Tuesday,

January 6, 2004

Part IV

Department of 

Health and Human 

Services

Centers for Medicare & Medicaid Services 

42 CFR Part 419

Medicare Program; Hospital Outpatient 

Prospective Payment System; Payment 

Reform for Calendar Year 2004; Interim 

Final Rule

820 Federal Register / Vol. 69, No. 3 / Tuesday, January 6, 2004 / Rules and Regulations 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

42 CFR Part 419

[CMS–1371–IFC] 

RIN 0938–AM96

Medicare Program; Hospital Outpatient 

Prospective Payment System; 

Payment Reform for Calendar Year 

2004

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS.

ACTION: Interim final rule with comment 

period. 

SUMMARY: This interim final rule with 

comment period implements provisions 

of the Medicare Prescription Drug, 

Improvement, and Modernization Act 

(DIMA) of 2003 that affect the Medicare 

outpatient prospective payment system 

(OPPS) that become effective January 1, 

2004. Sections 303 and 621 of the DIMA 

include provisions that alter the 

methods for drug payment in hospital 

outpatient departments, some of which 

become effective January 1, 2004. These 

provisions affect the methodology for 

paying for pass-through and non-passthrough drugs under the OPPS. Further, 

the new law includes a requirement that 

all brachytherapy sources be paid 

separately. Section 411 of the DIMA 

reinstates the hold-harmless protection 

for small rural hospitals with fewer than 

100 beds and extends that protection to 

sole community hospitals in rural areas.

DATES: Effective date: January 1, 2004. 

Comment date: We will consider 

comments if we receive them at the 

appropriate address, as provided below, 

no later than 5 p.m. on March 8, 2004.

ADDRESSES: In commenting, please refer 

to file code CMS–1371–IFC. Because of 

staff and resource limitations, we cannot 

accept comments by facsimile (FAX) 

transmission or e-mail. 

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–1371–

IFC, P.O. Box 8018, Baltimore, MD 

21244–8018. 

Please allow sufficient time for mailed 

comments to be timely received in the 

event of delivery delays. 

If you prefer, you may deliver (by 

hand or courier) your written comments 

(one original and two copies) to one of 

the following addresses: Room 445–G, 

Hubert H. Humphrey Building, 200 

Independence Avenue, SW., 

Washington, DC 20201, or Room C5–14–

03, 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 

could be considered late. 

For information on viewing public 

comments, see the beginning of the 

SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT:

Dana Burley, (410) 786–0378.

SUPPLEMENTARY INFORMATION: Inspection 

of Public Comments: 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, call (410) 786–

7195. 

Availability of Copies and Electronic 

Access 

Copies: To order copies of the Federal 

Register containing this document, send 

your request to: New Orders, 

Superintendent of Documents, P.O. Box 

371954, Pittsburgh, PA 15250–7954. 

Specify the date of the issue requested 

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This Federal Register document is 

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service of the U.S. Government Printing 

Office. The Web site address is: http://

www.access.gpo.gov/nara/index.html.

I. Background 

A. Authority for the Outpatient 

Prospective Payment System 

When the Medicare statute was 

originally enacted, Medicare payment 

for hospital outpatient services was 

based on hospital-specific costs. In an 

effort to ensure that Medicare and its 

beneficiaries pay appropriately for 

services and to encourage more efficient 

delivery of care, the Congress mandated 

replacement of the cost-based payment 

methodology with a prospective 

payment system (PPS). The Balanced 

Budget Act of 1997 (BBA) (Pub. L. 105–

33), enacted on August 5, 1997, added 

section 1833(t) to the Social Security 

Act (the Act) authorizing 

implementation of a PPS for hospital 

outpatient services. The Balanced 

Budget Refinement Act of 1999 (BBRA) 

(Pub. L. 106–113), enacted on November 

29, 1999, made major changes that 

affected the hospital outpatient PPS 

(OPPS). The Medicare, Medicaid, and 

SCHIP Benefits Improvement and 

Protection Act of 2000 (BIPA) (Pub. L. 

106–554), enacted on December 21, 

2000, made further changes in the 

OPPS. The OPPS was first implemented 

for services furnished on or after August 

1, 2000. 

The Medicare Prescription Drug, 

Improvement, and Modernization Act of 

2003 (DIMA) (Pub. L. 108–173), enacted 

on December 8, 2003, made additional 

changes to the Act relating to the OPPS 

and calendar year 2004 payment rates to 

be implemented January 1, 2004. 

We would ordinarily publish a notice 

of proposed rulemaking in the Federal 

Register and invite public comment on 

the proposed rule. This procedure can 

be waived, however, if an agency finds 

good cause that a notice-and-comment 

procedure is impracticable, 

unnecessary, or contrary to the public 

interest and incorporates a statement of 

the finding and its reasons in the rule 

issued. We find good cause to waive 

notice and comment procedures for this 

correction notice as set forth in section 

IV, ‘‘Waiver of Proposed Rulemaking 

and Waiver of 30-Day Delay in the 

Effective Date,’’ below. 

B. Summary of Relevant Provisions of 

the DIMA 

The DIMA, enacted December 8, 2003, 

made the following changes to the Act 

that relate to the OPPS:

1. Transitional Corridor Payments 

Extended 

Section 411 of the DIMA amends 

section 1833(t)(7)(D)(i) of the Act and 

extends the hold-harmless provision for 

small rural hospitals. The hold harmless 

Federal Register / Vol. 69, No. 3 / Tuesday, January 6, 2004 / Rules and Regulations 821

transitional corridor payments will 

continue through December 31, 2005 for 

small rural hospitals having 100 or 

fewer beds. Section 411 of the DIMA 

further amends section 1833(t)(7) of the 

Act to provide that hold-harmless 

transitional corridor payments shall 

apply to sole community hospitals as 

defined in section 1886(d)(5)(D)(iii) of 

the Act and will continue through 

December 31, 2005. 

2. Payment for ‘‘Specified Covered 

Outpatient Drugs’’

Section 621(a)(1) of the DIMA amends 

the Act by adding section 1833(t)(14) 

that requires classification of separately 

paid radiopharmaceutical agents and 

drugs or biologicals that had transitional 

pass-through status on or before 

December 31, 2002, into 3 categories: 

innovator multiple source drugs; 

noninnovator multiple source drugs; 

and sole source drugs. Payment levels 

based on the reference average 

wholesale price are specified for each 

category. 

3. Payment for Drug or Biological Before 

HCPCS Code Assigned 

Section 621(a)(1) of the DIMA amends 

the Act by adding section 1833(t)(15), 

which requires that payment be made at 

95 percent of the average wholesale 

price (AWP) for new drugs and 

biologicals until a HCPCS code is 

assigned. 

4. Payment for Pass-Through Drugs 

Section 303(b) of the DIMA amends 

section 1842(o) of the Act. As a result, 

certain pass-through drugs are to be 

paid at 95 percent, and others at 85 

percent, of the AWP. Drugs and 

biologicals furnished during 2004 for 

which pass-through payment was first 

made on or after January 1, 2003 (which 

removes them from application of 

section 621 of the DIMA) and were 

approved by the FDA for marketing as 

of April 1, 2003, will be paid 85 percent 

of AWP pursuant to section 

1842(o)(1)(B) and 1842(o)(4)(A), unless 

sections 1842(o)(4)(B), (C) or (D) apply. 

Blood clotting factors furnished during 

2004, drugs or biologicals furnished 

during 2004 that were not available for 

payment as of April 1, 2003, vaccines 

furnished on or after January 1, 2004, 

and drugs or biologicals furnished 

during 2004 in connection with the 

renal dialysis services if billed by renal 

dialysis facilities, are paid at 95 percent 

of the reference AWP. Drugs or 

biologicals that were paid on a passthrough basis under the OPPS on or 

after January 1, 2003 and that were 

available for payment as of April 1, 2003 

are paid at 85 percent of the reference 

AWP rather than 95 percent as was 

previously the policy under section 

1842(o) of the Act. 

5. Exclude Separately Payable Drugs 

and Biologicals From Outlier Payments 

Section 621(a)(3) amends section 

1833(t)(5) of the Act to require that 

separately paid drugs and biologicals be 

excluded from outlier payments.

6. Brachytherapy Sources Are To Be 

Paid Separately 

Section 621(b) amends the Act by 

adding section 1833(t)(16)(C) which 

requires that all devices of 

brachytherapy consisting of a seed or 

seeds (or radioactive source) be paid 

based on the hospital’s charge for each 

device adjusted to cost. Also included 

in the new provision is a requirement 

that all such brachytherapy sources be 

excluded from outlier payments. 

Payment Methodology That Applied 

Prior To Enactment 

In the hospital outpatient prospective 

payment update final rule published in 

the Federal Register on November 7, 

2003, CMS announced payments for 

2004 under the Medicare hospital 

outpatient prospective payment system 

(68 FR 63398). The provisions of that 

final rule with regard to payment for 

brachytherapy sources, for separately 

payable drugs, biologicals and 

radiopharmaceutical agents and for 

pass-through drugs and biologicals is 

superceded in part with enactment of 

the DIMA, effective for services 

furnished on or after January 1, 2004. 

This interim final rule with comment 

presents the payment amounts that 

apply in 2004 that result from the 

changes made by DIMA. 

The following is a summarization of 

the payment policies that we published 

for the 2004 OPPS before enactment of 

the new law. 

Drugs and biologicals that were 

within the 2–3 year pass-through 

payment period were paid amounts as 

specified in section 1842(o) of the Act. 

Under the November 7 final rule, that 

payment was 95 percent of AWP. 

Under the provisions of the November 

7 OPPS final rule, payment for nonpass-through drugs, biologicals and 

radiopharmaceutical agents with per 

day median costs greater than $50 was 

based on data compiled from hospital 

claims submitted on or after April 1, 

2002 through December 31, 2002. Those 

data were used to set median costs 

which were converted to relative 

weights, scaled for budget neutrality, 

and multiplied by the 2004 conversion 

factor, the same methodology used to set 

relative weights for procedural 

ambulatory payment classifications 

(APCs) under the OPPS. A detailed 

discussion of the rate setting 

methodology for the 2004 OPPS update 

is provided in the November 7, 2003 

final rule (68 FR 63416). 

Payment for drugs, biologicals and 

radiopharmaceutical agents that had per 

day median costs less than $50 and 

drugs, biologicals and 

radiopharmaceutical agents for which 

there was no HCPCS code, was included 

in the rate for the service in which the 

item was used. There were no separate 

payments for these drugs, biologicals 

and radiopharmaceutical agents. 

Changes Required Under the DIMA 

a. Changes in Payment for ‘‘specified 

covered outpatient drugs’’: 

radiopharmaceutical agents and drugs 

or biologicals that were paid as passthroughs under the OPPS on or before 

December 31, 2002. The DIMA amends 

the Act by adding section 1833(t)(14) 

which states that payment for specified 

covered outpatient drugs is to be based 

on its ‘‘reference average wholesale 

price,’’ that is, the average wholesale 

price for the drug as determined under 

section 1842(o) of the Act as of May 1, 

2003 (1833(t)(14)(G)). 

Under new section 1833(t)(14)(B)(i) a 

‘‘specified covered outpatient drug’’ is a 

covered outpatient drug as defined in 

1927(k)(2) of the Act, for which a 

separate ambulatory payment 

classification group (APC) exists and 

that is a radiopharmaceutical agent or a 

drug or biological for which payment 

was made on a pass-through basis on or 

before December 31, 2002.

Under section 1833(t)(14)(B)(ii) of the 

Act, certain drugs and biologicals are 

designated as exceptions, which are not 

included in the definition of ‘‘specified 

covered outpatient drugs.’’ These 

exceptions are the following: 

• A drug or biological for which 

payment is first made on or after 

January 1, 2003 under the transitional 

pass-through payment provision in 

section 1833(t)(6) of the Act. 

• A drug or biological for which a 

temporary HCPCS code has not been 

assigned. 

• During 2004 and 2005, an orphan 

drug (as designated by the Secretary). 

Section 1833(t)(14)(A)(i) specifies 

payment limits for 3 categories of 

‘‘specified covered outpatient drugs’’ in 

2004. Section 1833(t)(14)(F) defines the 

3 categories of ‘‘specified covered 

outpatient drugs’’ based on sections 

1861(t)(1) and 1927(k)(7)(A)(ii), (iii) and 

(iv) of the Act. The categories of drugs 

are ‘‘sole source drugs’’, ‘‘innovator 

multiple source drugs’’ and 

‘‘noninnovator multiple source drugs.’’

822 Federal Register / Vol. 69, No. 3 / Tuesday, January 6, 2004 / Rules and Regulations 

b. Definitions and payment rates for 

DIMA-specified categories for drugs, 

biologicals, and radiopharmaceutical 

agents. Section 1927(k) of the Act 

pertains to the Medicaid drug rebate 

program. In order to administer the 

Medicaid drug rebate program, CMS 

gathers information from manufacturers 

and classifies drugs into categories that 

are defined in sections 1927(k)(7)(A)(ii), 

(iii) and (iv) of the Act. We are using 

these category designations to guide our 

classification of covered OPPS drugs in 

order to implement the changes in 

payment under the OPPS that are 

required by DIMA in section 1833(t)(14) 

of the Act. The classifications are listed 

in the Medicaid average manufacturer 

price (AMP) database, which can be 

found at http://www.cms.gov/medicaid/

drugs/drug6.asp. In cases when the 

AMP database does not provide a 

classification for an affected drug or 

biological, we relied on our clinical and 

pharmaceutical experts to determine the 

appropriate classification. Further, 

when there are conflicting or 

incomplete designations in the AMP, we 

assigned drugs to the noninnovator 

multiple-source category for payment 

effective January 1, 2004, until we can 

resolve the conflicts and make a 

definitive classification. Classification 

changes will be implemented April 1, 

2004 effective for services furnished on 

or after January 1, 2004. We invite 

comments regarding the appropriate 

classification of the drugs listed in Table 

2. 

The Medicaid AMP database is 

updated on a quarterly basis. However, 

we believe that midyear changes in the 

classification of drugs could be 

confusing and burdensome for providers 

to administer. Therefore, the final 

category designations used to determine 

2004 OPPS drug payments for the 

‘‘specified covered outpatient drugs’’ to 

which section 1833(t)(14)(A)(i) of the 

Act applies, will remain in effect 

through December 31, 2004. We will 

update the category designations 

through rulemaking as part of the 

annual OPPS update for 2005. 

The sole source category is defined in 

section 1833(t)(14)(F)(i) of the Act as a 

biological product (as defined under 

section 1861(t)(1) of the Act) or a single 

source drug (as defined in section 

1927(k)(7)(A)(iv)) of the Act). Section 

1927(k)(7)(A)(iv) of the Act defines the 

term ‘‘single source drug’’ to mean a 

covered outpatient drug which is 

produced or distributed under an 

original new drug application (NDA) 

approved by the Food and Drug 

Administration (FDA), including a drug 

product marketed by any cross-licensed 

producers or distributors operating 

under the NDA. Based on this 

definition, in effect, single source drugs 

are brand name drugs for which there is 

no FDA generic approval, and the term 

is used interchangeably with ‘‘sole 

source drug’’ in this preamble.

Section 621(a) of the DIMA, amends 

the Act by adding section 

1833(t)(14)(A)(i)(I), which provides that 

a sole source drug shall, in 2004, be 

paid no less than 88 percent and no 

more than 95 percent of the reference 

AWP. 

Innovator multiple source drugs are 

defined in section 1833(t)(14)(F)(ii) of 

the Act according to the definition 

provided in section 1927(k)(7)(A)(ii) of 

the Act. Section 1927(k)(7)(A)(ii) of the 

Act defines an innovator multiple 

source drug as a multiple source drug 

that was originally marketed under an 

original NDA approved by the FDA. 

Under this definition, these drugs were 

originally sole source drugs for which 

FDA subsequently approved a generic 

alternative(s). An innovator multiple 

source drug first must be a sole source 

drug. 

Section 621(a) of the DIMA, amends 

the Act by adding section 

1833(t)(14)(A)(i)(II), which provides that 

an innovator multiple source drug shall, 

in 2004, be paid no more than 68 

percent of the reference AWP. 

Section 1833(t)(14)(F)(III) defines a 

noninnovator multiple source drug 

according to the definition of the term 

in 1927(k)(7)(A)(iii). Section 

1927(k)(7)(A)(iii) defines noninnovator 

multiple source drug as a multiple 

source drug that is not an innovator 

multiple source drug. Under this 

definition, noninnovator multiple 

source drugs are, in effect, generic drugs 

approved by the FDA. 

Section 621(a) of the DIMA, amends 

the Act by adding section 

1833(t)(14)(A)(i)(III), which provides 

that a noninnovator multiple source 

drug shall, in 2004, be paid no more 

than 46 percent of the reference AWP. 

There are several drugs that are 

classified in the AMP database as 

qualifying for all three categories. A 

drug that meets the criteria for all 3 

categories has FDA approval as an 

innovator drug. A generic version of the 

drug, the noninnovator, also has 

received FDA approval. In addition, 

there is an FDA approval for a different 

indication for use under a different NDA 

for which the drug is the sole source. 

When a single drug, biological or 

radiopharmaceutical agent that meets 

the definition of a single HCPCS code 

qualifies for all of the 3 categories in the 

AMP file, we are recognizing the 

product only as an innovator multiple 

source and noninnovator multiple 

source drug. That is, once a drug 

qualifies as a multiple source drug, we 

will not recognize it as a sole source 

drug for payment under the OPPS. We 

believe that it would be impossible to 

operationalize a system in which the 

same drug would be paid differently 

according to the clinical indication for 

its use. Medicare makes payment for a 

drug or biological that is reasonable and 

necessary to treat an illness or disease. 

Medicare does not base payment for 

drugs and biologicals according to their 

indicated uses, except when required by 

a national coverage decision. Further, to 

do so would circumvent the payment 

limitation that the law requires for 

drugs, biologicals and 

radiopharmaceutical agents that have 

generic competition by allowing 

payment for a drug that has generic 

competition at the sole source rate (88 

to 95 percent of AWP) rather than at the 

limit for innovator multiple source (68 

percent of AWP) or noninnovator 

multiple source (46 percent of AWP) 

drugs. 

c. Definition of ‘‘reference AWP’’ and 

determination of payment amounts.

Section 1833(t)(14)(G) of the Act defines 

reference AWP as the AWP determined 

under section 1842(o) as of May 1, 2003. 

We interpret this to mean the AWP set 

under the CMS single drug pricer (SDP) 

based on prices published in the Red 

Book on May 1, 2003.

We determined the payment amount 

for specified covered outpatient drugs 

under the provisions of the DIMA by 

comparing the payment amount 

calculated under the median cost 

methodology in effect prior to 

enactment of the DIMA to the 

percentages specified in new section 

1833(t)(14)(A) of the Act. 

Specifically, for sole source drugs, we 

compared the payments established in 

the November 7, 2003 final rule for the 

HCPCS code for the drug to its reference 

AWP. When the payment fell below 88 

percent of the reference AWP, we 

increased the payment to 88 percent of 

the reference AWP. When the payment 

exceeded 95 percent of the reference 

AWP, we reduced the payment to 95 

percent of the reference AWP. When the 

payment was no lower than 88 percent 

and no higher than 95 percent of 

reference AWP, we made no change. To 

receive payment for sole source drugs 

on or after January 1, 2004, hospitals 

should continue to bill the appropriate 

HCPCS code for the drug. Table 1 lists 

the payment amounts for sole source 

drugs, biologicals and 

radiopharmaceutical agents effective 

January 1, 2004 through December 31, 

2004. 

Federal Register / Vol. 69, No. 3 / Tuesday, January 6, 2004 / Rules and Regulations 823

There are a few drugs for which we 

cannot find an AWP rate. We are 

working to resolve this on a case-by-case 

basis for each of the drugs. The drugs 

are: Technetium TC 99M Sodium 

Glucoheptonate (C1200), Cobalt Co 57 

cobaltous chloride (C9013), I–131 

tositumomab, diagnostic (C1080) and I–

131 tositumomab, therapeutic (C1081). 

With regard to C1080 and C1081, 

there is no AWP available because this 

drug did not receive FDA approval until 

June, 2003 and so could not be in the 

May 1, 2003 Red Book (AWP) that we 

have identified as the source of the 

reference AWP. We presented an indepth discussion of our policy for 

payment of this drug, Bexxar, in our 

November 7 final rule. In that rule we 

explain our rationale for making 

payment for Bexxar parallel to that for 

another radiopharmaceutical called 

Zevalin. In order to set the payment rate 

for Bexxar in accordance with DIMA, 

we also have adhered to the policy 

regarding the pricing of Bexxar 

established in the November 7 final 

rule. 

For the remaining drugs for which we 

could not identify a May 1, 2003 AWP 

amount, we will continue our research 

to find an AWP. If we are able to 

identify the AWP established on dates 

other than May 1, 2003, we will use 

whichever is closest to May 2003. In the 

interim, we will implement the payment 

rates published in the November 7 final 

rule to make payments for these drugs 

for January 1, 2004 through March 31, 

2004. We will address our findings 

regarding development of payment rates 

for these drugs in our April update. 

APC 9024 is made up of 3 sole source 

drugs: Amphotericin B lipid complex 

(J0287); Amphotericin B cholesteryl 

sulfate (J0288); and Amphotericin B 

liposome injection (J0289). To comply 

with the statute, these 3 drugs must all 

be paid separately under the OPPS and 

that will require that we create an APC 

for each of the drugs. Due to the limited 

time available to implement the changes 

required for January 1, 2004, we will not 

be able to implement the new APCs 

until April 1, 2004. We will continue to 

pay for these drugs in APC 9024 at the 

rate published in the November 7 final 

rule. The new APCs will be 

implemented April 1, 2004 and will be 

effective for services furnished on or 

after January 1, 2004.

