MVP/Preferred Care BENEFIT INTERPRETATION MANUAL. Acute Inpatient Rehabilitation

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1 MVP/Preferred Care BENEFIT INTERPRETATION MANUAL Acute Inpatient Rehabilitation Type of Policy Medical Care Codes CPT codes: 99231, 99232, ICD-9 codes: X, 348.1, 357.0, 358.0, 359.X, 430.X-434.X, 436.X-438, 714.0, 715.X, 800.X, 801.X, 803.X, 806.X, 850.X, 851.X, 854.X, 897.X, 941.X-946.X HCPCS codes: Evidence Basis for Policy Standard of Care. The procedure, device, or drug is accepted medical practice as evidenced by an abundance of scientific literature and well-designed clinical trials. Description Rehabilitation is the restoration of the disabled person to self-sufficiency or the maximum possible functional independence for members who have experienced a physically- and/or functionally-disabling disease or trauma. Acute inpatient rehabilitation is a comprehensive, intensive unit or hospital-based rehabilitative program that employs a coordinated interdisciplinary, team-care delivery system of multiple services. The inpatient rehabilitative program involves at least two of the following rehabilitative disciplines (physical, occupational, speech/language, or psychological therapy), with a minimum of three hours of active rehabilitation each day, and continuing daily medical availability by a rehabilitative physician and rehabilitative nursing to ensure safe and effective treatment for complex medical conditions. Indications/Criteria Documentation Required Medical necessity must be documented in the medical record and available upon request. Specifics of physiatry evaluation must be submitted at the time of request including but not limited to: - the member s current clinical status; - the member s neurological deficits and functional status prior to event; - the member s current functional deficits, mental status and ability to learn; MVP/Preferred Care Benefit Interpretation Manual 1 of 4 Acute Inpatient Rehabilitation

2 - the member s motivation to participate in rehabilitation; - the member s functional communication, physical activity, and endurance; - the member s social/caregiver support, discharge environmental factors; and - the member/caregiver expectations of rehabilitation. Coordination of care in an acute inpatient rehabilitation program is determined by the Preferred Care clinical reviewer, Rehabilitative Case Manager, or designee in collaboration with the program s interdisciplinary team, attending physician, PCP, member, and/or family or responsible party and in compliance with the member s Preferred Care contract. Common indications for acute inpatient rehabilitation include, but are not limited to, when the member has experienced: an organic or traumatic brain injury (TBI); spinal cord injury; anoxia; toxic poisoning; cerebral vascular accident; aneurysm; infection or tumor; orthopedic or neuromuscular disease or injury; or unilateral above-the-knee and bilateral above- or below-the-knee amputations. A member will be considered for acute inpatient rehabilitation when all of these specific criteria are met: the member is medically stable so that he/she has the ability to participate for at least three (3) hours a day with therapy; the member has one or more persistent disabilities that require moderate to total assistance in mobility, basic Activities of Daily Living, bowel or bladder control, cognition, emotional functioning, pain management, swallowing or communication; the member has the potential for significant improvement in functional status and/or health; the member has a discharge residence other than a Residential Health Care Facility, sufficient family/caregiver support to ensure personal and medical safety, and consensus among the patient, family/caregivers and health care team of discharge setting; the member requires multidisciplinary services; the consent and involvement of the appropriate responsible party is obtained if the member is not able to give consent due to the member s medical or functional status; and the member meets all other admission requirements of the acute rehabilitation program. Exclusions/Limitations Not meeting Indications/Criteria as above. MVP/Preferred Care Benefit Interpretation Manual 2 of 4 Acute Inpatient Rehabilitation

