National Medical Policy

Transcription

National Medical Policy
Subject:
Benign Skin Lesion Removal
Policy Number:
NMP150
Effective Date:
June 2004
Updated:
May 2006, September 2009, November 2009,
January 2011, September 2011
This National Medical Policy is subject to the terms in the
IMPORTANT NOTICE
at the end of this document
The Centers for Medicare & Medicaid Services (CMS)
For Medicare Advantage members please refer to the following for coverage
guidelines first:
Use
Source
X
National Coverage Determination
(NCD)
National Coverage Manual Citation
Local Coverage Determination (LCD)
X
Article (Local)
Other
None
Reference/Website Link
Search Term Lesion Removal
Removal of Benign or Premalignant Skin Lesions
Removal of Benign Skin Lesions
Skin Lesion (Non-Melanoma) Removal
Skin LESION REMOVAL (Includes AK and Excludes
MOHS)
Treatment of Ulcers & Symptomatic
Hyperkeratoses
http://www.cms.gov/medicare-coveragedatabase/search/advanced-search.aspx
Non-malignant Skin LESION REMOVAL Policy –
Addendum
http://www.cms.gov/medicare-coveragedatabase/search/advanced-search.aspx
Use Health Net Policy
Instructions
 Medicare NCDs and National Coverage Manuals apply to ALL Medicare members
in ALL regions.
 Medicare LCDs and Articles apply to members in specific regions. To access your
specific region, select the link provided under “Reference/Website” and follow the
Benign Skin Lesion Removal Sep 11
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

search instructions. Enter the topic and your specific state to find the coverage
determinations for your region
If more than one source is checked, you need to access all sources as, on
occasion, an LCD or article contains additional coverage information than
contained in the NCD or National Coverage Manual.
If there is no NCD, National Coverage Manual or region specific LCD/Article,
follow the Health Net Hierarchy of Medical Resources for guidance.
Current Medical Policy (Update September 2011 – A Medline search failed to
reveal any studies that would cause Health Net, Inc. to change its current positon)
Benign skin lesions include seborrheic keratoses, sebaceous (epidermoid) cysts, skin
tags, milia (keratin-filled cysts), nevi (moles), acquired hyperkeratosis
(keratoderma), papillomas, hemangiomas and viral warts. Health Net, Inc. considers
removal of benign skin lesions as medically necessary, and not cosmetic, when any
of the following is met and is clearly documented in the medical record, operative
report or pathology report:
1. The lesion is symptomatic as documented by any of the following:







Intense itching
Burning
Irritation
Pain
Tenderness
Chronic, recurrent or persistent bleeding
Physical evidence of inflammation (e.g., purulence, oozing, edema,
erythema, etc.)
2.
The lesion demonstrates a significant change in color or size
3.
The lesion obstructs an orifice or clinically restricts vision.
4.
There is clinical uncertainty as to the likely diagnosis, particularly where
malignancy is a realistic consideration based on lesional appearance, change
in appearance and/or non-response to conventional treatment*
The lesion is likely to turn malignant as documented by medical peerreviewed literature or medical textbooks
5.
6.
A prior biopsy suggests the possibility of lesional malignancy.
7.
The lesion is in an anatomical region subjected to recurrent physical trauma
that has in fact occurred and objective evidence of such injury or the potential
for such injury is documented.
8.
Wart removals is considered medically necessary when any of 1 through 8
above is met; in addition, wart destructions are considered medically
necessary when any of the following is met:

Lesion causes symptoms of such a severity that the patient’s normal
bodily functions/activities of daily living are impeded (e.g., palmar or
plantar warts)
2
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
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
Periocular warts associated with chronic recurrent conjunctivitis thought
secondary to lesion virus shedding;
Warts showing evidence of spread from one body area to another,
particularly in immunosuppressed patients.
Lesions are condyloma acuminata or molluscum contagiosum.
Cervical dysplasia or pregnancy associated with genital warts
Warts showing evidence of spreading from one body area to another,
particularly in the immunosuppressed patients.
*Note: If the diagnosis is uncertain, biopsy or removal may be more prudent than
destruction.
Note: The decision to submit a specimen for pathological interpretation will be
independent of the decision to remove or not remove the lesion. It is assumed,
however, that the pathology description and tissue diagnosis will be part of the
medical record if a specimen is submitted to pathology.
Note: Should lesions be a concern but not be explicitly described in this policy, color
photographs must be submitted with the request.
Health Net, Inc. does not consider lesion removal medically necessary for any of the
following:
1. Lesions in sensitive anatomic locations that are non-problematic do not qualify
for removal coverage on the basis of location alone.
2. Rosacea
3. Vascular proliferative disorders
Actinic Keratoses – Update November 2009
Health Net Inc, consider the destruction of correctly diagnosed actinic keratoses, also
known as solar keratoses, medically necessary as they are considered to be
premalignant lesions with a low but real possibility of malignant transformation.
I.
Health Net Inc, considers any of the following treatment for actinic keratoses
medically necessary:
1.
Liquid nitrogen cryotherapy

Most common treatment, usually recommended for treatment of
solitary lesions or small numbers of scattered lesions and/or thin,
well-demarcated lesions

2.
Topical drug therapy (e.g. 5-fluorouracil)


3.
May cause skin redness; blistering may occur
Recommended for individuals with more than 15 actinic keratoses
Anatomic location of the lesions impacts response time. AK’s of the
face respond the quickest, whereas lesions on the arms usually take
the longest to respond.
Any of the following treatment for multiple actinic keratoses is considered
medically necessary when there is failure to adequately respond to topical 5FU or cryosurgery:
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II.
Laser skin resurfacing therapy
Chemical peel
Dermabrasion
Health Net, Inc. considers photodynamic therapy (PDT) with topical
aminolevulinic acid (Levulan Kerastick) and exposure to blue light medically
necessary for non-hyperkeratotic actinic keratoses of the face and scalp.
Note: Lesions treated with Levulan Kerastick that have not completely
resolved after 8 weeks may be treated a second time. However, in the
absence of data that indicate efficacy for a third treatment, the medical
necessity for a third treatment of the same lesion(s) is not established.
III.
Health Net, Inc. considers photodynamic therapy PDT with topical Metvixia,
followed by exposure to a red light source medically necessary in
immunocompetent patients in conjunction with lesion preparation (debridement
using a sharp dermal curette) when other therapies are unacceptable or
considered medically less appropriate.
Note: Metvixia Cream has not been studied for more than one course which
consists of two treatment sessions one week apart. Lesion response should
be assessed 3 months after the last treatment session.
IV.
