dial-in instructions · mary m. verhageis a nationally certified wound, ostomy, and continence...

Conference name: Assessing New Procedures and Technologies: Hyperbaric Oxygen Therapy

Scheduled conference date: Tuesday, February 13, 2007

Scheduled conference time: 1:00 p.m.–2:30 p.m. (Eastern), 12:00 p.m.–1:30 p.m. (Central), 11:00 a.m.–12:30 p.m. (Mountain), 10:00 a.m.–11:30 a.m. (Pacific)

Scheduled conference duration: 90 minutes

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In order to avoid delays in connecting to the conference, we recommendthat you dial into the audioconference 15 minutes prior to the start time.

Dial-in instructions1. Dial 877/407-2989 and follow the voice prompts.2. You will be greeted by an operator.3. Give the operator the pass code, 021307, and the last name of the person who registered for the audioconference.4. The operator will verify the name of your facility.5. You will then be placed into the conference.

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Program Evaluation

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Thank you for attending the HCPro program today. We hope you found it to be informative and helpful.

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Assessing New Procedures andTechnologies: Hyperbaric

Oxygen Therapy

1:00 p.m.–2:30 p.m. (Eastern)

12:00 p.m.–1:30 p.m. (Central)

11:00 a.m.–12:30 p.m. (Mountain)

10:00 a.m.–11:30 a.m. (Pacific)

A 90-minute interactive audioconference

Tuesday, February 13, 2007

ii Assessing New Procedures and Technologies: Hyperbaric Oxygen Therapy

In our materials, we strive to provide our audience with useful and timely information. The live audioconfer-ence will follow the enclosed agenda. Occasionally, our speakers will refer to the enclosed materials. Wehave noticed that non-HCPro audioconference materials often follow the speakers’ presentations bullet-by-bullet and page-by-page. However, because our presentations are less rigid and rely more on speaker inter-action, we do not include each speaker’s entire presentation. The enclosed materials contain helpful forms,crosswalks, policies, charts, and graphs. We hope that you will find this information useful in the future.

HCPro is not affiliated in any way with The Joint Commission, which owns the JCAHO and Joint Commissiontrademarks.

iiiAssessing New Procedures and Technologies: Hyperbaric Oxygen Therapy

The “Assessing New Procedures and Technologies: Hyperbaric Oxygen Therapy” audioconferencematerials package is published by HCPro, Inc., 200 Hoods Lane, P.O. Box 1168, Marblehead, MA 01945.

Copyright 2007, HCPro, Inc.

Attendance at the audioconference is restricted to employees, consultants, and members of the medical staffof the Licensee.

The audioconference materials are intended solely for use in conjunction with the associated HCPro audio-conference. The Licensee may make copies of these materials for internal use by attendees of the audio-conference only. All such copies must bear the following legend: Dissemination of any information in thesematerials or the audioconference to any party other than the Licensee or its employees is strictly prohibited.

Advice given is general, and attendees and readers of the materials should consult professional counsel forspecific legal, ethical, or clinical questions. HCPro is not affiliated in any way with The Joint Commission,which owns the JCAHO and Joint Commission trademarks.

For more information, please contact:

HCPro, Inc. 200 Hoods LaneP.O. Box 1168Marblehead, MA 01945Phone: 800/650-6787Fax: 781/639-0179E-mail: [email protected] site: www.hcpro.com

iv Assessing New Procedures and Technologies: Hyperbaric Oxygen Therapy

Dear Colleague,

Thank you for participating in our “Assessing New Procedures andTechnologies: Hyperbaric Oxygen Therapy” audioconference withRichard Clarke and Mary M. Verhage, RN, BSN, CWOCN, CHRN, mod-erated by Margot Suydam. We are excited about the opportunity to inter-act with you directly and encourage you to ask our experts your questionsduring the audioconference. If you would like to submit a question beforethe audioconference, please send it to [email protected] and providethe program date in the subject line. We cannot guarantee that your ques-tion will be answered during the program, but we will do our best to take a good cross section of questions.

If at any time you have comments, suggestions, or ideas about how wecan improve our audioconference, or if you have any questions about theaudioconference itself, please do not hesitate to contact me. And if youwould like any additional information about our other products and serv-ices, please contact our Customer Service Department at 800/650-6787.

We have enclosed an evaluation along with the audioconference materi-als. After the audioconference, please take a minute to complete the eval-uation to let us know what you think. We value your opinion.

Thanks again for working with us.

Best regards,

Abigail GreslaAssociate ProducerFax: 781/639-7857E-mail: [email protected]

200 Hoods Lane

P.O. Box 1168

Marblehead, MA 01945

Tel: 800/650-6787

Fax: 800/639-8511

vAssessing New Procedures and Technologies: Hyperbaric Oxygen Therapy

Agenda . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .vi

Speaker profiles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .vii

Exhibit A . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1Presentation by Richard Clarke and Mary M. Verhage, RN, BSN, CWOCN, CHRN

Exhibit B . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13Indications for Hyperbaric Oxygen Therapy and Definition of Hyperbaric Oxygen Therapy

Exhibit C . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15Medicare Coverage Database

Exhibit D . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .31Anthem Coverage Guideline

Exhibit E . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .43Hyperbaric Credentialing Criteria

Exhibit F . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .47Indications for Hyperbaric Oxygen Therapy

Resources . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .49

Contents

vi Assessing New Procedures and Technologies: Hyperbaric Oxygen Therapy

Agenda

I. Role of HBO in clinical practiceA. What is treatable?B. What is reimbursable?

i. Who says so? Medicare, common insurance companies

II. How do you treat it using hyperbaric medicine?A. Variables when moving forward

i. Capitalization requirementii. Physical plant needsiii. Installation costs

III. Common hyperbaric business modelsA. What kind of physicians, nurses, and technicians will be needed

for each model

IV. Implementation planA. Basic privileging criteria

V. Describe common program management and compliance pitfalls

A. Ensuring successful programsB. Minimizing compliance problems

VI. Live Q&A

viiAssessing New Procedures and Technologies: Hyperbaric Oxygen Therapy

Speaker profiles

Richard Clarke

Richard Clarke is president of National Baromedical Services (www.baromedical.com), a hyperbaric man-agement, training and consulting company he founded in 1986. Dick's background in hyperbaric medicineextends back four decades and includes technical, clinical, safety, education, administration and researchroles. He serves as program director and faculty for primary and advanced hyperbaric training courses, andhas been instrumental in the teaching of over 6,000 health care professionals.

Dick instituted the 'Certification in Hyperbaric Medical Technology' program and has held committee leader-ship positions with the Undersea and Hyperbaric Medical Society for more than 20 years. He founded a non-profit research organization (www.baromedicalresearch.org) that has dedicated itself to the scientificadvancement of hyperbaric medicine. Several multi-center and international clinical trials are underway andone has recently been completed. Dick's program has served as the 'evidence' resource during hyperbarictechnology assessments by CMS (Medicare) and Blue Cross Blue Shield. His headquarters facility is housedat Palmetto Health Richland Hospital/University of South Carolina School of Medicine, in Columbia, SouthCarolina.

Mary M. Verhage, RN, BSN, CWOCN, CHRN

Mary M. Verhage is a nationally certified wound, ostomy, and continence nurse, and a certified hyperbaricregistered nurse with 16 years of experience. She most recently worked as the practice manager and nurseclinician for Hyperbaric & Wound Care Associates, a healthcare group that provides advanced wound careand hyperbaric oxygen therapy to patients in southeastern Wisconsin. She has consulted and provided directpatient care to individuals in the acute, long-term, rehab, and home care environments since 1999.

Verhage is currently pursuing her master of science degree in nursing and master of science degree inhealthcare administration with the University of Phoenix.

Exhibit A

Presentation by Richard Clarke and Mary M. Verhage, RN, BSN, CWOCN, CHRN

EXHIBIT A

2 Assessing New Procedures and Technologies: Hyperbaric Oxygen Therapy

1

Assessing New Proceduresand Technologies: Hyperbaric

Oxygen Therapy

Presented by:Dick Clarke and Mary Verhage

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*** Appendix 3

3Assessing New Procedures and Technologies: Hyperbaric Oxygen Therapy

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EXHIBIT A


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Basic Privileging Criteria


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Ensure Successful Programs

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Exhibit B

Indications for Hyperbaric Oxygen Therapy and Definition of Hyperbaric Oxygen Therapy

Source: Richard Clarke. Reprinted with permission.

EXHIBIT B


Indications for Hyperbaric Oxygen Therapy

Definition of Hyperbaric Oxygen Therapy:

The patient breathes 100% oxygen intermittently while the pressure of the treatment chamber is increased

to greater than one atmosphere absolute (atm abs). Current information indicates that pressurization should

be at least 1.4 atm abs. This may occur in a single person chamber (monoplace) or multiplace chamber

(may hold 2 or more people). Breathing 100% oxygen at 1 atm abs or exposing isolated parts of the body

to 100% oxygen does not constitute HBO2 therapy.

Approved Indications:

The following indications are approved uses of hyperbaric oxygen therapy as defined by the Hyperbaric

Oxygen Therapy Committee. The Committee Report can be purchased directly through the UHMS

1 Air or Gas Embolism

2 Carbon Monoxide Poisoning

Carbon Monoxide Poisoning Complicated by Cyanide Poisoning

3 Clostridal Myositis and Myonecrosis (Gas Gangrene)

4 Crush Injury, Compartment Syndrome, and other Acute Traumatic Ischemias

5 Decompression Sickness

6 Enhancement of Healing in Selected Problem Wounds

7 Exceptional Blood Loss (Anemia)

8 Intracranial Abscess

9 Necrotizing Soft Tissue Infections

10 Osteomyelitis (Refractory)

11 Delayed Radiation Injury (Soft Tissue and Bony Necrosis)

12 Skin Grafts & Flaps (Compromised)

13 Thermal Burns

Selected references can be found by clicking directly on the topics or by selecting the full list via the button

on the left. RCTs here too, or see HBO Evidence website.

Exhibit C

Medicare Coverage Database

Source: www.cms.hhs.gov

EXHIBIT C


LCD: Centers for Medicare & Medicaid Services

Medicare Coverage Database mcd feedback | coverage

home | help | basket

Search Indexes Reports Download

View LCD

LCD for Hyperbaric Oxygen Therapy (HBO) (L1301)

Please note: If you are printing this document and it is truncated on the right margin, please try printing landscape.

Contractor Information

Contractor Name back to top

Palmetto GBA

Contractor Number back to top

00380

Contractor Type back to top

FI

LCD Information

https://www.cms.hhs.gov/mcd/viewlcd.asp?lcd_id=1301&lcd_version=24&show=all (1 of 15)2/7/2007 4:00:39 PM

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EXHIBIT C


LCD ID Number back to top

L1301

LCD Title back to top

Hyperbaric Oxygen Therapy (HBO)

Contractor's Determination Number back to top

98A-0016-L

AMA CPT / ADA CDT Copyright Statement back to top

CPT codes, descriptions and other data only are copyright 2006 American Medical Association (or such other date of publication of CPT). All Rights Reserved. Applicable FARS/DFARS Clauses Apply. Current Dental Terminology, (CDT) (including procedure codes, nomenclature, descriptors and other data contained therein) is copyright by the American Dental Association. © 2002, 2004 American Dental Association. All rights reserved. Applicable FARS/DFARS apply.

