Friday,

November 26, 2004

Part III

Department of 

Health and Human 

Services

Centers for Medicare & Medicaid Services 

42 CFR Part 416

Medicare Program; Update of Ambulatory 

Surgical Center List of Covered 

Procedures; Proposed Rule

69178 Federal Register / Vol. 69, No. 227 / Friday, November 26, 2004 / Proposed Rules 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

42 CFR Part 416 

[CMS–1478–P] 

RIN: 0938–AM85 

Medicare Program; Update of 

Ambulatory Surgical Center List of 

Covered Procedures

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS.

ACTION: Proposed rule.

SUMMARY: This proposed rule would 

make additions to and deletions from 

the current list of Medicare approved 

ambulatory surgical center (ASC) 

procedures.

DATES: To be assured consideration, 

comments must be received at one of 

the addresses provided below, no later 

than 5 p.m. on January 25, 2005.

ADDRESSES: In commenting, please refer 

to file code CMS–1478–P. Because of 

staff and resource limitations, we cannot 

accept comments by facsimile (FAX) 

transmission. You may submit 

comments in one of three ways (no 

duplicates, please): 

1. Electronically. You may submit 

electronic comments to http://

www.cms.hhs.gov/regulations/

ecomments or to http://

www.regulations.gov (attachments 

should be in Microsoft Word, 

WordPerfect, or Excel; however, we 

prefer Microsoft Word). 

2. By mail. You may mail written 

comments (one original and two copies) 

to the following address ONLY: Centers 

for Medicare & Medicaid Services, 

Department of Health and Human 

Services, Attention: CMS–1478–P, P.O. 

Box 8013, Baltimore, MD 21244–8013. 

Please allow sufficient time for mailed 

comments to be received before the 

close of the comment period. 

3. By hand or courier. If you prefer, 

you may deliver (by hand or courier) 

your written comments (one original 

and two copies) before the close of the 

comment period to one of the following 

addresses. If you intend to deliver your 

comments to the Baltimore address, 

please call telephone number (410) 786–

7195 in advance to schedule your 

arrival with one of our staff members. 

Room 445–G, Hubert H. Humphrey 

Building, 200 Independence Avenue, 

SW., Washington, DC 20201; or 7500 

Security Boulevard, Baltimore, MD 

21244–1850.

(Because access to the interior of the HHH 

Building is not readily available to persons 

without Federal Government identification, 

commenters are encouraged to leave their 

comments in the CMS drop slots located in 

the main lobby of the building. A stamp-in 

clock is available for persons wishing to 

retain a proof of filing by stamping in and 

retaining an extra copy of the comments 

being filed.)

Comments mailed to the addresses 

indicated as appropriate for hand or 

courier delivery may be delayed and 

received after the comment period. 

For information on viewing public 

comments, see the beginning of the 

SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT: Bob 

Cereghino, (410) 786–4645.

SUPPLEMENTARY INFORMATION: 

Submitting Comments: We welcome 

comments from the public on all issues 

set forth in this proposed rule to assist 

us in fully considering issues and 

developing policies. You can assist us 

by referencing the file code CMS–1478–

P and the specific ‘‘issue identifier’’ that 

precedes the section on which you 

choose to comment. 

Inspection of Public Comments: All 

comments received before the close of 

the comment period are available for 

viewing by the public, including any 

personally identifiable or confidential 

business information that is included in 

a comment. After the close of the 

comment period, CMS posts all 

electronic comments received before the 

close of the comment period on its 

public Web site. Comments received 

timely will be available for public 

inspection as they are received, 

generally beginning approximately 3 

weeks after publication of a document, 

at the headquarters of the Centers for 

Medicare & Medicaid Services, 7500 

Security Boulevard, Baltimore, 

Maryland 21244, Monday through 

Friday of each week from 8:30 a.m. to 

4 p.m. To schedule an appointment to 

view public comments, phone (410) 

786–7195. 

Copies 

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Register containing this document, send 

your request to: New Orders, 

Superintendent of Documents, P.O. Box 

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Specify the date of the issue requested 

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www.gpoaccess.gov/fr/index.html

I. Background 

A. Legislative History 

Section 1832(a)(2)(F)(i) of the Social 

Security Act (the Act) provides that 

benefits under the Medicare 

Supplementary Medical Insurance 

program (Part B) include payment for 

facility services furnished in connection 

with surgical procedures we specify and 

which are performed in an ambulatory 

surgical center (ASC). To participate in 

the Medicare program as an ASC, a 

facility must meet the standards 

specified in section 1832(a)(2)(F)(i) of 

the Act; in 42 CFR 416.25, which sets 

forth general conditions and 

requirements for ASCs; and, in 42 CFR 

416, Subpart C, which provides specific 

conditions for coverage for ASCs. 

There are two primary elements in the 

total cost of performing a surgical 

procedure—the cost of the physician’s 

professional services in performing the 

procedure and the cost of items and 

services furnished by the facility where 

the procedure is performed (for 

example, surgical supplies and 

equipment and nursing services). This 

proposed notice addresses the second 

element, the coverage and payment of 

facility fees for ASC services under the 

current payment system. As we note 

below, section 626(b) of the Medicare 

Prescription, Improvement and 

Modernization Act of 2003 (MMA) 

requires that we develop a revised 

payment system for ASC facility 

services that would be implemented no 

earlier than January 1, 2006. This 

proposed rule addresses additions to 

and deletions from the list of Medicare 

approved ASC procedures prior to the 

implementation of that revised payment 

system.

Under the current ASC facility 

services payment system, the ASC 

payment rate is a standard overhead 

amount established on the basis of our 

estimate of a fair fee that takes into 

account the costs incurred by ASCs 

generally in providing facility services 

in connection with performing a 

specific procedure. The report of the 

Conference Committee accompanying 

Federal Register / Vol. 69, No. 227 / Friday, November 26, 2004 / Proposed Rules 69179

section 934 of the Omnibus Budget 

Reconciliation Act of 1980 (OBRA) 

(Pub. L. 96–499), which enacted the 

ASC benefit in December 1980, states 

that this overhead factor is expected to 

be calculated on a prospective basis 

using sample survey and similar 

techniques to establish reasonable 

estimated overhead allowances, which 

take account of volume (within 

reasonable limits), for each of the listed 

procedures. (See H.R. Rep. No. 96–1479, 

at 134 (1980)). 