Electrodessication and curettage or full-thickness excision of actinic keratoses is
rarely medically necessary. However, excisional biopsy of actinic keratoses may
be considered medically necessary when the following criteria are met:
V.
1.
There is bleeding, induration, rapid growth or pain, which suggest
progression to squamous cell carcinoma
2.
The lesion does not respond to treatment
An alternative approach to treating AKs is to observe the lesions over time and
remove them only if they exhibit specific clinical features suggesting possible
transformation to invasive squamous cell carcinoma (SCC).
Note: Health Net, Inc. does not consider removal of skin lesions to improve
appearance medically necessary. Removal of certain benign skin lesions that do not
pose a threat to health or function are considered cosmetic, and as such, are not
medically necessary. In the absence of any of the above indications, removal of
seborrheic keratoses, sebaceous cysts, nevi (moles) or skin tags is considered
cosmetic.
Note: Excision of lesion with simple closure should be coded as excision only. A
simple repair is used when the wound is superficial; e.g., involving primarily
epidermis or dermis, or subcutaneous tissues without significant involvement of
deeper structures, and requires simple one layer closure/suturing. Excision of lesions
with intermediate or complex closure should be coded separately for benign lesions
with a diameter greater than 0.5cm or the excision of a malignant lesion of any size.
An intermediate repair includes the repair of wounds that require layered closure of
one or more of the deeper layers of subcutaneous tissue and superficial (nonmuscle) fasciae, in addition to the skin (epidermal and dermal) closure. Complex
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repair includes the repair of wounds requiring more than layered closure including
scar revision, debridement, (e.g., traumatic lacerations or avulsions, extensive
undermining, stents or retention sutures). Excision of lesion with adjacent tissue
transfer should be coded as adjacent tissue transfer only.
Codes Related To This Policy
ICD-9
078.0
078.10
078.11
078.19
135
210.0
214.0–
214.1
215.0
215.3
216.0
216.1
216.2
216.3
216.4
216.5
216.6
216.7
216.8
221.2
222.1
222.4
228.01
235.1
238.2
239.2
374.84
380.00380.02
455.9
448.1
528.5
682.0682.9
686.1
686.8
690.10
690.11
690.12
690.18
690.8
691.8
692.70
Molluscum contagiosum
Viral warts, unspecified
Condyloma acuminatum
Other specified viral warts
Sarcoidosis (cutaneous)
Benign neoplasm of lip (specify type)
Lipoma of skin and subcutaneous tissue
Other benign neoplasm of connective and other soft tissue of head,
face and neck
Other benign neoplasm of connective and other soft tissue of lower
limb, including hip
Benign neoplasm of skin of lip
Benign neoplasm of eyelid, including canthus
Benign neoplasm of skin of ear and external auditory canal
Benign neoplasm of skin of other and unspecified parts of face
Benign neoplasm of skin of scalp and neck
Benign neoplasm of skin of trunk except scrotum
Benign neoplasm of skin of upper limb, including shoulder
Benign neoplasm of skin of lower limb, including hip
Benign neoplasm of skin of other specified sites
Benign neoplasm of vulva
Benign neoplasm of penis
Benign neoplasm of scrotum
Hemangioma of skin and subcutaneous tissue
Neoplasm of uncertain behavior of lip
Neoplasm of uncertain behavior of skin
Neoplasm of unspecified nature, skin
Sebaceous cyst of eyelid
Perichondritis of pinna (chondrodermatitis)
Residual hemorrhoidal skin tags
Nevus, nonneoplastic
Diseases of lip
Cellulitis and abscess
Pyogenic granuloma of skin and subcutaneous tissue
Other specified local infections of skin and subcutaneous tissue
Seborrheic dermatitis, unspecified
Seborrhea capitis
Seborrheic infantile dermatitis
Other seborrheic dermatitis
Other erythematosquamous dermatosis
Other atopic dermatitis and related conditions
Unspecified dermatitis due to sun
5
692.75
695.89
695.9
698.9
698.3
701.0
701.2
701.1
701.4
701.9
702.0
702.11
702.19
706.2
709.9
744.1
759.39
782.0
959.8
Disseminated superficial actinic porokeratosis (DSAP)
Other specified erythematous conditions
Unspecified erythematous conditions
Unspecified pruritus disorder
Prurigo nodularis
Circumscribed scleroderma
Acquired acanthosis nigricans
Keratoderma (acquired) symptomatic, painful and/or inflamed
Keloid
Skin tags
Actinic keratosis
Inflamed seborrheic keratosis
Other seborrheic keratosis
Sebaceous cyst
Unspecified disorder of skin and subcutaneous tissue
Accessory auricle
Other anomalies of the skin
Pain, paresthesia, burning of skin
Injury [trauma] of other specified site, skin
CPT Codes
11200
11201
11300
11301
11302
11303
11305
11306
11307
11308
11310
11311
11312
11313
11400
11401
11402
11403
11404
11406
11420
11421
11422
11423
Removal of skin tags, multiple fibrocutaneous tags, any area; up to
and including 15 lesions
each additional ten lesions (List separately in addition to code for
primary procedure)
Shaving of epidermal or dermal lesions, single lesion, trunk, arms or
legs; lesion diameter 0.5 cm or less
lesion diameter 0.6 to1.0 cm
lesion diameter 1.1 to 2.0 cm
lesion diameter over 2.0 cm
Shaving of epidermal or dermal lesion, single lesion, scalp, neck,
hands, genitalia; lesion diameter 0.5 cm
Shaving of epidermal or dermal lesion, single lesion, face, ears,
eyelids, nose, lips, mucous membrane; lesion diameter 0.5 cm or less
Excision, benign lesion including margins, except skin tag (unless
listed elsewhere), trunk, arms or legs; excised diameter 0.5 or less
excised diameter 0.6 to 1.0 cm
excised diameter over 4.0 cm
Excision, benign lesion including margins, except skin tag (unless
listed elsewhere), scalp, neck, hands, feet, genitalia; excised diameter
0.5 cm or less
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11424
11426
11440
11441
11442
11443
11444
11446
1200112007
1201112018
1203112037
1204112047
1205112057
13100
12102
13120
13121
13131
13132
13133
13150
13151
13152
13153
13160
14000
14001
14020
14021
14040
14041
14060
10461
Excision, other benign lesion including margins(unless listed
elsewhere), face, ears, eyelids, nose, lips, mucous membrane; excised
diameter 0.5 cm or less
excised diameter over 4.0 cm
Simple repair of superficial wounds of scalp, neck, axillae, external
genitalia, trunk and or extremities (including hands and feet); 2.5cm
or less - over 30cm
Superficial repair of superficial wounds of face, ears, eyelids, nose,
lips and/or mucous membranes; 2.5cm or less - over 30cm
Repair, intermediate, wounds of scalp, axillae, trunk and/or
extremities (excluding hands and feet); 2.5 cm or less to 30.0 cm
Repair, intermediate, wounds of neck, hands, feet and/or external
genitalia; 2.5 cm or less -over 30 cm
Repair, intermediate, wounds of face, ears, eyelids, nose, lips and/or
mucous membranes; 2.5 cm or less- over 30 cm.