CMS National Coverage Policy back to top

Title XVIII of the Social Security Act, §1862(a)(1)(A) allows coverage and payment for only those services that are considered to be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.

Title XVIII of the Social Security Act; §1862 (a)(7) excludes routine physical examinations.

CMS Manual System, Pub 100-3, Medicare National Coverage Determinations Manual, Chapter 1, Part 1, §20.29

CMS Manual System, Pub. 100-4, Medicare Claims Processing Manual, Chapter 32, §30

CMS Manual System, Pub. 100-04, Medicare Claims Processing, Transmittal 187, dated May 28, 2004, Change Request 3172

CMS Manual System, Pub. 100-08, Medicare Program Integrity, Transmittal 63, dated January 23, 2004, Change Request 3010

Primary Geographic Jurisdiction back to top

South Carolina


EXHIBIT C



Secondary Geographic Jurisdiction back to top

Oversight Region back to top

Region IV

Original Determination Effective Date back to top

For services performed on or after 09/21/1998

Original Determination Ending Date back to top

Revision Effective Date back to top

For services performed on or after 10/01/2006

Revision Ending Date back to top

Indications and Limitations of Coverage and/or Medical Necessity back to top

Hyperbaric Oxygen Therapy is a medical treatment in which the patient is entirely enclosed in a pressure chamber breathing 100% oxygen (O2) at greater than one atmosphere (atm) pressure. Either a monoplace chamber pressurized with pure O2 or a larger multiplace chamber pressurized with compressed air where the patient receives pure O2 by mask, head tent, or endotracheal tube may be used.

Note: Topical application of oxygen (Topox) does not meet the definition of HBO therapy. Also, its clinical efficacy has not been established; therefore, no reimbursement may be made.

1. Acute carbon monoxide intoxication induces hypoxic stress. The cardiac and central nervous systems are the most susceptible to injury from carbon monoxide. The administration of supplemental oxygen is essential treatment. Hyperbaric oxygen causes a higher rate of dissociation of carbon monoxide from hemoglobin than can occur breathing pure air at sea level pressure. The chamber compressions should be between 2.5 and 3.0 atm abs. It is not uncommon in patients with persistent neurological dysfunction to require subsequent treatments within six to eight hours, continuing once or twice daily until there is no further improvement in cognitive functioning.

2. Decompression illness arises from the formation of gas bubbles in tissue or blood in volumes sufficient enough to interfere with the function of an organ or to cause alteration in



EXHIBIT C


sensation. The cause of this enucleated gas is rapid decompression during ascent. The clinical manifestations range from skin eruptions to shock and death. The circulating gas emboli may be heard with a doppler device. Treatment of choice for decompression illness is HBO with mixed gases. The result is immediate reduction in the volume of bubbles. The treatment prescription is highly variable and case specific. The depths could range between 60 to 165 feet of seawater for durations of 1.5 to over 14 hours. The patient may or may not require repeat dives.

3. Gas embolism occurs when gases enter the venous or arterial vasculature embolizing in a large enough volume to compromise the function of an organ or body part. This occlusive process results in ischemia to the affected areas. Air emboli may occur as a result of surgical procedures (e.g., cardiovascular surgery, intra-aortic balloons, arthroplasties, or endoscopies), use of monitoring devices (e.g., Swan-Ganz introducer, infusion pumps), in nonsurgical patients (e.g., diving, ruptured lung in respirator-dependent patient, injection of fluids into tissue space), or traumatic injuries (e.g., gunshot wounds, penetrating chest injuries). Hyperbaric oxygen therapy is the treatment of choice. It is most effective when initiated early. Therapy is directed toward reducing the volume of gas bubbles and increasing the diffusion gradient of the embolized gas. Treatment modalities range from high pressure to low pressure mixed gas dives.

4. Gas gangrene is an infection caused by the clostridium bacillus, the most common being clostridium perfringens. Clostridial myositis and myonecrosis (gas gangrene) is an acute, rapidly growing invasive infection of the muscle. It is characterized by profound toxemia, extensive edema, massive death of tissue and variable degree of gas production. The most prevalent toxin is the alpha-toxin which itself is hemolytic, tissue-necrotizing and lethal. The diagnosis of gas gangrene is based on clinical data supported by a positive gram-stained smear obtained from tissue fluids. X-ray radiographs, if obtained, can visualize tissue gas.

a. The onset of gangrene can occur one to six hours after injury and presents with severe and sudden pain at the infected area. The skin overlying the wound progresses from shiny and tense, to dusky, then bronze in color. The infection can progress as rapidly as six inches per hour. Hemorrhagic vesicles may be noted. A thin, sweet-odored exudate is present. Swelling and edema occur. The noncontractile muscles progress to dark red to black in color.

b. The acute problem in gas gangrene is to stop the rapidly advancing tissue destruction caused by alpha-toxin. Medical treatment is aimed at stopping the production of alpha-toxin and to continue treatment until the advancement of the disease process has been arrested. The goal of HBO therapy is to stop alpha-toxin production thereby inhibiting further bacterial growth at which point the body can use its own host defense mechanisms. HBO treatment starts as soon as the clinical picture presents and is supported by a positive gram-stained smear. A treatment approach utilizing HBO is adjunct to antibiotic therapy and surgery. Initial surgery may be limited to opening the wound. Debridement of necrotic tissue can be performed between HBO treatments when clear demarcation between dead and viable tissue is evident. The usual treatment consists of oxygen administered at 3.0 atm abs pressure for ninety minutes three times in the first 24 hours. Over the next four to five days, treatment sessions twice a day are usual. The sooner HBO treatment is initiated, the better the outcome in terms of life, limb and tissue saving.

5. Crush injuries and suturing of severed limbs, acute traumatic peripheral ischemia (ATI), and acute peripheral arterial insufficiency: Acute traumatic ischemia is the result of injury compromising circulation to an extremity. The extremity is then at risk for necrosis or amputation. Secondary complications are frequently seen: infection, non-healing wounds, and non-united fractures. For acute traumatic peripheral ischemia, crush injuries and suturing of severed limbs, HBO therapy is a valuable adjunctive treatment to be used in combination with


EXHIBIT C



accepted standard therapeutic measures, when loss of function, limb or life is threatened.

a. The goal of HBO therapy is to enhance oxygenation at the tissue level to support viability. When tissue oxygen tensions fall below 30 mmHg., the body’s ability to respond to infection and wound repair is compromised. Using HBO at 2 atm, the tissue oxygen tension is raised to a level such that the body’s responses can become functional again. The benefits of HBO for this indication are enhanced tissue oxygenation, edema reduction and increased oxygen delivery per unit of blood flow thereby reducing the complication rates for infection, non-union and amputation.

b. The usual treatment schedule is three 1.5 hour treatment periods daily for the first forty-eight hours. Additionally, two 1.5 hour treatment sessions daily for the next forty-eight hours may be required. On the fifth and sixth days of treatment, one 1.5 hour session would typically be utilized. At this point in treatment, outcomes of restored perfusion, edema reduction and either demarcation or recovery would be sufficient to guide discontinuing further treatments.

c. For acute traumatic peripheral ischemia, crush injuries and suturing of severed limbs, Hyperbaric Oxygen Therapy is a valuable adjunctive treatment to be used in combination with accepted standard therapeutic measures, when loss of function, limb, or life is threatened.

6. The principal treatment for progressive necrotizing infections (necrotizing fasciitis, Meleney ulcer) is surgical debridement and systemic antibiotics. HBO is recommended as an adjunct only in those settings where mortality and morbidity are expected to be high despite aggressive standard treatment. One of the necrotizing infections, Meleney’s ulcer, is a polymicrobial (mixed aerobic-anaerobic organisms) ulcer that slowly progresses affecting the total thickness of the skin. Also called a bacterial synergistic gangrene, the Meleney ulcer is associated with the formation of burrowing cutaneous fissures and sinus tracts that emerge at distant skin sites. This ulcer presents a wide area of pale red cellulitis that subsequently ulcerates and gradually enlarges to form a large ulcerative plaque, typically with a central area of granulation tissue encircled by gangrenous or necrotic tissue.

a. Another type of progression necrotizing infection is necrotizing fasciitis. This condition is a relatively rare infection. It is usually a result of a group A streptococcal infection beginning with severe or extensive cellulitis that spreads to involve the superficial and deep fascia, producing thrombosis of the subcutaneous vessels and gangrene of the underlying tissues. A cutaneous lesion usually serves as a portal of entry for the infection, but sometimes no such lesion is found.

7. Preparation and preservation of compromised skin grafts utilizes HBO for graft or flap salvage in cases where hypoxia or decreased perfusion have compromised viability. HBO enhances flap survival. Treatments are given at a pressure of 2.0 to 2.5 atm abs lasting from 90-120 minutes. It is not unusual to receive treatments twice a day. When the graft or flap appears stable, treatments are reduced to daily. Should a graft or flap fail, HBO may be used to prepare the already compromised recipient site for a new graft or flap. HBO therapy is not necessary for normal, uncompromised skin grafts or flaps. This excludes artificial skin grafts. This indication is not for primary management of wounds.

8. Chronic refractory osteomyelitis persists or recurs following appropriate interventions. These interventions include the use of antibiotics, aspiration of the abscess, immobilization of the affected extremity, and surgery. Antibiotics are chosen on the basis of bone culture and sensitivity studies. HBO can elevate the oxygen tensions found in infected bone to normal or above normal levels. This mechanism enhances healing and the body’s antimicrobial defenses. It is believed that HBO augments the efficacy of certain antibiotics (gentamicin, tobramycin,



EXHIBIT C


and amikacin). Finally, the body’s osteoclast function of removing necrotic bone is dependent on a proper oxygen tension environment. HBO provides this environment. HBO treatments are delivered at a pressure of 2.0 to 2.5 atm abs for a duration of 90-120 minutes. It is not unusual to receive daily treatments following major debridement surgery. The number of treatments required vary on an individual basis. Medicare Part A can cover the use of HBO for chronic refractory osteomyelitis that has been demonstrated to be unresponsive to conventional medical and surgical management.

9. HBO’s use in the treatment of osteoradionecrosis and soft tissue radionecrosis is one part of an overall plan of care. Also included in this plan of care are debridement or resection of nonviable tissues in conjunction with antibiotic therapy. Soft tissue flap reconstruction and bone grafting may also be indicated. HBO treatment can be indicated both preoperatively and postoperatively.

a. The patients who suffer from soft tissue damage or bone necrosis present with disabling, progressive, painful tissue breakdown. They may present with wound dehiscence, infection, tissue loss and graft or flap loss. The goal of HBO treatment is to increase the oxygen tension in both hypoxic bone and tissue to stimulate growth in functioning capillaries, fibroblastic proliferation and collagen synthesis. The recommended daily treatments last 90-120 minutes at 2.0 to 2.5 atm abs. The duration of HBO therapy is highly individualized.

10. Cyanide poisoning carries a high risk of mortality. Victims of smoke inhalation frequently suffer from both carbon monoxide and cyanide poisoning. The traditional antidote for cyanide poisoning is the infusion of sodium nitrite. This treatment can potentially impair the oxygen carrying capacity of hemoglobin. Using HBO as an adjunct therapy adds the benefit of increased plasma dissolved oxygen. The HBO treatment protocol is to administer oxygen at 2.5 to 3.0 atm abs for up to 120 minutes during the initial treatment. Most patients with combination cyanide and carbon monoxide poisoning will receive only one treatment.

