## 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 forpaying 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 and enclose a check or money order payable to the Superintendent of Documents, or enclose your Visa or Master Card number and expiration
date. Credit card orders can also be placed by calling the order desk at (202) 512–1800 (or toll-free at 1–888–293– 6498) or by faxing to (202) 512–2250. The cost for each copy is $10. As an alternative, you can view and photocopy the Federal Register document at most libraries designated as Federal Depository Libraries and at many other public and academic libraries throughout the country that
receive the Federal Register.

This Federal Register document is
also available from the Federal Register online database through GPO Access , a 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


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

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 orbiologicals 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 November7 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 drugsor 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.


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

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 thereference 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.—S OLE 

### S OURCE 

### D RUGS

HCPCS Status indicator Description APC OPPS CY2004 November 7, 2003

rate DIMA final rate

A4642 ........... K Satumomab pendetide per dose ................................................................. 0704 $124.46 $1,4 74.00
A9500 ........... K Technetium TC 99m sestamibi ................................................................... 1600 64.28 112.7 3
A9502 ........... K Technetium TC99M tetrofosmin .................................................................. 0705 58.06 665.2 8 A9507 ........... K Indium/111 capromab pendetid ................................................................... 1604 687.71 2,0 30.60 A9511 ........... K Technetium TC 99m depreotide .................................................................. 1095 37.87 704.0 0
A9521 ........... K Technetiumtc-99m exametazine ................................................................. 1096 210.65 825.0 0 A9524 ........... K Iodinated I–131 serumalbumin, per 5uci ..................................................... 9100 0.36 48.58
A9600 ........... K Strontium-89 chloride .................................................................................. 0701 40 2.85 892.43 C1079 ........... K CO 57/58 per 0.5 uCi .................................................................................. 1079 68. 51 235.14 C1080 ........... K I–131 tositumomab, dx ................................................................................ 1080 2,26 0.00 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 19,565.0022,210.19 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 299.7 0 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 1 18.60 218.33 C9202 ........... K Octafluoropropane ....................................................................................... 9202 1 18.60 137.28 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 20.8620.86 J0289 ............ K Amphotericin b liposome inj ........................................................................ 9024 20.8 6 20.86 J0350 ............ K Injection anistreplase 30 u .......................................................................... 1606 1,5 16.46 2,495.31 J0585 ............ K Botulinum toxin a per unit ........................................................................... 0902 3.2 1 4.58 J0587 ............ K Botulinum toxin type B ................................................................................ 9018 6. 98 8.14 J0637 ............ K Caspofungin acetate .................................................................................... 9019 2 9.64 30.52 J0850 ............ K Cytomegalovirus imm IV /vial ...................................................................... 0903 291.18 659.60 J1327 ............ K Eptifibatide injection ..................................................................................... 16 07 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 5.7 0 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.

