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Medicare Program; Hospital Outpatient Prospective Payment System; Payment Reform for Calendar Year 2004

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AGENCY:

Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION:

Interim final rule with comment period.

SUMMARY:

This interim final rule with comment period implements provisions of the Medicare Prescription Drug, Improvement, and Modernization Act (DIMA) of 2003 that affect the Medicare outpatient prospective payment system (OPPS) that become effective January 1, 2004. Sections 303 and 621 of the DIMA include provisions that alter the methods for drug payment in hospital outpatient departments, some of which become effective January 1, 2004. These provisions affect the methodology for paying for pass-through and non-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.

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FOR FURTHER INFORMATION CONTACT:

Dana Burley, (410) 786-0378.

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SUPPLEMENTARY INFORMATION:

Inspection of Public Comments: Comments received timely will be available for public inspection as they are received, generally beginning approximately 3 weeks after publication of a document, at the headquarters of the Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, Maryland 21244, Monday through Friday of each week from 8:30 a.m. to 4 p.m. To schedule an appointment to view public comments, call (410) 786-7195.

Availability of Copies and Electronic Access

Copies: To order copies of the Federal Register containing this document, send your request to: New Orders, Superintendent of Documents, P.O. Box 371954, Pittsburgh, PA 15250-7954. Specify the date of the issue requested and enclose a check or money order payable to the Superintendent of Documents, or enclose your Visa or Master Card number and expiration date. Credit card orders can also be placed by calling the order desk at (202) 512-1800 (or toll-free at 1-888-293-6498) or by faxing to (202) 512-2250. The cost for each copy is $10. As an alternative, you can view and photocopy the Federal Register document at most libraries designated as Federal Depository Libraries and at many other public and academic libraries throughout the country that receive the Federal Register.

This Federal Register document is also available from the Federal Register online database through GPO Access, a service of the U.S. Government Printing Office. The Web site address is: http://www.access.gpo.gov/​nara/​index.html.

I. Background

A. Authority for the Outpatient Prospective Payment System

When the Medicare statute was originally enacted, Medicare payment for hospital outpatient services was based on hospital-specific costs. In an effort to ensure that Medicare and its beneficiaries pay appropriately for services and to encourage more efficient delivery of care, the Congress mandated replacement of the cost-based payment methodology with a prospective payment system (PPS). The Balanced Budget Act of 1997 (BBA) (Pub. L. 105-33), enacted on August 5, 1997, added section 1833(t) to the Social Security Act (the Act) authorizing implementation of a PPS for hospital outpatient services. The Balanced Budget Refinement Act of 1999 (BBRA) (Pub. L. 106-113), enacted on November 29, 1999, made major changes that affected the hospital outpatient PPS (OPPS). The Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000 (BIPA) (Pub. L. 106-554), enacted on December 21, 2000, made further changes in the OPPS. The OPPS was first implemented for services furnished on or after August 1, 2000.

The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (DIMA) (Pub. L. 108-173), enacted on December 8, 2003, made additional changes to the Act relating to the OPPS and calendar year 2004 payment rates to be implemented January 1, 2004.

We would ordinarily publish a notice of proposed rulemaking in the Federal Register and invite public comment on the proposed rule. This procedure can be waived, however, if an agency finds good cause that a notice-and-comment procedure is impracticable, unnecessary, or contrary to the public interest and incorporates a statement of the finding and its reasons in the rule issued. We find good cause to waive notice and comment procedures for this correction notice as set forth in section IV, “Waiver of Proposed Rulemaking and Waiver of 30-Day Delay in the Effective Date,” below.

B. Summary of Relevant Provisions of the DIMA

The DIMA, enacted December 8, 2003, made the following changes to the Act that relate to the OPPS:

1. Transitional Corridor Payments Extended

Section 411 of the DIMA amends section 1833(t)(7)(D)(i) of the Act and extends the hold-harmless provision for small rural hospitals. The hold harmless Start Printed Page 821transitional 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:

  • A drug or biological for which payment is first made on or after January 1, 2003 under the transitional pass-through payment provision in section 1833(t)(6) of the Act.
  • A drug or biological for which a temporary HCPCS code has not been assigned.
  • During 2004 and 2005, an orphan drug (as designated by the Secretary).

Section 1833(t)(14)(A)(i) specifies payment limits for 3 categories of “specified covered outpatient drugs” in 2004. Section 1833(t)(14)(F) defines the 3 categories of “specified covered outpatient drugs” based on sections 1861(t)(1) and 1927(k)(7)(A)(ii), (iii) and (iv) of the Act. The categories of drugs are “sole source drugs”, “innovator multiple source drugs” and “noninnovator multiple source drugs.” Start Printed 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. Start Printed 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

HCPCSStatus indicatorDescriptionAPCOPPS CY 2004 November 7, 2003 rateDIMA final rate
A4642KSatumomab pendetide per dose0704$124.46$1,474.00
A9500KTechnetium TC 99m sestamibi160064.28112.73
A9502KTechnetium TC99M tetrofosmin070558.06665.28
A9507KIndium/111 capromab pendetid1604687.712,030.60
A9511KTechnetium TC 99m depreotide109537.87704.00
A9521KTechnetiumtc-99m exametazine1096210.65825.00
A9524KIodinated I-131 serumalbumin, per 5uci91000.3648.58
A9600KStrontium-89 chloride0701402.85892.43
C1079KCO 57/58 per 0.5 uCi107968.51235.14
C1080KI-131 tositumomab, dx10802,260.002,565.55
C1081KI-131 tositumomab, tx108119,565.0022,210.19
C1082KIn-111 ibritumomab tiuxetan91182,260.002,565.55
C1083KYttrium 90 ibritumomab tiuxetan911719,565.0022,210.19
C1092KIN 111 pentetate per 0.5 mCi1092217.45237.60
C1122KTc 99M ARCITUMOMAB PER VIAL1122534.771,144.00
C1166KCYTARABINE LIPOSOMAL, 10 mg1166278.99344.08
C1167KEPIRUBICIN HCL, 2 mg116720.4325.60
C1178KBUSULFAN IV, 6 Mg1178299.7027.87
C1200KTC 99M Sodium Glucoheptonat120030.2830.28
C1201KTC 99M SUCCIMER, PER Vial120180.24125.66
C1305KApligraf1305822.191,199.00
C9003KPalivizumab, per 50 mg9003344.15611.24
C9008KBaclofen Refill Kit-500mcg90086.9073.92
C9009KBaclofen Refill Kit-2000mcg900940.9240.92
C9010KBaclofen Refill Kit—4000mcg901042.2279.82
C9109KTirofiban hcl, 6.25 mg9109118.60218.33
C9202KOctafluoropropane9202118.60137.28
J0130KAbciximab injection1605289.44475.22
J0207KAmifostine7000289.40419.59
J0287KAmphotericin b lipid complex902420.8620.86
J0288KAmpho b cholesteryl sulfate902420.8620.86
J0289KAmphotericin b liposome inj902420.8620.86
J0350KInjection anistreplase 30 u16061,516.462,495.31
J0585KBotulinum toxin a per unit09023.214.58
J0587KBotulinum toxin type B90186.988.14
J0637KCaspofungin acetate901929.6430.52
J0850KCytomegalovirus imm IV /vial0903291.18659.60
J1327KEptifibatide injection16077.9911.88
J1438KEtanercept injection1608102.37143.73
J1440KFilgrastim 300 mcg injection0728123.48172.20
J1441KFilgrastim 480 mcg injection7049175.96290.93
J1565KRSV-ivig090648.6116.55
J1626KGranisetron HCl injection07645.7017.18
J1830KInterferon beta-1b / .25 MG0910100.5167.22
J1950KLeuprolide acetate /3.75 MG0800182.92479.20
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J2020KLinezolid injection900115.1234.09
J2353KOctreotide injection, depot120765.7473.62
J2354KOctreotide inj, non-depot70311.443.94
J2788KRho d immune globulin 50 mcg90231.6932.21
J2790KRho d immune globulin inj088410.1692.93
J2792KRho(D) immune globulin h, sd16099.7619.03
J2820KSargramostim injection073116.3226.92
J2941KSomatropin injection703441.18297.79
J2993KReteplase injection9005568.331,263.90
J3100KTenecteplase injection90021,296.752,492.60
J3245KTirofiban hydrochloride7041227.85436.66
J3305KInj trimetrexate glucoronate704561.36132.00
J3395KVerteporfin injection1203897.201,350.80
J7191KFactor VIII (porcine)09261.521.89
J7195KFactor IX recombinant09321.011.04
J7320KHylan G-F 20 injection1611123.46215.97
J7504KLymphocyte immune globulin0890127.89258.17
J7505KMonoclonal antibodies7038320.84792.33
J7507KTacrolimus oral per 1 MG08911.343.24
J7511KAntithymocyte globuln rabbit9104163.56331.23
J7520KSirolimus, oral90202.896.60
J7525KTacrolimus injection90065.72110.04
J8510KOral busulfan70151.571.93
J8520KCapecitabine, oral, 150 mg70421.653.14
J8700KTemozolmide10863.766.81
J9001KDoxorubicin hcl liposome inj7046256.34364.49
J9010KAlemtuzumab injection9110424.88541.46
J9017KArsenic trioxide901226.9134.32
J9020KAsparaginase injection081416.1358.00
J9045KCarboplatin injection081186.47137.79
J9098KCytarabine liposome1166278.99344.08
J9151KDaunorubicin citrate liposom0821163.5564.60
J9170KDocetaxel0823220.97331.53
J9178KInj, epirubicin hcl, 2 mg116720.4325.60
J9185KFludarabine phosphate inj0842205.74329.83
J9201KGemcitabine HCl082880.43112.09
J9202KGoserelin acetate implant0810285.16413.59
J9206KIrinotecan injection0830100.55135.00
J9213KInterferon alfa-2a inj083420.6132.31
J9214KInterferon alfa-2b inj083610.9313.78
J9215KInterferon alfa-n3 inj086579.658.17
J9216KInterferon gamma 1-b inj0838180.15290.70
J9217KLeuprolide acetate suspnsion9217312.37576.47
J9219KLeuprolide acetate implant70513,666.715,001.92
J9245KInj melphalan hydrochl 50 MG0840254.90389.14
J9268KPentostatin injection0844965.981,784.64
J9270KPlicamycin (mithramycin) inj086015.4286.89
J9293KMitoxantrone hydrochl / 5 MG0864173.68332.87
J9310KRituximab cancer treatment0849306.40464.20
J9320KStreptozocin injection085065.19131.05
J9350KTopotecan0852433.41739.80
J9355KTrastuzumab161340.5653.85
J9357KValrubicin, 200 mg1614461.78487.87
J9390KVinorelbine tartrate/10 mg085564.79100.97
J9600KPorfimer sodium08561,594.302,411.82
Q0136KNon esrd epoetin alpha inj07339.8311.76
Q0137KDarbepoetin alfa, non esrd07343.243.88
Q0166KGranisetron HCl 1 mg oral076534.49171.78
Q0180KDolasetron mesylate oral076341.00152.38
Q0187KFactor viia recombinant14091,083.931,495.30
Q2003KAprotinin, 10,000 kiu70191.1713.26
Q2005KCorticorelin ovine triflutat7024224.91375.00
Q2006KDigoxin immune fab (ovine)7025271.141.79
Q2007KEthanolamine oleate 100 mg702627.8267.10
Q2008KFomepizole, 15 mg70277.2310.65
Q2009KFosphenytoin, 50 mg70284.885.63
Q2011KHemin, per 1 mg70300.646.86
Q2013KPentastarch 10% solution704026.40139.94
Q2017KTeniposide, 50 mg7035137.41238.49
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Q2018KUrofollitropin, 75 iu703763.4863.48
Q3000KRubidium-Rb-829025143.89162.63
Q3003KTechnetium tc99m bicisate1620183.69392.93
Q3005KTechnetium tc99m mertiatide162220.631,650.00
Q3008KIndium 111-in pentetreotide1625449.841,144.00
Q4052KOctreotide injection, depot120765.7473.62