11. Actinomycosis is a bacterial infection caused by Actinomyces israelii. Its symptoms include slow growing granulomas that later break down, discharging viscid pus containing minute yellowish granules. The treatment includes prolonged administration of antibiotics (penicillin and tetracycline). Surgical incision and draining of accessible lesions is also helpful. Only after the disease process has been shown refractory to antibiotics and surgery, could HBO be covered by Medicare Part A.

12. HBO therapy may be used to treat patients with type I or type II diabetes and has a lower wound that is due to diabetes. (For definition of wound care and HBO, see CMS Manual System, Pub.100-3, Medicare National Coverage Determination Manual -Internet only Manual).

Note: Staging/grading of wounds in this policy is as follows and is a modified Wagner Cianci grading system (Wagner 1981, Cianci 1997):

Grade 0 No open lesion; skin changes including erythema (reddening), whitening, mild exfoliation (scaling), or luminous variations (shining, glowing, or dullness in relation to surrounding skin).

Grade 1 Superficial ulcer without penetration to deeper layers

Grade 2 Ulcer penetrates to tendon, bone, or joint

Grade 3 Lesion has penetrated deeper than grade 2 and there is abscess, osteomyelitis, pyarthrosis, or infection of the tendon and tendon sheaths

Grade 4 Wet or dry gangrene in the toes, forefoot, knee area, buttocks, elbow, or fingers


EXHIBIT C



Grade 5 Gangrene involving the whole foot, or hand, or hind quarter such that no local procedures are possible and limb amputation or major hind quarter reconstruction is indicated

Contraindications for use of HBO are:

1. Traumatic or spontaneous pneumothorax (especially if left untreated)

2. Pregnancy (except in cases of carbon monoxide poisoning and gas gangrene)

3. Premature infants

4. Concomitant administration of doxorubicin or cisplatin as chemotherapeutic agents

5. Use of disulfiram

Indications of effective treatment outcomes for HBO

1. There is improvement or healing of wounds.

2. There is improvement of tissue perfusion.

3. There is new epithelial tissue growth and granulation.

4. Tissue PO2 of at least 30 mmHg of oxygen is necessary for oxidative function to occur.

5. The mechanical reduction in the bubble size of air emboli alleviates decompression sickness (and gas/air emboli).

6. Tissue PO2 of 40 or greater defines resolved hypoxia. The body can now resume host functions of wound healing and anti-microbial defenses without the need of HBO.

Hyperbaric oxygen therapy is an “incident to” therapy that requires direct supervision by the physician to be covered. CMS encourages physicians who perform HBO therapy to obtain adequate training in the use of HBO therapy and in advanced cardiac life support. This is a professional activity that cannot be delegated in that it requires independent medical judgment by the physician. The physician does not have to dive with the patient unless clinically indicated. However, the physician must be present in the suite and carefully monitoring the patient during the hyperbaric oxygen therapy session and be immediately available should a complication occur.

Medicare will cover hyperbaric oxygen therapy only in the setting of a hospital, either inpatient or outpatient. Cardiopulmonary resuscitation team coverage must be immediately available during the hours of hyperbaric chamber operation.

Coverage Topic back to top

Outpatient Hospital Services

Coding Information



EXHIBIT C


Bill Type Codes: back to top

Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.

13x Hospital-outpatient (HHA-A also) (under OPPS 13X must be used for ASC claims submitted for OPPS payment -- eff. 7/00)

85x Special facility or ASC surgery-rural primary care hospital (eff 10/94)

Revenue Codes: back to top

Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory; unless specified in the policy services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.

0413 Respiratory services-hyperbaric oxygen therapy

0940 Other therapeutic services-general classification

CPT/HCPCS Codes back to top

*Code(99183)is for Critical Access Hospitals who elect Method I

99183 PHYSICIAN ATTENDANCE AND SUPERVISION OF HYPERBARIC OXYGEN THERAPY, PER SESSION

C1300 HYPERBARIC OXYGEN UNDER PRESSURE, FULL BODY CHAMBER, PER 30 MINUTE INTERVAL

ICD-9 Codes that Support Medical Necessity back to top


EXHIBIT C



039.0 - 039.9 CUTANEOUS ACTINOMYCOTIC INFECTION - ACTINOMYCOTIC INFECTION OF UNSPECIFIED SITE

040.0 GAS GANGRENE

444.21 - 444.22

ARTERIAL EMBOLISM AND THROMBOSIS OF UPPER EXTREMITY - ARTERIAL EMBOLISM AND THROMBOSIS OF LOWER EXTREMITY

444.81 EMBOLISM AND THROMBOSIS OF ILIAC ARTERY

526.89 OTHER SPECIFIED DISEASES OF THE JAWS

728.86 NECROTIZING FASCIITIS

730.10 - 730.19

CHRONIC OSTEOMYELITIS SITE UNSPECIFIED - CHRONIC OSTEOMYELITIS INVOLVING MULTIPLE SITES

785.4 GANGRENE

902.53 INJURY TO ILIAC ARTERY

903.01 INJURY TO AXILLARY ARTERY

903.1 INJURY TO BRACHIAL BLOOD VESSELS

904.0 INJURY TO COMMON FEMORAL ARTERY

904.41 INJURY TO POPLITEAL ARTERY

927.00 - 927.03

CRUSHING INJURY OF SHOULDER REGION - CRUSHING INJURY OF UPPER ARM

927.09 - 927.11

CRUSHING INJURY OF MULTIPLE SITES OF UPPER ARM - CRUSHING INJURY OF ELBOW

927.20 - 927.21

CRUSHING INJURY OF HAND(S) - CRUSHING INJURY OF WRIST

927.8 CRUSHING INJURY OF MULTIPLE SITES OF UPPER LIMB

927.9 CRUSHING INJURY OF UNSPECIFIED SITE OF UPPER LIMB

928.00 - 928.01

CRUSHING INJURY OF THIGH - CRUSHING INJURY OF HIP

928.10 - 928.11

CRUSHING INJURY OF LOWER LEG - CRUSHING INJURY OF KNEE

928.20 - 928.21

CRUSHING INJURY OF FOOT - CRUSHING INJURY OF ANKLE

928.3 CRUSHING INJURY OF TOE(S)

928.8 - 928.9 CRUSHING INJURY OF MULTIPLE SITES OF LOWER LIMB - CRUSHING INJURY OF UNSPECIFIED SITE OF LOWER LIMB



EXHIBIT C


929.0 CRUSHING INJURY OF MULTIPLE SITES NOT ELSEWHERE CLASSIFIED

929.9 CRUSHING INJURY OF UNSPECIFIED SITE

958.0 AIR EMBOLISM AS AN EARLY COMPLICATION OF TRAUMA

958.91 TRAUMATIC COMPARTMENT SYNDROME OF UPPER EXTREMITY

958.92 TRAUMATIC COMPARTMENT SYNDROME OF LOWER EXTREMITY

986 TOXIC EFFECT OF CARBON MONOXIDE

987.7 TOXIC EFFECT OF HYDROCYANIC ACID GAS

989.0 TOXIC EFFECT OF HYDROCYANIC ACID AND CYANIDES

990 EFFECTS OF RADIATION UNSPECIFIED

993.2 OTHER AND UNSPECIFIED EFFECTS OF HIGH ALTITUDE

993.3 CAISSON DISEASE

996.52 MECHANICAL COMPLICATION OF PROSTHETIC GRAFT OF OTHER TISSUE NOT ELSEWHERE CLASSIFIED

996.90 - 996.99

COMPLICATIONS OF UNSPECIFIED REATTACHED EXTREMITY - COMPLICATION OF OTHER SPECIFIED REATTACHED BODY PART

999.1 AIR EMBOLISM AS A COMPLICATION OF MEDICAL CARE NOT ELSEWHERE CLASSIFIED

Note: Claims submitted with diabetic wounds should be identified with ICD-9-CM code of 250.70-250.73 or 250.80-250.83 in addition to 707.10, 707.12-707.19 or 785.4 codes.

250.70 - 250.73

DIABETES WITH PERIPHERAL CIRCULATORY DISORDERS, TYPE II OR UNSPECIFIED TYPE, NOT STATED AS UNCONTROLLED - DIABETES WITH PERIPHERAL CIRCULATORY DISORDERS, TYPE I [JUVENILE TYPE], UNCONTROLLED

250.80 - 250.83

DIABETES WITH OTHER SPECIFIED MANIFESTATIONS, TYPE II OR UNSPECIFIED TYPE, NOT STATED AS UNCONTROLLED - DIABETES WITH OTHER SPECIFIED MANIFESTATIONS, TYPE I [JUVENILE TYPE], UNCONTROLLED

707.10 UNSPECIFIED ULCER OF LOWER LIMB

707.12 ULCER OF CALF

707.13 ULCER OF ANKLE

707.14 ULCER OF HEEL AND MIDFOOT

707.15 ULCER OF OTHER PART OF FOOT

707.19 ULCER OF OTHER PART OF LOWER LIMB

785.4 GANGRENE


EXHIBIT C



Diagnoses that Support Medical Necessity back to top

N/A

ICD-9 Codes that DO NOT Support Medical Necessity back to top

N/A

ICD-9 Codes that DO NOT Support Medical Necessity Asterisk

Explanation back to top

Diagnoses that DO NOT Support Medical Necessity back to top

N/A

General Information

Documentation Requirements back to top

1. There must be medical documentation to support the condition for which HBO therapy is being given. This medical documentation typically includes:

a. An initial assessment, which should include a medical history detailing the condition requiring HBO. The medical history should list prior treatments including antibiotic therapy and surgical interventions. This note should also list and/or describe any adjunctive treatment currently in progress.

b. Physician progress notes that also indicate that the physician was present throughout the treatment session.

c. Communication between physicians regarding treatment plans (past, current, future).

d. Definitive radiographic evidence and/or bone culture with sensitivity studies are required to confirm the diagnosis of osteomyelitis.

e. HBO treatment records describing the physical findings, the treatment rendered and the effect of the treatment upon the established goals for therapy.

f. Culture reports when appropriate.

2. Documentation supporting the medical necessity should be legible, maintained in the patient’s medical record, and must be made available to the Intermediary upon request.



EXHIBIT C


Appendices back to top

N/A

Utilization Guidelines back to top

REVENUE CODES: *The code (0940) is for Critical Access Hospitals who elect Method I

Sources of Information and Basis for Decision back to top

Cianci P. Adjunctive HBO Therapy in the Treatment of the Diabetic Foot. Journal of the American Podiatric Medical Association. 1994;84(9):448-455.

Dorlands Illustrated Medical Dictionary. 28th edition. Philadelphia: W.B. Saunders Co.

Undersea and Hyperbaric Medical Society. (1196). Hyperbaric Oxygen Therapy; A committee report.

Wagner FW. The Dysvascular Foot: A System for Diagnosis and Treatment. Foot and Ankle.1981;2(2):64-122.

