Dial-In Instructions

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1 Dial-In Instructions Conference name: Assessing New Procedures and Technologies: Hyperbaric Oxygen Therapy Scheduled conference date: Tuesday, February 13, 2007 Scheduled conference time: Scheduled conference duration: 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) 90 minutes PLEASE NOTE: If the audioconference occurs March through November, the time reflects daylight savings. If your area does NOT observe daylight savings, times will be one hour earlier. Your registration entitles you to ONE telephone connection to the audioconference. Invite as many people as you wish to listen to the audioconference on your speakerphone. Permission is given to make copies of the written materials for anyone who is listening. In order to avoid delays in connecting to the conference, we recommend that you dial into the audioconference 15 minutes prior to the start time. Dial-in instructions 1. Dial 877/ and follow the voice prompts. 2. You will be greeted by an operator. 3. Give the operator the pass code, , 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. Technical difficulties 1. If you experience any difficulties with the dial-in process, please call the conference center reservation line at 877/ If you need technical assistance during the audio portion of the program, please press the star (*) key, followed by the 0 key, on your touch-tone phone, and an operator will assist you. If you are disconnected during the conference, dial 877/ Q&A session 1. To enter the questioning queue during the Q&A session, callers need to push the star (*) key, followed by the 1 key, on their touch-tone phones. Note: For most programs, the Q&A portion of the program generally falls after the first hour of presentation. Please do not try to enter the queue before this portion of the program. 2. If you prefer not to ask your questions on the air, you can fax your questions to 877/ or 201/ However, note that you can only fax your questions during the program. Prior to the program You can also send your questions via to agresla@hcpro.com. The deadline to send presubmitted questions via e- mail is 5:30 PM Eastern. Please note that it is likely that not all questions will be answered. Program evaluation survey In this materials packet on page 2, we have included a program evaluation letter that has the URL link to our program survey. We would appreciate it if you could go to the link provided and complete the survey when you return to your office. Continuing education documentation If CEs are offered with this program, a separate link containing important information will be provided along with the program materials. Please follow the instructions in the CE documentation.

2 200 Hoods Lane PO Box 1168 Marblehead MA TEL FAX URL Program Evaluation Dear Program Participant, Thank you for attending the HCPro program today. We hope you found it to be informative and helpful. To ensure a positive experience for our customers and to deliver the best possible products and services, we would like your feedback. Because your time is valuable, we have limited the evaluation to some brief questions found at the link below: We would also ask that you forward the link to others in your facility who attended the program for their input as well. To ensure that your completed form receives our attention, please return to us within six days from the date of this program. If you enjoyed this program, you may purchase a tape or CD at the special attendee price of just $70. Simply call our customer service team at 800/ , and mention your source code: SURVEYAD. Keep the tape or CD handy, and listen again at your convenience whenever you or your staff might benefit from a refresher, or when your new employees are ready for training. We appreciate your time and suggestions. We hope that you will continue to rely on HCPro programs as an important resource for pertinent and timely information. Sincerely, Leokadia Marchwinski Director of Multimedia Production HCPro, Inc.

3 Assessing New Procedures and Technologies: Hyperbaric Oxygen Therapy A 90-minute interactive audioconference Tuesday, February 13, :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)

4 In our materials, we strive to provide our audience with useful and timely information. The live audioconference will follow the enclosed agenda. Occasionally, our speakers will refer to the enclosed materials. We have noticed that non-hcpro audioconference materials often follow the speakers presentations bullet-bybullet and page-by-page. However, because our presentations are less rigid and rely more on speaker interaction, 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 Commission trademarks. ii Assessing New Procedures and Technologies: Hyperbaric Oxygen Therapy