Table 2.—Multisource Drugs

HCPCSStatus indicatorDescriptionAPCOPPS CY 2004 November 7, 2003 rateDIMA final rate
A9505KThallous chloride TL 201/mci1603$19.89$18.29
A9508KIobenguane sulfate I-131, per 0.5 mCi1045165.82165.82
A9517KTh I131 so iodide cap millic10645.485.48
A9528KDx I131 so iodide cap millic10645.485.48
A9529KDx I131 so iodide sol millic10656.496.49
A9530KTh I131 so iodide sol millic10656.496.49
A9605KSamarium sm153 lexidronamm0702874.44493.89
C1091KIN111 oxyquinoline, per0.5mCi1091224.52224.52
C1775KFDG, per dose (4-40 mCi/ml)1775324.48324.48
C9013KCo 57 cobaltous chloride901356.6756.67
C9105KHep B imm glob, per 1 ml910571.3365.58
J1190KDexrazoxane HCl injection0726112.48112.48
J1563KImmune globulin, 1 g090543.9637.95
J1564KImmune globulin 10 mg90210.440.41
J1745KInfliximab injection704338.8631.81
J1825KInterferon beta-1a0909184.79123.77
J2430KPamidronate disodium /30 MG0730174.32128.74
J7190KFactor viii09250.510.42
J7192KFactor viii recombinant09271.010.61
J7193KFactor IX non-recombinant09310.510.51
J7194KFactor ix complex09280.510.18
J7198KAnti-inhibitor09291.010.69
J7310KGanciclovir long act implant091386.5486.54
J7317KSodium hyaluronate injection7316138.7867.16
J7502KCyclosporine oral 100 mg08882.562.41
J7517KMycophenolate mofetil oral90152.041.36
J8560KEtoposide oral 50 MG080227.3721.91
J9000KDoxorubic hcl 10 MG vl chemo08476.614.69
J9031KBcg live intravesical vac0809103.7577.54
J9040KBleomycin sulfate injection0857160.5688.32
J9060KCisplatin 10 MG injection081321.747.73
J9065KInj cladribine per 1 MG085837.8224.84
J9070KCyclophosphamide 100 MG inj08154.742.77
J9093KCyclophosphamide lyophilized08164.502.36
J9100KCytarabine hcl 100 MG inj08175.071.55
J9130KDacarbazine 100 mg inj08195.315.31
J9150KDaunorubicin082073.9735.94
J9181KEtoposide 10 MG inj08244.560.83
J9200KFloxuridine injection0827114.1966.24
J9208KIfosfomide injection0831106.0472.81
J9209KMesna injection073228.4317.66
J9211KIdarubicin hcl injection0832178.21178.21
J9218KLeuprolide acetate injection086143.6014.48
J9265KPaclitaxel injection0863112.1479.04
J9280KMitomycin 5 MG inj086253.0330.91
J9340KThiotepa injection085159.9345.31
Q2022KVonWillebrandFactr CmplxperIU16181.010.46
Q3002KGallium ga 67161911.2211.22
Q3007KSodium phosphate p32162470.6166.44
Q3011KChromic phosphate p32162898.5281.27
Q3012KCyanocobalamin cobalt co57108957.0747.38
Q3025KIM inj interferon beta 1-a902261.6013.36
Start Printed 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 Start Printed Page 827making 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

HCPCSAPCLong description2004 Payment amount2004 Co-payment amount
J93959120Injection, Fulvestrant, per 25 mg$78.36$13.09
C91219121Injection, Argotroban, per 5 mg14.632.44
C91239123TransCyte, per 247 sq cm689.78115.23
C92059205Injection, Oxaliplatin, per 5 mg8.451.41
C92039203Injection, Perflexane lipid microspheres, per single use vial127.5021.30
J33159122Injection, Triptorelin pamoate, per 3.75 mg356.6659.58
J34869204Injection, Ziprasidone mesylate, per 10 mg18.603.11
C92119211Injection, IV, Alefacept, per 7.5 mg595.0099.40
C92129212Injection, IM, Alefacept, per 7.5 mg422.8870.65

Table 3b.—Pass-Through Drugs Paid at 95% of AWP

HCPCSAPCLong descriptionAmountAmount
C92079207Injection, IV, Bortezomib, per 3.5 mg1,039.68155.40
C92089208Injection, IV, Agalsidase beta, per 1 mg123.7818.50
C92099209Injection, IV, Laronidase, per 2.9 mg644.1096.28
C92109210Injection, IV, Palonosetron HCI, per 0.25 mg (250 micrograms)307.8046.01

Table 3c.—Pass-Through Drugs Paid as Sole Source Drugs at 88% of AWP

HCPCSAPCLong descriptionOPPS CY2004 November 7 rateDIMA final rate
J05839111Injection, Bivalirudin, per 1 mg$1.43$1.61
C91129112Injection, Perflutren lipid microsphere, per 2 ml132.60137.28
C91139113Injection, Pantoprazole sodium, per vial22.4423.23
J13359116Injection, Ertapenem sodium, per 500 mg21.2421.99
J25059119Injection, Pegfilgrastim, per 6 mg single dose vial2,507.502,596.00
C92009200Orcel, per 36 sqare centimeters1,015.751,051.60
C92019201Dermagraft, per 37.5 square centimeters516.80535.04
J23249114Injection, Nesiritide, per 0.5 mg135.66140.45
J34879115Injection, Zoledronic acid, per 1 mg194.52211.07

Payment for New Drugs and Biologicals Before a HCPCS Code Is Assigned

Under new section 1833(t)(15) of the Act, as added by section 621(a)(1) of the DIMA a drug or biological that is furnished as part of covered outpatient department services for which a HCPCS codes has not been established, is to be paid at 95 percent of the AWP for the drug or biological.

We are in the process of determining how hospitals would bill Medicare for a drug prior to assignment of a HCPCS code. We will issue instructions once we have determined how to make this requirement operational.

Payment for Orphan Drugs as Designated by the Secretary

Section 1833(t)(14)(C) as added by section 621(a)(1) of the DIMA, provides that the amount of payment for orphan drugs designated by the Secretary shall, for 2004 and 2005, equal the amount the Secretary shall specify. We have determined that single indication orphan drugs as designated by the Secretary will be paid at the rates published in the November 7, 2003 Federal Register (68 FR 63398). Neither the definition nor the 2004 payment amounts for single indication orphan drugs under the OPPS have changed from what was published in the November 7 final rule.

Brachytherapy

Section 621(b)(1) of the DIMA of 2003 amends the Act by adding section 1833(t)(16)(C) and section 1833(t)(2)(H) which establish separate payment for devices of brachytherapy consisting of a seed or seeds (or radioactive source) based on a hospital's charges for the service, adjusted to cost. Further, charges for the brachytherapy devices shall not be used in determining any outlier payments and consistent with our practice under OPPS to exclude items paid at cost from budget neutrality consideration, these items will be excluded from budget neutrality as well. The period of payment under this provision is for brachytherapy sources furnished from January 1, 2004 through December 31, 2006.

We will pay for the brachytherapy sources listed in Table 4 on a cost basis, as required by the statute. The status indicator for brachytherapy sources is changed to “H.” The definition of status indicator “H” is currently for 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 Start Printed Page 828without 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

HCPCSDescriptorAPCAPC titleNew status indicator
C1716Brachytx source, Gold 1981716Brachytx source, Gold 198H
C1717Brachytx source, HDR Ir-1921717Brachytx source, HDR Ir-192H
C1718Brachytx source, Iodine 1251718Brachytx source, Iodine 125H
C1719Brachytx sour, Non-HDR Ir-1921719Brachytx source, Non-HDR Ir-192H
C1720Brachytx source, Paladium 1031720Brachytx source, Paladium 103H
C2616Brachytx source, Yttrium-902616Brachytx source, Yttrium-90H
C2632Brachytx solution, I-125, per mCi2632Brachytx sol, I-125, per mCiH
C2633Brachytx source, Cesium-1312633Brachytx source, Cesium-131H
C2632Brachytx sol, I-125, per mCi2632Brachytx sol, I-125, per mCiH

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 Start Printed Page 829DIMA) 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. Start Printed 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. Start Printed 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/​.