Advisory Committee Meeting Notes back to top

This policy does not reflect the sole opinion of the contractor or Contractor Medical Director. Although the final decision rests with the Intermediary, this policy was developed in cooperation with advisory groups, which include representatives from the affected provider community. Advisory Committee Meeting Date: NA.

Start Date of Comment Period back to top

06/02/1998

End Date of Comment Period back to top

07/17/1998

Start Date of Notice Period back to top

08/21/1998

Revision History Number back to top


EXHIBIT C



Revision #11, 10/01/2006 Revision #10, 05/26/2006 Revision #9, 08/19/2005 Revision #8, 11/22/2004 Revision #7, 10/01/2004 Revision #6, 11/28/2003 Revision #5, 10/01/2003 Revision #4, 04/01/2003 Revision #3, 10/01/2002 Revision #2, 05/15/2001 Revision #1, 03/15/2000

Revision History Explanation back to top

Revision #11, 10/01/2006 Under AMA/CPT & ADA/CDT Copyright Statement changed the copyright date from 2005 to 2006. Under ICD-9 Codes That Support Medical Necessity added ICD-9 codes 958.91 and 958.92. Under Sources of Information and Basis for Decision the references were placed in the AMA citation format. Under Advisory Committee Meeting Notes the verbiage was changed. This policy was reviewed for annual validation. This revision becomes effective 10/01/2006.

Revision #10, 05/26/2006 Under Indications and Limitations of Coverage and/or Medical Necessity section of this LCD the definition of chronic under #8 has been removed. Under the Documentation Requirements section the last sentence under #1a was changed to read; “This note should also list and/or describe any adjunctive treatment currently in progress.” #1c was changed to read; “Communication between physicians regarding treatment plans (past, current, future).” #1d was changed to read; “Definitive radiographic evidence and/or bone culture with sensitivity studies are required to confirm the diagnosis of osteomyelitis.” Also a #1f was added to read. “ Culture reports when appropriate.” These changes become effective on 05/26/2006.

Revision #9, 08/19/2005 The policy was converted to an LCD per instructions in Change Request 3010.Under CMS National Coverage Policy section of the policy the following citations were deleted: Program Memorandum AB-00-15, dated April 1, 2000, Change Request 1138. Program Memorandum AB-02-183, dated December 27, 2002, Change Request 2388 Program Memorandum AB-03-102, dated July 25, 2003, Change Request 2769

The following citations were added: Title XVIII of the Social Security Act; section 1862 (a)(7) excludes routine physical examinationsCMS Manual System, Pub.100-4, Medicare Claims Processing, Chapter 32, Section 30 CMS Manual System, Pub. 100-04, Medicare Claims Processing, Transmittal 187, dated May 28, 2004, Change Request 3172 CMS Manual System, Pub. 100-08, Medicare Program Integrity, Transmittal 63, dated January 23, 2004 Under Indications and Limitations of Coverage and/or Medical Necessity section under #10 the statement “HBO’s benefit for the pulmonary injury related to smoke inhalation remains experimental” has been deleted. #12 the verbiage has been changed to refer to the NCD description. Under Indications of effective treatment outcomes for HBO the “incident to” paragraph has been added. Under Bill Type Codes Skilled Nursing Facility 21x and 22x have been deleted. Under ICD-9 Codes That Support Medical Necessity section the ICD-9 code



EXHIBIT C


927.00-927.09 has been changed to 927.00-927.03, code 927.10-927.11 has been changed to 927.09-927.11. Under Documentation Requirements section b has been changed to read, “Physician progress notes that also indicates that the physician was present throughout the treatment session. Under Sources of Information and Basis for Decision section the following citations have been deleted: American College of Hyperbaric Medicine and Other Fiscal Intermediaries’ Policy.These citations have been added.Cianci P. Adjunctive HBO Therapy in the Treatment of the Diabetic Foot. Journal of the American Podiatric Medical Association. 1994;84(9):448-455 Wagner, FW. The Dysvascular Foot: A System for Diagnosis and Treatment . Foot and Ankle (1981:2(2):64-122These changes become effective 08/19/2005.

Revision #8, 11/22/2004 Under AMA CPT Copyright Statement section of the policy, deleted the reference to CDT-4 copyright language, as this policy does not contain CDT-4 codes or descriptions. This revision is effective 11/22/2004.

Revision #7, 10/01/2004 Under AMA CPT Copyright Statement the copyright date was changed from 2003 to 2004. Added the American Dental Copyright statement. Under CMS National Coverage Policy deleted Change Request 2592. Under ICD-9 Codes That Support Medical Necessity of HBO for the Treatment of Diabetic Wounds of the Lower Extremities note section, changed the verbiage to read: Claims submitted with diabetic wounds should be identified with ICD-9-CM code of 250.70-250.73 or 250.80-250.83 in addition to 707.10, 707.12-707.19, or 785.4 code. Under Coding Guidelines statement #7 changed the verbiage to read: Claims submitted with diabetic wounds should be identified with ICD-9-CM code of 250.70-250.73 or 250.80-250.83 in addition to 707.10, 707.12-707.19, or 785.4 code. Correction made to the start date of the notice period to read 08/21/98. These changes become effective 10/01/2004.

Revision #6 11/28/2003 Under CMS National Coverage Policy section of this policy the manual citation has been changed to reflect the Internet Only Manual (IOM). This change becomes effective 11/28/2003.

Revision #5 10/01/2003 Policy updated with Program Memorandum AB-03-102, Change Request 2769, dated July 25, 2003. ICD-9-CM code 250.7 has been expanded to 250.70-250.73. ICD-9-CM code 250.8 has been expanded to 250.80-250.83. ICD-9-CM code 707.15 has been added to the list of ICD-9-CM Codes That Support Medical Necessity section of the policy. This code is effective 08/08/2003. These changes will become effective 10/01/2003.

Revision #4 04/01/2003 Policy updated with PM AB-02-183, Change Request 2388, dated December 27, 2002. This PM added the coverate of diabetic wounds. This change becomes effective 04/01/2003.

Revision #3 10/01/2002 Under Type of Bill Code section Critical Access Hospital (85x) has been added. This change becomes effective 10/1/2002.

Revision #2 05/15/2001

Revision #1 03/15/2000

This LCD was converted from an LMRP on 7/29/2005


EXHIBIT C



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Exhibit D

Anthem Coverage Guideline

Source: Anthem Blue Cross-Blue Shield/American Medical Association. Reprinted with permission.

EXHIBIT D


Coverage Guideline MED.0 5Hyperbaric Oxygen Therap (S st m / o l)

F d aw, u f v k CG

z j

N

� P – A2 1

x Intracranial -

R

Not Medically Necessary:

3 Bmedically

I /

Li

:

Coverage Guideline

Federal and State law, as well as contract language, including definitions and specific contract provisions/exclusions, take precedence over CoverageGuidelines and must be considered first in determining eligibility for coverage. The me he date that services are renderedmust be used. Coverage Guidelines, which addresses medical efficacy, should be considered before utilizing medical opinion in adjudication. Medicaltechnology is constantly evolving, and we reserve the right to review and update Coverage Guidelines periodically.

No part of this publication may be reproduced, stored in a retrieval system or transmitted, in any form or by any means, electronic, mechanical, photocopying,or otherwise, without permission from the health plan.

� CPT Only – American Medical AssociationPage 1 of 11

Subject: Hyperbaric Oxygen Therapy (Systemic/Topical) CG #: MED.00005 Current Effective Date: 08/01/2006Status: Revised Last Review Date: 06/08/2006

Description/Scope

Systemic hyperbaric oxygen pressurization is a mode of medical treatment in which the patient is entirely enclosedin chamber, pressurized at 1.4-3.0 atmospheres absolute (atm abs) and breathing oxygen. This increases oxygenlevels in systemic circulation. Treatment may be carried out either in a monoplace chamber pressurized with pureoxygen, or in a larger, multiplace chamber pressurized with compressed air, in which case the patient receives pureoxygen by mask, head tent, or endotracheal tube.

Topical hyperbaric oxygen therapy is a technique of delivering 100% oxygen directly to an open moist wound at apressure slightly higher than atmospheric pressure. It is hypothesized that the high concentrations of oxygendiffuse directly in to the wound to increase the local cellular oxygen tension, which in turn promotes woundhealing.

Guideline Statement Medically Necessary:

1. Systemic hyperbaric oxygen pressurization is considered medically necessary as a primary therapy in thetreatment of any of the following conditions:x Carbon monoxide poisoningx Cerebral edema x Cyanide poisoningx Decompression sickness x Gas embolism x Profound anemia with exceptional blood loss: when transfusion is impossible or delayedx Prophylactic pre and post treatment for patients undergoing dental surgery of a radiated jaw

2. Systemic hyperbaric oxygen pressurization is considered medically necessary when used as adjuvant therapyin conjunction with standard medical and/or surgical treatment for any of the following conditions: x Acute or chronic refractory osteomyelitis (refractory osteomyelitis) x Acute peripheral arterial insufficiency (compartment syndrome) x Acute thermal burns: deep second degree or third degree in naturex Acute traumatic ischemiax Chronic non-healing woundsx Compartment syndromex Compromised skin grafts or flaps (enhancement of healing in selected wounds)x Crush injuriesx Gas gangrene (i.e., clostridial myositis and myonecrosis)


EXHIBIT D

Coverage Guideline MED.00005Hyperbaric Oxygen Therapy (Systemic/Topical)




x Intracranial abscess x Necrotizing soft-tissue infectionsx Radiation necrosis (osteoradionecrosis and soft tissue radiation necrosis)

Not Medically Necessary:

If the wound fails to show measurable signs of healing within 30 days of HBOT therapy, the therapy is considerednot medically necessary.

Investigational/Not Medically Necessary:

Topical hyperbaric oxygen is considered investigational/not medically necessary in all cases.

Limb specific hyperbaric oxygen pressurization is considered investigational/not medically necessary in all cases.

Systemic hyperbaric oxygen pressurization is considered investigational/not medically necessary in all cases notpreviously listed including but not limited to the following:

x Acute carbon tetrachloride poisoningxx Arthritic Diseases x Bone graftsx Brown recluse spider bitesx Cerebrovascular accident, acute (thrombotic or embolic)x Chemical pulmonary damage (smoke inhalation, carbon tetrachloride and hydrogen sulfide poisoning)

and/or pulmonary insufficiencyx Fracture healingx Hydrogen sulfide poisoningx Idiopathic sudden deafness (hypoacusis)x Intra-abdominal and intracranial abscessesxx Lepromatous leprosyx Lyme Disease x Meningitisx Multiple sclerosis x Myocardial Infarctionx Organ transplantationxx Pseudomembranous colitis, antibacterial agent induced colitisx Pyoderma gangrenosumx Radiation myelitis, enteritis, or proctitisx Retinal artery insufficiency x Retinopathy, as an adjunct to scleral buckling procedures for patients with sickle cell peripheral retinopathy

and retinal detachmentx Senilityx Septicemia due to anaerobic bacteria other than Clostridia

EXHIBIT D






xx Sickle cell crisis with or without hematuriax Spinal cord injuryx Tetanusx Traumatic brain injury

Rationale

Systemic Hyperbaric Oxygen

This guideline regarding systemic hyperbaric oxygen is based on guidelines published by the Undersea andHyperbaric Medical Society.

