Department of Health and Human Services 
OFFICE OF 
INSPECTOR GENERAL 
HYPERBARIC OXYGEN THERAPY 
Its Use and Appropriateness 
JUNE GIBBS BROWN 
Inspector General 
OCTOBER 2000 
OEI 06-99-00090  OFFICE OF INSPECTOR GENERAL 
The mission of the Office of Inspector General (OIG), as mandated by Public Law 95-452, is to 
protect the integrity of the Department of Health and Human Services programs as well as the 
health and welfare of beneficiaries served by them.  This statutory mission is carried out through a 
nationwide program of audits, investigations, inspections, sanctions, and fraud alerts.  The 
Inspector General informs the Secretary of program and management problems and recommends 
legislative, regulatory, and operational approaches to correct them. 
Office of Evaluation and Inspections 
The Office of Evaluation and Inspections (OEI) is one of several components of the Office of 
Inspector General.  It conducts short-term management and program evaluations (called 
inspections) that focus on issues of concern to the Department, the Congress, and the public.  The 
inspection reports provide findings and recommendations on the efficiency, vulnerability, and 
effectiveness of departmental programs. 
OEI's Region VI prepared this report under the direction of Chester B. Slaughter, Regional 
Inspector General and Judith V. Tyler, Deputy Regional Inspector General. 
Principal OEI staff included: 
DALLAS  HEADQUARTERS 
Amy Beeson  Jennifer Antico 
Kevin Golladay  Brian Ritchie 
Jnette Oshitoye  Barbara Tedesco 
To obtain copies of this report, please call the Dallas Regional Office at 214-767-3310. 
Reports are also available on the World Wide Web at our home page address: 
http://www.dhhs.gov/progorg/oei  E X E C U T I V E  S U M M A R Y  
PURPOSE 
To describe the extent and appropriateness of hyperbaric oxygen treatment (HBO2) 
provided to Medicare beneficiaries. 
BACKGROUND 
HBO2 involves giving a patient high concentrations of oxygen within a pressurized 
chamber.  Originally developed for the treatment of decompression sickness, HBO2 is 
primarily an adjunctive treatment for the management of select non-healing wounds.  To 
evaluate the extent and appropriateness of HBO2 we reviewed pertinent Health Care 
Financing Administration (HCFA) policies and published research, met with several 
interest groups representing hyperbaric physicians, analyzed Medicare claims data for 
HBO2 between 1995 and 1998, conducted medical review of HBO2 claims for a stratified 
sample of beneficiaries, surveyed a sample of facilities with HBO2 chambers, and surveyed 
contractor medical directors. 
FINDINGS 
$14.2 Million (of the $49.9 million allowed charges for outpatient hospitals and 
physicians) Was Paid in Error for Hyperbaric Treatments 
Nearly 32 percent of beneficiaries received treatments for either non-covered conditions 
(22.4 percent, $10.5 million) or documentation did not adequately support HBO2 
treatments (9.2 percent, $3.7 million).  While medical review would be necessary to 
identify most of these overpayments, some could have been detected had contractors 
utilized appropriate computer claims processing diagnoses edits. 
An Additional $4.9 Million Was Paid for Treatments Deemed to Be Excessive 
Eleven percent of beneficiaries were treated for appropriate indications, but received more 
treatments than were considered medically necessary by our physician reviewers.  The 
excessive treatments represent $4.9 million paid for potentially ineffective procedures. 
Lack of Testing and Treatment Monitoring Raise Quality of Care Concerns 
Of the 68 percent of beneficiaries treated for covered conditions, 37 percent received 
questionable quality care with respect to either lack of appropriate testing prior to initiation 
of treatment or insufficient progress documented to justify continuation of therapy.  The 
treatments with suspect quality account for as much as $11.1 million in payments. 
Additionally, our medical reviewers determined that more than 25 percent of beneficiaries 
had no documented physician oversight of their treatments; and almost twice 
 i 
HBO2: Its Use and Appropriateness OEI 06-99-00090  that many (44 percent) did not have a physician in attendance at their treatments.  While 
attendance is not specifically required, our medical review showed a correlation between 
certain quality of care factors and physician attendance. 
The Health Care Financing Administrations Guidance Is Limited 
The guidance provided by the Health Care Financing Administration (HCFA) has been 
limited only to specifying covered disease conditions.  As a result, carriers and 
intermediaries have varied payment guidelines (e.g., physician attendance, credentialing 
requirements), medical review procedures (i.e., use of diagnosis edits and post-payment 
review policies), and documentation requirements.  While practice protocols and standards 
of care have been proposed by the HBO2 industry, HCFA has not incorporated either into 
its coverage policy. 
Questions Over Appropriate Usage Along With a Potential for Expansion Increase 
the Risks Related to the Vulnerabilities Found 
Although HBO2 has been a covered treatment option for many years, some questions still 
remain about its appropriate place in the context of wound-care.  A recent assessment, 
performed in 1999 by the Blue Cross and Blue Shield Association, showed that some of the 
Medicare-covered indications do not have sufficient published evidence to determine that 
HBO2 is beneficial; however, this same study also documented evidence to support two 
conditions not specifically covered (chronic non-healing wounds and thermal burns). 
Questions of appropriate usage are magnified by the expense of the treatment.  Total costs 
for outpatient HBO2 treatments and physician supervision average between $7,000 and 
$12,000 with extremes exceeding $100,000.  Currently, the highest rates of use are in 
Colorado and the southern coastal states of Texas, Louisiana, and Mississippi.  If other 
states had the same utilization as Texas, total reimbursement would increase five-fold. 
While this expansion is possible, recent and proposed changes or clarifications in Medicare 
coverage (e.g., non-coverage of preparation for a graft not previously compromised) and 
reimbursement (outpatient prospective payment and physician fee schedule reductions) may 
curtail expansion. 
RECOMMENDATIONS 
To address concerns raised in this report, we recommend that the Health Care Financing 
Administration: 
!  Initiate its national coverage decision process for HBO2. 
!	 Improve policy guidance ( e.g., practice guidelines and physician attendance 
policy). 
!	 Improve oversight by requiring contractors to initiate edits and consistent 
medical review procedures, and by exploring the establishment of a registry 
of facilities and/or physicians providing HBO2. 
 ii 
HBO2: Its Use and Appropriateness OEI 06-99-00090  AGENCY COMMENTS 
The HCFA generally concurs with our recommendations, and reports several on-going 
efforts to address concerns raised in this report (e.g., reviewing coverage policy and 
alerting carriers to vulnerabilities associated with this procedure). 
 iii 
HBO2: Its Use and Appropriateness OEI 06-99-00090  T A B L E   O F   C O N T E N T S  
PAGE

EXECUTIVE SUMMARY  i

INTRODUCTION  1

FINDINGS  6

Questions persist concerning the appropriate usage of HBO2 . . . . . . . . . . . . . . . . . . . . .  6

Potential for expansion exists within the hyperbaric industry . . . . . . . . . . . . . . . . . . . . . .  8

$14.2 million was paid in error for hyperbaric treatments  . . . . . . . . . . . . . . . . . . . . . . . .  9

An additional $4.9 million was paid for excessive treatments  . . . . . . . . . . . . . . . . . . . .  11

Our review of HBO2 raised several quality of care concerns . . . . . . . . . . . . . . . . . . . . .  11

Some carriers and intermediaries do not apply edits and appropriate 

medical review standards  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  13

HCFAs guidance for this procedure is limited  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  15

Recent and impending regulatory changes may affect growth . . . . . . . . . . . . . . . . . . . .  19

RECOMMENDATIONS  20

ENDNOTES  22

APPENDICES 
A: Cellular and biochemical benefits of hyperbaric oxygen  . . . . . . . . . . . . . . . . . . . . .  A-1

B: Section 35-10 of the Coverage Instruction Manual  . . . . . . . . . . . . . . . . . . . . . . . .  B-1

C: Discussion of covered indications by Florida BC/BS  . . . . . . . . . . . . . . . . . . . . . . .  C-1

D: Appropriateness of Treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  D-1

E: Accepted usage of HBO2 by HCFA and Interest groups  . . . . . . . . . . . . . . . . . . . .  E-1

F: Comparison of ICD-9 Interpretations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . F-1

G: Key Questions from the Medical Review Protocol . . . . . . . . . . . . . . . . . . . . . . . . .  G-1

H: Agency Comments  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  H-1
 I N T R O D U C T I O N  
PURPOSE 
To describe the extent and appropriateness of hyperbaric oxygen treatment (HBO2) 
provided to Medicare beneficiaries. 
BACKGROUND 
Hyperbaric Oxygen Therapy 
Hyperbaric oxygen therapy (HBO2) provides a therapeutic dose of oxygen by creating a 
pressurized environment in which patients intermittently breathe 100 percent oxygen.1 
This procedure was originally developed for the treatment of decompression sickness; but 
the primary usage in the United States currently is for wound care.  Although the 
mechanisms are not firmly established in scientific literature, most agree that hyperbaric 
oxygen therapy serves four primary functions.  First, it increases the concentration of 
dissolved oxygen in the blood, which enhances perfusion. Second, it stimulates the 
formation of a collagen matrix so that new blood vessels may develop.  Third, it replaces 
inert gas in the bloodstream with oxygen, which is then metabolized by the body; and 
finally, it works as a bactericide.  The proposed biological and chemical benefits of HBO2 
are further described in Appendix A. 
The HCFA has established fourteen conditions in its Coverage Instruction Manual (CIM) 
section 35-10 for which hyperbaric therapy is reimbursable.  For additional information on 
the fourteen conditions, see Appendices B and C.  The indications include: 
(1)  Acute carbon monoxide intoxication

(2)  Decompression illness

(3)  Gas embolism

(4)  Gas gangrene

(5)  Acute traumatic peripheral ischemia 

(6)  Crush injuries

(7)  Progressive necrotizing infections

(8)  Acute peripheral arterial insufficiency

(9)  Preparation and preservation of compromised skin grafts

(10) Chronic refractory osteomyelitis

(11) Osteoradionecrosis (ORN)

(12) Soft tissue radionecrosis (STRN)

(13) Cyanide poisoning

(14) Actinomycosis

The standard definition of hyperbaric oxygen therapy is intermittent 100% oxygen 
breathing at greater than one absolute atmospheric pressure (1 ATA); however, the 
1 
HBO2: Its Use and Appropriateness  OEI-06-99-00090   Undersea and Hyperbaric Medical Society (UHMS) reports that the pressurization should 
be 1.4 ATA or higher.2  Each treatment (or dive, an analogy relating to the 
pressurization) is generally between 60 and 120 minutes in length3 ; and each patient will 
generally receive between 10 and 60 total sessions throughout the course of therapy. 
The delivery system for this therapy may be in the form of a monoplace or a multiplace 
chamber.  A monoplace chamber is designed for a single patient to lie in the supine 
position.  The entire chamber is filled with oxygen for the duration of the treatment.  The 
larger multiplace system (See Figure 1) is designed to accommodate between two and 
twelve patients comfortably and in a variety of positions.  It often has an additional 
compartment for attendants to go in and out of the chamber without interrupting 
treatments; however, in some cases the attendant may spend the duration of the treatment 
with a patient.  In this type of chamber, oxygen is administered through a mask or head tent 
during the procedure.  Topical and extremity hyperbaric units describe a third class of 
chamber, but this class is not considered an acceptable substitute for the full body chamber 
and is not covered by Medicare. 
Figure 1 
The literature states that the most common side effects are middle ear barotrauma and 
claustrophobia, which occur in 2 percent of treatments.  Other mild side effects include 
sinus squeeze, serous otitis, reversible progressive myopia, and in about 1 per 10,000 
treatments, pulmonary and neurologic manifestations of oxygen poisoning.4  Additional 
concerns have to do with safety related to the risk of fire created by the use of compressed 
oxygen. 
Medicare Payments 
Medicare allowed charges of approximately $76 million dollars ($47 million paid) for 
HBO2 in 1998 for 15,687 beneficiaries.  Outpatient reimbursement was $35 million for 
6,734 beneficiaries, physicians received $18 million for 7,282 beneficiaries, approximately 
2 
HBO2: Its Use and Appropriateness  OEI-06-99-00090  $19 million was associated with a hospital stay for 8,916 beneficiaries, and nearly $5

million was allowed as part of a skilled nursing facility stay for 1,408 beneficiaries.5

HBO2 treatments generally involve a facility charge and often a charge by a physician for

supervision.  Procedure code 99183 is billed for physician supervision and revenue center

413 includes facility charges for HBO2.  Facility reimbursement is typically included as part

of the prospective payments diagnosis related group (DRG) payment if provided during an

inpatient 

hospital stay or cost-based if provided by an outpatient department.  Physician

reimbursement is based on a fee schedule and was approximately $140 in 1998.  In

contrast, cost-based outpatient reimbursement varies considerably from hospital to hospital. 