Start List of Subjects

List of Subjects in 42 CFR Part 419

End List of Subjects Start Amendment Part

For the reasons set forth in the preamble, the Centers for Medicare & Medicaid Services amends 42 CFR chapter IV as set forth below:

End Amendment Part Start Part

PART 419—PROSPECTIVE PAYMENT SYSTEM FOR HOSPITAL OUTPATIENT DEPARTMENT SERVICES

End Part Start Amendment Part

1. The authority citation for part 419 continues to read as follows:

End Amendment Part Start Authority

Authority: Secs. 1102, 1833(t), and 1871 of the Social Security Act (42 U.S.C. 1302, 1395l(t), and 1395hh).

End Authority Start Printed Page 832

Subpart C—Basic Methodology for Determining Prospective Payment Rates for Hospital Outpatient Services

Start Amendment Part

2. Section 419.32 is amended by revising paragraph (d) to read as follows:

End Amendment Part
Calculation of prospective payment rates for hospital outpatient services.
* * * * *

(d) Budget neutrality. (1) CMS adjusts the conversion factor as needed to ensure that updates and adjustments under § 419.50(a) are budget neutral.

(2) In determining adjustments for 2004 and 2005, CMS will not take into account any additional expenditures per section 1833(t)(14) of the Act that would not have been made but for enactment of section 621 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003.

Subpart D—Payments to Hospitals

Start Amendment Part

3. Section § 419.43 is amended as follows:

End Amendment Part Start Amendment Part

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

End Amendment Part Start Amendment Part

B. Paragraph (e) is revised.

End Amendment Part Start Amendment Part

C. New paragraph (f) is added.

End Amendment Part

The revisions and additions read as follows:

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

Start Amendment Part

4. Section 419.64 is amended by revising paragraph (d).

End Amendment Part
Transitional pass-through payments: Drugs and biologicals.
* * * * *

(d) Amount of pass-through payment. (1) Subject to any reduction determined under § 419.62(b), the pass-through payment for a drug or biological as specified in section 1842(o)(1)(A) and (o)(1)(D)(i) of the Act is 95 percent of the average wholesale price of the drug or biological minus the portion of the APC payment CMS determines is associated with the drug or biological.

(2) Subject to any reduction determined under § 419.62(b), the 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

Start Amendment Part

5. Section 419.70 is amended as follows:

End Amendment Part Start Amendment Part

A. Paragraph (d)(1) is amended by removing “2004” and adding “2006” in its place.

End Amendment Part Start Amendment Part

B. A new paragraph (d)(3) is added to read as follows:

End Amendment Part
Transitional adjustment to limit decline and payment.
* * * * *

(d) * * *

(3) Temporary treatment for sole community hospitals located in rural areas. For covered hospital outpatient services furnished during cost reporting periods beginning on or after January 1, 2004, and continuing through December 31, 2005, for which the prospective payment system amount is less than the pre-BBA amount, the amount of payment under this part is increased by the amount of that difference if the hospital—

(i) Is a sole community hospital, under § 412.92 of this chapter; and

(ii) Is located in a rural area as defined in § 412.63(b) of this chapter or is treated as being located in a rural area under section 1886(d)(8)(E) of the Act.

Start Signature

(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.

End Signature Start Signature
Approved: December 23, 2003.

Tommy G. Thompson,

Secretary.

