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Title XVIII of the
Social Security Act; Section 1862(a)(1)(A). This section allows coverage
and payment for only those services that are considered to be reasonable
and necessary. Reasonable and necessary items or services are those used in
the diagnosis and treatment of illness or injury or to improve the function
of a malformed body part.
Title XVIII of the Social Security Act; Section 1833(e). No payment shall
be made unless there has been information (documentation) furnished to determine
that services were provided as billed.
Federal Register, Vol. 64. No 112/Tuesday, November 2, 1999/Rules and
regulations page 59426
Federal Register, Vol 67, No. 212, November 1, 2002. Changes to the
Hospital Outpatient Prospective Payment System (OPPS) and Calendar Year
Payment Rates.
42 CFR, Part 419, Medicare regulations governing Hospital OPPS.
Coverage Issues Manual 35-10 Hyperbaric Oxygen Therapy
Coverage Issues Manual 35-31 Treatment of Decubitus Ulcers
Coverage Issues Manual 35-98 Electronic Stimulation in the Treatment of
Wounds
Coverage Issues Manual 35-102 Electrical Stimulation for the Treatment of
Wounds (Effective for services on or after April 1, 2003)
Coverage Issues Manual 45-26 Platelet Derived Wound Healing Formula
Coverage Issues Manual 60-25 Noncontact Normothermic Wound Therapy (NNWT)
CMS Pub 100-4, 5-§§10, 10.1, 20-20.4, 40.2-40.5, 50, 100.3, 100.4, 100.7,
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100-4, Addendum A, 10-30
Program Memorandum AB-01-186, December 18, 2001
Program Memorandum AB-01-68, May 1, 2001
Program Memorandum AB-02-025, February 15, 2002
Program Memorandum AB-02-161, November 8, 2002
Program Memorandum A-02-129, January 3, 2003
Program Memorandum AB-03-057, May 02, 2003
Program Memorandum AB-03-073, May 23, 2003
Medicare Intermediary Manual, Part 3, Claims process, Transmittal 1828,
April 5, 2001
CMS Pub 100-2, 7-§40.2
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This policy addresses the non-operative care of wounds, including,
but not limited to ulcers, burns, pressure ulcers, open surgical sites,
fistulas, tube sites and tumor erosion sites when the skills of a licensed
therapist, qualified enterostomal therapy nurse, nurse or
physician/physician extender are required to safely and effectively provide
the care necessary for their treatment.
Wound healing involves several factors and is influenced by the severity of
the injury. Partial thickness wounds penetrate the epidermis and involve
the dermis. These wounds heal by reepithelialization, which is horizontal
movement of epidermal cells across the surface that is injured. Healing
also requires collagen synthesis and adequate nutrition. A full thickness
wound involves the epidermis and dermis and may include subcutaneous
tissue, muscle, tendon, and bone. Full thickness wounds normally heal by
means of hemostasis, inflammation, proliferation and maturation.
Wound care involves evaluation and treatment of a wound. Wound care thus
involves identifying potential causes of delayed wound healing and
modification of treatment as directed by the certifying physician.
Determining the agent of delayed wound healing such as vascular disease,
infection, diabetes or other metabolic disorders, immunosuppression,
unrelieved pressure, radiation injury and malnutrition will help determine
the course of treatment. Evaluations could include comprehensive medical
evaluation, vascular evaluation, orthopedic evaluation and
metabolic/nutritional evaluation leading to a plan of care. The plan may
include metabolic corrections including dietary supplementation,
specialized wound care, debridement and reconstruction, rehabilitation
therapy, possible general, vascular and/or orthopedic surgery, and
antimicrobial agents.
In order to be covered under Medicare, a service must be reasonable and
necessary. Among the requirements for a reasonable and necessary service
are that the service be safe and effective, furnished in the appropriate
setting, and ordered and/or furnished by qualified personnel.
This policy does not address metabolically active human skin
equivalent/substitute dressings such as Apligraf, Dermagraft, or Orcel.
Indications and Limitations
The coverage of services of nurses, including enterostomal nurses, and
therapists in the performance of wound care will depend on the specific
scope of practice formulated by each state.
