Department of Health and Human Services 

OFFICE OF 

INSPECTOR GENERAL 

PRESSURE REDUCING SUPPORT 

SURFACES 

JUNE GIBBS BROWN 

Inspector General 

JUNE 1997 

OEI-02-95-00370 
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. 

The OEI’s New York Regional Office prepared this report under the direction of Alan S. 

Meyer, Regional Inspector General. Principal OEI staff included: 

Region Headauarters 

Demetra Arapakos, Project Leader Brian Ritchie 

Jennifer Caves Barbara Tedesco 

Lucille Cop Stuart Wright 

Daniel Ginsberg 

Jane Liss, intern 

Panayiotis Beloyeannis, intern 

To obtain a copy of this report, call the New York Regional Office at (212) 264- 1998. 
Department of Health and Human Services 

OFFICE OF 

INSPECTOR GENERAL 

PRESSURE REDUCING SUPPORT 

SURFACES 

‘.o 

2, JUNE GIBBS BROWN 

/ Inspector General 
EXECUTIVE SUMMARY 

PURPOSE 

To determine the extent of inappropriate Medicare payments for pressure reducing support 

surfaces and to assess the effect of new 1996 Durable Medical Equipment Regional Carrier 

(DMERC) medical policies and coverage guidelines. 

BACKGROUND 

Pressure reducing support surfaces are a kind of durable medical equipment (DME) used for 

the care of pressure sores. These sores are lesions caused by unrelieved pressure resulting in 

damage of underlying tissue. Support surfaces are coded under one of 16 different HCFA 

Common Procedure Coding System (HCPCS) codes and categorized into three groups. A 

major distinction between support surfaces is that some are powered by electricity and others 

are not. 

In an effort to clarify and improve existing support surface medical policies, new Durable 

Medical Equipment Regional Carrier guidelines became effective January 1, 1996. These 

changes had the greatest impact on alternating pressure mattresses by no longer allowing 

reimbursement for these mattresses if used for preventive treatment, as they had been before 

1996. The new guidelines also no longer require certificates of medical necessity (CMNs) 

for support surface equipment, with the exception of air-fluidized beds. 

In conducting this inspection, we used the following combination of methods: a mail survey 

to a sample of Medicare beneficiaries who had claims paid for support surface equipment; a 

medical record review for a subsample of these Medicare beneficiaries; an examination of 

their support surface billing histories; and a review of Medicare reimbursement data for 

support surface codes. In order to assess the effect of new 1996 DMERC support surface 

medical policies, we selected two beneficiary samples for this inspection - the first from the 

last quarter (October, November, and December) of 1995, and the second from the second 

quarter (April, May, and June) of 1996. 

FINDINGS 

While New 1996 DMERC Guidelines Appear To Be Having A Positive Impact On 

Controlling Medicare Costs For Support Surfaces, Inappropriate Payments Are Still 

Noted 

Medicare reimbursement for alternating pressure mattresses has been decreasing, dropping 

from $183,358,943 in 1995, to $148,894,337 in 1996. In 1996, 29 percent of sample 

beneficiaries used support surfaces that were medically unnecessary, fewer than the 47 

percent of beneficiaries who used a medically unnecessary support surface in 1995. Finally, 

12 percent of beneficiaries in 1996, down from 22 percent in 1995, report receiving upcoded 

equipment or no equipment at all, or had duplicate support surface billings. Because of the 

i 
small sample size, we cannot demonstrate that these differences are statistically significant. 

However, these trends are consistent with recent actions taken by the Health Care Financing 

Administration (HCFA). 

A Variety of Other Problems Continue To Adversely Affect Medicare Support Surface 

Reimbursement 

These problems are due to a lack of adherence to existing DMERC guidelines, and were not 

impacted in any way by the establishment of new 1996 DMERC policies. They include: the 

use of group 2 equipment before a trial of less expensive and complex group 1 equipment; 

the continued use of support surface equipment after sores have healed completely; an 

apparent lack of physician involvement in and documentation for beneficiary use of support 

surfaces; and improper use of support surfaces by beneficiaries who do not plug in their 

electrical equipment. 

Most Beneficiaries With Appropriately Paid Claims Report Positive Experiences With 

Their Support Surface Equipment 

Of the beneficiaries in 1995 and 1996 who received electrical equipment which was both 

medically necessary and properly used, a majority (79 percent and 89 percent respectively) 

report that their pressure sores healed completely or improved because of their support 

surface use. 

RECOMMENDATIONS 

While the new 1996 DMERC guidelines appear to be having a positive impact on controlling 

Medicare costs for support surfaces, inappropriate payments are still being made and other 

problems continue to adversely affect Medicare reimbursement for this equipment. We 

therefore believe that additional steps can be taken to reduce the extent of inappropriate 

support surface payments. In particular, we recommend that: 

HCFA establish the requirement for periodic review and renewal of the medical 

necessity for beneficiaries’ use of group 2 support surface equipment. 

We recognize that establishing such a requirement may be cumbersome to both the DMERCs 

in processing claims and to the suppliers in obtaining the necessary information. However, 

we believe that this requirement should help to eliminate problems identified in this report. 

These include beneficiaries’ inappropriate and improper use of support surfaces, provision of 

upcoded equipment, and poor documentation of support surface use. Periodic recertifications 

could be done every 3 months and completed by a healthcare practitioner. 

We estimate that implementing this requirement would save as much as $12 million annually. 

Actual savings could be considerably larger than this amount. 

ii 
COMMENTS 

We received comments on the draft report from HCFA and the Assistant Secretary for 

Planning and Evaluation. We also solicited and received comments from 3 industry groups, 

the Health Industry Manufacturers Association (HIMA), the National Association for Medical 

Equipment Services (NAMES), and the Health Industry Distributors Association (HIDA). 

The HCFA does not concur with our recommendation that it establish the requirement for 

periodic review and renewal of the medical necessity for beneficiaries’ use of group 2 

support surface equipment. It does not believe such a requirement is necessary since group 2 

support surface claims must have a ZX modifier, which indicates the supplier has 

documentation that medical policy requirements have been met. Furthermore, the HCFA is 

concerned about the timeliness and costs associated with utilizing a certificate of medical 

necessity (CMN) for group 2 equipment. 

In response, we point out that our recommendation did not specifically state that a CMN be 

used for periodic review and renewal of medical necessity. In fact, we deliberately did not 

recommend that a CMN be used because of the same concerns of timeliness and costs. 

However, we feel strongly that some other mechanism be used to review and renew medical 

necessity. We do not believe the ZX modifier is sufficient to do this, since there is no 

requirement for additional medical evidence to support it beyond the initial medical necessity 

determination. Currently, there is no mandate for any additional, ongoing review of medical 

necessity. Furthermore, the findings of our report indicate inappropriate utilization which 

warrants, in our opinion, some type of corrective action. 

We believe that the Statement of the Ordering Physician, which must be filled out prior to 

delivery of the equipment and is kept on file with the supplier, could be used to implement 

our recommendation. This would assure that the equipment continues to be medically 

necessary. Such a review could also assure that the beneficiary is using the equipment 

appropriately and using equipment that is properly coded. 

All three industry groups support, on some level, our recommendation. The HIMA is in 

“complete agreement” and states that this is a position they have held for the past several 

years. The NAMES supports using the Statement of the Ordering Physician, but on a 6 

month basis; HIDA agrees with the 6 month timeframe. We believe a 3 month time 

requirement for review and renewal, as suggested by HIMA, is the best option, and have 

changed the recommendation accordingly. 

Both HCFA and ASPE raised questions about our cost savings estimate of $12 million. We 

have added a further explanation as to how we derived this estimate in the report’s 

methodology. The ASPE suggests we conduct a cost-benefit analysis for implementing our 

recommendation. While we acknowledge that certain costs would be incurred by 

implementing this recommendation, we believe that these costs are likely to be minimal, 

particularly since the Statement of the Ordering Physician is already kept on file by the 

supplier. 

. . . 111 
The HCFA also states that it is unaware of any new support surface coding verification 

process by the SADMERC. During discussions with SADMERC staff, however, they 

indicated that they had improved their existing coding verification process to accommodate 

changes in support surface policies and new support surface codes and now send out a sheet 

with guidelines for suppliers wanting written coding verification. As HCFA notes, this 

process is optional to suppliers requesting assistance. 

Finally, in response to HCFA’s other technical comments, we have made additional 

clarifications to the text in both the background and findings sections. The full text of all 

comments are included in Appendix D. 

iv 
TABLE OF CONTENTS 

PAGE 

EXECUTJYE SUMMARY 

INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..I . . . 1 

FINDINGS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 

� 1996 DMERC Guidelines Have Positive Impact on Controlling Medicare Costs . . 7 

� Problems Continue to Adversely Affect Medicare Reimbursement . . . . . . . . . 10 

� Beneficiaries Report Positive Experiences with Support Surfaces . . . . . . . . . . . 12 

RECOMMENDATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 

APPENDICES 

A: Sample Selection . . . . . . . I . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 

B: Confidence Intervals .................................... 

