TP08 Change 187 Published Paper Change · 3.5 Transanal Endoscopic Microsurgery (TEM) (CPT2...

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Transcript of TP08 Change 187 Published Paper Change · 3.5 Transanal Endoscopic Microsurgery (TEM) (CPT2...

Page 1: TP08 Change 187 Published Paper Change · 3.5 Transanal Endoscopic Microsurgery (TEM) (CPT2 procedure code 0184T) for treatment of benign lesions or malignant T1 tumors is proven
Page 2: TP08 Change 187 Published Paper Change · 3.5 Transanal Endoscopic Microsurgery (TEM) (CPT2 procedure code 0184T) for treatment of benign lesions or malignant T1 tumors is proven

CHANGE 1876010.57-MAUGUST 22, 2017

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REMOVE PAGE(S) INSERT PAGE(S)

CHAPTER 4

Section 13.1, pages 1 through 3 Section 13.1, pages 1 through 3

Section 21.1, pages 1 through 3 Section 21.1, pages 1 through 3

CHAPTER 7

Section 19.1, pages 1 through 4 Section 19.1, pages 1 through 4

CHAPTER 8

Section 2.1, pages 1 through 6 Section 2.1, pages 1 through 7

Section 13.1, pages 1 through 6 Section 13.1, pages 1 through 6

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CHANGE 1876010.57-M

AUGUST 22, 2017

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SUMMARY OF CHANGES

CHAPTER 4

1. Section 13.1. This changes clarifies that partial ankyloglossia treatment may be covered when medically necessary. EFFECTIVE DATE: 09/22/2017.

2. Section 21.1. This change adds codes and provides clarification language to include other Food and Drug Administration approved aqueous shunts or stents, to reduce intra-ocular pressure in the treatment of glaucoma, which cannot be controlled effectively with medications. EFFECTIVE DATE: 04/01/2011.

CHAPTER 7

3. Section 19.1. This change modifies the current policy on Diagnostic Sleep Studies. EFFECTIVE DATE: 09/22/2017.

CHAPTER 8

4. Section 2.1. This change adds codes and clarifies the policy language regarding the coverage of hospital beds as durable equipment. EFFECTIVE DATE: 11/09/2016.

5. Section 13.1. This changes clarifies that partial ankyloglossia treatment may be covered when medically necessary. EFFECTIVE DATE: 09/22/2017.

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TRICARE Policy Manual 6010.57-M, February 1, 2008Surgery

Chapter 4 Section 13.1

Digestive System

Issue Date: August 26, 1985Authority: 32 CFR 199.4(c)(2) and (c)(3)

1.0 CPT1 PROCEDURE CODES

40490 - 40831, 40899 - 43644, 43647, 43648, 43651 - 43761, 43800, 43810, 43820, 43842, 43846, 43848, 43880 - 43882, 43999, 44005 - 47362, 47370, 47371, 47379 - 47382, 47399 - 49999, 91123, 96570, 96571

2.0 DESCRIPTION

The digestive system involves the organs associated with the ingestion, digestion, and absorption of nutrients, and the elimination of solid waste.

3.0 POLICY

3.1 Services and supplies required in the diagnosis and treatment of illness or injury involving the digestive system are covered.

3.2 Gastric electrical stimulation (CPT1 procedure codes 43647, 43648, 43881, and 43882) for treatment of symptoms of nausea and vomiting from chronic gastroparesis that is refractory to medical management may be considered for coverage as a Humanitarian Use Device (HUD).

3.3 Radiofrequency Ablation (RFA) (CPT1 procedure codes 47370, 47380, and 47382) for treatment of unresectable hepatocellular carcinoma or unresectable liver metastases from colorectal cancer is proven and may be covered when all of the following conditions are met:

• Tumors are less than five centimeters in diameter;

• There are five or fewer tumors; and

• There is no evidence of extrahepatic metastasis.

Note: All procedures must be performed using an U.S. Food and Drug Administration (FDA) approved electrosurgical cutting and coagulation device.

3.4 Intraperitoneal Hyperthermic Chemotherapy (IPHC) (CPT1 procedure codes 77600, 77605, and 96445) in conjunction with cytoreductive surgery or peritonectomy for treatment of

1 CPT only © 2006 American Medical Association (or such other date of publication of CPT). All Rights Reserved.

C-19, November 6, 2009

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TRICARE Policy Manual 6010.57-M, February 1, 2008Chapter 4, Section 13.1

Digestive System

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pseudomyxoma peritonei resulting from appendiceal carcinoma may be covered under the Rare Diseases policy on a case-by-case basis for adult patients when all of the following criteria are met:

• There is no evidence of distant metastasis.

• There is evidence of low histological aggressiveness of the disease.

• The patient’s condition does not preclude major surgery.

• The chemotherapeutic agents used are mitomycin C, cisplatin (also known as cisplatinum), or fluorouracil.

3.5 Transanal Endoscopic Microsurgery (TEM) (CPT2 procedure code 0184T) for treatment of benign lesions or malignant T1 tumors is proven and may be covered when all of the following criteria are met:

• The lesion can be adequately identified in the rectum and is a mobile, non-fixed benign lesion or T1 tumor with a diameter less than three centimeters that covers less than 30% of the circumference of the bowel, located within eight centimeters of the anal verge.

• Pretreatment endorectal ultrasonography indicates an absence of lymphadenopathy and microscopic angiolymphatic invasion.

• The tumor is a moderately or well differentiated grade I, with no lymphatic, vascular, or perineural invasion.

• Resection margins are negative for greater than three millimeters.

• There is no evidence of distant metastasis.

3.6 Transanal Hemorrhoidal Dearterialization (THD) (CPT2 procedure code 0249T) as an alternative to conventional internal hemorrhoidectomy for the treatment of grade II to IV hemorrhoids is proven.

3.7 Surgery for total, complete, or partial ankyloglossia may be covered when medically necessary (e.g., feeding, eating, swallowing or speech difficulties exist).

4.0 EXCLUSIONS

4.1 Vestibuloplasty (CPT2 procedure codes 40840 - 40845) EXCEPT for adjunctive dental care (see Chapter 8, Section 13.1).