To establish those reasonable 

estimated allowances for services 

furnished prior to implementation of the 

revised payment system mandated by 

the MMA, we are required by section 

1833(i)(2)(A)(i) of the Act, as amended 

by section 626(b)(1) of MMA, to take 

into account the audited costs incurred 

by ASCs to perform a procedure, in 

accordance with a survey. Payment for 

ASC facility services is subject to the 

usual Medicare Part B deductible and 

coinsurance requirements, and the 

amounts paid by Medicare must be 80 

percent of the standard fee. 

Section 1833(i)(1) of the Act requires 

us to specify, in consultation with 

appropriate medical organizations, 

surgical procedures that can be safely 

performed in an ASC and to review and 

update the list of ASC procedures at 

least every two years. 

Section 141(b) of the Social Security 

Act Amendments of 1994 (SSAA 1994) 

requires us to establish a process for 

reviewing the appropriateness of the 

payment amount provided under 

section 1833(i)(2)(A)(iii) of the Act for 

IOLs with respect to a class of newtechnology IOLs. That process was the 

subject of a separate final rule entitled 

‘‘Adjustment in Payment Amounts for 

New Technology Intraocular Lenses 

Furnished by Ambulatory Surgical 

Centers,’’ published on June 16, 1999 in 

the Federal Register (64 FR 32198). 

B. Summary of Updates of the ASC List 

Section 934 of the Omnibus Budget 

Reconciliation Act of 1980 amended 

sections 1832(a)(2) and 1833 of the Act 

to authorize the Secretary to specify 

surgical procedures that, although 

appropriately performed in an inpatient 

hospital setting, can also be performed 

safely on an ambulatory basis in an 

ASC, a hospital outpatient department, 

or a rural primary care hospital. The 

report accompanying the legislation 

explained that the Congress intended 

procedures currently performed on an 

ambulatory basis in a physician’s office 

that do not generally require the more 

elaborate facilities of an ASC not be 

included in the list of covered 

procedures (H.R. Rep. No. 96–1167, at 

390, reprinted in 1980 U.S.C.C.A.N. 

5526, 5753). In a final rule published 

August 5, 1982 in the Federal Register

(47 FR 34082), we established 

regulations that included criteria for 

specifying which surgical procedures 

were to be included for purposes of 

implementing the ASC facility benefit. 

Subsequently, in accordance with 42 

CFR 416.65(c), we published updates of 

the ASC list in the Federal Register on 

April 21, 1987 (52 FR 13176), June 1, 

1989 (54 FR 23540), December 31, 1991 

(56 FR 67666), January 26, 1995 (60 FR 

5185), and March 28, 2003 (68 FR 

15268). 

During years when we do not update 

the list through the proposed rule and 

comment process in the Federal 

Register, we revise the list to be 

consistent with annual calendar year 

changes in codes established by the 

American Medical Association (AMA) 

Current Procedural Terminology (CPT), 

removing from the ASC list codes that 

are deleted by CPT and adding new 

codes that replace codes already on the 

ASC list. These annual CPT updates are 

implemented through program 

instructions to carriers who process 

ASC claims. 

C. Regulatory Requirements 

1. Sections 416.65(a) and (b) 

Section 416.65(a) specifies general 

standards for procedures on the ASC 

list. ASC procedures are those surgical 

and medical procedures that are: 

• Commonly performed on an 

inpatient basis but may be safely 

performed in an ASC; 

• Not of a type that are commonly 

performed or that may be safely 

performed in physicians’ offices; 

• Limited to procedures requiring a 

dedicated operating room or suite and 

generally requiring a post-operative 

recovery room or short term (not 

overnight) convalescent room; and 

• Not otherwise excluded from 

Medicare coverage. 

Specific standards in § 416.65(b) limit 

ASC procedures to those that do not 

generally exceed 90 minutes operating 

time and a total of 4 hours recovery or 

convalescent time. If anesthesia is 

required, the anesthesia must be local or 

regional anesthesia, or general 

anesthesia of not more than 90 minutes 

duration.

Section 416.65(c) excludes from the 

ASC list procedures that generally result 

in extensive blood loss, that require 

major or prolonged invasion of body 

cavities, that directly involve major 

blood vessels, or that are generally 

emergency or life-threatening in nature. 

2. Criteria for Additions to or Deletions 

From the ASC List 

In April 1987, we adopted 

quantitative criteria as a tool for 

identifying procedures that were 

commonly performed either in a 

hospital inpatient setting or in a 

physician’s office. Collectively, 

commenters responding to a notice 

published on February 16, 1984 in the 

Federal Register (49 FR 6023) had 

recommended that virtually every 

surgical CPT code be included on the 

ASC list. Consulting with other 

specialist physicians and medical 

organizations as appropriate, our 

medical staff reviewed the 

recommended additions to the list to 

determine which code or series of codes 

were appropriately performed on an 

ambulatory basis within the framework 

of the regulatory criteria in § 416.65. 

However, when we arrayed the 

proposed procedures by the site where 

they were most frequently performed 

according to our claims payment data 

files (1984 Part B Medicare Data 

(BMAD)), we found that many codes 

were not commonly performed on an 

inpatient basis or were performed in a 

physician’s office the majority of the 

time, and, thus, would not meet the 

standards in our regulations. Therefore, 

we decided that if a procedure was 

performed on an inpatient basis 20 

percent of the time or less, or in a 

physician’s office 50 percent of the time 

or more, it would be excluded from the 

ASC list. (See Federal Register April 21, 

1987 (52 FR 13176).) 

At the time, we believed that these 

utilization thresholds best reflected the 

legislative objectives of moving 

procedures from the more expensive 

hospital inpatient setting to the less 

expensive ASC setting without 

encouraging the migration of procedures 

from the less expensive physician’s 

office setting to the ASC. We applied 

these quantitative standards not only to 

codes proposed for addition to the ASC 

list, but also to the codes that were 

currently on the list, to delete codes that 

did not meet the thresholds. 