Cost-based reimbursement is currently being replaced with a prospective payment system

for these services.

METHODOLOGY 
To evaluate the extent and appropriateness of HBO2 we reviewed pertinent HCFA 
policies, met with several interest groups representing hyperbaric physicians, analyzed four 
years of Medicare payments, conducted medical review on a stratified sample of 
beneficiaries, surveyed a sample of facilities with HBO2 chambers, and surveyed contractor 
medical directors. 
Medicare Payment Data 
We identified all Medicare beneficiaries with hyperbaric treatments paid by Medicare 
between 1995 and 1998.  Identification of a hyperbaric procedure was based on the 
American Medical Associations (AMA) CPT code 99183  (hyperbaric oxygen treatment) 
or facility revenue center code 413 (hyperbaric).  We then extracted all payments 
maintained in HCFAs National Claims History (NCH), whether paid by a carrier 
(physician claims) or an intermediary (hospital inpatient, hospital outpatient, or skilled 
nursing facility claims).  This data was then utilized in sample selection, provider profiling, 
and trending (among states and over years). 
Sample Selection 
Sampling was done by beneficiary with stratification based on overall payments for the 
entire duration of HBO2 treatment.  Any beneficiary having HBO2 payments during a one 
year period (July 1, 1997 through July 1, 1998) represented the universe.  Stratification 
was as follows: 
3 
HBO2: Its Use and Appropriateness  OEI-06-99-00090  Sample Stratification 
Population  Sample 
Strata (Allowed Charges for HBO2  Size 
over entire course of treatment) 
$100 to $5,000  4962  95 
$5,001 to $10,000  2165  95 
$10,001 to $20,000  1661  95 
$20,001 to $100,000  622  95 
Over $100,000  15  15 
Beneficiaries with Physician or  9,425  395* 
Outpatient HBO2 Payments 
*Sample reduced to 378 because of facility non-response. 
We limited strata payment calculations to outpatient facility payments and physician 
payments.  Hospital inpatient services were excluded because reimbursement is based on a 
prospective payment system.  Since the receipt of HBO2 while in the hospital was unlikely 
to affect the diagnosis related group (DRG) or admission, no overpayments to the facility 
would result from unnecessary treatment. 
Medical Record Request 
For each beneficiary sampled, the complete patients medical history was requested from 
the point HBO2 treatments began to the point they stopped.  In most cases, records were 
provided by the hospital where services were provided; however, in some cases, the 
physician provided additional information.  We requested: 
1.  History and physical, 
2. 	 Substantiation of diagnosis for hyperbarics (e.g. lab work; photographs; 
operative notes; initial consult for hyperbarics; and, physicians evaluations), 
3.	 Substantiation of hyperbaric treatment (e.g. treatment logs; physician 
progress notes; and, technician progress notes), 
4.	 Substantiation of medical necessity for hyperbarics (e.g. progress notes and 
evaluations), and 
5.  Discharge summary. 
Medical Record Review Process 
Because of the specialized nature of hyperbarics and the need for reviewers with 
knowledge and expertise in hyperbarics, we contracted with four physicians who currently 
practice in the field and are experienced in wound management.  These physicians are 
involved in a variety of relevant activities such as the following: 
4 
HBO2: Its Use and Appropriateness  OEI-06-99-00090  - Used as a medical reviewer for the local Medicare contractor, 
- Contribute to the medical literature through journal articles, 
-	 Actively involved in HBO2 associations (e.g., Undersea Hyperbaric Oxygen 
Society (UHMS)). 
We developed a detailed medical review protocol which we refined with the assistance of 
the physician reviewers.  The review protocol assessed (1) medical necessity and 
appropriateness, (2) adherence to Medicare coverage policy, (3) utilization patterns, (4) 
documentation, and (5) outcome.  All reviews and medical appropriateness decisions were 
made by the medical reviewers. 
Contractor Medical Director Survey 
A brief survey was sent to each carrier and intermediary medical director asking questions 
about local HBO2 payment experience and policy (68 of the 74 medical directors 
responded).  Individual perceptions of the efficacy of HBO2 were also obtained. 
Facility Survey 
Each facility treating beneficiaries in our sample was identified and sent a survey along with 
the request for medical records (211 of the 217 facilities responded).  Facilities were asked 
to provide information about the type of chamber used and the qualifications of the staff. 
Statistical Analysis 
Chi-square and Cochran Mantel-Haenszel statistics, percentage estimates and 
corresponding 95 percent confidence intervals for key medical review data were computed 
using the computer program Sudaan.  Sudaan is a statistical analysis program with 
appropriate standard statistical formulas for calculating correct standard errors for complex 
sampling using stratification. 
Non-Response Analysis.  A non-response analysis was conducted for the seventeen 
facilities that failed to provide records for the medical review.  Thirteen of the facilities 
(76%) did complete the facility survey describing practices and characteristics of the 
hyperbaric department.  No significant differences were found between the responding and 
non-responding facilities with the exception that non-responding facilities were more likely 
to use a multiplace chamber (p=.04) and employ at least one full-time physician (p=.06). 
This inspection was conducted in accordance with the Quality Standards for Inspections Issued by 
the Presidents Council on Integrity and Efficiency. 
5 
HBO2: Its Use and Appropriateness  OEI-06-99-00090  F I N D I N G S  
Questions persist concerning the appropriate usage of 
hyperbaric oxygen therapy 
For years, hyperbaric oxygen therapy has been considered a controversial procedure 
because of a lack of  rigorous scientific evidence demonstrating the efficacy of its use for 
many of the conditions Medicare covers.  This was the conclusion, in 1995, by the 
Department of Health and Human Services Agency for Healthcare Research and Quality 
(AHRQ).6  Their review criticized available research studies for having poor study 
design(s), non-standardized protocols and poor patient selection which caused equivocal 
and conflicting conclusions concerning [HBO2's] efficacy.  In response to these criticisms, 
HBO2 interest groups countered that small sample size and lack of control groups were 
research problems inherent to the conditions being treated. Consequently, AHRQs review 
discounted much of the most compelling evidence as a result of methodological issues. 
Since AHRQs review, the body of research supporting HBO2 has continued to grow, with 
some studies achieving adequate research standards (i.e., appropriate control groups, 
adequate sample size, an appropriately defined and homogeneous patient population, a well 
described treatment regimen, valid health outcome measures, and publication of results in a 
full length, peer-reviewed journal article).  While the research has yet to fully prove the 
efficacy of all the currently approved conditions, a recent (1999) review by the Blue Cross 
and Blue Shield Associations Technology Evaluation Center for a select number of 
medical conditions found adequate scientific evidence to support acute traumatic peripheral 
ischemias, clostridial myonecrosis, and a few conditions not specifically covered by 
Medicare, such as chronic non-healing wounds7 and burns.8  Although this review found 
evidence of efficacy for these conditions, adequate evidence was not found to validate the 
efficacy of several conditions Medicare currently covers:  compromised skin grafts, chronic 
refractory osteomyelitis, and necrotizing soft-tissue infections.  The results support the 
claim that hyperbarics is a beneficial treatment; however, Medicare may not cover the 
appropriate conditions.  Furthermore,  hyperbarics may not be the most cost-effective 
treatment option for some patients and conditions. 
Carrier and intermediary medical directors support the use of HBO2, but vary in opinion on 
the extent of covered indications.  While over half of all carrier and intermediary medical 
directors responding to our survey said hyperbaric therapy is beneficial for all of the 
currently covered conditions, one third still believe that hyperbaric coverage is too broad. 
Outside the United States, HBO2 is viewed with less conservatism.  International medical 
communities cite as many as 20 classes of indications, relating to 66 specific conditions, for 
HBO2 (See Appendix E).  This is considerably more than the 14 indications approved by 
the HCFA. 
6 
HBO2: Its Use and Appropriateness  OEI-06-99-00090  Hyperbarics is most commonly used to treat wound related problems 
The most commonly treated indications for Medicare beneficiaries are arterial insufficiency, 
effects of radiation and compromised skin grafts.  The following figure (Figure 2) indicates 
the breakdown of primary treatment indications found in the medical review sample.9 
Figure 2

CIM 35-10 Indications for Treatment

(% of beneficiaries) 
Acute Peripheral Arterial Insufficiency  20.9% 
Effects of Radiation (ORN and STRN)  15.1% 
Preparation & Preservation of Skin Grafts  15.0% 
Chronic Refractory Osteomyelitis  8.6% 
Progressive Necrotizing Infections  4.0% 
Gas Gangrene  1.3% 
Decompression Sickness  0.8% 
Carbon Monoxide Poisoning  0.6% 
Acute Traumatic Peripheral Ischemia  0.2% 
Non-covered primary indications10  33.5% 
Costs per individual are very high 
The number of beneficiaries actually receiving hyperbarics remains relatively small, but the 
costs per beneficiary can be very high.  The average total allowed charge per treatment in 
1998 was approximately $405 ($140 for physician supervision and $265 for outpatient 
services).  Coupled with the relatively high average number of treatments per individual 
(29), this results in an average allowed therapy cost of over $12,000 for a single patient. 
The top five percent of beneficiaries have considerably higher costs, ranging from $50,000 
to $325,000 per individual. The hyperbaric societies contend that although the procedure is 
relatively expensive and benefits a very small group of individuals,  hyperbaric oxygen 
therapy is a cost-effective means to treat candidates with select wounds and a few life-
threatening medical conditions.  The UHMS Committee Report (1996) states that "aside 
from clinical efficacy, HBO2 yields direct cost savings by successfully resolving a high 
percentage of difficult and expensive disorders, thereby minimizing prolonged 
hospitalization." 
Individual outcomes vary greatly 
Although our medical review did not attempt to independently evaluate the overall efficacy 
of HBO2, the benefits of hyperbarics, as evaluated by our medical review team, ranged 
from saving lives to no benefit at all.  While a few are believed to have benefitted 
7 
HBO2: Its Use and Appropriateness  OEI-06-99-00090  to the extent that either life or limb was saved (0.7 percent), thirteen percent of 
beneficiaries showed no improvement of their medical condition after treatment with 
HBO2.  The treatment may also be considered burdensome to the beneficiary, for they are 
financially responsible for at least 20 percent of the cost of therapy; and according to our 
review, 18 percent demonstrated side effects as a result of the HBO2.4  Furthermore, there 
is no way to determine if those who do benefit would have seen improvement without the 
treatment or with other aggressive wound care.  However, to acknowledge the risks, costs 
and variable outcomes does not necessarily disparage this procedure.  Hyperbaric therapy is 
generally reserved as a last resort, when other treatment options are exhausted.  The 
population targeted is generally elderly and very ill.  The average age of a hyperbaric 
Medicare patient is 70.  At least 45 percent are diabetic; and almost 40 percent have some 
form of heart disease.  It also appears that about 18 percent are deceased within two years 
after treatment.  Hyperbarics is often an end of life procedure and may provide a reprieve 
from painful non-healing wounds; and in some cases, it is credited with saving lives. 
Potential for expansion exists within the hyperbaric industry 
Medicare Payments and Providers Steadily Increased From 1995 to 1998 
In 1998, allowed charges were approximately $76 million for 15,687 beneficiaries. 

Charges were distributed between physicians (24 percent), hospitals (70 percent), and

skilled nursing facilities (6 percent).  Between 1995 and 1998, charges increased by 52

percent (not adjusting for inflation) while the total number of Medicare beneficiaries

treated increased by only 27 percent. (See 

Figure 3.) 