Repair, complex, trunk; 1.1 cm to 2.5 cm
each additional 5 cm or less (List separately in addition to code for
primary procedure) (Code deleted)
Repair, complex, scalp, arms and/or legs:1.1.cm to 2.5 cm
primary procedure)
Repair, complex, forehead, cheek, chin, mouth, neck, axillae, genitalia,
hands and/or feet; 1.1 cm to 2.5 cm
2.6 cm to 7.5 cm
primary procedure)
Repair, complex, eyelids, nose, ears and/or lips; 1.0 cm or less
1.1 cm to 2.5 cm
2.6 cm to 7.5 cm
primary procedure)
Secondary closure of surgical wound or dehiscence, extensive or
complicated
Adjacent tissue transfer or rearrangement, trunk; defect 10 sq cm or
less
defect 10.1 sq cm to 30 sq cm
Adjacent tissue transfer or rearrangement, scalp, arms and/or legs;
defect 10 sq cm or less
Adjacent tissue transfer or rearrangement, forehead, cheeks, chin,
mouth, neck, axillae, genitalia, hands and/or feet; defect 10 sq cm or
less
Adjacent tissue transfer or rearrangement, eyelids nose, ears and/or
lips; defect 10sq cm or less
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14300
14301
14302
17000
17003
17004
17110
17111
96567
Adjacent tissue transfer or rearrangement, more than 30sq cm, usual
or complicated, any area (Code deleted in 2011. To report, see 14301,
14302)
Adjacent tissue transfer or rearrangement, any area; defect 30.1 sq
cm to 60.0 sq cm
Adjacent tissue transfer or rearrangement, each additional 30.0 sq cm.
Or part thereof (List separately in addition to code for primary
procedure)
Destruction (e.g., laser surgery, electrosurgery, cryosurgery,
chemosurgery, surgical curettement), premalignant lesions (e.g.,
actinic keratoses); first lesion
second through 14 lesions, each (List separately in addition to code for
first lesion)
chemosurgery, surgical curettement) premalignant lesions (e.g.,
actinic keratoses); 15 or more lesions
chemosurgery, surgical curettement), of benign lesions other than skin
tags or cutaneous vascular proliferative lesions; up to 14 lesions
15 or more lesions
Photodynamic therapy by external application of light to destroy
premalignant and/or malignant lesions of the skin and adjacent
mucosa (e.g.lip) by activation of photosensitive drug(s), each
phototherapy exposure session
HCPCS Codes
J3490
J7308
J9190
Unclassified drugs
Aminolevulinic acid HCL for topical administration, 20%, single unit
dosage form (354 mg)
Injection, fluorouracil, 500 mg (Use this code for Adrucil)
Scientific Rationale - Update September 2009
According to the American Academy of Dermatology, available treatment of actinic
keratoses (AK) may include cryosurgery, topical chemotherapy (e.g., 5-fluoruracil),
topical immunotherapy (e.g., imiquimod), topical non-steroidal anti-inflammatory
drugs (e.g. sodium diclofenac gel), photodynamic therapy with exposure to red or
blue light, chemical peels and laser therapy. Dermatologists may use one therapy or
combine therapies.
Photodynamic therapy (PDT) for the treatment of superficial nonhyperkeratotic AK
lesions of the face and scalp involves application of a light-sensitive drug that is then
activated by exposure to light of a specific wavelength. For PDT treatment of AKs, 5aminolevulinic acid (ALA) or methyl aminolevulinate (MAL) is applied to the lesion.
Once absorbed by the lesion, ALA and MAL undergo conversion via the heme
biosynthesis pathway to protoporphyrin IX (PpIX), which is an efficient
photosensitizer and makes the treated tissue particularly susceptible to damage
when exposed to a light source. One potential advantage of PDT, compared with peel
and liquid nitrogen therapy, is its ability to be applied more selectively, thus sparing
the surrounding skin from iatrogenic damage and reducing scarring. In addition, PDT
can be used to treat multiple lesions simultaneously; and treatment can be repeated
if necessary.
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PDT with Metvixia consists of the topical application of methyl aminolevulinate (MAL)
(in contrast to ALA used in the Kerastick procedure) followed by exposure with a red
light source (in contrast to the blue light source in the Kerastick procedure).
According to its FDA approval, Metvixia is indicated for treatment of nonhyperkeratotic actinic keratoses of the face and scalp in immunocompetent patients
when used in conjunction with lesion preparation (debridement using a sharp dermal
curette) in the physician’s office when other therapies are unacceptable or
considered medically less appropriate. One Metvixia-PDT session consists of:
lesion preparation, application of Metvixia Cream, application of occlusive dressing,
occlusion for 3 hours, removal of excess cream with saline and positioning lamp and
illumination with red light. During the time period between the application of
Metvixia Cream and exposure to red light illumination, the treatment site will become
photosensitive.
The FDA approval of Metvixia cream plus illumination with the CureLight BroadBand
was based on two clinical trials of 130 patients with non-hyperkeratotic actinic
keratoses. Both trials were randomized, multicenter, and double-blinded with
patients randomized to Metvixia -PDT and Vehicle-PDT study arms that required two
treatment sessions (7 days apart). One study was conducted in the U.S. and patients
were randomized 1:1 Metvixia to Vehicle and one study was conducted in Australia
with patients randomized 4:1 Metvixia to Vehicle. In both studies treatment
consisted of a multi-step process that was repeated after 7 days consisting of lesion
preparation (debridement with sharp curette) to roughen the surface of the lesion,
Metvixia or Vehicle Cream application to lesions with occlusion with an adhesive,
non-absorbent dressing, waiting at least 2.5 hours, but no more than 4 hours to
allow for conversion of the methyl aminolevulinate, removal of cream with gauze and
saline, and red light Dosimetry and Illumination with the CureLight BroadBand Model
CureLight 01 (a red light of 570 to 670 nm wavelength).
Study patients had previously untreated facial and scalp actinic keratoses (AKs) that
were slightly palpable (better felt than seen). Hyperkeratotic actinic keratoses were
excluded. In the U.S. study 100% of patients had 4 to 10 lesions at baseline
whereas in the Australian study, 63% (70/111) of patients had less than 4 lesions at
baseline, 31% (34/111) had 4 to 10 lesions, and 6% (7/111) had more than 10
lesions at baseline (a maximum of 6 treatment fields were allowed in this study).