The trend towards performing surgery 

on an ambulatory or outpatient basis 

grew steadily, and, by 1995, we 

discovered that a number of procedures 

that were on the ASC list at the time fell 

short of the 20 percent and 50 percent 

thresholds even though the procedures 

were obviously appropriate in the ASC 

setting. The most notable of these was 

cataract extraction with intraocular lens 

insertion, very few cases of which were 

being performed on an inpatient basis 

by the early 1990s. We were also 

excluding from the ASC list certain 

69180 Federal Register / Vol. 69, No. 227 / Friday, November 26, 2004 / Proposed Rules 

newer procedures, such as CPT code 

66825, Repositioning of intraocular lens 

prosthesis, requiring an incision 

(separate procedure), that were rarely 

performed on a hospital inpatient basis 

but that were appropriate for the ASC 

setting. Strict adherence to the same 20 

percent and 50 percent thresholds both 

to add and remove procedures did not 

provide latitude for minor fluctuations 

in utilization across settings or errors 

that could occur in the site-of-service 

data drawn from the National Claims 

History File that we were then using, 

replacing BMAD data, for analysis. 

In an effort to avoid these anomalies 

but still retain a relatively objective 

standard for determining which 

procedures should comprise the ASC 

list, we adopted in the Federal Register

notice published on January 26, 1995 

(60 FR 5185) a modified standard for 

deleting procedures already on the list. 

We deleted from the list only those 

procedures whose combined inpatient, 

hospital outpatient, and ASC site of 

service volume was less than 46 percent 

of the procedure’s total volume and that 

were either performed 50 percent of the 

time or more in the physician’s office or 

10 percent of the time or less in an 

inpatient hospital setting. We retained 

the 20 percent and 50 percent standard 

to determine which procedures would 

be appropriate additions to the ASC list.

D. Office of the Inspector General 

Recommendations, January 2003 

In January 2003, the Office of the 

Inspector General (OIG) issued the 

results of a study entitled ‘‘Payments for 

Procedures in Outpatient Departments 

and Ambulatory Surgical Centers’ (OEI–

05–00–00340). The objective of that 

study was to determine the extent to 

which Medicare payments for the same 

procedure codes continue to vary 

between hospital outpatient 

departments and ambulatory surgical 

centers and to assess the effect of this 

variance on the Medicare program. 

The OIG concluded, as a result of its 

study, that there should be a greater 

parity of payments for services 

performed in an outpatient setting and 

those performed in ASCs. The OIG 

based this conclusion both on its belief 

that the Congress intended Medicare to 

be a prudent purchaser of services and 

to pay only for those costs that are 

necessary for the efficient delivery of 

needed health services and on its 

finding that disparities in Medicare 

payment amounts for the same services 

furnished in ASCs and hospital 

outpatient departments resulted in an 

estimated $1.1 billion in additional 

Medicare program payments. The OIG 

also found that CMS’s failure to remove 

certain procedure codes from the list of 

ASC-approved procedures resulted in 

an estimated $8 to $14 million in 

additional Medicare program payments. 

The OIG recommended that we—

• Seek authority to set rates that are 

consistent across sites and reflect only 

the costs necessary for the efficient 

delivery of health services, 

• Conduct and use timely ASC-survey 

data to reevaluate ASC-payment rates, 

and 

• Remove the procedure codes that 

meet our criteria for removal from the 

ASC list of covered procedures. (In its 

final report, the OIG included a list of 

72 CPT codes that it found, based on its 

analysis of calendar year 1999 data, met 

our criteria for deletion from the ASC 

list.) 

In our response to the OIG’s 

recommendations, we indicated that we 

would consider the OIG’s first 

recommendation as we develop future 

legislative proposals. In response to the 

second recommendation, we indicated 

our concerns about using survey data as 

the basis for setting ASC payment rates 

and that we were considering how to 

implement the survey requirement. 

(Enactment of section 626(b) of the 

MMA repealing the survey requirement 

and mandating implementation of a 

revised payment system in accordance 

with certain requirements set forth in 

the MMA supersedes our earlier 

response to this OIG recommendation.) 

In this proposed notice, we are taking 

action to address the OIG’s third 

recommendation, that we remove codes 

that meet our criteria for deletion from 

the ASC list. We did not address this 

recommendation in the March 28, 2003 

final rule with comment period, because 

we had not provided an opportunity for 

public comment on the OIG’s 

recommended deletions prior to 

issuance of the March 28, 2003 final 

rule. However, in this proposed notice, 

we are proposing to remove 54 of the 72 

procedure codes recommended by the 

OIG for deletion from our current list. 

These codes are included in the list of 

proposed deletions in Table 2. In 

section II.C. of this proposed notice, we 

discuss why we are proposing to retain 

11 of the procedures recommended for 

deletion by the OIG. Seven codes 

proposed for deletion by the OIG were 

removed from the ASC list effective July 

1, 2003.

E. Current ASC Payment Rates 

Procedures on the ASC list are 

assigned to one of nine payment groups 

based on our estimate of the costs 

incurred by the facility to perform a 

procedure. Payment groups 1 through 8 

were first implemented in September 

1990, based on a survey of ASC costs 

conducted in 1986 (55 FR 4539). 

Payment group 9 was added on 

December 31, 1991 (56 FR 67666) to 

establish a payment rate for 

extracorporeal shockwave lithotripsy 

(ESWL). There is no clinical consistency 

among the procedures in a payment 

group. Rather, assignment to a payment 

group is based solely on an estimate of 

facility costs associated with performing 

the procedures. 

In a proposed rule published on June 

12, 1998 in the Federal Register (63 FR 

32290), we proposed a new ratesetting 

methodology based on ambulatory 

payment classification (APC) groups 

that were proposed for the new hospital 

outpatient prospective payment system 

(OPPS). We used data from a survey of 

ASC costs collected in 1994 as the basis 

for the APC payment rates in the June 

12, 1998 proposed rule. The Balanced 

Budget Refinement Act of 1999 (BBRA) 

(Pub. L. 106–113) required us to phase 

in full implementation of the proposed 

ASC rates over a 3-year period. The 

Medicare, Medicaid and SCHIP Benefit 

Improvement and Protection Act of 

2000 (BIPA) (Pub. L. 106–554) 

prohibited implementation of a revised 

prospective payment system for ASCs 

before January 1, 2002 and required 

that, by January 1, 2003, ASC rates be 

rebased using data from a 1999 or later 

Medicare survey of ASC costs. 

We discuss in the final rule published 

on March 28, 2003 in the Federal 

Register (68 FR 15270) the reasons why 

we did not implement the requirements 

set forth in BBRA and BIPA with regard 

to rebasing ASC payment rates. The 

March 28, 2003 final rule with comment 

period implemented additions to and 

deletions from the ASC list that had 

been proposed in the June 12, 1998 

proposed rule, but did not implement 

any of the other proposed changes, 

including the proposed ratesetting 

methodology. We indicated that we 

were studying approaches to ratesetting, 

some of which may require legislative 

changes. 