— S OLE 

### S OURCE 

### D RUGS



### — Continued

HCPCS Status indicator Description APC OPPS CY2004 November 7, 2003

rate DIMA final rate

J2020 ............ K Linezolid injection ........................................................................................ 90 01 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 10.1 6 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 2 27.85 436.66 J3305 ............ K Inj trimetrexate glucoronate ......................................................................... 7045 61. 36 132.00 J3395 ............ K Verteporfin injection ..................................................................................... 120 3 897.20 1,350.80 J7191 ............ K Factor VIII (porcine) ..................................................................................... 092 6 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 2 58.17
J7505 ............ K Monoclonal antibodies ................................................................................. 7038 32 0.84 792.33 J7507 ............ K Tacrolimus oral per 1 MG ........................................................................... 0891 1.34 3.24 J7511 ............ K Antithymocyte globuln rabbit ....................................................................... 9104 163.5 6 331.23 J7520 ............ K Sirolimus, oral .............................................................................................. 9020 2.89 6.60 J7525 ............ K Tacrolimus injection ..................................................................................... 90065.72 110.04
J8510 ............ K Oral busulfan ............................................................................................... 7 015 1.57 1.93 J8520 ............ K Capecitabine, oral, 150 mg ......................................................................... 7042 1.65 3.14
J8700 ............ K Temozolmide ............................................................................................... 108 6 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 ............................................................................................ 9 012 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 2 78.99 344.08 J9151 ............ K Daunorubicin citrate liposom ....................................................................... 0821 163.5 5 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 ....................................................................................... 08 30 100.55 135.00 J9213 ............ K Interferon alfa-2a inj .................................................................................... 083 4 20.61 32.31 J9214 ............ K Interferon alfa-2b inj .................................................................................... 083 6 10.93 13.78 J9215 ............ K Interferon alfa-n3 inj .................................................................................... 086 5 79.65 8.17 J9216 ............ K Interferon gamma 1-b inj ............................................................................. 0838 180 .15 290.70 J9217 ............ K Leuprolide acetate suspnsion ...................................................................... 9217 312.37576.47 J9219 ............ K Leuprolide acetate implant .......................................................................... 7051 3,66 6.71 5,001.92 J9245 ............ K Inj melphalan hydrochl 50 MG .................................................................... 0840 254.90 3 89.14 J9268 ............ K Pentostatin injection .................................................................................... 0844965.98 1,784.64 J9270 ............ K Plicamycin (mithramycin) inj ........................................................................ 0860 15.4 2 86.89 J9293 ............ K Mitoxantrone hydrochl / 5 MG ..................................................................... 0864 173.68 332.87
J9310 ............ K Rituximab cancer treatment ........................................................................ 0849 306.40464.20 J9320 ............ K Streptozocin injection .................................................................................. 0850 65.19 131.05 J9350 ............ K Topotecan .................................................................................................... 0852 433.41 739.80
J9355 ............ K Trastuzumab ................................................................................................ 16 13 40.56 53.85 J9357 ............ K Valrubicin, 200 mg ....................................................................................... 1614461.78 487.87 J9390 ............ K Vinorelbine tartrate/10 mg ........................................................................... 0855 64. 79 100.97
J9600 ............ K Porfimer sodium .......................................................................................... 08561,594.30 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 41.0 0 152.38 Q0187 ........... K Factor viia recombinant ............................................................................... 1409 1,0 83.93 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 4.8 8 5.63 Q2011 ........... K Hemin, per 1 mg .......................................................................................... 7030 0.64 6.86 Q2013 ........... K Pentastarch 10% solution ............................................................................ 7040 26.40139.94 Q2017 ........... K Teniposide, 50 mg ....................................................................................... 7035 1 37.41 238.49


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

TABLE 

### 1.

— S OLE 

### S OURCE 

### D RUGS



### — Continued

HCPCS Status indicator Description APC OPPS CY2004 November 7, 2003

rate DIMA final rate

Q2018 ........... K Urofollitropin, 75 iu ...................................................................................... 703 7 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 449.8 4 1,144.00 Q4052 ........... K Octreotide injection, depot ........................................................................... 1207 65. 74 73.62



### TABLE 

### 2.

— M ULTISOURCE 

### D RUGS

HCPCS Status indicator Description APC OPPS CY2004 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 6.4 9 6.49
A9605 ........... K Samarium sm153 lexidronamm ................................................................... 0702 874.44 493.8 9 C1091 ........... K IN111 oxyquinoline, per0.5mCi ................................................................... 1091 224.52 22 4.52 C1775 ........... K FDG, per dose (4

–40 mCi/ml) ..................................................................... 1775 324.48 324.48

C9013 ........... K Co 57 cobaltous chloride ............................................................................. 9013 56.6 7 56.67 C9105 ........... K Hep B imm glob, per 1 ml ........................................................................... 9105 71.33 65.58 J1190 ............ K Dexrazoxane HCl injection .......................................................................... 0726 112.4 8 112.48 J1563 ............ K Immune globulin, 1 g ................................................................................... 0905 4 3.96 37.95 J1564 ............ K Immune globulin 10 mg ............................................................................... 9021 0.440.41 J1745 ............ K Infliximab injection ....................................................................................... 70 43 38.86 31.81
J1825 ............ K Interferon beta-1a ........................................................................................ 090 9 184.79 123.77
J2430 ............ K Pamidronate disodium /30 MG .................................................................... 0730 174.32 12 8.74

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 86.5 4 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 1 03.75 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 3 7.82 24.84 J9070 ............ K Cyclophosphamide 100 MG inj ................................................................... 0815 4.74 2.77 J9093 ............ K Cyclophosphamide lyophilized .................................................................... 0816 4.50 2.3 6 J9100 ............ K Cytarabine hcl 100 MG inj ........................................................................... 0817 5.071.55 J9130 ............ K Dacarbazine 100 mg inj .............................................................................. 0819 5.31 5.31