TABLE 1.—SOLE SOURCE DRUGS

HCPCS Status 

indicator Description APC 

OPPS CY 

2004 November 7, 2003 

rate 

DIMA final rate 

A4642 ........... K Satumomab pendetide per dose ................................................................. 0704 $124.46 $1,474.00 

A9500 ........... K Technetium TC 99m sestamibi ................................................................... 1600 64.28 112.73 

A9502 ........... K Technetium TC99M tetrofosmin .................................................................. 0705 58.06 665.28 

A9507 ........... K Indium/111 capromab pendetid ................................................................... 1604 687.71 2,030.60 

A9511 ........... K Technetium TC 99m depreotide .................................................................. 1095 37.87 704.00 

A9521 ........... K Technetiumtc-99m exametazine ................................................................. 1096 210.65 825.00 

A9524 ........... K Iodinated I–131 serumalbumin, per 5uci ..................................................... 9100 0.36 48.58 

A9600 ........... K Strontium-89 chloride .................................................................................. 0701 402.85 892.43 

C1079 ........... K CO 57/58 per 0.5 uCi .................................................................................. 1079 68.51 235.14 

C1080 ........... K I–131 tositumomab, dx ................................................................................ 1080 2,260.00 2,565.55 

C1081 ........... K I–131 tositumomab, tx ................................................................................. 1081 19,565.00 22,210.19 

C1082 ........... K In-111 ibritumomab tiuxetan ........................................................................ 9118 2,260.00 2,565.55 

C1083 ........... K Yttrium 90 ibritumomab tiuxetan ................................................................. 9117 19,565.00 22,210.19 

C1092 ........... K IN 111 pentetate per 0.5 mCi ...................................................................... 1092 217.45 237.60 

C1122 ........... K Tc 99M ARCITUMOMAB PER VIAL ........................................................... 1122 534.77 1,144.00 

C1166 ........... K CYTARABINE LIPOSOMAL, 10 mg ........................................................... 1166 278.99 344.08 

C1167 ........... K EPIRUBICIN HCL, 2 mg ............................................................................. 1167 20.43 25.60 

C1178 ........... K BUSULFAN IV, 6 Mg ................................................................................... 1178 299.70 27.87 

C1200 ........... K TC 99M Sodium Glucoheptonat .................................................................. 1200 30.28 30.28 

C1201 ........... K TC 99M SUCCIMER, PER Vial ................................................................... 1201 80.24 125.66 

C1305 ........... K Apligraf ......................................................................................................... 1305 822.19 1,199.00 

C9003 ........... K Palivizumab, per 50 mg ............................................................................... 9003 344.15 611.24 

C9008 ........... K Baclofen Refill Kit-500mcg .......................................................................... 9008 6.90 73.92 

C9009 ........... K Baclofen Refill Kit-2000mcg ........................................................................ 9009 40.92 40.92 

C9010 ........... K Baclofen Refill Kit—4000mcg ...................................................................... 9010 42.22 79.82 

C9109 ........... K Tirofiban hcl, 6.25 mg .................................................................................. 9109 118.60 218.33 

C9202 ........... K Octafluoropropane ....................................................................................... 9202 118.60 137.28 

J0130 ............ K Abciximab injection ...................................................................................... 1605 289.44 475.22 

J0207 ............ K Amifostine .................................................................................................... 7000 289.40 419.59 

J0287 ............ K Amphotericin b lipid complex ...................................................................... 9024 20.86 20.86 

J0288 ............ K Ampho b cholesteryl sulfate ........................................................................ 9024 20.86 20.86 

J0289 ............ K Amphotericin b liposome inj ........................................................................ 9024 20.86 20.86 

J0350 ............ K Injection anistreplase 30 u .......................................................................... 1606 1,516.46 2,495.31 

J0585 ............ K Botulinum toxin a per unit ........................................................................... 0902 3.21 4.58 

J0587 ............ K Botulinum toxin type B ................................................................................ 9018 6.98 8.14 

J0637 ............ K Caspofungin acetate .................................................................................... 9019 29.64 30.52 

J0850 ............ K Cytomegalovirus imm IV /vial ...................................................................... 0903 291.18 659.60 

J1327 ............ K Eptifibatide injection ..................................................................................... 1607 7.99 11.88 

J1438 ............ K Etanercept injection ..................................................................................... 1608 102.37 143.73 

J1440 ............ K Filgrastim 300 mcg injection ........................................................................ 0728 123.48 172.20 

J1441 ............ K Filgrastim 480 mcg injection ........................................................................ 7049 175.96 290.93 

J1565 ............ K RSV-ivig ....................................................................................................... 0906 48.61 16.55 

J1626 ............ K Granisetron HCl injection ............................................................................ 0764 5.70 17.18 

J1830 ............ K Interferon beta-1b / .25 MG ......................................................................... 0910 100.51 67.22 

J1950 ............ K Leuprolide acetate /3.75 MG ....................................................................... 0800 182.92 479.20 

824 Federal Register / Vol. 69, No. 3 / Tuesday, January 6, 2004 / Rules and Regulations 

TABLE 1.—SOLE SOURCE DRUGS—Continued

HCPCS Status 

indicator Description APC 

OPPS CY 

2004 November 7, 2003 

rate 

DIMA final rate 

J2020 ............ K Linezolid injection ........................................................................................ 9001 15.12 34.09 

J2353 ............ K Octreotide injection, depot ........................................................................... 1207 65.74 73.62 

J2354 ............ K Octreotide inj, non-depot ............................................................................. 7031 1.44 3.94 

J2788 ............ K Rho d immune globulin 50 mcg .................................................................. 9023 1.69 32.21

J2790 ............ K Rho d immune globulin inj ........................................................................... 0884 10.16 92.93 

J2792 ............ K Rho(D) immune globulin h, sd .................................................................... 1609 9.76 19.03 

J2820 ............ K Sargramostim injection ................................................................................ 0731 16.32 26.92 

J2941 ............ K Somatropin injection .................................................................................... 7034 41.18 297.79 

J2993 ............ K Reteplase injection ...................................................................................... 9005 568.33 1,263.90 

J3100 ............ K Tenecteplase injection ................................................................................. 9002 1,296.75 2,492.60 

J3245 ............ K Tirofiban hydrochloride ................................................................................ 7041 227.85 436.66 

J3305 ............ K Inj trimetrexate glucoronate ......................................................................... 7045 61.36 132.00 

J3395 ............ K Verteporfin injection ..................................................................................... 1203 897.20 1,350.80 

J7191 ............ K Factor VIII (porcine) ..................................................................................... 0926 1.52 1.89 

J7195 ............ K Factor IX recombinant ................................................................................. 0932 1.01 1.04 

J7320 ............ K Hylan G–F 20 injection ................................................................................ 1611 123.46 215.97 

J7504 ............ K Lymphocyte immune globulin ...................................................................... 0890 127.89 258.17 

J7505 ............ K Monoclonal antibodies ................................................................................. 7038 320.84 792.33 

J7507 ............ K Tacrolimus oral per 1 MG ........................................................................... 0891 1.34 3.24 

J7511 ............ K Antithymocyte globuln rabbit ....................................................................... 9104 163.56 331.23 

J7520 ............ K Sirolimus, oral .............................................................................................. 9020 2.89 6.60 

J7525 ............ K Tacrolimus injection ..................................................................................... 9006 5.72 110.04 

J8510 ............ K Oral busulfan ............................................................................................... 7015 1.57 1.93 

J8520 ............ K Capecitabine, oral, 150 mg ......................................................................... 7042 1.65 3.14 

J8700 ............ K Temozolmide ............................................................................................... 1086 3.76 6.81 

J9001 ............ K Doxorubicin hcl liposome inj ........................................................................ 7046 256.34 364.49 

J9010 ............ K Alemtuzumab injection ................................................................................ 9110 424.88 541.46 

J9017 ............ K Arsenic trioxide ............................................................................................ 9012 26.91 34.32 

J9020 ............ K Asparaginase injection ................................................................................ 0814 16.13 58.00 

J9045 ............ K Carboplatin injection .................................................................................... 0811 86.47 137.79 

J9098 ............ K Cytarabine liposome .................................................................................... 1166 278.99 344.08 

J9151 ............ K Daunorubicin citrate liposom ....................................................................... 0821 163.55 64.60 

J9170 ............ K Docetaxel ..................................................................................................... 0823 220.97 331.53 

J9178 ............ K Inj, epirubicin hcl, 2 mg ............................................................................... 1167 20.43 25.60 

J9185 ............ K Fludarabine phosphate inj ........................................................................... 0842 205.74 329.83 

J9201 ............ K Gemcitabine HCl ......................................................................................... 0828 80.43 112.09 

J9202 ............ K Goserelin acetate implant ............................................................................ 0810 285.16 413.59 

J9206 ............ K Irinotecan injection ....................................................................................... 0830 100.55 135.00 

J9213 ............ K Interferon alfa-2a inj .................................................................................... 0834 20.61 32.31 

J9214 ............ K Interferon alfa-2b inj .................................................................................... 0836 10.93 13.78 

J9215 ............ K Interferon alfa-n3 inj .................................................................................... 0865 79.65 8.17 

J9216 ............ K Interferon gamma 1-b inj ............................................................................. 0838 180.15 290.70 

J9217 ............ K Leuprolide acetate suspnsion ...................................................................... 9217 312.37 576.47 

J9219 ............ K Leuprolide acetate implant .......................................................................... 7051 3,666.71 5,001.92 

J9245 ............ K Inj melphalan hydrochl 50 MG .................................................................... 0840 254.90 389.14 

J9268 ............ K Pentostatin injection .................................................................................... 0844 965.98 1,784.64 

J9270 ............ K Plicamycin (mithramycin) inj ........................................................................ 0860 15.42 86.89 

J9293 ............ K Mitoxantrone hydrochl / 5 MG ..................................................................... 0864 173.68 332.87 

J9310 ............ K Rituximab cancer treatment ........................................................................ 0849 306.40 464.20 

J9320 ............ K Streptozocin injection .................................................................................. 0850 65.19 131.05 

J9350 ............ K Topotecan .................................................................................................... 0852 433.41 739.80 

J9355 ............ K Trastuzumab ................................................................................................ 1613 40.56 53.85 

J9357 ............ K Valrubicin, 200 mg ....................................................................................... 1614 461.78 487.87 

J9390 ............ K Vinorelbine tartrate/10 mg ........................................................................... 0855 64.79 100.97 

J9600 ............ K Porfimer sodium .......................................................................................... 0856 1,594.30 2,411.82 

Q0136 ........... K Non esrd epoetin alpha inj .......................................................................... 0733 9.83 11.76 

Q0137 ........... K Darbepoetin alfa, non esrd .......................................................................... 0734 3.24 3.88 

Q0166 ........... K Granisetron HCl 1 mg oral .......................................................................... 0765 34.49 171.78 

Q0180 ........... K Dolasetron mesylate oral ............................................................................. 0763 41.00 152.38 

Q0187 ........... K Factor viia recombinant ............................................................................... 1409 1,083.93 1,495.30 

Q2003 ........... K Aprotinin, 10,000 kiu .................................................................................... 7019 1.17 13.26 

Q2005 ........... K Corticorelin ovine triflutat ............................................................................. 7024 224.91 375.00 

Q2006 ........... K Digoxin immune fab (ovine) ........................................................................ 7025 271.14 1.79 

Q2007 ........... K Ethanolamine oleate 100 mg ...................................................................... 7026 27.82 67.10 

Q2008 ........... K Fomepizole, 15 mg ...................................................................................... 7027 7.23 10.65 

Q2009 ........... K Fosphenytoin, 50 mg ................................................................................... 7028 4.88 5.63 

Q2011 ........... K Hemin, per 1 mg .......................................................................................... 7030 0.64 6.86 

Q2013 ........... K Pentastarch 10% solution ............................................................................ 7040 26.40 139.94 

Q2017 ........... K Teniposide, 50 mg ....................................................................................... 7035 137.41 238.49 

Federal Register / Vol. 69, No. 3 / Tuesday, January 6, 2004 / Rules and Regulations 825

TABLE 1.—SOLE SOURCE DRUGS—Continued

HCPCS Status 

indicator Description APC 

OPPS CY 

2004 November 7, 2003 

rate 

DIMA final rate 

Q2018 ........... K Urofollitropin, 75 iu ...................................................................................... 7037 63.48 63.48 

Q3000 ........... K Rubidium-Rb-82 ........................................................................................... 9025 143.89 162.63 

Q3003 ........... K Technetium tc99m bicisate .......................................................................... 1620 183.69 392.93 

Q3005 ........... K Technetium tc99m mertiatide ...................................................................... 1622 20.63 1,650.00 

Q3008 ........... K Indium 111-in pentetreotide ......................................................................... 1625 449.84 1,144.00 

Q4052 ........... K Octreotide injection, depot ........................................................................... 1207 65.74 73.62 

TABLE 2.—MULTISOURCE DRUGS

HCPCS Status 

indicator Description APC 

OPPS CY 

2004 November 7, 2003 

rate 

DIMA final rate 

A9505 ........... K Thallous chloride TL 201/mci ...................................................................... 1603 $19.89 $18.29 

A9508 ........... K Iobenguane sulfate I–131, per 0.5 mCi ....................................................... 1045 165.82 165.82 

A9517 ........... K Th I131 so iodide cap millic ........................................................................ 1064 5.48 5.48 

A9528 ........... K Dx I131 so iodide cap millic ........................................................................ 1064 5.48 5.48 

A9529 ........... K Dx I131 so iodide sol millic ......................................................................... 1065 6.49 6.49 

A9530 ........... K Th I131 so iodide sol millic .......................................................................... 1065 6.49 6.49 

A9605 ........... K Samarium sm153 lexidronamm ................................................................... 0702 874.44 493.89 

C1091 ........... K IN111 oxyquinoline, per0.5mCi ................................................................... 1091 224.52 224.52 

C1775 ........... K FDG, per dose (4–40 mCi/ml) ..................................................................... 1775 324.48 324.48 

C9013 ........... K Co 57 cobaltous chloride ............................................................................. 9013 56.67 56.67 

C9105 ........... K Hep B imm glob, per 1 ml ........................................................................... 9105 71.33 65.58 

J1190 ............ K Dexrazoxane HCl injection .......................................................................... 0726 112.48 112.48 

J1563 ............ K Immune globulin, 1 g ................................................................................... 0905 43.96 37.95 

J1564 ............ K Immune globulin 10 mg ............................................................................... 9021 0.44 0.41 

J1745 ............ K Infliximab injection ....................................................................................... 7043 38.86 31.81 

J1825 ............ K Interferon beta-1a ........................................................................................ 0909 184.79 123.77 

J2430 ............ K Pamidronate disodium /30 MG .................................................................... 0730 174.32 128.74 

J7190 ............ K Factor viii ..................................................................................................... 0925 0.51 0.42 

J7192 ............ K Factor viii recombinant ................................................................................ 0927 1.01 0.61 

J7193 ............ K Factor IX non-recombinant .......................................................................... 0931 0.51 0.51 

J7194 ............ K Factor ix complex ........................................................................................ 0928 0.51 0.18 

J7198 ............ K Anti-inhibitor ................................................................................................. 0929 1.01 0.69 

J7310 ............ K Ganciclovir long act implant ........................................................................ 0913 86.54 86.54 

J7317 ............ K Sodium hyaluronate injection ...................................................................... 7316 138.78 67.16 

J7502 ............ K Cyclosporine oral 100 mg ........................................................................... 0888 2.56 2.41 

J7517 ............ K Mycophenolate mofetil oral ......................................................................... 9015 2.04 1.36 

J8560 ............ K Etoposide oral 50 MG ................................................................................. 0802 27.37 21.91 

J9000 ............ K Doxorubic hcl 10 MG vl chemo ................................................................... 0847 6.61 4.69

J9031 ............ K Bcg live intravesical vac .............................................................................. 0809 103.75 77.54 

J9040 ............ K Bleomycin sulfate injection .......................................................................... 0857 160.56 88.32 

J9060 ............ K Cisplatin 10 MG injection ............................................................................ 0813 21.74 7.73 

J9065 ............ K Inj cladribine per 1 MG ................................................................................ 0858 37.82 24.84 

J9070 ............ K Cyclophosphamide 100 MG inj ................................................................... 0815 4.74 2.77 

J9093 ............ K Cyclophosphamide lyophilized .................................................................... 0816 4.50 2.36 

J9100 ............ K Cytarabine hcl 100 MG inj ........................................................................... 0817 5.07 1.55 

J9130 ............ K Dacarbazine 100 mg inj .............................................................................. 0819 5.31 5.31 

J9150 ............ K Daunorubicin ................................................................................................ 0820 73.97 35.94 

J9181 ............ K Etoposide 10 MG inj .................................................................................... 0824 4.56 0.83 

J9200 ............ K Floxuridine injection ..................................................................................... 0827 114.19 66.24 

J9208 ............ K Ifosfomide injection ...................................................................................... 0831 106.04 72.81 

J9209 ............ K Mesna injection ............................................................................................ 0732 28.43 17.66 

J9211 ............ K Idarubicin hcl injection ................................................................................. 0832 178.21 178.21 

J9218 ............ K Leuprolide acetate injection ......................................................................... 0861 43.60 14.48 

J9265 ............ K Paclitaxel injection ....................................................................................... 0863 112.14 79.04 

J9280 ............ K Mitomycin 5 MG inj ...................................................................................... 0862 53.03 30.91 

J9340 ............ K Thiotepa injection ........................................................................................ 0851 59.93 45.31 

Q2022 ........... K VonWillebrandFactr CmplxperIU ................................................................. 1618 1.01 0.46 

Q3002 ........... K Gallium ga 67 .............................................................................................. 1619 11.22 11.22 

Q3007 ........... K Sodium phosphate p32 ............................................................................... 1624 70.61 66.44 

Q3011 ........... K Chromic phosphate p32 .............................................................................. 1628 98.52 81.27 

Q3012 ........... K Cyanocobalamin cobalt co57 ...................................................................... 1089 57.07 47.38 

Q3025 ........... K IM inj interferon beta 1-a ............................................................................. 9022 61.60 13.36 

826 Federal Register / Vol. 69, No. 3 / Tuesday, January 6, 2004 / Rules and Regulations 

Coding for Specified Outpatient Drugs 

In order to implement these 

provisions timely on January 1, 2004, 

we are instructing hospitals to use the 

existing HCPCS code that describes the 

drug for services furnished on or after 

January 1, 2004. For sole source drugs, 

the existing HCPCS code is priced in 

accordance with the provisions of 

section 1833(t)(14)(A)(i) of the Act as 

indicated in Table 1. However, existing 

HCPCS codes do not allow us to 

differentiate payment amounts for 

innovator multiple source and 

noninnovator multiple source forms of 

the drug. 

Therefore, for implementation January 

1, 2004, we set payment rates for all 

multiple source innovator and 

noninnovator drugs, biologicals and 

radiopharmaceutical agents at the lower 

of the payment rate in the November 7, 

2003 final rule or 46 percent of the 

reference AWP. These rates are shown 

in Table 2. 

Initially, we will implement sections 

1833(t)(14)(A)(i)(II) and (III) of the Act 

in this manner because we are unable to 

compile a definitive list of the innovator 

multiple source drugs in time for 

January 1, 2004 implementation. On 

April 1, 2004, CMS will implement new 

HCPCS codes that providers may use to 

bill for innovator multiple source drugs 

in order to receive appropriate payment 

in accordance with section 

1833(t)(14)(A)(i)(II) of the Act, that is, 

the payment amount established in the 

November 7, 2003 final rule or 68 

percent of the reference AWP, 

whichever is lower. The new codes will 

be effective January 1, 2004 so that 

providers may submit adjustment bills 

after April 1, 2004 to receive 

appropriate payment for multiple source 

innovator drugs furnished on or after 

January 1, 2004 through March 31, 2004. 

Beginning April 1, 2004, innovator 

multiple source drugs will be paid at the 

statutory rate as long as the new codes 

are used. The multiple source 

noninnovator rate will be the default 

payment rate for the existing HCPCS 

code assigned to the drug, and providers 

will continue to use the current HCPCS 

codes to bill for noninnovator multiple 

source drugs after March 31, 2004. The 

new HCPCS codes will be very similar 

to the current codes with only the 

distinction that the drug being billed is 

an innovator multiple source drug 

eligible for payment of as much as 68 

percent of the AWP. 

We recognize that creation and use of 

a new code to designate a drug to be an 

innovator multiple source drug creates 

burden for hospitals. However, the law 

provides different payment rules based 

on the category into which the drug falls 

and therefore, to ensure correct 

payment, hospitals must report a code 

for the drug that identifies the category 

into which it falls. We request 

comments on ways that we can reduce 

the reporting burden on hospitals that 

results from the law’s imposing different 

payment limitations on brand name and 

generic versions of the same drug. 

Table 2 lists the drugs for which the 

new HCPCS codes will be implemented 

April 1, 2004 to distinguish innovator 

multiple source from noninnovator 

multiple source drugs.

Other changes in payment methodology 

effective January 1, 2004 as a result of 

enactment of the Medicare 

Prescription Drug, Improvement and 

Modernization Act of 2003

Payment for Pass-Through Drugs, 

Biologicals, and Radiopharmaceuticals 

Drugs and biologicals that are within 

the 2–3 year pass-through payment 

period in 2004 continue to be paid 

pursuant to section 1842(o) of the Act. 