Topical Hyperbaric Oxygen

Due to their different methods of delivery, topical and systemic hyperbaric oxygen are distinct technologies suchthat the outcomes associated with systemic hyperbaric oxygen therapy cannot be extrapolated to topical therapy.Topical hyperbaric oxygen has been primarily investigated as a treatment of chronic wounds. However, there isinadequate published data from controlled trials to permit scientific conclusions.

Background/Overview

Guidelines: Hyperbaric Oxygen Therapy Committee suggests utilization

of hyperbaric oxygen therapy (HBOT) guidelines as described below: 1. Acute traumatic ischemia - 3 treatments per day for 48 hours followed by 2 treatments per day over the

second 48 hours and 1 treatment per day over the third period of 48 hours. Beyond this time period,utilization review should be obtained;

2. Air or Gas Embolism - no more than 10 sessions should be needed to treat;3. Carbon Monoxide Poisoning - actual treatment pressure and time will vary, but compressions should be

between 2.4 and 3.0 atm abs. In patients with persistent neurologic dysfunction after the initial treatment, subsequent treatments may be performed within 6-8 hours and continued once or twice daily until there isno further improvement in cognitive functioning. No more that 5 sessions should be needed to treat;

4. Cerebral Edema - HBOT treatment is administered at a pressure of 2.0 to 2.5 atm abs, with oxygenadministration from 60 to 90 minutes per treatment. HBOT treatment may be one or two sessions per daydepending on the condition of the individual patient. No more than 20 treatments should be needed to treat;

5. Compromised Skin Grafts - HBOT usually starts twice a day and is then reduced to once a day when the graft appears stable. HBOT is not necessary for normal un-compromised skin grafts or flaps;

6. Cyanide Poisoning - usually requires HBOT at 2.5 - 3.0 atm abs for up to 120 minutes. Most patients withcyanide poisoning will receive only one treatment;

7. Decompression Sickness - treatment times vary, depending upon length of time elapsed between symptomsand initiation of treatment and between residual symptoms after initial treatment. Usual time betweentreatments ranges from 1.5 to 14.0 hours. Repetitive treatments may be necessary, depending upon the


EXHIBIT D





8. Exceptional Blood Loss Anemia - for class IV hemorrhage HBOT can be administered safely at pressuresup to 3 atm abs for 2 to 4 hour periods three or four times daily. The vital capacity should be monitored toassess the extent of pulmonary oxygen toxicity. HBOT should be discontinued when the red blood cellshave been replaced and the signs and symptoms of tissue hypoxia have been alleviated (approximatehemoglobin of 6-8 g/dl). HBOT is indicated when the patient will not accept blood replacement formedical or religious reasons and the following symptoms are present:

(a) shock, systolic blood pressure below 90 mmHg, or pressure maintained by vasopressors; (b) disorientation to coma;(c) ischemic changes of the myocardium as demonstrated on the EKG; and(d) ischemic gut.(e) HBOT therapy is continued as needed and discontinued when the red blood cells have been

replaced in numbers to alleviate the preceding signs and symptoms;9. Gas Gangrene - the recommended treatment profile consists of 100% oxygen at 3.0 atm abs pressure for 90

minutes, 3 times in the first 24 hours and then twice per day for the next 4-5 days. The decision toterminate treatment depends upon the patreatment needs to be extended. No more than 10 sessions should be needed to treat;

10. Necrotizing Soft-Tissue Infections - HBOT treatments are given at a pressure of 2.0-2.5 atm abs and rangefrom 90 to 120 minutes. In the initial phase, they shouldhas stabilized, treatments may be given on a daily basis until the infection is controlled. Because of thenature and general progression of these diseases, and because patient response is often slow, an extendedcourse of HBOT therapy may be necessary. No more than 30 treatments should be needed;

11. Radiation Necrosis - review is recommended after 60 treatments. Treatments are usually given daily for 90to 120 minutes.

Systemic Hyperbaric Oxygen Therapy Systemic hyperbaric oxygen therapy involves the inhalation of pure oxygen gas while enclosed in a high-pressurechamber (defined as pressure greater than standard atmospheric pressure). The treatment, given in a clear acrylicchamber, increases the available oxygen to the body by 10 to 20 times. The therapy works by supersaturating the blood tissues with oxygen. Treatment may be carried out in either a monoplace chamber pressurized with pureoxygen or in a larger, multiplace chamber pressurized with compressed air, in which case the individual receivespure oxygen by mask, head tent, or endotracheal tube. The number and duration of treatment sessions and theatmospheric pressure during treatment varies depending on the severity of the condition, and the proceduresdeveloped by individual hospitals and clinics. These individual procedures vary widely and have made theevaluation of the efficacy of hyperbaric oxygen therapy difficult.

Topical Hyperbaric Oxygen TherapyTopical hyperbaric oxygen therapy involves the delivery of pure oxygen directly to an open, moist wound at apressure slightly higher than atmospheric pressure. Much of the research on topical hyperbaric oxygen therapy hasfocused on chronic wounds arising in diabetic patients – specifically foot wounds responsible for significantmortality and morbidity.

Definitions

Adjuvant: the use of another form of treatment in addition to the primary therapy

EXHIBIT D






Anemia: a reduction in the number of circulating red blood cells or in the total hemoglobin content of the cells

Atmospheres absolute (ATA): the combination (or the sum) of the atmospheric pressure and the hydrostaticpressure is called atmospheres absolute (ATA); in other words, the ATA or atmospheres absolute is the total weight of the water and air above us

Carbon monoxide poisoning: toxicity that results from inhalation of small amounts of carbon monoxide (apoisonous gas) over a long period of time or from large amounts inhaled for a short time, which leads to decreasedoxygen delivery to the body

Cerebral edema: swelling of the brain

Chronic: of a long duration; a disease that persists or progresses over time

Compartmental syndrome: any condition in which a structure such as a nerve or tendon is being constricted in aspace and is no longer able to move freely in the compartment

Cyanide poisoning: poisoning by a cyanide compound

Decompression sickness: a condition that develops in divers subjected to rapid reduction of air pressure aftercoming to the surface following exposure to compressed air

Gangrene: the death of tissue or bone, usually resulting from a deficient or absent blood supply

Gas embolism: obstruction of a blood vessel by a gas bubble

Ischemia: a local and temporary deficiency of blood supply due to an obstruction of the circulation

Limb specific hyperbaric oxygen: a therapy that involves sealing a person's leg or arm into an airtight containerand exposing that limb to pure oxygen greater than one atmosphere of pressure

Mycosis: any condition caused by a fungus

Necrosis: a condition where cells or tissues are dead or dying

Osteomyelitis: inflammation of the bone due to infection

Osteoradionecrosis: death of bone following irradiation

Prophylactic: any agent or treatment that contributes to the prevention of infection or disease

Pyoderma gangrenosum: a condition of the skin leading to open ulcers

Systemic hyperbaric oxygen: a therapy that involves sealing a patient inside a room or container, then exposingthe patient to pure oxygen at greater than one atmosphere of pressure


EXHIBIT D





Thermal: related to heat

Topical hyperbaric oxygen: a therapy that involves sealing skin wounds under a plastic cover and then exposingthe wound to pure oxygen at greater than one atmosphere of pressure; an alternate form of this therapy involves theapplication of a mist of water droplets to the wound that are saturated with dissolved oxygen

Coding

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

When services are Medically Necessary: CPT

99183 Physician attendance and supervision of hyperbaric oxygen therapy, per session

ICD-9 Procedure93.95 Hyperbaric oxygenation

Revenue Code

0413 Hyperbaric oxygen therapy

ICD-9 Diagnosis039.0-039.9 Actinomycotic infections040.0 Gas gangrene111.0-111.9 Dermatomycosis, other and unspecified112.0-112.3 Candidiasis117.7 Zygomycosis (Phycomycosis, Mucormycosis, Conidiobolus infection)117.9 Other and unspecified mycoses 285.1 Acute posthemorrhagic anemia348.5 Cerebral edema376.03 Acute inflammation of orbit, orbital osteomyelitis383.20-383.22 Petrositis, osteomyelitis443.89 Other specified peripheral vascular diseases 443.9 Peripheral vascular disease, unspecified (peripheral arterial insufficiency) 444.21 Arterial embolism, upper extremity444.22 Arterial embolism, lower extremity444.81 Arterial embolism, iliac artery459.9 Unspecified circulatory system disorder526.4 Inflammatory conditions of jaw, osteomyelitis acute, chronic, suppurative526.89 Osteoradionecrosis of jaw595.82 Irradiation cystitis686.00-686.9 Other local infections of skin and subcutaneous tissue

EXHIBIT D






707.00-707.9 Chronic ulcer of skin728.86 Necrotizing fasciitis728.9 Unspecified disorder of muscle, ligament, and fascia730.00-730.09 Acute osteomyelitis730.10-730.19 Chronic osteomyelitis730.20-730.29 Unspecified osteomyelitis785.4 Gangrene870.0-897.7 Open wounds902.53 Injury to iliac artery903.01 Injury to axillary artery903.1-903.9 Injury to blood vessels of upper extremity904.0 Injury to common femoral artery904.1 Injury to superficial femoral artery904.41 Injury to popliteal artery904.51 Injury to anterior tibial artery904.53 Injury to posterior tibial artery904.6-904.9 Injury to other blood vessels of lower extremity906.0-906.1 Late effect of open wound906.4 Late effect of crushing909.2 Late effect of radiation925.1-929.9 Crushing injury941.20-941.59 Burns of face, head and neck, second and third degree942.20-942.59 Burns of trunk, second and third degree943.20-943.59 Burns of upper limb second and third degree944.20-944.59 Burns of wrist and hand, second and third degree945.20-945.59 Burns of lower limb, second and third degree946.2-946.5 Burns of multiple specified sites, second and third degree948.00-948.99 Burns classified according to extent of body surface involved, third degree 958.0 Air embolism958.8 Other early complications of trauma986 Toxic effect of carbon monoxide987.7 Toxic effect of hydrocyanic acid gas989.0 Toxic effect of hydrocyanic acid and cyanides990 Effects of radiation, unspecified993.3 Caisson disease (decompression sickness, bends)996.52 Mechanical complication due to graft of other tissue, not elsewhere classified

(skin graft failure)

996.69 Infection and inflammatory reaction due to other internal prosthetic device,implant, and graft

996.79 Other complications due to other internal prosthetic device, implant, and graft998.83 Non-healing surgical wound999.1 Air embolism


EXHIBIT D





When services are Investigational/Not Medically Necessary: For the procedure codes listed above, for all other diagnoses not listed; or when the code describes a procedureindicated in the Guideline section as investigational/not medically necessary.

When services are also Investigational/Not Medically Necessary:HCPCS

A4575 Topical hyperbaric oxygen chamber, disposable

ICD-9 DiagnosisAll diagnoses

References

Peer Reviewed Publications:1. Bennett M, Heard R. Hyperbaric oxygen therapy for multiple sclerosis. Cochrane Database Syst Rev. 2004;

(1):CD003057.2. Bennett HM, Kertasz T, Yeung P. Hyperbaric oxygen for idiopathic sudden sensorineural hearing loss and

tinnitus. Cochrane Database Syst Rev. 2005; (1):CD004739.3. Bevers RF, Bakker DJ, Kurth K. Hyperbaric oxygen treatment for haemorrhagic radiation cystitis. Lancet.