Standard wound care includes assessment of a patient’s vascular status and
correction of any vascular problems in the affected area, controlling
infection, optimization of nutritional status (including glucose control),
and debridement by appropriate means to remove devitalized tissue. Patients
with grade 3 through 5 wounds should have vascular and/or orthopedic
surgery consultations in their documentation. In special circumstances of
diabetic ulcers/infection/gangrene of Wagner Cianci grade 3 through 5,
hyperbaric oxygen treatment (CIM 35-10) may be beneficial. Documentation by
photographs is recommended of wounds higher than grade one.
Reasonable and Necessary Wound Care:
Medicare coverage for wound care on a continuing basis for a given wound in
a given patient is contingent upon evidence documented in the patient's
record that the wound is improving in response to the wound care being
provided. It is neither reasonable nor medically necessary to continue a given
type of wound care if evidence of wound improvement cannot be shown.
Evidence of improvement includes measurable changes in at least some of the
following:
- Drainage
- Inflammation
- Swelling
- Pain
- Wound dimensions (diameter, depth)
- Granulation tissue
- Necrotic tissue/slough
Such evidence must be documented weekly. A wound that shows no improvement
after 30 days requires a new approach, which may include a physician
reassessment of underlying infection, metabolic, nutritional, or vascular
problems inhibiting wound healing, or a new treatment approach.
In rare instances, the goal of wound care provided in outpatient settings
may be only to prevent progression of the wound, which, due to severe
underlying debility or other factors such as inoperability, is not expected
to improve.
Active Wound Care Management:
Active wound care procedures are performed to remove devitalized tissue and
promote healing, and involve selective and non-selective debridement
techniques.
1. Wound Care Selective - HCPCS 97597, 97598:
Debridement is indicated whenever necrotic tissue is present on an open
wound. Debridement may also be indicated in cases of abnormal wound healing
or repair. Debridement techniques usually progress from non-selective to
selective but can be combined. Debridement will not be considered a
reasonable and necessary procedure for a wound that is clean and free of
necrotic tissue.
Note: Selective debridement should only be done under the specific order of
a physician.
a. Conservative Sharp Debridement: Conservative sharp debridement is
the classical method of selective wound debridement. Conservative sharp
debridement is a minor procedure that typically requires no anesthesia.
Scalpel, scissors and tweezers/forceps may be used and only clearly
identified devitalized tissue is removed. Generally, there is no bleeding
associated with this procedure.
b. High Pressure Water Jet: Lavage (non-immersion high pressure
hydrotherapy) is an irrigation device, with or without pulsation, used to
provide a water jet to administer a shearing effect to loosen debris,
within a wound. Some electric pulsatile irrigation devices include suction
to remove debris from the wound after it is irrigated. (Do not report
97597, 97598, 97602 in addition to 11040-11044) High pressure lavage
constitutes selective debridement only when specifically ordered by the
physician and when the medical record documents both a need for selective
debridement in place of non-selective techniques. Typically this is due to
either a failure of non-selective techniques to adequately clean the wound
or a real risk of damage by non-selective techniques. The documentation
must specify the location, amount and quality of debris prior to removal.
The use of a high pressure water jet does not, of itself, imply necessity
for selective debridement, and selective debridement is not expected to be
a necessary part of every routine wound care visit.
2. Wound Care Non-Selective - HCPCS 97602:
a. Blunt Debridement: The removal of necrotic tissue by cleansing,
scraping, chemical application or wet to dry dressing technique. It may
also involve the cleaning and dressing of small or superficial lesions.
Generally this is not a skilled service and does not require the skills of
a therapist, enterostomal nurse, or nurse.
b. Enzymatic Debridement: Debridement with topical enzymes is used
when the necrotic substances to be removed from a wound are protein, fiber
and collagen. The manufacturers’ product insert contains indications,
contraindications, precautions, dosage and administration guidelines; it
would be the clinician’s responsibility to comply with those guidelines.
c. Autolytic Debridement: This type of debridement is indicated
where manageable amounts of necrotic tissue are present, and there is no infection.