4.2 The Stretta System (Curon Medical, Sunnyvale, CA), Bard Endoscopic Suturing System, and Transoral Incisionless Fundoplication using EsophyX (EndoGastric Solutions, Redmond, WA) for the treatment of refractory Gastro-Esophageal Reflux Disease (GERD) are unproven (CPT2 procedure codes 43201 and 43257).

2 CPT only © 2006 American Medical Association (or such other date of publication of CPT). All Rights Reserved.

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TRICARE Policy Manual 6010.57-M, February 1, 2008Chapter 4, Section 13.1

Digestive System

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4.3 For bariatric procedures, see Section 13.2.

4.4 RFA for treatment of liver metastases from primary sites other than colorectal metastases is unproven (CPT3 procedure codes 47370, 47380, and 47382).

4.5 Cytoreductive Surgery (CRS) for Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for treatment of Peritoneal Carcinomatosis (PC) from colorectal cancer.

4.6 Magnetic sphincter augmentation with the LINX™ Reflux Management System for the treatment of GERD is unproven.

5.0 EFFECTIVE DATES

5.1 RFA (CPT3 procedure codes 47370, 47380, and 47382) for treatment of unresectable hepatocellular carcinoma or unresectable liver metastases from colorectal cancer is proven and covered, effective April 28, 2004.

5.2 IPHC (CPT3 procedure codes 77600, 77605, and 96445) in conjunction with cytoreductive surgery or peritonectomy for treatment of pseudomyxoma peritonei arising from appendiceal carcinoma may be covered under the Rare Diseases policy on a case-by-case basis for adult patients, effective May 13, 2009.

5.3 TEM (CPT3 procedure code 0184T) for treatment of benign lesions or malignant T1 tumors is covered effective June 2, 2009.

5.4 THD (CPT3 procedure code 0249T) is covered effective October 28, 2013.

- END -

3 CPT only © 2006 American Medical Association (or such other date of publication of CPT). All Rights Reserved.

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TRICARE Policy Manual 6010.57-M, February 1, 2008Surgery

Chapter 4 Section 21.1

Eye And Ocular Adnexa

Issue Date: August 26, 1985Authority: 32 CFR 199.4(c)(2), (c)(3) and (g)(46)

1.0 CPT1 PROCEDURE CODES

0191T, 0253T, 0308T, 0376T, 0402T, 65091 - 65755, 65772 - 66175, 66179 - 68899, 77600 - 77615

2.0 HCPCS PROCEDURE CODES

C1783, L8612

3.0 DESCRIPTION

The eye is the organ of vision and the ocular adnexa are the appendages or adjunct parts; i.e., eyelids, lacrimal apparatus.

4.0 POLICY

4.1 Services and supplies required in the diagnosis and treatment of illness or injury involving the eye or ocular adnexa are covered.

4.2 Phototherapeutic Keratectomy (PTK) is covered for corneal dystrophies.

4.3 Strabismus. Surgical procedures and eye examinations to correct, treat, or diagnose strabismus are covered.

4.4 Corneal transplants. A corneal transplant (keratoplasty) is a covered surgical procedure. Relaxing keratotomy to relieve astigmatism following a corneal transplant is covered.

4.5 Transpupillary thermotherapy (laser hyperthermia, CPT1 procedure codes 77600 - 77615), with chemotherapy, is covered for the treatment of retinoblastoma. See also Chapter 5, Section 5.1.

4.6 Intrastromal Corneal Ring Segments (Intacs®) is covered for U.S. Food and Drug Administration (FDA) approved indications for beneficiaries with keratoconus who meet all of the following criteria: (1) are unable to achieve adequate vision using lenses or spectacles; and (2) for whom corneal transplant is the only remaining option. Coverage allowed effective July 17, 2005.

1 CPT only © 2006 American Medical Association (or such other date of publication of CPT). All Rights Reserved.

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TRICARE Policy Manual 6010.57-M, February 1, 2008Chapter 4, Section 21.1 Eye And Ocular Adnexa

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4.7 The Ex-PRESS Mini Glaucoma Shunt (CPT2 procedure code 66183) and other FDA approved aqueous shunts or stents may be considered for cost-sharing when they are used to reduce Intraocular Pressure (IOP) in the treatment of glaucoma, that cannot be controlled effectively with medications.

4.8 Off-label use of Photodynamic Therapy (CPT2 procedure code 67221) with Visudyne (HCPCS J3396) may be considered for cost-sharing for the treatment of retinal astrocytic hamartoma in Tuberous Sclerosis. The effective date is February 1, 2008.

4.9 Transpupillary thermotherapy (CPT2 procedure code 67299) with Plaque Radiotherapy (Brachytherapy) is covered for the treatment of choroidal melanoma. See also Chapter 5, Section 3.2.

4.10 Photodynamic Therapy for the treatment of Central Serous Chorioretinopathy in accordance with the TRICARE provisions for the treatment of rare diseases.

4.11 Implantable Miniature Telescope (IMT) is covered for FDA approved indications for beneficiaries with end-stage age-related macular degeneration.

4.12 Canaloplasty for the treatment of primary open angle glaucoma (CPT2 procedure codes 66174 and 66175) is covered.

4.13 Insertion of aqueous drainage device (iStent®) during cataract surgery to reduce IOP in the treatment of glaucoma, initial insertion (CPT2 procedure codes 0191T, C1783, and L8612), and each additional insertion (CPT2 procedure code 0376T).

4.14 Collagen Cross-linking for the treatment of corneal ectasia due to the rare disease Keratoconus is safe and effective and may be considered for cost-sharing.

5.0 EXCLUSIONS

5.1 Refractive corneal surgery except as noted in paragraph 4.4 (CPT2 procedure codes 65760, 65765, 65767, 65770, 65771).

5.2 Eyeglasses, and contact lenses except as noted in Chapter 7, Section 6.2.

5.3 Orthokeratology.

5.4 Orthoptics, also known as visual training, vision therapy, eye exercises, eye therapy, is excluded by 32 CFR 199.4(g)(46) (CPT2 procedure code 92065).