3 Members will be discharged from the acute rehabilitation program for any of the following conditions: the member has achieved the established goals or the goals can be attained at a lower level of care; the member s needs have been met or services can be provided at a lower level of care; the member no longer demonstrates functional improvement or appears to no longer benefit from acute rehabilitation; the member refuses to participate in the program or has been non-compliant with the rehabilitation program; or the member is unable to tolerate or regularly attend the prescribed rehabilitation program. Members with cognitive deficits severe enough to preclude effective learning generally do not benefit from rehabilitation programs. Admission to acute inpatient rehabilitation will be considered on an individual basis for members who are too debilitated to participate in an active rehabilitation program but who may benefit from a brief interdisciplinary program designed to educate caregivers and provide hands-on training in the skills needed to maintain a severely disabled member at home. Note: For authorization requirements refer to Appendix A and Appendix B in the Referral/Precertification/Prior Justification/Notification Administrative Policy. You may also refer to the Prior Justification/Precertification of Certain Prescription Drugs for information on drugs that require precertification and prior justification. Both policies are available on the easylink for Providers at References McKesson Health Solutions, LLC. (2004) InterQual Rehabilitation Criteria. Centers for Medicare & Medicaid Services (2003). Medicare Program; Changes to the Criteria for Being Classified as an Inpatient Rehabilitation Facility; Proposed Rule. (42 CFR Part 412). Centers for Medicare & Medicaid Services (2002). Inpatient rehabilitation facility patient assessment instrument (IRF PAI). Available: American Medical Rehabilitation Providers Association (2002). CMS issues therapy review protocols. Copyright American Medical Rehabilitation Providers Association (1999). Report of the AMRPA task force on a prospective payment system for inpatient rehabilitation. Available: American Medical Rehabilitation Providers Association (2002). Quick Web Links. National Guideline Clearinghouse (1998). Management of patients with stroke, IV: rehabilitation, prevention and management of complications, and discharge planning. A national clinical guideline. SIGN publication no. 24. Available: The Medicare News Brief MNB-97-2, March, MVP/Preferred Care Benefit Interpretation Manual 3 of 4 Acute Inpatient Rehabilitation

4 Medicare Regulation and INT Approval(s) & Review/Revision(s) Review: Surgical Advisory Team: 5/11/06 Approval: Clinical Quality Team: 6/19/06 Prior Approval Date: 3/14/05 Last Revision Date: 5/06 Origination Date: 9/97 Effective Date: 8/1/06 MVP/Preferred Care Benefit Interpretation Manual 4 of 4 Acute Inpatient Rehabilitation

5 MVP/Preferred Care BENEFIT INTERPRETATION MANUAL Age-Related Macular Degeneration (AMD) Treatments Deleted: Photodynamic Therapy (Ocular) Type of Policy Medical Codes CPT: 67221, & J3396 (DRUG), S0198 (USE FOR MACUGEN ), J2503 ICD-9: (PRIMARY) AND (SECONDARY),115.02, , , Deleted: J3490 Deleted: S0198 Evidence Basis for Policy Standard of Care. The procedure, device, or drug is accepted medical practice as evidenced by an abundance of scientific literature and well-designed clinical trials. Description Photodynamic Therapy with Verteporfin (Visudyne TM ) is medically indicated for the treatment of subfoveal choroidal neovascularization lesions caused by age-related macular degeneration (AMD), ocular histoplasmosis or pathologic myopia and when it is provided by an appropriately credentialed in-plan ophthalmologist who is a fellowship trained retinal specialist. Pegaptanib sodium injection (Macugen ) is a selective vascular endothelial growth factor (VEGF) antagonist that is administered intravitreally. Macugen is indicated for the treatment of neovascular (wet) age-related macular degeneration (AMD). Indications/Criteria Documentation Requirements Medical necessity must be documented in the medical record and available upon request. For Photodynamic Therapy, documentation should include results of a fluorescein angiogram and, if applicable, optical coherence tomography, which demonstrates classic or occult subfoveal choroidal neovascularization (CNV) and whether the member has previously undergone this procedure. For Macugen Therapy, the patient s medical record should contain documentation supporting the diagnosis of wet macular degeneration, including a history, physical examination with measurement of visual acuity, and at least a baseline diagnostic fluorescein angiography. MVP/Preferred Care Benefit Interpretation Manual Page 1 of 5 Age-related Macular Degeneration Treatment

