[Federal Register Volume 70, Number 171 (Tuesday, September 6, 2005)]
[Rules and Regulations]
[Pages 52930-52935]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-17655]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Part 414

CMS-1325-IFC2

RIN 0938-AN58


Medicare Program; Competitive Acquisition of Outpatient Drugs and 
Biologicals Under Part B: Interpretation and Correction

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

ACTION: Interim final rule; interpretation and correction.

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SUMMARY: This interim final rule clarifies our timeline for 
implementation of the competitive acquisition program under section 
1847B of the Social Security Act and corrects technical errors that 
appeared in the addenda to the interim final rule with comment period 
published in the Federal Register on July 6, 2005 entitled 
``Competitive Acquisition of Outpatient Drugs and Biologicals Under 
Part B.''

EFFECTIVE DATE: This rule is effective September 6, 2005.

FOR FURTHER INFORMATION CONTACT: Lia Prela, (410) 786-0548.

SUPPLEMENTARY INFORMATION:

I. Background

A. Clarification of Timeline for Implementation of CAP

    On July 6, 2005, we published an interim final rule with comment 
period (70 FR 39022) in the Federal Register with respect to provisions 
of the Medicare Prescription Drug, Improvement, and Modernization Act 
of 2003 (MMA) that require the implementation of a competitive 
acquisition program (CAP) for certain Medicare Part B drugs not paid on 
a cost or prospective payment system basis. Physicians will generally 
be given a choice between obtaining these drugs from vendors selected 
through a competitive bidding process or directly purchasing these 
drugs and being paid under the average sales price (ASP) system.
    In the July 6, 2005 interim final rule, we stated that 
implementation of the CAP would take place on January 1, 2006 to 
coordinate the CAP physician election process with the Medicare 
participating physician election process described in section 1842(h) 
of Social Security Act (the Act). Subsequent to the publication of the 
July 6, 2005 interim final rule, we received comments requesting a 
delay in implementation of the CAP from a variety of sources including 
written public comments as well as comments voiced during the 
conference call for potential vendors that we held on July 8, 2005.
    Effective August 3, 2005, we suspended the vendor bidding process 
that began with publication of the interim final rule on July 6, 2005, 
to allow us more time to fully review public comments on the interim 
final rule and also to further refine the bidding process. We provided 
notification of the suspension on the CMS Web site http://www.cms.hhs.gov/providers/drugs/compbid/ and through the pharmacy and 
physician Listservs. We will publish a final rule for implementing the 
CAP after we analyze the additional comments on the interim final rule 
and determine the best manner for improving the efficiency of the CAP 
and increasing potential participation of both vendors and physicians 
in the program.
    We will announce the dates for the new vendor bidding period 
concurrent with the publication of the final rule. We also will be 
announcing a special physician election period. Currently, we expect 
that drugs will first be delivered through the CAP by July 2006. During 
the special election period, physicians will have the opportunity to 
elect to participate in the CAP from its start date in 2006 through the 
end of calendar year 2006.
    As we specified in the July 2005 Federal Register document, we will 
continue to accept comments on the interim final rule until September 
6, 2005.
    In section II of this document, we provide clarification of the 
timeline for implementation of the CAP as well as further 
interpretation of what will

[[Page 52931]]

constitute an ``exigent circumstance'' for purposes of allowing a 
physician to elect to participate in the CAP and select a CAP vendor at 
a time other than the annual election period.

B. Corrections to the July 6, 2005 Interim Final Rule

    In FR Doc. 05-12938 of July 6, 2005 (70 FR 39022), we identified 
errors to Addendum A and Addendum B that are corrected under 
``Correction of Addenda Errors'' in section III of this document. These 
corrections are effective as if they had been included in the document 
published July 6, 2005.