However, section 1842(o) of the Act has 

been revised by section 303(b) of the 

DIMA and those revisions change the 

way that these drugs are paid.

Drugs and biologicals furnished 

during 2004 that are approved for passthrough payment under the OPPS and 

that were not approved by the FDA for 

marketing as of April 1, 2003 will be 

paid 95 percent of AWP pursuant to 

section 1842(o)(1)(A)(iii). See Table 3b 

for a list of these pass-through drugs. 

Drugs and biologicals furnished 

during 2004 for which pass-through 

payment was first made on or after 

January 1, 2003 (which removes them 

from application of section 621 of the 

DIMA) and were approved by the FDA 

for marketing as of April 1, 2003, will 

be paid 85 percent of AWP pursuant to 

section 1842(o)(1)(B) and 1842(o)(4)(A), 

unless sections 1842(o)(4)(B), (C) or (D) 

apply. See Table 3a for a list of these 

pass-through drugs. 

Table 3c lists 10 drugs and biologicals 

with pass-through status in 2004 that 

also meet the criteria for ‘‘specified 

covered outpatient drugs’’ under section 

1833(t)(14). That is, the drugs in Table 

3c are pass-through drugs in 2004 that 

were available for payment before April 

1, 2003 and would therefore be paid 85 

percent of AWP (determined as of April 

1, 2003) under the cross reference in 

section 1833(t)(6)(D)(i) to section 

1842(o). Separate APCs have been 

established for these drugs and they 

were paid as pass-through drugs on or 

before December 31, 2002. Therefore, 

these pass-through drugs qualify under 

section 1833(t)(14)(B) as ‘‘specified 

covered outpatient drugs.’’ As specified 

covered outpatient drugs, the ten drugs 

would be categorized as ‘‘sole source’’

drugs. 

Sole source drugs, under section 

1833(t)(14)(A)(i)(I) are paid no less than 

88 percent nor more than 95 percent of 

the reference AWP. To the extent that 

the ten drugs listed in Table 3c qualify 

as both pass-through drugs and sole 

source drugs under the DIMA, it appears 

that they are subject to two different 

payment provisions. We have 

reconciled the two apparently 

conflicting payment provisions in a way 

that we believe results in the fewest 

anomalies. The drugs will retain their 

pass-through status, and therefore, the 

rules and policies that otherwise apply 

to pass-through drugs continue to apply 

to them. They will also be considered 

sole source drugs for purposes of section 

1833(t)(14). We will pay for the drugs as 

follows. 

First, because the drugs are passthrough drugs, we will give them passthrough payments. The pass-through 

payments will equal 85 percent of AWP 

(determined as of April 1, 2003) under 

section 1833(t)(6)(D)(i). However, 

because the drugs are also sole source 

drugs, we will also apply the payment 

methodology set forth in section 

1833(t)(14)(A)(i)(I), and raise the 

payment to 88 percent of the reference 

AWP (the AWP determined as of May 1, 

2003). 

Under the payment methodology that 

we are applying to sole source drugs, we 

look at the payment that would 

otherwise be made and if it is less than 

88 percent or greater than 95 percent of 

reference AWP, we adjust it as 

minimally as necessary to ensure that it 

is within the required range. In the case 

of these drugs, absent the provisions of 

1833(t)(14)(i)(I), we would pay 85 

percent of AWP (determined as of April 

1, 2003). Therefore adjusting the 

payment that would otherwise be made 

results in payment at 88 percent of 

reference AWP. 

In light of the total revamping of the 

methodology for payment for drugs and 

biologicals under OPPS, we revisited 

the adjustment that we made under our 

authority in section 1833(t)(2)(E) of the 

Act to ensure equitable payments in 

2003 and in the November 7 final rule 

for the 2004 update of the OPPS. After 

considering the nature of the DIMA 

payment changes, we have concluded 

that it is still appropriate to apply this 

adjustment to the methodology 

discussed in the previous two 

paragraphs for the reasons we stated in 

the OPPS rulemaking during the past 

two years. Therefore, for darbepoetin 

alpha (Q0137 and C1774), we are 

Federal Register / Vol. 69, No. 3 / Tuesday, January 6, 2004 / Rules and Regulations 827

making an adjustment in accordance 

with section 1833(t)(2)(E) of the Act 

(which was unaffected by DIMA) to the 

combined pass-through amount and 3 

percent additional payment provided 

under section 1833(t)(14)(A)(i)(I) of 

DIMA, resulting in a payment rate of 

$3.88 per unit. This payment rate is 

budget neutral.

TABLE 3A.—PASS-THROUGH DRUGS REIMBURSED AT 85% OF AWP 

HCPCS APC Long description 2004 Payment 

amount 

2004 Co-payment amount 

J9395 ........... 9120 Injection, Fulvestrant, per 25 mg .................................................................................. $78.36 $13.09 

C9121 ........... 9121 Injection, Argotroban, per 5 mg .................................................................................... 14.63 2.44 

C9123 ........... 9123 TransCyte, per 247 sq cm ............................................................................................ 689.78 115.23 

C9205 ........... 9205 Injection, Oxaliplatin, per 5 mg ..................................................................................... 8.45 1.41 

C9203 ........... 9203 Injection, Perflexane lipid microspheres, per single use vial ........................................ 127.50 21.30 

J3315 ........... 9122 Injection, Triptorelin pamoate, per 3.75 mg .................................................................. 356.66 59.58 

J3486 ........... 9204 Injection, Ziprasidone mesylate, per 10 mg .................................................................. 18.60 3.11 

C9211 ........... 9211 Injection, IV, Alefacept, per 7.5 mg .............................................................................. 595.00 99.40 

C9212 ........... 9212 Injection, IM, Alefacept, per 7.5 mg .............................................................................. 422.88 70.65 

TABLE 3B.—PASS-THROUGH DRUGS PAID AT 95% OF AWP 

HCPCS APC Long description Amount Amount 

C9207 ........... 9207 Injection, IV, Bortezomib, per 3.5 mg ........................................................................... 1,039.68 155.40 

C9208 ........... 9208 Injection, IV, Agalsidase beta, per 1 mg ....................................................................... 123.78 18.50 

C9209 ........... 9209 Injection, IV, Laronidase, per 2.9 mg ............................................................................ 644.10 96.28 

C9210 ........... 9210 Injection, IV, Palonosetron HCI, per 0.25 mg (250 micrograms) ................................. 307.80 46.01 

TABLE 3C.—PASS-THROUGH DRUGS PAID AS SOLE SOURCE DRUGS AT 88% OF AWP 

HCPCS APC Long description 

OPPS CY2004 

November 7 

rate 

DIMA final rate 

J0583 ........... 9111 Injection, Bivalirudin, per 1 mg ..................................................................................... $1.43 $1.61 

C9112 ........... 9112 Injection, Perflutren lipid microsphere, per 2 ml ........................................................... 132.60 137.28 

C9113 ........... 9113 Injection, Pantoprazole sodium, per vial ....................................................................... 22.44 23.23 

J1335 ........... 9116 Injection, Ertapenem sodium, per 500 mg .................................................................... 21.24 21.99 

J2505 ........... 9119 Injection, Pegfilgrastim, per 6 mg single dose vial ....................................................... 2,507.50 2,596.00 

C9200 ........... 9200 Orcel, per 36 sqare centimeters ................................................................................... 1,015.75 1,051.60 

C9201 ........... 9201 Dermagraft, per 37.5 square centimeters ..................................................................... 516.80 535.04 

J2324 ........... 9114 Injection, Nesiritide, per 0.5 mg .................................................................................... 135.66 140.45 

J3487 ........... 9115 Injection, Zoledronic acid, per 1 mg ............................................................................. 194.52 211.07 

Payment for New Drugs and Biologicals 

Before a HCPCS Code Is Assigned 

Under new section 1833(t)(15) of the 

Act, as added by section 621(a)(1) of the 

DIMA a drug or biological that is 

furnished as part of covered outpatient 

department services for which a HCPCS 

codes has not been established, is to be 

paid at 95 percent of the AWP for the 

drug or biological. 

We are in the process of determining 

how hospitals would bill Medicare for 

a drug prior to assignment of a HCPCS 

code. We will issue instructions once 

we have determined how to make this 

requirement operational. 

Payment for Orphan Drugs as 

Designated by the Secretary 

Section 1833(t)(14)(C) as added by 

section 621(a)(1) of the DIMA, provides 

that the amount of payment for orphan 

drugs designated by the Secretary shall, 

for 2004 and 2005, equal the amount the 

Secretary shall specify. We have 

determined that single indication 

orphan drugs as designated by the 

Secretary will be paid at the rates 

published in the November 7, 2003 

Federal Register (68 FR 63398). Neither 

the definition nor the 2004 payment 

amounts for single indication orphan 

drugs under the OPPS have changed 

from what was published in the 

November 7 final rule. 

Brachytherapy 

Section 621(b)(1) of the DIMA of 2003 

amends the Act by adding section 

1833(t)(16)(C) and section 1833(t)(2)(H) 

which establish separate payment for 

devices of brachytherapy consisting of a 

seed or seeds (or radioactive source) 

based on a hospital’s charges for the 

service, adjusted to cost. Further, 

charges for the brachytherapy devices 

shall not be used in determining any 

outlier payments and consistent with 

our practice under OPPS to exclude 

items paid at cost from budget neutrality 

consideration, these items will be 

excluded from budget neutrality as well. 

The period of payment under this 

provision is for brachytherapy sources 

furnished from January 1, 2004 through 

December 31, 2006.

We will pay for the brachytherapy 

sources listed in Table 4 on a cost basis, 

as required by the statute. The status 

indicator for brachytherapy sources is 

changed to ‘‘H.’’ The definition of status 

indicator ‘‘H’’ is currently for passthrough payment for devices, but the 

brachytherapy sources affected by new 

sections 1833(t)(16)(C) and 1833(t)(2)(H) 

are not pass-through device categories. 

Therefore, we are also changing, for 

2004, the definition of payment status 

indicator ‘‘H’’ to include non-passthrough brachytherapy sources paid for 

on a cost basis. This use of status 

indicator ‘‘H’’ is a pragmatic decision 

that allows us to pay for brachytherapy 

sources in accordance with new section 

1833(t)(16)(C) effective January 1, 2004 

828 Federal Register / Vol. 69, No. 3 / Tuesday, January 6, 2004 / Rules and Regulations 

without having to modify our claims 

processing systems. We will revisit the 

use and definition of status indicator 

‘‘H’’ for this purpose for the OPPS 

update for 2005. Table 4 provides a 

complete listing of the HCPCS codes, 

descriptors, APC assignments and status 

indicators for brachytherapy sources.

TABLE 4.—BRACHYTHERAPY SOURCES TO BE PAID SEPARATELY, USING CHARGES REDUCED TO COST

HCPCS Descriptor APC APC title 

New 

status 

indicator 

C1716 ........... Brachytx source, Gold 198 ......................................... 1716 Brachytx source, Gold 198 ......................................... H 

C1717 ........... Brachytx source, HDR Ir-192 ..................................... 1717 Brachytx source, HDR Ir-192 ..................................... H 

C1718 ........... Brachytx source, Iodine 125 ...................................... 1718 Brachytx source, Iodine 125 ...................................... H 

C1719 ........... Brachytx sour, Non-HDR Ir-192 ................................. 1719 Brachytx source, Non-HDR Ir-192 ............................. H 

C1720 ........... Brachytx source, Paladium 103 ................................. 1720 Brachytx source, Paladium 103 ................................. H 

C2616 ........... Brachytx source, Yttrium-90 ....................................... 2616 Brachytx source, Yttrium-90 ....................................... H 

C2632 ........... Brachytx solution, I–125, per mCi .............................. 2632 Brachytx sol, I–125, per mCi ...................................... H 

C2633 ........... Brachytx source, Cesium-131 .................................... 2633 Brachytx source, Cesium-131 .................................... H 

C2632 ........... Brachytx sol, I–125, per mCi ...................................... 2632 Brachytx sol, I–125, per mCi ...................................... H 

As indicated in Table 4, 

brachytherapy source in HCPCS code 

C1717 will be paid based on the 

hospital’s charge reduced to cost 

beginning January 1, 2004. Prior to 

enactment of DIMA, these sources were 

paid as packaged services in APC 0313. 

As a result of the requirement to pay for 

C1717 separately, we are adjusting the 

payment rate for APC 0313 to reflect the 

unpackaging of the brachytherapy 

source. The new rate is listed in 

Addendum A. 

Section 1833(t)(2)(H) is added by 

section 621(b)(2)(C) of DIMA, mandating 

the creation of separate groups of 

covered OPD services that classify 

brachytherapy devices separately from 

other services or groups of services. The 

additional groups shall be created in a 

manner reflecting the number, isotope 

and radioactive intensity of the devices 

of brachytherapy furnished, including 

separate groups for palladium-103 and 

iodine-125. 

We invite the public to submit 

recommendations for new codes to 

describe brachytherapy sources in a 

manner reflecting the number, 

radioisotope, and radioactive intensity 

of the sources. We request that 

commenting parties provide a detailed 

rationale to support recommended new 

codes. We will propose appropriate 

changes in codes for brachytherapy 

sources in the 2005 OPPS update. 

Continuation of Transitional Corridor 

Payments for CY 2004 

Since the inception of the OPPS, 

providers have been eligible to receive 

additional transitional payments if the 

payments they received under the OPPS 

were less than the payments they would 

have received for the same services 

under the payment system in effect 

before the OPPS. Under 1833(t)(7) of the 

Act, most hospitals that realize lower 

payments under the OPPS received 

transitional corridor payments based on 

a percent of the decrease in payments. 

However, rural hospitals having 100 or 

fewer beds, as well as cancer hospitals 

and children’s hospitals described in 

section 1886(d)(1)(B)(iii) and (v) of the 

Act, were held harmless under this 

provision and paid the full amount of 

the decrease in payments under the 

OPPS. 

Transitional corridor payments were 

intended to be temporary payments to 

ease providers’ transition from the prior 

cost-based payment system to the 

prospective payment system. In 

accordance with section 1833(t)(7) of 

the Act, transitional corridor payments 

were to be eliminated January 1, 2004, 

for all providers other than cancer 

hospitals and children’s hospitals. 

Cancer hospitals and children’s 

hospitals are held harmless permanently 

under the transitional corridor 

provisions of the statute. 

Section 411 of the DIMA amends 

section 1833(t)(7) of the Act to provide 

that hold harmless transitional corridor 

payments will continue through 

December 31, 2005 for rural hospitals 

having 100 or fewer beds. 

Section 411 of the DIMA further 

amends section 1833(t)(7) of the Act to 

provide that hold harmless transitional 

corridor payments shall apply to sole 

community hospitals, as defined in 

section 1886(d)(5)(D)(iii) of the Act, 

which are located in rural areas, with 

respect to services furnished during cost 

reporting periods beginning on or after 

January 1, 2004, and continuing through 

December 31, 2005. For purposes of this 

provision, a sole community hospital’s 

location in a rural area will be 

determined as it is under the inpatient 

PPS, in 42 CFR 412.63(b). 

II. Provisions of the Interim Final Rule 

With Comment Period 

The Medicare Prescription Drug, 

Improvement, and Modernization Act of 

2003 (DIMA), enacted December 8, 2003 

makes changes to the Social Security 

Act (the Act) relating to calendar year 

2004 payments under the Hospital 

Outpatient Prospective Payment 

System. This interim final rule with 

comment period implements changes 

resulting from enactment of the DIMA 

that are effective January 1, 2004, as 

follows: 

Transitional Corridor Payments 

Extended 

Hold harmless transitional corridor 

payments are continued through 

December 31, 2005 for small rural 

hospitals having 100 or fewer beds. In 

addition, hold-harmless transitional 

corridor provisions shall apply to sole 

community hospitals as defined in 

section 1886(d)(5)(D)(iii) of the Act with 

respect to cost reporting periods 

beginning on or after January 1, 2004 

and will continue through December 31, 

2005.

Payment for ‘‘Specified Covered 

Outpatient Drugs’’

Separately paid radiopharmaceutical 

agents and drugs or biologicals that had 

transitional pass-through status on or 

before December 31, 2002, are classified 

into 3 categories: innovator multiple 

source drugs; noninnovator multiple 

source drugs; and sole source drugs. 

Payment levels based on the reference 

average wholesale price as of May 1, 

2003 are specified for each category. 

Payment for Pass-Through Drugs 

Drugs and biologicals furnished 

during 2004 for which pass-through 

payment was first made on or after 

January 1, 2003 (which removes them 

from application of section 621 of the 

Federal Register / Vol. 69, No. 3 / Tuesday, January 6, 2004 / Rules and Regulations 829

DIMA) and were approved by the FDA 

for marketing as of April 1, 2003, will 

be paid 85 percent of AWP pursuant to 

section 1842(o)(1)(B) and 1842(o)(4)(A), 

unless sections 1842(o)(4)(B), (C) or (D) 

apply. 

Certain drugs, biologicals and 

radiopharmaceutical agents that are 

pass-through drugs in 2004 and that also 

meet the definition of ‘‘specified 

covered outpatient drugs’’, except as 

otherwise specified, are paid 88 percent 

of the reference AWP. Those drugs, 

biologicals, and radiopharmaceutical 

agents remain pass-through drugs and 

all policies that apply to them as passthrough drugs continue to apply. 

Exclude Separately Payable Drugs and 

Biologicals From Outlier Payments 

Separately paid drugs and biologicals 

are excluded from outlier payments. 

Brachytherapy Sources Are To Be Paid 

Separately 

All devices of brachytherapy 

consisting of a seed or seeds (or 

radioactive source) are paid based on 

the hospital’s charge for the device 

adjusted to cost. All such brachytherapy 

sources are excluded from outlier 

payments. 

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. 

IV. Waiver of Notice of Proposed 

Rulemaking and the 30-Day Delay in 

the Effective Date 

We ordinarily publish a notice of 

proposed rulemaking in the Federal 

Register and invite public comment on 

the proposed rule in accordance with 5 

U.S.C. section 553(b) of the 

Administrative Procedure Act (APA). 

The notice of proposed rulemaking 

includes a reference to the legal 

authority under which the rule is 

proposed, and the terms and substances 

of the proposed rule or a description of 

the subjects and issues involved. This 

procedure can be waived, however, if an 

agency finds good cause that a noticeand-comment procedure is 

impracticable, unnecessary, or contrary 

to the public interest and incorporates a 

statement of the finding and its reasons 

in the rule issued. 

In this case, we believe that it is in the 

public interest to comply with the 

statutory requirement to implement 

these changes effective January 1, 2004. 

Failure to meet this deadline would 

cause a delay in payment increases for 

many drugs and biologicals and 

brachytherapy sources. 

Section 1871 of the Act also provides 

for publication of a notice of proposed 

rulemaking and opportunity for public 

comment before CMS issues a final rule. 

However, section 1871(b)(2)(B) provides 

an exception when a law establishes a 

specific deadline for implementation of 

a provision and the deadline is less than 

150 days after the law’s date of 

enactment. The DIMA was enacted by 

the Congress on November 25, 2003 and 

signed into law by the President on 

December 8, 2003. The provisions of 

this rule that amend the Medicare 

hospital outpatient prospective payment 

system are required to be implemented 

January 1, 2004. Therefore, these 

provisions are subject to waiver of 

proposed rulemaking in accordance 

with section 1871(b)(2)(B) of the Act.

In addition, we ordinarily provide a 

30-day delay in the effective date of the 

provisions of an interim final rule. 

Section 553(d) of the APA (5 U.S.C. 

section 553(d)) ordinarily requires a 30-

day delay in the effective date of final 

rules after the date of their publication 

in the Federal Register. This 30-day 

delay in effective date can be waived, 

however, if an agency finds for good 

cause that the delay is impracticable, 

unnecessary, or contrary to the public 

interest, and the agency incorporates a 

statement of the finding and its reasons 

in the rule issued. 

In this case, we believe that it is in the 

public interest to comply with the 

statutory requirement to implement 

these changes effective January 1, 2004 

without the 30-day delay in effective 

date. Failure to meet this deadline 

would cause a delay in payment 

increases for many drugs and biologicals 

and brachytherapy sources. 

In addition to the APA requirements, 

section 1871(e)(1), as amended by 

section 903(b)(1) of DIMA also requires 

that a substantive change in a regulation 

shall not become effective before the 

end of the 30-day period that begins on 

the date that the Secretary has issued or 

published the substantive change. 

Section 903(b)(1) provides an exception 

to the requirement of a 30-day delay in 

the effective date if the Secretary finds 

that the waiver of such 30-day period is 

necessary to comply with statutory 

requirements or that the application of 

such 30-day period is contrary to the 

public interest. 

For purposes of DIMA, we believe 

that it is in the public interest to comply 

with the statutory requirement to 

implement these changes effective 

January 1, 2004 without the 30-day 

delay in effective date for the same 

reasons stated above—failure to meet 

this deadline would cause a delay in 

payment increases for many drugs and 

biologicals and brachytherapy sources. 

In addition, we find it is necessary to 

waive the 30-day delay period in order 

to timely comply with the statutory 

requirement that new payment rates be 

effective on January 1, 2004. We are 

providing a 60-day public comment 

period. 

V. Regulatory Impact Analysis 

A. Overall Impact 

We have examined the impacts of this 

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 (as amended 

by Executive Order 13258, which 

merely reassigns responsibility of 

duties) 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). 

