Department of Health and Human Services

OFFICE OF

INSPECTOR GENERAL

 

CMS HAS NOT PROMULGATED 

REGULATIONS TO ESTABLISH 

PAYMENT REQUIREMENTS FOR 

PROSTHETICS AND 

CUSTOM-FABRICATED 

ORTHOTICS 

Daniel R. Levinson 

Inspector General

October 2012 

OEI-07-10-00410
EXECUTIVE SUMMARY: CMS HAS NOT PROMULGATED REGULATIONS 

TO ESTABLISH PAYMENT REQUIREMENTS FOR PROSTHETICS AND 

CUSTOM-FABRICATED ORTHOTICS 

OEI-07-10-00410

WHY WE DID THIS STUDY 

Section 427(a) of the Medicare, Medicaid, and SCHIP Benefits Improvement and 

Protection Act of 2000 (BIPA) prohibits Medicare payments for prosthetics and 

custom-fabricated orthotics unless the items are (1) furnished by a qualified practitioner 

and (2) fabricated by either a qualified practitioner or a qualified supplier. Section 427(b) 

of the BIPA required the Secretary to promulgate regulations to implement the

requirements at section 427(a) of the BIPA. As required by 42 CFR § 424.57(c)(12), 

Medicare suppliers must also maintain documentation supporting that prosthetics and 

custom-fabricated orthotics were delivered to beneficiaries. In 2010, the Centers for 

Medicare & Medicaid Services (CMS) allowed $276 million in Medicare payments for 

257,797 prosthetic and custom-fabricated orthotic claims (excluding accessories, 

additions, and other supplemental prosthetic and orthotic items).

HOW WE DID THIS STUDY

We selected a sample of 1,135 Medicare-allowed claims for prosthetics and 

custom-fabricated orthotics in 2010 to determine whether the claimed items were 

(1) furnished by qualified practitioners, (2) fabricated by either qualified practitioners or 

qualified suppliers, and (3) met delivery documentation requirements. We interviewed

CMS staff regarding the implementation status of the BIPA payment requirements. 

WHAT WE FOUND

To date, CMS has not promulgated regulations related to BIPA payment requirements for 

practitioner and supplier qualifications for prosthetics and custom-fabricated orthotics. 

CMS used other legal authorities that limit who can be paid for prosthetics and customfabricated orthotics; notwithstanding, in 2010, Medicare allowed nearly 1,000 claims

inappropriately. Despite the lack of regulations, most claims were allowed for prosthetics 

and custom-fabricated orthotics furnished and/or fabricated by practitioners and/or 

suppliers that were licensed, certified, or accredited. Finally, Medicare inappropriately

allowed 12 percent of claims for prosthetics and custom-fabricated orthotics that did not 

meet Federal requirements for delivery documentation.

WHAT WE RECOMMEND

We recommend that CMS (1) promulgate regulations to implement the BIPA payment 

requirements, (2) ensure that suppliers maintain delivery documentation that meets 

Federal requirements, and (3) take appropriate action to address inappropriately allowed

claims identified in the population related to payment edits and in our sample related to 

delivery documentation. CMS concurred with all three recommendations.
TABLE OF CONTENTS

Objectives ....................................................................................................1

Background..................................................................................................1

Methodology................................................................................................6

Findings......................................................................................................11

CMS has not promulgated regulations related to payment 

requirements for practitioner and supplier qualifications for 

prosthetics and custom-fabricated orthotics...................................11

CMS has used other legal authorities that limit who can be paid 

for prosthetics and custom-fabricated orthotics; notwithstanding, in

2010, Medicare allowed nearly 1,000 claims inappropriately. ......12

Despite the lack of regulations, most claims were allowed for 

prosthetics and custom-fabricated orthotics furnished and/or 

fabricated by practitioners and/or suppliers that were licensed, 

certified, or accredited ...................................................................12

Medicare inappropriately allowed 12 percent of claims for 

prosthetics and custom-fabricated orthotics that did not meet 

Federal requirements for delivery documentation .........................13

Conclusion and Recommendations............................................................16

Agency Comments and Office of Inspector General Response.....17

Appendixes ................................................................................................18

A: States That License Prosthetists and Orthotists.......................18

B: Specialty Codes Listed in Transmittal 656 ..............................19

C: Detailed Sampling Design and Response Rates.......................20

D: Specialty Codes for All “Other” Practitioners and 

Suppliers ........................................................................................21

E: Actions Taken That Limit Who Can Be Paid for Prosthetics and 

Custom-Fabricated Orthotics.........................................................22

F: Point Estimates, Sample Sizes, and Confidence Intervals........27

G: Agency Comments...................................................................29

Acknowledgments......................................................................................32
CMS Has Not Promulgated Regulations To Establish Payment Requirements (OEI-07-10-00410) 1

OBJECTIVES

To determine the extent to which:

1. the Centers for Medicare & Medicaid Services (CMS) has 

implemented the payment requirements found at Section 427(a) of the 

Medicare, Medicaid, and SCHIP Benefits Improvement and Protection 

Act of 2000 (BIPA); 

2. Medicare allowed claims for prosthetics and custom-fabricated 

orthotics furnished and/or fabricated by unqualified practitioners 

and/or suppliers; and

3. Medicare allowed claims for prosthetics and custom-fabricated 

orthotics that lacked delivery documentation that met Federal 

requirements.

BACKGROUND

Prosthetics and orthotics are covered under the Durable Medical 

Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Medicare 

benefit.1 In 2010, CMS allowed $276 million in Medicare payments for 

257,797 prosthetic and custom-fabricated orthotic claims (excluding 

accessories, additions, and other supplemental prosthetic and orthotic 

items). 2 Industry representatives have asserted that unqualified 

practitioners and suppliers are furnishing and/or fabricating Medicare-paid 

prosthetics and custom-fabricated orthotics. These representatives are

concerned that unqualified practitioners and suppliers, who lack necessary 

training and education, are providing substandard custom-fabricated items 

to Medicare beneficiaries.3 Additionally, a 2000 Office of Inspector 

General (OIG) report concluded that qualifications of orthotic suppliers 

varied, with noncertified suppliers being the ones most likely to provide 

inappropriate items and services.4 OIG has not specifically reviewed the 

qualifications of practitioners and suppliers of prosthetics and 

custom-fabricated orthotics previously.

1 To be payable by Medicare, prosthetics and orthotics must be reasonable and necessary 

for the diagnosis or treatment of an illness or injury or to improve the functioning of a 

malformed body member. Social Security Act (SSA) § 1862(a)(1)(A); 42 U.S.C. 

1395y(a)(1)(A). 2 Custom-fabricated items are individually fabricated over a positive model of the patient. 3 We conducted preinspection interviews with several industry representatives, who 

expressed their opinions that enforcement of Medicare qualifications is lax, and that 

many unqualified practitioners are fitting and fabricating prosthetics and 

custom-fabricated orthotics. 4 OIG, Medicare Payments for Orthotics: Inappropriate Payments, OEI-02-99-00120, 

March 2000.
 

CMS Has Not Promulgated Regulations To Establish Payment Requirements (OEI-07-10-00410) 2

Federal Statutory Payment Requirements

Section 427(a) of the BIPA, enacted on December 21, 2000, added special 

payment requirements for prosthetics and certain custom-fabricated 

orthotics at section 1834(h)(1)(F) of the SSA (the BIPA payment 

requirements).

5

 This section prohibits Medicare payments for prosthetics 

and custom-fabricated orthotics unless the items are (1) furnished by a 

qualified practitioner and (2) fabricated by a qualified practitioner or a 

qualified supplier at a facility that meets such criteria as the Secretary 

determines appropriate.

6

 Generally, Medicare qualifications are intended 

to protect beneficiaries, promote high-quality care, and safeguard 

Medicare funds by ensuring that only qualified individuals and health care 

organizations furnish Medicare items and services.7 Section 427(b) of the 

BIPA required the Secretary to promulgate regulations to implement 

Section 427(a) of the BIPA no later than December 21, 2001 (i.e., 1 year 

after the date of enactment), using a negotiated rulemaking process.8

Qualified practitioners. The BIPA payment requirements define a 

qualified practitioner as a physician or other individual who is: 

• a qualified physical or occupational therapist;9

• licensed in prosthetics or orthotics by the State in which the item is 

supplied;10 or 

• providing prosthetics or orthotics in a State that does not license 

practitioners of prosthetics and orthotics and is specifically trained and 

5 BIPA, H.R. 5601, 106thCong. § 427(a) (2000), adding SSA § 1834(h)(1)(F), 42 U.S.C. 

1395m(h)(1)(F). For purposes of this payment prohibition, “certain custom-fabricated 

orthotics” is defined to mean only those custom-fabricated orthotics that require 

education, training, and experience to custom fabricate and that are included in a list 

established by the Secretary of the Department of Health and Human Services (the 

Secretary) in consultation with appropriate experts in orthotics, including national 

organizations representing manufacturers of orthotics. SSA § 1834(h)(1)(F)(ii); 

42 U.S.C. 1395m(h)(1)(F)(ii). We refer to certain custom-fabricated orthotics simply as 

custom-fabricated orthotics. 6 SSA § 1834(h)(1)(F)(i); 42 U.S.C. 1395m(h)(1)(F)(i).

7 71 Fed. Reg. 20754 (Apr. 21, 2006). 8 CMS is the agency that would promulgate regulations to implement the BIPA payment 

requirements on the Secretary’s behalf.

