[Federal Register: January 6, 2004 (Volume 69, Number 3)]
[Rules and Regulations]
[Page 819-844]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06ja04-33]
[[Page 819]]
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Part IV
Department of Health and Human Services
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Centers for Medicare & Medicaid Services
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42 CFR Part 419
Medicare Program; Hospital Outpatient Prospective Payment System;
Payment Reform for Calendar Year 2004; Interim Final Rule
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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.
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SUMMARY: This interim final rule with comment period implements
provisions of the Medicare Prescription Drug, Improvement, and
Modernization Act (DIMA) of 2003 that affect the Medicare outpatient
prospective payment system (OPPS) that become effective January 1,
2004. Sections 303 and 621 of the DIMA include provisions that alter
the methods for drug payment in hospital outpatient departments, some
of which become effective January 1, 2004. These provisions affect the
methodology for paying for pass-through and non-pass-through 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.
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.
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
[[Page 821]]
transitional corridor payments will continue through December 31, 2005
for small rural hospitals having 100 or fewer beds. Section 411 of the
DIMA further amends section 1833(t)(7) of the Act to provide that hold-
harmless transitional corridor payments shall apply to sole community
hospitals as defined in section 1886(d)(5)(D)(iii) of the Act and will
continue through December 31, 2005.
2. Payment for ``Specified Covered Outpatient Drugs''
Section 621(a)(1) of the DIMA amends the Act by adding section
1833(t)(14) that requires classification of separately paid
radiopharmaceutical agents and drugs or biologicals that had
transitional pass-through status on or before December 31, 2002, into 3
categories: innovator multiple source drugs; noninnovator multiple
source drugs; and sole source drugs. Payment levels based on the
reference average wholesale price are specified for each category.
3. Payment for Drug or Biological Before HCPCS Code Assigned
Section 621(a)(1) of the DIMA amends the Act by adding section
1833(t)(15), which requires that payment be made at 95 percent of the
average wholesale price (AWP) for new drugs and biologicals until a
HCPCS code is assigned.
4. Payment for Pass-Through Drugs
Section 303(b) of the DIMA amends section 1842(o) of the Act. As a
result, certain pass-through drugs are to be paid at 95 percent, and
others at 85 percent, of the AWP. Drugs and biologicals furnished
during 2004 for which pass-through payment was first made on or after
January 1, 2003 (which removes them from application of section 621 of
the DIMA) and were approved by the FDA for marketing as of April 1,
2003, will be paid 85 percent of AWP pursuant to section 1842(o)(1)(B)
and 1842(o)(4)(A), unless sections 1842(o)(4)(B), (C) or (D) apply.
Blood clotting factors furnished during 2004, drugs or biologicals
furnished during 2004 that were not available for payment as of April
1, 2003, vaccines furnished on or after January 1, 2004, and drugs or
biologicals furnished during 2004 in connection with the renal dialysis
services if billed by renal dialysis facilities, are paid at 95 percent
of the reference AWP. Drugs or biologicals that were paid on a pass-
through basis under the OPPS on or after January 1, 2003 and that were
available for payment as of April 1, 2003 are paid at 85 percent of the
reference AWP rather than 95 percent as was previously the policy under
section 1842(o) of the Act.
5. Exclude Separately Payable Drugs and Biologicals From Outlier
Payments
Section 621(a)(3) amends section 1833(t)(5) of the Act to require
that separately paid drugs and biologicals be excluded from outlier
payments.
6. Brachytherapy Sources Are To Be Paid Separately
Section 621(b) amends the Act by adding section 1833(t)(16)(C)
which requires that all devices of brachytherapy consisting of a seed
or seeds (or radioactive source) be paid based on the hospital's charge
for each device adjusted to cost. Also included in the new provision is
a requirement that all such brachytherapy sources be excluded from
outlier payments.
Payment Methodology That Applied Prior To Enactment
In the hospital outpatient prospective payment update final rule
published in the Federal Register on November 7, 2003, CMS announced
payments for 2004 under the Medicare hospital outpatient prospective
payment system (68 FR 63398). The provisions of that final rule with
regard to payment for brachytherapy sources, for separately payable
drugs, biologicals and radiopharmaceutical agents and for pass-through
drugs and biologicals is superceded in part with enactment of the DIMA,
effective for services furnished on or after January 1, 2004. This
interim final rule with comment presents the payment amounts that apply
in 2004 that result from the changes made by DIMA.
The following is a summarization of the payment policies that we
published for the 2004 OPPS before enactment of the new law.
Drugs and biologicals that were within the 2-3 year pass-through
payment period were paid amounts as specified in section 1842(o) of the
Act. Under the November 7 final rule, that payment was 95 percent of
AWP.
Under the provisions of the November 7 OPPS final rule, payment for
non-pass-through drugs, biologicals and radiopharmaceutical agents with
per day median costs greater than $50 was based on data compiled from
hospital claims submitted on or after April 1, 2002 through December
31, 2002. Those data were used to set median costs which were converted
to relative weights, scaled for budget neutrality, and multiplied by
the 2004 conversion factor, the same methodology used to set relative
weights for procedural ambulatory payment classifications (APCs) under
the OPPS. A detailed discussion of the rate setting methodology for the
2004 OPPS update is provided in the November 7, 2003 final rule (68 FR
63416).
Payment for drugs, biologicals and radiopharmaceutical agents that
had per day median costs less than $50 and drugs, biologicals and
radiopharmaceutical agents for which there was no HCPCS code, was
included in the rate for the service in which the item was used. There
were no separate payments for these drugs, biologicals and
radiopharmaceutical agents.
Changes Required Under the DIMA
a. Changes in Payment for ``specified covered outpatient drugs'':
radiopharmaceutical agents and drugs or biologicals that were paid as
pass-throughs 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:
[sbull] 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.
[sbull] A drug or biological for which a temporary HCPCS code has
not been assigned.
[sbull] 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.''
[[Page 822]]
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.
[[Page 823]]
There are a few drugs for which we cannot find an AWP rate. We are
working to resolve this on a case-by-case basis for each of the drugs.
The drugs are: Technetium TC 99M Sodium Glucoheptonate (C1200), Cobalt
Co 57 cobaltous chloride (C9013), I-131 tositumomab, diagnostic (C1080)
and I-131 tositumomab, therapeutic (C1081).
With regard to C1080 and C1081, there is no AWP available because
this drug did not receive FDA approval until June, 2003 and so could
not be in the May 1, 2003 Red Book (AWP) that we have identified as the
source of the reference AWP. We presented an in-depth discussion of our
policy for payment of this drug, Bexxar, in our November 7 final rule.
In that rule we explain our rationale for making payment for Bexxar
parallel to that for another radiopharmaceutical called Zevalin. In
order to set the payment rate for Bexxar in accordance with DIMA, we
also have adhered to the policy regarding the pricing of Bexxar
established in the November 7 final rule.
For the remaining drugs for which we could not identify a May 1,
2003 AWP amount, we will continue our research to find an AWP. If we
are able to identify the AWP established on dates other than May 1,
2003, we will use whichever is closest to May 2003. In the interim, we
will implement the payment rates published in the November 7 final rule
to make payments for these drugs for January 1, 2004 through March 31,
2004. We will address our findings regarding development of payment
rates for these drugs in our April update.