A “Cleared” AK lesion was defined as being not visible and not palpable as assessed
3 months after the second treatment session. Patients with all treated lesions cleared
at 3 months were defined as Complete Responders.
In the Australian study, 86% (76/88) of patients had 75% or more lesions clear and
81% (71/88) were complete responders at three-month follow-up. In the U.S. study
83% (35/42) of patients had 75% or more lesions clear, and 79% (33/42) were
complete responders at three-month follow-up. Patients with 4 or more lesions had
lower success rates than those with less than 4 lesions when treated with PDT and
Metvixia. In the Austrailian study, 67% (18/27) of patients with 4-10 lesions were
complete responders whereas 79% (33/42) with 4-10 lesions were complete
responders in the U.S. study.
The FDA indicated data beyond the three-month follow-up was not available. The
FDA also noted that pretreatment debridement could be an essential component of
the therapy and, therefore, is included in the labeling for Metvixia
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Szeimes et al (2009) investigated one hundred thirty-one patients with 4 to 10 nonpigmented, previously untreated thin or moderately thick AKs on the face or scalp in
a multicenter, double-blind, randomized, placebo-controlled study. MAL or matching
placebo cream was applied to the débrided lesion surface for 3 hours before
illumination with noncoherent red light. Treatment was repeated 1 week later.
Efficacy was evaluated in 57 patients with 418 lesions treated with MAL PDT and 58
with 414 lesions treated with placebo PDT. Sixteen patients were excluded as
protocol violators (not randomized). The investigators reported that MAL PDT was
superior to placebo PDT in lesion complete response rates (83.3% vs 28.7%) and
patient complete response rates (all lesions showing complete response; 68.4% vs
6.9%).
Pariser et al (2008) evaluated the efficacy of MAL PDT using red light-emitting diode
light in a multicenter, double-blind, randomized study. A total of 49 patients with
363 AK lesions had 16.8% MAL cream applied under occlusion for 3 hours, and 47
patients with 360 AK lesions had vehicle cream similarly applied. The lesions were
then illuminated with repeated treatment 1 week later. Complete lesion and patient
(all lesions showing complete response) response rates were evaluated 3 months
after last treatment. MAL PDT was superior to vehicle PDT with respect to lesion
complete response (86.2% vs 52.2%) and patient complete response (59.2% vs
14.9%)
Moloney and Collins (2007) compared the efficacy of 5-aminolaevlinic acid
methylester (MAL) and 5-aminolaevulinic acid (ALA) PDT as treatment options for AK
of the scalp. Sixteen male patients aged 59-87 years with extensive scalp AK were
randomized into a double-blind, split-scalp prospective study. Two treatment fields
were defined (right and left frontoparietal scalp) and treated 2 weeks apart. These
fields were randomized to receive either MAL or ALA as first or second treatment.
MAL cream was applied for 3 h; 20% ALA cream was applied for 5 h. A blinded
observer assessed efficacy comparing AK counts before and 1 month after treatment.
Pain was assessed using a visual analogue scale at 3, 6, 12 and 16 min. Fifteen
patients completed treatment to both fields. There was a mean reduction from
baseline in AK counts with the use of ALA-PDT of 6.2 +/- 1.9 compared with 5.6 +/3.2 with MAL-PDT. All patients experienced pain which was of greater intensity in
the ALA-treated side at all time points. Similarly, duration of discomfort postprocedure persisted for longer following treatment with ALA when compared with
MAL-PDT. The authors concluded that both ALA-PDT and MAL-PDT result in a
significant reduction in scalp AK with no significant difference in efficacy. They also
noted that ALA-PDT is more painful than MAL-PDT in the treatment of extensive
scalp AK.
According to British Association of Dermatologists Therapy Guidelines and Audit on
the management of actinic keratoses, Photodynamic therapy is effective in up to
91% of AKs in trials comparing it with cryotherapy, with consistently good cosmetic
result.
Per the British Association of Dermatologists Guidelines for topical photodynamic
therapy:
Topical application of the prodrugs 5-aminolaevulinic acid (ALA) and methyl
aminolaevulinate (MAL) is effective in cutaneous photodynamic therapy (PDT)
(Strength of Recommendation A, Quality of Evidence I).
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Currently, a range of light sources, doses and irradiances continues to be
used in ALA-PDT, whereas in MAL-PDT the standard procedure now typically
involves a light-emitting diode (LED) source. A range of continuous wave light
sources is effective in topical PDT (Strength of recommendation A, Quality of
evidence II-iii).
Topical PDT is an effective therapy for thin and moderate thickness actinic
keratoses (AK), with superiority to cryotherapy depending on protocol.
Efficacy is relatively poorer for acral lesions, but PDT may still offer
therapeutic benefit. Cosmetic outcome following PDT for AK is superior to
cryotherapy (Strength of recommendation A, Quality of evidence I).
Scientific Rationale - Update May 2006
Actinic keratoses (AKs) are rough, scaly, or warty, pre-cancerous skin lesions that
occur primarily on sun-exposed skin surfaces. They are most common in older
individuals with fair complexions, with a prevalence of >80% in fair skinned people
over the age of 60. AKs appear as patches of hyperkeratosis with some surrounding
erythema on sun-exposed areas of the head and neck, forearms and hands, and
upper back. Treatment of AKs begins with prevention such as avoidance of sun
exposure along with the use of sunscreens in an effort to reduce the development of
AKs. Active treatment of AKs depends upon the size of the lesion and the number of
lesions present. Some physicians choose to observe the lesions over time and
remove them only if they exhibit specific clinical features suggesting possible
transformation to invasive squamous cell carcinoma (SCC).
The available treatments for actinic keratoses can generally be divided into surgical
and non-surgical methods. Surgical treatments used to treat one or a small number
of dispersed individual lesions include excision, cryosurgery, curettage (either alone
or combined with electrodesiccation), and laser surgery. Non-surgical treatments
include topical chemotherapy (5-fluorouracil or masoprocol creams), chemexfoliation
(also known as chemical peels), and dermabrasion. These methods are generally
used in patients with multiple lesions and the involvement of extensive areas of skin.
Under some circumstances, combinations of different treatment methods may be
used.
In 1999, Levulan Kerastick, a topical preparation of ALA, in conjunction with
illumination with the BLU-U Blue Light Photodynamic Therapy Illuminator, received
approval by the U.S. Food and Drug Administration (FDA) for the treatment of nonhyperkeratotic actinic keratoses of the face and scalp. The technique involves two
steps starting with application of the ALA Topical Solution in the physician's office.