Autolytic debridement occurs when the enzymes that are naturally found in
wound fluids are sequestered under synthetic dressings; it is
contraindicated for infected wounds.
d. Mechanical Debridement: Wet-to-dry dressings may be used with
wounds that have a high percentage of necrotic tissue. Wet-to-dry dressings
should be used cautiously as maceration of surrounding tissue may hinder
healing.
e. Jet Hydrotherapy and Wound Irrigation: Mechanical debridement is
used to remove necrotic tissue. They also should be used cautiously as
maceration of surrounding tissue may hinder healing. Documentation must
support the use of skilled personnel in order to be a covered service.
3. Whirlpool – HCPCS 97022
Whirlpool provides a means where a wound can be submerged in water and, if
appropriate, additive agent for cleansing. Whirlpool is a covered Medicare
procedure if medically necessary for the healing of the wound. Generally,
whirlpool treatments do not require the skills of a therapist to perform. The
skills of a physical therapist may be required to perform an accurate
assessment of the patient and the wound to assure the medical necessity of
the whirlpool for the specific wound type. Documentation must support the
use of skilled personnel in order to be a covered service. The skills,
knowledge and judgment of a qualified physical therapist might be required
when the patient's condition is complicated by circulatory deficiency,
areas of desensitization, complex open wounds, and fractures (MIM 3118.2.B.7).
Immersion in the whirlpool to facilitate removal of a dressing would not be
considered a skilled treatment modality and would not be billable.
Dressings:
Wet dressings: Water and medication can be applied to the skin with
dressings (finely woven cotton, linen, or gauze) soaked in solution. Wet
compresses, especially with frequent changes, provide gentle debridement.
These dressings are specifically effective for moist, oozing and weeping
lesions.
Dry dressings: Used to protect the skin, hold medications against
the skin, keep clothing and sheets from rubbing, or keep dirt and air away.
Such dressings also prevent patients from scratching or rubbing.
Occlusive dressings: Used with increasing frequency in the treatment
of acute wounds, chronic venous, diabetic and pressure ulcers. A variety of
dressings are available including films, non-transparent adhesive
hydrocolloids, and semitransparent non-adhesive hydrogels, all of which
enhance wound healing.
Dressing changes alone usually do not require the skills of physical
therapists, occupational therapists or enterostomal nurses and in fact are
usually performed by non-providers (nurses). More significantly, dressing
changes are not part of the therapy benefit but must be provided incident
to the physician’s service. Dressing changes are therefore not billed
independently but must be incorporated with another service. At the
minimum, a dressing change might be associated with a brief E&M visit
(99211). Documentation must support the need for the skilled intervention
and the provision of the dressing change incident to the physician service.
Supportive Services:
1. Electrical Stimulation - HCPCS 97032, G0281, G0282:
Electrical stimulation (ES) has been used or studied for many different
applications, one of which is accelerating wound healing. The types of ES
used for healing chronic venous and arterial wound and pressure ulcers are
direct current (DC), alternating current (AC), pulsed current (PC), pulsed
electromagnetic induction (PEMI), and spinal cord stimulation (SCS). An
example of AC is transcutaneous electrical stimulation (TENS). The pulsed
electromagnetic (PEM) types include Pulsed Electromagnetic Field (PEMF) and
Pulsed Electromagnetic Energy (PEE) using pulsed radio frequency energy, both
of which are non-thermal i.e., they do not produce heat. Some ES use
generators to create energy in the radio frequency band, delivered in
megahertz (MHz). They typically deliver energy by contacting means such as
coils, rather than by leads or surface electrodes.
High voltage pulsed current, also called electrogalvanic stimulation, may
be useful for the reduction of swelling and the control of pain. Its uses
in the treatment of wounds and ulcers are limited and will be reviewed on a
case-by-case basis.
Electrical stimulation will not be covered as an initial treatment
modality. The use of electrical stimulation will only be covered after
appropriate standard wound care (see standard wound care description at end
of this section) has been tried for at least 30 days and there are no
measurable signs of healing. Electrical stimulation is covered only for
diabetic ulcers, arterial ulcers, venous stasis ulcers, and pressure ulcers
involving full thickness of skin or greater (PM AB-02-161, CR 2313,
11/8/2002; CIM 35-102, 4/1/2003)
Constant attendance electrical stimulation (97032)is appropriately used
only when continuous visual, verbal or physical contact is required during
the therapy. This level of attendance is never medically necessary during
electrical stimulation for wound care [PM AB –03-093]. 97032 is therefore
not covered in the setting of wound care.