Section 626(b) of MMA repeals the 

requirement that we conduct a survey of 

ASC costs as the basis for rebasing ASC 

rates and requires us to implement a 

revised payment system between 

January 1, 2006 and January 1, 2008, 

that takes into account 

recommendations in the report to the 

Congress that is to be submitted by 

January 1, 2005 by the Comptroller 

General of the United States. Section 

626(b)(1) amends section 1833(i)(2) of 

Act, requiring us to base payment for 

ASC services on survey data prior to 

implementation of the revised payment 

system. Therefore, the proposed 

Federal Register / Vol. 69, No. 227 / Friday, November 26, 2004 / Proposed Rules 69181

additions to the ASC list in this 

proposed notice are assigned to one of 

the existing nine ASC payment groups 

and rates that are derived from data 

collected in the 1986 survey of ASC 

costs, updated for inflation. The 

proposed payment group for each 

addition to the ASC list in this proposed 

notice is based on the payment group to 

which procedures currently on the list, 

which our medical advisors judged to be 

similar in terms of time and resource 

inputs, are assigned. As of April 1, 2004, 

in accordance with the requirements in 

section 626(a) of MMA and instructions 

that we issued to our contractors who 

process ASC claims in Transmittal 51, 

Change Request 3082, on February 6, 

2004, the ASC payment rates are the 

following:

Group 1, $333 

Group 2, $446 

Group 3, $510 

Group 4, $630 

Group 5, $717 

Group 6, $826 ($676 plus $150 for IOL) 

Group 7, $995 

Group 8, $973 ($823 plus $150 for IOL) 

Group 9, $1339 

II. Provisions of the Proposed Notice 

A. Proposed Additions

(If you choose to comment on issues in this 

section, please include the caption 

‘‘PROPOSED ADDITIONS’’ at the beginning 

of your comments.)

1. Proposed Additions Recommended 

by Commenters and Other Interested 

Parties 

Commenters recommended that the 

codes in Table 1 be added to the list of 

Medicare-approved ASC procedures. 

These proposed additions are based on 

comments and recommendations that 

have been communicated to us by trade 

associations, medical specialty societies, 

physicians, ASC staff, and other 

individuals and organizations since the 

close of the extended comment period 

for the June 12, 1998 proposed rule, 

which ended July 30, 1999. After careful 

review by our medical staff to determine 

whether these procedures are consistent 

with our criteria (see section I.C.2 of this 

proposed notice), we agree with 

commenters that the procedures in 

Table 1 are appropriate and safely 

performed in an ASC setting. Therefore, 

we are proposing to add the following 

CPT codes to the ASC list and to assign 

them to the payment group that is 

designated for each code:

TABLE 1.—PROPOSED ADDITIONS RECOMMENDED BY COMMENTERS AND OTHER INTERESTED PARTIES

HCPCS code Short descriptor Payment group Payment amount 

15001 ........................................................................................ Skin graft add-on ...................................... 1 $333 

15836 ........................................................................................ Excise excessive skin tissue .................... 3 510 

15839 ........................................................................................ Excise excessive skin tissue .................... 3 510 

21120 ........................................................................................ Reconstruction of chin .............................. 7 995 

21125 ........................................................................................ Augmentation, lower jaw bone ................. 7 995 

29873 ........................................................................................ Knee arthroscopy/surgery ......................... 3 510 

30220 ........................................................................................ Insert nasal septal button ......................... 3 510 

31500 ........................................................................................ Insert emergency airway .......................... 1 333 

31603 ........................................................................................ Incision of windpipe .................................. 1 333 

35475 ........................................................................................ Repair arterial blockage ............................ 9 1,339 

35476 ........................................................................................ Repair venous blockage ........................... 9 1,339 

36834 ........................................................................................ Repair AV aneurysm ................................ 3 510 

37205 ........................................................................................ Transcatheter stent ................................... 9 1,339 

37206 ........................................................................................ Transcatheter stent add-on ...................... 9 1,339 

37500 ........................................................................................ Endoscopy ligate perf veins ..................... 3 510 

42665 ........................................................................................ Ligation of salivary duct ............................ 7 995 

44397 ........................................................................................ Colonoscopy w/stent ................................. 1 333 

45327 ........................................................................................ Proctosigmoidoscopy w/stent ................... 1 333 

45341 ........................................................................................ Sigmoidoscopy w/ultrasound .................... 1 333 

45342 ........................................................................................ Sigmoidoscopy w/us guide bx .................. 1 333 

45345 ........................................................................................ Sigmoidoscopy w/stent ............................. 1 333 

45387 ........................................................................................ Colonoscopy w/stent ................................. 1 333 

57288 ........................................................................................ Repair bladder defect ............................... 5 717 

62264 ........................................................................................ Epidural lysis on single day ...................... 1 333 

67343 ........................................................................................ Release eye tissue ................................... 7 995 

2. CPT Code Changes in 2004 

Effective for services furnished on or 

after January 1, 2004, we revised the 

ASC list to reflect changes in the 2004 

CPT (Transmittal AB–03–137, Change 

Request 2890, issued August 29, 2003). 

We deleted from the ASC list the 

following codes that were discontinued 

in the 2004 CPT:

HCPCS code Short descriptor 

36488 ................................................................................................................................................... Insertion of catheter, vein. 

36489 ................................................................................................................................................... Insertion of catheter, vein. 

36490 ................................................................................................................................................... Insertion of catheter, vein. 

36491 ................................................................................................................................................... Insertion of catheter, vein. 

36530 ................................................................................................................................................... Insertion of infusion pump. 

36531 ................................................................................................................................................... Revision of infusion pump. 

36532 ................................................................................................................................................... Removal of infusion pump. 

36533 ................................................................................................................................................... Insertion of access device. 

36534 ................................................................................................................................................... Revision of access device. 

36535 ................................................................................................................................................... Removal of access device. 