The package insert recommends that the application should involve either face or
scalp lesions, but not both simultaneously. The patient is told to return in 14 to 18
hours, at which point the lesion is exposed to blue light for 17 minutes. During this
period, the patient experiences sensations of tingling, stinging, or burning of the
treated lesions. Treated lesions that have not completely resolved after 8 weeks may
be treated a second time.
As summarized in the package insert, two similarly designed studies randomized 243
patients with 4 to 15 non-hyperkeratotic actinic keratoses to receive Levulan
Kerastick plus blue light exposure or a vehicle solution plus blue light exposure. From
63% to 69% of patients in the active treatment group reported complete response at
8 weeks, compared to 13% to 14% in the placebo group. Patients who were not
complete responders after 8 weeks had retreatment of the persistent lesions. Among
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these patients 43% showed a complete response after a second treatment,
compared to only 4% in the placebo group.
Scientific Rationale – Initial
The term "benign" refers to a condition, tumor, or growth that is not cancerous. This
means that it does not spread to other parts of the body or invade and destroy
nearby tissue. Benign tumors usually grow slowly. In general, a benign tumor or
condition is not harmful. However, this is not always the case. If a benign tumor is
big enough, its size and weight can press on nearby blood vessels, nerves, or
organs, or otherwise cause problems. Benign skin lesions are common and are
frequently removed at the patient’s request to improve appearance. As such,
excision of benign skin lesions that do not pose a threat to health or function are
considered cosmetic.
Seborrheic keratoses, also referred to as senile keratoses, are non-cancerous
growths of the outer layer of skin. The origin is unknown. It commonly appears after
age 40. The tumors appear as wart-like growths in a variety of colors. They may
appear in large numbers on the surface of the body. They are usually painless and
benign, but may become irritated and itch. They are usually brown, but can vary in
color from beige to black, and vary in size from a fraction of an inch to more than an
inch in diameter. They have the appearance of being glued or stuck on to skin.
Seborrheic keratoses are most often found on the chest or back, although, they can
also be found almost anywhere on the body. These become more common with age,
and most elderly patients develop one or more of these lesions. Seborrheic keratoses
can get irritated by clothing rubbing against them, and their removal may be
appropriate if they itch, get irritated, or bleed easily. Although seborrheic keratoses
are noncancerous, they may be difficult to distinguish from skin cancer if they turn
black. Diagnosis is based primarily on the appearance of the growths. A skin lesion
biopsy may be used to confirm the diagnosis. Seborrheic keratoses may be removed
by cryosurgery, curretage, or electrosurgery. Particular growths usually do not recur
after removal, but people who are prone to this condition may develop more in the
future.
Moles (nevi) are very common growths on the skin and can appear anywhere on the
skin. Melanocytes are spread evenly throughout the skin and produce the pigment
that gives skin its natural color. When skin is exposed to the sun, melanocytes
produce more pigment, causing the skin to tan, or darken in a cluster with tissue
surrounding them. They are usually brown in color, but can be skin colored or pink,
light tan to brown, or blue-black. Moles may be flat or raised and can be various
sizes and shapes and no larger than a pencil eraser. Most appear during the first 20
years of a person's life, although some may not appear until later in life. Sun
exposure increases the number of moles. The majority of moles are benign.
However, moles that raise suspicion of malignancy are those that significantly
change in size, shape or color, and those that bleed, itch, or become painful. Atypical
moles (dysplastic nevi) have an increased risk of developing into melanoma. Atypical
moles are larger than average (> 6 mm) and irregular in shape. They tend to have
uneven color with dark brown centers and lighter, sometimes reddish, uneven
borders or black dots at edge. The most common methods of removal include
shaving and excision.
A sebaceous (keratinous) cyst is a slow-growing, closed sac found just under the
skin containing "pasty" or "cheesy" looking skin secretions. The sebaceous cyst is
firm, globular, movable, and nontender. These cysts seldom cause discomfort unless
12
the cyst ruptures or becomes infected. Ranging in size, sebaceous cysts are usually
found on the scalp, face, ears, and genitals. They are formed when the release of
sebum from the sebaceous glands in the skin is blocked. Unless they become
infected and painful or large, sebaceous cysts do not require medical attention or
treatment, and usually go away on their own. These cysts may occasionally become
infected and form into painful abscesses. Infected cysts can be incised and drained,
or the entire cyst may be surgically removed. Recurrence after excision is also not
unusual.
A skin tag (arochordon) is a small growth of tissue that is painless, soft, and
moveable. It hangs from the surface of the skin on a thin piece of tissue called a
stalk. The prevalence of skin tags increases with age. They appear most often in skin
folds of the neck, armpits, trunk, beneath the breasts or in the genital region. They
may become painful if thrombosed or if irritated. They may become irritated if they
occur in an area where clothing or jewelry rubs against them. Skin tags may be
removed by excision, cryosurgery, or electrosurgery.
Warts (verruca vulgaris) are simply areas of skin that grow faster than normal due to
the presence of the wart virus. Warts are skin-colored and feel rough to the touch.
They are most common on the hands, feet and face but they can grow almost
anywhere in the body. They are infectious and some people, especially children, are
more susceptible than others. Flat warts are much smaller and are less rough than
hand or foot warts. They tend to grow in great numbers - 20 to 100 at any one time.
They can occur anywhere, but in children they are most common on the face. In
adults they are most often found in the beard area in men and on the legs in women.
Skin irritation from shaving probably accounts for this. A plantar wart is simply a
wart growing on the weight-bearing surface of the foot that grows inward rather than
outwards because it is pressed on when a person walks.
As warts are caused by a virus infection, the body will build up resistance over a
period of time and eventually the body will cause the warts to disappear. This may
take months or sometimes years but is the natural way the body deals with warts. If
they are allowed to disappear in this way it is less likely that a person will get any
further ones as one will then be immune to that virus. The first treatment to try on
warts is removal with a salicylic acid liquid or pad. A bottle of wart medication like
Occlusal-HP or Compound W, a roll of 1-inch surgical tape ('Micropore' or 'Blenderm'
are good) and a pumice stone or emery board can be tried next. One needs to keep
going down until just below the level of the surrounding skin to eradicate a wart
completely. When the base of the wart looks exactly like normal skin (i.e. no black
dots or 'graininess), medication can be stopped. Liquid nitrogen cryotherapy is what
dermatologists use most often to cure warts. This method can cause pain, soreness
and blistering and usually cures 50% of warts after one treatment. Frequent
applications of liquid nitrogen are needed to cure more stubborn warts. Burning
warts off with a CO2 Laser or electric needle is often effective, but scars may result.