APC 9024 is made up of 3 sole source drugs: Amphotericin B lipid
complex (J0287); Amphotericin B cholesteryl sulfate (J0288); and
Amphotericin B liposome injection (J0289). To comply with the statute,
these 3 drugs must all be paid separately under the OPPS and that will
require that we create an APC for each of the drugs. Due to the limited
time available to implement the changes required for January 1, 2004,
we will not be able to implement the new APCs until April 1, 2004. We
will continue to pay for these drugs in APC 9024 at the rate published
in the November 7 final rule. The new APCs will be implemented April 1,
2004 and will be effective for services furnished on or after January
1, 2004.
Table 1.--Sole Source Drugs
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OPPS CY 2004
HCPCS Status indicator Description APC November 7, DIMA final
2003 rate rate
----------------------------------------------------------------------------------------------------------------
A4642.................... K Satumomab pendetide per 0704 $124.46 $1,474.00
dose.
A9500.................... K Technetium TC 99m 1600 64.28 112.73
sestamibi.
A9502.................... K Technetium TC99M 0705 58.06 665.28
tetrofosmin.
A9507.................... K Indium/111 capromab 1604 687.71 2,030.60
pendetid.
A9511.................... K Technetium TC 99m 1095 37.87 704.00
depreotide.
A9521.................... K Technetiumtc-99m 1096 210.65 825.00
exametazine.
A9524.................... K Iodinated I-131 9100 0.36 48.58
serumalbumin, per 5uci.
A9600.................... K Strontium-89 chloride.. 0701 402.85 892.43
C1079.................... K CO 57/58 per 0.5 uCi... 1079 68.51 235.14
C1080.................... K I-131 tositumomab, dx.. 1080 2,260.00 2,565.55
C1081.................... K I-131 tositumomab, tx.. 1081 19,565.00 22,210.19
C1082.................... K In-111 ibritumomab 9118 2,260.00 2,565.55
tiuxetan.
C1083.................... K Yttrium 90 ibritumomab 9117 19,565.00 22,210.19
tiuxetan.
C1092.................... K IN 111 pentetate per 1092 217.45 237.60
0.5 mCi.
C1122.................... K Tc 99M ARCITUMOMAB PER 1122 534.77 1,144.00
VIAL.
C1166.................... K CYTARABINE LIPOSOMAL, 1166 278.99 344.08
10 mg.
C1167.................... K EPIRUBICIN HCL, 2 mg... 1167 20.43 25.60
C1178.................... K BUSULFAN IV, 6 Mg...... 1178 299.70 27.87
C1200.................... K TC 99M Sodium 1200 30.28 30.28
Glucoheptonat.
C1201.................... K TC 99M SUCCIMER, PER 1201 80.24 125.66
Vial.
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- 9008 6.90 73.92
500mcg.
C9009.................... K Baclofen Refill Kit- 9009 40.92 40.92
2000mcg.
C9010.................... K Baclofen Refill Kit-- 9010 42.22 79.82
4000mcg.
C9109.................... K Tirofiban hcl, 6.25 mg. 9109 118.60 218.33
C9202.................... K Octafluoropropane...... 9202 118.60 137.28
J0130.................... K Abciximab injection.... 1605 289.44 475.22
J0207.................... K Amifostine............. 7000 289.40 419.59
J0287.................... K Amphotericin b lipid 9024 20.86 20.86
complex.
J0288.................... K Ampho b cholesteryl 9024 20.86 20.86
sulfate.
J0289.................... K Amphotericin b liposome 9024 20.86 20.86
inj.
J0350.................... K Injection anistreplase 1606 1,516.46 2,495.31
30 u.
J0585.................... K Botulinum toxin a per 0902 3.21 4.58
unit.
J0587.................... K Botulinum toxin type B. 9018 6.98 8.14
J0637.................... K Caspofungin acetate.... 9019 29.64 30.52
J0850.................... K Cytomegalovirus imm IV / 0903 291.18 659.60
vial.
J1327.................... K Eptifibatide injection. 1607 7.99 11.88
J1438.................... K Etanercept injection... 1608 102.37 143.73
J1440.................... K Filgrastim 300 mcg 0728 123.48 172.20
injection.
J1441.................... K Filgrastim 480 mcg 7049 175.96 290.93
injection.
J1565.................... K RSV-ivig............... 0906 48.61 16.55
J1626.................... K Granisetron HCl 0764 5.70 17.18
injection.
J1830.................... K Interferon beta-1b / 0910 100.51 67.22
.25 MG.
J1950.................... K Leuprolide acetate / 0800 182.92 479.20
3.75 MG.
[[Page 824]]
J2020.................... K Linezolid injection.... 9001 15.12 34.09
J2353.................... K Octreotide injection, 1207 65.74 73.62
depot.
J2354.................... K Octreotide inj, non- 7031 1.44 3.94
depot.
J2788.................... K Rho d immune globulin 9023 1.69 32.21
50 mcg.
J2790.................... K Rho d immune globulin 0884 10.16 92.93
inj.
J2792.................... K Rho(D) immune globulin 1609 9.76 19.03
h, sd.
J2820.................... K Sargramostim injection. 0731 16.32 26.92
J2941.................... K Somatropin injection... 7034 41.18 297.79
J2993.................... K Reteplase injection.... 9005 568.33 1,263.90
J3100.................... K Tenecteplase injection. 9002 1,296.75 2,492.60
J3245.................... K Tirofiban hydrochloride 7041 227.85 436.66
J3305.................... K Inj trimetrexate 7045 61.36 132.00
glucoronate.
J3395.................... K Verteporfin injection.. 1203 897.20 1,350.80
J7191.................... K Factor VIII (porcine).. 0926 1.52 1.89
J7195.................... K Factor IX recombinant.. 0932 1.01 1.04
J7320.................... K Hylan G-F 20 injection. 1611 123.46 215.97
J7504.................... K Lymphocyte immune 0890 127.89 258.17
globulin.
J7505.................... K Monoclonal antibodies.. 7038 320.84 792.33
J7507.................... K Tacrolimus oral per 1 0891 1.34 3.24
MG.
J7511.................... K Antithymocyte globuln 9104 163.56 331.23
rabbit.
J7520.................... K Sirolimus, oral........ 9020 2.89 6.60
J7525.................... K Tacrolimus injection... 9006 5.72 110.04
J8510.................... K Oral busulfan.......... 7015 1.57 1.93
J8520.................... K Capecitabine, oral, 150 7042 1.65 3.14
mg.
J8700.................... K Temozolmide............ 1086 3.76 6.81
J9001.................... K Doxorubicin hcl 7046 256.34 364.49
liposome inj.
J9010.................... K Alemtuzumab injection.. 9110 424.88 541.46
J9017.................... K Arsenic trioxide....... 9012 26.91 34.32
J9020.................... K Asparaginase injection. 0814 16.13 58.00
J9045.................... K Carboplatin injection.. 0811 86.47 137.79
J9098.................... K Cytarabine liposome.... 1166 278.99 344.08
J9151.................... K Daunorubicin citrate 0821 163.55 64.60
liposom.