The increases in payments and

Figure 3

beneficiaries were outpaced by even 
larger increases in the number of

providers of HBO2 during this same

period.  For example, the number of

hospitals billing outpatient HBO2

increased by 122 percent (from 232

facilities to 514), while the number of

physicians billing HBO2 procedures

increased 64 percent (from 642 to

1053). 

The increases in billing and providers of

HBO2 parallel overall growth in the

wound care market and reflect increased

access to affordable chambers.  The

Florida-based American Academy

estimated that in 1998 the market for

hyperbaric chambers was $1.74 billion

and is expected to grow to 

8 
HBO2: Its Use and Appropriateness  OEI-06-99-00090  $2.57 billion by 2002.11  The dramatic rise in the wound care market has created an 
attractive opportunity for medical equipment suppliers who are making chambers available 
at costs of less than $100,000 or through lease arrangements. 
Utilization Varies Between Geographic Regions 
The highest rates of per capita use of HBO2 are in Colorado and the gulf states of Texas, 
Louisiana, and Mississippi.  By far, Texas is the state with the highest number of treatments 
and total billing; total allowed charges were over $21 million in 1998, nearly three times the 
charges of any other state.  The disproportionate use of HBO2 is most likely a result of 
geographic differences in exposure to hyperbarics in medical schools, professional 
environments, incidence of diabetes, and access to chambers.  Since chambers were 
originally developed to treat decompression illness, it is not surprising that chambers would 
be located in coastal areas, particularly areas proximate to deep sea oil wells.  As 
researchers discovered other uses for HBO2 (i.e., wound care), additional chambers were 
installed in those areas.  While chambers can be found in most states, variation in billing for 
HBO2 between states and the limited numbers of chambers in many states suggests an 
opportunity for expansion.  Whether hyperbaric therapy is under-utilized in most states or 
over-utilized in a few is not certain; however, if utilization were to expand across the 
country to levels similar to Texas, HBO2 reimbursements would increase nearly five-fold. 
Additionally, if HBO2 were found to be beneficial for other disease conditions (e.g., 
diabetic foot or non-healing wounds) and consequently added to Medicares coverage 
policy, use of HBO2 could substantially increase in every state. 
$14.2 Million was paid in error for hyperbaric treatments (of the 
$49.9 million allowed charges for outpatient hospitals and physicians) 
HBO2 treatments for 32 percent of beneficiaries were identified by our medical review 
team as inappropriate.  Either beneficiaries received treatments for non-covered conditions 
(22.4 percent of beneficiaries, $10.5 million) or documentation was not sufficient to 
support HBO2 treatments (9.2 percent, $3.7 million).  This projects to total allowed 
charges for HBO2 billed in error by physicians and outpatient hospitals of $14.2 million in 
the sample year (July 1, 1997 to July 1, 1998).  (See Appendix D.)  This represents 
approximately 28 percent of total payments paid to outpatient facilities and physicians 
during the sample year.  While medical review would be necessary to identify most of these 
overpayments, some could have been detected had contractors utilized appropriate 
computer claims processing diagnosis edits. 
The discrepancy between indications recommended by the hyperbaric community 
and those acceptable for Medicare reimbursement contribute to inappropriate 
billing 
Discrepancy exists between the treatment indications approved for Medicare 
reimbursement and indications considered appropriate by the hyperbaric medical societies 
(UHMS and ACHM).  The most prominent examples are the extension of treatment to the 
9 
HBO2: Its Use and Appropriateness  OEI-06-99-00090   diabetic foot and to thermal burns.  Appendix E - Recommended Usage of HBO2 by 
HCFA and Interest Groups, lists potential indications for HBO2 including HCFA 
coverage, as well as the recommendations of the two medical societies, plus one set of 
international guidelines.  The treatment indications for which there are discrepancies 
between HCFA coverage and the domestic interest group guidance are bolded. 
Many facilities rely on information provided by these groups to develop practice standards. 
The differing recommendations of these authorities can create confusion.  The failure of 
some providers to recognize the difference between interest group suggestions and 
HCFAs formal payment policies may lead to inappropriate billing.  One example described 
by a representative of UHMS regards the controversy surrounding non-healing wounds.12 
Reputable hyperbaric physicians around the country have tried to treat [patients with non-
covered hypoxic wounds] on the basis of good experimental and clinical evidence justifying 
their treatment plan in terms of arterial insufficiency and acute ischemia as the only 
available means to describe the aforementioned hypoxic wound.  This comment alludes to 
the parallel between covered and un-covered conditions13; and the fact that physicians will 
sway their interpretation of diagnosis codes to align treatment practices with their own 
medical judgements.  Difficulty discerning covered from uncovered conditions combined 
with the inclination of many physicians to follow their own medical judgement (as 
influenced by the medical societies) rather than payment guidelines sometimes result in 
inappropriate Medicare claims. 
Diagnosis codes are sometimes used inappropriately to obtain reimbursement for 
uncovered indications 
Although the guidelines specifically describe fourteen indications for which hyperbaric 
treatment is reimbursable by Medicare, some providers have taken great latitude in how 
they interpret those conditions, while others appear to deliberately use inaccurate ICD-9 
codes to bypass carrier and intermediary edits.  Our reviewers found 13 percent of 
beneficiaries had diagnoses listed on their claims that misrepresented their true medical 
condition.  For example, of the hyperbaric charts reviewed using the diagnosis code gas 
gangrene (n=24), only three were found to have wet (a.k.a. gas) gangrene (the only type 
of gangrene covered).  Ten of the remaining 21 charts showed a primary indication of dry 
gangrene, an indication not covered by CIM 35-10 in and of itself.  The reviewers also 
determined that treatment courses in accordance with the CIM 35-10 guidelines tended to 
have billing diagnoses that accurately described the beneficiarys condition; but, of 
treatment courses that did not comply with the CIM 35-10 guidelines, over half had a billed 
diagnosis that described a secondary or tertiary indication or was deemed to be 
erroneous.14  This relationship (p<.001) suggests that diagnosis codes are, at times, 
selected for the purpose of bypassing the carrier and intermediary edits used to flag 
potentially inappropriate treatments. 
The problems related to diagnosis codes are exacerbated by the absence of  ICD-9 codes 
specific to some of the covered conditions (e.g., Meleneys ulcer and Arterial 
Insufficiency).  Contractors, in their interpretation of the 35-10 guidelines to system edits, 
are forced to accept loosely related diagnoses on claims to justify medical necessity. The 
slack created by the interpretation allows physicians to treat non-covered indications 
10 
HBO2: Its Use and Appropriateness  OEI-06-99-00090  without falsifying the diagnosis.  A few billing diagnoses, identified by the medical review, 
are frequently associated with non-compliance of the 35-10 guidelines.  Claims with a 
billing diagnosis of chronic ulcer were found to be out of compliance almost two-thirds 
of the time (p<.001); and, those with a billing diagnosis of pyoderma were out of 
compliance in almost half of the cases (p<.01).15 
Some Providers did not provide sufficient documentation to justify Medicare 
reimbursement 
Billing errors and inadequate documentation account for 9 percent of beneficiaries treated 
with HBO2.  In most cases, sufficient documentation was simply not provided.  An on-site 
review at one of the hospitals failing to provide records resulted in recoupment action and a 
referral for a fraud investigation.  While treatments may have been provided, the facility 
was unable to provide the intermediary with adequate documentation (e.g., treatment logs) 
in nearly all of the cases requested.  In addition to documentation problems, three charts in 
the sample were counted as inappropriate because they billed Medicare for topical 
hyperbaric oxygen therapy - a procedure explicitly excluded in the reimbursement 
guidelines.  Five charts used the 99183 code or the revenue center 413 for related 
procedures other than HBO2 (e.g., basic wound care).  Medical records for three charts 
showed that the beneficiary for whom claims were received was never treated with 
hyperbarics.  The remainder of this group (12 charts) provided documentation, but it was 
not sufficient to complete the reviews. 
An additional $4.9 million was paid for treatments deemed to 
be excessive 
Eleven percent of beneficiaries were treated for appropriate indications, but received a 
greater number of treatments than were considered medically necessary by our physician 
reviewers.  The excessive treatments represent $4.9 million paid for potentially ineffective 
procedures.  (See Appendix D.)  The only controls concerning the length of therapy are a 
requirement that courses of therapy extending beyond two months be reviewed and that 
treatments should be medically necessary. 
Our review raised several quality of care concerns 
Another $11.1 million was spent on treatments of questionable quality 
Of the beneficiaries appropriately treated with hyperbarics, 37 percent16 received treatments 
that likely did not yield the maximum benefit possible.  This projects to $11.1 million spent 
on such treatments.  We examined two proxy variables for quality of care: (1) insufficient 
progress to justify continuation of therapy, and (2) inappropriate or inadequate testing.  Of 
beneficiaries treated for appropriate indications, 35 percent did not show sufficient 
documented progress to justify continuation of the therapy; and 15 percent did not have 
appropriate testing to confirm a diagnosis supporting the use of hyperbarics.  (See 
Appendix D.)  Existing Medicare guidelines do not set testing or monitoring standards; 
however, some of these services might be deemed medically unnecessary. 
11 
HBO2: Its Use and Appropriateness  OEI-06-99-00090  Physician attendance remains a point of contention 
Two perspectives on the meaning of attendance are prominent in the hyperbaric 
community: (1) the physician is physically present during the entirety of the treatment and 
uses that time to manage the patients overall care; and (2) physicians remain available to 
manage rare emergency situations.  Over 75 percent of medical directors agree that 
physician attendance is necessary to promote either safety or quality of care or both.  Fifty-
six percent of facilities claim to have a physician in the same or adjacent room 100 percent 
of the time.  In contrast, part-time physicians and those that supervise, but do not 
physically attend treatments, tend to be of the opinion that their purpose in attendance is 
not to manage the patient, but to manage emergencies. 
Our review indicates physician attendance is strongly correlated with quality of care 
and the reduction of inappropriate billing.  Almost two-thirds of medical directors do 
support the notion that physician attendance is necessary to achieve quality.  Similarly, our 
medical review results supported this concept, showing a significant relationship (p<.001) 
between quality of care variables and physician attendance and between compliance with 
HCFA guidelines and physician attendance (p<.001).  These relationships provide support 
for requiring physician attendance during all treatments.  For example, 74 percent of the 
payments termed inappropriate by our reviewers did not appear to have a physician in 
attendance.  We cannot be certain that physician attendance would have corrected all of 
these payments, but the strong relationship between quality and attendance suggests a 
potential for reducing inappropriate payments.17 
Many facilities do not require physical physician attendance.  The reviewers 
determined that more than 25 percent of beneficiaries had no physician oversight of their 
treatments; and twice that many (44 percent) did not have a physician in attendance at their 
treatments.18  Self-reported data from facilities confirms that some facilities (at least 10%) 
never have a physician in attendance and approximately one quarter have physicians in 
attendance less than half of the time.  Over half of the facilities surveyed stated that 
supervising physicians were employed part-time, if at all. 
Training requirements may provide a means of promoting quality care 
Some local medical review policies (LMRPs) aim at improving the quality of care by 
requiring physician attendance and setting qualifications or credentialling requirements for 
the supervising physicians.  One policy implemented by Blue Cross and Blue Shield of 
Texas (now Trailblazers) sets such requirements.  Under this policy, the supervising 
physician must meet the following criteria: 
(1)  Training, experience and privileges to manage cardiopulmonary 
emergencies; 
(2)  Training, experience and privileges to manage emergency myringotomies; 
(3)  Completion of a 60 hour course in hyperbaric medicine recognized by 
UHMS or ACHM 19; and, 
(4)  Completion of 16 CME credits every two years after credentialling. 
12 
HBO2: Its Use and Appropriateness  OEI-06-99-00090  Only 41 percent of the facilities we surveyed have even one physician who meets these 
requirements.  Facilities employing at least one full-time doctor meet the requirements 
more often than those that do not.20  A recent proposal by HCFA to modify the CIM 35-10 
guidelines suggested adopting requirements such as these.  Although the hyperbaric 
societies do support training requirements, they and the American Medical Association 
(AMA) object to the imposition of such requirements by HCFA on the grounds that 
credentialling is the responsibility of hospitals or licencing boards and does not 
meaningfully fall under the jurisdiction of the government.  However, we believe HBO2 is a 
service highly vulnerable to misuse (as seen by our medical review).  It is also a procedure 