9 Per 72 Fed. Reg. 66222, 66328 (Nov. 27, 2007), personnel qualifications in 42 CFR § 

484.4 are applicable to all outpatient physical and occupational therapy services. See 

also, CMS, Medicare Benefit Policy Manual, Pub. No. 100-02, ch. 15, §§ 230.1(B) and 

230.2(B) (defining qualified physical therapist and qualified occupational therapist, 

respectively).

10 If a practitioner (other than a physician, qualified physical therapist, or qualified 

occupational therapist) supplies the item in a State that provides for licensing of orthotics 

and prosthetics and the practitioner is not licensed by that State, under the BIPA payment 

requirement, the practitioner would not be a “qualified practitioner” and, therefore, would 

not be entitled to Medicare payment for the item. 
 

CMS Has Not Promulgated Regulations To Establish Payment Requirements (OEI-07-10-00410) 3

educated to provide or manage the provision of prosthetics and/or 

custom-fabricated orthotics, and is certified by the American Board for 

Certification in Orthotics, Prosthetics & Pedorthics (ABC) or the 

Board of Certification/Accreditation, International (BOC), or is 

credentialed and approved by a program that the Secretary determines 

(in consultation with appropriate experts in prosthetics and orthotics) 

has training and education standards that are necessary to provide such 

prosthetics and orthotics.11

See Appendix A for an overview of States that license prosthetists and 

orthotists. 

Qualified suppliers. The BIPA payment requirements define a qualified 

supplier as any entity that is: 

• accredited by ABC or BOC, or 

• accredited and approved by a program that the Secretary determines 

has accreditation and approval standards that are essentially equivalent 

to those of ABC or BOC.12

CMS Actions That Limit Medicare Payment for Prosthetics and 

Custom-Fabricated Orthotics

CMS has established payment edits and implemented Medicare supplier 

enrollment requirements that limit who can be paid for prosthetics and 

custom-fabricated orthotics.13 For example, CMS issued Transmittal 656 

to establish a payment edit based on an existing supplier standard.14 This 

transmittal explains that, in States that license prosthetists or orthotists, 

Medicare payments for prosthetics and custom-fabricated orthotics are 

prohibited unless the furnisher is licensed by the State.15 More 

specifically, in States that license prosthetists and orthotists, Transmittal 

11 SSA § 1834(h)(1)(F)(iii)(III). The Secretary has not issued guidance specifying which 

programs, if any, meet the latter requirement found at SSA § 1834(h)(1)(F)(iii)(III). 12 In December 2006, CMS issued a document entitled Medicare New Deemed 

Accreditation Organizations For Suppliers of Durable Medical Equipment, Prosthetics, 

Orthotics And Supplies (DMEPOS) that lists the accrediting organizations for durable 

medical equipment (DME) suppliers based on the quality standards. However, the 

Secretary has not issued guidance specifying which programs, if any, are essentially 

equivalent to those of ABC or BOC for the purposes of the BIPA payment requirements. 

See footnote 19.

13 Payment edits are safeguards built into claims processing computer systems designed 

to prevent payment for noncovered and/or not medically necessary services.

14 CMS, Medicare Claims Processing Manual, Pub. No. 100-04, Transmittal 656, 

Change Request 3959 (revising CMS, Medicare Claims Processing Manual, Pub. No. 

100-04, ch. 20, § 130.1). Accessed online at http://www.cms.gov on September 3, 2010. 15 Transmittal 656 is based on a CMS DMEPOS supplier standard, which requires that 

suppliers furnish all Medicare-covered items in compliance with all applicable Federal 

and State licensure and regulatory requirements. 42 CFR § 424.57(c)(1). See also 

SSA § 1834(j)(1)(B)(ii)(I).
 

CMS Has Not Promulgated Regulations To Establish Payment Requirements (OEI-07-10-00410) 4

656 directs suppliers to send a copy of their State licenses to the National 

Supplier Clearinghouse (NSC) to ensure that the correct specialty code is 

on file. The transmittal also directs that claims for prosthetics and 

custom-fabricated orthotics submitted by a supplier in one of those States 

be denied unless the claims contain one of the specialty codes listed in the 

transmittal.

16 See Appendix B for the specialty codes listed in 

Transmittal 656. Transmittal 656 also contains an attachment listing the 

Healthcare Common Procedure Coding System (HCPCS) codes for 

prosthetics and custom-fabricated orthotics affected by this payment edit.

CMS also implemented Medicare quality standards that require DMEPOS 

suppliers to be accredited to furnish certain items and services, including 

prosthetics and orthotics.17 Quality standards are applied by independent 

accreditation organizations designated by the Secretary.18 CMS has

deemed 10 organizations to be accrediting organizations, 9 of which 

(including ABC and BOC) are approved to accredit suppliers of 

prosthetics and custom-fabricated orthotics.19 Some suppliers, such as 

physicians, physical therapists, occupational therapists, prosthetists, and 

orthotists, are exempt from accreditation requirements.

20

16 Specialty codes indicate the specialty of the practitioner or supplier furnishing the item. 

For States that have licensure requirements, Transmittal 656 limits payment for 

prosthetics and custom-fabricated orthotics to items furnished by physicians, physical 

therapists, occupational therapists, prosthetic personnel, orthotics personnel, pedorthists, 

or medical supply companies with orthotics and/or prosthetics personnel as indicated by 

their specialty codes; these codes are listed in Transmittal 656. 

17 SSA § 1834(a)(20)(A) (paragraph 1834(a)(20) was added by Section 302(a) of the 

Medicare Prescription Drug, Improvement, and Modernization Act of 2003, 

P.L. 108-173). SSA § 1834(a)(20)(F)(i) (subparagraph 1834(a)(20)(F), directing 

suppliers to submit evidence of accreditation by October 1, 2009, was added by 

Section 154(b) of the Medicare Improvements for Patients and Providers Act of 2008, 

P.L. 110-275).

18 SSA § 1834(a)(20)(A) and (B).

19 Because the legal basis for these accreditation requirements is the DMEPOS quality 

standards, the accreditation requirements apply to a wide range of DMEPOS items, not 

just prosthetics and custom-fabricated orthotics. Notwithstanding, the accreditation 

requirements included in the DMEPOS quality standards overlap with the BIPA payment 

requirements regarding qualified suppliers. See SSA § 1834(a)(20)(F)(i) regarding the 

Medicare quality standards accreditation requirement. See also SSA § 1834(h)(1)(F)(iv) 

on the subject of the BIPA payment requirement regarding qualified suppliers. 20 SSA § 1834(a)(20)(F)(ii). CMS, One-Time Notification, Pub. No. 100-20, Transmittal 

710, Change Request 6566, dated May 21, 2010. See also Attachment A of Transmittal 

710 for a full list of exempt suppliers.
 

CMS Has Not Promulgated Regulations To Establish Payment Requirements (OEI-07-10-00410) 5

All suppliers are responsible for the delivery of Medicare-covered items to 

beneficiaries and are required to maintain proof of delivery for 7 years.21, 22 

CMS guidance outlines documentation requirements for different methods 

of delivery. Examples of delivery documentation include a delivery slip 

signed by the beneficiary or beneficiary’s designee or, if the supplier uses 

a shipping service, the service’s tracking slip and the supplier’s shipping 

invoice.23

Previous OIG Work

A 2000 OIG study found that miscoded orthotics resulted in $33 million in 

excessive Medicare payments in 1998.24 That study concluded that 

qualifications of orthotic suppliers varied, with noncertified suppliers 

being most likely to provide inappropriate devices and services. The study 

also found that Medicare payments occurred even when the orthotics did 

not meet the specifications billed, the orthotics were not custom 

fabricated, or the parts billed were included in the base code for a larger 

orthotic. 

A 2011 OIG study examining questionable billings found that, in 2009, 

Medicare inappropriately paid $43 million for lower limb prostheses that 

did not meet local coverage determination requirements and that payments 

for these items could have been prevented by using claims-processing 

edits.25 Further, Medicare paid an additional $61 million for lower limb 

prostheses for beneficiaries who had not received an office visit or any 

other services from their referring physicians in the last 5 years. The study 

also found that 267 suppliers providing lower limb prostheses had engaged 

in questionable billing practices. The study concluded that Medicare 

contractors’ efforts to safeguard payments for lower limb prostheses 

varied.

21 See 42 CFR § 424.57(a), stating that a DMEPOS supplier is an entity or individual, 

including a physician or a Part A provider, which sells or rents Part B-covered items to 

Medicare beneficiaries and meets the supplier standards outlined in 42 CFR § 424.57(c). 

The individual practitioners who received payments for the claims in our sample were 

also enrolled DMEPOS suppliers. Therefore, they must meet the supplier standards. 

Because the individual practitioners were also enrolled DMEPOS suppliers, we use the 

term “suppliers” only when discussing our findings regarding delivery documentation. 22 CMS, Medicare Program Integrity Manual, Pub. No. 100-08, ch. 4, § 4.26. See also, 

42 CFR § 424.57(c)(12). 23 Ibid., ch. 4, § 4.26.1.

24 OIG, Medicare Payments for Orthotics: Inappropriate Payments, OEI-02-99-00120, 

March 2000.

25 OIG, Questionable Billing by Suppliers of Lower Limb Prostheses, OEI-02-10-00170, 

August 2011.
 