69182 Federal Register / Vol. 69, No. 227 / Friday, November 26, 2004 / Proposed Rules 

We added to the ASC list the 

following new codes created in the 2004 

CPT to replace the discontinued codes:

HCPCS code Short descriptor Payment group Payment amount 

36555 ........................................................................................ Insert non-tunnel cv cath .......................... 1 $333 

36556 ........................................................................................ Insert non-tunnel cv cath .......................... 1 333 

36557 ........................................................................................ Insert tunneled cv cath ............................. 2 446 

36558 ........................................................................................ Insert tunneled cv cath ............................. 2 446 

36560 ........................................................................................ Insert tunneled cv cath ............................. 3 510 

36561 ........................................................................................ Insert tunneled cv cath ............................. 3 510 

36563 ........................................................................................ Insert tunneled cv cath ............................. 3 510 

36565 ........................................................................................ Insert tunneled cv cath ............................. 3 510 

36566 ........................................................................................ Insert tunneled cv cath ............................. 3 510 

36568 ........................................................................................ Insert tunneled cv cath ............................. 1 333 

36569 ........................................................................................ Insert tunneled cv cath ............................. 1 333 

36570 ........................................................................................ Insert tunneled cv cath ............................. 3 510 

36571 ........................................................................................ Insert tunneled cv cath ............................. 3 510 

36575 ........................................................................................ Repair tunneled cv cath ............................ 2 446 

36576 ........................................................................................ Repair tunneled cv cath ............................ 2 446 

36578 ........................................................................................ Replace tunneled cv cath ......................... 2 446 

36580 ........................................................................................ Replace tunneled cv cath ......................... 1 333 

36581 ........................................................................................ Replace tunneled cv cath ......................... 2 446 

36582 ........................................................................................ Replace tunneled cv cath ......................... 3 510 

36583 ........................................................................................ Replace tunneled cv cath ......................... 3 510 

36584 ........................................................................................ Replace tunneled cv cath ......................... 1 333 

36585 ........................................................................................ Replace tunneled cv cath ......................... 3 510 

36589 ........................................................................................ Removal tunneled cv cath ........................ 1 333 

36590 ........................................................................................ Removal tunneled cv cath ........................ 1 333 

B. Proposed Deletions

(If you choose to comment on issues in this 

section, please include the caption 

‘‘PROPOSED DELETIONS’’ at the beginning 

of your comments.)

Our medical advisors, in accordance 

with the statutory requirement that we 

review and update the ASC list at least 

every two years, reviewed the current 

ASC list against the criteria discussed in 

section I.C.2 of this proposed rule. We 

also carefully considered and took into 

account deletions recommended by 

medical specialty societies and other 

commenters. Further, we reviewed the 

codes that the OIG recommended be 

deleted from the ASC list. (See section 

I.D. of this proposed rule). In most 

cases, our medical advisors agreed that 

the procedures recommended by the 

OIG for deletion no longer meet the 

criteria for ASC procedures, and we are 

proposing to delete most of those codes 

from the ASC list, as indicated in Table 

2. We removed the following seven 

codes recommended for deletion by the 

OIG from the ASC list effective July 1, 

2003: 21920, 42104, 51725, 56405, 

56605, 62367, and 62368. However, 

there are 11 codes the OIG 

recommended for deletion that we 

believe should remain on the ASC list 

for reasons that we discuss in section 

II.C of this proposed notice. Based on 

our review, we are proposing to delete 

from the ASC list the codes listed in 

Table 2, for the reasons specified. 

Rationale for deletion is indicated as 

follows: 

1. Procedure is performed in 

physician’s office more than 50 percent 

of the time. 

2. Medical specialty organizations 

recommended deletion because of safety 

concerns.

3. Procedure is performed 

predominantly in the inpatient setting. 

4. OIG recommended for deletion and 

CMS medical advisors concur.

TABLE 2.—PROPOSED DELETIONS FROM THE ASC LIST

HCPCS code Short descriptor Rationale 

11404 ................................................................................................................... Removal of skin lesion .................................. 4 

11424 ................................................................................................................... Removal of skin lesion .................................. 4 

11444 ................................................................................................................... Removal of skin lesion .................................. 4 

11446 ................................................................................................................... Removal of skin lesion .................................. 4 

11604 ................................................................................................................... Removal of skin lesion .................................. 4 

11624 ................................................................................................................... Removal of skin lesion .................................. 4 

11644 ................................................................................................................... Removal of skin lesion .................................. 4 

12021 ................................................................................................................... Closure of split wound .................................. 4 

13100 ................................................................................................................... Repair of wound or lesion ............................. 4 

13101 ................................................................................................................... Repair of wound or lesion ............................. 4 

13120 ................................................................................................................... Repair of wound or lesion ............................. 4 

13121 ................................................................................................................... Repair of wound or lesion ............................. 4 

13131 ................................................................................................................... Repair of wound or lesion ............................. 4 

13132 ................................................................................................................... Repair of wound or lesion ............................. 4 

13150 ................................................................................................................... Repair of wound or lesion ............................. 4 

13151 ................................................................................................................... Repair of wound or lesion ............................. 4 

13152 ................................................................................................................... Repair of wound or lesion ............................. 4 

14000 ................................................................................................................... Skin tissue rearrangement ............................ 4 

14020 ................................................................................................................... Skin tissue rearrangement ............................ 4 

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TABLE 2.—PROPOSED DELETIONS FROM THE ASC LIST—Continued

HCPCS code Short descriptor Rationale 

14021 ................................................................................................................... Skin tissue rearrangement ............................ 4 

14040 ................................................................................................................... Skin tissue rearrangement ............................ 4 

14041 ................................................................................................................... Skin tissue rearrangement ............................ 4 

14060 ................................................................................................................... Skin tissue rearrangement ............................ 4 

14061 ................................................................................................................... Skin tissue rearrangement ............................ 4 

15732 ................................................................................................................... Muscle-skin graft, head/neck ........................ 2 

15734 ................................................................................................................... Muscle-skin graft, trunk ................................. 2 

15738 ................................................................................................................... Muscle-skin graft, leg .................................... 2 

15740 ................................................................................................................... Island pedicle flap graft ................................. 4 

19100 ................................................................................................................... Bx breast percut w/o image .......................... 4 

20670 ................................................................................................................... Removal of support implant .......................... 4 

21040 ................................................................................................................... Removal of jaw bone lesion .......................... 1 

21050 ................................................................................................................... Removal of jaw joint ...................................... 2 

21206 ................................................................................................................... Reconstruct upper jaw bone ......................... 1 

21210 ................................................................................................................... Face bone graft ............................................. 1 

21249 ................................................................................................................... Reconstruction of jaw .................................... 1 

21325 ................................................................................................................... Treatment of nose fracture ........................... 1 