We estimate the effects of the 

provisions that will be implemented by 

this final rule will result in 

expenditures exceeding $100 million in 

any 1 year. Our Office of the Actuary 

estimates that the total change in 

expenditures under the OPPS for CY 

2004 as a result of the changes made by 

DIMA to be approximately $150 million. 

Therefore, this final rule with comment 

is an economically significant rule 

under Executive Order 12866, and a 

major rule under 5 U.S.C. 804(2). 

Therefore the discussion below, in 

combination with the rest of this final 

rule constitutes a regulatory impact 

analysis. The RFA requires agencies to 

analyze options for regulatory relief of 

small businesses. However a regulatory 

flexibility analysis is not required for an 

interim final rule because no proposed 

rule is being issued. 

Therefore the discussion below 

constitutes a regulatory impact analysis 

but no regulatory flexibility analysis is 

provided. 

830 Federal Register / Vol. 69, No. 3 / Tuesday, January 6, 2004 / Rules and Regulations 

Unfunded Mandates 

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 

interim final rule will not mandate any 

requirements for State, local or tribal 

governments. This interim final rule 

will not impose unfunded mandates on 

the private sector of more than $110 

million dollars. 

Federalism 

Executive Order 13132 establishes 

certain requirements that an agency 

must meet when it promulgates a 

proposed rule (and subsequent final 

rule) that imposes substantial direct 

requirement costs on State and local 

governments, preempts State law, or 

otherwise has Federalism implications.

We have examined this interim final 

rule in accordance with Executive Order 

13132, Federalism, and have 

determined that it will not have an 

impact on the rights, roles, and 

responsibilities of State, local or tribal 

governments. 

B. Anticipated Effects of Changes in 

This Interim Final Rule and Alternatives 

Considered for Each Change 

All of the changes made in this 

interim final rule with comment are 

required by DIMA. We are required 

under section 621 of the DIMA to revise 

payments for certain drugs and 

biologicals and for 

radiopharmaceuticals. We are also 

required under section 621 of the DIMA 

to pay for brachytherapy sources on the 

basis of application of a cost to charge 

ratio to the charges for the sources. In 

addition, we are required under section 

621 of the DIMA to continue transitional 

outpatient payment for certain 

hospitals. 

Impact on Drugs and Biologicals That 

Will Be Paid Under Pass-Through 

Provisions in 2004 

Four of the drugs and biologicals that 

will be paid under pass-through 

provisions in 2004 will be paid at 95 

percent of AWP. Nine of the drugs and 

biologicals that will be paid under passthrough provisions in 2004 will be paid 

at 85 percent of AWP in 2004. This is 

a reduction of 10 percent of AWP 

compared to the payment that would 

have been made for these drugs and 

biologicals before passage of the DIMA. 

As discussed previously in this rule, 

some pass-through drugs and biologicals 

also meet the criteria for ‘‘specified 

covered outpatient drugs’’ under 

1833(t)(14) and, except as specified in 

this rule, will be paid 88 percent of the 

reference AWP. Notwithstanding the 

payment amount, however, they remain 

pass-through drugs. 

Hospitals that provide drugs paid at 

85 percent of AWP will be paid less 

than they would have been paid absent 

passage of the new law. 

It is unclear whether the reduction in 

payments for these drugs will have any 

effect on beneficiary access to them. 

Hospitals consider many factors when 

they determine whether they choose to 

provide the drugs and it is unclear 

whether the reduction in payment for 

Medicare will result in impaired access. 

However, reduction in the payment 

amounts for some drugs means that 

beneficiaries will have lower 

copayments for those drugs and that 

they, and complementary insurers who 

pay beneficiary cost sharing, will have 

reduced expenses. Hospitals, however, 

will clearly be paid reduced amounts by 

Medicare for these drugs compared to 

the amounts that would be paid had the 

statute not imposed these changes. 

Manufacturers and distributors of the 

pass-through drugs that will be paid at 

85 percent of AWP will be under 

increased pressure to reduce the price of 

the drugs since the hospitals to which 

they sell the items will be paid lower 

amounts by Medicare for them when 

used in hospital outpatient departments. 

We considered setting payment at 85 

percent for pass-through drugs that also 

meet the definition of ‘‘specified 

covered outpatient drugs’’ as allowed in 

the cross reference from 1833(t)(6) to 

1842(o). However, given that the drugs 

are eligible for payment under both sets 

of criteria, we chose to increase their 

payment to 88 percent of reference 

AWP, except as otherwise specified. We 

believe that this choice will result in the 

least possible disruption to beneficiary 

access to these drugs.

We considered no alternatives with 

regard to payment for pass-through 

drugs that did not meet the definition of 

‘‘specified covered outpatient drugs’’

because the law provides only one 

payment methodology for these drugs. 

Impact of Changes for ‘‘Specified 

Covered Outpatient Drugs’’

Radiopharmaceutical agents and 

drugs or biologicals for which payment 

was made on a pass-through basis on or 

before December 31, 2002, are now to be 

paid under section 1833(t)(14) of the Act 

as added by DIMA. Under these 

provisions, radiopharmaceuticals and 

drugs and biologicals that meet the 

criteria, are paid amounts that must be 

limited as specified in the law. 

Specifically, items that meet the 

definition of sole source drugs must be 

paid no less than 88 percent of reference 

AWP nor more than 95 percent of 

reference AWP. Items that meet the 

definition of innovator multiple source 

drugs must be paid no more than 68 

percent of AWP and items that meet the 

definition of noninnovator multiple 

source drugs must be paid no more than 

46 percent of AWP. 

As described previously, these 

categories are defined in section 

1927(k)(7) of the Act. That section 

classifies drugs, biologicals and 

radiopharmaceuticals for purposes of 

the Medicaid drug rebate program. CMS 

has a database in which these items are 

categorized to which we looked to seek 

the classification of each drug, 

biological and radiopharmaceutical paid 

under pass-through provisions before 

December 31, 2002. Table 1 shows those 

items that we believe meet the 

definition of sole source drug. Table 2 

shows those items for which it is not 

clear to us whether the item should be 

classified as a sole source drug or as 

both an innovator multiple source and 

a noninnovator multiple source drug 

and which we will pay as noninnovator 

multiple source drugs until we receive 

comments and determine the 

classification into which the drug falls. 

Paying for those drugs with 

questionable classification as 

noninnovator multiple source drugs 

allows payment to be made to hospitals 

for these drugs when they are furnished 

and also protects hospitals from 

incurring overpayments. Once we 

review the public comments and 

establish the correct classification and 

codes for the billing of innovator 

multiple source drugs, hospitals may 

subject adjustment bills to be paid the 

additional amounts due. 

We will pay the 121 drugs in Table 1 

at the amounts shown, as previously 

discussed. Six of these drugs will have 

no payment change from the payment 

announced in the November 7, 2003 

final rule. Six of these drugs will receive 

decreases in payment compared to the 

final rule because the payment 

established in the November 7, 2003 

final rule exceeded 95 percent of the 

reference AWP. The payment amounts 

for these drugs are now set at 95 percent 

of the reference AWP in accordance 

with the law. One hundred nine of these 

drugs will receive increases in payment 

compared to the final rule because the 

payment established in the November 7, 

2003 final rule was less than 88 percent 

of reference AWP. The payment 

amounts for these drugs, biologicals and 

radiopharmaceuticals is now set at 88 

percent of the reference AWP. 

Federal Register / Vol. 69, No. 3 / Tuesday, January 6, 2004 / Rules and Regulations 831

We will temporarily pay the 52 drugs 

in Table 2 at the amounts shown, as 

previously discussed. Thirteen of these 

items will be paid the amount that was 

published in the November 7, 2003 final 

rule. Thirty-eight of these items will 

receive payment decreases. One of these 

items did not have a reference AWP 

under the SDP and will require further 

research to determine the correct 

payment amount. Until we determine a 

reference AWP for this item it will be 

paid at the amount that was published 

in the November 7, 2003 final rule.

It is unclear what the final overall 

impact of these changes will be because 

we are, as yet, unable to determine into 

which categories 52 items in dispute 

will fall. Moreover, once they are 

categorized, we do not anticipate that 

we will know the frequency with which 

hospitals will use the innovator 

multiple source drug versus the 

noninnovator multiple source drug in 

the outpatient department. Moreover, it 

is not clear to what extent hospitals may 

change their behavior with regard to 

which type of a drug they choose to 

purchase and whether their purchasing 

decisions will be affected by whether 

they furnish the item to hospital 

outpatient departments or inpatient 

departments. 

We considered whether to classify the 

52 items with questionable category 

assignment as both innovator multiple 

source and noninnovator multiple 

source drugs and to create HCPCS codes 

to be used when innovator multiple 

source drugs are administered. 

However, we believe that public 

comment is necessary to determine the 

correct classification of these items. 

Similarly, we believe that, given the 

burden the law imposes on hospitals for 

reporting drugs by the category into 

which they fall, it was important to 

receive public comment regarding 

whether new codes should be created 

and regarding ways we can reduce the 

reporting burden on hospitals. Hence, 

until we receive and review the 

comments, we will not be able to assess 

the impact of these requirements of the 

law. 

We do acknowledge, however, that for 

the 52 drugs that are not sole source 

drugs, the temporary payments to 

hospitals at the noninnovator multiple 

source drug rate will be less than the 

payment that would have been made 

under the November 7, 2003 final rule. 

For those drugs that are sole source 

drugs, the payment will increase in 

most cases. 

Hospitals that provide sole source 

drugs will be paid more for these drugs 

under these provisions than they would 

have been paid before enactment of the 

DIMA. Hospitals that provide innovator 

multiple source drugs and noninnovator 

multiple source drugs will be paid less 

for these items than they would have 

been before enactment of the DIMA. 

This may encourage use of sole source 

drugs and discourage use of multiple 

source drugs. As a result, beneficiaries 

may have greater access to sole source 

drugs but will also incur greater 

copayments because those payment 

rates are higher than they would have 

been before enactment of DIMA. In turn, 

there may be increased payment by 

complementary insurers for these items. 

Manufacturers of sole source drugs may 

realize increased sales and 

manufacturers of generic drugs may see 

reduced sales. 

We considered whether to permit a 

drug that is classified by AMP as a sole 

source drug, an innovator multiple 

source drug and a noninnovator 

multiple source drug to be paid under 

all three classifications. We decided not 

to pay a drug as a sole source drug if it 

is also a multiple source drug for 

reasons described previously in this 

interim final rule. We considered no 

alternatives because the law is quite 

specific with regard to the classification 

of drugs and the payment rules that 

apply to each class of drug. 

Impact of Cost-Based Payment for 

Sources of Brachytherapy 

The law provides that sources of 

brachytherapy will be paid an amount 

equal to the hospital’s charge for the 

source adjusted by the applicable cost to 

charge ratio. It is unclear whether this 

will result in an increase or decrease in 

payment for brachytherapy sources. 

However, removing the brachytherapy 

source from packaged payment for the 

services with which it is furnished 

removes incentives for using the least 

number of sources needed for the 

therapeutic purpose. There is no 

evidence that packaged payment for 

brachytherapy sources resulted in 

inappropriately low utilization of 

brachytherapy, nor that separate 

payment will result in any change in 

availability of the service. We are unable 

to estimate the impact of this change on 

utilization and program payment. 

We considered no alternatives to this 

policy because the statute was specific 

with regard to how payment for 

brachytherapy sources must be made. 

Impact of Continuation of Transitional 

Outpatient Payments for Certain 

Hospitals 

The law provides that transitional 

outpatient payments must continue for 

rural hospitals with 100 or fewer beds 

and be provided for sole community 

hospitals in rural areas through 

December 31, 2005. There are 

approximately 600 sole community 

hospitals and approximately 1150 rural 

hospitals with 100 beds or fewer that 

may be affected by this provision. These 

hospitals will continue to receive 

transitional corridor payments in 

addition to the payments they will 

receive under OPPS. These payments 

should continue to strengthen the 

ability of these hospitals to furnish 

services to beneficiaries who reside in 

the areas served by these hospitals. 

Beneficiaries should be better assured of 

access to services in these hospitals. 

These hospitals will be assured of 

payment for the reasonable costs of 

providing outpatient services. 

We considered no alternatives 

because the statute is quite directive 

with regard to the extension of hold 

harmless protection to these hospitals. 

C. Conclusion 

We have prepared the analysis above 

because we have determined that this 

interim final rule will have a significant 

economic impact. In accordance with 

the provisions of Executive Order 

12866, this interim final rule was 

reviewed by the Office of Management 

and Budget. 

Publication of Addenda 

The addenda included in this interim 

final rule, Addenda A and D1 replace 

the addenda in the November 7, 2003 

Federal Register (68 FR 63478). The 

revised addenda reflect changes 

required by the DIMA as well as 

corrections to minor errors contained in 

the addenda published November 7, 

2003. 

In addition to the addenda included 

here, we will post the updated Addenda 

B and C on our Web site at http://

www.cms.hhs.gov/regulations/hopps/.

List of Subjects in 42 CFR Part 419 

Hospitals, Medicare, Reporting and 

recordkeeping requirements.

■ For the reasons set forth in the 

preamble, the Centers for Medicare & 

Medicaid Services amends 42 CFR 

chapter IV as set forth below:

PART 419—PROSPECTIVE PAYMENT 

SYSTEM FOR HOSPITAL OUTPATIENT 

DEPARTMENT SERVICES

■ 1. The authority citation for part 419 

continues to read as follows:

Authority: Secs. 1102, 1833(t), and 1871 of 

the Social Security Act (42 U.S.C. 1302, 

1395l(t), and 1395hh).

832 Federal Register / Vol. 69, No. 3 / Tuesday, January 6, 2004 / Rules and Regulations 

Subpart C—Basic Methodology for 

Determining Prospective Payment 

Rates for Hospital Outpatient Services

■ 2. Section 419.32 is amended by 

revising paragraph (d) to read as follows:

§ 419.32 Calculation of prospective 

payment rates for hospital outpatient 

services.

* * * * *

(d) Budget neutrality. (1) CMS adjusts 

the conversion factor as needed to 

ensure that updates and adjustments 

under § 419.50(a) are budget neutral. 

(2) In determining adjustments for 

2004 and 2005, CMS will not take into 

account any additional expenditures per 

section 1833(t)(14) of the Act that would 

not have been made but for enactment 

of section 621 of the Medicare 

Prescription Drug, Improvement, and 

Modernization Act of 2003.

Subpart D—Payments to Hospitals

■ 3. Section § 419.43 is amended as 

follows:

■ A. Paragraph (d)(1) introductory text is 

revised.

■ B. Paragraph (e) is revised.

■ C. New paragraph (f) is added.

The revisions and additions read as 

follows:

§ 419.43 Adjustments to national program 

payments and beneficiary copayment 

amounts.

* * * * *

(d) Outlier adjustment—(1) General 

rule. Subject to paragraph (d)(4) of this 

section, CMS provides for an additional 

payment for a hospital outpatient 

service (or group of services) not 

excluded under paragraph (f) of this 

section for which a hospital’s charges, 

adjusted to cost, exceed the following:

* * * * *

(e) Budget neutrality. CMS establishes 

payment under paragraph (d) of this 

section in a budget-neutral manner 

excluding services and groups specified 

in paragraph (f) of this section.

(f) Excluded services and groups.

Drugs and biologicals that are paid 

under a separate APC and devices of 

brachytherapy, consisting of a seed or 

seeds (including a radioactive source) 

are excluded from qualification for 

outlier payments.

Subpart G—Transitional Pass-Through 

Payments

■ 4. Section 419.64 is amended by 

revising paragraph (d).

§ 419.64 Transitional pass-through 

payments: Drugs and biologicals.

* * * * *

(d) Amount of pass-through payment.

(1) Subject to any reduction determined 

under § 419.62(b), the pass-through 

payment for a drug or biological as 

specified in section 1842(o)(1)(A) and 

(o)(1)(D)(i) of the Act is 95 percent of the 

average wholesale price of the drug or 

biological minus the portion of the APC 

payment CMS determines is associated 

with the drug or biological. 

(2) Subject to any reduction 

determined under § 419.62(b), the passthrough payment for a drug or biological 

as specified in section 1842(o)(1)(B) and 

(o)(1)(E)(i) of the Act is 85 percent of the 

average wholesale price, determined as 

of April 1, 2003, of the drug or 

biological minus the portion of the APC 

payment CMS determines is associated 

with the drug or biological.

Subpart H—Transitional Corridors

■ 5. Section 419.70 is amended as 

follows:

■ A. Paragraph (d)(1) is amended by 

removing ‘‘2004’’ and adding ‘‘2006’’ in 

its place.

■ B. A new paragraph (d)(3) is added to 

read as follows:

§ 419.70 Transitional adjustment to limit 

decline and payment.

* * * * *

(d) * * * 

(3) Temporary treatment for sole 

community hospitals located in rural 

areas. For covered hospital outpatient 

services furnished during cost reporting 

periods beginning on or after January 1, 

2004, and continuing through December 

31, 2005, for which the prospective 

payment system amount is less than the 

pre-BBA amount, the amount of 

payment under this part is increased by 

the amount of that difference if the 

hospital—

(i) Is a sole community hospital, 

under § 412.92 of this chapter; and 

(ii) Is located in a rural area as defined 

in § 412.63(b) of this chapter or is 

treated as being located in a rural area 

under section 1886(d)(8)(E) of the Act.

(Catalog of Federal Domestic Assistance 

Program No. 93.773, Medicare—Hospital 

Insurance; and Program No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program)

Dated: December 23, 2003. 

Dennis G. Smith, 

Acting Administrator, Centers for Medicare 

& Medicaid Services.

Approved: December 23, 2003. 

Tommy G. Thompson, 

Secretary.

Note: The following addenda will not 

appear in the Code of Federal Regulations.

ADDENDUM A.—LIST OF AMBULATORY PAYMENT CLASSIFICATIONS (APCS) WITH STATUS INDICATORS, RELATIVE

WEIGHTS, PAYMENT RATES, AND COPAYMENT AMOUNTS CALENDAR YEAR 2004 

APC Group title Status

indicator 

Relative

weight 

Payment

rate 

National

unadjusted

copayment 

Minimum

unadjusted

copayment 

0001 ......... Level I Photochemotherapy ............................................... S 0.4237 $23.12 $7.09 $4.62 

0002 ......... Level I Fine Needle Biopsy/Aspiration ............................... T 0.8083 $44.10 .................... $8.82 

0003 ......... Bone Marrow Biopsy/Aspiration ......................................... T 2.3229 $126.74 .................... $25.35 

0004 ......... Level I Needle Biopsy/ Aspiration Except Bone Marrow ... T 1.5882 $86.65 $22.36 $17.33 

0005 ......... Level II Needle Biopsy/Aspiration Except Bone Marrow ... T 3.2698 $178.40 $71.59 $35.68 

0006 ......... Level I Incision & Drainage ................................................ T 1.6527 $90.17 $23.26 $18.03 

0007 ......... Level II Incision & Drainage ............................................... T 11.8633 $647.27 .................... $129.45 

0008 ......... Level III Incision and Drainage .......................................... T 19.4831 $1,063.02 .................... $212.60 

0009 ......... Nail Procedures ................................................................. T 0.6652 $36.29 $8.34 $7.26 

0010 ......... Level I Destruction of Lesion ............................................. T 0.6480 $35.36 $10.08 $7.07 

0011 ......... Level II Destruction of Lesion ............................................ T 2.2217 $121.22 $27.88 $24.24 

0012 ......... Level I Debridement & Destruction .................................... T 0.7612 $41.53 $11.18 $8.31 

0013 ......... Level II Debridement & Destruction ................................... T 1.1302 $61.66 $14.20 $12.33 

0015 ......... Level III Debridement & Destruction .................................. T 1.5968 $87.12 $20.35 $17.42 

0016 ......... Level IV Debridement & Destruction ................................. T 2.5724 $140.35 $57.31 $28.07 

0017 ......... Level VI Debridement & Destruction ................................. T 16.3697 $893.15 $227.84 $178.63 

0018 ......... Biopsy of Skin/Puncture of Lesion ..................................... T 0.9178 $50.08 $16.04 $10.02 

Federal Register / Vol. 69, No. 3 / Tuesday, January 6, 2004 / Rules and Regulations 833

ADDENDUM A.—LIST OF AMBULATORY PAYMENT CLASSIFICATIONS (APCS) WITH STATUS INDICATORS, RELATIVE

WEIGHTS, PAYMENT RATES, AND COPAYMENT AMOUNTS CALENDAR YEAR 2004—Continued

APC Group title Status

indicator 

Relative

weight 

Payment

rate 

National

unadjusted

copayment 

Minimum

unadjusted

copayment 

0019 ......... Level I Excision/ Biopsy ..................................................... T 3.9493 $215.48 $71.87 $43.10 

0020 ......... Level II Excision/ Biopsy .................................................... T 7.0842 $386.52 $113.25 $77.30 

0021 ......... Level III Excision/ Biopsy ................................................... T 14.3594 $783.46 $219.48 $156.69 

0022 ......... Level IV Excision/ Biopsy .................................................. T 18.7932 $1,025.38 $354.45 $205.08 

0023 ......... Exploration Penetrating Wound ......................................... T 2.8141 $153.54 $40.37 $30.71 

0024 ......... Level I Skin Repair ............................................................ T 1.6850 $91.94 $33.10 $18.39 

0025 ......... Level II Skin Repair ........................................................... T 5.1912 $283.24 $107.00 $56.65 

0027 ......... Level IV Skin Repair .......................................................... T 15.8990 $867.47 $329.72 $173.49 

0028 ......... Level I Breast Surgery ....................................................... T 17.6584 $963.46 $303.74 $192.69 

0029 ......... Level II Breast Surgery ...................................................... T 30.1167 $1,643.20 $632.64 $328.64 

0030 ......... Level III Breast Surgery ..................................................... T 37.3083 $2,035.58 $763.55 $407.12 

0032 ......... Insertion of Central Venous/Arterial Catheter .................... T 11.4907 $626.94 .................... $125.39 

0033 ......... Partial Hospitalization ........................................................ P 5.2569 $286.82 .................... $57.36 

0035 ......... Placement of Arterial or Central Venous Catheter ............ T 0.1691 $9.23 $2.79 $1.85 

0036 ......... Level II Fine Needle Biopsy/Aspiration .............................. T 1.5170 $82.77 .................... $16.55 

0037 ......... Level III Needle Biopsy/Aspiration Except Bone Marrow .. T 9.8921 $539.72 $237.45 $107.94 

0039 ......... Implantation of Neurostimulator ......................................... S 235.1866 $12,832.02 .................... $2,566.40 

0040 ......... Level II Implantation of Neurostimulator Electrodes .......... S 52.1002 $2,842.64 .................... $568.53 

0041 ......... Level I Arthroscopy ............................................................ T 27.3819 $1,493.98 .................... $298.80 

0042 ......... Level II Arthroscopy ........................................................... T 43.0808 $2,350.53 $804.74 $470.11 

0043 ......... Closed Treatment Fracture Finger/Toe/Trunk ................... T 1.9074 $104.07 .................... $20.81 

0045 ......... Bone/Joint Manipulation Under Anesthesia ....................... T 13.5889 $741.42 $268.47 $148.28 

0046 ......... Open/Percutaneous Treatment Fracture or Dislocation .... T 32.5581 $1,776.40 $535.76 $355.28 

0047 ......... Arthroplasty without Prosthesis ......................................... T 29.9582 $1,634.55 $537.03 $326.91 

0048 ......... Arthroplasty with Prosthesis .............................................. T 51.4609 $2,807.76 $695.60 $561.55 

0049 ......... Level I Musculoskeletal Procedures Except Hand and 

Foot.