CMS Has Not Promulgated Regulations To Establish Payment Requirements (OEI-07-10-00410) 6

METHODOLOGY

We evaluated Medicare-allowed claims for prosthetics and 

custom-fabricated orthotics in 2010 to determine whether the claimed 

items were (1) furnished by qualified practitioners and (2) fabricated by 

either qualified practitioners or qualified suppliers. We conducted 

structured interviews with CMS staff regarding the status of the 

implementation of the BIPA payment requirements. For a sample of 

1,135 claims, we collected and reviewed documentation relating to (1) the 

qualifications of the practitioners and suppliers that furnished and/or 

fabricated the claimed items and (2) the delivery of the items. All 

estimates in this report are projected to the specified population or 

subpopulation of allowed claims excluding accessories, additions, and 

other supplemental prosthetic and orthotic items (e.g., straps and joints 

added to a prosthetic limb). 

Scope

We determined whether practitioners and suppliers were qualified to 

furnish and fabricate prosthetics and custom-fabricated orthotics using the 

definitions in Section 427(a) of the BIPA, together with the requirements 

in Transmittal 656 and the applicable quality standards. We analyzed

documentation submitted by the practitioners and suppliers that were paid 

for the sampled claims. We did not determine the medical necessity of the 

claimed items. 

Population

Our population included 257,797 Medicare-allowed claims in 2010, 

amounting to $276 million, for prosthetics and custom-fabricated 

orthotics. The population excluded accessories, additions, and other 

supplemental prosthetic and orthotic items. We obtained data from the 

2010 DME Standard Analytical File from the National Claims History 

File. From the Standard Analytical File, we constructed a population of all 

allowed claims for prosthetics and custom-fabricated orthotics. CMS 

provided a list of HCPCS codes for prosthetics and custom-fabricated 

orthotics. 

Sample Selection

We selected a stratified random sample totaling 1,135 claims. The sample 

had 12 strata based on specialty code and allowed dollar amounts. See 

Table 1 for a summarized sampling design; Appendix C provides a table 

showing all 12 strata and details regarding the sample and population. We 

designed the sample to produce estimates based on practitioner or supplier 

specialty codes and allowed dollar amounts. As our data analysis 

progressed, it became clear that the number of unqualified practitioners 

and suppliers was too small for us to make reliable estimates based on 
 

CMS Has Not Promulgated Regulations To Establish Payment Requirements (OEI-07-10-00410) 7

specialty codes and allowed dollar amounts as we had planned. Instead, 

we produced overall estimates of the number and amount of payments to 

unqualified practitioners and suppliers as defined in the BIPA payment 

requirements. 

Table 1: Population and Sample Data for Medicare-Allowed Claims for Prosthetics 

and Custom-Fabricated Orthotics by Practitioner and Supplier Specialty, 2010

Specialty Allowed 

Dollars Allowed Claims Sample Size

Prosthetics: Medical Supply Companies $45,607,574 28,465 165

Prosthetics: Individual Practitioners $118,473,931 69,997 335

Prosthetics: All Other Practitioners and Suppliers* $11,309,824 10,023 115

 Total Prosthetics: $175,391,329 108,485 615

Orthotics: Medical Supply Companies $24,950,710 29,663 145

Orthotics: Individual Practitioners $46,099,212 57,572 220

Orthotics: All Other Practitioners and Suppliers* $30,031,273 62,077 155

 Total Orthotics: $101,081,195 149,312 520

 Overall Total: $276,472,524 257,797 1,135

Source: OIG analysis of Medicare-allowed claims for prosthetics and custom-fabricated orthotics, 2010.

*Transmittal 656 sets up these general groups of specialty codes, listing medical supply companies, prosthetic and orthotic

personnel, physical and occupational therapists, and all other providers with specialty codes listed in Chapter 26 of the 

Medicare Claims Processing Manual. The “All Other Practitioners and Suppliers” category includes physical and 

occupational therapists and all other providers with specialty codes listed in Chapter 26 of the Medicare Claims Processing 

Manual. See Appendix D for a description of specialty codes for all “other” practitioners and suppliers.

We did not send requests for documentation to the practitioners and 

suppliers for eight sampled claims because they were associated with 

ongoing OIG investigations. As a result, we sent requests for 1,127 claims 

to practitioners and suppliers. 

Data Collection

For each sampled claim, we sent a letter requesting documentation to 

support the certification, licensure, or accreditation of the practitioner that

furnished and the practitioner or supplier that fabricated the prosthetic or 

custom-fabricated orthotic item. We also requested documentation to 

support delivery of the item. We sent a second letter to practitioners or 

suppliers that did not respond to our initial documentation request. We 

attempted to contact practitioners or suppliers that did not respond to our 

second request by telephone to verify that they were in business and that 

we had the correct mailing address. In a last attempt to contact the 

nonresponsive practitioners or suppliers, we sent a final certified letter 

through the U.S. Postal Service. 
 

CMS Has Not Promulgated Regulations To Establish Payment Requirements (OEI-07-10-00410) 8

We received responses for 1,116 of the 1,127 claims for which we 

requested documentation, a response rate of 98 percent.26 Of the 

11 sampled claims for which we did not receive documentation, 8 were 

from practitioners or suppliers that received but did not respond to our 

request for documentation, 2 were from suppliers that did not respond to 

our request and whose operational status could not be confirmed, and 

1 was from a supplier that was no longer in business.27 

Data Analysis

We determined whether the claimed prosthetic and custom-fabricated 

orthotic items were (1) furnished by qualified practitioners and 

(2) fabricated by either qualified practitioners or qualified suppliers. 

Although CMS may make different determinations when promulgating 

regulations to implement the BIPA payment requirements, for the purposes 

of this evaluation, we made certain broad assumptions regarding parts of 

the BIPA that are not yet defined. We assumed that the nine organizations 

currently approved to accredit suppliers of prosthetics and customfabricated orthotics will be approved once the BIPA payment requirements 

are implemented. We did not make any assumptions about the criteria the 

Secretary will determine to be appropriate for facilities at which 

prosthetics and custom-fabricated orthotics are fabricated.

Determination of Whether Practitioners and Suppliers Were Qualified. In 

the 38 States that do not license prosthetists and orthotists, we considered 

items to have been furnished or fabricated by unqualified practitioners or 

suppliers if:

• the furnisher (1) was not a physical or occupational therapist or a 

physician, or (2) did not have ABC or BOC certification on the date of 

the claim;28 or 

• the fabricator was not (1) a physical or occupational therapist or a 

physician, or (2) a practitioner that had ABC or BOC certification on 

26 We selected a sample of 1,135 claims but sent requests for documentation for only 

1,127 of those claims, as explained above. To calculate the response rate, we divided the 

1,116 responses received by the total sample size of 1,135. 27 We referred these 11 nonresponding practitioners and suppliers to CMS for appropriate 

action.

28 BIPA, H.R. 5601, 106thCong. § 427(a) (2000), adding SSA § 1834(h)(1)(F), 42 

U.S.C. 1395m(h)(1)(F). Under the BIPA payment requirements, a qualified practitioner 

would also include an individual credentialed and approved by another program 

designated by the Secretary. Therefore, if this provision is implemented, there may be 

other programs that can credential and approve individuals to become qualified 

practitioners.
 

CMS Has Not Promulgated Regulations To Establish Payment Requirements (OEI-07-10-00410) 9

the date of the claim, or (3) a supplier that had accreditation from one 

of the nine accrediting agencies on the date of the claim.29

For claims from the 13 States that license prosthetists and orthotists, we 

considered items to have been furnished or fabricated by unqualified 

practitioners or suppliers if: 

• the furnisher (1) was not a prosthetist, orthotist, physical or 

occupational therapist, or physician; or (2) did not have licensure in 

the appropriate State on the date of the claim; or

• the fabricator was not (1) a prosthetist, orthotist, physical or 

occupational therapist, or physician who had licensure in the 

appropriate State on the date of the claim; or (2) a supplier that had 

accreditation from one of the nine accrediting agencies on the date of 

the claim.

In some cases, practitioners or suppliers indicated that a furnisher or 

fabricator was qualified but did not supply supporting documentation

(e.g., a practitioner indicated that he or she was licensed but did not 

provide licensure documentation). In these instances, we contacted the 

practitioner or supplier and requested the missing documentation a second 

time. If the practitioner or supplier still did not provide the missing 

documentation, we attempted to verify the practitioner’s or supplier’s 

qualifications by independently researching publicly available State 

licensure and/or certification and accreditation information online. States 

and some certification and accreditation organizations maintain databases 

of their licensees and members online. For example, if a practitioner 

claimed to be licensed by the State of Texas, we checked the Texas 

Department of State Health Services Web site to attempt to verify his or 

her licensure. If a supplier claimed to be accredited by ABC, we checked

the ABC Web site to verify that supplier’s accreditation. If we neither 

received documentation from the practitioner or supplier nor were able to 

independently verify the information, we considered the furnisher or 

fabricator unqualified. 

Determination of Delivery Documentation Errors. In all States, we 

considered a claim to be allowed inappropriately if the documentation 

submitted did not meet Federal requirements for documentation of 

delivery to the beneficiary. We determined claims to have been allowed

inappropriately if we did not receive any delivery documentation or if the 

29 For purposes of the BIPA payment requirements, CMS has not issued guidance 

specifying which programs, if any, have accreditation and approval standards that are 

equivalent to ABC or BOC. However, for this evaluation, we consider accreditation from 

any of the nine CMS-approved accrediting organizations to be sufficient.
 

CMS Has Not Promulgated Regulations To Establish Payment Requirements (OEI-07-10-00410) 10

documentation that was provided lacked a beneficiary or designee 

signature.30

Communication With CMS Staff

Throughout our data collection and analysis, we conducted structured 

interviews and corresponded via email with CMS staff regarding: (1) the 

status of implementation of the BIPA payment requirements, and (2) the 

application of the requirements of Transmittal 656 and the Medicare 

quality standards to the practitioners and suppliers in our sample of claims.