6 For Photodynamic Therapy: Photodynamic Therapy with Verteporfin is indicated for those members with predominately classic, subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration. "Predominantly classic" subfoveal lesions are defined as those in which the area of classic CNV is at least 50% of the area of the entire lesion at baseline as determined by flurorescein angiograms. Members with subfoveal occult lesions with no CNV without classic lesions and members with minimally classic CNV < 50% of the entire area of the lesion (four (4) disk areas or less in size at time of initial treatment or within three (3) months prior to initial treatment). Evidence of progression should be documented by deterioration in visual acuity (at least five (5) letters on a standard eye examination chart), lesion growth (an increase in at least one (1) disk area), or appearance of blood associated with the lesion. Photodynamic Therapy with Verteporfin is also indicated for members with Pathologic Myopia (PM) and Presumed Occular Histoplasmosis (OH) when the choroidal neovasculization lies under the geometric center of the foveal avascular zone. Most members treated with verteporfin may need to be re-treated. All members having a re-treatment need to have a fluorescein angiogram performed prior to each treatment. Re-treatment is necessary if fluorescein angiograms show any sign of recurrence or persistence of leakage and the treating ophthalmologist believes that the therapy is indicated to reduce the risk of at least moderate vision loss compared to baseline visual acuity. Typically, treatment is not required greater than four (4) times per year. Deleted: <#>Members with subfoveal occult lesions with no CNV without classic lesions (4 disk areas or less in size at time of initial treatment or within three (3) months prior to initial treatment). Evidence of progression should be documented by deterioration in visual acuity (at least five (5) letters on a standard eye examination chart), lesion growth (an increase in at least one (1) disk area), or appearance of blood associated with the lesion. For Macugen Therapy: Members with subfoveal sites of CNV 2 to age-related MD: Members with subfoveal choroidal neovascularization secondary to age-related macular degeneration with a visual acuity between 20/40 20/320. All angiography subtypes (predominantly classic, minimally classic, occult) with lesion sizes up to 12 disc areas (including blood, scar/atrophy, and neovascularization) with no greater than 50% of the lesion comprised of subretinal hemorrhage. Members with minimally classic or occult lesions with at least one of the following: o subretinal hemorrhage but not more than 50% of the lesion; o presence of lipid; or o loss of 15 or more letters (approximately three (3) lines on the eye chart) of visual acuity during the previous 12 weeks. Exclusions/Limitations MVP/Preferred Care Benefit Interpretation Manual Page 2 of 5 Age-related Macular Degeneration Treatment

7 The following would not be medically indicated for Photodynamic Therapy: re-treatments greater than four (4) times a year; photodynamic therapy for subfoveal choroidal neovascularization (CNV) from other causes such as angioid streaks and idiopathic causes is still under investigation; lesions outside the fovea (juxtafoveal or extrafoveal); atropic or dry AMD or drusen; "off-label" use of verteporfin; or if the palliative effect of photodynamic therapy with verteporfin, which is to stem the inexorable loss of visual function, is lost, photodynamic therapy would no longer be medically indicated for the member. The following would not be medically indicated for Macugen therapy: atrophy exceeding 25% OF THE TOTAL LESION; subfoveal scarring in the treatment eye; other potential causes of CNV: o myopia of eight (8) diopters or more; o occular histoplasmosis; o angioid streaks; o choroidal rupture; and o multifocal choroiditis; presence of retinal pigment epithelial tears/rips; diabetic retinopathy; acute occular or periocular infection; or likelihood of requiring cataract surgery within two (2) years. Combination Therapies Treatment of neovascular (wet) age-related macular degeneration (AMD) with verteporfin, in combination with anti-angiogenesis drugs such as Macugen, is not supported by clinical trial outcomes and is not a covered benefit. Note: For Preferred Care authorization requirements refer to Appendix A and Appendix B in the Referral/Precertification/Prior Justification/Notification Administrative Policy. You may also refer to the "Prior Justification/Precertification of Certain Prescription Drugs" for information on drugs that require precertification and prior justification. Both policies are available on the easylink for Providers at References Literature (Search updated in 2005) Pegaptanib Sodium Injection (Macugen TM ), Eyetech Pharmaceuticals, Pfizer, Inc., Dermatologic and Ophthalmic Advisory Committee, August 27, Gragoudas Evangelos, Adamis Anthony, et al. Pegaptanib for Neovascular Age- RelatedMacular Degeneration. New England Journal of Medicine. 351:27 December 30, Macugen (pegaptanib sodium injection), Package insert. Eyetech, Pfizer. MVP/Preferred Care Benefit Interpretation Manual Page 3 of 5 Age-related Macular Degeneration Treatment