5 The Assessing New Procedures and Technologies: Hyperbaric Oxygen Therapy audioconference materials package is published by HCPro, Inc., 200 Hoods Lane, P.O. Box 1168, Marblehead, MA Copyright 2007, HCPro, Inc. Attendance at the audioconference is restricted to employees, consultants, and members of the medical staff of the Licensee. The audioconference materials are intended solely for use in conjunction with the associated HCPro audioconference. The Licensee may make copies of these materials for internal use by attendees of the audioconference only. All such copies must bear the following legend: Dissemination of any information in these materials 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 for specific 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 Lane P.O. Box 1168 Marblehead, MA Phone: 800/ Fax: 781/ Web site: Assessing New Procedures and Technologies: Hyperbaric Oxygen Therapy iii

6 200 Hoods Lane P.O. Box 1168 Marblehead, MA Tel: 800/ Fax: 800/ Dear Colleague, Thank you for participating in our Assessing New Procedures and Technologies: Hyperbaric Oxygen Therapy audioconference with Richard Clarke and Mary M. Verhage, RN, BSN, CWOCN, CHRN, moderated by Margot Suydam. We are excited about the opportunity to interact with you directly and encourage you to ask our experts your questions during the audioconference. If you would like to submit a question before the audioconference, please send it to agresla@hcpro.com and provide the program date in the subject line. We cannot guarantee that your question 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 we can improve our audioconference, or if you have any questions about the audioconference itself, please do not hesitate to contact me. And if you would like any additional information about our other products and services, please contact our Customer Service Department at 800/ We have enclosed an evaluation along with the audioconference materials. After the audioconference, please take a minute to complete the evaluation to let us know what you think. We value your opinion. Thanks again for working with us. Best regards, Abigail Gresla Associate Producer Fax: 781/ agresla@hcpro.com iv Assessing New Procedures and Technologies: Hyperbaric Oxygen Therapy

7 Contents Agenda vi Speaker profiles vii Exhibit A Presentation by Richard Clarke and Mary M. Verhage, RN, BSN, CWOCN, CHRN Exhibit B Indications for Hyperbaric Oxygen Therapy and Definition of Hyperbaric Oxygen Therapy Exhibit C Medicare Coverage Database Exhibit D Anthem Coverage Guideline Exhibit E Hyperbaric Credentialing Criteria Exhibit F Indications for Hyperbaric Oxygen Therapy Resources Assessing New Procedures and Technologies: Hyperbaric Oxygen Therapy v

8 Agenda I. Role of HBO in clinical practice A. What is treatable? B. What is reimbursable? i. Who says so? Medicare, common insurance companies II. III. IV. How do you treat it using hyperbaric medicine? A. Variables when moving forward i. Capitalization requirement ii. Physical plant needs iii. Installation costs Common hyperbaric business models A. What kind of physicians, nurses, and technicians will be needed for each model Implementation plan A. Basic privileging criteria V. Describe common program management and compliance pitfalls A. Ensuring successful programs B. Minimizing compliance problems VI. Live Q&A vi Assessing New Procedures and Technologies: Hyperbaric Oxygen Therapy

9 Speaker profiles Richard Clarke Richard Clarke is president of National Baromedical Services ( a hyperbaric management, training and consulting company he founded in Dick's background in hyperbaric medicine extends back four decades and includes technical, clinical, safety, education, administration and research roles. He serves as program director and faculty for primary and advanced hyperbaric training courses, and has 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 leadership positions with the Undersea and Hyperbaric Medical Society for more than 20 years. He founded a nonprofit research organization ( that has dedicated itself to the scientific advancement of hyperbaric medicine. Several multi-center and international clinical trials are underway and one has recently been completed. Dick's program has served as the 'evidence' resource during hyperbaric technology assessments by CMS (Medicare) and Blue Cross Blue Shield. His headquarters facility is housed at Palmetto Health Richland Hospital/University of South Carolina School of Medicine, in Columbia, South Carolina. Mary M. Verhage, RN, BSN, CWOCN, CHRN Mary M. Verhage is a nationally certified wound, ostomy, and continence nurse, and a certified hyperbaric registered nurse with 16 years of experience. She most recently worked as the practice manager and nurse clinician for Hyperbaric & Wound Care Associates, a healthcare group that provides advanced wound care and hyperbaric oxygen therapy to patients in southeastern Wisconsin. She has consulted and provided direct patient care to individuals in the acute, long-term, rehab, and home care environments since Verhage is currently pursuing her master of science degree in nursing and master of science degree in healthcare administration with the University of Phoenix. Assessing New Procedures and Technologies: Hyperbaric Oxygen Therapy vii