C: Non-respondent Analyses ................................. 

D: Comments ......................................... 

. A-l 

. B-l 

. C-l 

. D-l 
INTRODUCTION 

PURPOSE 

To determine the extent of inappropriate Medicare payments for pressure reducing support 

surfaces and to assess the effect of new 1996 Durable Medical Equipment Regional Carrier 

(DMERC) medical policies and coverage guidelines. 

BACKGROUND 

Medicare Program 

Medicare provides health insurance for approximately 37 million elderly and disabled 

beneficiaries under two parts. The first, Part A, is hospital insurance which covers services 

furnished by providers, such as hospitals, home health agencies, and skilled nursing 

facilities. The second, Part B, is supplementary medical insurance which covers physician 

services, outpatient hospital services, and other medical services and supplies. The Health 

Care Financing Administration (HCFA) administers the Medicare program and contracts with 

carriers and fiscal intermediaries to process, review, and pay claims for covered services. 

DME 

One benefit covered under Medicare Part B is durable medical equipment (DME). Home 

health agencies can also bill for DME under the Part A home health benefit if such 

equipment is part of their patient’s home health plan of care. In order for DME to be 

covered, it must: withstand repeated use; be used primarily and customarily to serve a 

medical purpose; generally not be useful to a person in the absence of illness or injury; and 

be appropriate for home use. 

In October, 1993, HCFA began processing DME claims through four regional carriers called 

the Durable Medical Equipment Regional Carriers (DMERCs). These four carriers cover the 

entire country, using common medical policies and coverage guidelines for DME. 

Support Sur$aces 

Pressure reducing support surfaces are a kind of DME used for the care of decubitus ulcers 

or pressure sores. These sores are lesions caused by unrelieved pressure resulting in damage 

of underlying tissue. They form when patients are not able to shift their weight from one 

part of their body to the other, thus resulting in pressure being applied to only one area 

where the sore then develops. Individuals with limited mobility who are confined to a bed or 

wheelchair for long periods of time, as well as those with impaired sensation, are susceptible 

to pressure sores. Thus, patients with conditions such as multiple sclerosis or spinal cord 

injuries, as well as the frail elderly, are particularly vulnerable. Pressure sores are classified 

into four stages, with stage I being the mildest and stage IV the most severe. 
Support surfaces are coded under one of 16 different HCFA Common Procedure Coding 

System (HCPCS) codes and categorized into three groups. A major distinction between 

support surfaces is that some are powered by electricity and others are not. Equipment in 

group 1 are generally less expensive than equipment in groups 2 and 3. 

Group 1 includes both powered and non-powered mattress overlays made of gel, air, water 

or foam. Group 2 includes two air mattress overlays, one powered and the other not, both 

of which were given their own codes in April 1996. It also includes a powered air flotation 

bed and an alternating pressure mattress. The only support surface included in group 3 is the 

air-fluidized bed, which uses the circulation of filtered air through silicone coated ceramic 

beads, thus simulating the movement of fluid. 

Medicare Coverage of Support Surj’aces 

In an effort to clarify and improve existing support surface medical policies and coverage 

requirements, new DMERC guidelines became effective January 1, 1996. These changes 

had the greatest impact on alternating pressure mattresses (code EO277), by no longer 

allowing reimbursement for these mattresses if used only for preventive treatment, as they 

had been before 1996. The new policies also no longer require certificates of medical 

necessity (CMN) for support surface equipment, with the exception of air-fluidized beds. 

Additionally, the Statistical Analysis DMERC (SADMERC) improved its existing process of 

support surface coding verification for suppliers with questions about which code to use for 

their equipment. 

For all three support surface groups, patients should have a care plan established by their 

physician or home care nurse, which is documented in their medical records. This plan 

generally should include, among other things, education of the patient and regular assessment 

by a healthcare practitioner. Coverage for all three groups continues until the patient’s 

pressure sore is healed. 

In addition to the above common requirements, coverage for specific groups of support 

surfaces varies as follows: 

GROUP 1. A group 1 support surface is covered if the patient is completely immobile. 

Otherwise, he or she must be partially immobile, or have any stage pressure sore, and 

demonstrate one of the following conditions: impaired nutritional status; incontinence; 

altered sensory perception; or compromised circulatory status. A physician order must be 

obtained prior to delivery of the equipment and should be kept on file by the supplier. 

GROUP 2. A group 2 support surface is covered if the patient has a stage II pressure sore 

located on the trunk or pelvis, has been on a comprehensive pressure sore treatment program 

(which has included the use of an appropriate group 1 support surface for at least one 

month), and has sores which have worsened or remained the same over the past month. A 

group 2 support surface is also covered if the patient has large or multiple stage III or IV 

pressure sores on the trunk or pelvis, or if he or she has had a recent mycutaneous flap .or 

skin graft for a pressure sore on the trunk or pelvis and has been on a group 2 or 3 support 

2 
surface immediately prior to recent discharge from a hospital or nursing facility. A 

physician order must be obtained prior to delivery and kept on file by the supplier. 

GROUP 3. Air-fluidized beds, the sole group 3 support surface, are covered if seven 

criteria are met. These are stage III or IV pressure sores; severely limited mobility; an 

unsuccessful conservative treatment trial; a trained adult caregiver who is available to assist 

the patient; physician direction of the home treatment regimen; and the consideration and 

ruling out of alternative equipment. For air-fluidized beds, an order and certificate of 

medical necessity (CMN) must be signed and dated by the ordering physician prior to 

delivery. These beds must have their medical necessity recertified on a monthly basis. 

OperationRestore Trust 

The Office of Inspector General (OIG) has over the past few years issued several reports on 

durable medical equipment (DME) which have documented problems with inappropriate 

Medicare payments. In response to these and other concerns with Medicare fraud and abuse, 

the Department of Health and Human Services designed an anti-fraud initiative called 

Operation Restore Trust (ORT) to target fraud, waste and abuse related to home health 

agencies, nursing homes and DME suppliers. Recent reports and investigations by the OIG 

showed that these areas are particularly vulnerable to fraud, waste, and abuse. The ORT 

initiative targets California, Florida, New York, Illinois, and Texas. These five States 

account for 40 percent of the nation’s Medicare beneficiaries and program expenditures. 

METHODOLOGY 

Multiple &fethods 

In conducting this inspection, we used the following combination of methods: a mail survey 

to a sample of Medicare beneficiaries who had claims paid for support surface equipment; a 

medical record review for a subsample of these Medicare beneficiaries; an examination of 

their support surface billing histories; and a review of Medicare reimbursement data for 

support surface codes. 

In order to assess the effect of new DMERC support surface medical policies which started 

on January 1, 1996, we selected two beneficiary samples for this inspection - the first from 

the last quarter (October, November, and December) of 1995, and the second from the 

second quarter (April, May, and June) of 1996. Both samples were selected from the HCFA 

National Claims History 5 percent file. 

See Appendix A for further discussion of our sample selection. Also see Appendix B for 

confidence intervals on key survey questions and medical record review results, and 

Appendix C for non-respondent analyses. 

1995 Sample 

For the 1995 sample, we selected a stratified random sample of 300 Medicare beneficiaries 

3 
who had a support surface claim paid during the last three months of 1995. We selected 50 

beneficiaries from each of the five ORT States and the remaining 50 from the rest of the 

country. We included the following five codes in this sample: E0194 (air-fluidized bed), 

E0193 (powered air flotation bed), E0277 (alternating pressure mattress), EO180 (alternating 

pressure pad), and El399 (miscellaneous durable medical equipment). These five codes 

accounted for over 90 percent of all support surface reimbursement in the last 3 months of 

1995. 

After our sample was selected, we determined that most of the claims (110 of 130) for the 

El399 code were for equipment that was not a support surface. We therefore excluded these 

110 beneficiaries from our sample, leaving us with a usable sample size of 190. After 

allowing 2 months for data collection, during which time we conducted a second mailing to 

non-respondents, 136 beneficiaries returned their mail questionnaire, for a response rate of 

72 percent. 

We also selected a subsample of 150 beneficiaries for a medical record review - 25 from 

each of the six strata. From these, we had to exclude 58 beneficiaries with El399 claims, 

leaving a usable sample size of 92. For each of these 92 beneficiaries, we requested medical 

records from the physician listed as the ordering physician on the claim. In some cases, the 

physician referred us to the patient’s home health agency for the medical records. After at 

least two efforts to obtain accurate addresses, we were unable to locate five of the 92 

physicians. 