5.5 Epikeratophakia for treatment of aphakia and myopia is unproven.

5.6 Transpupillary thermotherapy (CPT2 procedure code 67299) as primary treatment of choroidal melanoma is unproven.

2 CPT only © 2006 American Medical Association (or such other date of publication of CPT). All Rights Reserved.

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TRICARE Policy Manual 6010.57-M, February 1, 2008Chapter 4, Section 21.1 Eye And Ocular Adnexa

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5.7 Autologous serum eye drops for the treatment of dry eye syndrome, keratitis, or ocular hypertension is unproven.

6.0 EFFECTIVE DATES

6.1 April 1, 2011, coverage for Ex-PRESS Mini Glaucoma Shunt.

6.2 December 1, 2014, coverage for Photodynamic Therapy for Central Serous Chorioretinopathy.

6.3 February 14, 2015, coverage for Canaloplasty for the treatment of glaucoma.

6.4 June 17, 2015, coverage date for IMT.

6.5 October 7, 2015, coverage date for iStent®.

6.6 April 15, 2016, for Collagen Cross-linking for corneal ectasia due to the rare disease Keratoconus.

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TRICARE Policy Manual 6010.57-M, February 1, 2008Medicine

Chapter 7 Section 19.1

Diagnostic Sleep Studies

Issue Date: October 12, 1984Authority: 32 CFR 199.4(a)(1)

1.0 CPT1 PROCEDURE CODES

95805 - 95811, 95822, 95827

2.0 HCPCS PROCEDURE CODES

G0398, G0399

3.0 DESCRIPTION

A diagnostic sleep study is a test that can be used to assist in the diagnosis of sleep-wake disorders such as sleep apnea or narcolepsy. There are two types of sleep apnea tests:

• Polysomnography (PSG) is the gold standard for diagnosing sleep-wake disorders. PSG typically involves an overnight stay in a sleep laboratory. Monitoring during testing includes electroencephalography (EEG), electrooculography (EOG), chin electromyography (EMG), airflow, blood oxygen saturation, respiratory effort, and electrocardiography (ECG). Body position and leg EMG may also be monitored.

• Home Sleep Study (HST) refers to an unattended/portable sleep study. A HST is a PSG test typically furnished in the home. This test usually involves measurement of airflow, breathing patterns, blood oxygen levels, and possibly limb movements and snoring intensity.

4.0 POLICY

Diagnostic testing can be covered only if the patient has the symptoms or complaints of one of the conditions listed below:

4.1 Narcolepsy. This term refers to a syndrome characterized by abnormal sleep tendencies, including excessive daytime sleepiness, disturbed nocturnal sleep and pathological manifestation of Rapid Eye Movement (REM) sleep. The most typical REM sleep manifestations are cataplexy and sleep-onset REM periods, but sleep paralysis and hypnagogic hallucinations may also be present. Related diagnostic testing (e.g., Multiple Sleep Latency Test (MSLT) or Maintenance or Wakefulness Test (MWT) is covered if the patient has inappropriate sleep episodes, amnesiac episodes, or continuous agonizing drowsiness.

1 CPT only © 2006 American Medical Association (or such other date of publication of CPT). All Rights Reserved.

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TRICARE Policy Manual 6010.57-M, February 1, 2008Chapter 7, Section 19.1 Diagnostic Sleep Studies

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4.2 Impotence. Effective February 1, 1988.

4.3 Obstructive Sleep Apnea Syndrome (OSAS). A U.S. Food and Drug Administration (FDA) approved dental orthosis may be covered for the treatment of OSAS. The device must be used for the treatment of OSAS and not for adjunctive dental.

4.4 Parasomnias or abnormal sleep behavior, such as bruxism, sleepwalking, enuresis, and seizure disorder evaluations when the distinction between seizure activity and other forms of sleep disturbances is uncertain. Effective February 3, 1991.

5.0 HOME SLEEP TESTING (HST)

A HST is covered as an alternative to in-facility PSG for the diagnosis of OSAS in an adult when ALL of the following criteria are met:

5.1 When ordered by an authorized provider acting within the scope of his/her license.

5.2 When the beneficiary meets all of the following criteria:

• High pretest probability of OSAS as evidenced by clinical features, signs and symptoms (e.g., age, sex, Body Mass Index (BMI), loud snoring, awakening with gasping or choking, excessive daytime sleepiness, observed cessation of breathing during sleep);

• The ordering authorized provider determines a home portable sleep study is an appropriate alternative to in-laboratory PSG;

• No significant co-morbid conditions exist that could impact the accuracy of the study (e.g., moderate to severe pulmonary disease, neuromuscular disease, congestive heart failure);

And either:

• No sleep disorders other than OSAS are suspected (e.g., central sleep apnea, periodic limb movement disorder, insomnia, parasomnias, circadian rhythm disorders, or narcolepsy); or

• Diagnosis of OSAS has been established, therapy has been initiated, and response to treatment is to be evaluated.

5.3 When the following type of portable monitor is used:

• Type II monitor with a minimum of seven channels (e.g., electroencephalogram (EEG) and electro-oculogram (EOG) for sleep staging, electrocardiogram (ECG), chin electromyogram (EMG), airflow, breathing/respiratory effort, and oxygen saturation.

• Type III monitor with a minimum of four monitored channels including ventilation or airflow (at least two channels of respiratory movement or respiratory movement and airflow), heart rate or ECG, and oxygen saturation.

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TRICARE Policy Manual 6010.57-M, February 1, 2008Chapter 7, Section 19.1 Diagnostic Sleep Studies

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• Type IV monitors will not be covered.

5.4 When the portable monitor has been validated in a typical home environment.

5.5 When test results are reviewed and interpreted by a physician board eligible/board certified in sleep medicine.

5.6 All testing must be performed using an FDA approved portable monitoring device.

6.0 POLICY CONSIDERATIONS

6.1 Referral by Attending Physician. The patient must be referred to the sleep disorder center by the attending physician, and the center must maintain a record of the attending physician’s referral. If a copy of the referral is not submitted with the claim, the contractor must develop for a referral.

6.2 Diagnostic Testing. The need for diagnostic testing is confirmed by medical evidence, e.g., physical examinations and laboratory tests.

6.3 For narcolepsy, there must be documentation that the condition is severe enough to interfere with the patient’s health and well-being. Ordinarily, a maximum of two clinic sleep sessions is sufficient for diagnosis. Claims in excess of two clinic sleep sessions must be referred to the contractor’s medical review.