J9170.................... K Docetaxel.............. 0823 220.97 331.53
J9178.................... K Inj, epirubicin hcl, 2 1167 20.43 25.60
mg.
J9185.................... K Fludarabine phosphate 0842 205.74 329.83
inj.
J9201.................... K Gemcitabine HCl........ 0828 80.43 112.09
J9202.................... K Goserelin acetate 0810 285.16 413.59
implant.
J9206.................... K Irinotecan injection... 0830 100.55 135.00
J9213.................... K Interferon alfa-2a inj. 0834 20.61 32.31
J9214.................... K Interferon alfa-2b inj. 0836 10.93 13.78
J9215.................... K Interferon alfa-n3 inj. 0865 79.65 8.17
J9216.................... K Interferon gamma 1-b 0838 180.15 290.70
inj.
J9217.................... K Leuprolide acetate 9217 312.37 576.47
suspnsion.
J9219.................... K Leuprolide acetate 7051 3,666.71 5,001.92
implant.
J9245.................... K Inj melphalan hydrochl 0840 254.90 389.14
50 MG.
J9268.................... K Pentostatin injection.. 0844 965.98 1,784.64
J9270.................... K Plicamycin 0860 15.42 86.89
(mithramycin) inj.
J9293.................... K Mitoxantrone hydrochl / 0864 173.68 332.87
5 MG.
J9310.................... K Rituximab cancer 0849 306.40 464.20
treatment.
J9320.................... K Streptozocin injection. 0850 65.19 131.05
J9350.................... K Topotecan.............. 0852 433.41 739.80
J9355.................... K Trastuzumab............ 1613 40.56 53.85
J9357.................... K Valrubicin, 200 mg..... 1614 461.78 487.87
J9390.................... K Vinorelbine tartrate/10 0855 64.79 100.97
mg.
J9600.................... K Porfimer sodium........ 0856 1,594.30 2,411.82
Q0136.................... K Non esrd epoetin alpha 0733 9.83 11.76
inj.
Q0137.................... K Darbepoetin alfa, non 0734 3.24 3.88
esrd.
Q0166.................... K Granisetron HCl 1 mg 0765 34.49 171.78
oral.
Q0180.................... K Dolasetron mesylate 0763 41.00 152.38
oral.
Q0187.................... K Factor viia recombinant 1409 1,083.93 1,495.30
Q2003.................... K Aprotinin, 10,000 kiu.. 7019 1.17 13.26
Q2005.................... K Corticorelin ovine 7024 224.91 375.00
triflutat.
Q2006.................... K Digoxin immune fab 7025 271.14 1.79
(ovine).
Q2007.................... K Ethanolamine oleate 100 7026 27.82 67.10
mg.
Q2008.................... K Fomepizole, 15 mg...... 7027 7.23 10.65
Q2009.................... K Fosphenytoin, 50 mg.... 7028 4.88 5.63
Q2011.................... K Hemin, per 1 mg........ 7030 0.64 6.86
Q2013.................... K Pentastarch 10% 7040 26.40 139.94
solution.
Q2017.................... K Teniposide, 50 mg...... 7035 137.41 238.49
[[Page 825]]
Q2018.................... K Urofollitropin, 75 iu.. 7037 63.48 63.48
Q3000.................... K Rubidium-Rb-82......... 9025 143.89 162.63
Q3003.................... K Technetium tc99m 1620 183.69 392.93
bicisate.
Q3005.................... K Technetium tc99m 1622 20.63 1,650.00
mertiatide.
Q3008.................... K Indium 111-in 1625 449.84 1,144.00
pentetreotide.
Q4052.................... K Octreotide injection, 1207 65.74 73.62
depot.
----------------------------------------------------------------------------------------------------------------
Table 2.--Multisource Drugs
----------------------------------------------------------------------------------------------------------------
OPPS CY 2004
HCPCS Status indicator Description APC November 7, DIMA final
2003 rate rate
----------------------------------------------------------------------------------------------------------------
A9505.................... K Thallous chloride TL 1603 $19.89 $18.29
201/mci.
A9508.................... K Iobenguane sulfate I- 1045 165.82 165.82
131, per 0.5 mCi.
A9517.................... K Th I131 so iodide cap 1064 5.48 5.48
millic.
A9528.................... K Dx I131 so iodide cap 1064 5.48 5.48
millic.
A9529.................... K Dx I131 so iodide sol 1065 6.49 6.49
millic.
A9530.................... K Th I131 so iodide sol 1065 6.49 6.49
millic.
A9605.................... K Samarium sm153 0702 874.44 493.89
lexidronamm.
C1091.................... K IN111 oxyquinoline, 1091 224.52 224.52
per0.5mCi.
C1775.................... K FDG, per dose (4-40 mCi/ 1775 324.48 324.48
ml).
C9013.................... K Co 57 cobaltous 9013 56.67 56.67
chloride.
C9105.................... K Hep B imm glob, per 1 9105 71.33 65.58
ml.
J1190.................... K Dexrazoxane HCl 0726 112.48 112.48
injection.
J1563.................... K Immune globulin, 1 g... 0905 43.96 37.95
J1564.................... K Immune globulin 10 mg.. 9021 0.44 0.41
J1745.................... K Infliximab injection... 7043 38.86 31.81
J1825.................... K Interferon beta-1a..... 0909 184.79 123.77
J2430.................... K Pamidronate disodium / 0730 174.32 128.74
30 MG.
J7190.................... K Factor viii............ 0925 0.51 0.42
J7192.................... K Factor viii recombinant 0927 1.01 0.61
J7193.................... K Factor IX non- 0931 0.51 0.51
recombinant.
J7194.................... K Factor ix complex...... 0928 0.51 0.18
J7198.................... K Anti-inhibitor......... 0929 1.01 0.69
J7310.................... K Ganciclovir long act 0913 86.54 86.54
implant.
J7317.................... K Sodium hyaluronate 7316 138.78 67.16
injection.
J7502.................... K Cyclosporine oral 100 0888 2.56 2.41
mg.
J7517.................... K Mycophenolate mofetil 9015 2.04 1.36
oral.
J8560.................... K Etoposide oral 50 MG... 0802 27.37 21.91
J9000.................... K Doxorubic hcl 10 MG vl 0847 6.61 4.69
chemo.
J9031.................... K Bcg live intravesical 0809 103.75 77.54
vac.
J9040.................... K Bleomycin sulfate 0857 160.56 88.32
injection.
J9060.................... K Cisplatin 10 MG 0813 21.74 7.73
injection.
J9065.................... K Inj cladribine per 1 MG 0858 37.82 24.84
J9070.................... K Cyclophosphamide 100 MG 0815 4.74 2.77
inj.
J9093.................... K Cyclophosphamide 0816 4.50 2.36
lyophilized.
J9100.................... K Cytarabine hcl 100 MG 0817 5.07 1.55
inj.