8 FDA Approves New Drug Treatment for Age-Related Macular Degeneration. FDA News December 20, [On-Line] available: Empire Medicare Services LCD: Occular Photodynamic Therapy (OPT) (OP011E02). Effective: 4/1/03. Available: [On-Line] Verteporfin Therapy of Subfoveal Choiroidal Neovasculization in AMD: Meta: Analysis Of 2-Year Safety Results in Three Randomized Clinical Trials, Retina, (Abstract) February 2004, 24. The Centers for Medicare & Medicaid Services (CMS), National Coverage Determination, Occular Photodynamic Therapy, publication # 100-3, effective: 4/1/04. Available: [On-Line] Upstate Medicare Division, LMRP OP011E00, effective 8/17/03, Occular Photodynamic Therapy (OPT). [On-Line] Available: American Academy of Opthalmology, Preferred Practice Pattern: Age-Related Macular Degeneration. September, Aetna, (2002). Visudyne (Verteporfin) photodynamic therapy. Health Care Financing Administration (HCFA), (2001). Verteporfin(Visudyne ), The Coverage Issues Manual, Section and Section 45-30, July 1, Medicare News Brief New York :pp FDA Updates (2001). Visudyne approved for pathologic myopia, presumed occular histoplasmosis. Available: Wormalk, R., Evans, J., Smeeth, L. (2001). Photodynamic therapy for neovascular agerelated macular degeneration. The Cochrane Library, 2. Available: Centers for Medicare & Medicaid Services (CMS), (2001). Coverage Decision Memorandum for Occular Photodynamic Therapy with Verteporfin for Macular Degeneration (#CAG-00066R). Available: Centers for Medicare and Medicaid Services (CMS), Coverage Decision Memorandum for Occular Photodynamic Therapy with Verteporfin for Macular Degeneration (#CAG 00066R2). American Academy of Ophthalmology. (2000). Background on visudyne coding and payment history. Federal Affairs. Eyenet. (On-line) Available: American Academy of Ophthalmology. (2000). Photodynamic therapy using verteporfin for age-related macular degeneration. Rapid Clinical Report. Eyenet. (On-line) Available: ECRI (2000). Target Report #425: Photodynamic therapy (PDT) for wet age-related macular degeneration (AMD). ECRI (2000). FDA clears combined laser/drug therapy to slow vision loss. Health Technology Trends vol.12(5):1-2. Fine, S. L., Berger, J. W., Maguire, M. G., Ho, A. C. (2000). Age-related macular degeneration. New England Journal of Medicine, 342(7), Treatment of Age-related Macular Degeneration With Photodynamic Therapy (TAP) Study Group. (1999). Photodynamic therapy of subfoveal choroidal neovascularization in age-related macular degeneration with verteporfin: Oneyear results of two (2) randomized clinical trials-tap report 1. Archives of Ophthalmology, 117, (Oct.), (On-line) Available: Approvals & Review/Revisions MVP/Preferred Care Benefit Interpretation Manual Page 4 of 5 Age-related Macular Degeneration Treatment

9 Medical: Review: Eye Advisory Team: 6/21/06 Approval: Clinical Quality Team: 8/21/06 Prior Approval Date: 6/13/05 Last Revision Date: 6/06 Origination Date: 5/00 Effective Date: 10/1/06 MVP/Preferred Care Benefit Interpretation Manual Page 5 of 5 Age-related Macular Degeneration Treatment

10 MVP/Preferred Care BENEFIT INTERPRETATION MANUAL Allergy Testing & Allergen Immunotherapy Type of Policy Medical Codes CPT: 95004, 95010, 95015, 95024, 95028, 95044, ICD-9: , , , , 518.3, 989.5, , 692, & Evidence Basis for Policy Standard of Care. The procedure, device, or drug is accepted medical practice as evidenced by an abundance of scientific literature and well-designed clinical trials. Description Allergy Testing is necessary to confirm the presence of specific IgE antibodies directed toward inhalants,foods, hymenoptera venoms* (refer to MVP/Preferred Care Skin Endpoint Titration Policy), and pharmaceutical allergens implicated by the member s history. Although there are a variety of methods for assessing the presence of specific IgE antibodies, skin testing is preferred. Allergy skin testing may be performed by the percutaneous (prick testing) or the intracutaneous route (intradermal testing). Standardized allergen extracts should be used in diagnostic skin testing along with appropriate positive and negative controls. Fresh fruits and vegetables may be used as a source of skin testing extracts by a specialist when indicated. Deleted: or Allergen Immunotherapy, by subcutaneous administration, is the repeated administration of specific allergens to patients with IgE-mediated conditions for the purpose of providing protection against the allergic symptoms and inflammatory reactions associated with natural exposure to these allergens. Patch Testing/Photopatch testing is performed in Type IV reactions and some IgEmediated reactions, which present as contact dermatitis. The suspected allergens are applied in discs or on pre-made patches and kept in place by hypoallergenic tape for 48 hours. The first follow-up visit is at 48 hours and there may be another one up to 96 hours. Chemicals, plant resin, and lipid materials are the chief causes of classical allergic contact dermatitis. About antigens used in the screening panel of patch tests can diagnose 70% of the clinically relevant cases of allergic contact dermatitis. Following MVP/Preferred Care Benefit Interpretation Manual Page 1 of 6 Allergy Testing & Allergen Immunotherapy