6.4 Claims for diagnostic sleep studies shall be processed and paid as outpatient services. Patients who undergo the testing are not considered inpatients, although they may come to the facility in the evening for testing and then leave after their tests are over.

6.5 Institutional and professional charges related to sleep diagnostic testing performed in a TRICARE-approved hospital are covered only for narcolepsy, sleep apnea, impotency, parasomnia, and suspected epilepsy when the distinction between seizure activity and other forms of sleep disturbances is uncertain on an outpatient cost-sharing basis.

6.6 Authorized-Freestanding Clinics. Payment may be made for sleep diagnostic testing performed by a freestanding clinic under the “physician-directed clinic” category.

Note: A “physician-directed clinic” is one where (a) a physician (or a number of physicians) is present to perform medical (rather than administrative) services at all times the clinic is open; (b) each patient is under the care of a clinic physician; and (c) the non-physician services are under medical supervision.

7.0 EXCLUSIONS

7.1 Electrosleep Therapy. Electrosleep therapy is the application of short duration, low-amplitude pulses of direct current to the patient’s brain by externally placed occipital electrodes. Passage of the weak electric current through the tissues of the head induces sleep. This modality is considered unproven, as its efficacy has not been established in the United States. Claims for electrosleep therapy must, therefore, be denied.

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TRICARE Policy Manual 6010.57-M, February 1, 2008Chapter 7, Section 19.1 Diagnostic Sleep Studies

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7.2 Study, Grant, or Research Programs. Payment may not be made for any services or supplies provided as a part of or under a grant or research program.

7.3 Sleep testing is not indicated for patients whose complaint is of short duration or for patients who do not experience functional disability during the day.

7.4 Diagnostic testing that is duplicative of previous testing done by the attending physician, to the extent the results are still pertinent, is not covered.

7.5 Payment may not be made for diagnostic sleep testing of the conditions listed below. These conditions can be diagnosed through other, more appropriate means:

• Drug dependency• Hypersomnia (pathologically excessive sleep)• Insomnia• Night terrors or dream anxiety attacks• Nocturnal myoclonus (muscle jerks)• Restless leg syndrome• Shift work and schedule disturbances• Migraine headaches

7.6 If the patient has had documented episodes of cataplexy, diagnostic testing for narcolepsy would not be necessary and is, therefore, not covered.

7.7 Somnoplasty system for OSAS is unproven.

8.0 EFFECTIVE DATE

Home/portable sleep studies for the diagnosis of OSAS in adults who meet certain criteria are covered, effective May 29, 2008.

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C-187, August 22, 2017

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TRICARE Policy Manual 6010.57-M, February 1, 2008Other Services

Chapter 8 Section 2.1

Durable Equipment (DE): Basic Program

Issue Date: December 29, 1982Authority: 32 CFR 199.2, 32 CFR 199.4(d)(3)(ii), and 32 CFR 199.6(c)(3)(i), (ii), and (iii)

1.0 HCPCS PROCEDURE CODES

Level II Codes E0100 - E1900, E0250 - E0270, E0290 - E0297, E0301 - E0304, K0001 - K0547

2.0 POLICY

2.1 DE, which is a medically necessary and appropriate item, ordered by a TRICARE authorized individual professional provider for the specific use of the beneficiary, and which complies with the following DE definition and coverage criteria may be cost-shared. A TRICARE authorized individual professional provider who may order or prescribe DE is a physician, a dentist, or any TRICARE authorized allied health care professional as described in 32 CFR 199.6(c)(3)(ii) and (iii), when acting within the scope of their license or certification, including the following:

• Doctors of Podiatric Medicine (DPMs).• Doctors of Optometry (ODs).• Certified Physician Assistants (CPAs).• Certified Clinical Nurse Specialists (CCNSs) when recognized by TRICARE as:

• Certified Nurse Practitioners (CNPs),• Certified Nurse Midwives (CNMs), or• Certified Psychiatric Nurse Specialists (CPNSs).

• Certified Registered Nurse Anesthetists (CRNAs).• Certified Psychiatric Nurse Specialists (CPNSs).• Licensed Physical Therapists.• Licensed and Registered Occupational Therapists.

2.2 Definition. As defined in the 32 CFR 199.2, DE is a medically necessary item that:

2.2.1 Can withstand repeated use;

2.2.2 Is primarily and customarily to serve a medical purpose; and

2.2.3 Is generally not useful to an individual in the absence of an illness or injury.

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TRICARE Policy Manual 6010.57-M, February 1, 2008Chapter 8, Section 2.1

Durable Equipment (DE): Basic Program

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3.0 COVERAGE CRITERIA

3.1 Covered items that may be provided to a beneficiary as DE includes the following:

• Hospital beds.• Iron lungs.• Durable Medical Equipment (DME).• Wheelchairs.• Cardiorespiratory monitor under conditions specified in Section 2.2 of this chapter.

3.2 A covered DE shall be provided on a rental or purchase basis.

3.2.1 Coverage of DE shall be based on the price most advantageous to the government, taking into consideration the anticipated duration of the medically necessary need for the equipment and current price information for the type of item.

3.2.2 The cost analysis must include a comparison of the total price of the item as a monthly rental charge, a lease-purchase price, and a lump-sum purchase price and a provision for the time value of money at the rate determined by the U.S. Department of Treasury.

3.3 A prescribed item of DE that provides the medically appropriate level of performance and quality for the beneficiary’s medical condition present must be supported by adequate documentation, as defined in 32 CFR 199.2. Luxury, deluxe, immaterial, or non-essential features, which increase the cost of the item relative to a similar item without those features, based on industry standards for a particular item at the time the equipment is prescribed or replaced for a beneficiary, are not authorized. Only the “base” or “basic” model of equipment (or more cost-effective alternative equipment) shall be covered, except as authorized in paragraphs 3.6, 3.8, or 4.1.

3.4 The item of DE must be prescribed for a use consistent with required U.S. Food and Drug Administration (FDA) approved labeling for the item. When prescribed use of an item appears to be extraordinary, a signed statement from the manufacturer that a specific medical device is FDA approved for such a use is adequate evidence that the requirement of FDA approval is met.