J9130.................... K Dacarbazine 100 mg inj. 0819 5.31 5.31
J9150.................... K Daunorubicin........... 0820 73.97 35.94
J9181.................... K Etoposide 10 MG inj.... 0824 4.56 0.83
J9200.................... K Floxuridine injection.. 0827 114.19 66.24
J9208.................... K Ifosfomide injection... 0831 106.04 72.81
J9209.................... K Mesna injection........ 0732 28.43 17.66
J9211.................... K Idarubicin hcl 0832 178.21 178.21
injection.
J9218.................... K Leuprolide acetate 0861 43.60 14.48
injection.
J9265.................... K Paclitaxel injection... 0863 112.14 79.04
J9280.................... K Mitomycin 5 MG inj..... 0862 53.03 30.91
J9340.................... K Thiotepa injection..... 0851 59.93 45.31
Q2022.................... K VonWillebrandFactr 1618 1.01 0.46
CmplxperIU.
Q3002.................... K Gallium ga 67.......... 1619 11.22 11.22
Q3007.................... K Sodium phosphate p32... 1624 70.61 66.44
Q3011.................... K Chromic phosphate p32.. 1628 98.52 81.27
Q3012.................... K Cyanocobalamin cobalt 1089 57.07 47.38
co57.
Q3025.................... K IM inj interferon beta 9022 61.60 13.36
1-a.
----------------------------------------------------------------------------------------------------------------
[[Page 826]]
Coding for Specified Outpatient Drugs
In order to implement these provisions timely on January 1, 2004,
we are instructing hospitals to use the existing HCPCS code that
describes the drug for services furnished on or after January 1, 2004.
For sole source drugs, the existing HCPCS code is priced in accordance
with the provisions of section 1833(t)(14)(A)(i) of the Act as
indicated in Table 1. However, existing HCPCS codes do not allow us to
differentiate payment amounts for innovator multiple source and
noninnovator multiple source forms of the drug.
Therefore, for implementation January 1, 2004, we set payment rates
for all multiple source innovator and noninnovator drugs, biologicals
and radiopharmaceutical agents at the lower of the payment rate in the
November 7, 2003 final rule or 46 percent of the reference AWP. These
rates are shown in Table 2.
Initially, we will implement sections 1833(t)(14)(A)(i)(II) and
(III) of the Act in this manner because we are unable to compile a
definitive list of the innovator multiple source drugs in time for
January 1, 2004 implementation. On April 1, 2004, CMS will implement
new HCPCS codes that providers may use to bill for innovator multiple
source drugs in order to receive appropriate payment in accordance with
section 1833(t)(14)(A)(i)(II) of the Act, that is, the payment amount
established in the November 7, 2003 final rule or 68 percent of the
reference AWP, whichever is lower. The new codes will be effective
January 1, 2004 so that providers may submit adjustment bills after
April 1, 2004 to receive appropriate payment for multiple source
innovator drugs furnished on or after January 1, 2004 through March 31,
2004.
Beginning April 1, 2004, innovator multiple source drugs will be
paid at the statutory rate as long as the new codes are used. The
multiple source noninnovator rate will be the default payment rate for
the existing HCPCS code assigned to the drug, and providers will
continue to use the current HCPCS codes to bill for noninnovator
multiple source drugs after March 31, 2004. The new HCPCS codes will be
very similar to the current codes with only the distinction that the
drug being billed is an innovator multiple source drug eligible for
payment of as much as 68 percent of the AWP.
We recognize that creation and use of a new code to designate a
drug to be an innovator multiple source drug creates burden for
hospitals. However, the law provides different payment rules based on
the category into which the drug falls and therefore, to ensure correct
payment, hospitals must report a code for the drug that identifies the
category into which it falls. We request comments on ways that we can
reduce the reporting burden on hospitals that results from the law's
imposing different payment limitations on brand name and generic
versions of the same drug.
Table 2 lists the drugs for which the new HCPCS codes will be
implemented April 1, 2004 to distinguish innovator multiple source from
noninnovator multiple source drugs.
Other changes in payment methodology effective January 1, 2004 as a
result of enactment of the Medicare Prescription Drug, Improvement and
Modernization Act of 2003
Payment for Pass-Through Drugs, Biologicals, and Radiopharmaceuticals
Drugs and biologicals that are within the 2-3 year pass-through
payment period in 2004 continue to be paid pursuant to section 1842(o)
of the Act. However, section 1842(o) of the Act has been revised by
section 303(b) of the DIMA and those revisions change the way that
these drugs are paid.
Drugs and biologicals furnished during 2004 that are approved for
pass-through 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 pass-through drugs, we will give them
pass-through 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
[[Page 827]]
making an adjustment in accordance with section 1833(t)(2)(E) of the
Act (which was unaffected by DIMA) to the combined pass-through amount
and 3 percent additional payment provided under section
1833(t)(14)(A)(i)(I) of DIMA, resulting in a payment rate of $3.88 per
unit. This payment rate is budget neutral.
Table 3a.--Pass-Through Drugs Reimbursed at 85% of AWP
----------------------------------------------------------------------------------------------------------------
2004 Payment 2004 Co-
HCPCS APC Long description amount 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 127.50 21.30
microspheres, per single use vial.
J3315.............................. 9122 Injection, Triptorelin pamoate, 356.66 59.58
per 3.75 mg.
J3486.............................. 9204 Injection, Ziprasidone mesylate, 18.60 3.11
per 10 mg.
C9211.............................. 9211 Injection, IV, Alefacept, per 7.5 595.00 99.40
mg.
C9212.............................. 9212 Injection, IM, Alefacept, per 7.5 422.88 70.65
mg.
----------------------------------------------------------------------------------------------------------------
Table 3b.--Pass-Through Drugs Paid at 95% of AWP
----------------------------------------------------------------------------------------------------------------
HCPCS APC Long description Amount Amount
----------------------------------------------------------------------------------------------------------------
C9207.............................. 9207 Injection, IV, Bortezomib, per 3.5 1,039.68 155.40
mg.
C9208.............................. 9208 Injection, IV, Agalsidase beta, 123.78 18.50
per 1 mg.
C9209.............................. 9209 Injection, IV, Laronidase, per 2.9 644.10 96.28
mg.
C9210.............................. 9210 Injection, IV, Palonosetron HCI, 307.80 46.01
per 0.25 mg (250 micrograms).
----------------------------------------------------------------------------------------------------------------
Table 3c.--Pass-Through Drugs Paid as Sole Source Drugs at 88% of AWP
----------------------------------------------------------------------------------------------------------------
OPPS CY2004
HCPCS APC Long description November 7 DIMA final
rate rate
----------------------------------------------------------------------------------------------------------------
J0583.............................. 9111 Injection, Bivalirudin, per 1 mg.. $1.43 $1.61
C9112.............................. 9112 Injection, Perflutren lipid 132.60 137.28
microsphere, per 2 ml.
C9113.............................. 9113 Injection, Pantoprazole sodium, 22.44 23.23
per vial.
J1335.............................. 9116 Injection, Ertapenem sodium, per 21.24 21.99
500 mg.
J2505.............................. 9119 Injection, Pegfilgrastim, per 6 mg 2,507.50 2,596.00
single dose vial.
C9200.............................. 9200 Orcel, per 36 sqare centimeters... 1,015.75 1,051.60
C9201.............................. 9201 Dermagraft, per 37.5 square 516.80 535.04
centimeters.