End Signature

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

APCGroup titleStatus indicatorRelative weightPayment rateNational unadjusted copaymentMinimum unadjusted copayment
0001Level I PhotochemotherapyS0.4237$23.12$7.09$4.62
0002Level I Fine Needle Biopsy/AspirationT0.8083$44.10$8.82
0003Bone Marrow Biopsy/AspirationT2.3229$126.74$25.35
0004Level I Needle Biopsy/ Aspiration Except Bone MarrowT1.5882$86.65$22.36$17.33
0005Level II Needle Biopsy/Aspiration Except Bone MarrowT3.2698$178.40$71.59$35.68
0006Level I Incision & DrainageT1.6527$90.17$23.26$18.03
0007Level II Incision & DrainageT11.8633$647.27$129.45
0008Level III Incision and DrainageT19.4831$1,063.02$212.60
0009Nail ProceduresT0.6652$36.29$8.34$7.26
0010Level I Destruction of LesionT0.6480$35.36$10.08$7.07
0011Level II Destruction of LesionT2.2217$121.22$27.88$24.24
0012Level I Debridement & DestructionT0.7612$41.53$11.18$8.31
0013Level II Debridement & DestructionT1.1302$61.66$14.20$12.33
0015Level III Debridement & DestructionT1.5968$87.12$20.35$17.42
0016Level IV Debridement & DestructionT2.5724$140.35$57.31$28.07
0017Level VI Debridement & DestructionT16.3697$893.15$227.84$178.63
0018Biopsy of Skin/Puncture of LesionT0.9178$50.08$16.04$10.02
Start Printed Page 833
0019Level I Excision/ BiopsyT3.9493$215.48$71.87$43.10
0020Level II Excision/ BiopsyT7.0842$386.52$113.25$77.30
0021Level III Excision/ BiopsyT14.3594$783.46$219.48$156.69
0022Level IV Excision/ BiopsyT18.7932$1,025.38$354.45$205.08
0023Exploration Penetrating WoundT2.8141$153.54$40.37$30.71
0024Level I Skin RepairT1.6850$91.94$33.10$18.39
0025Level II Skin RepairT5.1912$283.24$107.00$56.65
0027Level IV Skin RepairT15.8990$867.47$329.72$173.49
0028Level I Breast SurgeryT17.6584$963.46$303.74$192.69
0029Level II Breast SurgeryT30.1167$1,643.20$632.64$328.64
0030Level III Breast SurgeryT37.3083$2,035.58$763.55$407.12
0032Insertion of Central Venous/Arterial CatheterT11.4907$626.94$125.39
0033Partial HospitalizationP5.2569$286.82$57.36
0035Placement of Arterial or Central Venous CatheterT0.1691$9.23$2.79$1.85
0036Level II Fine Needle Biopsy/AspirationT1.5170$82.77$16.55
0037Level III Needle Biopsy/Aspiration Except Bone MarrowT9.8921$539.72$237.45$107.94
0039Implantation of NeurostimulatorS235.1866$12,832.02$2,566.40
0040Level II Implantation of Neurostimulator ElectrodesS52.1002$2,842.64$568.53
0041Level I ArthroscopyT27.3819$1,493.98$298.80
0042Level II ArthroscopyT43.0808$2,350.53$804.74$470.11
0043Closed Treatment Fracture Finger/Toe/TrunkT1.9074$104.07$20.81
0045Bone/Joint Manipulation Under AnesthesiaT13.5889$741.42$268.47$148.28
0046Open/Percutaneous Treatment Fracture or DislocationT32.5581$1,776.40$535.76$355.28
0047Arthroplasty without ProsthesisT29.9582$1,634.55$537.03$326.91
0048Arthroplasty with ProsthesisT51.4609$2,807.76$695.60$561.55
0049Level I Musculoskeletal Procedures Except Hand and FootT19.6046$1,069.65$213.93
0050Level II Musculoskeletal Procedures Except Hand and FootT24.8651$1,356.66$271.33
0051Level III Musculoskeletal Procedures Except Hand and FootT34.5144$1,883.14$376.63
0052Level IV Musculoskeletal Procedures Except Hand and FootT42.7126$2,330.44$466.09
0053Level I Hand Musculoskeletal ProceduresT14.8831$812.04$253.49$162.41
0054Level II Hand Musculoskeletal ProceduresT24.2456$1,322.86$264.57
0055Level I Foot Musculoskeletal ProceduresT18.7205$1,021.41$355.34$204.28
0056Level II Foot Musculoskeletal ProceduresT25.3930$1,385.47$405.81$277.09
0057Bunion ProceduresT25.5035$1,391.50$475.91$278.30
0058Level I Strapping and Cast ApplicationS1.0931$59.64$11.93
0060Manipulation TherapyS0.2788$15.21$3.04
0068CPAP InitiationS1.0807$58.96$29.48$11.79
0069ThoracoscopyT28.9392$1,578.95$591.64$315.79
0070Thoracentesis/Lavage ProceduresT3.0717$167.60$33.52
0071Level I Endoscopy Upper AirwayT0.8799$48.01$12.89$9.60
0072Level II Endoscopy Upper AirwayT1.7613$96.10$26.68$19.22
0073Level III Endoscopy Upper AirwayT3.4541$188.46$73.38$37.69
0074Level IV Endoscopy Upper AirwayT13.9480$761.02$295.70$152.20
0075Level V Endoscopy Upper AirwayT20.3815$1,112.04$445.92$222.41
0076Level I Endoscopy Lower AirwayT9.2346$503.85$189.82$100.77
0077Level I Pulmonary TreatmentS0.2837$15.48$7.74$3.10
0078Level II Pulmonary TreatmentS0.7917$43.20$14.55$8.64
0079Ventilation Initiation and ManagementS2.1494$117.27$23.45
0080Diagnostic Cardiac CatheterizationT36.0160$1,965.07$838.92$393.01
0081Non-Coronary Angioplasty or AtherectomyT35.0285$1,911.19$382.24
0082Coronary AtherectomyT110.2196$6,013.69$1,293.59$1,202.74
0083Coronary Angioplasty and Percutaneous ValvuloplastyT59.2047$3,230.27$646.05
0084Level I Electrophysiologic EvaluationS10.5226$574.12$114.82
0085Level II Electrophysiologic EvaluationT35.4126$1,932.15$426.25$386.43
0086Ablate Heart Dysrhythm FocusT44.9389$2,451.91$833.33$490.38
0087Cardiac Electrophysiologic Recording/MappingT39.8161$2,172.41$434.48
0088ThrombectomyT34.6942$1,892.95$655.22$378.59
0089Insertion/Replacement of Permanent Pacemaker and ElectrodesT117.1896$6,393.98$1,722.59$1,278.80
0090Insertion/Replacement of Pacemaker Pulse GeneratorT96.8284$5,283.05$1,651.45$1,056.61
0091Level II Vascular LigationT28.8326$1,573.14$348.23$314.63
0092Level I Vascular LigationT25.0959$1,369.26$505.37$273.85
0093Vascular Reconstruction/Fistula Repair without DeviceT21.3104$1,162.72$277.34$232.54
0094Level I Resuscitation and CardioversionS2.6345$143.74$48.58$28.75
0095Cardiac RehabilitationS0.5994$32.70$16.35$6.54
Start Printed Page 834
0096Non-Invasive Vascular StudiesS1.7176$93.71$46.85$18.74
0097Cardiac and Ambulatory Blood Pressure MonitoringX1.0635$58.03$23.80$11.61
0098Injection of Sclerosing SolutionT1.0729$58.54$14.06$11.71
0099ElectrocardiogramsS0.3703$20.20$4.04
0100Cardiac Stress TestsX1.5862$86.54$41.44$17.31
0101Tilt Table EvaluationS4.4040$240.29$105.27$48.06
0103Miscellaneous Vascular ProceduresT11.6202$634.01$223.63$126.80
0104Transcatheter Placement of Intracoronary StentsT82.6713$4,510.63$902.13
0105Revision/Removal of Pacemakers, AICD, or VascularT19.1898$1,047.01$370.40$209.40
0106Insertion/Replacement/Repair of Pacemaker and/or ElectrodesT58.9719$3,217.57$643.51
0107Insertion of Cardioverter-DefibrillatorT337.1304$18,394.17$3,699.14$3,678.83
0108Insertion/Replacement/Repair of Cardioverter-Defibrillator LeadsT452.6995$24,699.74$4,939.95
0109Removal of Implanted DevicesT7.4705$407.60$131.49$81.52
0110TransfusionS3.6718$200.34$40.07
0111Blood Product ExchangeS13.1719$718.67$200.18$143.73
0112Apheresis, Photopheresis, and PlasmapheresisS37.5832$2,050.58$612.47$410.12
0113Excision Lymphatic SystemT19.9322$1,087.52$217.50
0114Thyroid/Lymphadenectomy ProceduresT37.5963$2,051.29$485.91$410.26
0115Cannula/Access Device ProceduresT25.6437$1,399.15$459.35$279.83
0116Chemotherapy Administration by Other Technique Except InfusionS0.7996$43.63$8.73
0117Chemotherapy Administration by Infusion OnlyS3.0360$165.65$42.54$33.13
0119Implantation of Infusion PumpT134.7194$7,350.43$1,470.09
0120Infusion Therapy Except ChemotherapyT1.9114$104.29$28.21$20.86
0121Level I Tube changes and RepositioningT2.1114$115.20$43.80$23.04
0122Level II Tube changes and RepositioningT8.8621$483.53$99.16$96.71
0123Bone Marrow Harvesting and Bone Marrow/Stem Cell TransplantS6.1499$335.54$67.11
0124Revision of Implanted Infusion PumpT23.8050$1,298.82$259.76
0125Refilling of Infusion PumpT2.1606$117.88$23.58
0130Level I LaparoscopyT32.7724$1,788.09$659.53$357.62
0131Level II LaparoscopyT40.8064$2,226.44$1,001.89$445.29
0132Level III LaparoscopyT57.2045$3,121.13$1,239.22$624.23
0140Esophageal Dilation without EndoscopyT6.4525$352.05$107.24$70.41
0141Upper GI ProceduresT7.8206$426.70$143.38$85.34
0142Small Intestine EndoscopyT8.7959$479.91$152.78$95.98
0143Lower GI EndoscopyT8.2957$452.62$186.06$90.52
0146Level I SigmoidoscopyT3.9826$217.29$64.40$43.46
0147Level II SigmoidoscopyT7.6808$419.07$83.81
0148Level I Anal/Rectal ProcedureT3.8320$209.08$63.38$41.82
0149Level III Anal/Rectal ProcedureT17.1425$935.31$293.06$187.06
0150Level IV Anal/Rectal ProcedureT22.1919$1,210.81$437.12$242.16
0151Endoscopic Retrograde Cholangio-Pancreatography (ERCP)T17.9462$979.16$245.46$195.83
0152Percutaneous Abdominal and Biliary ProceduresT9.1474$499.09$125.28$99.82
0153Peritoneal and Abdominal ProceduresT20.8723$1,138.81$410.87$227.76
0154Hernia/Hydrocele ProceduresT26.9636$1,471.16$464.85$294.23
0155Level II Anal/Rectal ProcedureT10.0809$550.02$188.89$110.00
0156Level II Urinary and Anal ProceduresT2.4747$135.02$40.52$27.00
0157Colorectal Cancer Screening: Barium EnemaS2.5693$140.18$28.04
0158Colorectal Cancer Screening: ColonoscopyT7.4244$405.08$101.27
0159Colorectal Cancer Screening: Flexible SigmoidoscopyS2.7823$151.81$37.95
0160Level I Cystourethroscopy and other Genitourinary ProceduresT6.8801$375.39$105.06$75.08
0161Level II Cystourethroscopy and other Genitourinary ProceduresT16.8407$918.85$249.36$183.77
0162Level III Cystourethroscopy and other Genitourinary ProceduresT21.9098$1,195.42$239.08
0163Level IV Cystourethroscopy and other Genitourinary ProceduresT33.8805$1,848.55$369.71
0164Level I Urinary and Anal ProceduresT1.2021$65.59$17.59$13.12
0165Level III Urinary and Anal ProceduresT14.6838$801.16$160.23
0166Level I Urethral ProceduresT16.7918$916.18$218.73$183.24
0167Level III Urethral ProceduresT30.0186$1,637.84$555.84$327.57
0168Level II Urethral ProceduresT30.0147$1,637.63$405.60$327.53
0169LithotripsyT45.1150$2,461.52$1,115.69$492.30
0170DialysisS5.9678$325.61$65.12
Start Printed Page 835
0180CircumcisionT18.6176$1,015.79$304.87$203.16
0181Penile ProceduresT29.4217$1,605.28$621.82$321.06
0183Testes/Epididymis ProceduresT21.6724$1,182.47$236.49
0184Prostate BiopsyT3.8995$212.76$96.27$42.55
0187Miscellaneous Placement/RepositioningX4.4288$241.64$90.71$48.33
0188Level II Female Reproductive ProcT1.1365$62.01$12.40
0189Level III Female Reproductive ProcT1.4232$77.65$18.09$15.53
0190Level I HysteroscopyT19.6922$1,074.43$424.28$214.89
0191Level I Female Reproductive ProcT0.1853$10.11$2.93$2.02
0192Level IV Female Reproductive ProcT2.7121$147.97$39.11$29.59