3.5 The item of DE must not be otherwise excluded by the regulation and policy (for example, those found in 32 CFR 199.4(g), to include communication devices other than those allowed in Chapter 7, Section 23.1, eyeglasses, exercise/relaxation/comfort devices, comfort or convenience items, etc.).

3.6 Durable Medical Equipment (DME) is DE (as defined in paragraph 2.2) that meets the following additional coverage criteria:

3.6.1 It is medically appropriate to:

3.6.1.1 Improve, restore, or maintain the function of a malformed, diseased, or injured body part, or can otherwise minimize or prevent the deterioration of the beneficiary’s function or condition; or

3.6.1.2 Maximize the beneficiary’s function consistent with the beneficiary’s physiological or medical needs.

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TRICARE Policy Manual 6010.57-M, February 1, 2008Chapter 8, Section 2.1

Durable Equipment (DE): Basic Program

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3.6.2 DME Customization. Customization of DME (equipment designed permanently to preclude the use of such equipment by another individual) owned by a beneficiary, and any accessory or item of supply for any such equipment, may be covered as determined by the Director (or designee) to be essential for:

• Achieving therapeutic benefit for the patient;• Making the equipment serviceable; or• Otherwise assuring the proper functioning of the equipment.

3.7 Hospital beds (e.g., a manual or electric fixed height, variable height, semi-electric, heavy duty extra wide, extra heavy duty, etc.) are covered when medically necessary.

• Accessories for hospital beds may also be covered when medically necessary.

3.8 Wheelchairs, which otherwise meet the DE definition in paragraph 2.2, are covered to provide medically appropriate basic mobility.

3.8.1 Electric wheelchairs. An electric wheelchair, or TRICARE approved alternative to an electric wheelchair (e.g., scooter), may be provided in lieu of a manual wheelchair to provide basic mobility. Benefits will not be extended for the use of both an electric-powered, cart-type vehicle and an electric wheelchair during the same period of time.

3.8.2 Lifts. A vehicle lift, which otherwise meets the requirements of paragraph 3.3 and all other applicable provisions of this policy, may be covered when necessary to transport an otherwise authorized wheelchair (or an approved alternative). Coverage is limited to the basic model lift and must be a temporary (non-permanent/transferable) lift that transports the wheelchair itself (or an approved alternative).

3.8.2.1 Labor charges may be allowed to cover only the installation of the allowable vehicle wheelchair lift.

3.8.2.2 TRICARE does not cover transportation of beneficiaries, including to and from medical appointments, except for ambulances when medical care is provided to the individual in transit. A lift may be authorized solely to transport the wheelchair so that a traveling beneficiary may have “basic” mobility once at his or her destination.

3.8.2.3 Vehicle conversions are excluded. That is conversions such as but not limited to, raising the roof, widening the door, or permanent attachments installed (e.g., items that are non-transferable to another vehicle). Purchases and (or) conversions of personal vehicles for a wheelchair bound beneficiary fall outside the scope of the TRICARE medical benefits and, therefore, are excluded.

3.8.2.4 TRICARE’s allowable charge is based on the basic (or standard) model lift and authorized installation fees. Lifts beyond the basic (or standard) model required for transport of an authorized wheelchair are excluded from TRICARE coverage and cannot be considered in determining the TRICARE allowable costs. Beneficiaries who choose a lift other than the basic (or standard) model (i.e., luxury/deluxe) are responsible for the costs above and beyond the allowable amount of the basic lift. In such a case, the beneficiary is responsible for submitting sufficient information

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regarding the otherwise authorized basic model lift and costs of installation along with the itemized costs of the luxury/deluxe model and installation costs.

Note: Refer to paragraph 4.0 for TRICARE description of “any item of DE beyond the basic/standard model.”

3.8.3 Modifications of wheelchairs. Medically appropriate modifications (i.e., slight or small changes or alterations) to the wheelchair (or an approved alternative) to accommodate a particular physiological or medical need may be covered if necessary to provide basic mobility and to allow proper use of the wheelchair. When an otherwise covered wheelchair requires substantial modification, or is uniquely built to meet the special needs of a beneficiary, for basic mobility and proper use of the wheelchair, coverage may be provided only under a lump-sum purchase or rental-purchase agreement resulting in the beneficiary owning the modified wheelchair.

3.9 Repairs. Benefits are allowed for repair of beneficiary-owned DE when necessary to make the equipment functional because of reasonable wear and usage and the manufacturer’s warranty has expired, but only on the condition that the repair cost is less than the replacement cost. Coverage includes the use of a temporary replacement item provided during a reasonable period of repair.

3.10 Replacements. Benefits are allowed for replacement of beneficiary-owned DE with documentation that the DE is lost or stolen and not otherwise covered by another insurance (such as a homeowner’s policy). Replacement of beneficiary-owned DE is also allowed when the item is not functional due to normal wear, accidental damage, a change in the beneficiary’s condition, or the device has been declared adulterated by the FDA. (Exceptions exist for prosthetic devices; see Section 4.1 for more information.)

Note: Replacement is subject to review of documentation supporting why the current DE item is no longer usable/repairable and that the replacement cost is less than the repair cost.

Note: Replacement equipment is allowed only upon a new order or prescription by a TRICARE authorized individual professional provider with an explanation of the medical need.

3.10.1 When a rented item of DE is lost or stolen, the supplier is required to use modifier RA to notify the TRICARE contractor that the item has been lost or stolen, and a replacement item is being provided. Payment for the original rented item of DE that was lost or stolen is the contractual responsibility of the supplier.

3.10.2 TRICARE will not continue to pay rental fees on equipment that has been lost or stolen. Once the medically necessary DE has been replaced by the supplier and provided to the beneficiary, rental fees for the replacement item shall resume based on the continuous use provision, if applicable.

3.11 An item of DE which otherwise meets the DE benefits requirement that is essential to provide a fail-safe in-home life-support system, or that replace in-like-kind an item of equipment that is not serviceable because of normal wear, accidental damage, a change in the beneficiary’s condition, has been declared adulterated by the FDA, or is being, or has been recalled by the manufacturer, is not considered duplicate and, therefore is covered.