After allowing 2 months for data collection, during which time non-responding physicians 

were sent a second follow-up request, we received responses from 58 physicians. Of these 

58 physicians, 55 sent us a medical record or other patient specific response (such as a 

detailed letter), two said they had never seen the beneficiary, and one said he had never 

ordered the support surface equipment. 

Once we obtained a medical record or other patient specific response, we used a medical 

review contractor to review the documents to determine whether the support surface 

equipment the beneficiary had a claim paid for was medically necessary. The contractor 

developed a screening document, based on DMERC medical guidelines, Agency for Health 

Care Policy and Research (AHCPR) pressure sore guidelines, and with input from one of the 

DMERC medical directors. Nurse reviewers then used this screening document to review 

the records. Any records which failed this initial screening were referred to a physician 

reviewer who then made a final determination of medical necessity. 

Due to the big difference between weights used in our analysis of 1995 sample data, the 

same number of responses may result in different percentages, depending on the strata from 

which those responses come. 

1996 Samnle 

Due to revised DMERC medical policy changes effective 1996, we stratified our 1996 

beneficiary sample differently than our 1995 sample. For 1996, we stratified by HCPCS 

4 
code rather than by ORT State, in order to assure a large enough number of the one code 

(E0277) that was most affected by the new policies. Additionally, we determined that it was 

necessary to stratify our sample by codes because of the wide variance in frequency of 

support surface codes. 

Therefore, we selected 420 Medicare beneficiaries for our 1996 sample: 290 from stratum 1 

(code EO277), 75 from stratum 2 (code EOBO), and all 55 from stratum 3 (E0193 and 

E0194). These four codes accounted for over 85 percent of all Medicare support surface 

reimbursement during the second 3 months of 1996. With the exception of E1399, these 

four codes were the same codes included in our 1995 sample. After allowing 2 months for 

data collection, during which time we conducted a second mailing to non-respondents, 286 

beneficiaries returned their mail questionnaire, for a response rate of 68 percent. 

We also selected a subsample of 250 of the 420 beneficiaries for the medical review - 145 

from stratum 1, 50 from stratum 2, and all 55 from stratum 3. Despite at least two efforts to 

obtain accurate addresses, we were unable to locate 11 physicians. After allowing 2 months 

for data collection, during which time non-responding physicians were sent a second followup request, we received responses from 127 physicians for a response rate of 51 percent. Of 

the 127 responding physicians, 113 sent us a medical record or other patient specific 

response, 10 said they had never seen the beneficiary, and four said they never ordered the 

equipment. The same contractor and review procedures used to conduct the 1995 medical 

record review were also used for the 1996 subsample. 

Determining InappropriateReimbursement 

In determming inappropriate Medicare reimbursement for support surface equipment, we 

looked at the following four categories of beneficiary use: equipment that was not medically 

necessary; equipment beneficiaries report they never received; equipment beneficiaries report 

was less what than Medicare paid for; and duplicate billings for support surface equipment. 

While percentages are given for the different categories of inappropriate reimbursement, we 

report numbers when discussing individual medically unnecessary claims. Reporting 

percentages for these claims would be imprecise, due to their relatively small number. 

EstimatingInappropriateMedicare Reimbursement Costs 

Estimates for inappropriate Medicare payments were based on allowed Medicare support 

surface charges for beneficiaries falling into one of the above four categories. These 

estimates are conservative, however, since we assumed Medicare payments were appropriate 

for the records not reviewed in the medical record subsample and for the beneficiaries who 

did not respond to the mail questionnaire. Additionally, due to relatively small sample sizes, 

especially in 1995, the confidence intervals for some estimates are considerably wide. 

The medically unnecessary 1996 claims represent $3 million in inappropriate Medicare 

payments in the second 3 months of 1996, or $12 million if projected to the entire year, 

assuming the rest of the year was comparable to that quarter. Of the 33 beneficiaries who 

5 
used medically unnecessary support surfaces in 1996, a large majority (88 percent) used a 

group 2 surface. Only four beneficiaries did not use a group 2 surface: three used an airfluidized bed and the other a mattress overlay. Furthermore, costs associated with the latter 

are minimal, since monthly rental costs for mattress overlays are significantly lower than 

those for group 2 equipment. 

This inspection was conducted in accordance with the Quality Standards for Inspections 

issued by the President’s Council on Integrity and Efficiency. 

6 
FINDINGS 

WHILE NEW 1996 DMERC GUIDELINES APPEAR TO BE HAVING A POSITIVE 

IMPACT ON CONTROLLING MEDICARE COSTS FOR SUPPORT SURFACES, 

INAPPROPRIATE PAYMENTS ARE STILL NOTED 

Medicare Reimbursementfor Alternating Pressure Mattresses Has Been Decreasing 

Up until 1996, Medicare reimbursement for support surfaces had been increasing 

significantly, due specifically to a dramatic growth in reimbursement for alternating pressure 

mattresses. Payment for these mattresses climbed from $2,777,056 in 1992 to $183,358,943 

in 1995. The 1996 DMERC medical policies, which stopped reimbursement for this 

equipment if used for prevention, was an attempt to control utilization of these mattresses. 

The support surface industry was well aware before the new policy became effective that 

such a change would occur. 

Since the beginning of 1996, reimbursement for alternating pressure mattresses has been 

decreasing. Reimbursement for these mattresses dropped from $183,358,943 in 1995 to 

$148,894,337 in 1996. Graph One below illustrates decreases in quarterly reimbursement 

amounts, from the last quarter of 1995 through all four quarters of 1996. However, despite 

this decrease, alternating pressure mattresses still rank highly in terms of overall Medicare 

DME costs. These mattresses were the 12th highest of all DME codes in terms of overall 

reimbursement in the third quarter of 1996. 

$ MILLION 

60-

50-

30-

20 -

MEDICARE REIMBURSEMENT FOR ALTERNATING 

PRESSURE MA-I-I-RESSES DECREASED IN 1996 

8 

Legend 

Medicare allowed $ 

Qtr 41995 Qtr 1:I 996 Qtr 2:1996 Qtr 3:i 996 Qtr 4:1996 

Graph 1 

7 
Despite the new 1996 DMERC medical policies which no longer allow reimbursement for 

the alternating pressure mattress solely for the purpose of prevention, 13 percent of our 

sample beneficiaries in that year report using their mattress for prevention only. 

Twenty-ninepercent of beneficiaries in 1996 used medically unnecessary support su?face 

equipment, fewer than did so in 1995 

In 1996, 29 percent of beneficiaries used medically unnecessary support surface equipment, 

fewer than the 47 percent who did so in 1995. Due to the small 1995 sample size, we 

cannot demonstrate that this difference is statistically significant; however, this trend is 

consistent with recent actions taken by HCFA. The beneficiaries used one of four different 

types of support surfaces, ranging from an inexpensive mattress overlay to a much more 

costly alternating pressure mattress. For 113 documents in the 1996 medical record review, 

half (50 percent) were medical records. The other half consisted of physician letters, office 

notes, and other patient specific responses. The medical review contractor was able to make 

a final decision on the question of medical necessity for 91 of the 113 beneficiaries. 

Insufficient medical documentation prevented such a decision from being made for the other 

22 beneficiaries. 

The medically unnecessary 1996 claims represent $3 million in inappropriate Medicare 

payments in the second ,3 months of 1996, or $12 million if projected to the entire year. 

However, the amount for the year is probably considerably larger than $12 million, since we 

were only able to review approximately half of the 250 records in the medical review 

subsample. Since we assumed that all of the other half we were unable to review were 

medically necessary, our projection of $12 million is a conservative estimate. 

The 33 beneficiaries who used a support surface that was medically unnecessary in 1996 are 

categorized as follows: 

0 12 used an alternating pressure mattress despite having no pressure sores. This 

contradicts the new 1996 DMERC medical policies for this support surface, which 

state that these mattresses must be used for treatment only. 

0 15 beneficiaries were using a group 2 support surface (mostly an alternating pressure 

mattress) before first trying a group 1 mattress overlay. 

0 four beneficiaries had insufficient medical evidence to warrant use of their support 

surface. \ 

0 two beneficiaries used a support surface for pressure sores on their limbs. 

More beneficiaries in 1995 than in 1996 used medically unnecessary support surfaces. Of 

the 55 beneficiaries in our 1995 medical record review subsample, 47 percent (21 

beneficiaries) had claims paid for a support surface that were determined to be not medically 

necessary. This represents $14 million in inappropriate Medicare payments in the last 3 

months of 1995. Of the 55 physicians, home health agencies, or nursing homes which 

8 
provided us with some medical documentation, more than half (57 percent) provided 

complete medical records. The remaining 43 percent provided some other patient specific 

response, such as a detailed letter or office notes. Despite poor documentation for many 

cases, however, the medical review contractor was able to make a determination on the 

question of medical necessity for all but three of the 55 beneficiaries. The contractor was 

unable to make a decision on medical necessity for these three beneficiaries because of 

insufficient medical documentation. 

