, Pohjola RT. Acupuncture compared with stomatognathic treatment for TMJ dysfunction. Part III: Effect of treatment on mobility. J Prosthet Dent. 1986 Nov; 56(5):616-623. http://www.ncbi.nlm.nih.gov/pubmed?term=%22The+Journal+of+prosthetic+den tistry%22%5BJour%5D+AND+56%5Bvolume%5D+AND+616%5Bpage%5D+A ND+1986%5Bpdat%5D&cmd=detailssearch

Regulatory/Government Source:

1. Centers for Medicare and Medicaid Services (CMS). National Coverage Determination (NCD) No 30.3 – Acupuncture. Effective date not posted: longstanding NCD. http://www.cms.gov/medicare-coverage- database/details/ncd- details.aspx?NCDId=11&ncdver=1&DocID=30.3&SearchType=Advanced&bc=I AAAAAgAAAAAAA%3d%3d& 2. Centers for Medicare and Medicaid Services (CMS). National Coverage Determination (NCD) No. 30.3.1 - Acupuncture for Fibromyalgia. Effective: 04/16/04. http://www.cms.gov/medicare-coverage-database/details/ncd- details.aspx?NCDId=283&ncdver=1&DocID=30.3.1&SearchType=Advanced&b c=IAAAAAgAAAAAAA%3d%3d& 3. Centers for Medicare and Medicaid Services (CMS). National Coverage Determination (NCD_ No. 30.3.2 - Acupuncture for Osteoarthritis. Effective: 04/16/04. http://www.cms.gov/medicare-coverage-database/details/ncd- details.aspx?NCDId=284&ncdver=1&DocID=30.3.2&SearchType=Advanced&b c=IAAAAAgAAAAAAA%3d%3d& 4. National Institutes of Health (NIH) Consensus Conference: NIH Consensus Development Panel on Acupuncture (No authors listed). Acupuncture. Published in: JAMA. 1998; 280(17): 1518-1524. http://jama.jamanetwork.com/article.aspx?articleid=188113

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