II. Delay in Implementation Date

    On March 4, 2005, we published a proposed rule (70 FR 10746) to 
implement a CAP program, as required by section 1847B of the Act, as 
added by section 303(d) of the MMA, for certain Medicare Part B drugs 
not paid on a cost or prospective payment system basis. In response to 
the proposed rule, commenters expressed concern about the short 
timeframe for implementation of the CAP, that is, the proposed January 
1, 2006 effective date stated in the July 6, 2005 interim final rule. 
These commenters suggested we delay the effective date of the CAP to 
allow us to fully structure the CAP to meet congressional objectives 
and benefit physicians without compromising beneficiary access to drug 
therapies and treatment.
    We responded to those comments in the July 6, 2005 interim final 
rule (70 FR 39025) by stating that we recognized that the timeframe for 
implementation was ambitious but we believed that the regulatory 
framework provided a firm basis for implementing the CAP in January 
2006.
    We also stated that the statute requires that we coordinate the 
physicians' election to participate in the CAP with the Medicare 
Participating Physician Process described in section 1842(h) of the 
Act.
    However, upon further consideration of these comments, as well as 
additional feedback we have received from potential participants in the 
program, we have concluded that more time is needed to further refine 
the program before implementation. After reviewing public comments, we 
agree that a short delay in implementing the CAP will allow us to 
improve the efficiency of the program and increase interest in 
participating in the program. Therefore, in accordance with our 
authority to phase-in the program as appropriate during 2006, we are 
delaying implementation of the CAP. The CAP program will not begin on 
January 1, 2006, and the initial physician election process will not 
occur in 2005.
    As noted above, we intend to implement the CAP during 2006 and we 
expect that the CAP program will begin sometime in or around July 2006. 
In addition, we expect the initial physician election period to occur 
in the spring of 2006 rather than in fall 2005. We consider the initial 
implementation of the CAP program to constitute an ``exigent 
circumstance'' for purposes of section 1847B(a)(5)(A)(i) of the Act and 
Sec.  414.908(a)(2) of our regulations, which allow for a physician 
election period at times other than the regular, annual election 
period. We are specifying the initial election period as an ``exigent 
circumstance'' because we intend the program to run on a calendar year 
basis, as stated in the July 2005 interim final rule, after the initial 
implementation of the CAP in 2006. In later years, the annual CAP 
election period will be coordinated with the annual Medicare 
Participating Physician Enrollment Process described in section 1842(h) 
of the Act, which occurs in the fall of each year, as specified in the 
July 2005 interim final rule.
    We believe that, after the initial election period in 2006, an 
annual election period that ends on November 15 before the beginning of 
each CAP year is still necessary to allow time for the carrier, the 
designated carrier, the vendors, and our claims processing system to 
complete tasks in preparation for that CAP year. We expect to include 
the dates of the initial physician election period in the final rule. 
Physicians will then be provided with a second election period in 2006 
for participation in the CAP in 2007.
    In the July 6, 2005 interim final rule, we stated in several other 
places in the preamble that the CAP would begin on January 1, 2006.
    For example, we referred to a January 1, 2006 start date in our 
discussion of the activities that would be necessary to implement the 
CAP on that date. These included CAP operations, analysis and coding of 
the CAP claims processing system, and educating beneficiaries and 
physicians about the program. In the July 2005 interim final rule, we 
specified that in response to the March 2005 proposed rule, several 
commenters expressed concern about introducing the CAP so quickly 
without any formal testing or analysis of the program. Other commenters 
expressed concern about education and outreach efforts relating to the 
CAP. Our decision to suspend the current vendor bidding process and 
delay the start date of the CAP will allow time for refining CAP 
operations, additional testing of the claims processing system, and for 
further beneficiary, physician, and vendor applicant educational 
efforts. We believe this additional preparation time will greatly 
improve and ease the implementation process.