0193Level V Female Reproductive ProcT15.0453$820.89$171.13$164.18
0194Level VIII Female Reproductive ProcT18.4286$1,005.48$397.84$201.10
0195Level IX Female Reproductive ProcT25.6950$1,401.94$483.80$280.39
0196Dilation and CurettageT16.1219$879.63$338.23$175.93
0197Infertility ProceduresT4.8280$263.42$52.68
0198Pregnancy and Neonatal Care ProceduresT1.3578$74.08$32.19$14.82
0199Obstetrical Care ServiceT17.2831$942.98$188.60
0200Level VII Female Reproductive ProcT17.9920$981.66$307.83$196.33
0201Level VI Female Reproductive ProcT16.8660$920.23$329.65$184.05
0202Level X Female Reproductive ProcT38.9821$2,126.90$1,042.18$425.38
0203Level IV Nerve InjectionsT11.5969$632.74$276.76$126.55
0204Level I Nerve InjectionsT2.1711$118.46$40.13$23.69
0206Level II Nerve InjectionsT5.2875$288.49$75.55$57.70
0207Level III Nerve InjectionsT6.4554$352.21$123.69$70.44
0208Laminotomies and LaminectomiesT40.2830$2,197.88$439.58
0209Extended EEG Studies and Sleep Studies, Level IIS11.5435$629.82$280.58$125.96
0212Nervous System InjectionsT2.9739$162.26$74.67$32.45
0213Extended EEG Studies and Sleep Studies, Level IS2.9055$158.53$65.74$31.71
0214ElectroencephalogramS2.2176$120.99$58.12$24.20
0215Level I Nerve and Muscle TestsS0.6457$35.23$15.76$7.05
0216Level III Nerve and Muscle TestsS2.8535$155.69$67.98$31.14
0218Level II Nerve and Muscle TestsS1.1404$62.22$12.44
0220Level I Nerve ProceduresT16.5554$903.28$180.66
0221Level II Nerve ProceduresT24.8875$1,357.89$463.62$271.58
0222Implantation of Neurological DeviceT232.2024$12,669.20$2,533.84
0223Implantation or Revision of Pain Management CatheterT26.7610$1,460.11$292.02
0224Implantation of Reservoir/Pump/ShuntT34.1770$1,864.73$453.41$372.95
0225Level I Implementation of Neurostimulator ElectrodesS206.0034$11,239.75$2,247.95
0226Implantation of Drug Infusion ReservoirT136.2989$7,436.60$1,487.32
0227Implantation of Drug Infusion DeviceT160.8363$8,775.39$1,755.08
0228Creation of Lumbar Subarachnoid ShuntT52.2880$2,852.89$639.03$570.58
0229Transcatherter Placement of Intravascular ShuntT61.9895$3,382.21$771.23$676.44
0230Level I Eye Tests & TreatmentsS0.7619$41.57$14.97$8.31
0231Level III Eye Tests & TreatmentsS2.1883$119.40$50.94$23.88
0232Level I Anterior Segment Eye ProceduresT4.9206$268.47$103.17$53.69
0233Level II Anterior Segment Eye ProceduresT14.4205$786.80$266.33$157.36
0234Level III Anterior Segment Eye ProceduresT21.4631$1,171.05$511.31$234.21
0235Level I Posterior Segment Eye ProceduresT5.0749$276.89$72.04$55.38
0236Level II Posterior Segment Eye ProceduresT18.6701$1,018.66$203.73
0237Level III Posterior Segment Eye ProceduresT34.1784$1,864.81$818.54$372.96
0238Level I Repair and Plastic Eye ProceduresT3.1954$174.34$58.96$34.87
0239Level II Repair and Plastic Eye ProceduresT6.1331$334.63$66.93
0240Level III Repair and Plastic Eye ProceduresT17.4535$952.28$315.31$190.46
0241Level IV Repair and Plastic Eye ProceduresT22.1969$1,211.09$384.47$242.22
0242Level V Repair and Plastic Eye ProceduresT29.4294$1,605.70$597.36$321.14
0243Strabismus/Muscle ProceduresT21.7323$1,185.74$431.39$237.15
0244Corneal TransplantT37.6284$2,053.04$803.26$410.61
0245Level I Cataract Procedures without IOL InsertT12.2973$670.95$222.22$134.19
0246Cataract Procedures with IOL InsertT22.9755$1,253.57$495.96$250.71
0247Laser Eye Procedures Except RetinalT4.9482$269.98$104.31$54.00
0248Laser Retinal ProceduresT4.8223$263.11$95.08$52.62
0249Level II Cataract Procedures without IOL InsertT27.7406$1,513.55$524.67$302.71
0250Nasal Cauterization/PackingT1.4697$80.19$28.07$16.04
0251Level I ENT ProceduresT1.7880$97.56$19.51
0252Level II ENT ProceduresT6.4469$351.75$113.41$70.35
0253Level III ENT ProceduresT15.2249$830.69$282.29$166.14
0254Level IV ENT ProceduresT21.8901$1,194.35$321.35$238.87
0256Level V ENT ProceduresT35.1548$1,918.08$383.62
0258Tonsil and Adenoid ProceduresT20.6265$1,125.40$437.25$225.08
Start Printed Page 836
0259Level VI ENT ProceduresT392.8622$21,434.95$9,394.83$4,286.99
0260Level I Plain Film Except TeethX0.7802$42.57$21.28$8.51
0261Level II Plain Film Except Teeth Including Bone Density MeasurementX1.3176$71.89$14.38
0262Plain Film of TeethX0.7540$41.14$9.82$8.23
0263Level I Miscellaneous Radiology ProceduresX2.1883$119.40$43.58$23.88
0264Level II Miscellaneous Radiology ProceduresX3.0287$165.25$79.41$33.05
0265Level I Diagnostic Ultrasound Except VascularS1.0289$56.14$28.07$11.23
0266Level II Diagnostic Ultrasound Except VascularS1.6117$87.94$43.97$17.59
0267Level III Diagnostic Ultrasound Except VascularS2.4586$134.14$65.52$26.83
0268Ultrasound Guidance ProceduresS1.3081$71.37$14.27
0269Level III Echocardiogram Except TransesophagealS3.2309$176.28$87.24$35.26
0270Transesophageal EchocardiogramS5.8546$319.43$146.79$63.89
0271MammographyS0.6499$35.46$16.80$7.09
0272Level I FluoroscopyX1.4184$77.39$38.36$15.48
0274MyelographyS3.5931$196.04$93.63$39.21
0275ArthrographyS3.2775$178.82$69.09$35.76
0276Level I Digestive RadiologyS1.5906$86.78$41.72$17.36
0277Level II Digestive RadiologyS2.4444$133.37$60.47$26.67
0278Diagnostic UrographyS2.7012$147.38$66.07$29.48
0279Level II Angiography and Venography except ExtremityS10.7073$584.20$174.57$116.84
0280Level III Angiography and Venography except ExtremityS19.1015$1,042.20$353.85$208.44
0281Venography of ExtremityS6.6031$360.27$115.16$72.05
0282Miscellaneous Computerized Axial TomographyS1.6834$91.85$44.51$18.37
0283Computerized Axial Tomography with Contrast MaterialS4.6543$253.94$126.27$50.79
0284Magnetic Resonance Imaging and Magnetic Resonance Angiography with ContrasS7.1165$388.28$194.13$77.66
0285Myocardial Positron Emission Tomography (PET)S14.1508$772.08$334.45$154.42
0287Complex VenographyS6.4923$354.23$111.33$70.85
0288Bone Density:Axial SkeletonS1.2726$69.43$13.89
0289Needle Localization for Breast BiopsyX3.4900$190.42$44.80$38.08
0296Level I Therapeutic Radiologic ProceduresS2.8635$156.24$69.20$31.25
0297Level II Therapeutic Radiologic ProceduresS7.7145$420.91$172.51$84.18
0299Miscellaneous Radiation TreatmentS5.7618$314.37$62.87
0300Level I Radiation TherapyS1.4912$81.36$16.27
0301Level II Radiation TherapyS2.1340$116.43$23.29
0302Level III Radiation TherapyS6.3268$345.20$130.77$69.04
0303Treatment Device ConstructionX2.8835$157.33$66.95$31.47
0304Level I Therapeutic Radiation Treatment PreparationX1.6742$91.35$41.52$18.27
0305Level II Therapeutic Radiation Treatment PreparationX3.6767$200.60$91.38$40.12
0310Level III Therapeutic Radiation Treatment PreparationX13.7165$748.39$325.27$149.68
0312Radioelement ApplicationsS3.6637$199.90$39.98
0313BrachytherapyS13.8073$753.34$150.67
0314Hyperthermic TherapiesS4.6041$251.20$101.77$50.24
0320Electroconvulsive TherapyS5.3785$293.46$80.06$58.69
0321Biofeedback and Other TrainingS1.4817$80.84$21.78$16.17
0322Brief Individual PsychotherapyS1.2802$69.85$13.97
0323Extended Individual PsychotherapyS1.8689$101.97$21.26$20.39
0324Family PsychotherapyS2.4473$133.53$26.71
0325Group PsychotherapyS1.4865$81.10$18.27$16.22
0330Dental ProceduresS0.5745$31.35$6.27
0332Computerized Axial Tomography and Computerized Angiography without ContrasS3.3936$185.16$91.27$37.03
0333Computerized Axial Tomography and Computerized Angio w/o Contrast MaterialS5.4241$295.94$146.98$59.19
0335Magnetic Resonance Imaging, MiscellaneousS6.3499$346.46$151.46$69.29
0336Magnetic Resonance Imaging and Magnetic Resonance Angiography without ContS6.3897$348.63$174.31$69.73
0337MRI and Magnetic Resonance Angiography without Contrast Material followedS9.2075$502.37$240.77$100.47
0339ObservationS6.6961$365.35$73.07
0340Minor Ancillary ProceduresX0.6314$34.45$6.89
0341Skin TestsX0.1365$7.45$3.03$1.49
0342Level I PathologyX0.2162$11.80$5.88$2.36
0343Level II PathologyX0.4617$25.19$12.55$5.04
0344Level III PathologyX0.6291$34.32$17.16$6.86
0345Level I Transfusion Laboratory ProceduresX0.2550$13.91$3.10$2.78
0346Level II Transfusion Laboratory ProceduresX0.3866$21.09$5.32$4.22
0347Level III Transfusion Laboratory ProceduresX0.9610$52.43$13.20$10.49
Start Printed Page 837
0348Fertility Laboratory ProceduresX0.8194$44.71$8.94
0352Level I InjectionsX0.1230$6.71$1.34
0353Level II Allergy InjectionsX0.3982$21.73$4.35
0355Level III ImmunizationsK0.2749$15.00$3.00
0356Level IV ImmunizationsK0.7698$42.00$8.40
0359Level II InjectionsX0.8000$43.65$8.73
0360Level I Alimentary TestsX1.7313$94.46$42.45$18.89
0361Level II Alimentary TestsX3.5510$193.75$83.23$38.75
0362Level III Otorhinolaryngologic Function TestsX2.6984$147.23$29.45
0363Level I Otorhinolaryngologic Function TestsX0.8641$47.15$17.44$9.43
0364Level I AudiometryX0.4459$24.33$9.06$4.87
0365Level II AudiometryX1.2132$66.19$18.95$13.24
0367Level I Pulmonary TestX0.5887$32.12$15.16$6.42
0368Level II Pulmonary TestsX0.9319$50.85$25.42$10.17
0369Level III Pulmonary TestsX2.4984$136.32$44.18$27.26
0370Allergy TestsX0.9185$50.11$11.58$10.02
0371Level I Allergy InjectionsX0.4105$22.40$4.48
0372Therapeutic PhlebotomyX0.5607$30.59$10.09$6.12
0373Neuropsychological TestingX2.3288$127.06$25.41
0374Monitoring Psychiatric DrugsX1.1252$61.39$12.28
0375Ancillary Outpatient Services When Patient ExpiresT$1,150.00$230.00
0376Level II Cardiac ImagingS4.4510$242.85$121.42$48.57
0377Level III Cardiac ImagingS6.8830$375.54$187.76$75.11
0378Level II Pulmonary ImagingS5.4852$299.28$149.63$59.86
0379Injection adenosine 6 MgK0.2078$11.34$2.27
0380Dipyridamole injectionK0.2525$13.78$2.76
0384GI Procedures with StentsT36.5400$1,993.66$433.01$398.73
0385Level I Prosthetic Urological ProceduresS67.1530$3,663.93$732.79
0386Level II Prosthetic Urological ProceduresS116.2382$6,342.07$1,268.41
0387Level II HysteroscopyT28.1480$1,535.78$655.55$307.16
0388DiscographyS11.6347$634.80$303.19$126.96
0389Non-imaging Nuclear MedicineS1.6328$89.09$44.54$17.82
0390Level I Endocrine ImagingS2.7907$152.26$76.13$30.45
0391Level II Endocrine ImagingS3.1956$174.36$87.18$34.87
0393Red Cell/Plasma StudiesS4.4354$242.00$121.00$48.40
0394Hepatobiliary ImagingS4.3714$238.51$119.25$47.70
0395GI Tract ImagingS3.9536$215.71$107.85$43.14
0396Bone ImagingS4.1883$228.52$114.26$45.70
0397Vascular ImagingS2.2183$121.03$60.51$24.21