that generates little attention because a low number of patients are affected and because the 
total dollar amount in jeopardy is relatively small.  In such a case, a national credentialing 
or training policy would ensure all contractors institute such requirements. 
Many carriers and intermediaries play only a limited role in assuring the quality of 
hyperbaric care 
Although the peer review organizations (PROs) may be primarily responsible for ensuring 
the quality of care provided in facilities, there are several ways that carriers and 
intermediaries could promote a higher quality of care, such as communicating new 
developments in medical standards highlighting differences between medical opinions and 
payment guidelines, and performing periodic post-pay edits to confirm that diagnostic and 
ancillary services are provided appropriately.  From surveying  the Medicare medical 
directors about their organizations activities promoting quality care, we found a mixed bag 
of approaches to quality issues.  Over half report that they provide voluntary guidance 
upon request and use edits to confirm that diagnostic and ancillary services are provided 
appropriately.  However, only 34 percent and 41 percent, respectively, publish standards of 
HBO2 care in a regular newsletter or deny claims when sub-standard care is found. 
Although prescriptive policies are somewhat controversial, 13 percent did report providing 
suggested protocols to hyperbaric facilities.  Several other medical directors mentioned 
referring cases to the PRO, creating additional requirements (such as attendance, 
credentialling, or specifying appropriate settings) in their LMRPs, and one medical director 
stated that his carrier/intermediary performs pre-pay reviews for hyperbaric treatments. 
Some carriers and intermediaries do not apply edits and 
appropriate medical review standards to ensure compliance 
with the CIM 35-10 
Billing data from our sample showed evidence that carriers and intermediaries do not 
uniformly use edits to detect procedures billed with inappropriate diagnoses; nor is there a 
uniform protocol for reviewing medical records for appropriateness of indication and 
medical necessity after two months of treatment.21  It appears that 23 percent of bills are 
paid with an inappropriate billing diagnosis (which could have been identified by a pre-
payment edit).  Of these, 53 percent are not in accordance with CIM 35-10 and should not 
have been paid. (This relationship is significant at p=.001.)22 
13 
HBO2: Its Use and Appropriateness  OEI-06-99-00090  Local medical review policies and implementation of system edits vary by contractor.  The 
implications of such variation include likely differences in coding patterns and rates of 
inappropriate reimbursements.  Further differences exist in the level of medical review 
employed.  As an example, one intermediary only verifies that the billing diagnosis is 
covered (ICD-9 code is valid) and does not routinely review medical records to 
substantiate the authenticity of the patients condition or question the amount charged. This 
limited medical review process leaves the contractor vulnerable to fraud, inappropriate 
utilization, and inflated charges.  Our review found one hospital taking extreme advantage 
of these vulnerabilities.  The facility routinely charged $5,500 and the contractor allowed 
$4,400 for each individual treatment.  In contrast, most facilities average allowed charges 
between $250 and $300.  Upon our request for the hyperbaric facilitys records, they sent 
virtually no documentation that the treatments were even performed.  At our request, post-
payment review at the facility was performed by the intermediary; and consequently, $1.3 
million in erroneous payments were identified and recoupment initiated.  Although these 
problems are extreme, the lack of oversight described is not unique.  For example, another 
intermediary reported that facilities were on the honor system.  As a result, claims were 
being paid for non-covered conditions such as multiple sclerosis, heart attacks, cancer, and 
pneumonia.  (Since being contacted by the Office of Inspector General (OIG), this 
contractor reported it has begun using a front-end editing tool called Super Op to detect 
these situations.) 
According to self-reported data, 42% (29/68) of medical directors confirm their institutions 
have no edits in place for hyperbarics.  The CIM 35-10 guidelines describe at least two 
conditions for which edits are a feasible method of screening: (1) limiting coverage to 
fourteen diagnosable conditions; and, (2) requiring a review for any course of treatments 
extending beyond two months.  Almost 60 percent of carriers and intermediaries do not 
have system edits for both of these conditions.23 
Once a bill is identified as requiring a pre- or post-payment review, the mechanism can 
differ by carrier or intermediary.  Fifteen percent of contractors self report that the process 
is comprised merely of reviewing diagnosis codes and nothing else.  In general, 
approximately 60 percent of medical directors reported that they do confirm that 
treatments are actually provided and that those treatments are medically necessary and 
within HCFA's diagnosis parameters.  However, the majority (72 percent) do not have 
medical review procedures to routinely detect over-utilization of treatments, whether 
hyperbaric therapy is used adjunctively (not as a primary therapy), and whether progress is 
monitored appropriately by a physician throughout the treatment.24 
14 
HBO2: Its Use and Appropriateness  OEI-06-99-00090  HCFAs guidance for this procedure is limited 
The guidance provided by HCFA controls usage only by (1) limiting indications for 
treatment, (2) creating a provision that HBO2 must be adjunctive to primary therapy, and 
(3) denying coverage for topical hyperbaric oxygen therapy.  The guidance may be found in 
Appendix B.  Although these restrictions appear quite clear, in application they often 
become vague, and in some areas, inconsistent.25 
Many carriers (68%) and intermediaries (54%) have no local medical review policy 
or payment guidelines independent of the CIM 35-10 
When asked about efforts to convey the intent of CIM 35-10 to physicians providing 
services, over one quarter (12/44) of carrier medical directors stated they do nothing 
beyond relying on information within the CIM 35-10 guidelines.  As one medical director 
expressed, CIM 35-10 is a national coverage policy.  In these cases [referencing potential 
misinterpretations], we feel it should be HCFA and not local contractors that clarify 
intent.  This stand may not be the position of all contractors; but in light of the wide-
spread misuse identified by the medical review analysis, one could conclude that the 
existing guidelines are not sufficient. 
Carriers and Intermediaries vary in how they interpret and implement CIM 35-10 
A comparative analysis of acceptable ICD-9 codes for four local medical review policies 
and HCFA's 1999 proposed revision to CIM 35-10 may be viewed in Appendix F.  The 
table clearly shows significant variation in interpretations of the CIM 35-10 guidelines.  For 
example, a LMRP from Transamerica of Southern California accepts only one code for 
arterial insufficiency (443.9 peripheral vascular disease), while HCFAs proposed 
interpretation of the indication arterial insufficiency included three codes very different 
from Southern California (444.21, 444.22, and 444.81, all for arterial embolism).  The two 
translations into ICD-9 codes without the context of the overarching indications might lead 
physicians to draw very different conclusions about Medicare coverage.  Further examples 
of interpretation problems include the extent of coverage for skin grafts, the use of the term 
Meleneys ulcer26, and coverage for the Marx protocol27. 
At the time of our survey, HCFA had previously released a memo stating its interpretation 
of the condition preparation and preservation of a compromised skin graft meant that a 
graft must have been previously placed in order for the treatments to be reimbursable.  This 
clarification was a response to the confusion regarding the intent of the word preparation in 
the term preparation and preservation of a compromised skin graft.  Our medical review 
demonstrated this problem.  Twenty-five percent of beneficiaries treated under the guise of 
this indication had neither a previous compromised graft nor a graft ultimately placed (64 
percent never had a previous graft failure and 44 percent did not have a graft ultimately 
placed).  Because of the confusion related to the skin graft indication, some contractors 
ceased coverage of preparation of a skin graft entirely, leaving only the preservation 
segment of this indication.  When asked, in general, if the preparation of a skin graft is a 
15 
HBO2: Its Use and Appropriateness  OEI-06-99-00090  covered condition, only 38 percent of Medicare medical directors agreed that it is covered 
at all (regardless of a previously compromised graft). 
Another such example is the interpretation of the condition progressive necrotizing 
infections.  Specifically included with the indication are the terms necrotizing fasciitis and 
Meleneys ulcer.  This creates a problem because there is no ICD-9 code describing 
Meleneys ulcer, a very specific condition.  In the absence of an appropriate code, bills are 
submitted with the diagnosis codes of necrotizing fasciitis, pyoderma, and cellulitis. 
Pyoderma and cellulitis are very broad terms and have created a niche for billing a broad 
variety of ulcers that do not necessarily fit the diagnostic criteria of Meleneys ulcer. 
Medical directors interpretations of the over-arching indication (progressive necrotizing 
infections) have ranged from a broad interpretation (including any wound with necrotic 
edges) to the specific classification of this indication as only applying to life-threatening 
emergency treatment of fasciitis. 
Coverage of the condition osteoradionecrosis poses a different interpretation problem. 
There is no effective way to diagnose this condition until a breakdown of the bone occurs. 
When symptoms are observed, it is often too late to gain much benefit from HBO2.  In this 
case, the primary usage of HBO2 is prophylactic, most frequently utilized in accordance 
with the Marx protocol.  Although no specific exception to the Medicare policy allows 
preventative care, this type of procedure is representative of as much as nine percent of 
HBO2 beneficiaries.  Moreover, almost 40 percent of medical directors state that this form 
of therapy is reimbursable and an additional 30 percent believe that, although it is not 
covered, it should be.  This form of hyperbaric therapy is one of the more well-supported in 
scientific literature28; however, the conflict between these two Medicare policies has never 
been addressed. 
Standards of care have not been incorporated into HCFAs guidance to reduce 
over-utilization 
The number of treatments considered appropriate is not the same across indications, nor is 
the testing required to determine diagnoses.  In 1995, the ACHM created Preferred 
Practice Protocols that, in most cases, describe diagnostic and treatment patterns specific 
to each indication.  In addition, the 1999 revision of UHMSs Committee Report 
includes a utilization review for each indication.  To date, neither these nor similar 
protocols have been promoted by HCFA as a method of evaluating appropriate treatment. 
Many hyperbaric practices are started with little information on proper utilization or 
reimbursement policies.  According to interviews with hyperbaric physicians, many 
hyperbaric units are not started by physicians.  They are started by facilities which may 
have little knowledge of proper utilization and standards of care.  This lack of knowledge is 
a likely cause for non-compliance with HCFAs guidelines, excessive treatments and a 
lower quality of care.  Solicitations and contractual arrangements with hyperbaric 
entrepreneurs contribute to this problem.  Some manufacturers will install chambers in a 
facility at no cost.  The incentive for the manufacturer is that they receive a portion of the 
revenue generated by the chamber.  This type of arrangement allows hospitals to institute 
16 
HBO2: Its Use and Appropriateness  OEI-06-99-00090  such facilities with no capital outlay cost (and possibly no risk).  The draw from institutions 
seeking a chamber for profit, combined with low risk acquisition, increases the pool of 
potential facilities thereby increasing the variation in the rigor of practice standards and 
expertise of personnel.  Evidence supporting this claim is anecdotal; however, the 
implications in terms of total billing and the degree to which billing might be inappropriate 
may be significant. 
Many billing physicians and facilities have little HBO2 experience.  Nearly half of all 
physicians (43 percent) and hospitals (47 percent) billing hyperbarics in 1998 treated no 
more than 5 Medicare beneficiaries.  Half of these treated only one beneficiary.  This 
finding raises concerns about the experience and expertise of these providers regarding 
current HBO2 practice protocols. 
Many facilities do not independently substantiate the diagnostic basis for treatment. 
Our reviewers found that almost half of beneficiaries whose treatments were considered to 
be appropriate did not receive proper testing to confirm their diagnosis.  Because 
hyperbaric units are considered secondary or tertiary treatment centers, documentation of 
diagnosis was sometimes never confirmed or even documented within the hyperbaric 
facility.  Those records are expected to be maintained by the patients primary physicians. 
In some cases, we found only an order for treatment and treatment logs.  This reliance on 
other physicians to determine the necessity of treatment may be a contributing factor to the 
number of patients treated inappropriately. 
An absence of documentation guidance combined with the inadequacy of medical 
records found in this review suggests this area needs attention.  Inadequate 
documentation was a complicating factor in our medical review.  The extent of 
documentation varied a great deal.  In a few cases, facilities provided only a date of service, 
documentation that a dive took place and a quick note on how the patient tolerated 
treatment.  Such records are grossly inadequate.  Oxygen delivered in a pressurized 
environment is analogous to a drug; and considering such a comparison, the dosage should 
be adequately recorded along with other pertinent information.  Our expectation of 
documentation was that each record would include: 
!  a history and physical, 