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

11 EXHIBIT A Assessing New Procedures and Technologies: Hyperbaric Oxygen Therapy Presented by: Dick Clarke and Mary Verhage 1 The Undersea and Hyperbaric Medical Society * CMS/Medicare; other government agencies ** Private health insurance companies *** *Appendix 1 ** Appendix 2 *** Appendix 3 2 Assessing New Procedures and Technologies: Hyperbaric Oxygen Therapy

12 EXHIBIT A Assessing New Procedures and Technologies: Hyperbaric Oxygen Therapy 3

13 EXHIBIT A 4 Assessing New Procedures and Technologies: Hyperbaric Oxygen Therapy

14 EXHIBIT A What represents a typical dosing schedule? with the treatment indication response 8 Assessing New Procedures and Technologies: Hyperbaric Oxygen Therapy 5

15 EXHIBIT A Capital Requirements expenses 9 6 Assessing New Procedures and Technologies: Hyperbaric Oxygen Therapy

16 EXHIBIT A Operational Installation Costs 12 Assessing New Procedures and Technologies: Hyperbaric Oxygen Therapy 7

17 EXHIBIT A Basic Privileging Criteria 14 8 Assessing New Procedures and Technologies: Hyperbaric Oxygen Therapy

18 EXHIBIT A Appendix 4 Assessing New Procedures and Technologies: Hyperbaric Oxygen Therapy 9

19 EXHIBIT A (cont d) Program Success Drivers Assessing New Procedures and Technologies: Hyperbaric Oxygen Therapy

20 EXHIBIT A Ensure Successful Programs 19 Assessing New Procedures and Technologies: Hyperbaric Oxygen Therapy 11

21 EXHIBIT A 12 Assessing New Procedures and Technologies: Hyperbaric Oxygen Therapy

22 Exhibit B Indications for Hyperbaric Oxygen Therapy and Definition of Hyperbaric Oxygen Therapy Source: Richard Clarke. Reprinted with permission.

23 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. 14 Assessing New Procedures and Technologies: Hyperbaric Oxygen Therapy

24 Exhibit C Medicare Coverage Database Source:

25 EXHIBIT C LCD: Centers for Medicare & Medicaid Services Search now Medicare Coverage Database mcd feedback coverage home help basket Search Indexes Reports Download View LCD LCD for Hyperbaric Oxygen Therapy (HBO) (L1301) Jump to Section... Please note: If you are printing this document and it is truncated on the right margin, please try printing landscape. Contractor Name Palmetto GBA Contractor Number Contractor Type FI Contractor Information LCD Information (1 of 15)2/7/2007 4:00:39 PM 16 Assessing New Procedures and Technologies: Hyperbaric Oxygen Therapy

26 EXHIBIT C LCD: Centers for Medicare & Medicaid Services LCD ID Number L1301 LCD Title Hyperbaric Oxygen Therapy (HBO) Contractor's Determination Number 98A-0016-L AMA CPT / ADA CDT Copyright Statement 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 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, CMS Manual System, Pub , Medicare Claims Processing Manual, Chapter 32, 30 CMS Manual System, Pub , Medicare Claims Processing, Transmittal 187, dated May 28, 2004, Change Request 3172 CMS Manual System, Pub , Medicare Program Integrity, Transmittal 63, dated January 23, 2004, Change Request 3010 Primary Geographic Jurisdiction South Carolina (2 of 15)2/7/2007 4:00:39 PM Assessing New Procedures and Technologies: Hyperbaric Oxygen Therapy 17