Limitations

Our analysis was limited to the information available in the claims data 

and the documentation that we requested from the practitioners and 

suppliers of the sampled claims. Therefore, we were unable to determine 

whether the furnishers and fabricators identified in the documentation that 

we received did indeed furnish and/or fabricate the prosthetic or 

custom-fabricated orthotic. For example, if a claim in our sample was 

billed by a licensed prosthetist, we requested documentation to support the 

qualifications of the prosthetist listed on the claim. Some items claimed in 

our sample were furnished by a registered assistant practicing under the 

supervision of a licensed prosthetist or orthotist. We confirmed with CMS 

staff that a registered assistant met the definition of a qualified practitioner. 

It is possible that other items claimed in our sample were furnished by a 

registered assistant not practicing under the supervision of a licensed 

prosthetist or orthotist. However, if the licensed prosthetist or orthotist did 

not inform us that the claimed item was furnished by the registered 

assistant and simply provided documentation to support his own 

qualifications, we had no way of determining that the registered assistant

furnished the item. 

While we did not set out to review the payment edits based on specialty 

codes in Transmittal 656, we noted that some claims in our sample were 

from practitioners and suppliers with specialty codes not listed in 

Transmittal 656. Our evaluation did not include determining why the 

payment edits failed; therefore, we cannot determine why claims were 

paid to practitioner and suppliers with specialty codes not listed in 

Transmittal 656. 

Standards

This study was conducted in accordance with the Quality Standards for 

Inspection and Evaluation issued by the Council of the Inspectors General 

on Integrity and Efficiency.

30 In cases in which the delivery documentation provided was a shipping receipt, the 

claim was not determined to be inappropriately allowed despite the lack of a beneficiary 

or designee signature.
 

CMS Has Not Promulgated Regulations To Establish Payment Requirements (OEI-07-10-00410) 11

FINDINGS

CMS has not promulgated regulations related to 

payment requirements for practitioner and supplier 

qualifications for prosthetics and custom-fabricated 

orthotics

Section 427(a) of the BIPA, enacted December 21, 2000, prohibits 

Medicare payment for prosthetics and custom-fabricated orthotics unless 

they are furnished by a qualified practitioner and fabricated by a qualified 

practitioner or a qualified supplier at a facility that meets criteria 

determined by the Secretary. Section 427(b) requires the Secretary to 

promulgate regulations to implement section 427(a) of BIPA not later than 

December 21, 2001, using a negotiated rulemaking process. To date, CMS

has not promulgated regulations to implement this requirement. 

Beginning in 2002, CMS established a negotiated rulemaking committee 

and held several meetings to attempt to reach consensus on the substance 

of a proposed rule.31 CMS set a deadline of 6 months, beginning with the 

date of the first meeting (October 1, 2002), for the committee to complete 

work on the proposed rule.32 The final meeting of the negotiated 

rulemaking committee was scheduled for July 2003 (i.e., more than 

8 months after the first meeting), and the committee failed to reach 

consensus.33

In 2002, CMS stated that if the negotiated rulemaking committee was 

unable to reach consensus, CMS would develop a proposed rule.34 

However, in October 2005, CMS indicated that it had terminated the 

rulemaking process in June 2005, almost 2 years after the final meeting of 

the negotiated rulemaking committee.35 Thus, despite the BIPA mandate 

to promulgate regulations to implement the BIPA payment requirements 

31 See, e.g., 67 Fed. Reg. 48839 (July 26, 2002) (announcing the establishment of the 

Negotiated Rulemaking Committee on Special Payment Provisions and Requirements for 

Prosthetics and Certain Custom-Fabricated Orthotics and the dates of the first two 

meetings) and 68 Fed. Reg. 38269 (June 27, 2003) (announcing the date of the final 

meeting).

32 67 Fed. Reg. 13297 (March 22, 2002).

33 68 Fed. Reg. 38269 (June 27, 2003).

34 67 Fed. Reg. 13297 (March 22, 2002).

35 A proposed rule implementing Section 427(a) was listed in the semiannual regulatory 

agenda, but CMS withdrew the item from its agenda in June 2005. See, e.g., 

69 Fed. Reg. 73119, 73168 (Dec. 13, 2004); and 70 Fed. Reg. 26817, 26871 

(May 16, 2005) (providing a timetable for issuance of a proposed rule implementing 

Section 427 of the BIPA). See 70 Fed. Reg. 64533, 64623 (Oct. 31, 2005) (indicating 

that action on the proposed rule was completed because it was withdrawn).
 

CMS Has Not Promulgated Regulations To Establish Payment Requirements (OEI-07-10-00410) 12

no later than December 21, 2001, to date, no regulations have been 

promulgated. 

CMS has used other legal authorities that limit who 

can be paid for prosthetics and custom-fabricated 

orthotics; notwithstanding, in 2010, Medicare allowed 

nearly 1,000 claims inappropriately

In lieu of implementing the BIPA payment requirements, CMS has used 

other legal authorities that limit who can be paid for prosthetics and 

custom-fabricated orthotics.36 For example, based on the supplier 

standards, CMS issued Transmittal 656, instructing its contractors to 

implement payment edits based on specialty codes in the 13 States that 

license prosthetists and orthotists. Notwithstanding, in 2010, Medicare 

allowed 966 claims, totaling $776,154, for prosthetics and 

custom-fabricated orthotics from practitioners and suppliers in the 

13 States that license prosthetists and orthotists that did not have a 

specialty code listed in Transmittal 656. Transmittal 656 states that claims 

from practitioners and suppliers with specialty codes not listed in that 

document should be denied payment. Therefore, these payments were 

inappropriate. 

Another approach CMS used, based on the quality standards, mandates 

that all nonexempt DMEPOS suppliers attain accreditation. See Appendix 

E for an overview of actions taken that limit who can be paid for 

prosthetics and custom-fabricated orthotics.

Despite the lack of regulations, most claims were 

allowed for prosthetics and custom-fabricated 

orthotics furnished and/or fabricated by practitioners 

and/or suppliers that were licensed, certified, or 

accredited

Approximately 97 percent of Medicare-allowed claims (246,081 claims) 

for prosthetics and custom-fabricated orthotics were for items furnished by 

practitioners and/or fabricated by practitioners or suppliers that were 

licensed, certified, or accredited per the BIPA definition of qualified 

practitioners or qualified suppliers. The payments for these claims 

amounted to $260 million in 2010. See Appendix F for 95-percent 

confidence intervals and sample sizes for all estimates presented in this 

report.

36 The limits established based on the other legal authorities do not fulfill the mandate to 

promulgate regulations to implement the BIPA payment requirements. 
 

CMS Has Not Promulgated Regulations To Establish Payment Requirements (OEI-07-10-00410) 13

Medicare inappropriately allowed 12 percent of claims

for prosthetics and custom-fabricated orthotics that 

did not meet Federal requirements for delivery 

documentation

For 12 percent of claims, amounting to $13.6 million, suppliers failed to 

provide documentation meeting Federal requirements to show that 

prosthetics and custom-fabricated orthotics were delivered to 

beneficiaries. These claims were either missing all documentation of 

delivery, or lacked a beneficiary signature on the provided documentation. 

As Table 2 indicates, claims for custom-fabricated orthotics were more 

likely to lack delivery documentation.37 Tables F-2 and F-3 in Appendix F 

show the statistical tests supporting this analysis. 

Table 2: Inappropriately Allowed Claims and Payments Because of Lack of

Delivery Documentation

Type of Claim Percentage of Claims 

Inappropriately Allowed

Inappropriate 

Payments

Overall 11.6* $13,588,310

Prosthetics 4.0 $4,771,226

Custom-Fabricated Orthotics 17.2 $8,817,084

*The weighted average of the inappropriately allowed rates for prosthetics and custom-fabricated 

orthotics using the estimated proportion of population claims for each type of claim as weights. 

Source: OIG analysis of Medicare-allowed claims for prosthetics and custom-fabricated orthotics, 2011.

Eight percent of claims had documentation of delivery that was 

insufficient because it lacked a beneficiary’s or designee’s signature. A 

beneficiary’s or designee’s signature acknowledges that the beneficiary or 

designee received the item. For 3 percent of claims, we received a 

response from the supplier, but the response did not include any 

documentation to support the delivery of the item. Table 3 provides 

estimates of the claims lacking beneficiary or designee signatures on 

delivery documents or lacking delivery documents altogether. 

37 The percentage of custom-fabricated orthotics claims lacking delivery documentation 

was statistically higher than the percentage of prosthetics claims lacking delivery 

documentation based on a Wald chi-square test of independence at the 95-percent 

confidence interval.
 

CMS Has Not Promulgated Regulations To Establish Payment Requirements (OEI-07-10-00410) 14

Table 3: Inappropriately Allowed Claims and Payments Because of Lack of 

Delivery Documentation by Type of Missing Documentation

Type of Missing 

Documentation

Percentage of Inappropriately 

Allowed Claims 

Inappropriate 

Payments

Overall 11.6 $13,588,310

Lacked Beneficiary’s or 

Designee’s Signature 8.3 $9,354,658

Lacked Any Documentation To 

Support Delivery 3.3 $4,233,652

Source: OIG analysis of Medicare-allowed claims for prosthetics and custom-fabricated orthotics, 2011.