11 this screening test panel, selected antigens, based on the patient s history, are then used to supplement the screening panel. Radioallergosorbent (Rast) and Fluoroallergosorbent (FAST) and Enzyme-Linked Immunosorbent assay are blood tests performed to determine serum IgE antibodies against specific allergens Indications/Criteria Allergy Testing Allergy skin testing may be considered when the member s history and physical examination indicate that allergic mechanisms may be the underlying cause of some of the following chronic conditions: asthma; allergic rhinitis; eczematous eruptions, including atopic dermatitis and contact dermatitis; urticaria/angioedema; anaphylaxis caused by food, pharmaceuticals or insects; gastrointestinal reactions; severe conjunctivitis; or non-behavioral adverse reactions to food, drugs and stinging insects*.(*refer to MVP/Preferred Care Skin Endpoint Titration policy). Deleted: The listing provided should not be considered all-inclusive. The Medical Director or designee may review indications for any technology request on an individual basis for medical necessity and appropriateness taking into consideration the needs of the individual and the member s individual policy coverage. This Medical Policy may be updated and therefore is subject to change. Patch testing is used to determine the causative agent in contact eczematous dermatitis. Indications for patch testing include: dermatitis that is suspected to be contact induced; chronic occupational dermatitis; or when clinical evaluation suggests that a specific allergen may be implicated in a clinical setting, patch testing can be used to confirm the diagnosis. Immunoassay blood tests for diagnosis and follow-up, such as the RAST test, may be indicated for the following situations: the presence of extensive dermatitis, eczema, and dermographism; suspected latex sensitivity; necessary for members with cardiac and/or pulmonary problems that necessitate the continued use of H-1 blockers (antihistamines), tricyclic antidepressants, or betablockers; a history of anaphylactic reaction to a specific allergen or secondary to previous skin testing; as an alternative when skin testing cannot be done, due to the member s mental capacity or to an anticipated behavioral response to skin testing; or to assess the change in the level of IgE sensitization over time and to help predict if tolerance has occurred in food allergy (i.e. peanuts, milk). MVP/Preferred Care Benefit Interpretation Manual Page 2 of 6 Allergy Testing & Allergen Immunotherapy

12 Allergen Immunotherapy Allergen immunotherapy may be considered appropriate for the following conditions: allergic rhinitis or conjunctivitis, allergic asthma, and stinging insect hypersensitivity* (refer to MVP/Preferred Care Skin Endpoint Titration policy); or when there is a poor response to environmental control or pharmacologic treatment of IgE-mediated allergy symptoms. Allergen Immunoassay Tests In-vitro allergen immunoassay tests such as the radioallergosorbent test (RAST), fluoroallergosorbent test (FAST), and multiple antigen simultaneous tests are techniques for determining whether a patient's serum contains IgE antibodies against specific allergens of clinical importance. As with any allergy testing, the need for such tests is based on the findings during a complete history and physical examination of the patient. The multiple antigen simultaneous testing technique is similar to the RAST/FAST techniques in that it depends upon the existence of allergic antibodies in the blood of the patient being tested. With the multiple antigen simultaneous test system, several antigens may be used to test for specific IgE simultaneously. ELISA (enzyme-linked immunosorbent assay) is another in vitro method of allergy testing for specific IgE antibodies against allergens. This method is also a variation of RAST. Use of RAST tests may be considered if there is medical documentation stating that the member cannot tolerate standard in vivo allergy test procedures. Exclusions/Limitations Allergy Testing Allergy Testing for the following antigens is not a covered benefit: grain mill dust; tobacco smoke; golden rod; orris root; pyrethrum; dandelion; marigold; soybean dust; honey suckle; processed wool; phenol; alcohol; or MVP/Preferred Care Benefit Interpretation Manual Page 3 of 6 Allergy Testing & Allergen Immunotherapy

13 sugar and yeast. The following allergy tests have unclear clinical significance and are not a covered benefit: qualitative multiallergen screens (via dipstick, paddle or disk); cytotoxic test; provocative-neutralization testing e.g Bronchial challenge (95071), Rinkel (95708), Ingestion (95075); organ challenge testing to the conjunctivae (eyes) and nares (nose); sublingual immunotherapy; pulse test; rebuck skin window; rhinomanometry; electrodermal testing; muscle response testing (applied kinesiology); or chemical analysis of body tissue. All organ challenge tests (including drug, biologic and food challenge materials applied to the mucosae of the conjunctivae, nares, GI tract, or bronchi) should be preceded by a control test and will be considered appropriate on an individual case review. Up to 50 prick tests and up to 50 intradermal/intracutaneous tests per member are covered every two years, within the same practice. When food is suspected as the etiology of a patient s symptoms such as atopic dermatitis, eczema or sometimes urticaria, a maximum of 65 prick tests for food allergies are allowed when performed by a qualified specialist or Allergist. Re-testing with the same antigen(s) is not covered more often than every three years within the same practice. Cases where the provider suspects either an increased tolerance or an increased reactivity to certain medications or foods, and needs to repeat testing more than every three years, will be considered on an individual basis. Deleted: 90 Deleted: 45 The use of RAST tests as a means of detecting cross-sensitivity for the purpose of establishing the starting dosage in a course of immunotherapy is not covered. Length of Therapy Treatment duration and the benefits of immunotherapy must be documented in the member s chart. The duration of all forms of immunotherapy must be individualized. A presumption of failure can be made when, after 24 months of therapy, a person does not experience a noticeable decrease of symptoms, an increase in tolerance to the offending allergen and a reduction in medication usage. Treatment will not be reimbursed after a two-year period when there is no apparent clinical benefit. MVP/Preferred Care Benefit Interpretation Manual Page 4 of 6 Allergy Testing & Allergen Immunotherapy