J9150 ............ K Daunorubicin ................................................................................................ 0 820 73.97 35.94 J9181 ............ K Etoposide 10 MG inj .................................................................................... 0824 4 .56 0.83 J9200 ............ K Floxuridine injection ..................................................................................... 082 7 114.19 66.24 J9208 ............ K Ifosfomide injection ...................................................................................... 083 1 106.04 72.81 J9209 ............ K Mesna injection ............................................................................................ 07 32 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 ....................................................................................... 08 63 112.14 79.04 J9280 ............ K Mitomycin 5 MG inj ...................................................................................... 0862 53.03 30.91 J9340 ............ K Thiotepa injection ........................................................................................ 085 1 59.93 45.31 Q2022 ........... K VonWillebrandFactr CmplxperIU ................................................................. 1618 1.01 0.46 Q3002 ........... K Gallium ga 67 .............................................................................................. 161 9 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 furnishedduring 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


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

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 

### 3 A



### . — P ASS 

### -T HROUGH 

### D RUGS 

### R EIMBURSED 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 ........................................ 127.5 0 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 

### 3 B



### . — P ASS 

### -T HROUGH 

### D RUGS 

### P AID 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 

### 3 C



### . — P ASS 

### -T HROUGH 

### D RUGS 

### P AID AS 

### S OLE 

### S OURCE 

### D RUGS 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.

— B RACHYTHERAPY 

### S OURCES 

### T O 

### B E 

### P AID 

### S EPARATELY 

### , U SING 

### C HARGES 

### R EDUCED TO 

### C OST

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


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

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 andall 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 anagency 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 andbiologicals 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.


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

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.



### A DDENDUM 

### A.

— L IST OF 

### A MBULATORY 

### P AYMENT 

### C LASSIFICATIONS 

### (APCS) W ITH 

### S TATUS 

### I NDICATORS 

### , R ELATIVE 

### W EIGHTS 

### , P AYMENT 

### R ATES



### , AND 

### C OPAYMENT 

### A MOUNTS 

### C ALENDAR 

### Y EAR 

### 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 .................... $12 9.45 0008 ......... Level III Incision and Drainage .......................................... T 19.4831 $1,063.02 .................... $21 2.60 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


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

A DDENDUM 

### A.

— L IST OF 

### A MBULATORY 

### P AYMENT 

### C LASSIFICATIONS 

### (APCS) W ITH 

### S TATUS 

### I NDICATORS 

### , R ELATIVE 

### W EIGHTS 

### , P AYMENT 

### R ATES



### , AND 

### C OPAYMENT 

### A MOUNTS 

### C ALENDAR 

### Y EAR 

### 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 .................... $3.0 4 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

A DDENDUM 

### A.

— L IST OF 

### A MBULATORY 

### P AYMENT 

### C LASSIFICATIONS 

### (APCS) W ITH 

### S TATUS 

### I NDICATORS 

### , R ELATIVE 

### W EIGHTS 

### , P AYMENT 

### R ATES



### , AND 

### C OPAYMENT 

### A MOUNTS 

### C ALENDAR 

### Y EAR 

### 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 $209.400106 ......... 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 $279.830116 ......... 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 .................... $37.950160 ......... 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


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

A DDENDUM 

### A.

— L IST OF 

### A MBULATORY 

### P AYMENT 

### C LASSIFICATIONS 

### (APCS) W ITH 

### S TATUS 

### I NDICATORS 

### , R ELATIVE 

### W EIGHTS 

### , P AYMENT 

### R ATES



### , AND 

### C OPAYMENT 

### A MOUNTS 

### C ALENDAR 

### Y EAR 

### 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 .................... $236.4 9 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 .................... $1 88.60 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 .................... $2,53 3.84 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 .................... $1,487.3 2 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 .................... $38 3.62 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

A DDENDUM 

### A.

— L IST OF 

### A MBULATORY 

### P AYMENT 

### C LASSIFICATIONS 

### (APCS) W ITH 

### S TATUS 

### I NDICATORS 

### , R ELATIVE 

### W EIGHTS 

### , P AYMENT 

### R ATES



### , AND 

### C OPAYMENT 

### A MOUNTS 

### C ALENDAR 

### Y EAR 

### 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 .................... $16.2 7 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