J2324.............................. 9114 Injection, Nesiritide, per 0.5 mg. 135.66 140.45
J3487.............................. 9115 Injection, Zoledronic acid, per 1 194.52 211.07
mg.
----------------------------------------------------------------------------------------------------------------
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 pass-through 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-pass-through 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
[[Page 828]]
without having to modify our claims processing systems. We will revisit
the use and definition of status indicator ``H'' for this purpose for
the OPPS update for 2005. Table 4 provides a complete listing of the
HCPCS codes, descriptors, APC assignments and status indicators for
brachytherapy sources.
Table 4.--Brachytherapy Sources To Be Paid Separately, Using Charges
Reduced to Cost
------------------------------------------------------------------------
New status
HCPCS Descriptor APC APC title indicator
------------------------------------------------------------------------
C1716............ Brachytx 1716 Brachytx H
source, Gold source, Gold
198. 198.
C1717............ Brachytx 1717 Brachytx H
source, HDR Ir- source, HDR Ir-
192. 192.
C1718............ Brachytx 1718 Brachytx H
source, Iodine source, Iodine
125. 125.
C1719............ Brachytx sour, 1719 Brachytx H
Non-HDR Ir-192. source, Non-
HDR Ir-192.
C1720............ Brachytx 1720 Brachytx H
source, source,
Paladium 103. Paladium 103.
C2616............ Brachytx 2616 Brachytx H
source, source,
Yttrium-90. Yttrium-90.
C2632............ Brachytx 2632 Brachytx sol, I- H
solution, I- 125, per mCi.
125, per mCi.
C2633............ Brachytx 2633 Brachytx H
source, Cesium- source, Cesium-
131. 131.
C2632............ Brachytx sol, I- 2632 Brachytx sol, I- H
125, per mCi. 125, per mCi.
------------------------------------------------------------------------
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
[[Page 829]]
DIMA) and were approved by the FDA for marketing as of April 1, 2003,
will be paid 85 percent of AWP pursuant to section 1842(o)(1)(B) and
1842(o)(4)(A), unless sections 1842(o)(4)(B), (C) or (D) apply.
Certain drugs, biologicals and radiopharmaceutical agents that are
pass-through drugs in 2004 and that also meet the definition of
``specified covered outpatient drugs'', except as otherwise specified,
are paid 88 percent of the reference AWP. Those drugs, biologicals, and
radiopharmaceutical agents remain pass-through drugs and all policies
that apply to them as pass-through drugs continue to apply.
Exclude Separately Payable Drugs and Biologicals From Outlier Payments
Separately paid drugs and biologicals are excluded from outlier
payments.
Brachytherapy Sources Are To Be Paid Separately
All devices of brachytherapy consisting of a seed or seeds (or
radioactive source) are paid based on the hospital's charge for the
device adjusted to cost. All such brachytherapy sources are excluded
from outlier payments.
III. Collection of Information Requirements
This document does not impose information collection and
recordkeeping requirements. Consequently, it need not be reviewed by
the Office of Management and Budget under the authority of the
Paperwork Reduction Act of 1995.
IV. Waiver of Notice of Proposed Rulemaking and the 30-Day Delay in the
Effective Date
We ordinarily publish a notice of proposed rulemaking in the
Federal Register and invite public comment on the proposed rule in
accordance with 5 U.S.C. section 553(b) of the Administrative Procedure
Act (APA). The notice of proposed rulemaking includes a reference to
the legal authority under which the rule is proposed, and the terms and
substances of the proposed rule or a description of the subjects and
issues involved. This procedure can be waived, however, if an agency
finds good cause that a 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.
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.
[[Page 830]]
Unfunded Mandates
Section 202 of the Unfunded Mandates Reform Act of 1995 also
requires that agencies assess anticipated costs and benefits before
issuing any rule that may result in expenditure in any 1 year by State,
local, or tribal governments, in the aggregate, or by the private
sector, of $110 million. This interim final rule will not mandate any
requirements for State, local or tribal governments. This interim final
rule will not impose unfunded mandates on the private sector of more
than $110 million dollars.
Federalism
Executive Order 13132 establishes certain requirements that an
agency must meet when it promulgates a proposed rule (and subsequent
final rule) that imposes substantial direct requirement costs on State
and local governments, preempts State law, or otherwise has Federalism
implications.
We have examined this interim final rule in accordance with
Executive Order 13132, Federalism, and have determined that it will not
have an impact on the rights, roles, and responsibilities of State,
local or tribal governments.
B. Anticipated Effects of Changes in This Interim Final Rule and
Alternatives Considered for Each Change
All of the changes made in this interim final rule with comment are
required by DIMA. We are required under section 621 of the DIMA to
revise payments for certain drugs and biologicals and for
radiopharmaceuticals. We are also required under section 621 of the
DIMA to pay for brachytherapy sources on the basis of application of a
cost to charge ratio to the charges for the sources. In addition, we
are required under section 621 of the DIMA to continue transitional
outpatient payment for certain hospitals.
Impact on Drugs and Biologicals That Will Be Paid Under Pass-Through
Provisions in 2004
Four of the drugs and biologicals that will be paid under pass-
through provisions in 2004 will be paid at 95 percent of AWP. Nine of
the drugs and biologicals that will be paid under pass-through
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.
[[Page 831]]
We will temporarily pay the 52 drugs in Table 2 at the amounts
shown, as previously discussed. Thirteen of these items will be paid
the amount that was published in the November 7, 2003 final rule.
Thirty-eight of these items will receive payment decreases. One of
these items did not have a reference AWP under the SDP and will require
further research to determine the correct payment amount. Until we
determine a reference AWP for this item it will be paid at the amount
that was published in the November 7, 2003 final rule.
It is unclear what the final overall impact of these changes will
be because we are, as yet, unable to determine into which categories 52
items in dispute will fall. Moreover, once they are categorized, we do
not anticipate that we will know the frequency with which hospitals
will use the innovator multiple source drug versus the noninnovator
multiple source drug in the outpatient department. Moreover, it is not
clear to what extent hospitals may change their behavior with regard to
which type of a drug they choose to purchase and whether their
purchasing decisions will be affected by whether they furnish the item
to hospital outpatient departments or inpatient departments.
We considered whether to classify the 52 items with questionable
category assignment as both innovator multiple source and noninnovator
multiple source drugs and to create HCPCS codes to be used when
innovator multiple source drugs are administered. However, we believe
that public comment is necessary to determine the correct
classification of these items. Similarly, we believe that, given the
burden the law imposes on hospitals for reporting drugs by the category
into which they fall, it was important to receive public comment
regarding whether new codes should be created and regarding ways we can
reduce the reporting burden on hospitals. Hence, until we receive and
review the comments, we will not be able to assess the impact of these
requirements of the law.
We do acknowledge, however, that for the 52 drugs that are not sole
source drugs, the temporary payments to hospitals at the noninnovator
multiple source drug rate will be less than the payment that would have
been made under the November 7, 2003 final rule. For those drugs that
are sole source drugs, the payment will increase in most cases.