14 Allergen Immunotherapy Allergen immunotherapy is not considered appropriate in the following circumstances: non IgE-mediated allergies; food allergenic extract immunotherapy; management of skin and mucous membrane disease such as atopic dermatitis, urticaria and Candida vulvovaginitis. As with all of the medical policies, exceptional cases will be considered for medical necessity on an individual basis; unsuccessful allergen immunotherapy that was administered within the past three years by credentialed physicians within the same practice; the member has had no significant reduction in symptoms after two years of allergen immunotherapy; allergen immunotherapy has been given longer than 24 months without appropriate re-evaluation; or children less than three years of age will be considered on an individual basis. Out-of-area allergen immunotherapy may be covered on a case-by-case basis. CMS Variation Injections out of the service area are covered when the same treatment schedule and the same safety procedures are followed as have been applied in-plan. Note: For Preferred Care authorization requirements refer to Appendix A and Appendix B in the Referral/Precertification/Prior Justification/Notification Administrative Policy. You may also refer to the "Prior Justification/Precertification of Certain Prescription Drugs" for information on drugs that require precertification and prior justification. Both policies are available on the easylink for Providers at Deleted: <#>child less than three years of age; Deleted: Allergen immunotherapy should only be administered in settings where emergency resuscitative equipment and trained personnel are immediately available to treat severe systemic reactions. Deleted: Sublingually administered antigens (drops placed under the tongue) have not been proven to be safe and effective and are not a covered benefit. Deleted: injections is utilized. References Literature (Search updated in 2004) Upstate Medicare Division (2001). Rast Type Tests. New York State Local Medical Review Policy #L Upstate Medicare Division, Part B. (2001). Allergy immunotherapy. New York State Medicare Local Medical Review Policy # AL001E03. (On-line). Available: Joint Council of Allergy, Asthma, and Immunology (1998). Practice parameters for allergen immunotherapy. (On-line) Available: Disorders with type IV hypersensitivity reactions(1995). The Merck Manual of Diagnosis and Therapy, 16 th edition: MVP/Preferred Care Benefit Interpretation Manual Page 5 of 6 Allergy Testing & Allergen Immunotherapy

15 The British Allergy Foundation, (2002). Patch testing. Available online: American Academy of Allergy Asthma and Immunology, (2000). Allergic and immunologic skin conditions. Available online: American Academy of Allergy, Asthma, & Immunology. (1996). Position statement #7: Resuscitative equipment and personnel. (On-line) Available: American Academy of Allergy, Asthma, & Immunology. (1996). Position statement #24: Allergen skin testing. (On-line) Available: American Academy of Otolaryngology Head and Neck Surgery, Policy Statement: Allergy Techniques, Revised April 13, Bernstein, I. L. & Storms, W. W. (1995) Summary statements of practice parameters for allergic diagnostic tests. Annals of Allergy, Asthma, & Immunology,Vol. 75, December, (Part II) pp American Academy of Allergy, Asthma and Immunology (October 2003). Practice Paper, Current Approach to the Diagnosis and Management of Adverse Reactions to Food Avail at aaaai.org. Approvals & Review/Revisions Medical: Review: Children s Advisory Team: 6/7/06 Approval: Clinical Quality Team: 8/21/06 Prior Approval Date: 1/10/05 Last Revision Date: 6/7/06 Origination Date: 11/92 Effective Date: 10/1/06 MVP/Preferred Care Benefit Interpretation Manual Page 6 of 6 Allergy Testing & Allergen Immunotherapy