The 21 beneficiaries who used a support surface that was medically unnecessary in 1995 can 

be categorized as follows: 

13 beneficiaries used a group 2 support surface (almost always an alternating pressure 

mattress for pressure sore care or prevention) before first trying a group 1 support 

surface as required. None of the 13 met the DMERC medical policy criteria that 

would have allowed use of a group 2 support surface without first trying a group 1 

surface. Included in this 1995 group are beneficiaries who would not qualify for 

support surface reimbursement under the new 1996 guidelines, since many had no 

pressure sores. 

three beneficiaries used a support surface for pressure sores on their limbs, not 

allowed by DMERC medical policy. 

three beneficiaries had insufficient medical evidence to warrant use of a support 

surface. 

one beneficiary was using a support surface for a diabetic foot infection, a noncovered 

medical condition. 

one beneficiary’s ordering physician stated that while the support surface he ordered 

for his patient was medically necessary, it was delivered after the patient died and 

therefore was never used. 

Twelvepercent of beneficiaries in 1996, downfrom 22 percent in 1995, report receiving 

upcoded equipment or no equipment at all, or had duplicate billings 

Fewer beneficiaries in 1996 (12 percent) than in 1995 (22 percent) report problems with 

upcoded or undelivered equipment, or had duplicate billings. Again, due to the small 1995 

sample size, we are unable to determine if this difference is statistically significant. While 

the new 1996 DMERC guidelines do not directly address these problems, the SADMERC’s 

improvement of its existing coding verification process for suppliers with questions about 

which code to use for their equipment may be having some positive effect here. The 

inappropriate 1996 claims represent $922,000 in allowed Medicare payments in the second 

quarter of 1996. 

9 
The 12 percent in 1996 are categorized as follows: 

0 7 percent of 286 beneficiaries report receiving equipment that was less than what 

Medicare paid. Seven beneficiaries had claims paid for alternating pressure 

mattresses, and another seven for alternating mattress overlays. While the claims 

paid for these 14 beneficiaries used codes for electrically powered equipment, they all 

report that their equipment does not have an electric plug. 

0 4 percent of beneficiaries report never receiving support surface equipment. Seven 

claims were paid for alternating pressure mattresses, two for alternating mattress 

overlays, and another two for powered air flotation beds. 

0 1 percent of beneficiaries had duplicate support surface billings, two for the same 

equipment and the third for two different types of equipment, all within the same 

month. 

In 1995, 22 percent of 136 Medicare beneficiaries report receiving either upcoded equipment 

or no equipment at all, or had duplicate support surface billings. These claims represent 

$6.6 million in allowed Medicare payments in the fourth quarter of 1995. 

The 22 percent in 1995 are categorized as follows: 

0 13 percent of beneficiaries report receiving equipment that was less than what 

Medicare paid for. These beneficiaries report that the equipment they are using for 

the care of their pressure sores does not have an electric plug. However, all of the 

claims paid for these individuals used codes for electrically powered equipment - eight 

for alternating pressure mattresses, one for a powered air flotation bed, and one for 

an alternating mattress overlay. 

0 4 percent of beneficiaries report never receiving any kind of support surface 

equipment. All of these beneficiaries, however, had a Medicare claim paid for some 

type of support surface equipment. Four claims were for alternating pressure 

mattresses, and three were for alternating mattress overlays. 

0 5 percent of beneficiaries had duplicate billings. In all of these cases, more than one 

support surface was billed and paid for under Medicare within the same month, which 

Medicare coverage policy does not permit. Two beneficiaries had two claims paid for 

the same equipment, while five had claims paid for two different types of support 

surfaces, usually a support surface overlay and a support surface mattress, within the 

same month. 

A VARIETY OF OTHER PROBLEMS CONTINUE TO ADVERSELY AFFECT 

MEDICARE SUPPORT SURFACE REIMBURSEMENT 

The following problems are due to a lack of adherence to existing DMERC guidelines, and 

were not impacted in any way by the establishment of new 1996 DMERC policies. 

10 
Some Beneficiaries Are Using Group 2 Support Surface Equipment Before First Trying A 

Less Expensive Support Surface From Group 1;9 Out Of 10Have No Documentation Of 

A Comprehensive Pressure Sore Treatment Program 

As noted in the medical record reviews for both years, some beneficiaries are using a support 

surface from group 2 without first trying equipment from group 1. These beneficiaries 

include those without any pressure sores as well as those with stage II pressure sores, all of 

whom should have first tried a lesser, group 1 support surface as part of their comprehensive 

treatment plan before moving to a group 2 support surface. Only 10 percent of beneficiaries 

in the 1996 medical record review had documentation which demonstrated the existence of a 

comprehensive pressure sore treatment program. 

Other Beneficiaries Report Continuing Use of Their Support Surface After Their Pressure 

Sore Healed 

In both 1995 and 1996, more than one-third (37 percent and 38 percent, respectively) of 

beneficiaries report continuing to use their group 2 support surface equipment after their 

pressure sores healed completely. While DMERC medical policies do not allow continued 

coverage of support surfaces once the patient’s pressure sore has healed completely, 

Medicare continued to pay rental for 63 percent of beneficiaries with healed sores in 1995 

and 8 1 percent in 1996. 

PhysiciansPlayA Limited Role 

Based on the limited medical documentation of beneficiaries’ pressure sore treatment in both 

years, physicians appear to be playing a limited role in their patients’ use of support 

surfaces. In 1995, plans of care were submitted to us for just 23 percent of beneficiaries, 

only four of which included a reference to pressure sore treatment. Documentation showing 

the patient tried preventative treatment prior to the use of a support surface was available for 

only 38 percent of beneficiaries. Furthermore, according to the medical record review, just 

37 percent were educated on the management of their pressure sores, and only 23 percent 

were regularly assessed by a healthcare practitioner; both of these practices are listed in 

DMERC medical policies as being part of a patient’s plan of care. 

In 1996, we received plans of care for just 30 percent of beneficiaries, only one-third of 

which specifically addressed pressure sore treatment. Furthermore, documentation of 

preventive treatment tried prior to use of a support surface was available for only 23 percent 

of beneficiaries. According to the medical record review, only one-third of beneficiaries 

were educated on the management of their pressure sores, and just one-third were regularly 

assessed by a healthcare practitioner. 

Finally, on a related note, in 1995, 5 percent of physicians report either having no record of 

the patient for whom they were listed as the ordering physician or report never ordering 

support surface equipment for their patients. Even more physicians in 1996 - 14 percent -

report the same problems. 

11 
Some Beneficiaries Report Using Their Equipment Improperly 

Five percent of beneficiaries in each year appear not to be using their electrical equipment 

properly. This improper use reduces the medical efficacy of their equipment. Some of these 

beneficiaries report never plugging in their support surface bed, mattress or mattress overlay, 

despite the fact that their equipment has a plug that must be used in order for it to work. 

Others plug it in only occasionally when using it. 

Such improper use of equipment may suggest a lack of adequate patient education. 

However, most of all beneficiaries in both 1995 and 1996 (72 and 77 percent respectively) 

report that the supplier taught them how to use their equipment. Only 2 percent in 1995 and 

3 percent in 1996 report having to teach themselves how to use their equipment by reading a 

manual. Furthermore, more than one-third of all beneficiaries in both years report 

contacting their supplier when they have any questions about their support surface equipment. 

Place Of Service Coding Is Not AlwaysAccurate 

Twelve percent of beneficiaries in 1995 and 4 percent in 1996 report living in a nursing 

home on their survey questionnaire. However, more than half of these beneficiaries in 1995 

and all of them in 1996 had claims with “home” coded as the place of service. These cases 

may not necessarily be problematic. However, a supplier billing for the equipment in this 

way makes a greater profit: they would be paid 15 months of a high rental price by the 

DMERC and beneficiary, as opposed to being paid a lower purchase price by the nursing 

home. 

MOST BENEFICIARIES WITH APPROPRIATELY PAID CLAIMS REPORT 

POSITIVE EXPERIENCES WITH THEIR SUPPORT SURFACE EQUIPMENT 

Beneficiaries Report Benefitting From Their Support Surface Use 

Of the beneficiaries in 1995 and 1996 who received electrical equipment which was both 

medically necessary and properly used, a majority report positive experiences with their 

equipment. More specifically, in 1995, 79 percent of these beneficiaries report that their 

pressure sores healed completely or improved because of their support surface. Of these, 47 

percent say it took 1 month or less for this healing or improvement to occur, while the 

remaining 53 percent say it took longer than 1 month (for 20 percent, more than 6 months). 

One beneficiary reports that his equipment is “a very good product. I would have trouble 

without it. ” Another says “my mattress does wonders. ” 

In 1996, 89 percent of beneficiaries with appropriately paid claims report a complete 

recovery from or improvement of their pressure sores since using their support surface 

equipment. Almost half (46 percent) say this took 1 month or less, while the remaining 54 

percent say it took longer than 1 month (longer than 6 months for 9 percent of beneficiaries). 