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Note: For the purpose of this policy, “duplicate” means an item of equipment that meets the definition of DE and serves the same purpose that is served by an item of DE previously cost-shared by TRICARE. For example, various models of a stationary oxygen concentrator with no significant differences are considered duplicates, whereas stationary and portable concentrators are not considered duplicates of each other because the latter is intended to provide a beneficiary with mobility outside the home. Also for example, an electric wheelchair, which otherwise meets the definition of DE would not be duplicative of a manual wheelchair previously cost-shared by TRICARE in that the electric wheelchair provides independent mobility not provided by the manual wheelchair.

4.0 POLICY CONSIDERATION

4.1 Upgraded DE (Deluxe, Luxury, or Immaterial Features)

4.1.1 Medically Necessary Upgrades. An upgraded item of DE, which otherwise meets the DE benefit requirement and is medically necessary, is covered if the prescription specifically states the medical reason why an upgrade is necessary. For example, the beneficiary does not have the physical strength or balance required to lift a standard walker and, therefore, one with wheels is required. Equipment lacking documentation of medical necessity for the deluxe, luxury, or immaterial feature device may have the TRICARE allowed amount for the base model applied to the upgraded equipment, with the beneficiary responsible for the difference between the allowed amount for the base model and the provider’s billed charges. For a wheelchair, the upgrade must be required for the beneficiary to maintain basic mobility. See the TRICARE Reimbursement Manual (TRM), Chapter 1, Section 11 for pricing and payment policy.

4.1.2 If the beneficiary prefers to upgrade an item of DE, which otherwise meets the DE benefit requirements, the beneficiary will be solely responsible for the cost that exceeds the cost of what the government would pay for the standard equipment. The upgraded item must be within the range of services that are appropriate for the beneficiary’s medical condition (e.g., beneficiaries can upgrade from a standard manual wheelchair to a power wheelchair, when there is no medical objection from the physician, but not from a walker to a wheelchair).

4.2 Beneficiary Liability

4.2.1 When the beneficiary prefers to upgrade an item of DE, which otherwise meets the DE benefit requirements, the provider may collect the charges that exceed the cost of what the government would pay for the standard equipment, only if the beneficiary were given written notice that the item has been (or may be) denied and agrees in writing, to be financially liable for the difference between the charges for the upgraded item, and the charges for the standard item. Should the provider fail to provide written notice and receive written agreement from the beneficiary of financial liability, for network providers, the beneficiary is “held harmless” in accordance with the TRICARE Operations Manual (TOM), Chapter 5, Section 1, paragraph 2.5.1. For non-network providers, Chapter 1, Section 4.1 of this manual applies.

4.2.2 Beneficiaries are also liable for the repairs on the upgraded item/features.

Note: Deluxe, luxury, or immaterial features are items of DE that are more expensive than the item that is medically necessary. Deluxe items include comfort or convenience features that enhance standard DE equipment, but are not considered medically necessary. Comfort and

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convenience items are defined as those optional items, which the patient may elect at an additional charge, but are not medically necessary in the treatment of a patient’s condition. These devices exceed what is medically necessary and increase the cost of the item to the government relative to a similar item without those features.

5.0 EXCLUSIONS

5.1 DE for a beneficiary who is a patient in a type of facility that ordinarily provides the same type of DME item to its patients at no additional charge in the usual course of providing its services is excluded.

5.2 DE that is available to the beneficiary from a Uniformed Services Medical Treatment Facility (USMTF).

5.3 An item of DE that has been lost or stolen (except as provided in paragraph 3.10), or for an item under warranty, or when a DE is damaged while using the equipment in a manner inconsistent with its common use.

5.4 DE with luxury, deluxe, immaterial, or non-essential features, which increase the cost of the item relative to a similar item without those features, based on industry standards for a particular item at the time the equipment is prescribed or replaced for a beneficiary. (See paragraph 4.0 for Policy Consideration.)

5.5 Exercise, relaxation, comfort, sporting items, or sporting devices. Exercise equipment, to include wheelchairs and items primarily and customarily designed for use in sports or recreational activities, spas, whirlpools, hot tubs, swimming pools health club memberships or other such charges, or items.

5.6 Repairs of deluxe, luxury, or immaterial features of DE (except as provided in paragraph 3.9).

5.7 Repairs of DE damaged while using the equipment in a manner inconsistent with its common use.

5.8 Maintenance agreement.

5.9 Routine periodic servicing, such as testing, cleaning, regulating, and checking which the manufacturer does not require be performed by an authorized technician.

5.10 Duplicate items of otherwise allowable DE to be used solely as a back-up to currently owned or rented equipment, except as provided in paragraph 3.11.

5.11 DE must be considered durable -- can withstand repeated use. Therefore, DE does not include expendable items such as incontinent pads, diapers, ace bandages, etc. Such items are excluded from DE coverage. Refer to Section 6.1 for policy regarding supplies and dressings (consumables).

5.12 Non-medical equipment (e.g., humidifier, electric air cleaners, exercycle, safety grab bars, training equipment, etc.). See 32 CFR 199.4.

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5.13 Beds that are not medical in nature and used for comfort or convenience (e.g, power or manual lounge beds, sleep-number beds, ordinary beds typically sold as furniture, etc.) are excluded.

6.0 EFFECTIVE DATE

September 1, 2005.

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TRICARE Policy Manual 6010.57-M, February 1, 2008Other Services

Chapter 8 Section 13.1

Adjunctive Dental Care

Issue Date: October 8, 1986Authority: 32 CFR 199.4(e)(10)

1.0 DESCRIPTION

Adjunctive dental care is that dental care which is medically necessary in the treatment of an otherwise covered medical (not dental) condition, is an integral part of the treatment of such medical condition; or is required in preparation for, or as the result of, dental trauma which may be or is caused by medically necessary treatment of an injury or disease.

2.0 POLICY

2.1 Adjunctive dental care requires preauthorization. However, if a beneficiary fails to obtain preauthorization before receiving the services, the contractor shall extend benefits if the services or supplies qualify for benefits. Where adjunctive dental care involves a medical (not dental) emergency (such as facial injuries resulting from an accident), the requirement for preauthorization is waived. Such waiver is limited to the essential adjunctive dental care related to the medical condition requiring the immediate emergency treatment.