HCPCS Codes
N/A
Review History
June 8, 2004
May 2006
March 2007
August 2008
Medical Advisory Council, initial approval
Change in position on treatment of Actinic Keratoses
Code Update
CA reconstructive surgery law added to disclaimer
13
September 2009
November 2009
January 2011
September 2011
Added PDT with topical Metvixia, followed by exposure to a red
light source as medically necessary for treatment of Actinic
Keratoses, when criteria is met for commercial members.
Added separate Medicare criteria.
Removed requirement of topical 5-FU or cryosurgery prior to
photodynamic therapy with topical aminolevulinic acid (Levulan
Kerastick) and exposure to blue light for non-hyperkeratotic
actinic keratoses of the face and scalp.
Added Medicare LCD link. No revisions.
Update. Added Revised Medicare Table. No Revisions.
Patient Education Websites
English
1. American Academy of Dermatology. What are Actinic Keratoses. Available at:
http://www.skincarephysicians.com/actinickeratosesnet/whatare.html
Spanish
1. National Cancer Institute. Skin Cancer (PDQ): Treatment. Acesso en:
http://www.cancer.gov/espanol/pdq/tratamiento/piel/patient
This policy is based on the following evidence-based guidelines:
1.
2.
3.
4.
National Institute for Health and Clinical Excellence. Photodynamic Therapy for
Non-Melanoma Skin Tumors (Including Premalignant and Primary NonMetastatic Skin Lesions.) February 2006. Available at:
http://www.nice.org.uk/page.aspx?o=IPG155guidance
Morton CA, McKenna KE, Rhodes LE, British Association of Dermatologists
Therapy Guidelines and Audit Subcommittee. Guidelines for topical
photodynamic therapy: update. Br J Dermatol 2008 Dec; 159(6): 1245-66.
Available at:
http://www.guideline.gov/summary/summary.aspx?ss=15&doc_id=13568&nbr=
006940&string=photodynamic+AND+therapy
de Berker D, McGregor JM, Hughes BR, British Association of Dermatologists
Therapy Guidelines and Audit. Guidelines for the management of actinic
keratoses. Br J Dermatol 2007 Feb; 156(2): 222-30. Available at:
http://www.guideline.gov/summary/summary.aspx?doc_id=10831&nbr=005656
&string=actinic+AND+keratosis
McIntyre W, Downs M, Bedwell S. Treatment Options for Actinic Keratoses. Am
Fam Physician 2007;76:667-71, 672. Available at:
http://www.aafp.org/afp/20070901/667.html
References – Updated September 2011
1.
2.
3.
4.
Goldstein BG, Goldstein AO. Overview of benign lesions of the skin. September
2, 2010. Available at: http://www.uptodate.com/contents/overview-of-benignlesions-of-the-skin?view=print
Kumaraswamy KL, Vidhya M. Human papilloma virus and oral infections: An
update. J Cancer Res Ther. 2011 Apr-Jun;7(2):120-7.
Argenziano G, Zalaudek I, Hofmann-Wellenhof R, et al. Total body skin
examination for skin cancer screening in patients with focused symptoms. J Am
Acad Dermatol. 2011 Jul 12. [Epub ahead of print].
Matteucci P, Pinder R, Magdum A, et al. Accuracy in skin lesion diagnosis and the
exclusion of malignancy. J Plast Reconstr Aesthet Surg. 2011 Jul 6. [Epub ahead
of print]
14
References – Updated September 2009
1. Annemans L, Caekelbergh K, Roelandts R et al. Real-life practice study of the
clinical outcome and cost-effectiveness of photodynamic therapy using methyl
aminolevulinate (MAL-PDT) in the management of actinic keratosis and basal cell
carcinoma. Eur J Dermatol. 2008 Sep-Oct; 18(5): 539-46.
2. Braathen LR, Paredes BE, Saksela O, et al. Short incubation with methyl
aminolevulinate for photodynamic therapy of actinic keratoses. J Eur Acad
Dermatol Venereol. 2009 May; 23(5): 550-5.
3. Fernández-Guarino M, Harto A, Sánchez-Ronco M, et al. Retrospective,
descriptive, observational study of treatment of multiple actinic keratoses with
topical methyl aminolevulinate and red light: results in clinical practice and
correlation with fluorescence imaging. Actas Dermosifiliogr. 2008 Dec; 99(10):
779-87.
4. Hayes Medical Technology Directory. Photodynamic Therapy for Actinic
Keratoses. May 2004. Updated Oct. 2008.
5. Kasche A, Luderschmidt S, Ring J, Hein R. Photodynamic therapy induces less
pain in patients treated with methyl aminolevulinate compared to aminolevulinic
acid. J Drugs Dermatol. 2006 Apr; 5(4): 353-6.
6. Kaufmann R, Spelman L, Weightman W et al. Multicentre intraindividual
randomized trial of topical methyl aminolaevulinate-photodynamic therapy vs.
cryotherapy for multiple actinic keratoses on the extremities. Br J Dermatol.
2008 May; 158(5): 994-9
7. Lehmann P. Methyl aminolaevulinate-photodynamic therapy: a review of clinical
trials in the treatment of actinic keratoses and nonmelanoma skin cancer. Br J
Dermatol. 2007 May; 156(5): 793-801
8. Moloney FJ, Collins P. Randomized, double-blind, prospective study to compare
topical 5-aminolaevulinic acid methylester with topical 5-aminolaevulinic acid
photodynamic therapy for extensive scalp actinic keratosis. Br J Dermatol. 2007
Jul; 157(1): 87-91
9. Morton C, Campbell S, Gupta G, et al. Intraindividual, right-left comparison of
topical methyl aminolaevulinate-photodynamic therapy and cryotherapy in
subjects with actinic keratoses: a multicentre, randomized controlled study. Br J
Dermatol 2006; 155:1029.
10. Morton, CA. Methyl aminolevulinate: actinic keratoses and Bowen's disease.
Dermatol Clin 2007; 25:81Ortiz-Policarpio B, Lui H. Methyl aminolevulinate-PDT
for actinic keratoses and superficial nonmelanoma skin cancers. Skin Therapy
Lett. 2009 Jul-Aug; 14(6): 1-3.
11. Pariser D, Loss R, Jarratt M et al. Topical methyl-aminolevulinate photodynamic
therapy using red light-emitting diode light for treatment of multiple actinic
keratoses: A randomized, double-blind, placebo-controlled study. J Am Acad
Dermatol. 2008 Oct; 59(4): 569-76.
12. Piacquadio DJ, Chen DM, Farber HF et al. Photodynamic therapy with
aminolevulinic acid topical solution and visible blue light in the treatment of
multiple actinic keratoses of the face and scalp: investigator-blinded, phase 3,
multicenter trials. Arch Dermatol. 2004 Jan;140(1):41-6
13. Smith S, Piacquadio D, Morhenn V et al. 3: Short incubation PDT versus 5-FU in
treating actinic keratoses. J Drugs Dermatol. 2003 Dec;2(6):629-35.