12 
RECOMMENDATIONS 

While the new 1996 DMERC guidelines appear to be having a positive impact on controlling 

Medicare costs for support surfaces, inappropriate payments are still being made and other 

problems continue to adversely affect Medicare reimbursement for this equipment. We 

therefore believe that additional steps can be taken to reduce the extent of inappropriate 

support surface payments. In particular, we recommend that: 

HCFA establish the requirement for periodic review and renewal of the medical 

necessity for beneficiaries’ use of group 2 support surface equipment. 

We recognize that establishing such a requirement may be cumbersome to both the DMERCs 

in processing claims and to the suppliers in obtaining the necessary information. However, 

we believe that this requirement should help to eliminate problems identified in this report. 

These include beneficiaries’ inappropriate and improper use of support surfaces, provision of 

upcoded equipment, and poor documentation of support surface use. Periodic recertifications 

could be done every 3 months and completed by a healthcare practitioner. 

We estimate that implementing this requirement would save as much as $12 million annually. 

Actual savings could be considerably larger than this amount. 

COMMENTS 

We received comments on the draft report from HCFA and the Assistant Secretary for 

Planning and Evaluation. We also solicited and received comments from 3 industry groups, 

the Health Industry Manufacturers Association (HIMA), the National Association for Medical 

Equipment Services (NAMES), and the Health Industry Distributors Association (HIDA). 

The HCFA does not concur with our recommendation that it establish the requirement for 

periodic review and renewal of the medical necessity for beneficiaries’ use of group 2 

support surface equipment. It does not believe such a requirement is necessary since group 2 

support surface claims must have a ZX modifier, which indicates the supplier has 

documentation that medical policy requirements have been met. Furthermore, the HCFA is 

concerned about the timeliness and costs associated with utilizing a certificate of medical 

necessity (CMN) for group 2 equipment. 

In response, we point out that our recommendation did not specifically state that a CMN be 

used for periodic review and renewal of medical necessity. In fact, we deliberately did not 

recommend that a CMN be used because of the same concerns of timeliness and costs. 

However, we feel strongly that some other mechanism be used to review and renew medical 

necessity. We do not believe the ZX modifier is sufficient to do this, since there is no 

requirement for additional medical evidence to support it beyond the initial medical necessity 

determination. Currently, there is no mandate for any additional, ongoing review of medical 

necessity. Furthermore, the findings of our report indicate inappropriate utilization which 

warrants, in our opinion, some type of corrective action. 

13 
We believe that the Statement of the Ordering Physician, which must be filled out prior to 

delivery and is kept on file with the supplier, could be used to implement our 

recommendation. This would assure that the equipment continues to be medically necessary. 

Such a review could also assure that the beneficiary is using the equipment appropriately and 

using equipment that is properly coded. 

All three industry groups support, on some level, our recommendation. The HIMA is in 

“complete agreement” and states that this is a position they have held for the past several 

years. The NAMES supports using the Statement of the Ordering Physician, but on a 6 

month basis; HIDA agrees with the 6 month timeframe. We believe a 3 month time 

requirement for review and renewal, as suggested by HIMA, is the best option, and have 

changed the recommendation accordingly. 

Both HCFA and ASPE raised questions about our cost savings estimate of $12 million. We 

have added a further explanation as to how we derived this estimate in the report’s 

methodology. The ASPE suggests we conduct a cost-benefit analysis for implementing our 

recommendation. While we acknowledge that certain costs would be incurred by 

implementing this recommendation, we believe that these costs are likely to be minimal, 

particularly since the Statement of the Ordering Physician is already kept on file by the 

supplier. 

The HCFA also states that it is unaware of any new support surface coding verification 

process by the SADMERC. During discussions with SADMERC staff, however, they 

indicated that they had improved their existing coding verification process to accommodate 

changes in support surface policies and new support surface codes and now sends out a sheet 

with guidelines for suppliers wanting written coding verification. As HCFA notes, this 

process is optional to suppliers requesting assistance. 

Finally, in response to HCFA’s other technical comments, we have made additional 

clarifications to the text in both the background and findings sections. The full text of all 

comments are included in Appendix D. 

14 
APPENDIX A 

SAMPLE SELECTION 

I. Defining the Universe 

We selected two samples of beneficiaries for this inspection, one from 1995 and the other 

from 1996. We also selected subsamples from each of the two samples. Using HCFA’s 

National Claims History (NCH) 5 percent sample file, we extracted all Medicare Part B line 

items meeting the following five criteria: 

1. Processed by DMERCs 

2. HCFA had received and posted the claims as of 

12/31/95 for the 1995 sample and 06/30/96 for the 1996 sample 

3. HCPCS code of E0180, E0193, E0194, E0277, or El399 for 

the 1995 sample and HCPCS code of EO180, E0193, E0194, E0277 for 

the 1996 sample. 

4. Allowed dollar amount greater than zero 

5. An ending date for line item services (TDT) between 

lo/O1195 and 12131195for the 1995 sample, 

and between 04/01/96 and 06/30/96 for the 1996 

sample. 

II. 1995 Sample Selection 

: 

The original universe consisted of 7,454 line items attributable to 4,178 beneficiaries. 

After removing the line items of 648 beneficiaries whom HCFA’s Enrollment Database 

(EDB) show to be deceased, and by selecting the most recent line item for each 

beneficiary, we were left with a final universe of 3,530 line items, each attributable to a 

unique beneficiary. 

We stratified the universe by ORT State and an “all other” category based on 

beneficiaries’ zip codes. We then randomly selected 50 beneficiaries from each of the six 

strata, for a total original sample size of 300. Our original subsample was then 

constructed by randomly selecting 25 beneficiaries from each stratum, for an initial 

subsample of 150. 

Once it became clear that only 20 of the 130 beneficiaries with HCPCS code El399 

claims had used support surface equipment, we dropped them from the original sample. 

This reduced the original sample size from 300 to a final sample size of 190 and the 

original subsample size from 150 to a final sample size of 92. 

A-l 
1995 SAMPLE 

Strata Universe Original Sample Final Sample 

1. (FL) I 285 50 33 

2. (NY) I 125 50 46 

3. (CA) I 441 50 15 

4. (IL) I 99 50 I 32 11 

5. (TX) I 272 50 31 

6. (Other States) I 2308 50 33 

TOTAL I 3530 

1995 SUBSAMPLE 

Strata Universe Oz2F / Final S;rample 

1. (FL) I 285 

2. (NY) 

3. (CA) 

4. (IL) 

5. (TX) 

6. (Other States) 

TOTAL 

III. 1996 Sample Selection 

125 25 23 

441 25 8 

99 25 12 

272 25 15 

2308 25 18 

3530 150 92 

The original universe consisted of 3,225 line items attributable to 1,701 beneficiaries. 

After removing the line items of 228 beneficiaries whom HCFA’s Enrollment Database 

(EDB) show to be deceased, and by selecting the most recent line item for each 

beneficiary, we were left with a final universe of 1,473 line items, each attributable to a 

unique beneficiary, 

We stratified the 1996 sample by HCPCS code, one stratum for E0277, one for E0180, 

A-2 
and one for both E0193 and E0194. We then randomly selected 290 cases from stratum 

1, 75 from stratum 2, and 55 from stratum 3, to form a sample of 420 beneficiaries. Our 

subsample was then constructed by randomly selecting 145 cases from stratum 1, 50 from 

stratum 2 and 55 from stratum 3, yielding a subsample of 250 beneficiaries. 

Strata 

1. (HCPCS E0277) 

2. (HCPCS E0180) 

3. (HCPCS E0193/E0194) 

TOTAL 

Strata 

1. (HCPCS E0277) 

2. (HCPCS E0180) 

-3. (HCPCS E0193/E0194) 

TOTAL 

1996 SAMPLE 

Universe Sample 

800 290 

618 75 

55 55 

1473 420 

1996 SUBSAMPLE 

Universe Subsample 

800 145 

618 50 

55 55 

1473 250 

A-3 
APPENDIX B 

CONFIDENCE INTERVALS FOR KEY QUESTIONS 

We calculated confidence intervals for 14 key questions (seven from the beneficiary mail 

questionnaire and seven from the medical record review). The response estimate and 95 

percent confidence interval are given for each of the following: 

From the mail auestionnaire 

1. Have you ever received medical equipment, such as a special bed, mattress or 

mattress overlay, for the care of pressure sores? 

1995 1996 

“Yes” response estimate: 96% 96% 

Lower interval: 90% 93% 

Upper interval: 100% 99% 

2. Was the support surface paid inappropriately (i.e., was the support surface never 

received, was the equipment upcoded, or were duplicate billings paid)? 