0398Level I Cardiac ImagingS4.5091$246.02$123.01$49.20
0399Nuclear Medicine Add-on ImagingS1.5273$83.33$41.66$16.67
0400Hematopoietic ImagingS3.8242$208.65$104.32$41.73
0401Level I Pulmonary ImagingS3.3736$184.07$92.03$36.81
0402Brain ImagingS5.4063$294.97$147.48$58.99
0403CSF ImagingS3.8402$209.53$104.76$41.91
0404Renal and Genitourinary Studies Level IS3.7303$203.53$101.76$40.71
0405Renal and Genitourinary Studies Level IIS4.3432$236.97$118.48$47.39
0406Tumor/Infection ImagingS4.3955$239.82$119.91$47.96
0407Radionuclide TherapyS3.5841$195.55$97.77$39.11
0409Red Blood Cell TestsX0.1390$7.58$2.32$1.52
0410Mammogram Add OnS0.1523$8.31$1.66
0411Respiratory ProceduresS0.4367$23.83$4.77
0412IMRT Treatment DeliveryS5.3904$294.11$58.82
0415Level II Endoscopy Lower AirwayT20.7348$1,131.31$459.92$226.26
0600Low Level Clinic VisitsV0.9278$50.62$10.12
0601Mid Level Clinic VisitsV0.9816$53.56$10.71
0602High Level Clinic VisitsV1.5041$82.07$16.41
0610Low Level Emergency VisitsV1.3691$74.70$19.57$14.94
0611Mid Level Emergency VisitsV2.3967$130.77$36.16$26.15
0612High Level Emergency VisitsV4.1476$226.30$54.12$45.26
0620Critical CareS8.9992$491.01$142.30$98.20
0648Breast Reconstruction with ProsthesisT54.0165$2,947.19$589.44
0651Complex Interstitial Radiation Source ApplicationS10.2314$558.24$111.65
0652Insertion of Intraperitoneal CathetersT27.0364$1,475.13$295.03
0653Vascular Reconstruction/Fistula Repair with DeviceT30.0334$1,638.65$327.73
0654Insertion/Replacement of a permanent dual chamber pacemakerT112.6957$6,148.79$1,229.76
0655Insertion/Replacement/Conversion of a permanent dual chamber pacemakerT142.7039$7,786.07$1,557.21
Start Printed Page 838
0656Transcatheter Placement of Intracoronary Drug-Eluting StentsT103.4907$5,646.56$1,129.31
0657Placement of Tissue ClipsS1.5102$82.40$16.48
0658Percutaneous Breast BiopsiesT5.5779$304.34$60.87
0659Hyperbaric OxygenS3.0228$164.93$32.99
660Level II Otorhinolaryngologic Function TestsX1.7353$94.68$30.66$18.94
0661Level IV PathologyX3.2576$177.74$88.87$35.55
0662CT AngiographyS5.8775$320.68$156.47$64.14
0664Proton Beam Radiation TherapyS9.7295$530.85$106.17
0665Bone Density: Appendicular SkeletonS0.7257$39.59$7.92
0668Level I Angiography and Venography except ExtremityS10.2660$560.12$237.76$112.02
0669Digital MammographyS0.9009$49.15$9.83
0670Intravenous and Intracardiac UltrasoundS27.4483$1,497.61$542.37$299.52
0671Level II Echocardiogram Except TransesophagealS1.6384$89.39$44.69$17.88
0672Level IV Posterior Segment ProceduresT38.9476$2,125.02$988.43$425.00
0673Level IV Anterior Segment Eye ProceduresT26.8390$1,464.36$649.56$292.87
0674Prostate CryoablationT119.9733$6,545.86$1,309.17
0675Prostatic ThermotherapyT49.3452$2,692.32$538.46
0676Level II Transcatheter ThrombolysisT2.7315$149.03$40.30$29.81
0677Level I Transcatheter ThrombolysisT2.1805$118.97$23.79
0678External CounterpulsationT2.0659$112.72$22.54
0679Level II Resuscitation and CardioversionS5.4887$299.47$95.30$59.89
0680Insertion of Patient Activated Event RecordersS62.8252$3,427.81$685.56
0681Knee ArthroplastyT98.1613$5,355.78$2,131.36$1,071.16
0682Level V Debridement & DestructionT8.0790$440.80$174.57$88.16
0683Level II PhotochemotherapyS1.5489$84.51$30.42$16.90
0685Level III Needle Biopsy/Aspiration Except Bone MarrowT4.8100$262.44$115.47$52.49
0686Level III Skin RepairT7.9247$432.38$198.89$86.48
0687Revision/Removal of Neurostimulator ElectrodesT20.4416$1,115.31$513.05$223.06
0688Revision/Removal of Neurostimulator Pulse Generator ReceiverT46.7347$2,549.89$1,249.45$509.98
0689Electronic Analysis of Cardioverter-defibrillatorsS0.5533$30.19$6.04
0690Electronic Analysis of Pacemakers and other Cardiac DevicesS0.4074$22.23$10.63$4.45
0691Electronic Analysis of Programmable Shunts/PumpsS2.8066$153.13$76.56$30.63
0692Electronic Analysis of Neurostimulator Pulse GeneratorsS1.1057$60.33$30.16$12.07
0693Level II Breast ReconstructionT39.0111$2,128.48$798.17$425.70
0694Mohs SurgeryT2.9752$162.33$64.93$32.47
0695Level VII Debridement & DestructionT19.1849$1,046.75$266.59$209.35
0697Level I Echocardiogram Except TransesophagealS1.4415$78.65$39.32$15.73
0698Level II Eye Tests & TreatmentsS0.9599$52.37$18.72$10.47
0699Level IV Eye Tests & TreatmentsT2.2303$121.69$47.46$24.34
0700Antepartum ManipulationT2.4306$132.62$37.13$26.52
0701SR 89 chloride, per mCiK$892.43$178.49
0702SM 153 lexidronam, 50 mCiK$493.89$98.78
0704IN 111 Satumomab pendetide per doseK$1,474.00$294.80
0705Technetium TC99M tetrofosminK1.0642$665.28$133.06
0726Dexrazoxane hcl injection, 250 mgK2.0616$112.48$22.50
0728Filgrastim 300 mcg injectionK$172.20$34.44
0730Pamidronate disodium , 30 mgK$128.74$25.75
0731Sargramostim injectionK$26.92$5.38
0732Mesna injection 200 mgK$17.66$3.53
0733Non esrd epoetin alpha inj, 1000 uK$11.76$2.35
0734Injection, darbepoetin alfa (for non-ESRD), per 1 mcgK$3.88$0.78
0763Dolasetron mesylate oralK$152.38$30.48
0764Granisetron HCl injectionK$17.18$3.44
0765Granisetron HCl 1 mg oralK$171.78$34.36
0800Leuprolide acetate, 3.75 mgK$479.20$95.84
0802Etoposide oral 50 mgK$21.91$4.38
0807Aldesleukin/single use vialK$680.35$136.07
0809Bcg live intravesical vacK$77.54$15.51
0810Goserelin acetate implant 3.6 mgK$413.59$82.72
0811Carboplatin injection 50 mgK$137.79$27.56
0813Cisplatin 10 mg injectionK$7.73$1.55
0814Asparaginase injectionK$58.00$11.60
0815Cyclophosphamide 100 MG injK$2.77$0.55
0816Cyclophosphamide lyophilizedK$2.36$0.47
0817Cytarabine hcl 100 MG injK$1.55$0.31
0819Dacarbazine 100 mg injK0.0974$5.31$1.06
Start Printed Page 839
0820Daunorubicin 10 mgK$35.94$7.19
0821Daunorubicin citrate liposom 10 mgK$64.60$12.92
0823Docetaxel, 20 mgK$331.53$66.31
0824Etoposide 10 MG injK$0.83$0.17
0827Floxuridine injection 500 mgK$66.24$13.25
0828Gemcitabine HCL 200 mgK$112.09$22.42
0830Irinotecan injection 20 mgK$135.00$27.00
0831Ifosfomide injection 1 gmK$72.81$14.56
0832Idarubicin hcl injection 5 mgK3.2663$178.21$35.64
0834Interferon alfa-2a injK$32.31$6.46
0836Interferon alfa-2b inj recombinant, 1 millionK$13.78$2.76
0838Interferon gamma 1-b inj, 3 million uK$290.70$58.14
0840Melphalan hydrochl 50 mgK$389.14$77.83
0842Fludarabine phosphate inj 50 mgK$329.83$65.97
0844Pentostatin injection, 10 mgK$1,784.64$356.93
0847Doxorubic hcl 10 MG vl chemoK$4.69$0.94
0849Rituximab, 100 mgK$464.20$92.84
0850Streptozocin injection, 1 gmK$131.05$26.21
0851Thiotepa injectionK$45.31$9.06
0852Topotecan, 4 mgK$739.80$147.96
0855Vinorelbine tartrate, 10 mgK$100.97$20.19
0856Porfimer sodium, 75 mgK$2,411.82$482.36
0857Bleomycin sulfate injection 15 uK$88.32$17.66
0858Cladribine, 1mgK$24.84$4.97
0860Plicamycin (mithramycin) injK$86.89$17.38
0861Leuprolide acetate injection 1 mgK$14.48$2.90
0862Mitomycin 5 mg injK$30.91$6.18
0863Paclitaxel injection, 30 mgK$79.04$15.81
0864Mitoxantrone hcl, 5 mgK$332.87$66.57
0865Interferon alfa-n3 inj, human leukocyte derived, 2K$8.17$1.63
0884Rho d immune globulin inj, 1 dose pkgK$92.93$18.59
0888Cyclosporine oral 100 mgK$2.41$0.48
0890Lymphocyte immune globulin 250 mgK$258.17$51.63
0891Tacrolimus oral per 1 mgK$3.24$0.65
0900Alglucerase injection, per 10 uK$37.13$7.43
0901Alpha 1 proteinase inhibitor, 10 mgK$3.43$0.69
0902Botulinum toxin a, per unitK$4.58$0.92
0903Cytomegalovirus imm IV/vialK$659.60$131.92
0905Immune globulin, 1gK$37.95$7.59
0906RSV-ivig, 50 mgK$16.55$3.31
0907Ganciclovir sodium injectionK0.5918$32.29$6.46
0909Interferon beta-1a, 33 mcgK$123.77$24.75
0910Interferon beta-1b /0.25 mgK$67.22$13.44
0911Streptokinase per 250,000 iuK1.5733$85.84$17.17
0913Ganciclovir long act implantK1.5861$86.54$17.31
0916Imiglucerase injection/unitK$3.71$0.74
0917Adenosine injectionK1.0393$56.71$11.34
0925Factor viii per iuK$0.42$0.08
0926Factor VIII (porcine) per iuK$1.89$0.38
0927Factor viii recombinant per iuK$0.61$0.12
0928Factor ix complex per iuK$0.18$0.04
0929Anti-inhibitor per iuK$0.69$0.14
0931Factor IX non-recombinant, per iuK$0.51$0.10
0932Factor IX recombinant, per iuK$1.04$0.21
0949Plasma, Pooled Multiple Donor, Solvent/DetergentK$124.31$24.86
0950Blood (Whole) For TransfusionK$87.93$17.59
0952CryoprecipitateK$29.31$5.86
0954RBC leukocytes reducedK$119.26$23.85
0955Plasma, Fresh FrozenK$95.00$19.00
0956Plasma Protein FractionK$92.98$18.60
0957Platelet ConcentrateK$41.44$8.29
0958Platelet Rich PlasmaK$53.56$10.71
0959Red Blood CellsK$86.41$17.28
0960Washed Red Blood CellsK$160.69$32.14
0961Infusion, Albumin (Human) 5%, 50 mlK0.2802$15.29$3.06
0963Albumin (human), 5%, 250 mlK1.0901$59.48$11.90
0964Albumin (human), 25%, 20 mlK0.3741$20.41$4.08
0965Albumin (human), 25%, 50mlK0.8869$48.39$9.68
0966Plasmaprotein fract,5%,250mlK$464.90$92.98
Start Printed Page 840
1009Cryoprecip reduced plasmaK$37.39$7.48
1010Blood, L/R, CMV-negK$121.78$24.36
1011Platelets, HLA-m, L/R, unitK$499.77$99.95
1013Platelet concentrate, L/R, unitK$49.52$9.90
1016Blood, L/R, froz/deglycerol/washedK$301.68$60.34
1017Platelets, aph/pher, L/R, CMV-neg, unitK$393.15$78.63
1018Blood, L/R, irradiatedK$132.40$26.48
1019Platelets, aph/pher, L/R, irradiated, unitK$406.28$81.26
1020Pit, pher,L/R,CMV,irradK$495.22$99.04
1021RBC, frz/deg/wsh, L/R, irradK$336.04$67.21
1022RBC, L/R, CMV neg, irradK$201.12$40.22
1045Iobenguane sulfate I-131per 0.5 mCiK3.0392$165.82$33.16
1064I-131 sodium iodide capsuleK0.1004$5.48$1.10
1065I-131 sodium iodide solutionK0.1189$6.49$1.30
1079CO 57/58 per 0.5 uCiK$235.14$47.03
1080I-131 tositumomab, dxK$2,565.55$513.11
1081I-131 tositumomab, txK$22,210.19$4,442.04
1084Denileukin diftitox, 300 MCGK$1,232.88$246.58
1086Temozolomide,oral 5 mgK$6.81$1.36
1089Cyanocobalamin cobalt co57K$47.38$9.48
1091IN 111 Oxyquinoline, per .5 mCiK4.1151$224.52$44.90
1092IN 111 Pentetate, per 0.5 mCiK$237.60$47.52
1095Technetium TC 99M DepreotideK$704.00$140.80
1096TC 99M Exametazime, per doseK$825.00$165.00
1122TC 99M arcitumomab, per vialK$1,144.00$228.80
1166Cytarabine liposomeK$344.08$68.82
1167Epirubicin hcl, 2 mgK$25.60$5.12
1178Busulfan IV, 6 mgK$27.87$5.57
1200TC 99M Sodium GlucoheptonatK$30.28$6.06
1201TC 99M SUCCIMER, PER VialK$125.66$25.13
1203Verteporfin for injectionK$1,350.80$270.16