21355 ................................................................................................................... Treat cheek bone fracture ............................. 1 

21440 ................................................................................................................... Treat dental ridge fracture ............................ 1 

21485 ................................................................................................................... Reset dislocated jaw ..................................... 1 

22305 ................................................................................................................... Treat spine process fracture ......................... 4 

23600 ................................................................................................................... Treat humerus fracture ................................. 4 

23620 ................................................................................................................... Treat humerus fracture ................................. 4 

24576 ................................................................................................................... Treat humerus fracture ................................. 1 

24670 ................................................................................................................... Treat ulnar fracture ....................................... 4 

25505 ................................................................................................................... Treat fracture of radius ................................. 1 

26605 ................................................................................................................... Treat metacarpal fracture .............................. 4 

27520 ................................................................................................................... Treat kneecap fracture .................................. 4 

27760 ................................................................................................................... Treatment of ankle fracture ........................... 4 

27780 ................................................................................................................... Treatment of fibula fracture ........................... 4 

27786 ................................................................................................................... Treatment of ankle fracture ........................... 4 

27808 ................................................................................................................... Treatment of ankle fracture ........................... 4 

28400 ................................................................................................................... Treatment of heel fracture ............................ 4 

30801 ................................................................................................................... Cauterization, inner nose .............................. 4 

30915 ................................................................................................................... Ligation, nasal sinus artery ........................... 2 

30920 ................................................................................................................... Ligation, upper jaw artery ............................. 2 

31233 ................................................................................................................... Nasal/sinus endoscopy, dx ........................... 4 

31235 ................................................................................................................... Nasal/sinus endoscopy, dx ........................... 4 

31237 ................................................................................................................... Nasal/sinus endoscopy, surg ........................ 4 

31238 ................................................................................................................... Nasal/sinus endoscopy, surg ........................ 4 

38505 ................................................................................................................... Needle biopsy, lymph nodes ......................... 4 

40700 ................................................................................................................... Repair cleft lip/nasal ...................................... 2 

40701 ................................................................................................................... Repair cleft lip/nasal ...................................... 2 

40814 ................................................................................................................... Excise/repair mouth lesion ............................ 4 

41009 ................................................................................................................... Drainage of mouth lesion .............................. 1 

41010 ................................................................................................................... Incision of tongue fold ................................... 1 

41112 ................................................................................................................... Excision of tongue lesion .............................. 4 

41520 ................................................................................................................... Reconstruction, tongue fold .......................... 1 

41800 ................................................................................................................... Drainage of gum lesion ................................. 1 

41827 ................................................................................................................... Excision of gum lesion .................................. 1 

42000 ................................................................................................................... Drainage mouth roof lesion ........................... 1 

42107 ................................................................................................................... Excision lesion, mouth roof ........................... 1 

42200 ................................................................................................................... Reconstruct cleft palate ................................ 2 

42205 ................................................................................................................... Reconstruct cleft palate ................................ 2 

42210 ................................................................................................................... Reconstruct cleft palate ................................ 2 

42215 ................................................................................................................... Reconstruct cleft palate ................................ 2 

42220 ................................................................................................................... Reconstruct cleft palate ................................ 2 

42409 ................................................................................................................... Drainage of salivary cyst ............................... 1 

42425 ................................................................................................................... Excise parotid gland/lesion ........................... 3 

42860 ................................................................................................................... Excision of tonsil tags ................................... 1 

42892 ................................................................................................................... Revision pharyngeal walls ............................ 3 

52000 ................................................................................................................... Cystoscopy .................................................... 4 

52281 ................................................................................................................... Cystoscopy and treatment ............................ 4 

53850 ................................................................................................................... Prostatic microwave thermotx ....................... 1 

55700 ................................................................................................................... Biopsy of prostate ......................................... 4 

58820 ................................................................................................................... Drain ovary abscess, open ........................... 3 

60000 ................................................................................................................... Drain thyroid/tongue cyst .............................. 1 

64420 ................................................................................................................... N block inj, intercost, sng .............................. 4 

64430 ................................................................................................................... N block inj, pudendal .................................... 1 

64736 ................................................................................................................... Incision of chin nerve .................................... 1 

65800 ................................................................................................................... Drainage of eye ............................................. 1 

65805 ................................................................................................................... Drainage of eye ............................................. 4 

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TABLE 2.—PROPOSED DELETIONS FROM THE ASC LIST—Continued

HCPCS code Short descriptor Rationale 

67141 ................................................................................................................... Treatment of retina ........................................ 4 

68340 ................................................................................................................... Separate eyelid adhesions ............................ 1 

68810 ................................................................................................................... Probe nasolacrimal duct ............................... 4 

69145 ................................................................................................................... Remove ear canal lesion(s) .......................... 4 

69450 ................................................................................................................... Eardrum revision ........................................... 2 

69725 ................................................................................................................... Release facial nerve ..................................... 1 

69740 ................................................................................................................... Repair facial nerve ........................................ 2 

69745 ................................................................................................................... Repair facial nerve ........................................ 2 

69840 ................................................................................................................... Revise inner ear window ............................... 1 

C. Procedures Recommended for 

Deletion by OIG That We Propose To 

Retain on the ASC List

(If you choose to comment on issues in this 

section, please include the caption 

‘‘DELETIONS RECOMMENDED BY OIG’’ at 

the beginning of your comments.)

Our medical staff carefully reviewed 

the 72 codes recommended by the OIG 

for deletion from the ASC list to 

determine if they meet the criteria for 

ASC procedures. We agreed that 54 of 

the codes on the current ASC list 

recommended for deletion by the OIG 

no longer meet our criteria, and we are 

proposing to delete them from the ASC 

list (see Table 2). However, our medical 

advisors determined that for health and 

safety reasons, the following codes 

should be retained on the list:

HCPCS code Short descriptor 

30802 ................................................................................................................................................... Cauterization, inner nose. 

31525 ................................................................................................................................................... Diagnostic laryngoscopy. 

31570 ................................................................................................................................................... Laryngoscopy with injection. 

45305 ................................................................................................................................................... Proctosigmoidoscopy w/bx. 

46050 ................................................................................................................................................... Incision of anal abscess. 

51710 ................................................................................................................................................... Change of bladder tube. 

51726 ................................................................................................................................................... Complex cystometrogram. 

51772 ................................................................................................................................................... Urethra pressure profile. 