!  an assessment of the patient as a candidate for hyperbarics, 

!  an evaluation of medical necessity, 

!  a treatment plan, 

!  regular documentation of progress and reassessments of the

treatment plan, 
!  and daily logs of the procedure (including ascent time, descent time, 
total bottom time, dose of oxygen, pressurization level (ATA), 
documentation of attendance, and a recording of events). 
This full level of documentation was rarely provided.  Only 28 percent of records reviewed 
showed both an adequate plan of care and adequate objective treatment measures.29  The 
absence of this information, along with the previously discussed problem 
17 
HBO2: Its Use and Appropriateness  OEI-06-99-00090  that many facilities do not independently substantiate diagnoses, suggests the possibility of 
a systemic problem with the determination of medical necessity.  In addressing this issue, 
we found no guidance from HCFA on the necessary level of documentation to support 
Medicare billing.  The medical directors surveyed had differing opinions on what 
constitutes adequate documentation for billing.  Many feel that it is the responsibility of the 
referring physician to maintain records supporting medical necessity (whether or not these 
medical directors intended on using referring the physicians records in a post-pay review 
varied).  Other medical directors argued that it is the responsibility of the hyperbaric facility 
to keep sufficient documentation of the diagnosis and that the treatment is reasonable and 
necessary. 
The role of the hyperbaric physician is unclear 
The duties implicit in billing the 99183 hyperbaric code are unclear.  The role of the 
physician has been defined by ACHM as an exhaustive list of duties to be performed 
before, during and after treatment.  The ACHM stated that this list was produced at the 
express request of HCFA to describe the physician work as a component of the resource-
based relative value system (RBRVS), on which the physician payment of approximately 
$140 is based.  The list of duties described by the ACHM suggests that oversight of the 
wound and some routine wound care are implicit in the duties of the 99183 code for 
hyperbarics.30  However, the AMAs Physicians Current Procedural Terminology since 
1994 and similarly, the Federal Register in 1993 state that E/M [Evaluation and 
Managment] services and/or procedures (e.g., wound debridement) provided in a 
hyperbaric oxygen treatment facility in conjunction with a hyperbaric oxygen therapy 
session should be reported separately.  The absence of a document describing the duties 
implicit in billing the 99183 code creates a vulnerability where some physicians bill for 
routine services in addition to the 99183 code while others believe that the same services 
are included in the fee assessed for hyperbarics. 
The definition of attendance is unclear.  An additional source of confusion relates to 
the previously discussed concept of attendance and supervision.  Many hyperbaric doctors 
disagree on whether a doctor can supervise a treatment without being in attendance. 
However, if the ACHM guidelines truly do represent the physicians responsibilities, his or 
her duties could not be performed without being in physical attendance for each treatment. 
On the other hand, some argue that this procedure is routine; and consequently, a physician 
might merely be available in case of emergencies, and thus, could supervise the treatments 
from afar.  In light of these varied opinions, HCFA announced an additional code for 
hyperbaric oxygen treatments not requiring physician attendance (G0167) in the November 
2, 1999 issue of the Federal Register.  This code allows for the same payment to the 
physician as the 99183 code, minus the cost associated with physician work.  There is some 
concern in the medical community that the existence of two codes will have significant 
implications in terms of documentation requirements.  If a determination of medical 
necessity is required for each code, some form of triage will be necessitated.  In addition, 
58 percent of medical directors do not personally support the addition of the new code. 
For, if attendance is truly a cornerstone of quality, the additional code undermines the 
rationale originally implied within the 99183 code. 
18 
HBO2: Its Use and Appropriateness  OEI-06-99-00090  Recent and impending regulatory changes may affect growth 
Several changes (both recently effected and proposed) to the reimbursement structure and 
the CIM 35-10 coverage guidelines may have an impact on the hyperbaric industry. 
Coverage Guidance:  On three occasions in 1999, revisions to the current CIM 35-10 have 
been proposed and then delayed.  The most recent proposal is delayed until April 1, 2001. 
While HCFA contended that the proposed revisions did not make substantive changes, 
some hyperbaric physicians argued that the modifications would reduce coverage and 
impose additional requirements (such as physician attendance) that could not be met by 
many facilities and would consequently cause many HBO2 providers to go out of business. 
Outpatient Rate:  When payment rates were initially calculated by the HCFA, 
reimbursement was proposed at $145.  (Strikingly, the beneficiary was responsible for 
nearly all of this amount with a coinsurance of $141.)  This reimbursement rate was far 
short of the average costs, which ranged between $273 and $292 as calculated by the 
Hyperbaric Oxygen Therapy Association (HBOTA).  The obvious concern within the 
hyperbaric community was that low reimbursement levels might cause HBO2 units to shut 
down or force hospitals to subsidize their costs. 
In response to these concerns, the HCFA reclassified the HBO2 procedure as a new 
technology and reset the reimbursement rate at $75 per 30 minute period.  The 
reclassification as a new technology also replaces the excessively high beneficiary 
coinsurance payment with the standard 20 percent.  Since a typical HBO2 treatment is 90 
minutes long, the new reimbursement rate is approximately $225.  While still short of the 
industrys estimated costs, this rate appears fair, given that our analysis of 1998 payments 
shows half of the facilities have average charges over this amount and half are under this 
amount.  The overall average allowed for all facilities was $265 ($605 submitted and $145 
paid). 
Physician Fee:  Changes to the Medicare fee schedule payments for physician services are 
gradually decreasing the reimbursement rate from 1998 levels.  Between 1998 and 2002, 
the practice expense relative value is expected to decrease by 60 percent (from 1.81 to 
0.73).  This reduction will result in a 33% reduction in current payments to approximately 
$100.  The reduction is a result of congressionally mandated changes in the fee schedule 
from charge-based RVUs to resource-based RVUs.  Our medical reviewers (who are 
currently practicing HBO2 physicians) are concerned that these reductions may discourage 
physicians from specializing in hyperbarics, which could further reduce access to the 
procedure.  However, the mechanism utilized to establish fee schedules has several 
protections to ensure that rates are calculated fairly.  These mechanisms include an appeal 
process through HCFA and a practice expense advisory panel of AMA representatives to 
advise HCFA when resource inputs are incorrect. 
19 
HBO2: Its Use and Appropriateness  OEI-06-99-00090  R  E  C  O  M  M  E  N  D  A  T  I  O  N  S  
Our results show that a significant percentage of HBO2 is provided inappropriately.  Either HBO2 
should never have been used (not a covered diagnosis), excessive treatments were provided, or 
documentation of services was not available. 
To address concerns raised in this report, we recommend that the Health Care Financing 
Administration: 
!  Initiate its national coverage decision process for HBO2. 
This review is requested because (1) questions persist concerning the appropriate 
usage of HBO2, (2) there are program integrity issues surrounding significant 
inappropriate payments, and (3) there are conflicting carrier and intermediary 
policies.  Considering the overlap of HBO2 with other wound-care procedures, this 
review might consider HBO2 within the broad context of wound care and in terms 
of its relative cost-effectiveness. 
!  Improve policy guidance: 
1.  Provide clear descriptions of covered conditions; 
2.	 Propose additional ICD-9 codes as needed to more closely parallel 
covered conditions; 
3.  Establish a clear physician attendance policy; 
4.  Consider establishing training requirements; 
5.	 Consider incorporating clinical standards of patient selection and 
treatment protocols designed with the aid of hyperbaric physicians; 
and, 
6.  Specify medical record documentation requirements. 
!  Improve oversight: 
1.	 Require contractors to initiate edits and medical review procedures 
which insure that uncovered diagnoses are not paid and high 
treatment thresholds are subject to review. 
2.	 Explore the establishment of a registry of facilities and/or physicians 
providing HBO2 to improve communication and facilitate 
monitoring. 
20 
HBO2: Its Use and Appropriateness  OEI-06-99-00090  Agency Comments 
The Health Care Financing Administration (HCFA) generally concurs with our 
recommendations.  They expressed that their goal, as ours, is to provide beneficiaries 
access to effective services and to make payments for those services appropriately.  We 
recognize HCFAs on-going efforts to improve and clarify Medicares policy on Hyperbaric 
Oxygen Therapy (HBO2) such as responding to national coverage requests and issuing 
guidance memoranda.  We also appreciate their plan of alerting carriers to the 
vulnerabilities associated with this procedure and calling for increased carriers oversight. 
See appendix H for the full text of HCFAs comments. 
21 
HBO2: Its Use and Appropriateness  OEI-06-99-00090  E N D N O T E S  
1.  At times oxygen dosages may range anywhere between 30 and 100 percent. 
2. 	 Camporesi, Enrico, Hyperbaric Oxygen Therapy: A Committee Report; Undersea and 
Hyperbaric Medical Society, Kensington, MD: Revised 1996. 
3.	 The length of treatment is measured in total bottom time or TBT which does not include 
the  time dedicated during ascent to increased atmospheric pressure or descent to surface 
pressure. 
4.	 According to our review, 18 percent of beneficiaries exhibit side effects (significantly 
greater than the literature suggests).  The most common side effect is ear-related trauma, 
representing 63 percent of all observed side effects.  While side effects are generally not 
severe, two individuals within our sample showed signs of oxygen toxicity.  This relates to 
1.3 percent of the population which also is significantly greater than the expected value 
cited in the literature. 
5.	 These statistics were based on our analysis of the 1998 National Claims History file 
maintained by HCFA.  Estimated reimbursement for facility payments was based on an 
approximation of the proportion of payment attributed to HBO2 according to a cost to 
charge ratio calculated for revenue center 413 (hyperbaric oxygen treatment). 
6.	 The Agency for Healthcare Research and Quality (AHRQ) was established in 1989 as the 
Agency for Health Care Policy and Research.  Reauthorizing legislation passed in 
November 1999 establishes AHRQ as the lead Federal agency on quality research. 
AHRQ, part of the U.S. Department of Health and Human Services, is the agency charged 
with supporting research designed to improve the quality of health care, reduce its cost, 
and broaden access to essential services.  AHRQs broad programs of research bring 
practical, science-based information to medical practitioners and to consumers and other 
health care purchasers. 
In December 1995, the Agency for Health Research and Quality (AHRQ) wrote a memo 
to HCFA regarding the medical conditions covered by the CIM 35-10 finding that 
patterns of use do not validate the clinical effectiveness of any intervention, and it cannot 
be concluded that its use by proponents has either established its acceptance by the general 
medical community or provided acceptable proof of clinical utility. 
7.	 In evaluation of the costs and benefits of using HBO2 to treat diabetic feet, the American 
Diabetic Association (ADA) recently concluded that, although adequate research 
(randomized controlled trials) was not available, HBO2 use is reasonable to treat severe 
and limb- or life-threatening wounds. (Special Report by the ADA, Consensus 
Development Conference on Diabetic Foot Wound Care, 7-8 April 1999, Boston MA, 
Advances in Wound Care, Vol. 12: No. 7; September 1999.) 
22 
HBO2: Its Use and Appropriateness  OEI-06-99-00090  8.	 The Blue Cross and Blue Shield Association, Technical Assessment Center; Assessment 
Program Vol. 14: No. 13:  August, 1999. 
9.	 For simplicity in this figure, each beneficiary was counted in only one category based on a 
prioritization of conditions.  Also note that some indications were combined to create a 
more meaningful breakdown of the indications. 
10.	 Conditions not covered by the 35-10 guidelines including conditions not meeting the 
qualifications (e.g., chronic and refractory) were counted in the category non-covered 
indications.  The discrepancy between non-covered conditions as primary indications 
(33.5%) and treatments not compliant with CIM 35-10 (22.4%) describes courses of 
therapy that either (1) were compliant with CIM 35-10 based on a secondary or tertiary 
indication, or (2) were identified as being compliant by the physician reviewers, but a 
covered condition was not indicated as a reason for treatment. 
11.	 Schwab, Robert (On Small Business), Denver Post; Health care tempts firms local 
entrepreneurs market new products in growing field.; Denver, Colo.; Oct 17, 1998. 
12. 	 Commenting on Appendix D of this report, one representative of UHMS stated, This is 
the crux of this issue as far as HBO2 in the broad picture of wound healing is concerned. 
Both of the US professional organizations responsible for providing clinical guidelines, 
similar international organizations, and now BC/BS with its recent endorsement of HBO2 
for chronic non-healing wounds (Assessment Program vol 14: No 13, Aug, 1999) define 
the clear value of HBO2 in ischemic/hypoxic wounds where such hypoxia cannot be 
adequately corrected by other means (refer also to the ADA statement (Diabetes Care 
22(8): 1354-1360, 1999) but responsive to HBO2 should be treated.  Reputable 
hyperbaric physicians around the country have tried to treat these patients on the basis 
of good experimental and clinical evidence justifying their treatment plan in terms of 
arterial insufficiency and acute ischemia as the only available means to describe the 
aforementioned hypoxic wound.  HCFA has not kept pace with this long standing 
recommendation by the UHMS Oxygen Therapy Committee (dating back at least to 
1989), the recent ADA recommendation, and now the recommendation by the BC/BS 
technology assessment.  We have medically and physiologically defined these wounds 
using the best available descriptions of ischemia, but this is really both inadequate and 
confusing and should be resolved by a clearly defined new indication and terminology. 
13.	 One source of confusion in CIM 35-10 is the potential parallel between covered and 
uncovered conditions.  Acute peripheral arterial insufficiency and preparation and 
preservation of a compromised skin graft (covered conditions), may be used to describe or 
treat conditions that are explicitly uncovered such as cutaneous, decubitus, and stasis 
ulcers; or skin burns.  There is no terminology as to which standard has precedence. 
14. 	 A chi-square test for this relationship was significant at p<.001 using a Sudaan-weighted 
sample. 
23 
HBO2: Its Use and Appropriateness  OEI-06-99-00090  15.	 A chi-square test of significance found relationships between compliance with the CIM 
35-10 guidelines and several billing diagnosis in the Sudaan-weighted sample.  Both 
positive and negative relationships were found to be significant.  Those mentioned in the 
text (pyoderma and chronic ulcer) were more likely to be out of compliance. 
16.	 The 37 percent represents beneficiaries who did not meet the review expectations in one 
or more of the two quality of care variables.  This group may overlap with the group of 
beneficiaries having excessive treatments. 
17.	 The variables evaluated for a relationship with physician attendance and their associated p 
values from a Sudaan-weighted chi-square follow: 
Variable Quality  p Value with  p Value with 
Attendance  Supervision 
1. Compliance with 35-10  <.001  <.001 
2. Sufficient progress noted to justify  <.001  <.001 
continued treatment 
3. Appropriate testing prior to treatment  .023  .020 
4. Either quality of care variables  <.001  <.001 
(appropriate testing or sufficient progress 
to justify continuation) 
18. 	 As one of our reviewers explained, it is difficult to determine if a physician is truly in 
attendance.  There may be documentation of attendance; combined with other evidence 
suggesting that they were not there.  Some examples of this include (1) notes are written 
by the nurse but signed by the doctor, (2) doctors have written notes but they do not 
follow the chronological sequence of the nurses notes, (3) documentation that the doctor 
was paged or faxed.  Despite these difficulties, we asked our panel of experts to make a 
judgement regarding the level of attendance present. 
19. 	 There is some debate as to whether the requirement of 60 hours of hyperbaric education 
was intended to be a single course or should be divided between multiple courses. 
20.  The chi-square relationship is significant at p=.001 
21. 	 The CIM 35-10 designates that a medical review should be performed in instances that the 
course of therapy exceeds two months. 
22.	 A relationship between appropriateness of the billed diagnosis and compliance with the 
CIM 35-10 guidelines was found to be a significant chi=square relationship at p=.001 in 
the Sudaan weighted sample. 
23. 	 Medical directors self-reported whether the following conditions would elicit a medical 
review: 
24 
HBO2: Its Use and Appropriateness  OEI-06-99-00090  1. Bills for indications not covered under 35-10  81% 
2. Treatments courses extending beyond two months  31% 
3. Any measure of length of treatment  43% 
4. Conditions 1 and 2 (as listed above)  25% 
5. Conditions 1 and 3 (as listed above)  41% 
24.  Medical directors self-reported their medical review process to include: 
Confirm treatment is not over-utilized  53% 
Confirm progress is monitored appropriately  65% 
Confirm primary therapy for condition is also provided  65% 
25. 	 The currently effective version of the CIM 35-10 is separated into four distinct sections: 
A, B, C, and D.  Part A identifies the conditions that are covered.  Part B identifies explicit 
conditions that should not be covered.  Part C states that reasonable utilization parameters 
should be used; and, Part D states that topical oxygen does not qualify for reimbursement. 
One source of confusion is the potential parallel between covered and uncovered 
conditions.  Acute peripheral arterial insufficiency and preparation and preservation of a 
compromised skin graft, covered conditions, may be used to describe or treat conditions 
that are explicitly uncovered such as cutaneous, decubitus, and stasis ulcers; or skin burns. 
There is no terminology as to which standard has precedence. There is currently some 
discussion that any new policy will remove the Part B restrictions; however, this act alone 
will not resolve this problem.  Subpart C provides a short description of reasonable 
utilization parameters only specifically referencing length of therapy course.  However, 
legal advice sought by Dr. Kelly Hill of the ACHM in 1995 found that the section [Part C 
of the CIM 35-10] must be interpreted to expand rather than limit covered services.  The 
attorney explained that clearly if a provision contains lists which are both inclusive and 
exclusive, the proper reading of it would be that those items excluded are explicit.  Since 
the provision cannot itemize all possible items inclusive, that part of the provision is 
expandable.  Such is the case with Section 35-10 because Subpart C provides a 
mechanism where additional items may be considered as included.  Such an interpretation 
is proper since it gives meaning to all subparts of Section 35-10, not just one subpart. 
(Letter dated 3/8/95 from Attorney Kent Masterson Brown to Kelly Hill, M.D.) 
26.	 Meleneys Ulcer was originally defined in 1926 as a progressively expanding infection 
created by the synergism between aerophilic and anaerobic/microaerophilic bacteria, the 
ACHM Preferred Practice Protocols now equate the terms Meleney Ulcer and progressive 
necrotizing infection.  This reference now states that the diagnostic criteria includes a 
slowly (1 to 2 cm per day) progressive, superficial necrotizing environment, and 
microvascular thrombosis in a full thickness ulcer. 
25 
HBO2: Its Use and Appropriateness  OEI-06-99-00090  27. 	 R. Marx created a specific hyperbaric oxygen therapy protocol for the prophylactic 
treatment of osteoradionecrosis of the jaw prior to dental procedures.  The use of this 
therapy is considered to be a standard of care by many dentists and hyperbaric physicians. 
28.	 Marx, R., Johnson, R., Kline, S. Prevention of Osteoradionecrosis: A Randomized 
Prospective Clinical Trial of Hyperbaric Oxygen Versus Penicillin, JADA, Vol. 111, July 
1985. 
Marx, R. A New Concept in the Treatment of Osteoradionecrosis, J Oral Maxillofacial 
Surgery 1983; 41: 283-288. 
Marx,R., and Myers, R. Use of Hyperbaric Oxygen in Postradiation Head and Neck 
Surgery, NCI Monographs, Number 9, 1990. 
Epstein, J., Lepawsky, M., McKenzie, M., et al. Hyperbaric Oxygen and Postradiation 
Osteonecrosis of the Mandible, Oral Oncol, Eur J Cancer, Vol 29B, No. 3, 201-207, 
1993. 
Consensus Statement: Oral Complications of Cancer Therapies. National Institutes of 
Health Consensus Development Panel. NCI Monographs, Number 9, 1990. 
Bergstrom, K., Branemark, P., Granstrom, G., et al. A Detailed Analysis of Titanium 
Implants Lost in Irradiated Tissue, The International Journal of Oral & Maxillofacial 
Implants, Vol 9, No 6, 1994. 
Dempsey, J., Hynes, N., Smith, T., et al. Cost Effectiveness Analysis of Hyperbaric 
Therapy is Osteoradionecrosis, Can J Plast Surg., Vol 5, No 4, Winter 1997. 
29.  Less than 40 percent had both progress measures and a plan of care in any form. 
30.	 ACHM Physician Duties in Hyperbaric Medicine, 1993.  Wound care is referenced 
under Physician Work Performed Before or After Hyperbaric Treatment, with the Patient 
numbers 3-5. 
26 
HBO2: Its Use and Appropriateness  OEI-06-99-00090  APPENDIX  A 
Cellular and Biochemical Benefits of Hyperbaric Oxygen 
Although the number of indications for hyperbarics may be quite large, the mechanisms of therapy 
are few.  HBO2 is believed to (1) enhance perfusion, (2) stimulate angiogenesis, (3) supersaturate 
the bloodstream with oxygen, (4) act as a bactericide, and (5) prevent the production of alpha 
toxin.  The theories supporting these mechanisms are based on fundamental principles of medicine 
and physics. 
Perfusion 
Hyperbaric oxygen therapy increases the concentration of dissolved oxygen in the blood, 
which enhances perfusion.  At sea level the blood (plasma) oxygen concentration is .3 ml 
per deciliter of blood, assuming normal perfusion.  100% oxygen at ambient (normobaric 
pressure increases the amount of oxygen dissolved in the blood fivefold to 1.5 ml per 
deciliter, and at 3 atmospheres, the dissolved oxygen content is approximately 6 ml per 
deciliter, more than enough to meet resting cellular requirements without any contribution 
from oxygen bound to hemoglobin.2 
Angiogenesis 
Hyperbaric oxygen therapy stimulates the formation of a collagen matrix so that 
angiogenesis, a necessary component of wound healing, may take place. 
Supersaturation of Blood with Oxygen 
Hyperbaric oxygen therapy replaces inert gas in the bloodstream with oxygen, which is then 
metabolized by the body.  Boyles law, which states that the volume of gas in an enclosed 
space is inversely proportional to the pressure exerted on it, governs this process and 
explains some of the beneficial effects of hyperbaric oxygen in conditions caused by the 
formation of gas bubbles.2 
Bactericide 
!  Kills certain anaerobes