“Other” practitioners and suppliers of custom-fabricated 

orthotics, such as physicians, physical and occupational 

therapists, and podiatrists, were most likely to lack delivery 

documentation 

“Other” practitioners and suppliers (i.e., physicians, physical and 

occupational therapists, podiatrists, and orthopedic surgeons) of 

custom-fabricated orthotics were most likely to lack delivery 

documentation. 38 See Appendix D for a description of the specialty codes 

for all “other” practitioners and suppliers. 

As Table 4 shows, 40 percent of the “other” practitioners and suppliers of 

custom-fabricated orthotics lacked delivery documentation, whereas less 

than 4 percent of the medical supply companies and individual 

practitioners lacked delivery documentation.39 Tables F-2 and F-4 in 

Appendix F show the statistical tests supporting this analysis.

38 Ten percent of “other” practitioners and suppliers who submitted claims for prosthetics 

lacked delivery documentation, whereas 1 percent of medical supply companies and 4 

percent of individual prosthetists lacked delivery documents. However, these differences 

are not statistically significant and, therefore, “other” practitioners and suppliers of 

prosthetics were not more likely to lack delivery documentation than the medical supply 

companies or individual practitioners who submitted claims for prosthetics. 

See Table F-2 in Appendix F for these point estimates and their confidence intervals.

39 The percentage of “other” practitioners and suppliers of custom-fabricated orthotics 

lacking delivery documentation was statistically higher than both the percentages of 

medical supply companies and individual practitioners of custom-fabricated orthotics 

lacking delivery documentation at the 95-percent confidence interval.
 

CMS Has Not Promulgated Regulations To Establish Payment Requirements (OEI-07-10-00410) 15

Table 4: Percentage of Practitioners and Suppliers of Custom-Fabricated 

Orthotics Lacking Delivery Documentation by Specialty

Specialty Percentage of Providers Lacking 

Delivery Documentation Claims in Sample

Overall 17.2* 507

Medical Supply Companies 3.2 139

Individual Orthotists 0.2 219

“Other” Practitioners and Suppliers 40.1 149

*The weighted average of the percentages for each specialty using the estimated proportion of population claims 

for each specialty as weights. 

Source: OIG analysis of delivery documentation for custom-fabricated orthotics, 2011.
 

CMS Has Not Promulgated Regulations To Establish Payment Requirements (OEI-07-10-00410) 16

CONCLUSION AND RECOMMENDATIONS

Section 427(a) of the BIPA, enacted December 21, 2000, prohibits 

Medicare payment for prosthetics and custom-fabricated orthotics unless 

they are furnished by a qualified practitioner and fabricated by a qualified 

practitioner or a qualified supplier at a facility that meets criteria 

determined by the Secretary. Section 427(b) requires the Secretary to 

promulgate regulations to implement section 427(a) of BIPA not later than 

December 21, 2001, using a negotiated rulemaking process. To date, CMS 

has not promulgated regulations to implement this requirement. In lieu of 

implementing the BIPA payment requirements, CMS has used other legal 

authorities that limit who can be paid for prosthetics and 

custom-fabricated orthotics. For example, based on the supplier standards, 

CMS issued Transmittal 656, instructing its contractors to implement 

payment edits based on specialty codes in the 13 States that license 

prosthetists and orthotists. Notwithstanding, in 2010, Medicare allowed 

966 claims, totaling $776,154, for prosthetics and custom-fabricated 

orthotics from practitioners and suppliers in the 13 States that did not have 

a specialty code listed in Transmittal 656. Another method, based on the 

quality standards, mandates that all nonexempt DMEPOS suppliers attain 

accreditation.

Despite the lack of regulations, approximately 97 percent of 

Medicare-allowed claims for prosthetics and custom-fabricated orthotics 

were for items furnished by practitioners and/or fabricated by practitioners 

or suppliers that were licensed, certified, or accredited per the BIPA 

definition of qualified practitioners or qualified suppliers. Medicare 

inappropriately allowed an additional $13.6 million for prosthetics and 

custom-fabricated orthotics that did not meet Federal requirements for 

delivery documentation. “Other” practitioners and suppliers of 

custom-fabricated orthotics, such as physicians, physical and occupational 

therapists, and podiatrists, were most likely to lack delivery 

documentation.

To ensure appropriate Medicare payments and beneficiary quality of care, 

we recommend that CMS:

Promulgate Regulations To Implement the BIPA Payment 

Requirements

Section 427(b) of the BIPA required regulations to implement the payment 

requirements found in Section 427(a) to be promulgated no later than 

December 21, 2001; however, CMS failed to do so. To comply with 

Federal law and clarify who may be paid for prosthetics and custom-
 

CMS Has Not Promulgated Regulations To Establish Payment Requirements (OEI-07-10-00410) 17

fabricated orthotics, CMS should promulgate regulations to implement the 

BIPA payment requirements. 

Ensure That Suppliers Maintain Delivery Documentation That 

Meets Federal Requirements

CMS should ensure that suppliers are aware of their responsibility to 

maintain delivery documentation. CMS should consider aiming its 

education efforts at suppliers of custom-fabricated orthotics other than 

medical supply companies and individual practitioners because these 

“other” practitioners and suppliers (e.g., physicians, physical and 

occupational therapists, podiatrists, and orthopedic surgeons) are most 

likely to lack required delivery documentation. CMS could accomplish 

this by educating suppliers that they must meet certain standards, 

including maintaining delivery documentation. 

Take Action To Address Inappropriately Allowed Claims

Identified in the Population Related to Payment Edits and in 

Our Sample Related to Delivery Documentation

We will provide information regarding the claims inappropriately allowed 

in the population related to payment edits and in our sample related to 

delivery documentation to CMS in a separate memorandum. 

AGENCY COMMENTS AND OFFICE OF INSPECTOR GENERAL 

RESPONSE 

In its comments, CMS concurred with all three recommendations. In 

response to the first recommendation, CMS stated that it is developing 

proposed regulations to implement the BIPA payment requirements. In 

response to the second recommendation, CMS stated that it will direct the 

NSC to disseminate educational material about maintaining delivery 

documentation on its Web site and through other media as appropriate. In 

response to the final recommendation, CMS indicated that it will 

investigate our finding of inappropriate payments for claims paid to 

suppliers that did not meet the specialty requirements, and it will 

determine the need to strengthen the exiting claims processing edit, or 

establish a new edit, to ensure proper payment of claims. See Appendix G 

for the full text of CMS’s comments.

We did not make any changes to the report based on the CMS’s comments. 
 

CMS Has Not Promulgated Regulations To Establish Payment Requirements (OEI-07-10-00410) 18

APPENDIX A

Table A-1: States That License Prosthetists and Orthotists

Does State License

Prosthetists and Orthotists? States Number of States

Yes

Alabama, Arkansas, Florida, Georgia, Illinois, Mississippi, 

New Jersey, Ohio, Oklahoma, Rhode Island, Tennessee, 

Texas, Washington

13

No

Alaska, Arizona, California, Colorado, Connecticut, 

Delaware, District of Columbia, Hawaii, Idaho, Indiana, Iowa, 

Kansas, Kentucky, Louisiana, Maine, Maryland, 

Massachusetts, Michigan, Minnesota, Missouri, Montana, 

Nebraska, Nevada, New Hampshire, New Mexico, New York, 

North Carolina, North Dakota, Oregon, Pennsylvania, 

South Carolina, South Dakota, Utah, Vermont, Virginia, 

West Virginia, Wisconsin, Wyoming

38

 Total: 51

Source: Office of Inspector General analysis of States’ licensing of prosthetists and orthotists, 2011.
 

CMS Has Not Promulgated Regulations To Establish Payment Requirements (OEI-07-10-00410) 19

APPENDIX B

Specialty Codes Listed in Transmittal 656

Transmittal 656 updated the Medicare Claims Processing Manual to 

require that, in those States that license prosthetists and orthotists, only 

claims for prosthetics and custom-fabricated orthotics from suppliers with 

the following specialty codes be paid:

40

• Medical supply company with orthotics personnel—specialty 

code 51; 

• Medical supply company with prosthetics personnel—specialty 

code 52; 

• Medical supply company with prosthetics and orthotics 

personnel—specialty code 53;

• Orthotics personnel—specialty code 55; 

• Prosthetics personnel—specialty code 56;

• Prosthetics personnel, orthotics personnel, and pedorthists 

(i.e., practitioners who design and fabricate therapeutic 

shoes)—specialty code 57;

• Physical therapist—specialty code 65;

• Occupational therapist—specialty code 67; and

• Any Medicare physician specialty code, as listed in § 10.8.2 of 

chapter 26 of the Medicare Claims Processing Manual. 41

40 Centers for Medicare & Medicaid Services, Medicare Claims Processing Manual

(Internet-only manual), Pub. No. 100-04, ch. 20, § 130.1. 41 In addition, Transmittal 656 contains a list of Healthcare Common Procedure Coding 

System codes for prosthetics and custom-fabricated orthotics that are subject to the 

payment edits defined in the transmittal.
CMS Has Not Promulgated Regulations To Establish Payment Requirements (OEI-07-10-00410) 20

APPENDIX C

Table C-1: Detailed Sampling Design and Response Rates

Stratum Provider Type Dollar Amount Total Claims in 

Population

Average 

Payment per 

Population 

Claim

Claims in 

Sample

Number of 

Nonresponding 

Sample Claims*

Response 

Rate 

(Percentage)