T 19.6046 $1,069.65 .................... $213.93 

0050 ......... Level II Musculoskeletal Procedures Except Hand and 

Foot.

T 24.8651 $1,356.66 .................... $271.33 

0051 ......... Level III Musculoskeletal Procedures Except Hand and 

Foot.

T 34.5144 $1,883.14 .................... $376.63 

0052 ......... Level IV Musculoskeletal Procedures Except Hand and 

Foot.

T 42.7126 $2,330.44 .................... $466.09 

0053 ......... Level I Hand Musculoskeletal Procedures ........................ T 14.8831 $812.04 $253.49 $162.41 

0054 ......... Level II Hand Musculoskeletal Procedures ....................... T 24.2456 $1,322.86 .................... $264.57 

0055 ......... Level I Foot Musculoskeletal Procedures .......................... T 18.7205 $1,021.41 $355.34 $204.28 

0056 ......... Level II Foot Musculoskeletal Procedures ......................... T 25.3930 $1,385.47 $405.81 $277.09 

0057 ......... Bunion Procedures ............................................................ T 25.5035 $1,391.50 $475.91 $278.30 

0058 ......... Level I Strapping and Cast Application ............................. S 1.0931 $59.64 .................... $11.93 

0060 ......... Manipulation Therapy ........................................................ S 0.2788 $15.21 .................... $3.04 

0068 ......... CPAP Initiation ................................................................... S 1.0807 $58.96 $29.48 $11.79 

0069 ......... Thoracoscopy ..................................................................... T 28.9392 $1,578.95 $591.64 $315.79

0070 ......... Thoracentesis/Lavage Procedures .................................... T 3.0717 $167.60 .................... $33.52 

0071 ......... Level I Endoscopy Upper Airway ...................................... T 0.8799 $48.01 $12.89 $9.60 

0072 ......... Level II Endoscopy Upper Airway ..................................... T 1.7613 $96.10 $26.68 $19.22 

0073 ......... Level III Endoscopy Upper Airway .................................... T 3.4541 $188.46 $73.38 $37.69 

0074 ......... Level IV Endoscopy Upper Airway .................................... T 13.9480 $761.02 $295.70 $152.20 

0075 ......... Level V Endoscopy Upper Airway ..................................... T 20.3815 $1,112.04 $445.92 $222.41 

0076 ......... Level I Endoscopy Lower Airway ...................................... T 9.2346 $503.85 $189.82 $100.77 

0077 ......... Level I Pulmonary Treatment ............................................ S 0.2837 $15.48 $7.74 $3.10 

0078 ......... Level II Pulmonary Treatment ........................................... S 0.7917 $43.20 $14.55 $8.64 

0079 ......... Ventilation Initiation and Management .............................. S 2.1494 $117.27 .................... $23.45 

0080 ......... Diagnostic Cardiac Catheterization ................................... T 36.0160 $1,965.07 $838.92 $393.01 

0081 ......... Non-Coronary Angioplasty or Atherectomy ....................... T 35.0285 $1,911.19 .................... $382.24 

0082 ......... Coronary Atherectomy ....................................................... T 110.2196 $6,013.69 $1,293.59 $1,202.74 

0083 ......... Coronary Angioplasty and Percutaneous Valvuloplasty .... T 59.2047 $3,230.27 .................... $646.05 

0084 ......... Level I Electrophysiologic Evaluation ................................ S 10.5226 $574.12 .................... $114.82 

0085 ......... Level II Electrophysiologic Evaluation ............................... T 35.4126 $1,932.15 $426.25 $386.43 

0086 ......... Ablate Heart Dysrhythm Focus .......................................... T 44.9389 $2,451.91 $833.33 $490.38 

0087 ......... Cardiac Electrophysiologic Recording/Mapping ................ T 39.8161 $2,172.41 .................... $434.48 

0088 ......... Thrombectomy ................................................................... T 34.6942 $1,892.95 $655.22 $378.59 

0089 ......... Insertion/Replacement of Permanent Pacemaker and 

Electrodes.

T 117.1896 $6,393.98 $1,722.59 $1,278.80 

0090 ......... Insertion/Replacement of Pacemaker Pulse Generator .... T 96.8284 $5,283.05 $1,651.45 $1,056.61 

0091 ......... Level II Vascular Ligation .................................................. T 28.8326 $1,573.14 $348.23 $314.63 

0092 ......... Level I Vascular Ligation ................................................... T 25.0959 $1,369.26 $505.37 $273.85 

0093 ......... Vascular Reconstruction/Fistula Repair without Device .... T 21.3104 $1,162.72 $277.34 $232.54 

0094 ......... Level I Resuscitation and Cardioversion ........................... S 2.6345 $143.74 $48.58 $28.75 

0095 ......... Cardiac Rehabilitation ........................................................ S 0.5994 $32.70 $16.35 $6.54 

834 Federal Register / Vol. 69, No. 3 / Tuesday, January 6, 2004 / Rules and Regulations 

ADDENDUM A.—LIST OF AMBULATORY PAYMENT CLASSIFICATIONS (APCS) WITH STATUS INDICATORS, RELATIVE

WEIGHTS, PAYMENT RATES, AND COPAYMENT AMOUNTS CALENDAR YEAR 2004—Continued

APC Group title Status

indicator 

Relative

weight 

Payment

rate 

National

unadjusted

copayment 

Minimum

unadjusted

copayment 

0096 ......... Non-Invasive Vascular Studies .......................................... S 1.7176 $93.71 $46.85 $18.74 

0097 ......... Cardiac and Ambulatory Blood Pressure Monitoring ........ X 1.0635 $58.03 $23.80 $11.61 

0098 ......... Injection of Sclerosing Solution ......................................... T 1.0729 $58.54 $14.06 $11.71 

0099 ......... Electrocardiograms ............................................................ S 0.3703 $20.20 .................... $4.04 

0100 ......... Cardiac Stress Tests ......................................................... X 1.5862 $86.54 $41.44 $17.31 

0101 ......... Tilt Table Evaluation .......................................................... S 4.4040 $240.29 $105.27 $48.06 

0103 ......... Miscellaneous Vascular Procedures .................................. T 11.6202 $634.01 $223.63 $126.80 

0104 ......... Transcatheter Placement of Intracoronary Stents ............. T 82.6713 $4,510.63 .................... $902.13 

0105 ......... Revision/Removal of Pacemakers, AICD, or Vascular ..... T 19.1898 $1,047.01 $370.40 $209.40 

0106 ......... Insertion/Replacement/Repair of Pacemaker and/or Electrodes.T 58.9719 $3,217.57 .................... $643.51 

0107 ......... Insertion of Cardioverter-Defibrillator ................................. T 337.1304 $18,394.17 $3,699.14 $3,678.83 

0108 ......... Insertion/Replacement/Repair of Cardioverter-Defibrillator 

Leads.

T 452.6995 $24,699.74 .................... $4,939.95 

0109 ......... Removal of Implanted Devices .......................................... T 7.4705 $407.60 $131.49 $81.52 

0110 ......... Transfusion ........................................................................ S 3.6718 $200.34 .................... $40.07 

0111 ......... Blood Product Exchange ................................................... S 13.1719 $718.67 $200.18 $143.73 

0112 ......... Apheresis, Photopheresis, and Plasmapheresis ............... S 37.5832 $2,050.58 $612.47 $410.12 

0113 ......... Excision Lymphatic System ............................................... T 19.9322 $1,087.52 .................... $217.50 

0114 ......... Thyroid/Lymphadenectomy Procedures ............................ T 37.5963 $2,051.29 $485.91 $410.26 

0115 ......... Cannula/Access Device Procedures ................................. T 25.6437 $1,399.15 $459.35 $279.83 

0116 ......... Chemotherapy Administration by Other Technique Except Infusion.S 0.7996 $43.63 .................... $8.73 

0117 ......... Chemotherapy Administration by Infusion Only ................ S 3.0360 $165.65 $42.54 $33.13 

0119 ......... Implantation of Infusion Pump ........................................... T 134.7194 $7,350.43 .................... $1,470.09 

0120 ......... Infusion Therapy Except Chemotherapy ........................... T 1.9114 $104.29 $28.21 $20.86 

0121 ......... Level I Tube changes and Repositioning .......................... T 2.1114 $115.20 $43.80 $23.04 

0122 ......... Level II Tube changes and Repositioning ......................... T 8.8621 $483.53 $99.16 $96.71 

0123 ......... Bone Marrow Harvesting and Bone Marrow/Stem Cell 

Transplant.

S 6.1499 $335.54 .................... $67.11 

0124 ......... Revision of Implanted Infusion Pump ................................ T 23.8050 $1,298.82 .................... $259.76 

0125 ......... Refilling of Infusion Pump .................................................. T 2.1606 $117.88 .................... $23.58 

0130 ......... Level I Laparoscopy ........................................................... T 32.7724 $1,788.09 $659.53 $357.62 

0131 ......... Level II Laparoscopy .......................................................... T 40.8064 $2,226.44 $1,001.89 $445.29 

0132 ......... Level III Laparoscopy ......................................................... T 57.2045 $3,121.13 $1,239.22 $624.23 

0140 ......... Esophageal Dilation without Endoscopy ........................... T 6.4525 $352.05 $107.24 $70.41 

0141 ......... Upper GI Procedures ......................................................... T 7.8206 $426.70 $143.38 $85.34 

0142 ......... Small Intestine Endoscopy ................................................ T 8.7959 $479.91 $152.78 $95.98 

0143 ......... Lower GI Endoscopy ......................................................... T 8.2957 $452.62 $186.06 $90.52 

0146 ......... Level I Sigmoidoscopy ....................................................... T 3.9826 $217.29 $64.40 $43.46 

0147 ......... Level II Sigmoidoscopy ...................................................... T 7.6808 $419.07 .................... $83.81 

0148 ......... Level I Anal/Rectal Procedure ........................................... T 3.8320 $209.08 $63.38 $41.82 

0149 ......... Level III Anal/Rectal Procedure ......................................... T 17.1425 $935.31 $293.06 $187.06 

0150 ......... Level IV Anal/Rectal Procedure ......................................... T 22.1919 $1,210.81 $437.12 $242.16 

0151 ......... Endoscopic Retrograde Cholangio-Pancreatography 

(ERCP).

T 17.9462 $979.16 $245.46 $195.83 

0152 ......... Percutaneous Abdominal and Biliary Procedures ............. T 9.1474 $499.09 $125.28 $99.82 

0153 ......... Peritoneal and Abdominal Procedures .............................. T 20.8723 $1,138.81 $410.87 $227.76 

0154 ......... Hernia/Hydrocele Procedures ............................................ T 26.9636 $1,471.16 $464.85 $294.23 

0155 ......... Level II Anal/Rectal Procedure .......................................... T 10.0809 $550.02 $188.89 $110.00 

0156 ......... Level II Urinary and Anal Procedures ............................... T 2.4747 $135.02 $40.52 $27.00 

0157 ......... Colorectal Cancer Screening: Barium Enema ................... S 2.5693 $140.18 .................... $28.04 

0158 ......... Colorectal Cancer Screening: Colonoscopy ...................... T 7.4244 $405.08 .................... $101.27 

0159 ......... Colorectal Cancer Screening: Flexible Sigmoidoscopy ..... S 2.7823 $151.81 .................... $37.95 

0160 ......... Level I Cystourethroscopy and other Genitourinary Procedures.T 6.8801 $375.39 $105.06 $75.08 

0161 ......... Level II Cystourethroscopy and other Genitourinary Procedures.T 16.8407 $918.85 $249.36 $183.77 

0162 ......... Level III Cystourethroscopy and other Genitourinary Procedures.T 21.9098 $1,195.42 .................... $239.08 

0163 ......... Level IV Cystourethroscopy and other Genitourinary Procedures.T 33.8805 $1,848.55 .................... $369.71 

0164 ......... Level I Urinary and Anal Procedures ................................ T 1.2021 $65.59 $17.59 $13.12 

0165 ......... Level III Urinary and Anal Procedures .............................. T 14.6838 $801.16 .................... $160.23 

0166 ......... Level I Urethral Procedures ............................................... T 16.7918 $916.18 $218.73 $183.24 

0167 ......... Level III Urethral Procedures ............................................. T 30.0186 $1,637.84 $555.84 $327.57 

0168 ......... Level II Urethral Procedures .............................................. T 30.0147 $1,637.63 $405.60 $327.53 

0169 ......... Lithotripsy ........................................................................... T 45.1150 $2,461.52 $1,115.69 $492.30 

0170 ......... Dialysis ............................................................................... S 5.9678 $325.61 .................... $65.12 

Federal Register / Vol. 69, No. 3 / Tuesday, January 6, 2004 / Rules and Regulations 835

ADDENDUM A.—LIST OF AMBULATORY PAYMENT CLASSIFICATIONS (APCS) WITH STATUS INDICATORS, RELATIVE

WEIGHTS, PAYMENT RATES, AND COPAYMENT AMOUNTS CALENDAR YEAR 2004—Continued

APC Group title Status

indicator 

Relative

weight 

Payment

rate 

National

unadjusted

copayment 

Minimum

unadjusted

copayment 

0180 ......... Circumcision ....................................................................... T 18.6176 $1,015.79 $304.87 $203.16 

0181 ......... Penile Procedures .............................................................. T 29.4217 $1,605.28 $621.82 $321.06 

0183 ......... Testes/Epididymis Procedures .......................................... T 21.6724 $1,182.47 .................... $236.49 

0184 ......... Prostate Biopsy .................................................................. T 3.8995 $212.76 $96.27 $42.55 

0187 ......... Miscellaneous Placement/Repositioning ........................... X 4.4288 $241.64 $90.71 $48.33 

0188 ......... Level II Female Reproductive Proc ................................... T 1.1365 $62.01 .................... $12.40 

0189 ......... Level III Female Reproductive Proc .................................. T 1.4232 $77.65 $18.09 $15.53 

0190 ......... Level I Hysteroscopy ......................................................... T 19.6922 $1,074.43 $424.28 $214.89 

0191 ......... Level I Female Reproductive Proc .................................... T 0.1853 $10.11 $2.93 $2.02 

0192 ......... Level IV Female Reproductive Proc .................................. T 2.7121 $147.97 $39.11 $29.59 

0193 ......... Level V Female Reproductive Proc ................................... T 15.0453 $820.89 $171.13 $164.18 

0194 ......... Level VIII Female Reproductive Proc ................................ T 18.4286 $1,005.48 $397.84 $201.10 

0195 ......... Level IX Female Reproductive Proc .................................. T 25.6950 $1,401.94 $483.80 $280.39 

0196 ......... Dilation and Curettage ....................................................... T 16.1219 $879.63 $338.23 $175.93 

0197 ......... Infertility Procedures .......................................................... T 4.8280 $263.42 .................... $52.68 

0198 ......... Pregnancy and Neonatal Care Procedures ....................... T 1.3578 $74.08 $32.19 $14.82 

0199 ......... Obstetrical Care Service .................................................... T 17.2831 $942.98 .................... $188.60 

0200 ......... Level VII Female Reproductive Proc ................................. T 17.9920 $981.66 $307.83 $196.33 

0201 ......... Level VI Female Reproductive Proc .................................. T 16.8660 $920.23 $329.65 $184.05 

0202 ......... Level X Female Reproductive Proc ................................... T 38.9821 $2,126.90 $1,042.18 $425.38 

0203 ......... Level IV Nerve Injections ................................................... T 11.5969 $632.74 $276.76 $126.55 

0204 ......... Level I Nerve Injections ..................................................... T 2.1711 $118.46 $40.13 $23.69 

0206 ......... Level II Nerve Injections .................................................... T 5.2875 $288.49 $75.55 $57.70 

0207 ......... Level III Nerve Injections ................................................... T 6.4554 $352.21 $123.69 $70.44 

0208 ......... Laminotomies and Laminectomies .................................... T 40.2830 $2,197.88 .................... $439.58 

0209 ......... Extended EEG Studies and Sleep Studies, Level II ......... S 11.5435 $629.82 $280.58 $125.96 

0212 ......... Nervous System Injections ................................................ T 2.9739 $162.26 $74.67 $32.45 

0213 ......... Extended EEG Studies and Sleep Studies, Level I .......... S 2.9055 $158.53 $65.74 $31.71 

0214 ......... Electroencephalogram ....................................................... S 2.2176 $120.99 $58.12 $24.20 

0215 ......... Level I Nerve and Muscle Tests ........................................ S 0.6457 $35.23 $15.76 $7.05 

0216 ......... Level III Nerve and Muscle Tests ...................................... S 2.8535 $155.69 $67.98 $31.14 

0218 ......... Level II Nerve and Muscle Tests ....................................... S 1.1404 $62.22 .................... $12.44 

0220 ......... Level I Nerve Procedures .................................................. T 16.5554 $903.28 .................... $180.66 

0221 ......... Level II Nerve Procedures ................................................. T 24.8875 $1,357.89 $463.62 $271.58 

0222 ......... Implantation of Neurological Device .................................. T 232.2024 $12,669.20 .................... $2,533.84 

0223 ......... Implantation or Revision of Pain Management Catheter .. T 26.7610 $1,460.11 .................... $292.02 

0224 ......... Implantation of Reservoir/Pump/Shunt .............................. T 34.1770 $1,864.73 $453.41 $372.95 

0225 ......... Level I Implementation of Neurostimulator Electrodes ...... S 206.0034 $11,239.75 .................... $2,247.95 

0226 ......... Implantation of Drug Infusion Reservoir ............................ T 136.2989 $7,436.60 .................... $1,487.32 

0227 ......... Implantation of Drug Infusion Device ................................ T 160.8363 $8,775.39 .................... $1,755.08 

0228 ......... Creation of Lumbar Subarachnoid Shunt .......................... T 52.2880 $2,852.89 $639.03 $570.58 

0229 ......... Transcatherter Placement of Intravascular Shunt ............. T 61.9895 $3,382.21 $771.23 $676.44 

0230 ......... Level I Eye Tests & Treatments ........................................ S 0.7619 $41.57 $14.97 $8.31 

0231 ......... Level III Eye Tests & Treatments ...................................... S 2.1883 $119.40 $50.94 $23.88 

0232 ......... Level I Anterior Segment Eye Procedures ........................ T 4.9206 $268.47 $103.17 $53.69 

0233 ......... Level II Anterior Segment Eye Procedures ....................... T 14.4205 $786.80 $266.33 $157.36 

0234 ......... Level III Anterior Segment Eye Procedures ...................... T 21.4631 $1,171.05 $511.31 $234.21 

0235 ......... Level I Posterior Segment Eye Procedures ...................... T 5.0749 $276.89 $72.04 $55.38 

0236 ......... Level II Posterior Segment Eye Procedures ..................... T 18.6701 $1,018.66 .................... $203.73 

0237 ......... Level III Posterior Segment Eye Procedures .................... T 34.1784 $1,864.81 $818.54 $372.96 

0238 ......... Level I Repair and Plastic Eye Procedures ....................... T 3.1954 $174.34 $58.96 $34.87 

0239 ......... Level II Repair and Plastic Eye Procedures ...................... T 6.1331 $334.63 .................... $66.93 

0240 ......... Level III Repair and Plastic Eye Procedures ..................... T 17.4535 $952.28 $315.31 $190.46 

0241 ......... Level IV Repair and Plastic Eye Procedures .................... T 22.1969 $1,211.09 $384.47 $242.22 

0242 ......... Level V Repair and Plastic Eye Procedures ..................... T 29.4294 $1,605.70 $597.36 $321.14 

0243 ......... Strabismus/Muscle Procedures ......................................... T 21.7323 $1,185.74 $431.39 $237.15 

0244 ......... Corneal Transplant ............................................................ T 37.6284 $2,053.04 $803.26 $410.61 

0245 ......... Level I Cataract Procedures without IOL Insert ................ T 12.2973 $670.95 $222.22 $134.19 

0246 ......... Cataract Procedures with IOL Insert ................................. T 22.9755 $1,253.57 $495.96 $250.71 

0247 ......... Laser Eye Procedures Except Retinal ............................... T 4.9482 $269.98 $104.31 $54.00 

0248 ......... Laser Retinal Procedures .................................................. T 4.8223 $263.11 $95.08 $52.62 

0249 ......... Level II Cataract Procedures without IOL Insert ............... T 27.7406 $1,513.55 $524.67 $302.71 

0250 ......... Nasal Cauterization/Packing .............................................. T 1.4697 $80.19 $28.07 $16.04 

0251 ......... Level I ENT Procedures .................................................... T 1.7880 $97.56 .................... $19.51

0252 ......... Level II ENT Procedures ................................................... T 6.4469 $351.75 $113.41 $70.35 

0253 ......... Level III ENT Procedures .................................................. T 15.2249 $830.69 $282.29 $166.14 

0254 ......... Level IV ENT Procedures .................................................. T 21.8901 $1,194.35 $321.35 $238.87 

0256 ......... Level V ENT Procedures ................................................... T 35.1548 $1,918.08 .................... $383.62 

0258 ......... Tonsil and Adenoid Procedures ........................................ T 20.6265 $1,125.40 $437.25 $225.08 

836 Federal Register / Vol. 69, No. 3 / Tuesday, January 6, 2004 / Rules and Regulations 

ADDENDUM A.—LIST OF AMBULATORY PAYMENT CLASSIFICATIONS (APCS) WITH STATUS INDICATORS, RELATIVE

WEIGHTS, PAYMENT RATES, AND COPAYMENT AMOUNTS CALENDAR YEAR 2004—Continued

APC Group title Status

indicator 

Relative

weight 

Payment

rate 

National

unadjusted

copayment 

Minimum

unadjusted

copayment 

0259 ......... Level VI ENT Procedures .................................................. T 392.8622 $21,434.95 $9,394.83 $4,286.99 

0260 ......... Level I Plain Film Except Teeth ......................................... X 0.7802 $42.57 $21.28 $8.51 

0261 ......... Level II Plain Film Except Teeth Including Bone Density 

Measurement.