!  Prevents growth of species such as Pseudomonas

!  Restores neutrophil-mediated bacterial killing in previously hypoxic tissues

Hyperbaric oxygen therapy reduces leucocyte adhesion in reperfusion injury, preventing the

release of protease and free radicals which cause vasoconstriction and cellular damage.  Local

hypoxia predisposes wounds to infection, because the neutrophil-mediated killing of bacteria by

free radicals is decreased.  HBO restores this defense against infection and increases the rate of

killing of some common bacteria by phagocytes.  In addition, HBO alone is bactericidal for

certain anaerobes.2

A-1 
HBO2: Its Use and Appropriateness  OEI-06-99-00090  Prevention of the Production of Alpha Toxin 
Hyperbaric oxygen therapy inhibits the production of alpha toxin, a by-product of gas 
gangrene. 
Sources: 
1.	 Leach, et al. , ABC of oxygen: Hyperbaric oxygen therapy; British Medical Journal; 
London: 1998. 
2.	 Tibbles and Edelsberg, Hyperbaric Oxygen Therapy; The New England Journal of 
Medicine; Massachusetts Medical Society: 1996. 
A-2 
HBO2: Its Use and Appropriateness  OEI-06-99-00090  APPENDIX B 
Section 35-10 of the Coverage Instruction Manual 
[ 35-10 HYPERBARIC OXYGEN THERAPY 
For purposes of coverage under Medicare, hyperbaric oxygen (HBO) therapy is a modality in which the entire body is 
exposed to oxygen under increased atmospheric pressure. 
A. Covered Conditions. 
Program reimbursement for HBO therapy will be limited to that which is administered in a chamber (including the one 
man unit) and is limited to the following conditions: 
1. Acute carbon monoxide intoxication. 
2. Decompression illness. 
3. Gas embolism. 
4. Gas gangrene. 
5. Acute traumatic peripheral ischernia. HBO 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. Crush injuries and suturing of severed limbs. As in the previous conditions, HBO therapy would be an 
adjunctive treatment when loss of function, limb, or life is threatened. 
7. Progressive necrotizing infections (necrotizing fasciitis, meleney ulcer). 
8. Acute peripheral arterial insufficiency. 
9. Preparation and preservation of compromised skin grafts. 
10. Chronic refractory osteomyelitis, unresponsive to conventional medical and surgical management. 
11. Osteoradionecrosis as an adjunct to conventional treatment. 
The following uses of HBO are covered for services rendered on and after 10/1/82. 
12. Soft tissue radionecrosis as an adjunct to conventional treatment. 
13. Cyanide poisoning. 
The following use of HBO is covered for services rendered on or after 2/22/84 
14. Actinomycosis, only as an adjunct to conventional therapy when the disease process is refractory to 
antibiotics and surgical treatment. 
B-1 
HBO2: Its Use and Appropriateness  OEI-06-99-00090  B. Noncovered Conditions 