1 Medical Supply 

Companies $1–$960 21,299 $570 80 4 (4) 95.0

2 Medical Supply 

Companies Over $960 8,364 $1,530 65 2 (0) 96.9

3 Individual Practitioners $1–$930 42,829 $557 110 0 (0) 100.0

4 Individual Practitioners Over $930 14,743 $1,510 110 1 (1) 99.1

5 Other Practitioners $1–$740 52,321 $338 95 3 (1) 96.8

6 Other Practitioners Over $740 9,756 $1,265 60 3 (1) 95.0

 Total orthotics 149,312 $677 520 13 (7) 97.5

7 Medical Supply 

Companies $1–$1,400 14,866 $454 45 3 (1) 93.3

8 Medical Supply 

Companies Over $1,400 13,599 $2,857 120 0 (0) 100.0

9 Individual Practitioners $1–$1,360 34,592 $445 50 0 (0) 100.0

10 Individual Practitioners $1,361–$4,250 33,120 $2,681 235 2 (0) 99.1

11 Individual Practitioners Over $4,250 2,285 $6,257 50 0 (0) 100.0

12 Other Practitioners All 10,023 $1,128 115 1 (0) 99.1

 Total prosthetics 108,485 $1,617 615 6 (1) 99.3

 Total overall 257,797 $1,072 1,135 19 (8) 98.3

* The first value is the number of claims for which practitioners and suppliers did not respond. The number in parentheses indicates how many of the nonresponding 

claims were from practitioners and suppliers that did not receive requests because they were associated with ongoing Office of Inspector General (OIG) investigations.

Source: OIG analysis of Medicare-allowed claims for prosthetics and custom-fabricated orthotics, 2011.
CMS Has Not Promulgated Regulations To Establish Payment Requirements (OEI-07-10-00410) 21

APPENDIX D

Specialty Codes for All “Other” Practitioners and Suppliers

We selected a stratified random sample totaling 1,135 claims. The sample 

had 12 strata based on specialty code and allowed dollar amounts. We 

defined the following groups of specialty codes for use in stratification: 

medical supply companies (specialty codes 51–53), individual 

practitioners of prosthetics and orthotics (specialty codes 55–57), and all 

“other” practitioners and suppliers. The specialty codes of the “other” 

practitioners and suppliers that were in our sample appear below.

01—General practitioner

02—General surgery

08—Family practice 

20—Orthopedic surgery

35—Chiropractic

40—Hand surgery

41—Optometry

48—Podiatry

54—Medical supply company not included in specialty codes 51–53

65—Physical therapist

67—Occupational therapist

70—Single or multispecialty clinic or group practice

77—Vascular surgery

87—All other suppliers (e.g., drugstores)

99—Unknown physician specialty

A0—Hospital

A5—Pharmacy

A6—Medical supply company with respiratory therapist

B2—Pedorthic personnel
 

CMS Has Not Promulgated Regulations To Establish Payment Requirements (OEI-07-10-00410) 22

APPENDIX E

Table E-1: Actions Taken That Limit Who Can Be Paid for Prosthetics and Custom-Fabricated 

Orthotics

Date

Legal Basis

Additional Information Statutory Payment 

Prohibition

SSA* § 1834(h)(1)(F)

Supplier Standard

42 CFR § 

424.57(c)(1)

Quality Standards

SSA § 1834(a)(20) 

December 

21, 2000

Medicare, Medicaid, and 

SCHIP** Benefits 

Improvement and 

Protection Act of 2000 

(BIPA) enacted:

(1) adding payment 

prohibition at 

1834(h)(1)(F), and

(2) mandating issuance of 

regulations within 1 year 

using negotiated 

rulemaking process

(1) Section 427(a) of BIPA added subsection 

(F) to SSA § 1834(h)(1), the payment 

prohibition for prosthetics and certain 

custom-fabricated orthotics.

(2) Section 427(b) of BIPA provided that “[n]ot

later than 1 year after the date of enactment of 

this Act, the Secretary of Health and Human 

Services shall promulgate revised regulations 

to carry out the amendment made by 

subsection (a) using a negotiated rulemaking 

process under subchapter III of chapter 5 of 

title 5, United States Code.” However, to date, 

the Centers for Medicare & Medicaid Services 

(CMS) has not promulgated regulations to 

implement this provision.

October 1, 

2002

First scheduled negotiated 

rulemaking committee 

meeting

CMS established the Negotiated Rulemaking 

Committee on Special Payment Provisions and 

Requirements for Prosthetics and Certain 

Custom-Fabricated Orthotics. 67 Fed. Reg. 

48839 (July 26, 2002). According to that 

notice, the first meeting for the negotiated 

rulemaking committee was scheduled for 

October 1–3, 2002.

In an earlier notice of intent to establish the 

negotiated rulemaking committee at 67 Fed. 

Reg. 13297, 13300 (Mar. 22, 2002), CMS 

stated that “[i]f the committee is unable to 

reach consensus, we will proceed to develop a 

proposed rule.”

July 14, 

2003

Final scheduled negotiated 

rulemaking committee 

meeting

In 68 Fed. Reg. 38269 (June 27, 2003), CMS 

scheduled the final negotiated rulemaking 

committee meeting for July 14, 2003, and 

stated that the “Committee does not anticipate 

the need for additional meetings.”

*Social Security Act.

**State Children’s Health Insurance Program.
 

 

Table E-1: Actions Taken That Limit Who Can Be Paid for Prosthetics and Custom-Fabricated Orthotics 

(continued) 

*

Date 

Legal Basis 

Statutory Payment Additional Information 

Prohibition 

SSA § 1834(h)(1)(F) 

Supplier Standard 

42 CFR § 

424.57(c)(1) 

Quality Standards 

SSA § 1834(a)(20) 

December 8, 

2003 

Medicare 

Prescription Drug, 

Improvement, and 

Modernization Act 

of 2003 (MMA) 

enacted, adding 

supplier quality 

standards at SSA § 

Section 302(a) of MMA added SSA § 

1834(a)(20), requiring the Secretary of Health 

and Human Services (the Secretary) to 

establish and implement quality standards for 

Durable Medical Equipment, Prosthetics, 

Orthotics, and Supplies (DMEPOS) suppliers to 

be applied by independent accreditation 

organizations. It also requires suppliers to 

comply with the quality standards to furnish 

items set forth in 1834(a)(20)(D), including 

prosthetic devices, orthotics, and prosthetics, 

and to receive or retain their provider or 

supplier numbers. 

1834(a)(20). SSA § 1834(a)(20)(E) permits the Secretary to 

establish the quality standards “by program 

instruction or otherwise” and requires the 

standards to be “published on the Internet 

website of the Centers for Medicare & Medicaid 

Services.” 

October 22, 

2004 

CMS issued Transmittal 

329, Change Request 

3373, entitled “DMERC* 

Only - Payment to 

Providers/Suppliers 

Qualified to Bill Medicare 

for Prosthetics and Certain 

Custom-Fabricated 

Orthotics.” 

The effective date was 

July 1, 2005, but the 

transmittal was rescinded 

before that date. 

 

November 23, 

2004 

CMS rescinded 

Transmittal 329, Change 

Request 3373. 

 

December 13, 

2004 

In its semiannual 

regulatory agenda, CMS 

stated that it was 

considering issuance of a 

proposed rule 

implementing the payment 

prohibition at § 427 of 

BIPA by July 2005. 

 

CMS included a Notice of Proposed Rule 

Making to implement 427 of BIPA in its 

semiannual regulatory agenda at 69 Fed. Reg. 

73119, 74268 (Dec. 13, 2004), with a timetable 

date of July 2005. That date was postponed in 

other Federal Register documents (see e.g., 70 

Fed. Reg. 26817, 26871 (May 16, 2005) 

(postponing date to November 2005)). 

Durable Medical Equipment Regional Carrier (DMERC). 

CMS Has Not Promulgated Regulations To Establish Payment Requirements (OEI-07-10-00410) 23 
 

CMS Has Not Promulgated Regulations To Establish Payment Requirements (OEI-07-10-00410) 24

Table E-1: Actions Taken That Limit Who Can Be Paid for Prosthetics and Custom-Fabricated Orthotics 

(continued)

Date

Legal Basis

Statutory Payment Additional Information

Prohibition

SSA § 1834(h)(1)(F)

Supplier Standard

42 CFR § 

424.57(c)(1)

Quality Standards

SSA § 1834(a)(20) 

August 19, 

2005

CMS issued 

Transmittal 656, 

Change Request 

3959, entitled “Full 

Replacement of 

Change Request 

3607, Payment Edits 

in Applicable States 

for DMEPOS

Suppliers of

Prosthetics and 

Certain 

Custom-Fabricated 

Orthotics, Change 

Request 3607 is 

rescinded (DMERC 

only).”

Acknowledging the “absence of national 

Medicare payment policy regarding who may 

bill and be paid for prosthetics and certain 

custom-fabricated orthotics,” Transmittal 656 

directed Durable Medical Equipment Medicare 

Administrative Contractors (DMEMACs) to 

implement payment edits in States that 

license/certify orthotists or prosthetists, 

effective October 1, 2005. This transmittal was 

based on the supplier standard at 42 CFR 

424.57(c)(1), requiring suppliers to comply with 

all applicable Federal and State licensure and 

regulatory requirements.

Transmittal 656 also revised Chapter 20, 

section 130.1 of the Medicare Claims 

Processing Manual, Pub. No. 100-04, to 

address this payment edit.

October 31, 

2005

In its semiannual 

regulatory agenda, CMS 

indicated that the 

proposed rule that would 

have implemented 

section 427 of BIPA was 

“[w]ithdrawn” on 

June 28, 2005.