14. Smits T, Moor AC. New aspects in photodynamic therapy of actinic keratoses.
15. J Photochem Photobiol B. 2009 Jun 13
16. Szeimies RM, Matheson RT, Davis SA et al. Topical methyl aminolevulinate
photodynamic therapy using red light-emitting diode light for multiple actinic
keratoses: a randomized study. Dermatol Surg. 2009 Apr; 35(4): 586-92
15
17. Tarstedt M, Rosdahl I, Berne B et al. A randomized multicenter study to compare
two treatment regimens of topical methyl aminolevulinate (Metvix)-PDT in actinic
keratosis of the face and scalp. Acta Derm Venereol. 2005; 85(5): 424-8.
18. Tschen EH, Wong DS, Pariser DM et al. Photodynamic therapy using
aminolaevulinic acid for patients with nonhyperkeratotic actinic keratoses of the
face and scalp: phase IV multicentre clinical trial with 12-month follow up. Br J
Dermatol. 2006 Dec; 155(6): 1262-9.
19. Tschen EH, Wong DS, Pariser DM et al. 1: Photodynamic therapy using
aminolaevulinic acid for patients with nonhyperkeratotic actinic keratoses of the
face and scalp: phase IV multicentre clinical trial with 12-month follow up. Br J
Dermatol. 2006 Dec;155(6):1262-9.
20. United States Food and Drug Administration. Metvixia. Available at:
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Se
arch.DrugDetails
21. Wennberg AM, Stenquist B, Stockfleth E, et al. Photodynamic therapy with
methyl aminolevulinate for prevention of new skin lesions in transplant
recipients: a randomized study. Transplantation. 2008 Aug 15; 86(3): 423-9.
22. Centers for Medicare and Medicaid Services. NCD for Treatment of Actinic
Keratosis (AKs). Nov. 2001 Available at:
23. http://www.cms.hhs.gov/mcd/viewncd.asp?ncd_id=250.4&ncd_version=1&baske
t=ncd%3A250%2E4%3A1%3ATreatment+of+Actinic+Keratosis+%28AKs%29
24. Centers for Medicare and Medicaid Services. LCD for Removal of Benign Skin
Lesions. July 2009. Available at:
http://www.cms.hhs.gov/mcd/viewlcd.asp?lcd_id=27362&lcd_version=22&baske
t=lcd%3A27362%3A22%3ARemoval+of+Benign+Skin+Lesions%3AMAC+%2D+
Part+A%3ANational+Government+Services%7C%7C+Inc%2E+%2813101%29
%3A
References – Updated May 2006
1. Babilas P, Karrer S, Sidoroff A, et al. Photodynamic therapy in dermatology--an
update. Photodermatol Photoimmunol Photomed. 2005 Jun;21(3):142-9.
2. US. Food and Drug Administration. Levulan Kerastick. Accessed May 2006.
Available at: http://www.fda.gov/cder/foi/label/1999/20965lbl.pdf
3. Hayes Alert - Technology Assessment Brief. Photodynamic Therapy for Acne
Vulgaris.Volume VIII, Number 8 - August 2005. Accessed May 2006. Available
at: http://www.hayesinc.com/subscribers/searchArticles.do
4. Garcia-Zuazaga J, Cooper KD, Baron ED. Photodynamic therapy in dermatology:
current concepts in the treatment of skin cancer. Expert Rev Anticancer Ther.
2005 Oct;5(5):791-800
5. Gilaberte Y, Serra-Guillen C, De Las Heras ME, et al. Photodynamic therapy in
dermatology. Actas Dermosifiliogr. 2006 Mar;97(2):83-102
6. Gold MH, Nestor MS. Current treatments of actinic keratosis. J Drugs
Dermatol. 2006 Feb;5(2 Suppl):17-25.
7. Jeffes, EW, McCullough, JL, Weinstein, GD, et al. Photodynamic therapy of actinic
keratoses with topical aminolevulinic acid hydrochloride and fluorescent blue
light. J Am Acad Dermatol 2001; 45:96.
8. Kasche A, Luderschmidt S, Ring J, Hein R. Photodynamic therapy induces less
pain in patients treated with methyl aminolevulinate compared to aminolevulinic
acid. J Drugs Dermatol. 2006 Apr;5(4):353-6.
9. Langan SM, Collins P. Randomized, double-blind, placebo-controlled prospective
study of the efficacy of topical anaesthesia with a eutetic mixture of lignocaine
2.5% and prilocaine 2.5% for topical 5-aminolaevulinic acid-photodynamic
16
therapy for extensive scalp actinic keratoses. Br J Dermatol. 2006
Jan;154(1):146-9.
10. Melnick S. Cystic acne improved by photodynamic therapy with short-contact 5aminolevulinic acid and sequential combination of intense pulsed light and blue
light activation. J Drugs Dermatol. 2005 Nov-Dec;4(6):742-5.
11. Radakovic-Fijan S, Blecha-Thalhammer U, Kittler H, et al. Efficacy of 3 different
light doses in the treatment of actinic keratosis with 5-aminolevulinic acid
photodynamic therapy: a randomized, observer-blinded, intrapatient, comparison
study. J Am Acad Dermatol. 2005 Nov;53(5):823-7.
12. Sekula-Gibbs S, Uptmore D, Otillar L. Retinoids. J Am Acad Dermatol. 2004
Mar;50(3):405-15
13. Zakhary K, Ellis DA. Applications of aminolevulinic Acid-based photodynamic
therapy in cosmetic facial plastic practices. Facial Plast Surg. 2005
May;21(2):110-6.
References - Initial
1. Luba MC, M.D., Bangs SA. Common Benign Skin Tumors. Am Fam Physician
2003;67:729-38.
2. Andrews MD. Cryosurgery for common skin conditions. Am Fam Physician. 2004
May 15;69(10):2365-72.
3. Kelley LC, Hruza GJ. Benign skin tumors. Facial Plast Surg Clin North Am. 2003
May;11(2):243-51.
4. De Gannes GC, Ip JL, Martinka M, et al. Early Detection of Skin Cancer by Family
Physicians: A Pilot Project. J Cutan Med Surg. 2004 Mar 25
5. Beers MH, Berkow R, eds. Disorders of hair follicles and sebaceous glands:
Keratinous cyst. In: The Merck Manual of Diagnosis and Therapy. 17th ed. Sec.
10, Ch. 116. White House Station, NJ: Merck; 2002.
6. Berg P, Lindelof B. Congenital nevocytic nevi: Follow-up of a Swedish birth
register sample regarding etiologic factors, discomfort, and removal rate. Pediatr
Dermatol. 2002;19(4):293-297.