1207Octreotide injection, depdK$73.62$14.72
1305ApligrafK$1,199.00$239.80
1409Factor viia recombinant, per 1.2 mgK$1,495.30$299.06
1501New Technology - Level I ($0-$50)S$25.00$5.00
1502New Technology - Level II ($50-$100)S$75.00$15.00
1503New Technology - Level III ($100-$200)S$150.00$30.00
1504New Technology - Level IV ($200-$300)S$250.00$50.00
1505New Technology - Level V ($300-$400)S$350.00$70.00
1506New Technology - Level VI ($400-$500)S$450.00$90.00
1507New Technology - Level VII ($500-$600)S$550.00$110.00
1508New Technology - Level VIII ($600-$700)S$650.00$130.00
1509New Technology - Level IX ($700-$800)S$750.00$150.00
1510New Technology - Level X ($800-$900)S$850.00$170.00
1511New Technology - Level XI ($900-$1000)S$950.00$190.00
1512New Technology - Level XII ($1000-$1100)S$1,050.00$210.00
1513New Technology - Level XIII ($1100-$1200)S$1,150.00$230.00
1514New Technology - Level XIV ($1200-$1300)S$1,250.00$250.00
1515New Technology - Level XV ($1300-$1400)S$1,350.00$270.00
1516New Technology - Level XVI ($1400-$1500)S$1,450.00$290.00
1517New Technology - Level XVII ($1500-$1600)S$1,550.00$310.00
1518New Technology - Level XVIII ($1600-$1700)S$1,650.00$330.00
1519New Technology - Level IXX ($1700-$1800)S$1,750.00$350.00
1520New Technology - Level XX ($1800-$1900)S$1,850.00$370.00
1521New Technology - Level XXI ($1900-$2000)S$1,950.00$390.00
1522New Technology - Level XXII ($2000-$2500)S$2,250.00$450.00
1523New Technology - Level XXIII ($2500-$3000)S$2,750.00$550.00
1524New Technology - Level XIV ($3000-$3500)S$3,250.00$650.00
1525New Technology - Level XXV ($3500-$4000)S$3,750.00$750.00
1526New Technology - Level XXVI ($4000-$4500)S$4,250.00$850.00
1527New Technology - Level XXVII ($4500-$5000)S$4,750.00$950.00
1528New Technology - Level XXVIII ($5000-$5500)S$5,250.00$1,050.00
1529New Technology - Level XXIX ($5500-$6000)S$5,750.00$1,150.00
1530New Technology - Level XXX ($6000-$6500)S$6,250.00$1,250.00
1531New Technology - Level XXXI ($6500-$7000)S$6,750.00$1,350.00
1532New Technology - Level XXXII ($7000-$7500)S$7,250.00$1,450.00
1533New Technology - Level XXXIII ($7500-$8000)S$7,750.00$1,550.00
1534New Technology - Level XXXIV ($8000-$8500)S$8,250.00$1,650.00
1535New Technology - Level XXXV ($8500-$9000)S$8,750.00$1,750.00
Start Printed Page 841
1536New Technology - Level XXXVI ($9000-$9500)S$9,250.00$1,850.00
1537New Technology - Level XXXVII ($9500-$10000)S$9,750.00$1,950.00
1538New Technology - Level I ($0-$50)T$25.00$5.00
1539New Technology - Level II ($50-$100)T$75.00$15.00
1540New Technology - Level III ($100-$200)T$150.00$30.00
1541New Technology - Level IV ($200-$300)T$250.00$50.00
1542New Technology - Level V ($300-$400)T$350.00$70.00
1543New Technology - Level VI ($400-$500)T$450.00$90.00
1544New Technology - Level VII ($500-$600)T$550.00$110.00
1545New Technology - Level VIII ($600-$700)T$650.00$130.00
1546New Technology - Level IX ($700-$800)T$750.00$150.00
1547New Technology - Level X ($800-$900)T$850.00$170.00
1548New Technology - Level XI ($900-$1000)T$950.00$190.00
1549New Technology - Level XII ($1000-$1100)T$1,050.00$210.00
1550New Technology - Level XIII ($1100-$1200)T$1,150.00$230.00
1551New Technology - Level XIV ($1200-$1300)T$1,250.00$250.00
1552New Technology - Level XV ($1300-$1400)T$1,350.00$270.00
1553New Technology - Level XVI ($1400-$1500)T$1,450.00$290.00
1554New Technology - Level XVII ($1500-$1600)T$1,550.00$310.00
1555New Technology - Level XVIII ($1600-$1700)T$1,650.00$330.00
1556New Technology - Level XIX ($1700-$1800)T$1,750.00$350.00
1557New Technology - Level XX ($1800-$1900)T$1,850.00$370.00
1558New Technology - Level XXI ($1900-$2000)T$1,950.00$390.00
1559New Technology - Level XXII ($2000-$2500)T$2,250.00$450.00
1560New Technology - Level XXIII ($2500-$3000)T$2,750.00$550.00
1561New Technology - Level XXIV ($3000-$3500)T$3,250.00$650.00
1562New Technology - Level XXV ($3500-$4000)T$3,750.00$750.00
1563New Technology - Level XXVI ($4000-$4500)T$4,250.00$850.00
1564New Technology - Level XXVII ($4500-$5000)T$4,750.00$950.00
1565New Technology - Level XXVIII ($5000-$5500)T$5,250.00$1,050.00
1566New Technology - Level XXIX ($5500-$6000)T$5,750.00$1,150.00
1567New Technology - Level XXX ($6000-$6500)T$6,250.00$1,250.00
1568New Technology - Level XXXI ($6500-$7000)T$6,750.00$1,350.00
1569New Technology - Level XXXII ($7000-$7500)T$7,250.00$1,450.00
1570New Technology - Level XXXIII ($7500-$8000)T$7,750.00$1,550.00
1571New Technology - Level XXXIV ($8000-$8500)T$8,250.00$1,650.00
1572New Technology - Level XXXV ($8500-$9000)T$8,750.00$1,750.00
1573New Technology - Level XXXVI ($9000-$9500)T$9,250.00$1,850.00
1574New Technology - Level XXXVII ($9500-$10000)T$9,750.00$1,950.00
1600Technetium TC 99m sestamibiK$112.73$22.55
1603Thallous chloride TL 201/mciK$18.29$3.66
1604IN 111 capromab pendetide, per doseK$2,030.60$406.12
1605Abciximab injection, 10 mgK$475.22$95.04
1606Anistreplase, 30 uK$2,495.31$499.06
1607Eptifibatide injection, 5mgK$11.88$2.38
1608Etanercept injectionK$143.73$28.75
1609Rho(D) immune globulin h, sd, 100 iuK$19.03$3.81
1611Hylan G-F 20 injection, 16 mgK$215.97$43.19
1612Daclizumab, parenteral, 25 mgK$393.78$78.76
1613Trastuzumab, 10 mgK$53.85$10.77
1614Valrubicin, 200 mgK$487.87$97.57
1615Basiliximab, 20 mgK$1,425.06$285.01
1618Vonwillebrandfactrcmplx, per iuK$0.46$0.09
1619Gallium ga 67K0.2056$11.22$2.24
1620Technetium tc99m bicisateK$392.93$78.59
1622Technetium tc99m mertiatideK$1,650.00$330.00
1624Sodium phosphate p32K$66.44$13.29
1625Indium 111-in pentetreotideK$1,144.00$228.80
1628Chromic phosphate p32K$81.27$16.25
1716Brachytx source, Gold 198H
1717Brachytx source, HDR Ir-192H
1718Brachytx source, Iodine 125H
1719Brachytx source,Non-HDR Ir-192H
1720Brachytx source, Palladium 103H
1775FDG, per dose (4-40 mCi/ml)K5.9471$324.48$64.90
1783Ocular implant, aqueous drain deviceH$-
1814Retinal Tamp, silicone oilH$-
1818Integrated keratoprosthesisH$-
1819Tissue localization-excision devH$-
Start Printed Page 842
1884Embolization Protect systH$-
1888Catheter, ablation, non-cardiac, endovascular (implantable)H$-
1900Lead coronary venousH$-
2614Probe, percutaneous lumbar discH$-
2616Brachytx source, Yttrium-90H
2632Brachytx sol, I-125, per mCiH$-
2633Brachytx source, Cesium-131H
7000Amifostine, 500 mgK$419.59$83.92
7007Inj milrinone lactate, per 5 mgK0.2129$11.62$2.32
7011Oprelvekin injection, 5 mgK$248.16$49.63
7015Busulfan, oral, 2 mgK$1.93$0.39
7019Aprotinin, 10,000 kiuK$13.26$2.65
7024Corticorelin ovine triflutatK$375.00$75.00
7025Digoxin immune FAB (ovine)K$1.79$0.36
7026Ethanolamine oleate 100 mgK$67.10$13.42
7027Fomepizole, 15mgK$10.65$2.13
7028Fosphenytoin, 50 mgK$5.63$1.13
7030Hemin, per 1 mgK$6.86$1.37
7031Octreotide acetate injectionK$3.94$0.79
7034Somatropin injectionK$297.79$59.56
7035Teniposide, 50 mgK$238.49$47.70
7036Urokinase 250,000 iu injK3.7855$206.54$41.31
7037Urofollitropin, 75 iuK1.1634$63.48$12.70
7038Muromonab-CD3, 5 mgK$792.33$158.47
7040Pentastarch 10% solutionK$139.94$27.99
7041Tirofiban hydrochloride 12.5 mgK$436.66$87.33
7042Capecitabine, oral, 150 mgK$3.14$0.63
7043Infliximab injection 10 mgK$31.81$6.36
7045Trimetrexate glucoronateK$132.00$26.40
7046Doxorubicin hcl liposome inj 10 mgK$364.49$72.90
7048Alteplase recombinantK0.2856$15.58$3.12
7049Filgrastim 480 mcg injectionK$290.93$58.19
7051Leuprolide acetate implant, 65 mgK$5,001.92$1,000.38
7316Sodium hyaluronate injectionK$67.16$13.43
9001Linezolid injectionK$34.09$6.82
9002Tenecteplase, 50mg/vialK$2,492.60$498.52
9003Palivizumab, per 50mgK$611.24$122.25
9004Gemtuzumab ozogamicin inj,5mgK$2,022.90$404.58
9005Reteplase injectionK$1,263.90$252.78
9006Tacrolimus injectionK$110.04$22.01
9008Baclofen Refill Kit-500mcgK$73.92$14.78
9009Baclofen refill kit - per 2000 mcgK0.7499$40.92$8.18
9010Baclofen refill kit - per 4000 mcgK$79.82$15.96
9012Arsenic TrioxideK$34.32$6.86
9013Co 57 cobaltous chlorideK$56.67$11.33
9015Mycophenolate mofetil oral 250 mgK$1.36$0.27
9018Botulinum toxin B, per 100 uK$8.14$1.63
9019Caspofungin acetate, 5 mgK$30.52$6.10
9020Sirolimus tablet, 1 mgK$6.60$1.32
9021Immune globulin 10 mgK$0.41$0.08
9022IM inj interferon beta 1-aK$13.36$2.67
9023Rho d immune globulin 50 mcgK$32.21$6.44
9024Amphotericin B, lipid formulationK$20.86$4.17
9025Radiopharms Used to Image Perfusion of HeartK$162.63$32.53
9100Iodinated I-131albumin, per 5 uciK$48.58$9.72
9104Anti-thymocycte globulin rabbitK$331.23$66.25
9105Hep B imm glob, per 1 mlK$65.58$13.12
9108Thyrotropin alfa, per 1.1 mgK$572.00$114.40
9109Tirofliban hcl, per 6.25 mgK$218.33$43.67
9110Alemtuzumab, per 10 mgK$541.46$108.29
9111Inj, bivalirudin, per 250 mg vialG$1.61$0.32
9112Perflutren lipid micro, per 2mlG$137.28$27.46
9113Inj, pantoprazole sodium, vialG$23.23$4.65
9114Nesiritide, per 0.5 mg vialG$140.45$28.09
9115Inj, zoledronic acid, per 1 mgG$211.07$42.21
9116Inj, Ertapenem sodium, per 500 mgG$21.99$4.40
9117Yttrium 90 ibritumomab tiuxetanK$22,210.19$4,442.04
9118In-111 ibritumomab tiuxetanK$2,565.55$513.11
Start Printed Page 843
9119Pegfilgrastim, per 1 mgG$2,596.00$519.20
9120Inj, Fulvestrant, per 50 mgG$78.36$13.09
9121Inj, Argatroban, per 5 mgG$14.63$2.44
9122Inj, Triptorelin pamoate, per 3.75 mgG$356.66$59.58
9123Transcyte, per 247 sq cmG$689.78$115.23
9200Orcel, per 36 cm2G$1,051.60$210.32
9201Dermagraft, per 37.5 sq cmG$535.04$107.01
9202OctafluoropropaneK$137.28$27.46
9203Perflexane lipid microG$127.50$21.30
9204Ziprasidone mesylateG$18.60$3.11
9205OxaliplatinG$8.45$14.12
9207Injection, bortezomibG$1,039.68$155.40
9208Injection, agalsidase betaG$123.78$18.50
9209Injection, laronidaseG$644.10$96.28
9210Injection, palonosetron HCLG$307.80$46.01
9211Inj, alefacept, IVG$595.00$99.40
9212Inj, alefacept, IMG$422.88$70.65
9217Leuprolide acetate suspnsion, 7.5 mgK$576.47$115.29
9500Platelets, irradiatedK$74.79$14.96
9501Platelets, pheresisK$408.81$81.76
9502Platelet pheresis irradiatedK$443.68$88.74
9503Fresh frozen plasma, ea unitK$69.74$13.95
9504RBC deglycerolizedK$183.44$36.69
9505RBC irradiatedK$108.65$21.73
9506Granulocytes, pheresisK$1,248.66$249.73