1995; 346(8978): 803-5.4. Bill TJ, Hoard MA, Gampper TJ. Management of facial cutaneous defects, part II: applications of hyperbaric

oxygen in otolaryngology head and neck surgery. Otolaryngol Clin North Am. 2001; 34(4):753-66.5. Cesaro S, Brugiolo A, Faraci M, et al. Incidence and treatment of hemorrhagic cystitis in children given

hematopoietic stem cell transplantation: a survey from the Italian association of pediatric hematologyoncology-bone marrow transplantation group. Bone Marrow Transplant. 2003; 32(9):925-31.

6. Capelli-Schellpfeffer M, Gerber GS. The use of hyperbaric oxygen in urology. J Urol. 1999; 162(3 Pt 1):647-54.

7. Chong KT, Hampson NB, Corman JM. Early hyperbaric oxygen therapy improves outcome for radiation-induced hemorrhagic cystitis. Urology. 2005; 65(4): 649-53.

8. Cianci P, Sato R. Adjunctive hyperbaric oxygen therapy in the treatment of thermal burns: a review. Burns. 1994; 20(1):5-14.

9. Cotti G, Seid V, Araujo S, et al. Conservative therapies for hemorrhagic radiation proctitis: a review. Rev HospClin Fac Med S Paulo. 2003; 58(5):284-292.

10. Di Piero V, Cappagli M, Pastena L, et al. Cerebral effects of hyperbaric oxygen breathing: a CBF SPECT studyon professional divers. Eur J Neurol. 2002; 9(4):419-21.

11. Faglia E, Favales F, Aldeghi A, et al. Adjunctive systemic hyperbaric oxygen therapy in treatment of severeprevalently ischemic diabetic foot ulcer. Diabetes Care. 1996; 19:1338-43.

12. Feldmeier JJ, Hampson NB. A systematic review of the literature reporting the application of hyperbaric oxygen prevention and treatment of delayed radiation injuries: an evidence based approach. Undersea Hyperb Med. 2002; 29(1):4-30.

13. Gonzalez D. Hyperbaric oxygen therapy for cognitive disorders after irradiation of the brain. Strahlenther Onkol. 2002; 178(4):192-8.

14. Gordillo GM, Sen CK. Revisiting the essential role of oxygen in wound healing. Am J Surg. 2003; 186(3):259-63.





15. Hawkins M, Harrison J, Charters P. Severe carbon monoxide poisoning: outcome after hyperbaric oxygentherapy. British Journal of Anaesthesia. 2000; 84(5):584-586.

16. Heng MC, Harker J, Csathy G, et al. Angiogenesis in necrotic ulcers treated with hyperbaric oxygen. OstomyWound Manage. 2000; 46(9):18-28, 30-2.

17. Kalani M, Jorneskog G, Naderi N, et al. Hyperbaric oxygen (HBO) therapy in treatment of diabetic foot ulcers.Long-term follow-up. J Diabetes Complications. 2002; 16(2):153-8.

18. Kochanek PM, Jenkins LW, Edward-Dixon C, Clark RS. HBO: It's not ready for prime time for the treatmentof acute central nervous system trauma. Crit Care Med. 2001; 29(4):906-8.

19. Korhonen K. Hyperbaric oxygen therapy in acute necrotizing infections. With a special reference to the effectson tissue gas tensions. Ann Chir Gynaecol. 2000; 89 (Suppl) 214:7-36.

20. Landau Z. Topical hyperbaric oxygen and low energy laser for the treatment of diabetic foot ulcers. ArchOrthop Trauma Surg. 1998; 117(3):156-8.

21. Landau Z, Schattner A. Topical hyperbaric oxygen and low energy laser therapy for chronic diabetic foot ulcersresistant to conventional treatment. Yale J Biol Med. 2001; 74(2):95-100.

22. Leach RM, Rees PJ, Wilmhurst P. ABC of oxygen: hyperbaric oxygen therapy. BMJ. 1998; 317:1140-1143.23. Marx RE, Johnson RP. Studies in the radiobiology of osteoradionecrosis and their clinical significance. Oral

Surg. 1987; 64(4):379-390.24. McFarlane RM, Wermuth RE. The use of hyperbaric oxygen to prevent necrosis in experimental pedicle flaps

and composite skin grafts. Plastic and reconstructive Surgery. 1996; 37(5):422-430.25. Muth CM, Shank ES. Gas embolism. NEJM. 2000; 342(7):476-82.26. Myers RA. Hyperbaric oxygen therapy for trauma: crush injury, compartment syndrome, and other acute

traumatic peripheral ischemias. Int Anesthesiol Clin. 2000; 38(1):139-51.27. Niezgoda JA, Cianci P. The effect of hyperbaric oxygen therapy on a burn wound model in human volunteers.

Plast Reconstr Surg. 1997; 99(6): 1620-1625.28. Nuthall G, Seear M, Lepawsky M, et al. Hyperbaric oxygen therapy for cerebral palsy: two complications of

treatment. Pediatrics. 2000;106(6):1-3.29. Ren H, Wang W, Ge Z. Glasgow Coma Scale, brain electric activity mapping and Glasgow Outcome Scale

after hyperbaric oxygen treatment of severe brain injury. Chin J Traumatol. 2001; 4(4):239-41.30. Rockswold SB, Rockswold GL, Vargo JM, et al. Effects of hyperbaric oxygenation therapy on cerebral

metabolism and intracranial pressure in severely brain injured patients. J Neurosurg. 2001; 94(3):403-11.31. Rusnyiak DE, Kirk MA, et al. Hyperbaric oxygen therapy in acute ischemic stroke; results of the hyperbaric

oxygen in acute ischemia attack stroke trial pilot study. Stroke. 2003;34:571-574.32. Scheinkestel CD, Bailey M, Myles PS, et al. Hyperbaric or normobaric oxygen for acute carbon monoxide

poisoning: a randomized controlled clinical trial. Med J Aust. 1999; 170(5):203-10.33. Sen CK, Khanna S, Gordillo G, et al. Oxygen, oxidants, and antioxidants in wound healing: an emerging

paradigm. Ann N Y Acad Sci. 2002; 957:239-49.34. Senior C. Treatment of diabetic foot ulcers with hyperbaric oxygen. J Wound Care. 2000; 9(4):193-7.35. Shank ES, Muth CM. Decompression illness, iatrogenic gas embolism, and carbon monoxide poisoning: the

role of hyperbaric oxygen therapy. Int Anesthesiol Clin. 2000; 38(1):111-38.36. Tibbles PM, Edelsberg JS. Hyperbaric Oxygen Therapy. NEJM. 1996; 334(25):1642-1648.37. Van Meter KW. A systematic review of the application of hyperbaric oxygen in the treatment of severe

anemia: an evidence-based approach. Undersea Hyperb Med. 2005; 32(1):61-83. 38. Waisman D, Shupak A, Weisz G, Melamed Y.. Hyperbaric oxygen therapy in the pediatric patient: the

experience of the Israel Naval Medical Institute. Pediatrics. 1998;102(5):1-9.





15. Hawkins M, Harrison J, Charters P. Severe carbon monoxide poisoning: outcome after hyperbaric oxygentherapy. British Journal of Anaesthesia. 2000; 84(5):584-586.

16. Heng MC, Harker J, Csathy G, et al. Angiogenesis in necrotic ulcers treated with hyperbaric oxygen. OstomyWound Manage. 2000; 46(9):18-28, 30-2.

17. Kalani M, Jorneskog G, Naderi N, et al. Hyperbaric oxygen (HBO) therapy in treatment of diabetic foot ulcers.Long-term follow-up. J Diabetes Complications. 2002; 16(2):153-8.

18. Kochanek PM, Jenkins LW, Edward-Dixon C, Clark RS. HBO: It's not ready for prime time for the treatmentof acute central nervous system trauma. Crit Care Med. 2001; 29(4):906-8.

19. Korhonen K. Hyperbaric oxygen therapy in acute necrotizing infections. With a special reference to the effectson tissue gas tensions. Ann Chir Gynaecol. 2000; 89 (Suppl) 214:7-36.

20. Landau Z. Topical hyperbaric oxygen and low energy laser for the treatment of diabetic foot ulcers. ArchOrthop Trauma Surg. 1998; 117(3):156-8.

21. Landau Z, Schattner A. Topical hyperbaric oxygen and low energy laser therapy for chronic diabetic foot ulcersresistant to conventional treatment. Yale J Biol Med. 2001; 74(2):95-100.

22. Leach RM, Rees PJ, Wilmhurst P. ABC of oxygen: hyperbaric oxygen therapy. BMJ. 1998; 317:1140-1143.23. Marx RE, Johnson RP. Studies in the radiobiology of osteoradionecrosis and their clinical significance. Oral

Surg. 1987; 64(4):379-390.24. McFarlane RM, Wermuth RE. The use of hyperbaric oxygen to prevent necrosis in experimental pedicle flaps

and composite skin grafts. Plastic and reconstructive Surgery. 1996; 37(5):422-430.25. Muth CM, Shank ES. Gas embolism. NEJM. 2000; 342(7):476-82.26. Myers RA. Hyperbaric oxygen therapy for trauma: crush injury, compartment syndrome, and other acute

traumatic peripheral ischemias. Int Anesthesiol Clin. 2000; 38(1):139-51.27. Niezgoda JA, Cianci P. The effect of hyperbaric oxygen therapy on a burn wound model in human volunteers.

Plast Reconstr Surg. 1997; 99(6): 1620-1625.28. Nuthall G, Seear M, Lepawsky M, et al. Hyperbaric oxygen therapy for cerebral palsy: two complications of

treatment. Pediatrics. 2000;106(6):1-3.29. Ren H, Wang W, Ge Z. Glasgow Coma Scale, brain electric activity mapping and Glasgow Outcome Scale

after hyperbaric oxygen treatment of severe brain injury. Chin J Traumatol. 2001; 4(4):239-41.30. Rockswold SB, Rockswold GL, Vargo JM, et al. Effects of hyperbaric oxygenation therapy on cerebral

metabolism and intracranial pressure in severely brain injured patients. J Neurosurg. 2001; 94(3):403-11.31. Rusnyiak DE, Kirk MA, et al. Hyperbaric oxygen therapy in acute ischemic stroke; results of the hyperbaric

oxygen in acute ischemia attack stroke trial pilot study. Stroke. 2003;34:571-574.32. Scheinkestel CD, Bailey M, Myles PS, et al. Hyperbaric or normobaric oxygen for acute carbon monoxide

poisoning: a randomized controlled clinical trial. Med J Aust. 1999; 170(5):203-10.33. Sen CK, Khanna S, Gordillo G, et al. Oxygen, oxidants, and antioxidants in wound healing: an emerging

paradigm. Ann N Y Acad Sci. 2002; 957:239-49.34. Senior C. Treatment of diabetic foot ulcers with hyperbaric oxygen. J Wound Care. 2000; 9(4):193-7.35. Shank ES, Muth CM. Decompression illness, iatrogenic gas embolism, and carbon monoxide poisoning: the

role of hyperbaric oxygen therapy. Int Anesthesiol Clin. 2000; 38(1):111-38.36. Tibbles PM, Edelsberg JS. Hyperbaric Oxygen Therapy. NEJM. 1996; 334(25):1642-1648.37. Van Meter KW. A systematic review of the application of hyperbaric oxygen in the treatment of severe

anemia: an evidence-based approach. Undersea Hyperb Med. 2005; 32(1):61-83. 38. Waisman D, Shupak A, Weisz G, Melamed Y.. Hyperbaric oxygen therapy in the pediatric patient: the

experience of the Israel Naval Medical Institute. Pediatrics. 1998;102(5):1-9.