27 EXHIBIT C LCD: Centers for Medicare & Medicaid Services Secondary Geographic Jurisdiction Oversight Region Region IV Original Determination Effective Date For services performed on or after 09/21/1998 Original Determination Ending Date Revision Effective Date For services performed on or after 10/01/2006 Revision Ending Date Indications and Limitations of Coverage and/or Medical Necessity 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 (3 of 15)2/7/2007 4:00:39 PM 18 Assessing New Procedures and Technologies: Hyperbaric Oxygen Therapy

28 EXHIBIT C LCD: Centers for Medicare & Medicaid Services 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 (4 of 15)2/7/2007 4:00:39 PM Assessing New Procedures and Technologies: Hyperbaric Oxygen Therapy 19

29 EXHIBIT C LCD: Centers for Medicare & Medicaid Services 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 fortyeight 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 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, (5 of 15)2/7/2007 4:00:39 PM 20 Assessing New Procedures and Technologies: Hyperbaric Oxygen Therapy

30 EXHIBIT C LCD: Centers for Medicare & Medicaid Services 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 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 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 (6 of 15)2/7/2007 4:00:39 PM Assessing New Procedures and Technologies: Hyperbaric Oxygen Therapy 21

31 EXHIBIT C LCD: Centers for Medicare & Medicaid Services 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 Outpatient Hospital Services Coding Information (7 of 15)2/7/2007 4:00:39 PM 22 Assessing New Procedures and Technologies: Hyperbaric Oxygen Therapy

32 EXHIBIT C LCD: Centers for Medicare & Medicaid Services Bill Type Codes: 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: 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 Respiratory services-hyperbaric oxygen therapy 0940 Other therapeutic services-general classification CPT/HCPCS Codes *Code(99183)is for Critical Access Hospitals who elect Method I 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 (8 of 15)2/7/2007 4:00:39 PM Assessing New Procedures and Technologies: Hyperbaric Oxygen Therapy 23

33 EXHIBIT C LCD: Centers for Medicare & Medicaid Services CUTANEOUS ACTINOMYCOTIC INFECTION - ACTINOMYCOTIC INFECTION OF UNSPECIFIED SITE GAS GANGRENE ARTERIAL EMBOLISM AND THROMBOSIS OF UPPER EXTREMITY - ARTERIAL EMBOLISM AND THROMBOSIS OF LOWER EXTREMITY EMBOLISM AND THROMBOSIS OF ILIAC ARTERY OTHER SPECIFIED DISEASES OF THE JAWS NECROTIZING FASCIITIS CHRONIC OSTEOMYELITIS SITE UNSPECIFIED - CHRONIC OSTEOMYELITIS INVOLVING MULTIPLE SITES GANGRENE INJURY TO ILIAC ARTERY INJURY TO AXILLARY ARTERY INJURY TO BRACHIAL BLOOD VESSELS INJURY TO COMMON FEMORAL ARTERY INJURY TO POPLITEAL ARTERY CRUSHING INJURY OF SHOULDER REGION - CRUSHING INJURY OF UPPER ARM CRUSHING INJURY OF MULTIPLE SITES OF UPPER ARM - CRUSHING INJURY OF ELBOW CRUSHING INJURY OF HAND(S) - CRUSHING INJURY OF WRIST CRUSHING INJURY OF MULTIPLE SITES OF UPPER LIMB CRUSHING INJURY OF UNSPECIFIED SITE OF UPPER LIMB CRUSHING INJURY OF THIGH - CRUSHING INJURY OF HIP CRUSHING INJURY OF LOWER LEG - CRUSHING INJURY OF KNEE CRUSHING INJURY OF FOOT - CRUSHING INJURY OF ANKLE CRUSHING INJURY OF TOE(S) CRUSHING INJURY OF MULTIPLE SITES OF LOWER LIMB - CRUSHING INJURY OF UNSPECIFIED SITE OF LOWER LIMB (9 of 15)2/7/2007 4:00:39 PM 24 Assessing New Procedures and Technologies: Hyperbaric Oxygen Therapy