52285 ................................................................................................................................................... Cystoscopy and treatment. 

67031 ................................................................................................................................................... Laser surgery, eye strands. 

67921 ................................................................................................................................................... Repair eyelid defect. 

CPT codes 30802, 31525 and 31570, 

according to our 2002 claims data, are 

being performed less than 50 percent in 

a physician office. Therefore, we are 

retaining these codes on the ASC list. 

While the remaining eight procedures 

may be safely performed in a 

physician’s office for the majority of 

patients, our medical advisors believe 

that, in certain cases, the patient’s 

health or medical condition may 

demand the more extensive services 

afforded by ASCs in order to ensure a 

safe surgical outcome. Therefore, we are 

proposing not to delete these codes from 

the ASC list. 

D. Proposed Changes in Response to 

Public Comments on the March 28, 2003 

Final Rule With Comment Period 

Only certain designated codes that we 

identified in the Addendum of the 

March 28, 2003 final rule with comment 

period published in the Federal 

Register (68 FR 15268) were subject to 

public comment during the 60-day 

comment period following publication 

of the rule. That is, we solicited 

comment on new codes created by CPT 

in 1999, 2000, 2001, 2002, and 2003 that 

we believe meet our criteria for the ASC 

list, but were not included in the 

additions to the ASC list that we 

proposed in the June 12, 1998 proposed 

rule and, therefore, were not among the 

proposed additions to the ASC list that 

we made final in the March 2003 final 

rule with comment period. We received 

more than 100 timely comments, the 

overwhelming majority of which 

addressed payment rates, codes, and 

issues other than the designated codes 

for which comments were solicited. 

Because these other issues were not 

subject to public comment, we are not 

responding to comments on them in this 

proposed notice. However, we did 

review recommended additions to and 

deletions from the ASC list and, where 

appropriate, we included those codes in 

Table 1 and Table 2, above. Only seven 

commenters addressed the designated 

codes that were subject to public 

comment. 

None of the commenters disagreed 

with the designated codes for which we 

requested comment on as additions to 

the ASC list. However, the seven 

commenters that addressed the 

designated codes that were subject to 

public comment disagreed with the 

payment group assignments for several 

of those codes. We address those 

comments below.

Comment: Seven commenters 

recommended that the following CPT 

codes be assigned to a higher payment 

group for which we requested comment 

in the March 28, 2003 final rule with 

comment period: CPT codes 29827, 

43231, 43232, 43240, 43242, 43256, 

52344, 52345, and 52346. 

Response: We did not make final the 

payment groups and rates based on data 

collected in a 1994 survey of ASC costs 

that we had proposed in the June 12, 

1998 proposed rule. Because provisions 

in BIPA prohibited us from using the 

1994 survey data to set rates, we had no 

data upon which to base payment rate 

assignments or changes in the March 28, 

2003 final rule with comment period. 

Therefore, we assigned both the 

proposed and final additions to the ASC 

list in the March 28 final rule with 

comment period to payment groups to 

which related codes already on the list, 

that are similar in terms of time and 

resource inputs, are assigned. Although 

commenters expressed concern that the 

payment group assignments for the nine 

codes listed above were too low, they 

did not furnish information or data to 

demonstrate that resource costs for the 

codes were similar to resource costs 

associated with codes in higher 

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payment groups. We reviewed the 

payment group assignments proposed 

for the nine codes cited by the 

commenters, and our medical advisors 

determined that, in the absence of 

corroborative data to the contrary, the 

payment groups proposed for the codes 

were appropriate and consistent with 

the method we explained in the March 

28, 2003 final rule. Therefore, we are 

not proposing changes based on these 

comments in this proposed rule. 

III. Collection of Information 

Requirements 

This document does not impose 

information collection and 

recordkeeping requirements. 

Consequently, it need not be reviewed 

by the Office of Management and 

Budget under the authority of the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 35). 

IV. Response to Comments 

Because of the large number of public 

comments we normally receive on 

Federal Register documents, we are not 

able to acknowledge or respond to them 

individually. We will consider all 

comments we receive by the date and 

time specified in the ‘‘DATES’’ section 

of this preamble, and, when we proceed 

with a subsequent document, we will 

respond to the comments in the 

preamble to that document. 

V. Regulatory Impact Statement 

A. Overall Impact

We have examined the impact of this 

proposed rule as required by Executive 

Order 12866 (September 1993, 

Regulatory Planning and Review), the 

Regulatory Flexibility Act (RFA) 

(September 16, 1980, Pub. L. 96–354), 

section 1102(b) of the Social Security 

Act, the Unfunded Mandates Reform 

Act of 1995 (Pub. L. 104–4), and 

Executive Order 13132. 

Executive Order 12866 directs 

agencies to assess all costs and benefits 

of available regulatory alternatives and, 

if regulation is necessary, to select 

regulatory approaches that maximize 

net benefits (including potential 

economic, environmental, public health 

and safety effects, distributive impacts, 

and equity). A regulatory impact 

analysis (RIA) must be prepared for 

major rules with economically 

significant effects ($100 million or more 

in any 1 year). Our Actuary has 

prepared a fiscal impact estimate. As 

shown in the table below, for fiscal 

years 2005 through 2009, the effect on 

Medicare program expenditures if we 

implement the additions to and 

deletions from the ASC list proposed in 

this proposed rule is estimated to have 

zero impact in 2005, increasing to $20 

million savings per year from 2007 

through 2009. We expect the estimated 

savings to result from procedures 

proposed for deletion moving to a less 

costly office or clinic setting, and 

proposed additions shifting to ASCs 

from the more costly hospital setting. 

Therefore, this notice will not have a 

major impact on the Medicare budget.

FY 

Cost

(tens of $ 

millions) 

2005 .......................................... 0 

2006 .......................................... ¥10 

2007 .......................................... ¥20 

2008 .......................................... ¥20 

2009 .......................................... ¥20 

The RFA requires agencies to analyze 

options for regulatory relief of small 

businesses. For purposes of the RFA, 

small entities include small businesses, 

nonprofit organizations, and 

government agencies. Most hospitals 

and most other providers and suppliers 

are small entities, either because of their 

nonprofit status or because they have 

revenues of $6 million to $29 million in 

any 1 year. According to small business 

associations, approximately 73 percent 

of all ASCs are considered small entities 

because they have revenues of $11.5 

million or less. Individuals and States 

are not included in the definition of a 

small entity. 