Hospitals that provide sole source drugs will be paid more for
these drugs under these provisions than they would have been paid
before enactment of the DIMA. Hospitals that provide innovator multiple
source drugs and noninnovator multiple source drugs will be paid less
for these items than they would have been before enactment of the DIMA.
This may encourage use of sole source drugs and discourage use of
multiple source drugs. As a result, beneficiaries may have greater
access to sole source drugs but will also incur greater copayments
because those payment rates are higher than they would have been before
enactment of DIMA. In turn, there may be increased payment by
complementary insurers for these items. Manufacturers of sole source
drugs may realize increased sales and manufacturers of generic drugs
may see reduced sales.
We considered whether to permit a drug that is classified by AMP as
a sole source drug, an innovator multiple source drug and a
noninnovator multiple source drug to be paid under all three
classifications. We decided not to pay a drug as a sole source drug if
it is also a multiple source drug for reasons described previously in
this interim final rule. We considered no alternatives because the law
is quite specific with regard to the classification of drugs and the
payment rules that apply to each class of drug.
Impact of Cost-Based Payment for Sources of Brachytherapy
The law provides that sources of brachytherapy will be paid an
amount equal to the hospital's charge for the source adjusted by the
applicable cost to charge ratio. It is unclear whether this will result
in an increase or decrease in payment for brachytherapy sources.
However, removing the brachytherapy source from packaged payment for
the services with which it is furnished removes incentives for using
the least number of sources needed for the therapeutic purpose. There
is no evidence that packaged payment for brachytherapy sources resulted
in inappropriately low utilization of brachytherapy, nor that separate
payment will result in any change in availability of the service. We
are unable to estimate the impact of this change on utilization and
program payment.
We considered no alternatives to this policy because the statute
was specific with regard to how payment for brachytherapy sources must
be made.
Impact of Continuation of Transitional Outpatient Payments for Certain
Hospitals
The law provides that transitional outpatient payments must
continue for rural hospitals with 100 or fewer beds and be provided for
sole community hospitals in rural areas through December 31, 2005.
There are approximately 600 sole community hospitals and approximately
1150 rural hospitals with 100 beds or fewer that may be affected by
this provision. These hospitals will continue to receive transitional
corridor payments in addition to the payments they will receive under
OPPS. These payments should continue to strengthen the ability of these
hospitals to furnish services to beneficiaries who reside in the areas
served by these hospitals. Beneficiaries should be better assured of
access to services in these hospitals. These hospitals will be assured
of payment for the reasonable costs of providing outpatient services.
We considered no alternatives because the statute is quite
directive with regard to the extension of hold harmless protection to
these hospitals.
C. Conclusion
We have prepared the analysis above because we have determined that
this interim final rule will have a significant economic impact. In
accordance with the provisions of Executive Order 12866, this interim
final rule was reviewed by the Office of Management and Budget.
Publication of Addenda
The addenda included in this interim final rule, Addenda A and D1
replace the addenda in the November 7, 2003 Federal Register (68 FR
63478). The revised addenda reflect changes required by the DIMA as
well as corrections to minor errors contained in the addenda published
November 7, 2003.
In addition to the addenda included here, we will post the updated
Addenda B and C on our Web site at http://www.cms.hhs.gov/regulations/hopps/
.
List of Subjects in 42 CFR Part 419
Hospitals, Medicare, Reporting and recordkeeping requirements.
0
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
0
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).
[[Page 832]]
Subpart C--Basic Methodology for Determining Prospective Payment
Rates for Hospital Outpatient Services
0
2. Section 419.32 is amended by revising paragraph (d) to read as
follows:
Sec. 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 Sec. 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
0
3. Section Sec. 419.43 is amended as follows:
0
A. Paragraph (d)(1) introductory text is revised.
0
B. Paragraph (e) is revised.
0
C. New paragraph (f) is added.
The revisions and additions read as follows:
Sec. 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
0
4. Section 419.64 is amended by revising paragraph (d).
Sec. 419.64 Transitional pass-through payments: Drugs and
biologicals.
* * * * *
(d) Amount of pass-through payment. (1) Subject to any reduction
determined under Sec. 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 Sec. 419.62(b), the
pass-through 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
0
5. Section 419.70 is amended as follows:
0
A. Paragraph (d)(1) is amended by removing ``2004'' and adding ``2006''
in its place.
0
B. A new paragraph (d)(3) is added to read as follows:
Sec. 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 Sec. 412.92 of this
chapter; and
(ii) Is located in a rural area as defined in Sec. 412.63(b) of
this chapter or is treated as being located in a rural area under
section 1886(d)(8)(E) of the Act.
(Catalog of Federal Domestic Assistance Program No. 93.773,
Medicare--Hospital Insurance; and Program No. 93.774, Medicare--
Supplementary Medical Insurance Program)
Dated: December 23, 2003.
Dennis G. Smith,
Acting Administrator, Centers for Medicare & Medicaid Services.
Approved: December 23, 2003.
Tommy G. Thompson,
Secretary.
Note: The following addenda will not appear in the Code of
Federal Regulations.
Addendum A.--List of Ambulatory Payment Classifications (APCS) With Status Indicators, Relative Weights, Payment
Rates, and Copayment Amounts Calendar Year 2004
----------------------------------------------------------------------------------------------------------------
National Minimum
APC Group title Status Relative Payment unadjusted unadjusted
indicator weight rate copayment copayment
----------------------------------------------------------------------------------------------------------------
0001................. Level I S 0.4237 $23.12 $7.09 $4.62
Photochemotherapy.
0002................. Level I Fine Needle T 0.8083 $44.10 ........... $8.82
Biopsy/Aspiration.
0003................. Bone Marrow Biopsy/ T 2.3229 $126.74 ........... $25.35
Aspiration.
0004................. Level I Needle Biopsy/ T 1.5882 $86.65 $22.36 $17.33
Aspiration Except Bone
Marrow.
0005................. Level II Needle Biopsy/ T 3.2698 $178.40 $71.59 $35.68
Aspiration Except Bone
Marrow.
0006................. Level I Incision & T 1.6527 $90.17 $23.26 $18.03
Drainage.
0007................. Level II Incision & T 11.8633 $647.27 ........... $129.45
Drainage.
0008................. Level III Incision and T 19.4831 $1,063.02 ........... $212.60
Drainage.
0009................. Nail Procedures........ T 0.6652 $36.29 $8.34 $7.26
0010................. Level I Destruction of T 0.6480 $35.36 $10.08 $7.07
Lesion.
0011................. Level II Destruction of T 2.2217 $121.22 $27.88 $24.24
Lesion.
0012................. Level I Debridement & T 0.7612 $41.53 $11.18 $8.31
Destruction.
0013................. Level II Debridement & T 1.1302 $61.66 $14.20 $12.33
Destruction.
0015................. Level III Debridement & T 1.5968 $87.12 $20.35 $17.42
Destruction.
0016................. Level IV Debridement & T 2.5724 $140.35 $57.31 $28.07
Destruction.
0017................. Level VI Debridement & T 16.3697 $893.15 $227.84 $178.63
Destruction.
0018................. Biopsy of Skin/Puncture T 0.9178 $50.08 $16.04 $10.02
of Lesion.
[[Page 833]]
0019................. Level I Excision/ T 3.9493 $215.48 $71.87 $43.10
Biopsy.