34 EXHIBIT C LCD: Centers for Medicare & Medicaid Services CRUSHING INJURY OF MULTIPLE SITES NOT ELSEWHERE CLASSIFIED CRUSHING INJURY OF UNSPECIFIED SITE AIR EMBOLISM AS AN EARLY COMPLICATION OF TRAUMA TRAUMATIC COMPARTMENT SYNDROME OF UPPER EXTREMITY TRAUMATIC COMPARTMENT SYNDROME OF LOWER EXTREMITY 986 TOXIC EFFECT OF CARBON MONOXIDE TOXIC EFFECT OF HYDROCYANIC ACID GAS TOXIC EFFECT OF HYDROCYANIC ACID AND CYANIDES 990 EFFECTS OF RADIATION UNSPECIFIED OTHER AND UNSPECIFIED EFFECTS OF HIGH ALTITUDE CAISSON DISEASE MECHANICAL COMPLICATION OF PROSTHETIC GRAFT OF OTHER TISSUE NOT ELSEWHERE CLASSIFIED COMPLICATIONS OF UNSPECIFIED REATTACHED EXTREMITY - COMPLICATION OF OTHER SPECIFIED REATTACHED BODY PART 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 or in addition to , or codes DIABETES WITH PERIPHERAL CIRCULATORY DISORDERS, TYPE II OR UNSPECIFIED TYPE, NOT STATED AS UNCONTROLLED - DIABETES WITH PERIPHERAL CIRCULATORY DISORDERS, TYPE I [JUVENILE TYPE], UNCONTROLLED DIABETES WITH OTHER SPECIFIED MANIFESTATIONS, TYPE II OR UNSPECIFIED TYPE, NOT STATED AS UNCONTROLLED - DIABETES WITH OTHER SPECIFIED MANIFESTATIONS, TYPE I [JUVENILE TYPE], UNCONTROLLED UNSPECIFIED ULCER OF LOWER LIMB ULCER OF CALF ULCER OF ANKLE ULCER OF HEEL AND MIDFOOT ULCER OF OTHER PART OF FOOT ULCER OF OTHER PART OF LOWER LIMB GANGRENE (10 of 15)2/7/2007 4:00:39 PM Assessing New Procedures and Technologies: Hyperbaric Oxygen Therapy 25

35 EXHIBIT C LCD: Centers for Medicare & Medicaid Services Diagnoses that Support Medical Necessity N/A ICD-9 Codes that DO NOT Support Medical Necessity N/A ICD-9 Codes that DO NOT Support Medical Necessity Asterisk Explanation Diagnoses that DO NOT Support Medical Necessity N/A General Information Documentation Requirements 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. (11 of 15)2/7/2007 4:00:39 PM 26 Assessing New Procedures and Technologies: Hyperbaric Oxygen Therapy

36 EXHIBIT C LCD: Centers for Medicare & Medicaid Services Appendices N/A Utilization Guidelines REVENUE CODES: *The code (0940) is for Critical Access Hospitals who elect Method I Sources of Information and Basis for Decision Cianci P. Adjunctive HBO Therapy in the Treatment of the Diabetic Foot. Journal of the American Podiatric Medical Association. 1994;84(9): 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): Advisory Committee Meeting Notes 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 06/02/1998 End Date of Comment Period 07/17/1998 Start Date of Notice Period 08/21/1998 Revision History Number (12 of 15)2/7/2007 4:00:39 PM Assessing New Procedures and Technologies: Hyperbaric Oxygen Therapy 27

37 EXHIBIT C LCD: Centers for Medicare & Medicaid Services 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 Revision #11, 10/01/2006 Under AMA/CPT & ADA/CDT Copyright Statement changed the copyright date from 2005 to Under ICD-9 Codes That Support Medical Necessity added ICD-9 codes and 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 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 Program Memorandum AB , dated December 27, 2002, Change Request 2388 Program Memorandum AB , 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 examinations CMS Manual System, Pub.100-4, Medicare Claims Processing, Chapter 32, Section 30 CMS Manual System, Pub , Medicare Claims Processing, Transmittal 187, dated May 28, 2004, Change Request 3172 CMS Manual System, Pub , 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 (13 of 15)2/7/2007 4:00:39 PM 28 Assessing New Procedures and Technologies: Hyperbaric Oxygen Therapy