Assessing New Procedures and Technologies: Hyperbaric Oxygen Therapy40

EXHIBIT D





39. Weaver LK, Churchill S. Pulmonary edema associated with hyperbaric oxygen therapy. Chest. 2001; 120(4):1407-1409.

40. Weaver LK, Hopkins RO, Chan K, et al. Hyperbaric oxygen for acute carbon monoxide poisoning. N Engl JMed. 2002; 347(14):1057-67.

41. Wood Z. Hyperbaric oxygen in the management of chronic wounds. Br J Nurs. 2002;11:S16, S18-9, S22-4.42. Zamboni, WA. Applications of hyperbaric oxygen therapy in plastic surgery. Handbook of Hyperbaric

Medicine 1996; 443-483.

Government Agency, Medical Society, and Other Authoritative Publications:1. Agency for Healthcare Research and Quality. Hyperbaric Oxygen Therapy in the Treatment of Hypoxic

Wounds and Diabetic Wounds of the Lower Extremities. Technology Assessment 2001.2. Blue Cross Blue Shield Association. Hyperbaric Oxygen Therapy for Wound Healing—Part I. TEC

Assessment, 1999; 14 (13).3. Blue Cross Blue Shield Association. Hyperbaric Oxygen Therapy for Wound Healing—Part II. TEC

Assessment, 1999; 14 (15).4. Blue Cross Blue Shield Association. Hyperbaric Oxygen Therapy for Wound Healing—Part III. TEC

Assessment, 1999; 14 (16).5. Centers for Medicare and Medicaid Services. National Coverage Determination for Hyperbaric Oxygen

Therapy. NCD #20.29. Effective April 1, 2003. http://www.cms.hhs.gov. Accessed on March 29, 2006.6. Centers for Medicare and Medicaid Services. National Coverage Determination for Treatment of Decubitus

Ulcers. NCD #270.4. Effective date not posted. http://www.cms.hhs.gov. Accessed on March 29, 2006.7. Hayes, Inc. Hayes Medical Technology Directory: Hyperbaric Oxygen Therapy for Carbon Monoxide

Poisoning. Lansdale, PA: Hayes, Inc.; October 2003. Search updated December 7, 2005.8. Hayes, Inc. Hayes Medical Technology Directory. Topical Oxygen Therapy for Chronic Wound Healing.

Lansdale, PA: Hayes, Inc.; January 2002. Search updated February 21, 2006.9. Hayes, Inc. Hayes Medical Technology Directory. Hyperbaric Oxygen Therapy for Carbon Monoxide

Poisoning. Lansdale, PA: Hayes, Inc.; May 2002. Search updated January 3, 2006.10. Hayes, Inc. Hayes Medical Technology Directory. Hyperbaric Oxygen Therapy for Burns, Infections, and

Wounds. Lansdale, PA: Hayes, Inc.; May 2002. Search updated November 23, 2005.11. National Institutes of Health Consensus Development Conference Statement: Oral Complications of Cancer

Therapies: Diagnosis, Prevention, and Treatment. 1989 (update 1995). Bethesda, MD.12. Undersea and Hyperbaric Medical Society. Feldmeier JJ, Hopf HW, Warriner RA 3rd, et al. UHMS position

statement: Topical oxygen for chronic wounds. Undersea Hyperb Med. 2005; 32:157-168.13. Undersea and Hyperbaric Medical Society. Bennett M, Heard R. . UHMS position statement: Treatment of

multiple sclerosis with hyperbaric oxygen therapy. Undersea Hyperb Med. 2001; 28(3):117-22.

Web Sites for Additional Information

1. National Library of Medicine. Medical Encyclopedia. Hyperbaric oxygen therapy. Available at:http://www.nlm.nih.gov/medlineplus/ency/article/002375.htm. Accessed March 30, 2006.

Index

Air Embolism Extreme Chamber TherapyExtremity Oxygen Therapy





39. Weaver LK, Churchill S. Pulmonary edema associated with hyperbaric oxygen therapy. Chest. 2001; 120(4):1407-1409.

40. Weaver LK, Hopkins RO, Chan K, et al. Hyperbaric oxygen for acute carbon monoxide poisoning. N Engl JMed. 2002; 347(14):1057-67.

41. Wood Z. Hyperbaric oxygen in the management of chronic wounds. Br J Nurs. 2002;11:S16, S18-9, S22-4.42. Zamboni, WA. Applications of hyperbaric oxygen therapy in plastic surgery. Handbook of Hyperbaric

Medicine 1996; 443-483.

Government Agency, Medical Society, and Other Authoritative Publications:1. Agency for Healthcare Research and Quality. Hyperbaric Oxygen Therapy in the Treatment of Hypoxic

Wounds and Diabetic Wounds of the Lower Extremities. Technology Assessment 2001.2. Blue Cross Blue Shield Association. Hyperbaric Oxygen Therapy for Wound Healing—Part I. TEC

Assessment, 1999; 14 (13).3. Blue Cross Blue Shield Association. Hyperbaric Oxygen Therapy for Wound Healing—Part II. TEC

Assessment, 1999; 14 (15).4. Blue Cross Blue Shield Association. Hyperbaric Oxygen Therapy for Wound Healing—Part III. TEC

Assessment, 1999; 14 (16).5. Centers for Medicare and Medicaid Services. National Coverage Determination for Hyperbaric Oxygen

Therapy. NCD #20.29. Effective April 1, 2003. http://www.cms.hhs.gov. Accessed on March 29, 2006.6. Centers for Medicare and Medicaid Services. National Coverage Determination for Treatment of Decubitus

Ulcers. NCD #270.4. Effective date not posted. http://www.cms.hhs.gov. Accessed on March 29, 2006.7. Hayes, Inc. Hayes Medical Technology Directory: Hyperbaric Oxygen Therapy for Carbon Monoxide

Poisoning. Lansdale, PA: Hayes, Inc.; October 2003. Search updated December 7, 2005.8. Hayes, Inc. Hayes Medical Technology Directory. Topical Oxygen Therapy for Chronic Wound Healing.

Lansdale, PA: Hayes, Inc.; January 2002. Search updated February 21, 2006.9. Hayes, Inc. Hayes Medical Technology Directory. Hyperbaric Oxygen Therapy for Carbon Monoxide

Poisoning. Lansdale, PA: Hayes, Inc.; May 2002. Search updated January 3, 2006.10. Hayes, Inc. Hayes Medical Technology Directory. Hyperbaric Oxygen Therapy for Burns, Infections, and

Wounds. Lansdale, PA: Hayes, Inc.; May 2002. Search updated November 23, 2005.11. National Institutes of Health Consensus Development Conference Statement: Oral Complications of Cancer

Therapies: Diagnosis, Prevention, and Treatment. 1989 (update 1995). Bethesda, MD.12. Undersea and Hyperbaric Medical Society. Feldmeier JJ, Hopf HW, Warriner RA 3rd, et al. UHMS position

statement: Topical oxygen for chronic wounds. Undersea Hyperb Med. 2005; 32:157-168.13. Undersea and Hyperbaric Medical Society. Bennett M, Heard R. . UHMS position statement: Treatment of

multiple sclerosis with hyperbaric oxygen therapy. Undersea Hyperb Med. 2001; 28(3):117-22.

Web Sites for Additional Information

1. National Library of Medicine. Medical Encyclopedia. Hyperbaric oxygen therapy. Available at:http://www.nlm.nih.gov/medlineplus/ency/article/002375.htm. Accessed March 30, 2006.

Index

Air Embolism Extreme Chamber TherapyExtremity Oxygen Therapy

EXHIBIT D

Assessing New Procedures and Technologies: Hyperbaric Oxygen Therapy 41





Osteomyelitis, Acute and Chronic Osteoradionecrosis

Guideline History

Status Date Action Revised 06/08/2006 Medical Policy & Technology Assessment Committee (MPTAC) review.

Moved radiation necrosis from I/E-NMN to MN. Updated coding andreference sections. Published on the web 08/01/2006

11/22/2005 Added reference for Centers for Medicare and Medicaid Services (CMS) –National Coverage Determination (NCD).

Reviewed 07/14/2005 MPTAC review. Revision based on Policy Harmonization: Pre-mergerAnthem and Pre-merger WellPoint.

Pre-Merger Organizations Last Review Date

GuidelineNumber

Title

Anthem, Inc. 04/28/2005 MED.00005 Hyperbaric Oxygen Therapy(Systemic/Topical)

WellPoint Health Networks, Inc. 04/28/2005 2.01.01 Hyperbaric Oxygen Therapy: Systemic 09/23/2004 2.02.01 Oxygen Therapy (Low Pressure) for

Wound Care





Osteomyelitis, Acute and Chronic Osteoradionecrosis

Guideline History

Status Date Action Revised 06/08/2006 Medical Policy & Technology Assessment Committee (MPTAC) review.

Moved radiation necrosis from I/E-NMN to MN. Updated coding andreference sections. Published on the web 08/01/2006

11/22/2005 Added reference for Centers for Medicare and Medicaid Services (CMS) –National Coverage Determination (NCD).

Reviewed 07/14/2005 MPTAC review. Revision based on Policy Harmonization: Pre-mergerAnthem and Pre-merger WellPoint.

Pre-Merger Organizations Last Review Date

GuidelineNumber

Title

Anthem, Inc. 04/28/2005 MED.00005 Hyperbaric Oxygen Therapy(Systemic/Topical)

WellPoint Health Networks, Inc. 04/28/2005 2.01.01 Hyperbaric Oxygen Therapy: Systemic 09/23/2004 2.02.01 Oxygen Therapy (Low Pressure) for

Wound Care


EXHIBIT D

Hyperbaric Credentialing Criteria


Exhibit E

____________________ HOSPITAL


PRIVILEGES: Hyperbaric Medicine and Related Case Management.

DEFINITION: Hyperbaric medicine (hyperbaric oxygen therapy) is a mode of therapy in which

the patient breathes 100% oxygen at pressures greater than normal atmospheric (sea level) pressure. In

contrast to attempts to force oxygen into tissues by topical applications at levels only slightly higher than

atmospheric pressure, hyperbaric oxygen therapy involves the systemic delivery of oxygen at values 2-3

times greater than atmospheric pressure.

Applicant must meet all credentialing requirements for staff membership and clinical privileges on the

General Staff of ____________________ Hospital as outlined in the General Staff Bylaws and supporting

documents.

GENERAL REQURIEMENTS SPECIFIC REQUIREMENTS

A. Education M.D. or D.O.

B. Board Specifications Board qualified or certified, as required in the Hospital

Credentials Manual.

C. Training/Experience References:

1. Applicant trained in hyperbaric medicine through a residency or fellowship program who is

applying immediately after completion of the program: documentation shall be provided by the

director of the training program of the practitioner’s competence and satisfactory completion of the

program to include a case log, complications and outcomes.