0020................. Level II Excision/ T 7.0842 $386.52 $113.25 $77.30
Biopsy.
0021................. Level III Excision/ T 14.3594 $783.46 $219.48 $156.69
Biopsy.
0022................. Level IV Excision/ T 18.7932 $1,025.38 $354.45 $205.08
Biopsy.
0023................. Exploration Penetrating T 2.8141 $153.54 $40.37 $30.71
Wound.
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 T 37.3083 $2,035.58 $763.55 $407.12
Surgery.
0032................. Insertion of Central T 11.4907 $626.94 ........... $125.39
Venous/Arterial
Catheter.
0033................. Partial Hospitalization P 5.2569 $286.82 ........... $57.36
0035................. Placement of Arterial T 0.1691 $9.23 $2.79 $1.85
or Central Venous
Catheter.
0036................. Level II Fine Needle T 1.5170 $82.77 ........... $16.55
Biopsy/Aspiration.
0037................. Level III Needle Biopsy/ T 9.8921 $539.72 $237.45 $107.94
Aspiration Except Bone
Marrow.
0039................. Implantation of S 235.1866 $12,832.02 ........... $2,566.40
Neurostimulator.
0040................. Level II Implantation S 52.1002 $2,842.64 ........... $568.53
of Neurostimulator
Electrodes.
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 T 1.9074 $104.07 ........... $20.81
Fracture Finger/Toe/
Trunk.
0045................. Bone/Joint Manipulation T 13.5889 $741.42 $268.47 $148.28
Under Anesthesia.
0046................. Open/Percutaneous T 32.5581 $1,776.40 $535.76 $355.28
Treatment Fracture or
Dislocation.
0047................. Arthroplasty without T 29.9582 $1,634.55 $537.03 $326.91
Prosthesis.
0048................. Arthroplasty with T 51.4609 $2,807.76 $695.60 $561.55
Prosthesis.
0049................. Level I Musculoskeletal T 19.6046 $1,069.65 ........... $213.93
Procedures Except Hand
and Foot.
0050................. Level II T 24.8651 $1,356.66 ........... $271.33
Musculoskeletal
Procedures Except Hand
and Foot.
0051................. Level III T 34.5144 $1,883.14 ........... $376.63
Musculoskeletal
Procedures Except Hand
and Foot.
0052................. Level IV T 42.7126 $2,330.44 ........... $466.09
Musculoskeletal
Procedures Except Hand
and Foot.
0053................. Level I Hand T 14.8831 $812.04 $253.49 $162.41
Musculoskeletal
Procedures.
0054................. Level II Hand T 24.2456 $1,322.86 ........... $264.57
Musculoskeletal
Procedures.
0055................. Level I Foot T 18.7205 $1,021.41 $355.34 $204.28
Musculoskeletal
Procedures.
0056................. Level II Foot T 25.3930 $1,385.47 $405.81 $277.09
Musculoskeletal
Procedures.
0057................. Bunion Procedures...... T 25.5035 $1,391.50 $475.91 $278.30
0058................. Level I Strapping and S 1.0931 $59.64 ........... $11.93
Cast Application.
0060................. Manipulation Therapy... S 0.2788 $15.21 ........... $3.04
0068................. CPAP Initiation........ S 1.0807 $58.96 $29.48 $11.79
0069................. Thoracoscopy........... T 28.9392 $1,578.95 $591.64 $315.79
0070................. Thoracentesis/Lavage T 3.0717 $167.60 ........... $33.52
Procedures.
0071................. Level I Endoscopy Upper T 0.8799 $48.01 $12.89 $9.60
Airway.
0072................. Level II Endoscopy T 1.7613 $96.10 $26.68 $19.22
Upper Airway.
0073................. Level III Endoscopy T 3.4541 $188.46 $73.38 $37.69
Upper Airway.
0074................. Level IV Endoscopy T 13.9480 $761.02 $295.70 $152.20
Upper Airway.
0075................. Level V Endoscopy Upper T 20.3815 $1,112.04 $445.92 $222.41
Airway.
0076................. Level I Endoscopy Lower T 9.2346 $503.85 $189.82 $100.77
Airway.
0077................. Level I Pulmonary S 0.2837 $15.48 $7.74 $3.10
Treatment.
0078................. Level II Pulmonary S 0.7917 $43.20 $14.55 $8.64
Treatment.
0079................. Ventilation Initiation S 2.1494 $117.27 ........... $23.45
and Management.
0080................. Diagnostic Cardiac T 36.0160 $1,965.07 $838.92 $393.01
Catheterization.
0081................. Non-Coronary T 35.0285 $1,911.19 ........... $382.24
Angioplasty or
Atherectomy.
0082................. Coronary Atherectomy... T 110.2196 $6,013.69 $1,293.59 $1,202.74
0083................. Coronary Angioplasty T 59.2047 $3,230.27 ........... $646.05
and Percutaneous
Valvuloplasty.
0084................. Level I S 10.5226 $574.12 ........... $114.82
Electrophysiologic
Evaluation.
0085................. Level II T 35.4126 $1,932.15 $426.25 $386.43
Electrophysiologic
Evaluation.
0086................. Ablate Heart Dysrhythm T 44.9389 $2,451.91 $833.33 $490.38
Focus.
0087................. Cardiac T 39.8161 $2,172.41 ........... $434.48
Electrophysiologic
Recording/Mapping.
0088................. Thrombectomy........... T 34.6942 $1,892.95 $655.22 $378.59
0089................. Insertion/Replacement T 117.1896 $6,393.98 $1,722.59 $1,278.80
of Permanent Pacemaker
and Electrodes.
0090................. Insertion/Replacement T 96.8284 $5,283.05 $1,651.45 $1,056.61
of Pacemaker Pulse
Generator.
0091................. Level II Vascular T 28.8326 $1,573.14 $348.23 $314.63
Ligation.
0092................. Level I Vascular T 25.0959 $1,369.26 $505.37 $273.85
Ligation.
0093................. Vascular Reconstruction/ T 21.3104 $1,162.72 $277.34 $232.54
Fistula Repair without
Device.
0094................. Level I Resuscitation S 2.6345 $143.74 $48.58 $28.75
and Cardioversion.
0095................. Cardiac Rehabilitation. S 0.5994 $32.70 $16.35 $6.54
[[Page 834]]
0096................. Non-Invasive Vascular S 1.7176 $93.71 $46.85 $18.74
Studies.
0097................. Cardiac and Ambulatory X 1.0635 $58.03 $23.80 $11.61
Blood Pressure
Monitoring.
0098................. Injection of Sclerosing T 1.0729 $58.54 $14.06 $11.71
Solution.
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 T 11.6202 $634.01 $223.63 $126.80
Procedures.
0104................. Transcatheter Placement T 82.6713 $4,510.63 ........... $902.13
of Intracoronary
Stents.
0105................. Revision/Removal of T 19.1898 $1,047.01 $370.40 $209.40
Pacemakers, AICD, or
Vascular.
0106................. Insertion/Replacement/ T 58.9719 $3,217.57 ........... $643.51
Repair of Pacemaker
and/or Electrodes.