See 70 Fed. Reg. 64553, 64623 

(Oct. 31, 2005).

May 25, 

2007

CMS announced 

that it had deemed 

10 national 

accreditation 

organizations for 

DMEPOS.

See 72 Fed. Reg. 29326 (May 25, 2007).

February 1, 

2008

CMS issued 

Transmittal 236, 

Change Request 

5892, entitled 

“Update to 

Chapter 10.”

Transmittal 236 added a new § 21.1 (entitled 

“DMEPOS Supplier Accreditation”) to 

Chapter 10 of the Medicare Program Integrity 

Manual, Pub. No. 100-08, providing that:

(1) on or after March 1, 2008, new DMEPOS 

suppliers must be accredited before submitting 

an application to the National Supplier 

Clearinghouse (NSC);

(2) DMEPOS suppliers that enrolled for the first 

time with NSC between January 1 and 

February 28, 2008, must obtain and submit 

evidence of accreditation to NSC by 

January 1, 2009;

(3) DMEPOS suppliers that enrolled in 

Medicare prior to January 1, 2008, must 

provide evidence of accreditation to NSC by 

September 30, 2009; and

 

(4) NSC shall revoke a supplier’s billing 

privileges if the supplier fails to obtain and 

submit required evidence of accreditation.
 

CMS Has Not Promulgated Regulations To Establish Payment Requirements (OEI-07-10-00410) 25

Table E-1: Actions Taken That Limit Who Can Be Paid for Prosthetics and Custom-Fabricated Orthotics 

(continued)

Date

Legal Basis

Statutory Payment Additional Information

Prohibition

SSA § 1834(h)(1)(F)

Supplier Standard

42 CFR § 

424.57(c)(1)

Quality Standards

SSA § 1834(a)(20) 

July 15, 

2008

Medicare 

Improvements for 

Patients and 

Providers Act of 

2008 (MIPPA) 

enacted, adding 

SSA 

§ 1834(a)(20)(F), 

requiring suppliers 

to provide evidence 

of accreditation by 

October 1, 2009.

Section 154(b) of MIPPA added subparagraph 

(F) to SSA 1834(a)(20):

(1) requiring suppliers furnishing items and 

services on or after October 1, 2009, directly or 

as a subcontractor for another entity, to have 

submitted evidence of accreditation;

(2) stating that eligible professionals (as defined 

at SSA 1848(k)(3)(B)) and other persons 

specified by the Secretary are exempt from the 

accreditation deadline, unless the Secretary 

determines that the quality standards are 

specifically designed to apply to such 

professionals and persons; and

(3) allowing the Secretary to exempt such 

professionals and other persons specified by 

the Secretary from the accreditation deadline if 

the Secretary determines that licensing, 

accreditation, or other mandatory quality 

requirements apply to such professionals and 

persons.

October 

2008

CMS issued final 

guidance entitled 

“Durable Medical 

Equipment, 

Prosthetics, 

Orthotics, and 

Supplies 

(DMEPOS) Quality 

Standards”

This final guidance (the “DMEPOS Quality 

Standards”) is at

http://www.cms.gov/Medicare/ProviderEnrollment-andCertification/MedicareProviderSupEnroll/Downl

oads/DMEPOSAccreditationStandardsCMB.pdf

Appendix C of the DMEPOS Quality Standards 

is entitled “Custom Fabricated and Custom 

Fitted Orthoses, Prosthetic Devices, External 

Breast Prostheses, Therapeutic Shoes and 

Inserts, and their Accessories and Supplies; 

Custom-Made Somatic, Ocular and Facial 

Prostheses.”

May 4, 

2010

CMS issued a 

document entitled 

“Medicare New 

Deemed 

Accreditation 

Organizations For 

Suppliers of 

Durable Medical 

Equipment, 

Prosthetics, 

Orthotics and 

Supplies 

(DMEPOS).”

This document lists the 10 accreditation 

organizations and refers to the DMEPOS 

Quality Standards document.

This document is at:

http://www.cms.gov/Medicare/ProviderEnrollment-andCertification/MedicareProviderSupEnroll/Downl

oads/DeemedAccreditationOrganizationsCMB.

pdf
 

CMS Has Not Promulgated Regulations To Establish Payment Requirements (OEI-07-10-00410) 26

Date

Legal Basis

Statutory Payment Additional Information

Prohibition

SSA § 1834(h)(1)(F)

Supplier Standard

42 CFR § 

424.57(c)(1)

Quality Standards

SSA § 1834(a)(20) 

May 21, 

2010

CMS issued 

Transmittal 710, 

Change Request 

6566, entitled 

“Guidance on 

Implementing 

System Edits for 

Certain Durable 

Medical 

Equipment, 

Prosthetics, 

Orthotics, and 

Supplies 

(DMEPOS)”

Transmittal 710 identified the following as 

being exempt from the September 30, 2009, 

accreditation deadline:

(1) eligible professionals (as defined at SSA 

1848(k)(3)(B)), including, but not limited to, 

physicians, physical therapists, and 

occupational therapists; and

(2) specified “other persons,” including, but not 

limited to, orthotists and prosthetists.

(See Attachment A of Transmittal 710.)

If a supplier is not exempt from accreditation, 

Transmittal 710 directs DMEMACs to deny a 

supplier’s claim for Healthcare Common 

Procedures Coding System (HCPCS) codes in 

Attachment C if the supplier has not been 

identified by NSC as being accredited to supply 

the specific product/service. This requirement 

applies to claims with dates of service on or 

after July 6, 2010.

Transmittal 710 states that edits for 

accreditation will begin by “phasing in a limited 

number of product categories and HCPCS 

codes, as listed in Attachment C....” 

Attachment C does not include orthotics or 

prosthetics.

Source: Office of Inspector General analysis of actions taken that limit who can be paid for prosthetics and custom-fabricated orthotics, 2012.

Table E-1: Actions Taken That Limit Who Can Be Paid for Prosthetics and Custom-Fabricated Orthotics 

(continued)
 

CMS Has Not Promulgated Regulations To Establish Payment Requirements (OEI-07-10-00410) 27

APPENDIX F

Table F-1: Point Estimates, Sample Sizes, and Confidence Intervals

Estimate Description Sample Size Point Estimate 95-Percent Confidence Interval

Estimates Related to Practitioner and Supplier Qualifications

Percentage of claims that were furnished and 

fabricated by qualified providers as defined in 

the Medicare, Medicaid, and SCHIP* Benefits 

Improvement and Protection Act of 2000 (BIPA) 

in 2010

1,116 97.3 96.2–98.1

Total claims for items furnished by practitioners 

and/or fabricated by practitioners or suppliers 

that were licensed, certified, or accredited per 

the BIPA definition of qualified practitioners or 

qualified suppliers in 2010

1,116 246,081 242,668.5–249,494.2

Payments for claims for items furnished by 

practitioners and/or fabricated by practitioners 

or suppliers that were licensed, certified, or 

accredited per the BIPA definition of qualified 

practitioners or qualified suppliers in 2010

1,116 $259,998,432.51 $253,578,219.90–$266,418,645.12

Estimates Related to Delivery Documentation

Payments for claims that did not meet Federal 

requirements for delivery documentation 1,116 $13,588,310 $10,162,404–$17,014,217

Percentage of claims that did not meet Federal 

requirements for delivery documentation 1,116 11.6 9.5–14.2

Percentage of prosthetics claims that did not 

meet Federal requirements for delivery 

documentation

609 4.0 2.2–7.1

Payments for prosthetics claims that did not 

meet Federal requirements for delivery 

documentation

609 $4,771,226 $2,388,422–$7,154,030

Percentage of custom-fabricated orthotics 

claims that did not meet Federal requirements 

for delivery documentation

507 17.2 13.9–21.2

Payments for custom-fabricated orthotics 

claims that did not meet Federal requirements 

for delivery documentation

507 $8,817,084 $6,355,564–$11,278,605

Percentage of claims that lacked beneficiary 

signatures on delivery documentation 1,116 8.3 6.4–10.8

Percentage of claims that lacked any 

documentation to support delivery 1,116 3.3 2.1–5.1

Payments for claims that lacked beneficiary 

signatures on delivery documentation 1,116 $9,354,658 $6,487,930–12,221,386

Payments for claims that lacked any 

documentation to support delivery 1,116 $4,233,652 $2,190,121–$6,277,183

Source: Office of Inspector General (OIG) analysis of Medicare-allowed claims for prosthetics and custom-fabricated orthotics, 2011.

*State Children’s Health Insurance Program, now referred to as CHIP.
 

CMS Has Not Promulgated Regulations To Establish Payment Requirements (OEI-07-10-00410) 28

Table F-2: Point Estimates and Confidence Intervals Related to Delivery Documentation 

by Supplier Specialty 

Estimate Description Sample Size Point Estimate 95-Percent Confidence 

Interval

Percentage of claims from “other” practitioners and 

suppliers of custom-fabricated orthotics lacking 

delivery documentation

149 40.1 31.8–49.1

Percentage of claims from medical supply 

companies providing custom-fabricated orthotics 

lacking delivery documentation

139 3.2 1.3–8.0

Percentage of claims from individual practitioners 

providing custom-fabricated orthotics lacking delivery 

documentation

219 0.2 0.03–1.6

Percentage of claims from “other” practitioners and 

suppliers of prosthetics lacking delivery 

documentation

114 10.5 6.1–17.6

Percentage of claims from medical supply 

companies providing prosthetics lacking delivery 

documentation

162 1.2 0.4–3.7

Percentage of claims from individual practitioners 

providing prosthetics lacking delivery documentation 333 4.1 1.8–9.3

Source: OIG analysis of Medicare-allowed claims for prosthetics and custom-fabricated orthotics, 2012.