2.2 Hospital services and supplies will be covered for a patient who requires a hospital setting for noncovered, nonadjunctive dental care when medically necessary to safeguard the life of the patient from the effects of dentistry on an underlying nondental organic condition. Professional services related to the noncovered dental care are not covered; professional services related to the medical condition (excluding the dentist and anesthesiologist) are covered.

2.3 Benefits may be cost-shared for the treatment of the following conditions:

2.3.1 Intraoral Abscesses

An intraoral abscess should be considered a medical condition only when it extends beyond the dental alveolus. These abscesses may require immediate attention in an acute phase which would preclude preauthorization.

2.3.2 Extraoral Abscesses

In some cases, it is necessary to incise and treat abscesses extraorally; e.g., when the infection follows the facial planes.

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2.3.3 Cellulitis and Osteitis

Elimination of a non-local infection which is clearly exacerbating and directly affecting a medical condition currently under treatment.

2.3.4 Facial Trauma Requiring Removal of Teeth or Tooth Fragments

2.3.4.1 Removal of teeth and tooth fragments in order to treat and repair facial trauma resulting from an accidental injury.

2.3.4.2 Removal of an impacted tooth in the line of a fracture may be required in order to treat the fracture.

2.3.5 Myofacial Pain Dysfunction Syndrome, also known as Temporomandibular Joint (TMJ) Syndrome

2.3.5.1 Treatment of this syndrome may be considered a medical problem only when it involves immediate relief of pain.

2.3.5.2 Emergency treatment may include initial radiographs, up to four office visits and the construction of an occlusal splint, if necessary to relieve pain and discomfort.

2.3.5.3 Treatment beyond four visits, or any repeat episodes of care within a six (6) month period, must receive individual consideration and be documented by the provider of services.

Note: Occlusal equilibration and restorative occlusal rehabilitation are specifically excluded for myofacial pain dysfunction syndrome and TMJ syndrome. See Chapter 4, Section 7.1.

2.3.6 Total or Complete Ankyloglossia

This condition is commonly known as tongue-tie. It involves the lingual frenum resulting in fixation of the tip of the tongue to the degree that it interferes with swallowing and speech. Surgery for total, complete, or partial ankyloglossia may be covered when medically necessary (e.g., feeding, eating, swallowing, or speech difficulties exist).

2.3.7 Severe Congenital Anomaly

Adjunctive dental and orthodontia is covered when directly related to, and an integral part of, the medical and surgical correction of a severe congenital anomaly.

2.3.7.1 Coverage Guidelines

Depending on the severity or degree of involvement of the congenital anomaly, the patient may require adjunctive dental or orthodontic support from birth until the medical/surgical treatment of the anomaly has been completed; i.e., until the dentoalveolar arch discrepancies and/or maxillomandibular disharmonies are corrected through a combined effort of the surgeon and orthodontist. Treatment may include the fabrication of obturators early in life, and splints at the time of surgical treatment for stabilization of the maxilla and mandible. As the arches develop and teeth erupt, orthodontic treatment may be required to establish a functional relationship of the

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dental arches. When the deformity is severe and function is greatly impaired, obturators and pharyngeal bulb appliances may be required to assure proper nutrition, deglutition and to avoid aspiration of foreign matter during the intake of food.

2.3.7.1.1 Vestibuloplasty (CPT1 procedure codes 40840 - 40845) may be considered adjunctive dental when it is determined to be an appropriate and medical necessary surgical procedure for correction of a severe cleft lip/cleft palate.

Note: Vestibuloplasty is EXCLUDED when performed to prepare the mouth for dentures.

2.3.7.1.2 Orthodontics should be a covered treatment in any congenital deformity of the head and neck, wherein the orthodontia:

2.3.7.1.2.1 Corrects dentoalveolar arch discrepancies that are part of, or the result of, the congenital anomaly and are severe enough to prevent the usual and normal action of mastication and ingestion of normally solid foods.

2.3.7.1.2.2 Corrects dentoalveolar arch discrepancies, the correction of which is necessary to satisfactorily correct other aspects of the general deformity, or to prevent relapse of such treatment.

2.3.7.1.2.3 Corrects dentoalveolar arch discrepancies that are, in themselves, severe enough to obviously disfigure the face.

2.3.7.1.2.4 The following is a listing of congenital anomalies that affect the face and possibly the dentoalveolar arches, or their relationships to each other:

• Cleft palate isolated.• Lateral or oblique facial clefting.• Cleft mandible.• Klippel-Fiel Syndrome.• Pierre Robin Syndrome.• Trisomies 18, 21, 13 - 15.• Chondroectodermal dysplasia (Ellis-van Creveld Syndrome).• Bird headed dwarfism (Nanocephalic or primordial dwarfism).• Turner’s Syndrome (X-0 Syndrome).• Klinefelter’s Syndrome.• Craniofacial dysostosis (Crouzon’s Syndrome).• Occuloauriculovertebral dysplasia (Goldenhar’s Syndrome).• Occulamandibulofacial Syndrome (Hallerman Striff Syndrome, Ullrich et al

Syndrome).• Treacher Collins Syndrome.• Hemifacial microsomia.• Hemifacial hyperplasia.

1 CPT only © 2006 American Medical Association (or such other date of publication of CPT). All Rights Reserved.

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2.3.7.1.2.5 Coverage of orthodontia for congenital anomalies of the head and/or neck which do not appear in the above listing must be evaluated to assess the significance of their functional impairments related to the dentoalveolar arch discrepancies described in paragraphs 2.3.7.1.2.1 and 2.3.7.1.2.2; i.e., the dentoalveolar arch discrepancies of an unlisted congenital anomaly must impose a significant functional impairment in order for coverage of orthodontia under TRICARE.

2.3.7.1.2.6 The severity and functional impairment of a given congenital anomaly must be assessed on a case-by-case basis from a series of medical records over a period of time. The congenital impairment of the head and/or neck must be at a level resulting in an inability of a beneficiary to perform normal bodily functions (e.g., the inability to eat, breathe, and/or speak normally) in order for coverage to be extended. The functional impairment must be disabling and ongoing.