0107................. Insertion of T 337.1304 $18,394.17 $3,699.14 $3,678.83
Cardioverter-
Defibrillator.
0108................. Insertion/Replacement/ T 452.6995 $24,699.74 ........... $4,939.95
Repair of Cardioverter-
Defibrillator Leads.
0109................. Removal of Implanted T 7.4705 $407.60 $131.49 $81.52
Devices.
0110................. Transfusion............ S 3.6718 $200.34 ........... $40.07
0111................. Blood Product Exchange. S 13.1719 $718.67 $200.18 $143.73
0112................. Apheresis, S 37.5832 $2,050.58 $612.47 $410.12
Photopheresis, and
Plasmapheresis.
0113................. Excision Lymphatic T 19.9322 $1,087.52 ........... $217.50
System.
0114................. Thyroid/Lymphadenectomy T 37.5963 $2,051.29 $485.91 $410.26
Procedures.
0115................. Cannula/Access Device T 25.6437 $1,399.15 $459.35 $279.83
Procedures.
0116................. Chemotherapy S 0.7996 $43.63 ........... $8.73
Administration by
Other Technique Except
Infusion.
0117................. Chemotherapy S 3.0360 $165.65 $42.54 $33.13
Administration by
Infusion Only.
0119................. Implantation of T 134.7194 $7,350.43 ........... $1,470.09
Infusion Pump.
0120................. Infusion Therapy Except T 1.9114 $104.29 $28.21 $20.86
Chemotherapy.
0121................. Level I Tube changes T 2.1114 $115.20 $43.80 $23.04
and Repositioning.
0122................. Level II Tube changes T 8.8621 $483.53 $99.16 $96.71
and Repositioning.
0123................. Bone Marrow Harvesting S 6.1499 $335.54 ........... $67.11
and Bone Marrow/Stem
Cell Transplant.
0124................. Revision of Implanted T 23.8050 $1,298.82 ........... $259.76
Infusion Pump.
0125................. Refilling of Infusion T 2.1606 $117.88 ........... $23.58
Pump.
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 T 6.4525 $352.05 $107.24 $70.41
without Endoscopy.
0141................. Upper GI Procedures.... T 7.8206 $426.70 $143.38 $85.34
0142................. Small Intestine T 8.7959 $479.91 $152.78 $95.98
Endoscopy.
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 T 3.8320 $209.08 $63.38 $41.82
Procedure.
0149................. Level III Anal/Rectal T 17.1425 $935.31 $293.06 $187.06
Procedure.
0150................. Level IV Anal/Rectal T 22.1919 $1,210.81 $437.12 $242.16
Procedure.
0151................. Endoscopic Retrograde T 17.9462 $979.16 $245.46 $195.83
Cholangio-
Pancreatography (ERCP).
0152................. Percutaneous Abdominal T 9.1474 $499.09 $125.28 $99.82
and Biliary Procedures.
0153................. Peritoneal and T 20.8723 $1,138.81 $410.87 $227.76
Abdominal Procedures.
0154................. Hernia/Hydrocele T 26.9636 $1,471.16 $464.85 $294.23
Procedures.
0155................. Level II Anal/Rectal T 10.0809 $550.02 $188.89 $110.00
Procedure.
0156................. Level II Urinary and T 2.4747 $135.02 $40.52 $27.00
Anal Procedures.
0157................. Colorectal Cancer S 2.5693 $140.18 ........... $28.04
Screening: Barium
Enema.
0158................. Colorectal Cancer T 7.4244 $405.08 ........... $101.27
Screening: Colonoscopy.
0159................. Colorectal Cancer S 2.7823 $151.81 ........... $37.95
Screening: Flexible
Sigmoidoscopy.
0160................. Level I T 6.8801 $375.39 $105.06 $75.08
Cystourethroscopy and
other Genitourinary
Procedures.
0161................. Level II T 16.8407 $918.85 $249.36 $183.77
Cystourethroscopy and
other Genitourinary
Procedures.
0162................. Level III T 21.9098 $1,195.42 ........... $239.08
Cystourethroscopy and
other Genitourinary
Procedures.
0163................. Level IV T 33.8805 $1,848.55 ........... $369.71
Cystourethroscopy and
other Genitourinary
Procedures.
0164................. Level I Urinary and T 1.2021 $65.59 $17.59 $13.12
Anal Procedures.
0165................. Level III Urinary and T 14.6838 $801.16 ........... $160.23
Anal Procedures.
0166................. Level I Urethral T 16.7918 $916.18 $218.73 $183.24
Procedures.
0167................. Level III Urethral T 30.0186 $1,637.84 $555.84 $327.57
Procedures.
0168................. Level II Urethral T 30.0147 $1,637.63 $405.60 $327.53
Procedures.
0169................. Lithotripsy............ T 45.1150 $2,461.52 $1,115.69 $492.30
0170................. Dialysis............... S 5.9678 $325.61 ........... $65.12
[[Page 835]]
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 T 21.6724 $1,182.47 ........... $236.49
Procedures.
0184................. Prostate Biopsy........ T 3.8995 $212.76 $96.27 $42.55
0187................. Miscellaneous Placement/ X 4.4288 $241.64 $90.71 $48.33
Repositioning.
0188................. Level II Female T 1.1365 $62.01 ........... $12.40
Reproductive Proc.
0189................. Level III Female T 1.4232 $77.65 $18.09 $15.53
Reproductive Proc.
0190................. Level I Hysteroscopy... T 19.6922 $1,074.43 $424.28 $214.89
0191................. Level I Female T 0.1853 $10.11 $2.93 $2.02
Reproductive Proc.
0192................. Level IV Female T 2.7121 $147.97 $39.11 $29.59
Reproductive Proc.
0193................. Level V Female T 15.0453 $820.89 $171.13 $164.18
Reproductive Proc.
0194................. Level VIII Female T 18.4286 $1,005.48 $397.84 $201.10
Reproductive Proc.
0195................. Level IX Female T 25.6950 $1,401.94 $483.80 $280.39
Reproductive Proc.
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 T 1.3578 $74.08 $32.19 $14.82
Care Procedures.
0199................. Obstetrical Care T 17.2831 $942.98 ........... $188.60
Service.
0200................. Level VII Female T 17.9920 $981.66 $307.83 $196.33
Reproductive Proc.
0201................. Level VI Female T 16.8660 $920.23 $329.65 $184.05
Reproductive Proc.
0202................. Level X Female T 38.9821 $2,126.90 $1,042.18 $425.38
Reproductive Proc.
0203................. Level IV Nerve T 11.5969 $632.74 $276.76 $126.55
Injections.
0204................. Level I Nerve T 2.1711 $118.46 $40.13 $23.69
Injections.
0206................. Level II Nerve T 5.2875 $288.49 $75.55 $57.70
Injections.
0207................. Level III Nerve T 6.4554 $352.21 $123.69 $70.44
Injections.
0208................. Laminotomies and T 40.2830 $2,197.88 ........... $439.58
Laminectomies.
0209................. Extended EEG Studies S 11.5435 $629.82 $280.58 $125.96
and Sleep Studies,
Level II.
0212................. Nervous System T 2.9739 $162.26