16 MVP/Preferred Care BENEFIT INTERPRETATION MANUAL Alopecia/Wigs /Scalp Prosthesis Type of Policy Durable Medical Equipment/Prosthetics Codes HCPCS code: S8095 Non-covered ICD 9 Procedure Code: Non-covered CPT 4 procedure codes: 15775, Non-covered HCPCS codes: S0138,S0139 Evidence Basis for Policy MVP Administrative Policy Description Alopecia andartificial hair/wigs Alopecia, or hair loss, affects millions of people including children. The cause of alopecia is complex and includes hormonal imbalance, endocrine abnormalities, genetics, medications, stress, severe illness, malnourishment, infections and autoimmune diseases. Types of alopecia can be classified as the following: Androgenic Alopecia is male or female pattern baldness, is caused by a combination of genetics and hormones, and is the most common type of hair loss. Since up to two thirds of men, and a number of women, experience androgenic alopecia, this condition is considered a normal variant rather than a disease. Telogen and Anagen Effluvium is a temporary hair loss caused by medications, cessation of birth control pills, acute illness, surgery, stress, pregnancy or other medical treatment. The hair usually grows back when the external cause is treated, removed or resolved. Loose Anagen Hair Syndrome is a form of hair loss that is often patchy in appearance but sometimes has a diffuse presentation. It is a condition that affects children most. In Loose Anagen Syndrome, the hair fiber is poorly anchored to the hair follicle. The syndrome improves with age of its own accord in children but it can be more persistent in older individuals. There are no known effective treatments. Alopecia Areata is believed to be caused by an autoimmune reaction and is manifested as hair falling out in patches. It is subdivided into three categories based on the extent of hair loss. Deleted: a large proportion of MVP/Preferred Care Benefit Interpretation Manual Page 1 of 4 Alopecia/Wigs/Scalp Prosthesis

17 - Alopecia Areata is considered a mild form of the disease and only a few spots become bald. - Alopecia Totalis is total loss of hair on the scalp. - Alopecia Universalis is complete hair loss of all hair on the scalp and body including eyelashes, brows, and pubic hair. Scarring Alopecias result from infection and inflammation of the hair follicles and are characterized by extensive follicular destruction. Some examples of scarring alopecias include, but are not limited to: - lichen Planopilaris; - discoid Lupus Erythematosus; - folliculitis Declavans/Pseudopelade; and - follicular Degeneration Syndrome. Trichotillomania is a compulsive disorder characterized by pulling out of one s own hair. Drug-Induced Alopecia may occur with certain drugs such as cytotoxics, antithyroid drugs, anticoagulants, antituberculous drug agents, excessive vitamin A or oral contraceptives. Hair loss may indicate the use of a wig. MVP s New York and Vermont certificates and Preferred Care contracts do not consider wigs to be a prosthetic or DME item. They are considered a cosmetic item and, therefore, are not considered for coverage. The MVP New Hampshire certificate provides coverage for wigs/scalp prosthesis as directed by a state mandate. Indications/Criteria Medical information as indicated below: All of the following must apply for New Hampshire Members only: must be a resident of the state of New Hampshire and principal place of employment must be in the state of New Hampshire; and coverage for hair loss is considered for one of the following reasons: - permanent loss of scalp hair due to an injury; or - hair loss due to alopecia areata, alopecia totalis, alopecia medicamentosa (hair loss from the treatment of any form of cancer or leukemia). Exclusions/Limitations Hair loss due to an inherited baldness trait, malnutrition or other disorder not specified under criteria. Other treatments that are considered cosmetic and not a covered benefit include: drugs (e.g. Monoxidil (S0139)/Rogaine, Finasteride (S0138)/Propecia and other over the counter hair growth medications or products); hair transplantation (86.83); surgical treatment, e.g. punch graphs, rotation flaps, sclap reduction (15775, 15776); and MVP/Preferred Care Benefit Interpretation Manual Page 2 of 4 Alopecia/Wigs/Scalp Prosthesis