Addendum D1.—Payment Status Indicators for the Hospital Outpatient Prospective Payment System

IndicatorItem/Code/ServiceExplanation
AServices furnished to a Hospital Outpatient that are paid under a Fee Schedule/Payment System other than OPPS, e.g.: • Ambulance Services • Clinical Diagnostic Laboratory Services • Non-Implantable Prosthetic and Orthotic Devices • EPO for ESRD Patients • Physical, Occupational and Speech Therapy • Routine Dialysis Services for ESRD Patients Provided in a Certified Dialysis Unit of a Hospital • Screening MammographyNot paid under OPPS. Paid by Intermediaries under a Fee Schedule/Payment System other than OPPS.
BCodes that are not recognized by OPPS when submitted on an Outpatient Hospital Part B bill type (12x, 13x, and 14x)Not paid under OPPS. • May be paid by Intermediaries when submitted on a different bill type, e.g., 75x (CORF), but not paid under OPPS. • An alternate code that is recognized by OPPS when submitted on an Outpatient Hospital Part B bill type (12x, 13x, and 14x) may be available.
CInpatient ProceduresNot paid under OPPS. Admit patient; Bill as Inpatient.
DDeleted CodesNot paid under OPPS. Not paid under Medicare.
EItems, Codes, and Services: • That are not covered by Medicare based on Statutory Exclusion • That are not covered by Medicare for reasons other than Statutory Exclusion • That are not recognized by Medicare but for which an alternate code for the same item or service may be available • For which separate payment is not provided by Medicare Not paid under OPPS
FCorneal Tissue Acquisition; Certain CRNA ServicesNot paid under OPPS. Paid at reasonable cost.
GDrug/Biological Pass-ThroughPaid under OPPS; Separate APC payment includes Pass-Through amount.
HDevice Category Pass-Through and Brachytherapy SourcePaid under OPPS; Separate cost-based
KNon Pass-Through Drugs and Biologicals; Radiopharmaceutical AgentsPaid under OPPS; Separate APC payment.
LInfluenza Vaccine; Pneumococcal Pneumonia VaccineNot paid under OPPS. Paid at reasonable cost; Not subject to deductible or coinsurance.
NItems and Services packaged into APC RatesPaid under OPPS. However, payment is packaged into payment for other services, including Outliers. Therefore, there is no separate APC payment.
Start Printed Page 844
PPartial HospitalizationPaid under OPPS; Per diem APC payment.
SSignificant Procedure, Not Discounted when MultiplePaid under OPPS; Separate APC payment.
TSignificant Procedure, Multiple Procedure Reduction AppliesPaid under OPPS; Separate APC payment.
VClinic or Emergency Department VisitPaid under OPPS; Separate APC payment.
YNon-Implantable Durable Medical EquipmentNot paid under OPPS. All institutional providers other than Home Health Agencies bill to DMERC.
XAncillary ServicePaid under OPPS; Separate APC payment.
End Supplemental Information

[FR Doc. 03-32322 Filed 12-31-03; 12:00 pm]

BILLING CODE 4120-01-P