X 1.3176 $71.89 .................... $14.38 

0262 ......... Plain Film of Teeth ............................................................. X 0.7540 $41.14 $9.82 $8.23 

0263 ......... Level I Miscellaneous Radiology Procedures .................... X 2.1883 $119.40 $43.58 $23.88 

0264 ......... Level II Miscellaneous Radiology Procedures ................... X 3.0287 $165.25 $79.41 $33.05 

0265 ......... Level I Diagnostic Ultrasound Except Vascular ................ S 1.0289 $56.14 $28.07 $11.23 

0266 ......... Level II Diagnostic Ultrasound Except Vascular ............... S 1.6117 $87.94 $43.97 $17.59 

0267 ......... Level III Diagnostic Ultrasound Except Vascular .............. S 2.4586 $134.14 $65.52 $26.83 

0268 ......... Ultrasound Guidance Procedures ...................................... S 1.3081 $71.37 .................... $14.27 

0269 ......... Level III Echocardiogram Except Transesophageal .......... S 3.2309 $176.28 $87.24 $35.26 

0270 ......... Transesophageal Echocardiogram .................................... S 5.8546 $319.43 $146.79 $63.89 

0271 ......... Mammography ................................................................... S 0.6499 $35.46 $16.80 $7.09 

0272 ......... Level I Fluoroscopy ............................................................ X 1.4184 $77.39 $38.36 $15.48 

0274 ......... Myelography ....................................................................... S 3.5931 $196.04 $93.63 $39.21 

0275 ......... Arthrography ...................................................................... S 3.2775 $178.82 $69.09 $35.76 

0276 ......... Level I Digestive Radiology ............................................... S 1.5906 $86.78 $41.72 $17.36 

0277 ......... Level II Digestive Radiology .............................................. S 2.4444 $133.37 $60.47 $26.67 

0278 ......... Diagnostic Urography ........................................................ S 2.7012 $147.38 $66.07 $29.48 

0279 ......... Level II Angiography and Venography except Extremity .. S 10.7073 $584.20 $174.57 $116.84 

0280 ......... Level III Angiography and Venography except Extremity S 19.1015 $1,042.20 $353.85 $208.44 

0281 ......... Venography of Extremity ................................................... S 6.6031 $360.27 $115.16 $72.05 

0282 ......... Miscellaneous Computerized Axial Tomography .............. S 1.6834 $91.85 $44.51 $18.37 

0283 ......... Computerized Axial Tomography with Contrast Material .. S 4.6543 $253.94 $126.27 $50.79 

0284 ......... Magnetic Resonance Imaging and Magnetic Resonance 

Angiography with Contras.

S 7.1165 $388.28 $194.13 $77.66 

0285 ......... Myocardial Positron Emission Tomography (PET) ............ S 14.1508 $772.08 $334.45 $154.42 

0287 ......... Complex Venography ........................................................ S 6.4923 $354.23 $111.33 $70.85 

0288 ......... Bone Density:Axial Skeleton .............................................. S 1.2726 $69.43 .................... $13.89 

0289 ......... Needle Localization for Breast Biopsy ............................... X 3.4900 $190.42 $44.80 $38.08 

0296 ......... Level I Therapeutic Radiologic Procedures ....................... S 2.8635 $156.24 $69.20 $31.25 

0297 ......... Level II Therapeutic Radiologic Procedures ...................... S 7.7145 $420.91 $172.51 $84.18 

0299 ......... Miscellaneous Radiation Treatment .................................. S 5.7618 $314.37 .................... $62.87 

0300 ......... Level I Radiation Therapy .................................................. S 1.4912 $81.36 .................... $16.27 

0301 ......... Level II Radiation Therapy ................................................. S 2.1340 $116.43 $23.29 

0302 ......... Level III Radiation Therapy ................................................ S 6.3268 $345.20 $130.77 $69.04 

0303 ......... Treatment Device Construction ......................................... X 2.8835 $157.33 $66.95 $31.47 

0304 ......... Level I Therapeutic Radiation Treatment Preparation ...... X 1.6742 $91.35 $41.52 $18.27 

0305 ......... Level II Therapeutic Radiation Treatment Preparation ..... X 3.6767 $200.60 $91.38 $40.12 

0310 ......... Level III Therapeutic Radiation Treatment Preparation .... X 13.7165 $748.39 $325.27 $149.68 

0312 ......... Radioelement Applications ................................................ S 3.6637 $199.90 .................... $39.98

0313 ......... Brachytherapy .................................................................... S 13.8073 $753.34 .................... $150.67 

0314 ......... Hyperthermic Therapies ..................................................... S 4.6041 $251.20 $101.77 $50.24 

0320 ......... Electroconvulsive Therapy ................................................. S 5.3785 $293.46 $80.06 $58.69 

0321 ......... Biofeedback and Other Training ........................................ S 1.4817 $80.84 $21.78 $16.17 

0322 ......... Brief Individual Psychotherapy .......................................... S 1.2802 $69.85 .................... $13.97 

0323 ......... Extended Individual Psychotherapy ................................... S 1.8689 $101.97 $21.26 $20.39 

0324 ......... Family Psychotherapy ........................................................ S 2.4473 $133.53 .................... $26.71 

0325 ......... Group Psychotherapy ........................................................ S 1.4865 $81.10 $18.27 $16.22 

0330 ......... Dental Procedures ............................................................. S 0.5745 $31.35 .................... $6.27 

0332 ......... Computerized Axial Tomography and Computerized 

Angiography without Contras.

S 3.3936 $185.16 $91.27 $37.03 

0333 ......... Computerized Axial Tomography and Computerized 

Angio w/o Contrast Material.

S 5.4241 $295.94 $146.98 $59.19 

0335 ......... Magnetic Resonance Imaging, Miscellaneous .................. S 6.3499 $346.46 $151.46 $69.29 

0336 ......... Magnetic Resonance Imaging and Magnetic Resonance 

Angiography without Cont.

S 6.3897 $348.63 $174.31 $69.73 

0337 ......... MRI and Magnetic Resonance Angiography without Contrast Material followed.S 9.2075 $502.37 $240.77 $100.47 

0339 ......... Observation ........................................................................ S 6.6961 $365.35 .................... $73.07 

0340 ......... Minor Ancillary Procedures ................................................ X 0.6314 $34.45 .................... $6.89 

0341 ......... Skin Tests .......................................................................... X 0.1365 $7.45 $3.03 $1.49 

0342 ......... Level I Pathology ............................................................... X 0.2162 $11.80 $5.88 $2.36 

0343 ......... Level II Pathology .............................................................. X 0.4617 $25.19 $12.55 $5.04 

0344 ......... Level III Pathology ............................................................. X 0.6291 $34.32 $17.16 $6.86 

0345 ......... Level I Transfusion Laboratory Procedures ...................... X 0.2550 $13.91 $3.10 $2.78 

0346 ......... Level II Transfusion Laboratory Procedures ..................... X 0.3866 $21.09 $5.32 $4.22 

0347 ......... Level III Transfusion Laboratory Procedures .................... X 0.9610 $52.43 $13.20 $10.49 

Federal Register / Vol. 69, No. 3 / Tuesday, January 6, 2004 / Rules and Regulations 837

ADDENDUM A.—LIST OF AMBULATORY PAYMENT CLASSIFICATIONS (APCS) WITH STATUS INDICATORS, RELATIVE

WEIGHTS, PAYMENT RATES, AND COPAYMENT AMOUNTS CALENDAR YEAR 2004—Continued

APC Group title Status

indicator 

Relative

weight 

Payment

rate 

National

unadjusted

copayment 

Minimum

unadjusted

copayment 

0348 ......... Fertility Laboratory Procedures .......................................... X 0.8194 $44.71 .................... $8.94 

0352 ......... Level I Injections ................................................................ X 0.1230 $6.71 .................... $1.34 

0353 ......... Level II Allergy Injections ................................................... X 0.3982 $21.73 .................... $4.35 

0355 ......... Level III Immunizations ...................................................... K 0.2749 $15.00 .................... $3.00 

0356 ......... Level IV Immunizations ...................................................... K 0.7698 $42.00 .................... $8.40 

0359 ......... Level II Injections ............................................................... X 0.8000 $43.65 .................... $8.73 

0360 ......... Level I Alimentary Tests .................................................... X 1.7313 $94.46 $42.45 $18.89 

0361 ......... Level II Alimentary Tests ................................................... X 3.5510 $193.75 $83.23 $38.75 

0362 ......... Level III Otorhinolaryngologic Function Tests ................... X 2.6984 $147.23 .................... $29.45 

0363 ......... Level I Otorhinolaryngologic Function Tests ..................... X 0.8641 $47.15 $17.44 $9.43 

0364 ......... Level I Audiometry ............................................................. X 0.4459 $24.33 $9.06 $4.87 

0365 ......... Level II Audiometry ............................................................ X 1.2132 $66.19 $18.95 $13.24 

0367 ......... Level I Pulmonary Test ...................................................... X 0.5887 $32.12 $15.16 $6.42 

0368 ......... Level II Pulmonary Tests ................................................... X 0.9319 $50.85 $25.42 $10.17 

0369 ......... Level III Pulmonary Tests .................................................. X 2.4984 $136.32 $44.18 $27.26 

0370 ......... Allergy Tests ...................................................................... X 0.9185 $50.11 $11.58 $10.02 

0371 ......... Level I Allergy Injections .................................................... X 0.4105 $22.40 .................... $4.48 

0372 ......... Therapeutic Phlebotomy .................................................... X 0.5607 $30.59 $10.09 $6.12 

0373 ......... Neuropsychological Testing ............................................... X 2.3288 $127.06 .................... $25.41

0374 ......... Monitoring Psychiatric Drugs ............................................. X 1.1252 $61.39 .................... $12.28 

0375 ......... Ancillary Outpatient Services When Patient Expires ......... T .................... $1,150.00 .................... $230.00 

0376 ......... Level II Cardiac Imaging .................................................... S 4.4510 $242.85 $121.42 $48.57 

0377 ......... Level III Cardiac Imaging ................................................... S 6.8830 $375.54 $187.76 $75.11 

0378 ......... Level II Pulmonary Imaging ............................................... S 5.4852 $299.28 $149.63 $59.86 

0379 ......... Injection adenosine 6 Mg ................................................... K 0.2078 $11.34 .................... $2.27

0380 ......... Dipyridamole injection ........................................................ K 0.2525 $13.78 .................... $2.76 

0384 ......... GI Procedures with Stents ................................................. T 36.5400 $1,993.66 $433.01 $398.73 

0385 ......... Level I Prosthetic Urological Procedures .......................... S 67.1530 $3,663.93 .................... $732.79 

0386 ......... Level II Prosthetic Urological Procedures ......................... S 116.2382 $6,342.07 .................... $1,268.41

0387 ......... Level II Hysteroscopy ........................................................ T 28.1480 $1,535.78 $655.55 $307.16 

0388 ......... Discography ....................................................................... S 11.6347 $634.80 $303.19 $126.96 

0389 ......... Non-imaging Nuclear Medicine .......................................... S 1.6328 $89.09 $44.54 $17.82 

0390 ......... Level I Endocrine Imaging ................................................. S 2.7907 $152.26 $76.13 $30.45 

0391 ......... Level II Endocrine Imaging ................................................ S 3.1956 $174.36 $87.18 $34.87 

0393 ......... Red Cell/Plasma Studies ................................................... S 4.4354 $242.00 $121.00 $48.40 

0394 ......... Hepatobiliary Imaging ........................................................ S 4.3714 $238.51 $119.25 $47.70 

0395 ......... GI Tract Imaging ................................................................ S 3.9536 $215.71 $107.85 $43.14 

0396 ......... Bone Imaging ..................................................................... S 4.1883 $228.52 $114.26 $45.70 

0397 ......... Vascular Imaging ............................................................... S 2.2183 $121.03 $60.51 $24.21 

0398 ......... Level I Cardiac Imaging ..................................................... S 4.5091 $246.02 $123.01 $49.20 

0399 ......... Nuclear Medicine Add-on Imaging .................................... S 1.5273 $83.33 $41.66 $16.67 

0400 ......... Hematopoietic Imaging ...................................................... S 3.8242 $208.65 $104.32 $41.73 

0401 ......... Level I Pulmonary Imaging ................................................ S 3.3736 $184.07 $92.03 $36.81 

0402 ......... Brain Imaging ..................................................................... S 5.4063 $294.97 $147.48 $58.99 

0403 ......... CSF Imaging ...................................................................... S 3.8402 $209.53 $104.76 $41.91 

0404 ......... Renal and Genitourinary Studies Level I ........................... S 3.7303 $203.53 $101.76 $40.71 

0405 ......... Renal and Genitourinary Studies Level II .......................... S 4.3432 $236.97 $118.48 $47.39 

0406 ......... Tumor/Infection Imaging .................................................... S 4.3955 $239.82 $119.91 $47.96 

0407 ......... Radionuclide Therapy ........................................................ S 3.5841 $195.55 $97.77 $39.11 

0409 ......... Red Blood Cell Tests ......................................................... X 0.1390 $7.58 $2.32 $1.52 

0410 ......... Mammogram Add On ........................................................ S 0.1523 $8.31 .................... $1.66 

0411 ......... Respiratory Procedures ..................................................... S 0.4367 $23.83 .................... $4.77

0412 ......... IMRT Treatment Delivery ................................................... S 5.3904 $294.11 .................... $58.82 

0415 ......... Level II Endoscopy Lower Airway ..................................... T 20.7348 $1,131.31 $459.92 $226.26 

0600 ......... Low Level Clinic Visits ....................................................... V 0.9278 $50.62 .................... $10.12 

0601 ......... Mid Level Clinic Visits ........................................................ V 0.9816 $53.56 .................... $10.71 

0602 ......... High Level Clinic Visits ...................................................... V 1.5041 $82.07 .................... $16.41 

0610 ......... Low Level Emergency Visits .............................................. V 1.3691 $74.70 $19.57 $14.94 

0611 ......... Mid Level Emergency Visits .............................................. V 2.3967 $130.77 $36.16 $26.15 

0612 ......... High Level Emergency Visits ............................................. V 4.1476 $226.30 $54.12 $45.26 

0620 ......... Critical Care ....................................................................... S 8.9992 $491.01 $142.30 $98.20 

0648 ......... Breast Reconstruction with Prosthesis .............................. T 54.0165 $2,947.19 .................... $589.44 

0651 ......... Complex Interstitial Radiation Source Application ............. S 10.2314 $558.24 .................... $111.65 

0652 ......... Insertion of Intraperitoneal Catheters ................................ T 27.0364 $1,475.13 .................... $295.03 

0653 ......... Vascular Reconstruction/Fistula Repair with Device ......... T 30.0334 $1,638.65 .................... $327.73 

0654 ......... Insertion/Replacement of a permanent dual chamber 

pacemaker.

T 112.6957 $6,148.79 .................... $1,229.76 

0655 ......... Insertion/Replacement/Conversion of a permanent dual 

chamber pacemaker.

T 142.7039 $7,786.07 .................... $1,557.21 

838 Federal Register / Vol. 69, No. 3 / Tuesday, January 6, 2004 / Rules and Regulations 

ADDENDUM A.—LIST OF AMBULATORY PAYMENT CLASSIFICATIONS (APCS) WITH STATUS INDICATORS, RELATIVE

WEIGHTS, PAYMENT RATES, AND COPAYMENT AMOUNTS CALENDAR YEAR 2004—Continued

APC Group title Status

indicator 

Relative

weight 

Payment

rate 

National

unadjusted

copayment 

Minimum

unadjusted

copayment 

0656 ......... Transcatheter Placement of Intracoronary Drug-Eluting 

Stents.

T 103.4907 $5,646.56 .................... $1,129.31 

0657 ......... Placement of Tissue Clips ................................................. S 1.5102 $82.40 .................... $16.48

0658 ......... Percutaneous Breast Biopsies ........................................... T 5.5779 $304.34 .................... $60.87 

0659 ......... Hyperbaric Oxygen ............................................................ S 3.0228 $164.93 .................... $32.99 

660 ........... Level II Otorhinolaryngologic Function Tests .................... X 1.7353 $94.68 $30.66 $18.94 

0661 ......... Level IV Pathology ............................................................. X 3.2576 $177.74 $88.87 $35.55 

0662 ......... CT Angiography ................................................................. S 5.8775 $320.68 $156.47 $64.14 

0664 ......... Proton Beam Radiation Therapy ....................................... S 9.7295 $530.85 .................... $106.17 

0665 ......... Bone Density: Appendicular Skeleton ............................... S 0.7257 $39.59 .................... $7.92 

0668 ......... Level I Angiography and Venography except Extremity ... S 10.2660 $560.12 $237.76 $112.02 

0669 ......... Digital Mammography ........................................................ S 0.9009 $49.15 .................... $9.83

0670 ......... Intravenous and Intracardiac Ultrasound ........................... S 27.4483 $1,497.61 $542.37 $299.52 

0671 ......... Level II Echocardiogram Except Transesophageal ........... S 1.6384 $89.39 $44.69 $17.88 

0672 ......... Level IV Posterior Segment Procedures ........................... T 38.9476 $2,125.02 $988.43 $425.00 

0673 ......... Level IV Anterior Segment Eye Procedures ...................... T 26.8390 $1,464.36 $649.56 $292.87 

0674 ......... Prostate Cryoablation ........................................................ T 119.9733 $6,545.86 .................... $1,309.17 

0675 ......... Prostatic Thermotherapy .................................................... T 49.3452 $2,692.32 .................... $538.46 

0676 ......... Level II Transcatheter Thrombolysis ................................. T 2.7315 $149.03 $40.30 $29.81 

0677 ......... Level I Transcatheter Thrombolysis .................................. T 2.1805 $118.97 .................... $23.79 

0678 ......... External Counterpulsation .................................................. T 2.0659 $112.72 .................... $22.54 

0679 ......... Level II Resuscitation and Cardioversion .......................... S 5.4887 $299.47 $95.30 $59.89 

0680 ......... Insertion of Patient Activated Event Recorders ................. S 62.8252 $3,427.81 .................... $685.56 

0681 ......... Knee Arthroplasty .............................................................. T 98.1613 $5,355.78 $2,131.36 $1,071.16 

0682 ......... Level V Debridement & Destruction .................................. T 8.0790 $440.80 $174.57 $88.16 

0683 ......... Level II Photochemotherapy .............................................. S 1.5489 $84.51 $30.42 $16.90 

0685 ......... Level III Needle Biopsy/Aspiration Except Bone Marrow .. T 4.8100 $262.44 $115.47 $52.49 

0686 ......... Level III Skin Repair .......................................................... T 7.9247 $432.38 $198.89 $86.48 

0687 ......... Revision/Removal of Neurostimulator Electrodes ............. T 20.4416 $1,115.31 $513.05 $223.06 

0688 ......... Revision/Removal of Neurostimulator Pulse Generator 

Receiver.

T 46.7347 $2,549.89 $1,249.45 $509.98 

0689 ......... Electronic Analysis of Cardioverter-defibrillators ............... S 0.5533 $30.19 .................... $6.04 

0690 ......... Electronic Analysis of Pacemakers and other Cardiac 

Devices.