Section 1102(b) of the Act requires us 

to prepare a regulatory impact analysis 

if a proposed rule may have a significant 

impact on the operations of a substantial 

number of small rural hospitals. This 

analysis must conform to the provisions 

of section 604 of the RFA. For purposes 

of section 1102(b) of the Act, we define 

a small rural hospital as a hospital that 

is located outside of a Metropolitan 

Statistical Area and has fewer than 100 

beds. This notice does not have a 

significant impact on the operations of 

small rural hospitals. 

Section 202 of the Unfunded 

Mandates Reform Act of 1995 also 

requires that agencies assess anticipated 

costs and benefits before issuing any 

rule that may result in expenditure in 

any 1 year by State, local or tribal 

governments, in the aggregate, or by the 

private sector, of $110 million. This 

proposed rule will not have an effect on 

the governments mentioned, and the 

private sector costs will be less than the 

$110 million threshold. 

Executive Order 13132 establishes 

certain requirements that an agency 

must meet when it promulgates a final 

rule that imposes substantial direct 

requirement costs on State and local 

governments, preempts State law, or 

otherwise has Federalism implications. 

This rule will not have a substantial 

effect on State or local governments. 

B. Anticipated Effects 

The entities affected by this proposed 

notice are Medicare certified ASCs, 

physician offices and clinics, hospitals, 

and beneficiaries. No other providers 

are affected. This proposed rule will not 

affect State or local governments. There 

are more than 3,000 ASCs currently 

certified by Medicare, nearly threequarters of which fit the definition of a 

‘‘small entity’’. 

This proposed rule would add 25 CPT 

codes to the ASC list of approved 

procedures. Professional societies, 

physicians, ASC administrators, and 

ASC associations recommended most of 

the codes proposed for addition to the 

ASC list. Currently, the procedures that 

we propose to add to the ASC list are 

performed predominantly in a hospital 

outpatient setting. Our medical advisors 

agree that the proposed additions meet 

the criteria for ASC procedures that are 

discussed in section I.C.2 of this 

preamble and that they can be safely 

and appropriately performed in an ASC.

Currently, if ASCs perform the 25 

procedures proposed for addition, 

Medicare does not allow payment of an 

ASC facility fee. By adding these 

procedures to the ASC list, ASCs would 

benefit because Medicare would allow 

payment of a facility fee for the 

procedures. ASCs could serve a greater 

number of beneficiaries if they are able 

to offer an increased number of surgical 

services, and beneficiaries would have 

an additional setting from which to 

choose were it necessary for them to 

have one of these surgical procedures 

performed. We expect that most of the 

physician office volume for the 

proposed additions will, to the limited 

extent they are performed in physician 

offices, migrate to an ASC setting. This 

would increase Medicare program 

spending and beneficiary copayment 

amounts because the ASC facility fee for 

these procedures exceeds the practice 

expense payment that is allowed when 

the procedures are performed in an 

office setting. However, cases would 

also move to the ASC setting from 

hospital outpatient departments. To the 

extent that hospital outpatient 

utilization decreases and ASC 

utilization increases, the Medicare 

program will realize a savings because 

the ASC facility fee for most of the 

proposed additions to the ASC list is 

lower than the payment rate for the 

same procedures under the OPPS. 

Beneficiary copayments will also 

decrease for those procedures for which 

69186 Federal Register / Vol. 69, No. 227 / Friday, November 26, 2004 / Proposed Rules 

the beneficiary coinsurance under the 

OPPS exceeds 20 percent. Because 

hospitals perform a much higher 

volume of ambulatory surgeries overall 

than are performed in ASCs, we do not 

expect significant hospital revenue 

losses from procedures proposed for 

addition to the ASC list shifting to the 

ASC setting. 

In addition, we are proposing to 

delete 105 procedures from the existing 

ASC list. There are a few codes that we 

are proposing to delete on the basis of 

recommendations from physicians or 

specialty societies because the 

procedures do not meet our safety 

criteria; however, these codes are very 

seldom performed in ASCs, so deleting 

these codes from the list will have no 

effect on ASCs or beneficiaries. As we 

explained above, most of the codes that 

we are proposing to delete are 

procedures that are being performed 

primarily in a physician office setting, 

and they do not require the more 

elaborate resources of an ASC to be 

safely performed. Because many of the 

procedures that we propose to delete 

from the ASC list are for reconstructive 

surgery, ASCs that limit their services to 

this specialty would no longer receive a 

Medicare facility fee for these 

procedures and could be adversely 

affected. However, we do not believe 

that deleting these procedures from the 

ASC list would limit beneficiary access 

or compromise patient safety because 

the procedures are being widely and 

safely performed in either an office or 

hospital outpatient setting. Further, the 

Medicare program would realize 

substantial savings from discontinuing 

payment to ASCs for the codes that we 

propose to delete from the ASC list 

because payment when these 

procedures are performed in a hospital 

or physician office setting is lower than 

the current ASC payments for the same 

procedures. 

For the above reasons, we are not 

preparing analyses for either the RFA or 

section 1102(b) of the Act because we 

have determined, and we certify, that 

this notice would not have a significant 

economic impact on a substantial 

number of small entities or a significant 

impact on the operations of a substantial 

number of small rural hospitals. 

C. Alternatives Considered 

We are issuing this proposed notice to 

meet a statutory requirement to update 

the list of approved ASC procedures 

biennially. We last updated the ASC list 

effective July 1, 2003. We implement the 

biennial update of the list through 

notice in the Federal Register and give 

interested parties an opportunity to 

comment on proposed additions to and 

deletions from the ASC list. If we do not 

update the ASC list by July 2005, we 

would be out of compliance with the 

statute, and we would be denying 

beneficiary access to surgical 

procedures in the ASC setting that meet 

our criteria and are safely and 

appropriately performed in an ASC. 

In accordance with the provisions of 

Executive Order 12866, this proposed 

regulation was reviewed by the Office of 

Management and Budget.

Authority: (Catalog of Federal Domestic 

Assistance Program No. 93.774, Medicare—

Supplementary Medical Insurance Program)

Dated: June 10, 2004. 

Mark B. McClellan, 

Administrator, Centers for Medicare Medicaid 

Services.

Approved: August 6, 2004. 

Tommy G. Thompson, 

Secretary.

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[FR Doc. 04–25968 Filed 11–19–04; 4:09 pm] 

BILLING CODE 4120–03–C


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