1995 1996 

“Yes” response estimate: 22% 12% 

Lower interval: 10% 8% 

Upper interval: 34% 16% 

3. Have you ever had a pressure sore? 

1995 1996 

“No” response estimate: N/A 13% 

Lower interval: N/A 8% 

Upper interval: N/A 18% 

4. Who taught you how to use your special bed, mattress or mattress overlay? 

1995 1996 

“The company that supplies the 

product” response estimate: 72% 77% 

Lower interval: 58% 71% 

Upper interval: 86% 84% 

5. Since using your special bed, mattress or mattress overlay, have your pressure 

sore(s) healed completely, improved, remained the same, or gotten worse? 

1995 1996 

“Healed completely” response estimate: 37% 38% 

Lower interval: 21% 31% 

Upper interval : 54% 45% 

B-l 
6. Who do you talk to when you have questions about using your special bed, 

mattress or mattress overlay? 

“Someone from the company that supplies 

the product” response estimate: 

Lower interval: 

Upper interval: 

7. Where do you live? 

“In a nursing home” response estimate: 

Lower interval: 

Upper interval: 

From the medical record review 

1995 

37% 

23% 

52% 

1995 

12% 

22% 

2% 

1995 

47% 

24% 

70% 

1995 

56% 

34% 

78% 

1996 

57% 

50% 

64% 

1996 

4% 

2% 

7% 

1996 

29% 

20% 

38% 

1996 

50% 

39% 

61% 

1996 

30% 

20% 

40% 

1996 

31% 

21% 

41% 

8. 

9. 

10. 

11. 

Was support surface medically indicated? 

“No” response estimate: 

Lower interval: 

Upper interval: 

Information source

; 

“Medical record” response estimate: 

Lower interval: 

Upper interval : 

Was there a written plan of care that addressed patient risk? 

1995 

“Yes” response estimate: 33% 

Lower interval: 12% 

Upper interval : 54% 

Did the plan of care address pressure ulcer treatment? 

1995 

“Yes” response estimate: 25% 

Lower interval: 5% 

Upper interval: 45% 

B-2 
12. Was preventative treatment initiated prior to ordering surface? 

1995 1996 

“Yes” response estimate: 38% 23% 

Lower interval: 16% 31% 

Upper interval : 54% 15% 

13. Was there documentation of education of the patient and caregiver on the 

prevention and/or management of pressure ulcers? 

1995 1996 

“Yes” response estimate: 37% 31% 

Lower interval: 15% 21% 

Upper interval: 59% 41% 

14. Was there documentation of regular assessment by a nurse, physician, or other 

licensed healthcare practitioner at least weekly? 

1995 1996 

“Yes” response estimate: 23% 33% 

Lower interval: 5% 23% 

Upper interval: 41% 43% 

B-3 
1 

2 

3 

4 

5 

6 

APPENDIX C 

NON-RESPONDENT ANALYSES 

When surveys are used to collect data, the results may be biased if non-respondents differ 

from respondents. For this inspection, a beneficiary for whom a survey was not received 

is a non-respondent. 

1995 Samrde 

For the 1995 beneficiary sample, due to the relatively small sample size and resulting 

small cell sizes in the two-variable tables, we were only able to analyze one variable. 

To test for the presence of any non-response bias in the 1995 survey data, we obtained 

information from HCFA’s National Claims History 5 percent file for all 190 beneficiaries 

who were sent a questionnaire. A total of 136 surveys were returned, for a response rate 

of 72 percent. The following table illustrates the number of responses and the response 

rate by strata: 

STRATA NUMBER 

(FL) 33 

WY) 46 

(CA) 15 

(IL) ; 32 

(TX) 31 

(U.S.) 33 

Total Respondents 190 

RESPONSE RATE 

73 

61 

67 

75 

84 

73 

72 

The survey data are analyzed as a whole and not by strata. However, we did exceed the 

desired minimum 60 percent response rate for each stratum. 

For the 190 individuals in our sample, we looked at their sex. This categorical variable 

was tested using the Chi-Square with the appropriate degrees of freedom. The results are 

presented in Table A. 

C-l 
TABLE A 

SEX 

Respondents Non-respondents Total Response 

Rate 

Male 41 30% 15 28% 56 73% 

Female 95 70% 39 72% 134 71% 

Total 136 54 190 72% 

CHI-SQ = .104 

Degree of Freedom = 1 

1996 SamDle 

To test for the presence of any non-response bias in the 1996 survey data, we obtained 

information from HCFA’s National Claims History 5 percent file for all 420 beneficiaries 

who were sent a questionnaire. A total of 287 surveys were returned, for a response rate 

of 68 percent. The following 

rate by strata: 

STRATA 

1 (H&S E0277) 

2 (HCPCS EO180) 

3 (HCPCS E0193/E0194) 

Total Respondents 

The survey data are analyzed 

table illustrates the number of responses and the response 

NUMBER RESPONSE RATE 

196 68 

54 72 

37 67 

287 68 

as a whole and not by strata. However, we did exceed the 

desired minimum 60 percent response rate for each strata. 

To test for the presence of any non-respondent bias, we analyzed the variables that might 

influence whether an individual would respond to the survey or that might affect his or her 

responses. For the 420 individuals in our sample, we looked at their sex, support surface 

used, and place of service. These categorical variables were tested using the Chi-square 

with the appropriate degrees of freedom. 

The results of this analysis are presented in tables A, B and C. The Chi-square values 

given in the tables provide a test of the difference between the distribution of the 

respondents and that of the non-respondents for the variable of interest. Also provided in 

the tables are the response rates by the different values of the variables. 

c-2 
These tables show no statistically significant difference between respondents and nonrespondents for any of the variables tested. Given the results of this analysis, we believe 

that the original results fairly represent the opinions of the sample of beneficiaries to 

whom the questionnaires were sent. We therefore believe that our survey results can be 

generalized to the universe of Medicare beneficiaries who had a support surface claim 

paid during the second 3 months of 1996. 

TABLE A 

SEX 

Respondents Non-respondents 

Male 105 37% 46 35% 

Female 182 63% 87 65% 

Total 287 133 

CHI-SQ = .158 

Degree of Freedom = 1 

TABLE B 

SUPPORT SURFACE BILLED 

Respondents Non-respondents 

Alternate 196 68% 94 71% 

pressure 

mattress 

mO277) 

Other sample 91 32% 39 29% 

equipment 

(EO180, 

E0193, 

E0194) 

Total 287 133 

CHI-SQ = .242 

Degree of Freedom = 1 

Total Response 

Rate 

151 70% 

269 68% 

420 68% 

Total Response 

Rate 

290 68% 

130 70% 

420 68% 

c-3 
TABLE C 

PLACE OF SERVICE 

II I Respondents 1 Non-respondents 1 Total 1 Response 

Rate 

Home 273 95% 128 96% 401 68% 

Not Home 14 4% 5 5% 19 73% 

Total 287 133 420 68% 

CHI-SQ = .263 II Degrees of Freedom = 1 II

c-4 
APPENDIX D 

In this appendix, we present in full the comments from the Health Care Financing 

Administration and the Assistant Secretary for Planning and Evaluation. 

D-l 
DEPARTMENT OF HEALTH & HUMAN SERVICES Health Care Financing Administration 

_ 

DATE: 

TO: 

FROM: 

SUBJECT: 

The Administrator 

Washington, D.C. 20201 

MAY I 6 1997 

June Gibbs Brown 

InsDector General I 

Bruce C. Vladeck’ 

Administrator 

Office of Inspector General (OIG) Draft Report: “Pressure Reducing 

Support Surfaces,” (OEI-02-95-00370) 

We reviewed the above-referenced report that describes the extent of inappropriate 

Medicare payments for pressure reducing support surfaces and assesses the effect of new 

1996 durable medical equipment regional carrier medical policies and coverage 

guidelines. 

Our detailed comments on the report’s recommendation are attached for your 

consideration. Thank you for the opportunity to review and comment on this report. 

Attachment -
Comments of the Health Care Financing. Administration (HCFA) 

on Office of Insuector General (OIG) Draft Reoort: 

“Pressure Reducing Sunport Surfaces.” 

/OEI-02-95-00370) 

OIG Recommendation 

HCFA should re-establish the requirement for periodic review and renewal of the medical 

necessity for beneficiaries’ use of group 2 support surface equipment. 

HCFA Resnonse 

We do not concur. Additionally, we do not believe such a requirement would save as much as 

$12 million annually. We believe use of the ZX modifier will continue to decrease the 

inappropriate utilization of support surfaces. As noted in the report, the new 1996 durable 

medical equipment regional carrier (DMERC) guidelines have had significant impact on 

controlling medically-unnecessary Medicare reimbursement for support surfaces. The downward 

trends in inappropriate payment for this equipment appear to be continuing. 