18 trichotillomania is considered for coverage for Preferred Care contracts as a Mental Health benefit. Refer to the Preferred Care Mental Health Medical policy. Note: For authorization requirements refer to Appendix A and Appendix B in the Referral/Precertification/Prior Justification/Notification Administrative policy. You may also refer to the Prior Justification/Precertification of Certain Prescription Drugs for information on drugs that require precertification and prior justification. Both policies are available on the easylink for Providers at References MVP contracts New Hampshire state mandates Preferred Care contracts Bissonnette R., Shapiro J., Zeng H., Mclean D.I., Lui H., (2000), Topical photodynamic therapy with 5-aminolaevulinic acid does not induce hair regrowth in patients with extensive alopecia areata. British Journal of Dermatology 143(5): Adams J., (2000), Alopecia areata and celiac disease: no effect of a gluten-free diet on hair growth. Available: Alabdulkareem, A.S., Abahussein, A.A., & Okoro, A. (1998) Severe alopecia areata treated with systemic corticosteroids. International Journal of Dermotology,37(8), (On-line). Available: PubMed. American Academy of Dermatology. (1998). White paper on alopecia areata: AAD ad hoc committee to review reimbursement for alopecia areata (On-line) Available: Fiedler, V.C. & Alaita, S. (1996) Treatment of alopecia areata. Dermatology Clinic, 14(4) (On-line). Available: PubMed. Friedli, A., Labarthe, M.P., Englehardt, E., Feldmann, R., Salomon, D., & Saurat, J.H. (1998) Pulse methylprednisolone therapy for severe alopecia areata: an open prospective study of 45 patients. Journal of the American Academy of Dermatology, 39(4 Pt 1) (On-line). Available: PubMed. Harrist, T.J., Clark, W.H., Gonzalez-Serva, A., et al. (editors). (1996). Alopecia review part two: nonscarring alopecia. Pathology Review 6(3), (On-line). Available: Hordinsky, M.K. Chapter 8, Alopecia Areata. Disorders of hair growth: diagnosis and treatment. Kiesch, N., Stene, J.J., Goens, J., Vanhooteghem, O., & Song, M. (1997). Pulse steroid therapy for children s severe alopecia areata? Dermatology, 194(4) (On-line). Available: PubMed. Pericin, M. & Trueb, R.M. (1998). Topical immunotherapy of severe alopecia areata with diphenycyclopropenone: evaluation of 68 cases. Dermatology, 196(4) (Online). Available: PubMed. Sahin, S., Yalcin, B., & Karaduman, A. (1998). PUVA treatment for alopecia areata. Experience in a Turkish population. Dermatology,197(3) (On-line). Available: PubMed. Shapiro, J., Sharma, V.K., & Muralidhar, S. (1998). Treatment of widespread alopecia MVP/Preferred Care Benefit Interpretation Manual Page 3 of 4 Alopecia/Wigs/Scalp Prosthesis

19 areata in young patients with monthly oral corticosteroid pulse. Pediatric Dermatology, 15(4) (On-line). Available: PubMed. Approvals & Review/Revisions Medical: Review: Medical Advisory Team: 3/28/06 Approval: Clinical Quality Team: 5/15/06 Prior Approval Date: 1/10/05 Last Revision Date: 4/06 Effective Date: 7/1/06 MVP/Preferred Care Benefit Interpretation Manual Page 4 of 4 Alopecia/Wigs/Scalp Prosthesis

20 MVP/Preferred Care BENEFIT INTERPRETATION MANUAL Ambulatory Holter Monitors and 30-day Cardiac Event Recorders/Monitors Type of Policy Diagnostic Testing Codes Holter Monitor CPT 4 codes: , , ICD-9 codes: 89.50, ICD 9 diagnosis codes: , , , , 422.0, , , 426.0, , 426.6, 426.7, , , , 426.9, 427.0, 427.2, , , 427.5, , , 427.9, 429.0, , , 435.8, , 780.4, 785.0, 785.1, Day Cardiac Event Recorders/Monitors CPT- 4 codes , 93727, 93012, ICD 9 codes: 89.50, ICD 9 Diagnosis codes: 426.7, , 427.0, 427.1, 427.2, , , , , , 435.9, 780.2, 780.4, 785.1, , Evidence Basis for Policy Standard of Care. The procedure, device, or drug is accepted medical practice as evidenced by an abundance of scientific literature and well-designed clinical trials. Description Holter Monitors are portable electrocardiograph devices that record and store up to 24 hours of the patient s cardiac activity. The test is done in an ambulatory setting. A 24- hour Holter monitor is useful in diagnosing cardiac arrhythmias that occur daily and that might not be recorded in a standard electrocardiogram. The recording is completed either on a magnetic cassette, a digitized recorder or by specialized "real time" recorder. Cardiac Event Recorders involve the use of long-term monitoring to evaluate patients with symptoms suggestive of cardiac arrhythmias such as palpitations, chest pain, dizziness, syncope, lightheadedness or shortness of breath for up to a 30-day period. These are patient activated devices that permit the patient to record an EKG upon manifestation of symptoms. These devices may also be patient activated or in response to a physician s order (e.g. immediately following strenuous physical activity). There are several types of Cardiac Event Recorders/Monitors: MVP/Preferred Care Benefit Interpretation Manual Page 1 of 5 Holter Monitors and Cardiac Event Recorders

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