Table F-3: Chi Square Analysis on Delivery Documentation and Claim Type

Claim Type Compared 

(Group A vs. Group B)

Group A

Rate

Group B 

Rate

Wald Chi-Square 

Test Statistic

F-Test Degrees of 

Freedom P-Value

Prosthetics vs. 

Custom-Fabricated Orthotics 4.0 17.2 36.1 numerator = 1 denominator = 1104 <0.0001

Source: OIG analysis of Medicare claims data and supplier documentation, 2012.

Table F-4: Chi Square Analysis on Delivery Documentation and Practitioner and Supplier 

Specialty

Practitioner and Supplier

Specialties Compared 

(Group A vs. Group B)

Group A 

Rate

Group B 

Rate

Wald 

Chi-Square 

Test Statistic

F-Test Degrees of 

Freedom

Bonferroni 

Threshold*

Unadjusted 

P-Value

Medical Supply Companies 

vs. “Other” Practitioners and 

Suppliers

3.2 40.1 61.1 numerator = 1 

denominator = 284 0.01667 <0.0001

Individual Practitioners vs.

“Other” Practitioners and 

Suppliers

0.2 40.1 79.6 Numerator = 1 

Denominator = 364 0.01667 <0.0001

*We did not plan on statistically testing whether “other” practitioners and suppliers were more likely to lack required delivery documentation than 

medical supply companies and individual practitioners, but we saw this through exploratory data analysis. Consequently, we included a Bonferroni 

correction to account for this in the two comparisons above to keep our confidence level for these comparison tests at 95 percent. For the percentages 

for the groups compared to be considered statistically different at the 95-percent confidence level, the unadjusted p-values need to be less than the 

Bonferroni Threshold of 0.05/3 = 0.01667. 

Source: OIG analysis of Medicare claims data and supplier documentation, 2012.
APPENDIX G 

Agency Comments 

Cl AAm lli~ hltur 

w..~~>~M nc x:r.&n 

DAltt 	 MJG 1 1 2lH! 

'fO: &tiel R. Levin$>'m 

ln~ t'!<!c\fll: Ge.netal 

FROM: 	 f"tll'l'~ 

Acting Adlt#!ni.mawr 


SOOJJ.lCf: 	 Olliee oflr~ O<:!Wtld f0K1) Drn.fi Report; "CMS H~:~ No~ l'tottl ul~ated 

ltcgul:;tfiOt\11 to Establish l

1

aym<:tlt Requirements 1\n P'mslheticsand Custum­


ed Orthotks" (0 EI.07.ttl.-00410) 


The Centet''l for Medicate & MedicaiJ Sc.rvices {CMSI appreciroes the oPf!Qrtt~nit) to re~ie and 


i:X~UIInent oo the Of(i dm.t\ ft!l<)l't entitled. "CM~ Has Not f'tl!l.nulgateJ Regul:utions '(I Establislt 


Payment Requirernmu ror l,'n>titbeti<..'Sarul {,utifOf!l·Fahrkated Onhntk:.."' Scction 4·27tn) ofthc: 


Med1t"l!J"e, Medicaid, and State O tldnm Hmlt k hl-.;utuce Pt~g:rn Bendll!> impti)Vill'l'Wnt ud 


Pt~J -ection Act f>f ~!000 {BI Pi\) pt\>hi!~ ts Medicare tta;mmts fm fll'lhthcties and cu:.too:~>· 

fnhticate<J mtlt(>tics ttnlesl>. tht' items are {I) filtlll.sh¢<d hr a (ltullified pmctitiutl<':t. and I~} 

fi1bfkured try citl-£1" a. quaiHicd prnclitiuru;r or a qualified 'IU )pli er at a lhciifiy thm m~~-cts such 


crilc:ria &.'>the &"\:rctacy detertrtil1¢i' ·appropru1 Ti'.cse qualifk,ali<ms tire htt<tlded lu prntet:l 


I'IC'Iu:lidaries, promote lugh quality a tre. aoo lia~:uuro Mctticare funds b) msurin that P!l!l)' 


qualified indh•i<tuals and health cm-e organih:Kim:u• fttm!!lh Mcdiare itttt1s and service 


The (:MS take!l :u:ri wdy ils rc>JX>nsibility to ~1 the Mediet~ re Tt'Utlt Funds and ensure that 


IJ0)!1'tldlU mllilk to o ld:et~ IUld suwlim for ea.,~ health ~"!.\ ~rvi<;a 11re approprlalc and 


c tstcnl wit!t Medicare J»(rcy CMS Is~ the p~t1f dt• •I ·~ p:rup;.t&ed · tivm to 


implementlbe fUPA pmviMons. 


As detai.~ in OI<J·, C~-IS ha'.l tak¢fl atthm by Is-suing Tfmxsmiltal 656 (Chug.e Request 

3?59. issued on 1\Uitusl tq. ~I:JOS') n:nl$ttlittal 656 di&cecet the t.~~-----lt---

~;l ms pr~,j n •eJi1 tQ ensme tlmt prof!Cf ting uf mat !l. t~daim n oe<lil' in tho!SC 

~~ here prusthetics {II onhotits mu~l be provided by a li or fied ot1bvt1~ {or 

rrosthetist Uwu ~tthout rcgulat in place. the rc;p<n1 ti;nmd that 91 ~rcent fM~ care

aJ.kl\\~ claim:> for p.rostbctk11 lflil'ld l.l.<iW~U-fahricated ortltuli \\<'e«l (ot ifA:mi> 1\mlish\.-d by 

! . tmlftc<t m aeere~fi~ provi<Jer'$ ud ~$1~.: 

We apj'»'l:.'X':iah:; OlG' s eltoos In worldn& wilh CMS to help cftsute tlmt prosd>~k,-s tuld <U$1!»· 


tiihric•w:d <Jttholics ® tt(l.t wn ili~.~t to he vulnemhle to uln.l&e. Our respt1fH>e.'l: to tile ()JG 


e\.~.WI fotro:w. 


CMS Has Not Promulgated Regulations To Establish Payment Requirements (OEI-07-10-00410) 29 

----­
 

CMS Has Not Promulgated Regulations To Establish Payment Requirements (OEI-07-10-00410) 30

Agency Comments (continued)
 

CMS Has Not Promulgated Regulations To Establish Payment Requirements (OEI-07-10-00410) 31

Agency Comments (continued)
 

CMS Has Not Promulgated Regulations To Establish Payment Requirements (OEI-07-10-00410) 32

ACKNOWLEDGMENTS

This report was prepared under the direction of Brian T. Pattison, Regional 

Inspector General for Evaluation and Inspections in the Kansas City 

regional office, and Brian T. Whitley, Deputy Regional Inspector General. 

Rae Hutchison served as the project leader for this study. Other Office of 

Evaluation and Inspections staff from the Kansas City regional office who 

conducted the study include Jordan Clementi and Michala Walker. Central 

office staff who provided support include Kevin Farber, Scott Manley, and 

Debra Roush. 
Office of Inspector General

http://oig.hhs.gov

The mission of the Office of Inspector General (OIG), as mandated by Public Law 95-452, as 

amended, is to protect the integrity of the Department of Health and Human Services 

(HHS) programs, as well as the health and welfare of beneficiaries served by those 

programs. This statutory mission is carried out through a nationwide network of audits, 

investigations, and inspections conducted by the following operating components:

Office of Audit Services

The Office of Audit Services (OAS) provides auditing services for HHS, either by conducting 

audits with its own audit resources or by overseeing audit work done by others. Audits 

examine the performance of HHS programs and/or its grantees and contractors in carrying 

out their respective responsibilities and are intended to provide independent assessments of 

HHS programs and operations. These assessments help reduce waste, abuse, and 

mismanagement and promote economy and efficiency throughout HHS.

Office of Evaluation and Inspections

The Office of Evaluation and Inspections (OEI) conducts national evaluations to provide 

HHS, Congress, and the public with timely, useful, and reliable information on significant 

issues. These evaluations focus on preventing fraud, waste, or abuse and promoting 

economy, efficiency, and effectiveness of departmental programs. To promote impact, OEI 

reports also present practical recommendations for improving program operations. 

Office of Investigations

The Office of Investigations (OI) conducts criminal, civil, and administrative investigations 

of fraud and misconduct related to HHS programs, operations, and beneficiaries. With 

investigators working in all 50 States and the District of Columbia, OI utilizes its resources 

by actively coordinating with the Department of Justice and other Federal, State, and local 

law enforcement authorities. The investigative efforts of OI often lead to criminal 

convictions, administrative sanctions, and/or civil monetary penalties.

Office of Counsel to the Inspector General

The Office of Counsel to the Inspector General (OCIG) provides general legal services to 

OIG, rendering advice and opinions on HHS programs and operations and providing all 

legal support for OIG’s internal operations. OCIG represents OIG in all civil and 

administrative fraud and abuse cases involving HHS programs, including False Claims Act, 

program exclusion, and civil monetary penalty cases. In connection with these cases, OCIG 

also negotiates and monitors corporate integrity agreements. OCIG renders advisory 

opinions, issues compliance program guidance, publishes fraud alerts, and provides other 

guidance to the health care industry concerning the anti-kickback statute and other OIG 

enforcement authorities.