7. Bader RS, Scarborough DA. Surgical pearl: intralesional electrodesiccation of
sebaceous hyperplasia. J Am Acad Dermatol 2000;42(1 Pt 1):127-8.
8. Christenson L, Patterson J, Davis D. Surgical pearl: use of the cutaneous punch
for the removal of lipomas. J Am Acad Dermatol 2000;42:675-6.
9. Dinehart SM. Actinic keratoses: scientific evaluation and public health
implications. Journal of the American Academy of Dermatology. 2000;42(1):25-8
10. Plunkett A, Merlin K, Gill D, Zuo Y, Jolley D, Marks R. The frequency of common
nonmalignant skin conditions in adults in central Victoria, Australia. Int J
Dermatol 1999;38:901-8.
11. Rosenthal TC, Kraybill W. Soft tissue sarcomas: integrating primary care
recognition with tertiary care center treatment. Am Fam Physician 1999;60: 56772.
12. Feldman SR, Fleischer AB, Williford PM, Jorizza JL. Clinical and laboratory studies;
destructive procedures are the standard of care for treatment of actinic
keratoses. Journal of the American Academy of Dermatology. 1999;40(1):43-7
13. Signorini M, Campiglio GL. Posttraumatic lipomas: where do they really come
from? Plast Reconstr Surg 1998;101:699-705.
14. Pariser RJ. Benign neoplasms of the skin. Med Clin North Am 1998;82:1285-307.
15. Manstein CH, Frauenhoffer CJ, Besden JE. Keratoacanthoma: is it a real entity?
Ann Plast Surg 1998;40:469-72.
16. Canas GC, Robson KJ, Arpey CJ. Persistent keratoacanthoma: challenges in
management. Dermatol Surg 1998;24:1364-9.
17
17. Miller AM, Sahl WJ, Brown SA, Young SK, Quinlan CM, Patel PR, et al. The role of
human papillomavirus in the development of pyogenic granulomas. Int J
Dermatol 1997;36:673-6.
18. Requena L, Sangueza OP. Cutaneous vascular proliferation. Part II. Hyperplasias
and benign neoplasms. J Am Acad Dermatol 1997;37:887-919.
19. Callen JP, Bickers DR, Moy RL. From the academy; actinic keratoses. Journal of
the American Academy of Dermatology. 1997;36(4):650-3
20. Drake LA et al. Academy guidelines: guidelines of care for
photoaging/photodamage. Journal of the American Academy of Dermatology.
1996;35(3):462-464
21. de Berker DA, Taylor AE, Quinn AG, Simpson NB. Sebaceous hyperplasia in organ
transplant recipients: shared aspects of hyperplastic and dysplastic processes? J
Am Acad Dermatol 1996;35(5 Pt 1):696-9.
22. Weiss SW. Lipomatous tumors. Monogr Pathol 1996;38:207-39.
23. Schwartz RA. Keratoacanthoma. J Am Acad Dermatol 1994;30:1-19.
24. Rosian R, Goslen JB, Brodell RT. The treatment of benign sebaceous hyperplasia
with the topical application of bichloracetic acid. J Dermatol Surg Oncol
1991;17:876-9.
25. Patrice SJ, Wiss K, Mulliken JB. Pyogenic granuloma (lobular capillary
hemangioma): a clinicopathologic study of 178 cases. Pediatr Dermatol
1991;8:267-76.
26. Scott MA. Benign cutaneous neoplasms. Prim Care 1989;16:645-63.
27. Lanigan SW, Robinson TW. Cryotherapy for dermatofibromas. Clin Exp Dermatol
1987;12:121-3.
28. Rydholm A, Berg NO. Size, site and clinical incidence of lipoma. Factors in the
differential diagnosis of lipoma and sarcoma. Acta Orthop Scand 1983;54:929-34.
29. Myhre-Jensen O. A consecutive 7-year series of 1331 benign soft tissue tumours.
Clinicopathologic data. Comparison with sarcomas. Acta Orthop Scand
1981;52:287-93.
30. Taira JW, Hill TL, Everett MA. Lobular capillary hemangioma (pyogenic
granuloma) with satellitosis. J Am Acad Dermatol 1992;27(2 Pt 2):297-300.
31. Gonzalez S, Vibhagool C, Falo LD Jr, Momtaz KT, Grevelink J, Gonzalez E.
Treatment of pyogenic granulomas with the 585 nm pulsed dye laser. J Am Acad
Dermatol 1996;35(3 Pt 1):428-31.
32. Crile G Jr. Thirteen shortcuts in office surgery. Surg Clin North Am
1975;55:1025-9.
33. Zuber TJ. Minimal excision technique for epidermoid (sebaceous) cysts. Am Fam
Physician 2002; 65:1409-12.
Important Notice
General Purpose.
Health Net's National Medical Policies (the "Policies") are developed to assist Health Net in administering
plan benefits and determining whether a particular procedure, drug, service or supply is medically
necessary. The Policies are based upon a review of the available clinical information including clinical
outcome studies in the peer-reviewed published medical literature, regulatory status of the drug or device,
evidence-based guidelines of governmental bodies, and evidence-based guidelines and positions of select
national health professional organizations. Coverage determinations are made on a case-by-case basis
and are subject to all of the terms, conditions, limitations, and exclusions of the member's contract,
including medical necessity requirements. Health Net may use the Policies to determine whether under the
facts and circumstances of a particular case, the proposed procedure, drug, service or supply is medically
necessary. The conclusion that a procedure, drug, service or supply is medically necessary does not
constitute coverage. The member's contract defines which procedure, drug, service or supply is covered,
excluded, limited, or subject to dollar caps. The policy provides for clearly written, reasonable and current
criteria that have been approved by Health Net’s National Medical Advisory Council (MAC). The clinical
criteria and medical policies provide guidelines for determining the medical necessity criteria for specific
18
procedures, equipment, and services. In order to be eligible, all services must be medically necessary and
otherwise defined in the member's benefits contract as described this " Important Notice" disclaimer. In all
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any conflicts between medical policy guidelines and applicable contract language, the contract language
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For information regarding the effective dates of Policies, contact your provider
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The Policies do not constitute medical advice. Health Net does not provide or recommend treatment to
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The Policies do not constitute authorization or guarantee of coverage of particular procedure, drug, service
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Reconstructive Surgery.
California Health and Safety Code 1367.63 requires health care service plans to cover reconstructive
surgery. “Reconstructive surgery” means surgery performed to correct or repair abnormal structures of
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Reconstructive surgery does not mean “cosmetic surgery," which is surgery performed to alter or reshape
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19

National Medical Policy

Transcription

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