S 0.4074 $22.23 $10.63 $4.45 

0691 ......... Electronic Analysis of Programmable Shunts/Pumps ....... S 2.8066 $153.13 $76.56 $30.63 

0692 ......... Electronic Analysis of Neurostimulator Pulse Generators S 1.1057 $60.33 $30.16 $12.07 

0693 ......... Level II Breast Reconstruction ........................................... T 39.0111 $2,128.48 $798.17 $425.70 

0694 ......... Mohs Surgery ..................................................................... T 2.9752 $162.33 $64.93 $32.47 

0695 ......... Level VII Debridement & Destruction ................................ T 19.1849 $1,046.75 $266.59 $209.35 

0697 ......... Level I Echocardiogram Except Transesophageal ............ S 1.4415 $78.65 $39.32 $15.73 

0698 ......... Level II Eye Tests & Treatments ....................................... S 0.9599 $52.37 $18.72 $10.47 

0699 ......... Level IV Eye Tests & Treatments ...................................... T 2.2303 $121.69 $47.46 $24.34 

0700 ......... Antepartum Manipulation ................................................... T 2.4306 $132.62 $37.13 $26.52 

0701 ......... SR 89 chloride, per mCi .................................................... K .................... $892.43 .................... $178.49 

0702 ......... SM 153 lexidronam, 50 mCi .............................................. K .................... $493.89 .................... $98.78 

0704 ......... IN 111 Satumomab pendetide per dose ........................... K .................... $1,474.00 .................... $294.80 

0705 ......... Technetium TC99M tetrofosmin ........................................ K 1.0642 $665.28 .................... $133.06 

0726 ......... Dexrazoxane hcl injection, 250 mg ................................... K 2.0616 $112.48 .................... $22.50 

0728 ......... Filgrastim 300 mcg injection .............................................. K .................... $172.20 .................... $34.44 

0730 ......... Pamidronate disodium , 30 mg .......................................... K .................... $128.74 .................... $25.75 

0731 ......... Sargramostim injection ...................................................... K .................... $26.92 .................... $5.38 

0732 ......... Mesna injection 200 mg ..................................................... K .................... $17.66 .................... $3.53 

0733 ......... Non esrd epoetin alpha inj, 1000 u ................................... K .................... $11.76 .................... $2.35 

0734 ......... Injection, darbepoetin alfa (for non-ESRD), per 1 mcg ..... K .................... $3.88 .................... $0.78 

0763 ......... Dolasetron mesylate oral ................................................... K .................... $152.38 .................... $30.48 

0764 ......... Granisetron HCl injection ................................................... K .................... $17.18 .................... $3.44 

0765 ......... Granisetron HCl 1 mg oral ................................................. K .................... $171.78 .................... $34.36 

0800 ......... Leuprolide acetate, 3.75 mg .............................................. K .................... $479.20 .................... $95.84 

0802 ......... Etoposide oral 50 mg ......................................................... K .................... $21.91 .................... $4.38 

0807 ......... Aldesleukin/single use vial ................................................. K .................... $680.35 .................... $136.07 

0809 ......... Bcg live intravesical vac .................................................... K .................... $77.54 .................... $15.51 

0810 ......... Goserelin acetate implant 3.6 mg ...................................... K .................... $413.59 .................... $82.72 

0811 ......... Carboplatin injection 50 mg ............................................... K .................... $137.79 .................... $27.56 

0813 ......... Cisplatin 10 mg injection .................................................... K .................... $7.73 .................... $1.55 

0814 ......... Asparaginase injection ....................................................... K .................... $58.00 .................... $11.60 

0815 ......... Cyclophosphamide 100 MG inj .......................................... K .................... $2.77 .................... $0.55 

0816 ......... Cyclophosphamide lyophilized ........................................... K .................... $2.36 .................... $0.47 

0817 ......... Cytarabine hcl 100 MG inj ................................................. K .................... $1.55 .................... $0.31 

0819 ......... Dacarbazine 100 mg inj ..................................................... K 0.0974 $5.31 .................... $1.06 

Federal Register / Vol. 69, No. 3 / Tuesday, January 6, 2004 / Rules and Regulations 839

ADDENDUM A.—LIST OF AMBULATORY PAYMENT CLASSIFICATIONS (APCS) WITH STATUS INDICATORS, RELATIVE

WEIGHTS, PAYMENT RATES, AND COPAYMENT AMOUNTS CALENDAR YEAR 2004—Continued

APC Group title Status

indicator 

Relative

weight 

Payment

rate 

National

unadjusted

copayment 

Minimum

unadjusted

copayment 

0820 ......... Daunorubicin 10 mg ........................................................... K .................... $35.94 .................... $7.19 

0821 ......... Daunorubicin citrate liposom 10 mg .................................. K .................... $64.60 .................... $12.92 

0823 ......... Docetaxel, 20 mg ............................................................... K .................... $331.53 .................... $66.31 

0824 ......... Etoposide 10 MG inj .......................................................... K .................... $0.83 .................... $0.17 

0827 ......... Floxuridine injection 500 mg .............................................. K .................... $66.24 .................... $13.25 

0828 ......... Gemcitabine HCL 200 mg ................................................. K .................... $112.09 .................... $22.42 

0830 ......... Irinotecan injection 20 mg .................................................. K .................... $135.00 .................... $27.00 

0831 ......... Ifosfomide injection 1 gm ................................................... K .................... $72.81 .................... $14.56 

0832 ......... Idarubicin hcl injection 5 mg .............................................. K 3.2663 $178.21 .................... $35.64 

0834 ......... Interferon alfa-2a inj ........................................................... K .................... $32.31 .................... $6.46 

0836 ......... Interferon alfa-2b inj recombinant, 1 million ...................... K .................... $13.78 .................... $2.76 

0838 ......... Interferon gamma 1-b inj, 3 million u ................................. K .................... $290.70 .................... $58.14 

0840 ......... Melphalan hydrochl 50 mg ................................................ K .................... $389.14 .................... $77.83 

0842 ......... Fludarabine phosphate inj 50 mg ...................................... K .................... $329.83 .................... $65.97 

0844 ......... Pentostatin injection, 10 mg .............................................. K .................... $1,784.64 .................... $356.93 

0847 ......... Doxorubic hcl 10 MG vl chemo ......................................... K .................... $4.69 .................... $0.94 

0849 ......... Rituximab, 100 mg ............................................................. K .................... $464.20 .................... $92.84 

0850 ......... Streptozocin injection, 1 gm .............................................. K .................... $131.05 .................... $26.21 

0851 ......... Thiotepa injection ............................................................... K .................... $45.31 .................... $9.06 

0852 ......... Topotecan, 4 mg ................................................................ K .................... $739.80 .................... $147.96 

0855 ......... Vinorelbine tartrate, 10 mg ................................................ K .................... $100.97 .................... $20.19 

0856 ......... Porfimer sodium, 75 mg .................................................... K .................... $2,411.82 .................... $482.36 

0857 ......... Bleomycin sulfate injection 15 u ........................................ K .................... $88.32 .................... $17.66 

0858 ......... Cladribine, 1mg .................................................................. K .................... $24.84 .................... $4.97 

0860 ......... Plicamycin (mithramycin) inj .............................................. K .................... $86.89 .................... $17.38 

0861 ......... Leuprolide acetate injection 1 mg ...................................... K .................... $14.48 .................... $2.90 

0862 ......... Mitomycin 5 mg inj ............................................................. K .................... $30.91 .................... $6.18 

0863 ......... Paclitaxel injection, 30 mg ................................................. K .................... $79.04 .................... $15.81 

0864 ......... Mitoxantrone hcl, 5 mg ...................................................... K .................... $332.87 .................... $66.57 

0865 ......... Interferon alfa-n3 inj, human leukocyte derived, 2 ............ K .................... $8.17 .................... $1.63

0884 ......... Rho d immune globulin inj, 1 dose pkg ............................. K .................... $92.93 .................... $18.59 

0888 ......... Cyclosporine oral 100 mg .................................................. K .................... $2.41 .................... $0.48 

0890 ......... Lymphocyte immune globulin 250 mg ............................... K .................... $258.17 .................... $51.63 

0891 ......... Tacrolimus oral per 1 mg ................................................... K .................... $3.24 .................... $0.65 

0900 ......... Alglucerase injection, per 10 u .......................................... K .................... $37.13 .................... $7.43 

0901 ......... Alpha 1 proteinase inhibitor, 10 mg ................................... K .................... $3.43 .................... $0.69 

0902 ......... Botulinum toxin a, per unit ................................................. K .................... $4.58 .................... $0.92 

0903 ......... Cytomegalovirus imm IV/vial ............................................. K .................... $659.60 .................... $131.92 

0905 ......... Immune globulin, 1g .......................................................... K .................... $37.95 .................... $7.59 

0906 ......... RSV-ivig, 50 mg ................................................................. K .................... $16.55 .................... $3.31 

0907 ......... Ganciclovir sodium injection .............................................. K 0.5918 $32.29 .................... $6.46 

0909 ......... Interferon beta-1a, 33 mcg ................................................ K .................... $123.77 .................... $24.75 

0910 ......... Interferon beta-1b /0.25 mg ............................................... K .................... $67.22 .................... $13.44 

0911 ......... Streptokinase per 250,000 iu ............................................. K 1.5733 $85.84 .................... $17.17 

0913 ......... Ganciclovir long act implant ............................................... K 1.5861 $86.54 .................... $17.31 

0916 ......... Imiglucerase injection/unit .................................................. K .................... $3.71 .................... $0.74 

0917 ......... Adenosine injection ............................................................ K 1.0393 $56.71 .................... $11.34 

0925 ......... Factor viii per iu ................................................................. K .................... $0.42 .................... $0.08 

0926 ......... Factor VIII (porcine) per iu ................................................. K .................... $1.89 .................... $0.38 

0927 ......... Factor viii recombinant per iu ............................................ K .................... $0.61 .................... $0.12 

0928 ......... Factor ix complex per iu .................................................... K .................... $0.18 .................... $0.04 

0929 ......... Anti-inhibitor per iu ............................................................. K .................... $0.69 .................... $0.14 

0931 ......... Factor IX non-recombinant, per iu ..................................... K .................... $0.51 .................... $0.10 

0932 ......... Factor IX recombinant, per iu ............................................ K .................... $1.04 .................... $0.21 

0949 ......... Plasma, Pooled Multiple Donor, Solvent/Detergent .......... K .................... $124.31 .................... $24.86 

0950 ......... Blood (Whole) For Transfusion .......................................... K .................... $87.93 .................... $17.59 

0952 ......... Cryoprecipitate ................................................................... K .................... $29.31 .................... $5.86 

0954 ......... RBC leukocytes reduced ................................................... K .................... $119.26 .................... $23.85 

0955 ......... Plasma, Fresh Frozen ....................................................... K .................... $95.00 .................... $19.00 

0956 ......... Plasma Protein Fraction .................................................... K .................... $92.98 .................... $18.60 

0957 ......... Platelet Concentrate .......................................................... K .................... $41.44 .................... $8.29 

0958 ......... Platelet Rich Plasma .......................................................... K .................... $53.56 .................... $10.71 

0959 ......... Red Blood Cells ................................................................. K .................... $86.41 .................... $17.28 

0960 ......... Washed Red Blood Cells ................................................... K .................... $160.69 .................... $32.14 

0961 ......... Infusion, Albumin (Human) 5%, 50 ml ............................... K 0.2802 $15.29 .................... $3.06 

0963 ......... Albumin (human), 5%, 250 ml ........................................... K 1.0901 $59.48 .................... $11.90 

0964 ......... Albumin (human), 25%, 20 ml ........................................... K 0.3741 $20.41 .................... $4.08 

0965 ......... Albumin (human), 25%, 50ml ............................................ K 0.8869 $48.39 .................... $9.68 

0966 ......... Plasmaprotein fract,5%,250ml ........................................... K .................... $464.90 .................... $92.98 

840 Federal Register / Vol. 69, No. 3 / Tuesday, January 6, 2004 / Rules and Regulations 

ADDENDUM A.—LIST OF AMBULATORY PAYMENT CLASSIFICATIONS (APCS) WITH STATUS INDICATORS, RELATIVE

WEIGHTS, PAYMENT RATES, AND COPAYMENT AMOUNTS CALENDAR YEAR 2004—Continued

APC Group title Status

indicator 

Relative

weight 

Payment

rate 

National

unadjusted

copayment 

Minimum

unadjusted

copayment 

1009 ......... Cryoprecip reduced plasma ............................................... K .................... $37.39 .................... $7.48 

1010 ......... Blood, L/R, CMV-neg ......................................................... K .................... $121.78 .................... $24.36 

1011 ......... Platelets, HLA-m, L/R, unit ................................................ K .................... $499.77 .................... $99.95 

1013 ......... Platelet concentrate, L/R, unit ........................................... K .................... $49.52 .................... $9.90 

1016 ......... Blood, L/R, froz/deglycerol/washed ................................... K .................... $301.68 .................... $60.34 

1017 ......... Platelets, aph/pher, L/R, CMV-neg, unit ............................ K .................... $393.15 .................... $78.63 

1018 ......... Blood, L/R, irradiated ......................................................... K .................... $132.40 .................... $26.48 

1019 ......... Platelets, aph/pher, L/R, irradiated, unit ............................ K .................... $406.28 .................... $81.26 

1020 ......... Pit, pher,L/R,CMV,irrad ...................................................... K .................... $495.22 .................... $99.04 

1021 ......... RBC, frz/deg/wsh, L/R, irrad .............................................. K .................... $336.04 .................... $67.21 

1022 ......... RBC, L/R, CMV neg, irrad ................................................. K .................... $201.12 .................... $40.22 

1045 ......... Iobenguane sulfate I-131per 0.5 mCi ................................ K 3.0392 $165.82 .................... $33.16 

1064 ......... I-131 sodium iodide capsule .............................................. K 0.1004 $5.48 .................... $1.10 

1065 ......... I-131 sodium iodide solution .............................................. K 0.1189 $6.49 .................... $1.30 

1079 ......... CO 57/58 per 0.5 uCi ........................................................ K .................... $235.14 .................... $47.03 

1080 ......... I-131 tositumomab, dx ....................................................... K .................... $2,565.55 .................... $513.11 

1081 ......... I-131 tositumomab, tx ........................................................ K .................... $22,210.19 .................... $4,442.04 

1084 ......... Denileukin diftitox, 300 MCG ............................................. K .................... $1,232.88 .................... $246.58 

1086 ......... Temozolomide,oral 5 mg ................................................... K .................... $6.81 .................... $1.36 

1089 ......... Cyanocobalamin cobalt co57 ............................................. K .................... $47.38 .................... $9.48 

1091 ......... IN 111 Oxyquinoline, per .5 mCi ....................................... K 4.1151 $224.52 .................... $44.90 

1092 ......... IN 111 Pentetate, per 0.5 mCi ........................................... K .................... $237.60 .................... $47.52 

1095 ......... Technetium TC 99M Depreotide ....................................... K .................... $704.00 .................... $140.80 

1096 ......... TC 99M Exametazime, per dose ....................................... K .................... $825.00 .................... $165.00 

1122 ......... TC 99M arcitumomab, per vial .......................................... K .................... $1,144.00 .................... $228.80 

1166 ......... Cytarabine liposome .......................................................... K .................... $344.08 .................... $68.82 

1167 ......... Epirubicin hcl, 2 mg ........................................................... K .................... $25.60 .................... $5.12 

1178 ......... Busulfan IV, 6 mg .............................................................. K .................... $27.87 .................... $5.57 

1200 ......... TC 99M Sodium Glucoheptonat ........................................ K .................... $30.28 .................... $6.06 

1201 ......... TC 99M SUCCIMER, PER Vial ......................................... K .................... $125.66 .................... $25.13 

1203 ......... Verteporfin for injection ...................................................... K .................... $1,350.80 .................... $270.16 

1207 ......... Octreotide injection, depd .................................................. K .................... $73.62 .................... $14.72 

1305 ......... Apligraf ............................................................................... K .................... $1,199.00 .................... $239.80 

1409 ......... Factor viia recombinant, per 1.2 mg .................................. K .................... $1,495.30 .................... $299.06 

1501 ......... New Technology - Level I ($0–$50) .................................. S .................... $25.00 .................... $5.00 

1502 ......... New Technology - Level II ($50–$100) ............................. S .................... $75.00 .................... $15.00 

1503 ......... New Technology - Level III ($100–$200) .......................... S .................... $150.00 .................... $30.00 

1504 ......... New Technology - Level IV ($200–$300) .......................... S .................... $250.00 .................... $50.00 

1505 ......... New Technology - Level V ($300–$400) ........................... S .................... $350.00 .................... $70.00 

1506 ......... New Technology - Level VI ($400–$500) .......................... S .................... $450.00 .................... $90.00 

1507 ......... New Technology - Level VII ($500–$600) ......................... S .................... $550.00 .................... $110.00 

1508 ......... New Technology - Level VIII ($600–$700) ........................ S .................... $650.00 .................... $130.00 

1509 ......... New Technology - Level IX ($700–$800) .......................... S .................... $750.00 .................... $150.00 

1510 ......... New Technology - Level X ($800–$900) ........................... S .................... $850.00 .................... $170.00 

1511 ......... New Technology - Level XI ($900–$1000) ........................ S .................... $950.00 .................... $190.00 

1512 ......... New Technology - Level XII ($1000–$1100) ..................... S .................... $1,050.00 .................... $210.00 

1513 ......... New Technology - Level XIII ($1100–$1200) .................... S .................... $1,150.00 .................... $230.00 

1514 ......... New Technology - Level XIV ($1200–$1300) ................... S .................... $1,250.00 .................... $250.00 

1515 ......... New Technology - Level XV ($1300–$1400) .................... S .................... $1,350.00 .................... $270.00 

1516 ......... New Technology - Level XVI ($1400–$1500) ................... S .................... $1,450.00 .................... $290.00 

1517 ......... New Technology - Level XVII ($1500–$1600) .................. S .................... $1,550.00 .................... $310.00 

1518 ......... New Technology - Level XVIII ($1600–$1700) ................. S .................... $1,650.00 .................... $330.00 

1519 ......... New Technology - Level IXX ($1700–$1800) ................... S .................... $1,750.00 .................... $350.00 

1520 ......... New Technology - Level XX ($1800–$1900) .................... S .................... $1,850.00 .................... $370.00 

1521 ......... New Technology - Level XXI ($1900–$2000) ................... S .................... $1,950.00 .................... $390.00 

1522 ......... New Technology - Level XXII ($2000–$2500) .................. S .................... $2,250.00 .................... $450.00 

1523 ......... New Technology - Level XXIII ($2500–$3000) ................. S .................... $2,750.00 .................... $550.00 

1524 ......... New Technology - Level XIV ($3000–$3500) ................... S .................... $3,250.00 .................... $650.00 

1525 ......... New Technology - Level XXV ($3500–$4000) .................. S .................... $3,750.00 .................... $750.00 

1526 ......... New Technology - Level XXVI ($4000–$4500) ................. S .................... $4,250.00 .................... $850.00 

1527 ......... New Technology - Level XXVII ($4500–$5000) ................ S .................... $4,750.00 .................... $950.00 

1528 ......... New Technology - Level XXVIII ($5000–$5500) ............... S .................... $5,250.00 .................... $1,050.00 

1529 ......... New Technology - Level XXIX ($5500–$6000) ................. S .................... $5,750.00 .................... $1,150.00 

1530 ......... New Technology - Level XXX ($6000–$6500) .................. S .................... $6,250.00 .................... $1,250.00 

1531 ......... New Technology - Level XXXI ($6500–$7000) ................. S .................... $6,750.00 .................... $1,350.00 

1532 ......... New Technology - Level XXXII ($7000–$7500) ................ S .................... $7,250.00 .................... $1,450.00 

1533 ......... New Technology - Level XXXIII ($7500–$8000) ............... S .................... $7,750.00 .................... $1,550.00 

1534 ......... New Technology - Level XXXIV ($8000–$8500) ............... S .................... $8,250.00 .................... $1,650.00 

1535 ......... New Technology - Level XXXV ($8500–$9000) ................ S .................... $8,750.00 .................... $1,750.00 

Federal Register / Vol. 69, No. 3 / Tuesday, January 6, 2004 / Rules and Regulations 841

ADDENDUM A.—LIST OF AMBULATORY PAYMENT CLASSIFICATIONS (APCS) WITH STATUS INDICATORS, RELATIVE

WEIGHTS, PAYMENT RATES, AND COPAYMENT AMOUNTS CALENDAR YEAR 2004—Continued

APC Group title Status

indicator 

Relative

weight 

Payment

rate 

National

unadjusted

copayment 

Minimum

unadjusted

copayment 

1536 ......... New Technology - Level XXXVI ($9000–$9500) ............... S .................... $9,250.00 .................... $1,850.00 

1537 ......... New Technology - Level XXXVII ($9500–$10000) ............ S .................... $9,750.00 .................... $1,950.00 

1538 ......... New Technology - Level I ($0–$50) .................................. T .................... $25.00 .................... $5.00 

1539 ......... New Technology - Level II ($50–$100) ............................. T .................... $75.00 .................... $15.00 

1540 ......... New Technology - Level III ($100–$200) .......................... T .................... $150.00 .................... $30.00 

1541 ......... New Technology - Level IV ($200–$300) .......................... T .................... $250.00 .................... $50.00 

1542 ......... New Technology - Level V ($300–$400) ........................... T .................... $350.00 .................... $70.00 