No program payment may be made for HBO in the treatment of the following conditions: 

1. Cutaneous, decubitus, and stasis ulcers. 

2. Chronic peripheral vascular insufficiency. 

3. Anaerobic septicemia and infection other than clostridial. 

4. Skin burns (thermal). 

5. Senility. 

6. Myocardial infarction. 

7. Cardiogenic shock. 

8. Sickle cell crisis. 

9. Acute thermal and chemical pulmonary damage, i.e., smoke inhalation with pulmonary insufficiency. 

10. Acute or chronic cerebral vascular insufficiency. 

11. Hepatic necrosis. 

12. Aerobic septicemia. 

13. Nonvascular causes of chronic brain syndrome (Pick's disease, Alzheimer's disease, Korsakoffs disease). 

14. Tetanus. 

15. Systemic aerobic infection 

16. Organ transplantation, 

17. Organ storage. 

18. Pulmonary emphysema, 

19. Exceptional blood loss anemia 

20. Multiple Sclerosis, 

21. Arthritic Diseases. 

Effective for services rendered on or after September 6, 1984: 

22. Acute cerebral edema. 

B-2 
HBO2: Its Use and Appropriateness  OEI-06-99-00090  C. Reasonable Utilization Parameters 
Make payment where HBO therapy is clinically practical. HBO therapy should not be a replacement for other 
standard successful therapeutic measures. Depending on the response of the individual patient and the severity of 
the original problem, treatment may range from less than 1 week to several months duration, the average being 2 to 
4 weeks. Review and document the medical necessity for use of hyperbaric oxygen for more than 2 months, 
regardless of the condition of the patient, before further reimbursement is made. 
D. Topical Application of Oxygen 
This method of administering oxygen does not meet the definition of HBO therapy as stated above. Also, its clinical 
efficacy has not been established. Therefore, no Medicare reimbursement may be made for the topical application 
of oxygen. (Cross refer: 35-31.) 
B-3 
HBO2: Its Use and Appropriateness  OEI-06-99-00090  APPENDIX  C 
Discussion of covered indications by Florida BC/BS 
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 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 HBO2 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 sea water 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 embolism may occur as a result of 
surgical procedures (e.g., cardiovascular surgery, infra-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, infection 
of fluids into tissue space), or traumatic injuries (e.g., gunshot wound, 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 in 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. 
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 
C-1 
HBO2: Its Use and Appropriateness  OEI-06-99-00090  is present.  Swelling and edema occur.  The noncontractile muscles progress to dark red to 
black in color. 
The acute problem in gas gangrene is to stop the rapidly advancing infection caused by 
alpha-toxin and to continue treatment until the advancement of the disease process has 
been arrested.  The goal of HBO2 therapy is to stop alpha-toxin production thereby 
inhibiting further bacterial growth at which point the body can use its own host defense 
mechanisms.  HBO2 treatment starts as soon as the clinical picture presents and is 
supported by a positive gram-stained smear.  A treatment approach utilizing HBO2, is 
adjunct to antibiotic therapy and surgery.  Initial surgery may be limited to opening the 
wound.  Debridement of necrotic tissue can be performed between HBO2 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 90 minutes three times in the 
first 24 hours.  Over the next four to five days, treatment sessions twice a day are usual. 
The sooner HBO2 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 
(ATPI), and acute peripheral arterial insufficiency: Acute traumatic ischemia is the 
result of injury by external force or violence 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. 
The goal of HBO2 therapy is to enhance oxygen at the tissue level to support viability. 
When tissue oxygen tensions fall below 30 mmHg., the bodys ability to respond to 
infection and wound repair is compromised.  Using HBO2 at 2-2.4 atm, the tissue oxygen 
tension is raised to a level such that the bodys responses can become functional again. 
The benefits of HBO2 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, nonunion and amputation. 
The usual treatment schedule is three 1.5 hour treatment periods daily for the first 48 
hours.  Additionally, two 1.5 hour treatment session daily for the next 48 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. 
For acute traumatic peripheral ischemic, 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.  Arterial insufficiency ulcers may be treated by HBO2 therapy if they are 
persistent after reconstructive surgery has restored large vessel function. 
6.	 The principal treatment for progressive necrotizing infections (nectrotizing fasciitis, 
meleney ulcer) is surgical debridement and systemic antibiotics.  HBO2 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, Meleneys ulcer, 
is a polymicrobial (mixed aerobic-anaerobic organisms) ulcer which 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 as a wide 
C-2 
HBO2: Its Use and Appropriateness  OEI-06-99-00090  area of pale red cellulitis that typically with a central area of granulation tissue encircled by 
gangrenous or necrotic tissue. 
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 HBO2 for graft or 
flap salvage in cases where hypoxia or decreased perfusion have compromised viability. 
HBO2 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, 
HBO2 may be used to prepare the already compromised recipient site for a new graft or 
flap.  It does not apply to the initial preparation of the body site for a graft.  HBO2 
therapy is not necessary for normal, uncompromised skin grafts or flaps. 
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.  The Undersea and Hyperbaric Medical Society 
have defined chronic as existing six months or more.  HBO2 is an adjunctive therapy 
used with the appropriate antibiotics.  Antibiotics are chosen on the basis of bone culture 
and sensitivity studies.  HBO2 can elevate the oxygen tensions found in infected bone to 
normal or above normal levels.  This mechanism enhances healing and the bodys 
antimicrobial defenses.  It is believed that HBO2 augments the efficacy of certain 
antibiotics (gentamicin, tobramycin, and amikacin).  Finally, the bodys osteoclast function 
of removing necrotic bone is dependent on a proper oxygen tension environment.  HBO2 
provides this environment.  HBO2 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 B can cover the use of HBO2 for chronic refractory 
osteomyelitis that has been demonstrated to be unresponsive to conventional medical and 
surgical management. 
9.	 HBO2s 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 non-viable tissues in conjunction with antibiotic therapy.  Soft tissue flap 
reconstruction and bone grafting may also be indicated.  HBO2 treatment can be indicated 
both preoperatively and postoperatively. 
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 HBO2 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 HBO2 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 
C-3 
HBO2: Its Use and Appropriateness  OEI-06-99-00090   antidote for cyanide poisoning is the infusion of sodium nitrite.  This treatment can 
potentially impair the oxygen carrying capacity of hemoglobin.  Using HBO2 as an adjunct 
therapy adds the benefit of increased plasma dissolved oxygen.  HBO2s benefit for the 
pulmonary injury related to smoke inhalation remains experimental.  The HBO2 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 breakdown, 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 shown refractory to antibiotics and surgery, 
should HBO2 be covered by Medicare Part B. 
**Note that some of the 14 indications covered by CIM 35-10 are grouped into broader 
categories. 
C-4 
HBO2: Its Use and Appropriateness  OEI-06-99-00090  APPENDIX D 
Appropriateness of Treatment 
Appropriateness of Treatment (in % beneficiaries and total dollars) 
ESTIMATED 
95% CONFIDENCE 
ALLOWED 
Class  %  SE (+/-)  INTERVAL 
CHARGES 
(millions) 
(millions) 
INAPPROPRIATE  31.6  3.0  $14.2  $12.5 to $16.0 
EXCESSIVE*  7.3  1.2  $4.9  $3.3 to $6.4 
QUESTIONABLE 
20.2  2.55  $11.1  $9.7 to $12.6 
QUALITY 
APPROPRIATE  40.9  3.1  $19.7  $17.9 to $21.5 
TOTAL  100  N/A  $49.9  N/A 
*Dollars associated with excessive treatments include only the amount that was considered excessive, the 
remainder of the associated monies are included under the categories questionable quality or appropriate. 
Variables determining Appropriateness of Treatment 
(in % beneficiaries and total dollars) 
N=378* 
ESTIMATED 
95% CONFIDENCE 
Class  ALLOWED 
%  SE (+/-)  INTERVAL 
CHARGES 
(millions) 
( millions) 
NO PROBLEM*  40.9  3.1  $18.8  $17.2 to $20.5 
NO HBO2*  9.2  2.0  $3.7  $2.6 to $4.8 
NOT CONSISTENT 
22.4  2.6  $10.5  $9.1 to $11.9 
WITH 35-10* 
EXCESSIVE 
12.9  1.7  $3.3  $2.2 to $4.3 
TREATMENT* 
TREATMENT 
10.9  1.6  $2.7  $1.8 to $3.7 
BEYOND PLATEAU* 
INADEQUATE 
20.0  2.5  $10.5  $9.3 to $11.8 
TESTING* 
INSUFFICIENT 
JUSTIFICATION OF  38.0  3.0  $19.6  $17.9 to $21.3 
CONTINUATION* 
*Categories are not necessarily mutually exclusive. The proportion and dollars represent all beneficiaries whereas 
the first table above is prioritized (mutually exclusive) such that if a beneficiarys treatment was inappropriate, it was 
not included when considering excessive treatments or excessive quality care. 
D-1 
HBO2: Its Use and Appropriateness  OEI-06-99-00090  APPENDIX  E 
Accepted Usage of HBO2 by HCFA and Interest Groups