In order to perform the type of recertification suggested by OIG, the DMERCs would need to 

utilize a certificate of medical necessity (CMN). However, at this time there is no applicable or 

appropriate CMN for the DMERCs to use for support surface equipment other than the CMN for 

air-fluidized beds. CMN changes must be made via the national standard format system. These 

changes are iostly and can only be made once a year. The earliest we could institute this 

requirement would be July 1998. 

In lieu of using a CMN, the DMERCs require suppliers to use a HCFA common procedure 

coding system ZX modifier for support surface equipment. The ZX modiier indicates the 

supplier has documentation that medical policy requirements have been met and evidence is 

available in the supplier’s records. The documentation section of the support surface policy 

requires that an order for a mattress or bed be signed and dated by the ordering physician and 

kept on file by the supplier. This statement must be supported by information in the patient’s 

medical record which would be available to the DMERC on request. Suppliers are instructed to 

add the ZX metier to the code for the equipment only ifall of the specified medical necessity 

and documentation requirements are met. The use of this modifier will allow the DMERCs to 

monitor and analyze utilization of the modifier for support surface equipment. Consequently, data 

analysis can be performed consistent with the focused-medical review approach and actions can be 

taken to correct inappropriate billing practices. The policy also states that once the ulcer has 

healed, the ZX modifier should not be used. If the requirements for use of the modifier are not 

met, the supplier can submit additional information with the claim to just@ coverage, but the ZX 

modifier should not be used. If a supplier uses the ZX modifier despite the applicable 

requirements not being met, the supplier is submitting fraudulent claims to the Medicare program. 
Page 2 

At this time, we have no way to control whether or not suppliers submit accurate and truthful 

medical necessity information regardless of the mechanism used to collect the information. This 

type of fraudulent behavior may only be discovered through a post-payment review of claims. 

Therefore, the DMERCs are continuing to require that suppliers substantiate the medical necessity 

of equipment, but have chosen to do so through the use of the ZX modiier instead of a CMN. 

The use of the ZX modifier has significantly decreased inappropriate utilization of support surface 

equipment. However, it should be noted that neither the ZX modifier nor a CMN will solve many 

of the abuses identified in the OIG report. For example, neither mechanism will be able to 

discover whether beneficiaries are improperly or inappropriately using their equipment; i.e., 

beneficiaries never plugging in their equipment. In addition, neither mechanism will be able to 

determine whether or not the supplier delivered the same equipment that was billed to Medicare 

or whether the equipment was delivered at all. 

Technical Comments 

We believe there is incorrect information in the Background section of the report, sub-heading 

“Medicare Coverage of Support Surfaces.” The first paragraph, last two sentences state: “The 

new guidelines also no longer require monthly recertification for support surface equipment, with 

the exception of air-fluidized beds. Additionally, the Statistical Analysis DMERC (SADMERC) 

initiated a new process of coding verification for support surface equipment.” These statements 

are incorrect. Monthly recertification has never been required for all support surface equipment. 

Air-fluid&d beds are the only items that were ever subject to recertification requirements. This 

requirement continues. Additionally, we are unaware of any new coding verification process that 

has been developed by the SADMERC. The SADMERC coding verification process is an 

optional process whereby a supplier may get assistance in identifying the appropriate code for 

billing. The SADMERC has always been responsible for responding to inquiries from suppliers 

regarding the appropriate codes to use when billing Medicare. Suppliers are not required to 

contact the SADMERC for coding guidance for support surface products. 

One of the findings states that “13 beneficiaries used a group 2 support surface that was medically 

unnecessary before first trying a group 1 support surface as required.” It should be noted the 

policy allows for a group 2 support surface to be covered under certain circumstances without 

first trying a group 1 surface; e.g., if the patient has large or multiple stage III or IV pressure 

ulcers on the trunk or pelvis or if the patient had myocutaneous flap or skin graft surgery within 

the past 60 days for a pressure ulcer on the trunk or pelvis. 

Another finding states the DMERCs continued to pay the rental of support surface equipment for 

63 percent of beneficiaries with healed ulcers despite the policy not allowing “continued coverage 

of support surfaces once the patient’s pressure sore has healed completely.” It is not clear 

whether this statement means that coverage of just the group 2 product would be 
Page 3 

discontinued, or ifall support surface equipment would not be covered once the ulcer healed. 

Therefore, it should be noted that if a patient qualified for a group 2 support surface, and the 

pressure ulcer healed, the DMERCs would cover a Group 1 support surface to prevent the 

recurrence of the pressure ulcer. 

The study also found that “physicians appear to be playing a limited role in their patients’ use of 

support surfaces” and that “nine out of ten beneficiaries have no documentation of a 

comprehensive pressure sore treatment program.” Although this may be true, the DMJZRC policy 

requires that patients have a comprehensive care plan established by the patient’s physician or 

home care nurse, and documented in the patient’s medical records. In addition, the policy also 

requires the supplier obtain a signed and dated statement from the physician attesting to the 

medical necessity of the equipment. Questions pertaining to medical necessity on any form used 

to collect this’information may not be completed by the supplier or anyone in a financial 

relationship with the supplier. Therefore, we believe the policy goes as far as it can in requiring 

an active role on the part of the patient’s physician. 
DEPARTMENT OF HEALTH & HUMAN SERVICES Office of the Secretary 

Washington, D.C. 20201 

TO: June Gibbs Brown 

Inspector General 

FROM: David F. Garrison dPrincipal Deputy Assistant Secretary 

for Planning and Evaluation 

02-+5= a0370 

SUBJECT: OIG Draft Report: “Pressure Reducing Support Surfaces,” m 

CONCUR WITH COMMENT 

The Medicare DME benefit includes coverage of three different types of pressure reducing 

surfaces -- categorized as group 1, group 2, and group 3. These surfaces (e.g., beds, mattresses, 

and related equipment) are considered durable medical equipment and they are used to reduce 

decubitus ulcers. Groups 1 and 2 surfaces must be ordered by a physician and the order must be 

kept on file by the supplier. For group 3 surfaces there is an additional requirement for a 

certificate of medical necessity, which must be updated monthly. The OIG inspection described 

in the report found frequent use of more expensive group 2 equipment without prior trial of 

simpler group 1 devices. 

The OIG recommends that HCFA periodically review the medical necessity of group 2 support 

surfaces for beneficiaries who use these surfaces and indicates that such a review process will 

produce $12 million in annual savings. However, it was unclear how this amount of savings was 

determined. The OIG study points out that, in 1996, had & medically unnecessary claims not 

been paid, $12 million would have been saved. Given that the scope of the OIG’s 

recommendation seems to address only a subset of these medically unnecessary claims, it was 

unclear how a subset of those claims could also produce $12 million in savings. We recommend 

the report clarify how it arrived at the $12 million in savings. 

In addition, the OIG report does not indicate the costs of implementing a requirement to conduct 

periodic reviews and the extent to which any savings would be reduced by these costs. Such an 

estimate should be fairly straightforward since monthly recertifications were previously 

conducted. We recommend the report estimate the administrative costs of conducting the 

recommended reviews and recertifications, and emphasize how much the estimated savings 

would be offset by these added costs. J 

L zzz 

iti: z 

DIG-AS ,y 

E-E I& 

D&I 

DIG-MP = 
HEALTH INDUSTRY MANUFACTURERS ASSOCIATION 

May 1, 1997 

The Honorable June Gibbs Brown 

Inspector General 

Department of Health and Human Services 

330 Independence Avenue, S.W. 

Room 5246 

Washington D.C. 20201 

Dear Inspector General Brown: 

DIGAS 

ZiE V 

DIG-01 

!EE 

O&O 

Extcscc 

DateSen 

The Health Industry Manufacturers Association (HIMA) is pleased to be asked by your office to 

respond to the draft report titled “ Pressure Reducing Support Surfaces.” The Health Industry 

Manufacturers Association (HIMA) is a Washington, D.C.-based.trade association and the 

largest medical technology association in the world. HIMA represents more than 700 

manufacturers of medical devices, diagnostic products, and medical information systems. 

HIMA’s members manufacture nearly 90 percent of the $55 biion of health care technology 

products purchased annually in the United States, and more than 50 percent of the $130 billion 

purchased annually around the world. 

*First of all, we appreciate that you addressed our concerns when we suggested in our February 

21,1996 letter to Penny Thompson, Chief, Health Care Branch, that the time period during 

which you would be collecting the data be changed to take into consideration proper 

implementation of the support surfaces medical coverage policy. We believe that your data has 

more validity coming from the second quarter of 1996, rather than retrieving it from the first 

quarter as you originally intended to do. 