1543 ......... New Technology - Level VI ($400–$500) .......................... T .................... $450.00 .................... $90.00 

1544 ......... New Technology - Level VII ($500–$600) ......................... T .................... $550.00 .................... $110.00 

1545 ......... New Technology - Level VIII ($600–$700) ........................ T .................... $650.00 .................... $130.00 

1546 ......... New Technology - Level IX ($700–$800) .......................... T .................... $750.00 .................... $150.00 

1547 ......... New Technology - Level X ($800–$900) ........................... T .................... $850.00 .................... $170.00 

1548 ......... New Technology - Level XI ($900–$1000) ........................ T .................... $950.00 .................... $190.00 

1549 ......... New Technology - Level XII ($1000–$1100) ..................... T .................... $1,050.00 .................... $210.00 

1550 ......... New Technology - Level XIII ($1100–$1200) .................... T .................... $1,150.00 .................... $230.00 

1551 ......... New Technology - Level XIV ($1200–$1300) ................... T .................... $1,250.00 .................... $250.00 

1552 ......... New Technology - Level XV ($1300–$1400) .................... T .................... $1,350.00 .................... $270.00 

1553 ......... New Technology - Level XVI ($1400–$1500) ................... T .................... $1,450.00 .................... $290.00 

1554 ......... New Technology - Level XVII ($1500–$1600) .................. T .................... $1,550.00 .................... $310.00 

1555 ......... New Technology - Level XVIII ($1600–$1700) ................. T .................... $1,650.00 .................... $330.00 

1556 ......... New Technology - Level XIX ($1700–$1800) ................... T .................... $1,750.00 .................... $350.00 

1557 ......... New Technology - Level XX ($1800–$1900) .................... T .................... $1,850.00 .................... $370.00 

1558 ......... New Technology - Level XXI ($1900–$2000) ................... T .................... $1,950.00 .................... $390.00 

1559 ......... New Technology - Level XXII ($2000–$2500) .................. T .................... $2,250.00 .................... $450.00 

1560 ......... New Technology - Level XXIII ($2500–$3000) ................. T .................... $2,750.00 .................... $550.00 

1561 ......... New Technology - Level XXIV ($3000–$3500) ................. T .................... $3,250.00 .................... $650.00 

1562 ......... New Technology - Level XXV ($3500–$4000) .................. T .................... $3,750.00 .................... $750.00 

1563 ......... New Technology - Level XXVI ($4000–$4500) ................. T .................... $4,250.00 .................... $850.00 

1564 ......... New Technology - Level XXVII ($4500–$5000) ................ T .................... $4,750.00 .................... $950.00 

1565 ......... New Technology - Level XXVIII ($5000–$5500) ............... T .................... $5,250.00 .................... $1,050.00 

1566 ......... New Technology - Level XXIX ($5500–$6000) ................. T .................... $5,750.00 .................... $1,150.00 

1567 ......... New Technology - Level XXX ($6000–$6500) .................. T .................... $6,250.00 .................... $1,250.00 

1568 ......... New Technology - Level XXXI ($6500–$7000) ................. T .................... $6,750.00 .................... $1,350.00 

1569 ......... New Technology - Level XXXII ($7000–$7500) ................ T .................... $7,250.00 .................... $1,450.00 

1570 ......... New Technology - Level XXXIII ($7500–$8000) ............... T .................... $7,750.00 .................... $1,550.00 

1571 ......... New Technology - Level XXXIV ($8000–$8500) ............... T .................... $8,250.00 .................... $1,650.00 

1572 ......... New Technology - Level XXXV ($8500–$9000) ................ T .................... $8,750.00 .................... $1,750.00 

1573 ......... New Technology - Level XXXVI ($9000–$9500) ............... T .................... $9,250.00 .................... $1,850.00 

1574 ......... New Technology - Level XXXVII ($9500–$10000) ............ T .................... $9,750.00 .................... $1,950.00 

1600 ......... Technetium TC 99m sestamibi .......................................... K .................... $112.73 .................... $22.55 

1603 ......... Thallous chloride TL 201/mci ............................................. K .................... $18.29 .................... $3.66 

1604 ......... IN 111 capromab pendetide, per dose .............................. K .................... $2,030.60 .................... $406.12 

1605 ......... Abciximab injection, 10 mg ................................................ K .................... $475.22 .................... $95.04 

1606 ......... Anistreplase, 30 u .............................................................. K .................... $2,495.31 .................... $499.06 

1607 ......... Eptifibatide injection, 5mg .................................................. K .................... $11.88 .................... $2.38 

1608 ......... Etanercept injection ........................................................... K .................... $143.73 .................... $28.75 

1609 ......... Rho(D) immune globulin h, sd, 100 iu ............................... K .................... $19.03 .................... $3.81 

1611 ......... Hylan G-F 20 injection, 16 mg ........................................... K .................... $215.97 .................... $43.19 

1612 ......... Daclizumab, parenteral, 25 mg .......................................... K .................... $393.78 .................... $78.76 

1613 ......... Trastuzumab, 10 mg .......................................................... K .................... $53.85 .................... $10.77 

1614 ......... Valrubicin, 200 mg ............................................................. K .................... $487.87 .................... $97.57 

1615 ......... Basiliximab, 20 mg ............................................................. K .................... $1,425.06 .................... $285.01 

1618 ......... Vonwillebrandfactrcmplx, per iu ......................................... K .................... $0.46 .................... $0.09 

1619 ......... Gallium ga 67 ..................................................................... K 0.2056 $11.22 .................... $2.24 

1620 ......... Technetium tc99m bicisate ................................................ K .................... $392.93 .................... $78.59 

1622 ......... Technetium tc99m mertiatide ............................................ K .................... $1,650.00 .................... $330.00 

1624 ......... Sodium phosphate p32 ...................................................... K .................... $66.44 .................... $13.29 

1625 ......... Indium 111-in pentetreotide ............................................... K .................... $1,144.00 .................... $228.80 

1628 ......... Chromic phosphate p32 ..................................................... K .................... $81.27 .................... $16.25 

1716 ......... Brachytx source, Gold 198 ................................................ H .................... .................... .................... ....................

1717 ......... Brachytx source, HDR Ir-192 ............................................. H .................... .................... .................... ....................

1718 ......... Brachytx source, Iodine 125 .............................................. H .................... .................... .................... ....................

1719 ......... Brachytx source,Non-HDR Ir-192 ...................................... H .................... .................... .................... ....................

1720 ......... Brachytx source, Palladium 103 ........................................ H .................... .................... .................... ....................

1775 ......... FDG, per dose (4-40 mCi/ml) ............................................ K 5.9471 $324.48 .................... $64.90 

1783 ......... Ocular implant, aqueous drain device ............................... H .................... .................... .................... $- 

1814 ......... Retinal Tamp, silicone oil ................................................... H .................... .................... .................... $- 

1818 ......... Integrated keratoprosthesis ............................................... H .................... .................... .................... $- 

1819 ......... Tissue localization-excision dev ........................................ H .................... .................... .................... $- 

842 Federal Register / Vol. 69, No. 3 / Tuesday, January 6, 2004 / Rules and Regulations 

ADDENDUM A.—LIST OF AMBULATORY PAYMENT CLASSIFICATIONS (APCS) WITH STATUS INDICATORS, RELATIVE

WEIGHTS, PAYMENT RATES, AND COPAYMENT AMOUNTS CALENDAR YEAR 2004—Continued

APC Group title Status

indicator 

Relative

weight 

Payment

rate 

National

unadjusted

copayment 

Minimum

unadjusted

copayment 

1884 ......... Embolization Protect syst .................................................. H .................... .................... .................... $- 

1888 ......... Catheter, ablation, non-cardiac, endovascular 

(implantable).

H .................... .................... .................... $- 

1900 ......... Lead coronary venous ....................................................... H .................... .................... .................... $- 

2614 ......... Probe, percutaneous lumbar disc ...................................... H .................... .................... .................... $- 

2616 ......... Brachytx source, Yttrium-90 .............................................. H .................... .................... .................... ....................

2632 ......... Brachytx sol, I-125, per mCi .............................................. H .................... .................... .................... $- 

2633 ......... Brachytx source, Cesium-131 ............................................ H .................... .................... .................... ....................

7000 ......... Amifostine, 500 mg ............................................................ K .................... $419.59 .................... $83.92 

7007 ......... Inj milrinone lactate, per 5 mg ........................................... K 0.2129 $11.62 .................... $2.32 

7011 ......... Oprelvekin injection, 5 mg ................................................. K .................... $248.16 .................... $49.63 

7015 ......... Busulfan, oral, 2 mg ........................................................... K .................... $1.93 .................... $0.39 

7019 ......... Aprotinin, 10,000 kiu .......................................................... K .................... $13.26 .................... $2.65 

7024 ......... Corticorelin ovine triflutat ................................................... K .................... $375.00 .................... $75.00 

7025 ......... Digoxin immune FAB (ovine) ............................................. K .................... $1.79 .................... $0.36 

7026 ......... Ethanolamine oleate 100 mg ............................................. K .................... $67.10 .................... $13.42 

7027 ......... Fomepizole, 15mg ............................................................. K .................... $10.65 .................... $2.13 

7028 ......... Fosphenytoin, 50 mg ......................................................... K .................... $5.63 .................... $1.13 

7030 ......... Hemin, per 1 mg ................................................................ K .................... $6.86 .................... $1.37 

7031 ......... Octreotide acetate injection ............................................... K .................... $3.94 .................... $0.79 

7034 ......... Somatropin injection .......................................................... K .................... $297.79 .................... $59.56 

7035 ......... Teniposide, 50 mg ............................................................. K .................... $238.49 .................... $47.70 

7036 ......... Urokinase 250,000 iu inj .................................................... K 3.7855 $206.54 .................... $41.31 

7037 ......... Urofollitropin, 75 iu ............................................................. K 1.1634 $63.48 .................... $12.70 

7038 ......... Muromonab-CD3, 5 mg ..................................................... K .................... $792.33 .................... $158.47 

7040 ......... Pentastarch 10% solution .................................................. K .................... $139.94 .................... $27.99 

7041 ......... Tirofiban hydrochloride 12.5 mg ........................................ K .................... $436.66 .................... $87.33 

7042 ......... Capecitabine, oral, 150 mg ................................................ K .................... $3.14 .................... $0.63 

7043 ......... Infliximab injection 10 mg .................................................. K .................... $31.81 .................... $6.36 

7045 ......... Trimetrexate glucoronate ................................................... K .................... $132.00 .................... $26.40 

7046 ......... Doxorubicin hcl liposome inj 10 mg ................................... K .................... $364.49 .................... $72.90 

7048 ......... Alteplase recombinant ....................................................... K 0.2856 $15.58 .................... $3.12 

7049 ......... Filgrastim 480 mcg injection .............................................. K .................... $290.93 .................... $58.19 

7051 ......... Leuprolide acetate implant, 65 mg .................................... K .................... $5,001.92 .................... $1,000.38 

7316 ......... Sodium hyaluronate injection ............................................. K .................... $67.16 .................... $13.43 

9001 ......... Linezolid injection ............................................................... K .................... $34.09 .................... $6.82 

9002 ......... Tenecteplase, 50mg/vial .................................................... K .................... $2,492.60 .................... $498.52 

9003 ......... Palivizumab, per 50mg ...................................................... K .................... $611.24 .................... $122.25 

9004 ......... Gemtuzumab ozogamicin inj,5mg ..................................... K .................... $2,022.90 .................... $404.58 

9005 ......... Reteplase injection ............................................................. K .................... $1,263.90 .................... $252.78 

9006 ......... Tacrolimus injection ........................................................... K .................... $110.04 .................... $22.01 

9008 ......... Baclofen Refill Kit-500mcg ................................................. K .................... $73.92 .................... $14.78 

9009 ......... Baclofen refill kit - per 2000 mcg ....................................... K 0.7499 $40.92 .................... $8.18 

9010 ......... Baclofen refill kit - per 4000 mcg ....................................... K .................... $79.82 .................... $15.96 

9012 ......... Arsenic Trioxide ................................................................. K .................... $34.32 .................... $6.86 

9013 ......... Co 57 cobaltous chloride ................................................... K .................... $56.67 .................... $11.33 

9015 ......... Mycophenolate mofetil oral 250 mg .................................. K .................... $1.36 .................... $0.27 

9018 ......... Botulinum toxin B, per 100 u ............................................. K .................... $8.14 .................... $1.63 

9019 ......... Caspofungin acetate, 5 mg ................................................ K .................... $30.52 .................... $6.10 

9020 ......... Sirolimus tablet, 1 mg ........................................................ K .................... $6.60 .................... $1.32 

9021 ......... Immune globulin 10 mg ..................................................... K .................... $0.41 .................... $0.08 

9022 ......... IM inj interferon beta 1-a ................................................... K .................... $13.36 .................... $2.67 

9023 ......... Rho d immune globulin 50 mcg ......................................... K .................... $32.21 .................... $6.44 

9024 ......... Amphotericin B, lipid formulation ....................................... K .................... $20.86 .................... $4.17 

9025 ......... Radiopharms Used to Image Perfusion of Heart .............. K .................... $162.63 .................... $32.53 

9100 ......... Iodinated I-131albumin, per 5 uci ...................................... K .................... $48.58 .................... $9.72 

9104 ......... Anti-thymocycte globulin rabbit .......................................... K .................... $331.23 .................... $66.25 

9105 ......... Hep B imm glob, per 1 ml ................................................. K .................... $65.58 .................... $13.12 

9108 ......... Thyrotropin alfa, per 1.1 mg .............................................. K .................... $572.00 .................... $114.40 

9109 ......... Tirofliban hcl, per 6.25 mg ................................................. K .................... $218.33 .................... $43.67 

9110 ......... Alemtuzumab, per 10 mg .................................................. K .................... $541.46 .................... $108.29 

9111 ......... Inj, bivalirudin, per 250 mg vial .......................................... G .................... $1.61 .................... $0.32 

9112 ......... Perflutren lipid micro, per 2ml ............................................ G .................... $137.28 .................... $27.46 

9113 ......... Inj, pantoprazole sodium, vial ............................................ G .................... $23.23 .................... $4.65 

9114 ......... Nesiritide, per 0.5 mg vial .................................................. G .................... $140.45 .................... $28.09 

9115 ......... Inj, zoledronic acid, per 1 mg ............................................ G .................... $211.07 .................... $42.21 

9116 ......... Inj, Ertapenem sodium, per 500 mg .................................. G .................... $21.99 .................... $4.40 

9117 ......... Yttrium 90 ibritumomab tiuxetan ........................................ K .................... $22,210.19 .................... $4,442.04 

9118 ......... In-111 ibritumomab tiuxetan .............................................. K .................... $2,565.55 .................... $513.11 

Federal Register / Vol. 69, No. 3 / Tuesday, January 6, 2004 / Rules and Regulations 843

ADDENDUM A.—LIST OF AMBULATORY PAYMENT CLASSIFICATIONS (APCS) WITH STATUS INDICATORS, RELATIVE

WEIGHTS, PAYMENT RATES, AND COPAYMENT AMOUNTS CALENDAR YEAR 2004—Continued

APC Group title Status

indicator 

Relative

weight 

Payment

rate 

National

unadjusted

copayment 

Minimum

unadjusted

copayment 

9119 ......... Pegfilgrastim, per 1 mg ...................................................... G .................... $2,596.00 .................... $519.20 

9120 ......... Inj, Fulvestrant, per 50 mg ................................................. G .................... $78.36 .................... $13.09 

9121 ......... Inj, Argatroban, per 5 mg ................................................... G .................... $14.63 .................... $2.44 

9122 ......... Inj, Triptorelin pamoate, per 3.75 mg ................................ G .................... $356.66 .................... $59.58 

9123 ......... Transcyte, per 247 sq cm .................................................. G .................... $689.78 .................... $115.23 

9200 ......... Orcel, per 36 cm2 .............................................................. G .................... $1,051.60 .................... $210.32 

9201 ......... Dermagraft, per 37.5 sq cm ............................................... G .................... $535.04 .................... $107.01 

9202 ......... Octafluoropropane ............................................................. K .................... $137.28 .................... $27.46 

9203 ......... Perflexane lipid micro ........................................................ G .................... $127.50 .................... $21.30 

9204 ......... Ziprasidone mesylate ......................................................... G .................... $18.60 .................... $3.11 

9205 ......... Oxaliplatin .......................................................................... G .................... $8.45 .................... $14.12 

9207 ......... Injection, bortezomib .......................................................... G .................... $1,039.68 .................... $155.40 

9208 ......... Injection, agalsidase beta .................................................. G .................... $123.78 .................... $18.50 

9209 ......... Injection, laronidase ........................................................... G .................... $644.10 .................... $96.28 

9210 ......... Injection, palonosetron HCL .............................................. G .................... $307.80 .................... $46.01 

9211 ......... Inj, alefacept, IV ................................................................. G .................... $595.00 .................... $99.40 

9212 ......... Inj, alefacept, IM ................................................................ G .................... $422.88 .................... $70.65 

9217 ......... Leuprolide acetate suspnsion, 7.5 mg ............................... K .................... $576.47 .................... $115.29 

9500 ......... Platelets, irradiated ............................................................ K .................... $74.79 .................... $14.96 

9501 ......... Platelets, pheresis .............................................................. K .................... $408.81 .................... $81.76 

9502 ......... Platelet pheresis irradiated ................................................ K .................... $443.68 .................... $88.74 

9503 ......... Fresh frozen plasma, ea unit ............................................. K .................... $69.74 .................... $13.95 

9504 ......... RBC deglycerolized ........................................................... K .................... $183.44 .................... $36.69 

9505 ......... RBC irradiated ................................................................... K .................... $108.65 .................... $21.73 

9506 ......... Granulocytes, pheresis ...................................................... K .................... $1,248.66 .................... $249.73 

ADDENDUM D1.—PAYMENT STATUS INDICATORS FOR THE HOSPITAL OUTPATIENT PROSPECTIVE PAYMENT SYSTEM

Indicator Item/Code/Service Explanation 

A ................ Services furnished to a Hospital Outpatient that are paid under 

a Fee Schedule/Payment System other than OPPS, e.g.: 

• Ambulance Services 

• Clinical Diagnostic Laboratory Services 

• Non-Implantable Prosthetic and Orthotic Devices 

• EPO for ESRD Patients 

• Physical, Occupational and Speech Therapy 

• Routine Dialysis Services for ESRD Patients Provided in a 

Certified Dialysis Unit of a Hospital.

• Screening Mammography 

Not paid under OPPS. Paid by Intermediaries under a Fee 

Schedule/Payment System other than OPPS. 

B ................ Codes that are not recognized by OPPS when submitted on an 

Outpatient Hospital Part B bill type (12x, 13x, and 14x).

Not paid under OPPS. 

• May be paid by Intermediaries when submitted on a different 

bill type, e.g., 75x (CORF), but not paid under OPPS. 

• An alternate code that is recognized by OPPS when submitted on an Outpatient Hospital Part B bill type (12x, 13x, 

and 14x) may be available. 

C ................ Inpatient Procedures ..................................................................... Not paid under OPPS. Admit patient; Bill as Inpatient. 

D ................ Deleted Codes .............................................................................. Not paid under OPPS. Not paid under Medicare. 

E ................ Items, Codes, and Services: 

• That are not covered by Medicare based on Statutory Exclusion.

• That are not covered by Medicare for reasons other than 

Statutory Exclusion.

• That are not recognized by Medicare but for which an alternate code for the same item or service may be available.

• For which separate payment is not provided by Medicare Not 

paid under OPPS.

F ................ Corneal Tissue Acquisition; Certain CRNA Services ................... Not paid under OPPS. Paid at reasonable cost. 

G ............... Drug/Biological Pass-Through ...................................................... Paid under OPPS; Separate APC payment includes PassThrough amount. 

H ................ Device Category Pass-Through and Brachytherapy Source ....... Paid under OPPS; Separate cost-based 

K ................ Non Pass-Through Drugs and Biologicals; Radiopharmaceutical 

Agents.

Paid under OPPS; Separate APC payment. 

L ................ Influenza Vaccine; Pneumococcal Pneumonia Vaccine .............. Not paid under OPPS. Paid at reasonable cost; Not subject to 

deductible or coinsurance. 

N ................ Items and Services packaged into APC Rates ............................ Paid under OPPS. However, payment is packaged into payment for other services, including Outliers. Therefore, there is 

no separate APC payment. 

844 Federal Register / Vol. 69, No. 3 / Tuesday, January 6, 2004 / Rules and Regulations 

ADDENDUM D1.—PAYMENT STATUS INDICATORS FOR THE HOSPITAL OUTPATIENT PROSPECTIVE PAYMENT SYSTEM—

Continued

Indicator Item/Code/Service Explanation 

P ................ Partial Hospitalization ................................................................... Paid under OPPS; Per diem APC payment. 

S ................ Significant Procedure, Not Discounted when Multiple ................. Paid under OPPS; Separate APC payment. 

T ................ Significant Procedure, Multiple Procedure Reduction Applies ..... Paid under OPPS; Separate APC payment. 

V ................ Clinic or Emergency Department Visit ......................................... Paid under OPPS; Separate APC payment. 

Y ................ Non-Implantable Durable Medical Equipment .............................. Not paid under OPPS. All institutional providers other than 

Home Health Agencies bill to DMERC. 

X ................ Ancillary Service ........................................................................... Paid under OPPS; Separate APC payment. 

[FR Doc. 03–32322 Filed 12–31–03; 12:00 

pm] 

BILLING CODE 4120–01–P