38 EXHIBIT C LCD: Centers for Medicare & Medicaid Services has been changed to , code has been changed to 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): Wagner, FW. The Dysvascular Foot: A System for Diagnosis and Treatment. Foot and Ankle (1981:2(2): These 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 Added the American Dental Copyright statement. Under CMS National Coverage Policy deleted Change Request 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 or in addition to , , or 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 or in addition to , , or 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 , Change Request 2769, dated July 25, ICD-9-CM code has been expanded to ICD-9-CM code has been expanded to ICD-9-CM code 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 , Change Request 2388, dated December 27, 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/ (14 of 15)2/7/2007 4:00:39 PM Assessing New Procedures and Technologies: Hyperbaric Oxygen Therapy 29

39 EXHIBIT C LCD: Centers for Medicare & Medicaid Services Last Reviewed On Date Related Documents This LCD has no Related Documents. LCD Attachments There are no attachments for this LCD. Other Versions Updated on 05/16/2006 with effective dates 05/26/ /30/2006 Updated on 08/17/2005 with effective dates 08/19/ /25/2006 Updated on 08/18/2005 with effective dates 11/22/ /18/2005 Some older versions have been archived. Please visit the MCD Archive Site to retrieve them. Read the LCD Disclaimer Note: To view PDFs, please download and install Adobe Acrobat Reader. Add to basket this to a friend New Search www2 Web Policies & Important Links (15 of 15)2/7/2007 4:00:39 PM 30 Assessing New Procedures and Technologies: Hyperbaric Oxygen Therapy

40 Exhibit D Anthem Coverage Guideline Source: Anthem Blue Cross-Blue Shield/American Medical Association. Reprinted with permission.

41 EXHIBIT D Coverage Guideline Subject: Hyperbaric Oxygen Therapy (Systemic/Topical) CG #: MED Current Effective Date: 08/01/2006 Status: 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 enclosed in chamber, pressurized at atmospheres absolute (atm abs) and breathing oxygen. This increases oxygen levels in systemic circulation. Treatment may be carried out either in a monoplace chamber pressurized with pure oxygen, or in a larger, multiplace chamber pressurized with compressed air, in which case the patient receives pure oxygen 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 a pressure slightly higher than atmospheric pressure. It is hypothesized that the high concentrations of oxygen diffuse directly in to the wound to increase the local cellular oxygen tension, which in turn promotes wound healing. Guideline Statement Medically Necessary: 1. Systemic hyperbaric oxygen pressurization is considered medically necessary as a primary therapy in the treatment of any of the following conditions: Carbon monoxide poisoning Cerebral edema Cyanide poisoning Decompression sickness Gas embolism Profound anemia with exceptional blood loss: when transfusion is impossible or delayed 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 therapy in conjunction with standard medical and/or surgical treatment for any of the following conditions: Acute or chronic refractory osteomyelitis (refractory osteomyelitis) Acute peripheral arterial insufficiency (compartment syndrome) Acute thermal burns: deep second degree or third degree in nature Acute traumatic ischemia Chronic non-healing wounds Compartment syndrome Compromised skin grafts or flaps (enhancement of healing in selected wounds) Crush injuries Gas gangrene (i.e., clostridial myositis and myonecrosis) Federal and State law, as well as contract language, including definitions and specific contract provisions/exclusions, take precedence over Coverage Guidelines and must be considered first in determining eligibility for coverage. The me he date that services are rendered must be used. Coverage Guidelines, which addresses medical efficacy, should be considered before utilizing medical opinion in adjudication. Medical technology 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 Association Page 1 of Assessing New Procedures and Technologies: Hyperbaric Oxygen Therapy