2. Electromagnetic therapy - HCPCS G0295:
Electromagnetic therapy in any form is not covered [PM AB-03-093].
3. Infrared Application - HCPCS 97026:
Heat treatments ordinarily do not require the skills of a qualified
physical therapist. However, in a particular case, the skills, knowledge
and judgment of a qualified physical therapist might be required for such
treatments or baths (e.g., where the patient's condition is complicated by
circulatory deficiency, areas of desensitization, open wounds, fractures or
other complications). However, heat treatments in the setting of open
wounds used to promote healing are not medically necessary as the evidence
is not sufficient to show that this service is effective (see CIM 60-25).
4. Hyperbaric Oxygen - HCPCS C1300, 99183:
Hyperbaric oxygen therapy is addressed in Coverage Issues Manual 35-10. It
is covered for refractory diabetic wound of the lower extremities that are
at least Wagner Grade III. Refer to CIM 35-10 for a complete discussion of
indications.
5. Platelet-derived wound healing preparations:
Platelet derived wound healing preparations are considered investigational
and not covered as medical efficacy has not been established (CIM 45-26).
6. Ultraviolet therapy - HCPCS 97028:
Ultraviolet therapy does not have established medical efficacy in wound
healing, nor does it require the skills of a qualified therapist.
Ultraviolet therapy is medically necessary for the treatment of many
chronic skin conditions but it is not covered in the context of wound
healing.
Assessments – HCPCS 97001,
97002 and 99202,
99211:
1. Initial Assessment: The initial patient assessment constitutes a
primary service and cannot be rendered “incident to” a physician service
since no physician service has yet occurred. The initial assessment can
therefore only be provided by a physician or physician extender (99202) or
by a therapist (97001). Wound care nurses who are not Medicare
practitioners may not provide an initial assessment.
2. Follow-up assessment: A follow-up wound assessment is typically
provided in association with a wound care service. In those instances the
assessment is bundled with the primary service and should not be billed
separately. On rare occasions a follow-up assessment may be indicated on a
weekly basis if no other skilled services are being provided during that
week. This should be billed by all providers as 99211 and should not be
medically necessary after 3 consecutive weeks in which no significant
additional services were required.
Reasons for Denial:
1. Visits made by an enterostomal nurse skilled nurse and/or therapist for
the sole purpose of performing wound care for one of the following reasons,
may result in denial:
- Grade 0 wound (modified Wagner Cianci)
- A first degree burn
- Wounds caused by trauma which do not
require surgical closure or debridement, e.g., minor skin tear or
abrasion
2. Therapists, therapy assistants, nurses including enterostomal nurses,
performing wound care will not be covered if wound care does not fall
within the scope of practice or the auspices of the State Practice Act. If
the visits are found to be excessive or not reasonable and necessary the
visits will be considered non-covered regardless of who is providing the
visits.
3. Noncontact Normothermic Wound Therapy (NNWT) - There is insufficient
scientific or clinical evidence to consider this device as reasonable and
necessary for the treatment of wounds and will not be covered by Medicare.
(CIM, Section 60-25)
4. Platelet-Derived Wound-Healing – Non-covered under Medicare because it
is not considered reasonable and necessary with the Title 18 SSA 1862
(a)(1)(A). There is lack or sufficient published data to determine the
safety and efficacy of the platelet-derived wound healing formula. (CIM
45-26)
5. Ultrasound-deep thermal modality.- The effectiveness of this modality
has not been proven in wound care.
6. Phototherapies-ultraviolet. Used to promote healing of skin disorders.
This is not a covered service for decubitus ulcers. (Coverage Issue Manual,
Section 35-31)
7. Wounds of the face, ears, neck, axilla, and genitalia generally should
be debrided and cared for by physicians.
Outpatient wound care clinics provide a multidisciplinary approach for
patients whose wounds are generally chronic and/or complicated. Services
provided are those types of services described in Indications and
Limitations of Coverage and/or Medical Necessity, and must be reasonable
and necessary for Medicare coverage.
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