Condition  HCFA  UHMS  ACHM  International 
Bubbles 
Decompression Illness  Yes  Yes  Yes  Yes 
Gas Embolism  Yes  Yes  Yes  Yes 
Poisoning 
Acute Carbon Monoxide Intoxication  Yes  Yes  Yes  Yes 
Cyanide Poisoning  Yes  Yes  Yes  Yes 
Hydrogen Sulfide Poisoning  No  No  No  Yes 
Carbon Tetrachloride Poisoning  No  No  No  Yes 
Infections 
Clostridial Myonecrosis (Gas Gangrene)  Yes  Yes  Yes  Yes 
Progressive Necrotizing Infection  Yes  Yes  Yes  Yes 
Chronic Refractory Osteomyelitis  Yes  Yes  Yes  Yes 
Meleneys Ulcer  Yes  Yes  Yes  Yes 
Actinomycosis  Yes  No  Yes  Yes 
Refractory Mycoses  No  No  No  Yes 
Leprosy  No  No  No  Yes 
Plastics 
Problem Wounds  No  Yes  Yes  Yes 
Acute Peripheral Arterial Insufficiency  Yes  No  Yes  Yes 
Compromised Skin Grafts  Yes  Yes  Yes  Yes 
Thermal Burns  No  Yes  Yes  Yes 
Aid to Re-Implantation Surgery  No  Yes  No  Yes 
Traumatology 
Acute Traumatic Peripheral Ischemia  Yes  Yes  Yes  Yes 
Crush Injury and Suturing of Severed Limbs  Yes  Yes  Yes  Yes 
Compartment Syndrome  Yes  Yes  Yes  Yes 
Soft tissue Sports Injuries  No  No  No  Yes 
E-1 
HBO2: Its Use and Appropriateness  OEI-06-99-00090  Condition  HCFA  UHMS  ACHM  International 
Orthopedics 
Osteoradionecrosis  Yes  Yes  Yes  Yes 
Soft-tissue Radionecrosis  Yes  Yes  Yes  Yes 
Nonunion of Fractures  No  No  No  Yes 
Bone Grafts  No  No  No  Yes 
PVD-1 
Diabetic Wounds  No  Yes  Yes  Yes 
Ischemic Gangrene (Related)  No  Yes  Yes  Yes 
Leg Pain  No  No  No  Yes 
PVD - 2 
Shock  No  No  No  Yes 
Myocardial Ischemia  No  No  No  Yes 
Aid to Cardiac Surgery  No  No  No  Yes 
Neurological 
Stroke  No  No  No  Yes 
Multiple Sclerosis  No  No  No  Yes 
Migraine  No  No  No  Yes 
Cerebral Edema  No  No  No  Yes 
Multi-infract Dementia  No  No  No  Yes 
Spinal Cord Injury  No  No  No  Yes 
Vascular Diseases of the Spinal Cord  No  No  No  Yes 
Intra cranial Abscess  No  Yes  No  Yes 
Peripheral Neuropathy  No  No  No  Yes 
Radiation Myelitis  No  No  No  Yes 
Vegetative Coma  No  No  No  Yes 
Hematology 
Sickle Cell Crises  No  No  No  Yes 
Severe Blood Loss Anemia  No  Yes  No  Yes 
E-2 
HBO2: Its Use and Appropriateness  OEI-06-99-00090  Condition  HCFA  UHMS  ACHM  International 
Opthamology 
Occlusion of Central Artery of Retina  No  No  No  Yes 
Gastro-intestinal 
Gastric Ulcer  No  No  No  Yes 
Necrotizing Enterocolitis  No  No  No  Yes 
Paralytic Ileus  No  No  No  Yes 
Pneumotiodes Cystoides Intestinalis  No  No  No  Yes 
Hepatitis  No  No  No  Yes 
Enhancement of Radiosensitivity of Malignant Ulcers 
Enhancement of Radiosensitivity  No  No  No  Yes 
Otorhinolaryngology 
Sudden Deafness  No  No  No  Yes 
Acute Acoustic Trauma  No  No  No  Yes 
Labyrithitis  No  No  No  Yes 
Menieres Disease  No  No  No  Yes 
Malignant Otitis Externa  No  No  No  Yes 
Lung Disease 
Lung Abscess  No  No  No  Yes 
Pulmonary Embolism  No  No  No  Yes 
Endocrines 
Diabetes  No  No  No  Yes 
Obstetrics 
Complicated Pregnancy - Diabetes  No  No  No  Yes 
Congenital Heart Disease of the Neonate  No  No  No  Yes 
Heart Disease  No  No  No  Yes 
Placental Hypoxia  No  No  No  Yes 
Fetal Hypoxia  No  No  No  Yes 
Asphyxiation 
Drowning  No  No  No  Yes 
Near Hanging  No  No  No  Yes 
Smoke Inhalation  No  No  No  Yes 
E-3 
HBO2: Its Use and Appropriateness  OEI-06-99-00090  Condition  HCFA  UHMS  ACHM  International 
Aid to Rehabilitation 
Spastic Hemiplegia of Stroke  No  No  No  Yes 
Paraplegia  No  No  No  Yes 
Chronic Myocardial Insufficiency  No  No  No  Yes 
Peripheral Vascular Disease  No  No  No  Yes 
E-4 
HBO2: Its Use and Appropriateness  OEI-06-99-00090  APPENDIX  F 
Comparison of ICD-9 Interpretations (HCFA vs. several LMRPs) 
Category  ICD-9  HCFA  TEXAS  FLORIDA  Transamerica  AR (LA) 
Proposal  BC/BS*  BC/BS  Southern CA  BC/BS 
Date  7/97  10/97  4/98  3/97  1/99 
Carbon 
Monoxide  986  YES  YES  YES  YES  YES 
Poison 
Decompression 
Sickness  993.3  YES  YES  YES  YES  YES 
Arterial Gas 
Embolism  993.9  NO  NO  YES  NO  YES 
958.0  YES  YES  YES  YES  YES 
999.1  NO  NO  NO  NO  YES 
996.7-996.79  NO  NO  NO  NO  YES 
Gas Gangrene 
040.0  YES  YES  YES  YES  YES 
Crush Injuries 
and Severed  906.4  NO  NO  NO  YES  NO 
Limbs  925.0  NO  NO  NO  NO  YES 
925.1-925.9  YES  NO  NO  NO  YES 
926  NO  NO  NO  NO  YES 
927.00-927.03  NO  YES  YES  YES  YES 
927.04-927.08  NO  NO  YES  YES  YES 
YES  YES  YES  YES  YES 
927.09-927.11 
NO  NO  NO  YES  YES 
927.12-927.19 
YES  YES  YES  YES  YES 
927.20-927.21 
NO  NO  NO  YES  YES 
927.22-927.79 
YES  YES  YES  YES  YES 
927.8-927.9 
YES  YES  YES  YES  YES 
928.00-928.01 
NO  NO  NO  YES  YES 
928.02-928.09 
YES  YES  YES  YES  YES 
928.10-928.11 
NO  NO  NO  YES  YES 
928.12-928.19 
YES  YES  YES  YES  YES 
928.2-928.21 
NO  NO  NO  YES  YES 
928.22-928.29 
YES  YES  NO  YES  YES 
928.3  NO  NO  NO  YES  YES 
928.4-928.7  YES  YES  YES  YES  YES 
928.8-928.9  YES  YES  NO  NO  YES 
929.0  NO  NO  NO  NO  YES 
929.1-929.8  YES  YES  NO  NO  YES 
929.9  NO  NO  YES  NO  YES 
996.90-996.99 
Progressive 
Necrotizing  686.0  NO  YES  NO  YES  NO 
Infections  686.01  YES  NO  YES  NO  NO 
686.09  YES  NO  YES  NO  YES 
728.86  YES  YES  YES  NO  YES 
785.4  YES  YES  NO  NO  NO 
F-1 
HBO2: Its Use and Appropriateness  OEI-06-99-00090  Category  ICD-9  HCFA  TEXAS  FLORIDA  Transamerica  AR (LA) 
Proposal  BC/BS*  BC/BS  Southern CA  BC/BS 
Acute 
Traumatic  900-902.52  NO  NO  NO  NO  YES 
Peripheral  902.53  YES  NO  NO  NO  YES 
Ischemia  903.01  YES  NO  YES  NO  YES 
903.2  YES  NO  NO  NO  YES 
904.0  YES  NO  YES  NO  YES 
904.01-904.4  NO  NO  NO  NO  YES 
904.41  YES  NO  YES  NO  YES 
NO  NO  NO  NO  YES 
904.42-904.9 
YES  YES  NO  YES  NO 
443.9 
PARTIAL  PARTIAL  PARTIAL  PARTIAL  YES 
925-929 
NO  NO  NO  YES  NO 
991.1 
NO  NO  NO  YES  NO 
991.2 
Arterial 
Insufficiency  250.7  NO  NO  NO  NO  YES 
362.30-362.31  NO  NO  NO  NO  YES 
443.81  NO  NO  NO  NO  YES 
443.9  NO  NO  NO  YES  YES 
444.0-444.20  NO  NO  NO  NO  YES 
444.21  YES  YES  YES  NO  YES 
YES  YES  YES  NO  YES 
444.22 
NO  NO  NO  NO  YES 
444.23-444.80 
YES  YES  NO  NO  YES 
444.81 
NO  NO  NO  NO  YES 
444.82-444.99 
NO  NO  YES  NO  NO 
733.41-733.49 
Compromised 
Skin Grafts  996.52  YES  YES  YES  YES  YES 
996.90-996.96  YES  NO  NO  NO  NO 
Osteomyelitis 
730.10-730.19  YES  YES  YES  YES  YES 
ORN 
526.89  YES  YES  YES  YES  YES 
909.2  NO  YES  YES  YES  NO 
990  YES  YES  YES  YES  YES 
STRN 
990  YES  YES  YES  YES  YES 
909.2  NO  YES  YES  YES  NO 
Cyanide 
987.7  YES  NO  YES  NO  YES 
989.0  YES  NO  YES  YES  YES 
Actinomycosis 
039.0-039.4  YES  YES  YES  YES  YES 
039.5-039.7  NO  NO  YES  YES  YES 
039.8  YES  YES  YES  YES  YES 
039.9  YES  YES  YES  YES  YES 
* Texas Blue Cross/Blue Shield is now Trailblazers. 
F-2 
HBO2: Its Use and Appropriateness  OEI-06-99-00090  APPENDIX  G 
Key Questions From the Medical Review Protocol

95% 
N  %  S.E.  Confidence 
Interval 
1. The ICD-9 codes billed to Medicare: 
A. Accurately Describe the Primary Indication  142  42.9  3.3  36.4 to 49.3 
B. Approximate the Primary Indication  80  21.7  2.6  16.6 to 26.8 
C. Describe a Secondary or Tertiary Indication  51  18.2  2.7  13.0 to 23.4 
D. Seem Erroneous  47  13.1  2.2  8.8 to 17.5 
E. Other  13  4.1  1.3  1.6 to 6.7 
Total  333 
2. Did the physician establish a plan of care? 
A. Yes  154  45.6  3.2  39.2 to 52.0 
B. Yes, but inadequate  65  17.7  2.4  12.9 to 22.4 
C. Not documented  121  36.7  3.2.  30.5 to 43.0 
Total  340 
3. Did the physician establish objective 
progress measures? 
32.0  3.0  26.1 to 37.9 
A. Yes  109  12.9  2.1  8.7 to 17.1 
B. Yes, but inadequate  49  55.1  3.2  48.8 to 61.5 
C. Not documented  181 
Total  339 
4. Was sufficient progress to justify 
continuation noted in the medical record? 
A. Yes  177  55.2  3.3  48.6 to 61.7 
B. No  146  44.8  3.3  38.3 to 51.4 
Total  323 
5. In your opinion, did treatments continue after 
benefits plateaued? 
A. Yes  73  13.2  1.8  9.6 to 16.8 
B. No  191  63.2  3.1  57.2 to 69.2 
C. Unable to determine  75  23.6  2.8  18.1 to 29.1 
Total  339 
6. Was physician attendance specifically 
documented in the chart? 
A. Always  101  27.5  2.9  21.9 to 33.1 
B. Sometimes  66  20.6  2.7  15.3 to 25.9 
C. Never  171  51.7  3.3  45.3 to 58.1 
Total  338 
G-1 
HBO2: Its Use and Appropriateness  OEI-06-99-00090  7. Does it appear that a physician was 
present? 
A. Yes  145  39.0  3.1  32.8 to 45.1 
B. No  135  44.1  3.3  37.8 to 50.5 
C. Unable to determine  55  16.2  2.4  11.4 to 20.9 
Total  335 
8. Is there evidence that the physician was 
supervising treatments? 
A. Yes  207  58.8  3.3  52.4 to 65.2 
B. No  75  25.2  2.9  19.4 to 30.9 
C. Unable to determine  52  16.1  2.5  11.2 to 20.9 
Total  334 
9. Did the patient receive appropriate testing for 
the diagnosis? 
A. Yes  223  67.2  3.1  61.2 to 73.2 
B. No  83  22.0  2.7  16.8 to 27.3 
C. Unable to determine  33  10.8  2.1  6.7 to 14.8 
Total  339 
10. Was treatment prior to initial HBO2 
appropriate? 
A. Yes  212  63.0  3.2  56.8 to 69.2 
B. No  38  10.7  2.1  6.7 to 14.8 
C. Unable to determine  88  26.3  2.9  20.6 to 32.0 
Total  338 
11. Was payment and coverage consistent 
with HCFAs 35-10 guidelines? 
A. Yes  239  72.9  2.9  67.1 to 78.6 
B. No  84  25.6  2.9  19.9 to 31.3 
C. Unable to determine  8  1.6  0.6  0.4 to 2.7 
Total  331 
G-2 
HBO2: Its Use and Appropriateness  OEI-06-99-00090  APPENDIX  H 
Agency Comments 
In this appendix, we present comments from the Health Care Financing Administration. 
H-1 
HBO2: Its Use and Appropriateness  OEI-06-99-00090  H-2 
HBO2: Its Use and Appropriateness  OEI-06-99-00090  H-3 
HBO2: Its Use and Appropriateness  OEI-06-99-00090  H-4 
HBO2: Its Use and Appropriateness  OEI-06-99-00090