2.3.7.2 Preauthorization Requirements

2.3.7.3 Preauthorization is required for all adjunctive dental and orthodontia directly related to, and an integral part of, the medical and surgical correction of a severe congenital anomaly.

2.3.7.4 Orthodontia benefits for severe congenital anomalies of the head and neck will be continued as long as the primary physician requires support of his/her treatment or until the best reasonably attainable results have been achieved by the orthodontist. Once active orthodontic treatment has been completed and the patient is placed in the retention phase of treatment, benefit payment ends. If the primary physician or dentist subsequently determines that additional orthodontia work is required, a new preauthorization is required.

2.3.8 Iatrogenic Dental Trauma

Dental care which is prophylactic, restorative, prosthodontic (e.g., dentures and bridge work) and/or periodontic qualifies as adjunctive dental care when performed in preparation for, or as a result of, trauma to the teeth and supporting structures caused by medically necessary treatment of an injury or disease. There must be a direct cause-effect relationship between the otherwise covered medical treatment and the ensuing dental trauma, and the ensuing dental trauma must be functionally associated (adjunct) with the treatment of the physician induced trauma. This must be based on sound medical practice and substantiated in the current medical literature. The following are examples of conditions which are eligible for payment under the iatrogenic dental trauma provision. Because these examples are not meant to be all-inclusive, similar conditions or circumstances may be brought to the attention of the Deputy Director, Defense Health Agency (DHA), or designee, for consideration.

2.3.8.1 Radiation Therapy for Oral or Facial Cancer

2.3.8.1.1 It is generally recognized that certain dental care may be required in preparation for or as a result of in-line radiation therapy for oral or facial cancer.

2.3.8.1.2 Treatment may include dental prophylactic, restorative, periodontic and/or orthodontic procedures. Without this necessary care, patients who undergo radiation therapy around the head may be at risk for development of osteonecrosis because their dental needs were not met either prior to, or in conjunction with, radiation therapy. Since the problem here deals with cancer, it may not be possible to wait for prior authorization before beginning radiation therapy.

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Out of necessity, dental care may have to be initiated before benefit authorization is granted. Extraction of affected teeth due to poor dental health (e.g., multiple dental caries and/or periodontal disease) may necessitate the coverage of dentures or bridge work.

2.3.8.2 Gingival Hyperplasia

2.3.8.2.1 Gingival hyperplasia, or overgrowth of the gingival tissues, occurs frequently in patients who have undergone prolonged Dilantin therapy for epilepsy or seizure disorders. The incidence of this problem can be reduced by good oral hygiene and prophylactic gum care. Severe cases of gingival overgrowth may require surgical intervention to reduce the excessive fibrous tissue growth. The problem is more prevalent among young children, as the older population is not prone to the condition. Also, there is an important difference in the character of tissue between gingival hyperplasia and periodontal disease. Because of this, care needs to be taken in differentiating true gingival hyperplasia from periodontally diseased tissue.

2.3.8.2.2 Treatment usually entails excision of the hyperplastic tissue; however, in some severe cases, free soft tissue grafts may be required.

Note: Because the above examples are not meant to be all-inclusive, similar conditions or circumstances may be brought to the attention of the contractors for review and consideration. Coverage will again be based on whether a direct cause-effect relationship can be established between the treatment of an otherwise covered medical condition and the ensuing dental trauma. Dental procedures will only apply when required to treat or rectify the dental trauma/damage resulting from the treatment of an underlying medical condition. For instance, if a beneficiary cracks or chips a tooth as a result of a fall, coverage would not be extended under the iatrogenic provision, since the trauma was purely dental in nature (i.e., trauma to the teeth and/or dental alveoli) and not related to the treatment of an underlying medical condition. The only possible coverage that could be extended would be for removal of teeth fragments from surrounding oral tissue other than the dental alveolus (e.g., from the tongue or inside of the cheek) resulting from the accident. On the other hand, if a beneficiary sustained a fracture to the mandible or maxilla requiring the extraction of a tooth for stabilization of the jaw (i.e., removal of a tooth to allow for wiring of the fracture site), coverage would be allowed since the resulting physician or oral surgeon induced dental trauma was directly related to the treatment of an otherwise covered medical condition. In this particular case, adjunctive dental coverage would extend up through prosthodontic restoration of the missing tooth.

2.3.8.3 Preauthorization Requirements

The preauthorization criteria for dental care required in preparation for, or as a result of, trauma to the teeth and supporting structures caused by medically necessary treatment of an injury or disease are the same as those described in paragraphs 2.3.7.3 and 2.3.7.4.

2.3.9 Dental Metal Amalgam/Alloy Hypersensitivity

The removal of dental metal amalgam/alloy source may be cost-shared for procedures rendered after April 18, 1983, under the following conditions:

2.3.9.1 Independent diagnosis by a physician allergist based upon generally accepted test(s) for any dental metal amalgam/alloy hypersensitivity, and

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2.3.9.2 Contemporary clinical record documentation which reasonably rules out sources of metal exposure other than the dental amalgam/alloy.

3.0 POLICY CONSIDERATIONS

3.1 Dental care which is routine, preventive, restorative, prosthodontic (adding or modifying of bridge work and dentures), periodontic or emergency does not qualify as adjunctive dental care except when performed in preparation for, or as a result of, dental trauma caused by medically necessary treatment of an injury or disease.

3.2 Orthodontia is only covered when it is an integral part of the medical or surgical correction of a severe congenital anomaly or when required in preparation for, or as a result of, physician induced dental trauma.

3.3 Clinical oral examinations, radiographs and laboratory tests and examinations may be payable only when necessary in conjunction with the diagnosis and treatment of covered adjunctive dental or oral surgery procedures.

3.4 The Frankel Dental Appliance is categorized as orthodontia and must be denied unless adjunctive to the surgical correction of a cleft palate.

3.5 The treatment of generally poor dental health (dental caries) due to certain systemic causes (e.g., congenital syphilis, malabsorption syndromes, rickets, etc.) is excluded from coverage.

3.6 American Dental Association (ADA) claim forms and procedure codes may be used in the processing and payment of adjunctive dental claims.

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