HIMA is in complete agreement with your recommendation that HCFA re-establish the 

requirement for periodic review and renewal of the medical necessity for beneficiaries’ use of 

group 2 support surfaces. In fact, this is a position that we have held throughout the development 

and implementation of the Durable Medical Equipment Regional Carrier (DMERC) medical 

policy for support surfaces. We would suggest, however, as we did in our October 25, 1995 letter 

to the DMERC medical directors concerning the support surface policy, that review and renewal 

of medical necessity documentation should occur every three months. 

We would recommend that the current medical necessity document (i.e., the “Statement of the 

Ordering Physician”) and procedures be utilized to initially establish the medical necessity and 

to renew. Utilizing this document and procedure would achieve the goals outlined in the OIG 

report, while not making the claims fling and processing tasks more cumbersome. Based on the 

current DMERC support surface medical coverage policy, the Statement of the Ordering 

Physician is required before set-up. It is not filed with the claim; but rather it is maintained inthe 

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Inspector General Brown 

May 1, 1997 

Page 2 

patient’s chart and provided upon request. In this way, electronic claims filing is available if 

requested or as part of a post payment audit. This procedure and documentation appears to be 

working well in initially establishing medical necessity. We believe that it should be fairly easy 

for the DMERC medical directors to add similar language to the current policy to require it for 

renewal. 

In addition, to reinforce the results of your study, we believe that the “cascading” coverage 

criteria from overlay to mattress replacement should be reinstated. Again in our comments to the 

DMERC medical directors, we noted that in the September 1995 support surfaces medical 

coverage policy, the coverage criteria for all group 2 products is the same. However, in the 

August 1994 proposed policy and in the recommendations of the interested associations, a 

coverage criteria cascade existed from overlay, to mattress replacement, to bed system. The 

cascade approach allowed for a much clearer selection process based not only on therapeutic 

wound care benefit, but on the physical needs of the beneficiary; and on their other clinical 

indicators, (i.e. need for frequent adjustment, weight factors, etc.) 

HIMA’s recommendation was (and still is) that, for the most part, industry agreed with the 

“cascading” coverage criterion that was included in the August 1994 proposed policy. This 

included “bottoming out” as an additional criterion to move from a group 2 overlay to a group 2 

mattress replacement. Industry agreed to these parameters. Also, such standards would result in a 

selection process which is more customized to the patient. Based on this, we believe that it 

would be advantageous for the DMERC medical directors to reinstate the “cascading” coverage 

criteria from overlay to mattress replacement in group 2. 

Finally, we would like to compliment the staff that were involved in the creation and 

implementation of this draft report. We have worked closely with your staff in the past and have 

developed an excellent working relationship. We were delighted to have the opportunity to work 

with and serve as an educational resource to Demetra Arapakos and her stti concerning support 

surfaces during the course of the study and at the Medtrade exposition in Atlanta. 

Again as always, we appreciate the opportunity to comment on the draft report. 

Sincerely, 

Marcia Nusgar& Ph. 

Associate Vice President, Home Care 
HEALTH INDUSTRY DISTRIBUTORS ASSOCIATION 

Serving Medical Products Distributors & Home Care Companies Since 7902 

April 29, 1997 

June Gibbs Brown 

Inspector General 

Office of the Inspector General 

Department of Health and Human Services 

Washington, DC 20201 

RE: Comments on Draft Inspection Report on Pressure Reducing Support Surfaces 

(pa- uz- czsdm37c, 

Dear Ms. Brown 

Thank you for providing HIDA with a copy of the draft inspection report entitled “Pressure 

Reducing Support Surfaces.” HIDA is the national trade association of home care companies and 

health and medical product distribution firms. Created in 1902, I-IIDA now represents 

approximately 800 home care companies and wholesale and retail medical product distributors 

with over 2,000 locations. 

Subsequent to reviewing the draft report, HIDA recommends that the OIG modify the 

recommendation that HCFA require periodic recertification of medical necessity for support 

surface equipment on a monthly or bi-monthly basis. Given that the internal part of a wound often 

needs greater than three months to properly heal, HIDA believes any requirement of recertification 

in less than a three month interval is intrusive, and not in the clinical interests of the Medicare 

beneficiaries. HIDA maintains that six month intervals are a far more reasonable time fi-ame, and 

should be incorporated in the final version of the report. 

Please feel free to contact myself or Mark Hobratschk at (703)-549-4432 with any question or for 

additional information 

Sincerely, 

Cam C. Bachenheimer 

Executive Director 

Home Care and Long Term Care 

cc: Mark Hobratschk 

S. Wayne Kay DIG-AS -

CCB:mh DIG-01 -

66 Canal Center Plaza, Suite 520, Alexandria. VA 223 14- 159 7 �  703-549-4432 . FAX 703-549-6495 
NAMES 

National Association for 

Medical Equipment Services 

May 2,1997 Via Hand Delivery 

The Honorable June Gibbs Brown 

Inspector General 

Department of Health and Human Services 

Room 5246 Cohen Building 

330 Independence Avenue, S. W. 

Washington, D. C. 20201 

Re: Comments on Draft Renort: Pressure Reducing Sunnort Surfaces 

&+ag- 9s- 00390 

Dear Inspector General Brown: 

The National Association for Medical Equipment Services (NAMES) submits the following 

comments on the Office of Inspector General’s (OIG) draft report, Pressure Reducing Support 

Surfaces. The draft report, which NAMES received on April 18,1997, requested comments 

within fourteen (14) days. 

NAMES is a nonprofit trade association comprised of over 1400 home medical equipment 

(HME) services providers in approximately 4,000 sites across the country. NAMES members 

furnish a wide variety of equipment, supplies, and services for home use. These items may range 

from traditional medical equipment such as walkers, oxygen and hospital beds, to highly 

sophisticated items and services such as enteral and parenteral supplies for complete nutrition 

support for individuals who can not digest food normally; apnea monitors, which allow parents 

to closely monitor high risk infants’ breathing; and specialized wheelchairs and other 

technologically advanced equipment which are custom designed for the needs of rehabilitation 

patients. A substantial portion of HME patients are Medicare beneficiaries or Medicaid 

recipients. 

NAMES has had a sustained commitment to helping eliminate fraud and abuse in the home 

625 Slaters Lane. Suite 200 � Alexandria, VA 22314-1171 �  (703) 836-6263 FAX (703) 836-6730 
medical equipment (HME) services industry. For example, the NAMES initiative, Operation 

Build Trust (OBT), was created in response to requests from state Medicaid programs for 

information about the HME services industry. OBT now serves as a vehicle through which 

NAMES works with the Medicare and Medicaid programs to identify sources of fraud and abuse 

within the HME services industry. NAMES also supports anti-fraud and abuse measures 

proposed by HCFA, such as bonding, and it is advancing a legislative plan that includes 

accreditation and on site inspections of HME services providers. 

NAMES is pleased to have the opportunity to comment on the OIG’s draft report. NAMES 

likewise is pleased to note the favorable trends that the OIG cites in the report, including the 

following: 

. medically unnecessary use of pressure reducing support 

surfaces has declined; 

. fewer beneficiaries report receiving up coded or no 

equipment; 

. fewer beneficiaries report problems with duplicate billings; 

. almost all beneficiaries report receiving training in the 

proper use of the equipment from their HME services 

provider; and 

; . patient outcomes are favorable when the support surface is 

used properly. 

Your report also notes that Medicare reimbursement for alternating pressure mattresses has been 

declining since the beginning of 1996. These outcomes, as you point out, demonstrate the 

effectiveness of the new guidelines that the DMERCs implemented in 1996. In light of these 

positive trends, NAMES has serious concerns about reestablishing monthly or bi-monthly 

certification of the medical necessity for group 2 support surfaces. 

As you clearly state in your report, this requirement would be burdensome on the DMERCs and 

HME services providers. It is our experience that physicians would find this requirement 

burdensome as well. Wound care patients typically are bedridden and have a severely 

compromised health status. The healing process may be lengthy and will depend on a number of 

variables in addition to the use of a support surface, including the patient’s nutrition, oxidation, 

and drug therapy. Consequently, it would be unlikely to see much improvement in these patients’ 

condition on a monthly or bi-monthly recertification schedule. 

Documentation of continuing medical necessity could be accomplished in a less burdensome 

manner by requiring that the physician provide to the HME services provider an updated 

Statement of Ordering Physician - Group 2 Support Surfaces every six months. This information 

would not need to be submitted with a claim, but would be kept on file by the HME services 
provider. The DMERCs currently require that HME services providers maintain a Statement of 

Ordering Physician on file for beneficiaries who receive group 2 support surfaces. The 

requirement to update this form, combined with HCFA’s bonding initiative and NAMES 

legislative proposal to require accreditation and on site inspections, would reduce the problems 

with group 2 support surfaces cited in your report. 

Again, thank you for the opportunity to comment on the draft report. Please feel free to call me 

if you have any questions, or if NAMES can be of further assistance to you. 

Sincerely yours, 

Asela M. Cuervo, Esq. 

Director of Regulatory Affairs