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

A DDENDUM 

### A.

— L IST OF 

### A MBULATORY 

### P AYMENT 

### C LASSIFICATIONS 

### (APCS) W ITH 

### S TATUS 

### I NDICATORS 

### , R ELATIVE 

### W EIGHTS 

### , P AYMENT 

### R ATES



### , AND 

### C OPAYMENT 

### A MOUNTS 

### C ALENDAR 

### Y EAR 

### 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 .................... $8.4 0 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 .................... $58.8 2 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 .................... $1 0.12 0601 ......... Mid Level Clinic Visits ........................................................ V 0.9816 $53.56 .................... $ 10.71 0602 ......... High Level Clinic Visits ...................................................... V 1.5041 $82.07 .................... $1 6.41 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 .................... $295.0 3 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

A DDENDUM 

### A.

— L IST OF 

### A MBULATORY 

### P AYMENT 

### C LASSIFICATIONS 

### (APCS) W ITH 

### S TATUS 

### I NDICATORS 

### , R ELATIVE 

### W EIGHTS 

### , P AYMENT 

### R ATES



### , AND 

### C OPAYMENT 

### A MOUNTS 

### C ALENDAR 

### Y EAR 

### 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 .................... $3 2.99 660 ........... 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


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

A DDENDUM 

### A.

— L IST OF 

### A MBULATORY 

### P AYMENT 

### C LASSIFICATIONS 

### (APCS) W ITH 

### S TATUS 

### I NDICATORS 

### , R ELATIVE 

### W EIGHTS 

### , P AYMENT 

### R ATES



### , AND 

### C OPAYMENT 

### A MOUNTS 

### C ALENDAR 

### Y EAR 

### 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 .................... $17.3 1 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

A DDENDUM 

### A.

— L IST OF 

### A MBULATORY 

### P AYMENT 

### C LASSIFICATIONS 

### (APCS) W ITH 

### S TATUS 

### I NDICATORS 

### , R ELATIVE 

### W EIGHTS 

### , P AYMENT 

### R ATES



### , AND 

### C OPAYMENT 

### A MOUNTS 

### C ALENDAR 

### Y EAR 

### 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


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

A DDENDUM 

### A.

— L IST OF 

### A MBULATORY 

### P AYMENT 

### C LASSIFICATIONS 

### (APCS) W ITH 

### S TATUS 

### I NDICATORS 

### , R ELATIVE 

### W EIGHTS 

### , P AYMENT 

### R ATES



### , AND 

### C OPAYMENT 

### A MOUNTS 

### C ALENDAR 

### Y EAR 

### 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

A DDENDUM 

### A.

— L IST OF 

### A MBULATORY 

### P AYMENT 

### C LASSIFICATIONS 

### (APCS) W ITH 

### S TATUS 

### I NDICATORS 

### , R ELATIVE 

### W EIGHTS 

### , P AYMENT 

### R ATES



### , AND 

### C OPAYMENT 

### A MOUNTS 

### C ALENDAR 

### Y EAR 

### 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 .................... $3.1 2 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


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

A DDENDUM 

### A.

— L IST OF 

### A MBULATORY 

### P AYMENT 

### C LASSIFICATIONS 

### (APCS) W ITH 

### S TATUS 

### I NDICATORS 

### , R ELATIVE 

### W EIGHTS 

### , P AYMENT 

### R ATES



### , AND 

### C OPAYMENT 

### A MOUNTS 

### C ALENDAR 

### Y EAR 

### 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



### A DDENDUM 

### D1.

— P AYMENT 

### S TATUS 

### I NDICATORS FOR THE 

### H OSPITAL 

### O UTPATIENT 

### P ROSPECTIVE 

### P AYMENT 

### S YSTEM

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 co st. 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; N ot subject to

deductible or coinsurance. N ................ Items and Services packaged into APC Rates ............................ Paid under OPPS. However, payment is pac kaged 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

A DDENDUM 

### D1.

— P AYMENT 

### S TATUS 

### I NDICATORS FOR THE 

### H OSPITAL 

### O UTPATIENT 

### P ROSPECTIVE 

### P AYMENT 

### S YSTEM



### — Continued

Indicator Item/Code/Service Explanation

P ................ Partial Hospitalization ................................................................... Paid under OPPS; Perdiem 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 pay ment. 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; S eparate APC payment.

[FR Doc. 03

– 32322 Filed 12

– 31

– 03; 12:00 pm]

BILLING CODE 4120

–01

– P