OR

2. Applicant trained in hyperbaric medicine through a residency or fellowship program who has

been in practice for one or more years: documentation shall be provided by the director of the

training program of the practitioner’s competence and satisfactory completion of the program to

include case log, complications and outcome and documentation from the practitioner of the

performance of a minimum of 12 consultations (and related case managements) in each year of

practice since the completion of the program.

OR

3. Documentation of completion of training in an introductory/primary course in hyperbaric

medicine approved by the Undersea and Hyperbaric Medicine Society (documentation shall

include course outline and certificate of course completion). At the end of the training program, the

participant shall have the:

a. knowledge of the accepted and common investigational indications for hyperbaric oxygen

therapy;

b. knowledge of the potential risks and side effects of exposure to hyperbaric doses of oxygen, and

the ability to explain such risks and side effects in terms understandable to patients;

c. competency to effectively manage such expected complications, as ear and sinus barotrauma,

pneumothorax and central nervous system intolerance to hyperoxia;

d. ability to appropriately document each hyperbaric referral, knowing and documenting the

correct diagnosis, assessment, planning, evaluation, appropriate progress notes, discharge

criteria, complications and be able to make recommendations regarding continuing treatments to

determine effective utilization of hyperbaric oxygen therapy.

D. Privilege Specifications: practitioner must request an extension for this privilege and must hold clinical

privileges and staff membership on the General Staff of this facility, or a practitioner may request this

privilege only but must be a member of the General Staff of this facility.

E. Monitoring Recommendations following initial granting of privileges:

____________________ HOSPITAL


PRIVILEGES: Hyperbaric Medicine and Related Case Management.

DEFINITION: Hyperbaric medicine (hyperbaric oxygen therapy) is a mode of therapy in which

the patient breathes 100% oxygen at pressures greater than normal atmospheric (sea level) pressure. In

contrast to attempts to force oxygen into tissues by topical applications at levels only slightly higher than

atmospheric pressure, hyperbaric oxygen therapy involves the systemic delivery of oxygen at values 2-3

times greater than atmospheric pressure.

Applicant must meet all credentialing requirements for staff membership and clinical privileges on the

General Staff of ____________________ Hospital as outlined in the General Staff Bylaws and supporting

documents.

GENERAL REQURIEMENTS SPECIFIC REQUIREMENTS

A. Education M.D. or D.O.

B. Board Specifications Board qualified or certified, as required in the Hospital

Credentials Manual.

C. Training/Experience References:

1. Applicant trained in hyperbaric medicine through a residency or fellowship program who is

applying immediately after completion of the program: documentation shall be provided by the

director of the training program of the practitioner’s competence and satisfactory completion of the

program to include a case log, complications and outcomes.

OR

2. Applicant trained in hyperbaric medicine through a residency or fellowship program who has

been in practice for one or more years: documentation shall be provided by the director of the

training program of the practitioner’s competence and satisfactory completion of the program to

include case log, complications and outcome and documentation from the practitioner of the

performance of a minimum of 12 consultations (and related case managements) in each year of

practice since the completion of the program.

OR

3. Documentation of completion of training in an introductory/primary course in hyperbaric

medicine approved by the Undersea and Hyperbaric Medicine Society (documentation shall

include course outline and certificate of course completion). At the end of the training program, the

participant shall have the:

a. knowledge of the accepted and common investigational indications for hyperbaric oxygen

therapy;

b. knowledge of the potential risks and side effects of exposure to hyperbaric doses of oxygen, and

the ability to explain such risks and side effects in terms understandable to patients;

c. competency to effectively manage such expected complications, as ear and sinus barotrauma,

pneumothorax and central nervous system intolerance to hyperoxia;

d. ability to appropriately document each hyperbaric referral, knowing and documenting the

correct diagnosis, assessment, planning, evaluation, appropriate progress notes, discharge

criteria, complications and be able to make recommendations regarding continuing treatments to

determine effective utilization of hyperbaric oxygen therapy.

D. Privilege Specifications: practitioner must request an extension for this privilege and must hold clinical

privileges and staff membership on the General Staff of this facility, or a practitioner may request this

privilege only but must be a member of the General Staff of this facility.

E. Monitoring Recommendations following initial granting of privileges:


EXHIBIT E

1. Practitioner must submit a minimum of five cases (medical record number, date procedure) to the

Medical Staff Office; all cases must have been performed at _______________ Hospital.

2. The appropriate performance improvement committee will review these cases to determine if criteria

were met and no untoward trends identified. A report will be submitted of their findings to the

Credentials and Medical Executive Committees,

F. Continuing Privileges – Reappointment:

1. Practitioner must submit documentation of experience in a minimum of twelve hyperbaric

medicine consultations (and related case management) in the two year period preceding the

application for reappointment.

2. Practitioner must provide documentation of sixteen hours of CME credits every two years with

education specific to hyperbaric medicine and approved by the Undersea and Hyperbaric

Medicine Society.

NOTE: These credentialing criteria were approved by the __________ on __________, 200_, for

_______________ Hospital.

CREDENTIALS COMMITTEE: _____________________________

MEDICAL EXECUTIVE COMMITTEE: _____________________________

MEDICAL AFFAIRS COMMITTEE: _____________________________

1. Practitioner must submit a minimum of five cases (medical record number, date procedure) to the

Medical Staff Office; all cases must have been performed at _______________ Hospital.

2. The appropriate performance improvement committee will review these cases to determine if criteria

were met and no untoward trends identified. A report will be submitted of their findings to the

Credentials and Medical Executive Committees,

F. Continuing Privileges – Reappointment:

1. Practitioner must submit documentation of experience in a minimum of twelve hyperbaric

medicine consultations (and related case management) in the two year period preceding the

application for reappointment.

2. Practitioner must provide documentation of sixteen hours of CME credits every two years with

education specific to hyperbaric medicine and approved by the Undersea and Hyperbaric

Medicine Society.

NOTE: These credentialing criteria were approved by the __________ on __________, 200_, for

_______________ Hospital.

CREDENTIALS COMMITTEE: _____________________________

MEDICAL EXECUTIVE COMMITTEE: _____________________________

MEDICAL AFFAIRS COMMITTEE: _____________________________

EXHIBIT E


_______________ HOSPITAL

NAME: ___________________ DATE: ____________________

I hereby request privileges in hyperbaric medicine and related case management. My request is based on

the credentialing requirements as attached. The documentation attached is provided to support my

request and conforms to the following section of training and experience (check appropriate section and

attached required documentation):

1. _____ Trained in hyperbaric medicine through a residency or fellowship program with

application immediately upon completion of program.

2. _____ Trained in hyperbaric medicine through a residency or fellowship program and have been

in practice for one or more years.

3. _____ Documentation of training in an introduction/primary course in hyperbaric medicine

approved by the Undersea and Hyperbaric Medical Society.

SIGNATURE: _________________________________________________________________________

SERVICE CHIEF RECOMMENDATION

Service Chief Recommendation: I have reviewed the requested the requested clinical privilege and

supporting documentation for this applicant and based upon that information find that the applicant is

capable of performing those privileges delineated herein; therefore, I recommend the applicant for these

privileges as requested, upon approval by the Medical Affairs Committee.

Comments:_____________________________________________________________________________

______________________________________________________________________________________

Signed: ______________________________ Date: _________________________

This section is to be completed by the Medical Staff Office Based upon action by the Medical Affairs

Committee (Board)

Effective date of privileges: __________ Expiration date of privileges: __________

Completed by: __________________________________________________________________________

(Fdrive/Brandy/Generic Credentialing Criteria)

_______________ HOSPITAL

NAME: ___________________ DATE: ____________________

I hereby request privileges in hyperbaric medicine and related case management. My request is based on

the credentialing requirements as attached. The documentation attached is provided to support my

request and conforms to the following section of training and experience (check appropriate section and

attached required documentation):

1. _____ Trained in hyperbaric medicine through a residency or fellowship program with

application immediately upon completion of program.

2. _____ Trained in hyperbaric medicine through a residency or fellowship program and have been

in practice for one or more years.

3. _____ Documentation of training in an introduction/primary course in hyperbaric medicine

approved by the Undersea and Hyperbaric Medical Society.

SIGNATURE: _________________________________________________________________________

SERVICE CHIEF RECOMMENDATION

Service Chief Recommendation: I have reviewed the requested the requested clinical privilege and

supporting documentation for this applicant and based upon that information find that the applicant is

capable of performing those privileges delineated herein; therefore, I recommend the applicant for these

privileges as requested, upon approval by the Medical Affairs Committee.

Comments:_____________________________________________________________________________

______________________________________________________________________________________

Signed: ______________________________ Date: _________________________

This section is to be completed by the Medical Staff Office Based upon action by the Medical Affairs

Committee (Board)

Effective date of privileges: __________ Expiration date of privileges: __________

Completed by: __________________________________________________________________________

(Fdrive/Brandy/Generic Credentialing Criteria)


EXHIBIT E

Indications for Hyperbaric Oxygen Therapy


Exhibit F

Indications for Hyperbaric Oxygen TherapyDefinition of Hyperbaric Oxygen Therapy:

The patient breathes 100% oxygen intermittently while the pressure of the treatment chamber is increased to greater than one atmosphere absolute (atm abs). Current information indicates that pressurization should be at least 1.4 atm abs. This may occur in a single person chamber(monoplace) or multiplace chamber (may hold 2 or more people). Breathing 100% oxygen at 1atm abs or exposing isolated parts of the body to 100% oxygen does not constitute HBO2 therapy.


The following indications are approved uses of hyperbaric oxygen therapy as defined by theHyperbaric Oxygen Therapy Committee. The Committee Report can be purchased directlythrough the UHMS


2 Carbon Monoxide Poisoning Carbon Monoxide Poisoning Complicated by Cyanide Poisoning











13 Thermal Burns

Selected references can be found by clicking directly on the topics or by selecting the full list via the button on the left. RCTs here too, or see HBO Evidence website.

If you have more / better references please contact Guy Dear.

A list of Diplomates in Hyperbaric Medicine is now on the web to indicates those practitioners who have passed the Board Exam this is to allow the lay public to find a reputable doctor in any given area.

Indications for Hyperbaric Oxygen TherapyDefinition of Hyperbaric Oxygen Therapy:

The patient breathes 100% oxygen intermittently while the pressure of the treatment chamber is increased to greater than one atmosphere absolute (atm abs). Current information indicates that pressurization should be at least 1.4 atm abs. This may occur in a single person chamber(monoplace) or multiplace chamber (may hold 2 or more people). Breathing 100% oxygen at 1atm abs or exposing isolated parts of the body to 100% oxygen does not constitute HBO2 therapy.


The following indications are approved uses of hyperbaric oxygen therapy as defined by theHyperbaric Oxygen Therapy Committee. The Committee Report can be purchased directlythrough the UHMS


2 Carbon Monoxide Poisoning Carbon Monoxide Poisoning Complicated by Cyanide Poisoning











13 Thermal Burns

Selected references can be found by clicking directly on the topics or by selecting the full list via the button on the left. RCTs here too, or see HBO Evidence website.

If you have more / better references please contact Guy Dear.

A list of Diplomates in Hyperbaric Medicine is now on the web to indicates those practitioners who have passed the Board Exam this is to allow the lay public to find a reputable doctor in any given area.


EXHIBIT F

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