III. Correction of Addenda Errors

    In the July 6, 2005 interim final rule, Addendum A ``Single Drug 
Category List'' does not include the column reflecting the weights 
assigned to each CAP drug that will be used in computing the composite 
bids. In this interim final rule, we are correcting the error by 
republishing Addendum A in its entirety, with the third column 
included. In addition, in Addendum B, ``New Drugs for CAP Bidding for 
2006,'' we inadvertently included J7518 (mycophenolic acid), which 
should be excluded from this list because it is an orally administered 
immunosuppressive agent rather than a physician-administered drug. We 
are correcting this error by republishing Addendum B, which reflects 
the omission of J7518 (mycophenolic acid).
    In FR Doc. 05-12938 of July 6, 2005 (70 FR 39022), make the 
following corrections:
    1. On pages 39099 through 39102, Addendum A is corrected to read as 
follows:

                  Addendum A--Single Drug Category List
------------------------------------------------------------------------
          HCPCS                    Long description             Weight
------------------------------------------------------------------------
J0150....................  INJECTION, ADENOSINE FOR           0.00069338
                            THERAPEUTIC USE, 6 MG.
J0152....................  INJECTION, ADENOSINE FOR           0.00455133
                            DIAGNOSTIC USE, 30 MG.
J0170....................  INJECTION, ADRENALIN,              0.00007823
                            EPINEPHRINE, 1 ML AMPULE.
J0207....................  INJECTION, AMIFOSTINE, 500 MG...   0.00015946
J0215....................  INJECTION, ALEFACEPT, 0.5 MG....   0.00082595
J0280....................  INJECTION, AMINOPHYLLIN, 250 MG.   0.00081312
J0290....................  INJECTION, AMPICILLIN SODIUM,      0.00012537
                            500 MG.

[[Page 52932]]

 
J0475....................  INJECTION, BACLOFEN, 10 MG......   0.00024410
J0540....................  INJECTION, PENICILLIN G            0.00007140
                            BENZATHINE AND PENICILLIN G
                            PROCAINE, 1,200,000 UNITS.
J0550....................  INJECTION, PENICILLIN G            0.00001814
                            BENZATHINE AND PENICILLIN G
                            PROCAINE, 2,400,000 UNITS.
J0570....................  INJECTION, PENICILLIN G            0.00004561
                            BENZATHINE, 1,200,000 UNITS.
J0585....................  BOTULINUM TOXIN TYPE A, PER UNIT   0.03707810
J0587....................  BOTULINUM TOXIN TYPE B, PER 100    0.00149279
                            UNITS.
J0600....................  INJECTION, EDETATE CALCIUM         0.00004417
                            DISODIUM, 1000 MG.
J0637....................  INJECTION, CASPOFUNGIN ACETATE,    0.00008403
                            5 MG.
J0640....................  INJECTION, LEUCOVORIN CALCIUM,     0.01054437
                            PER 50 MG.
J0670....................  INJECTION, MEPIVACAINE             0.00038034
                            HYDROCHLORIDE, PER 10 ML.
J0690....................  INJECTION, CEFAZOLIN SODIUM, 500   0.00042009
                            MG.
J0692....................  INJECTION, CEFEPIME                0.00024611
                            HYDROCHLORIDE, 500 MG.
J0696....................  INJECTION, CEFTRIAXONE SODIUM,     0.00662508
                            PER 250 MG.
J0698....................  INJECTION, CEFOTAXIME SODIUM,      0.00014738
                            PER GM.
J0702....................  INJECTION, BETAMETHASONE ACETATE   0.00284989
                            & BETAMETHASONE SODIUM
                            PHOSPHATE, PER 3 MG.
J0704....................  INJECTION, BETAMETHASONE SODIUM    0.00056519
                            PHOSPHATE, PER 4 MG.
J0735....................  INJECTION, CLONIDINE               0.00033826
                            HYDROCHLORIDE, 1 MG.
J0800....................  INJECTION, CORTICOTROPIN, 40       0.00360503
                            UNITS.
J0880....................  INJECTION, DARBEPOETIN ALFA, 5     0.11998845
                            MCG.
J0895....................  INJECTION, DEFEROXAMINE            0.00024217
                            MESYLATE, 500 MG.
J1000....................  INJECTION, DEPO-ESTRADIOL          0.00020815
                            CYPIONATE, 5 MG.
J1020....................  INJECTION, METHYLPREDNISOLONE      0.00126125
                            ACETATE, 20 MG.
J1030....................  INJECTION, METHYLPREDNISOLONE      0.00587530
                            ACETATE, 40 MG.
J1040....................  INJECTION, METHYLPREDNISOLONE      0.00522812
                            ACETATE, 80 MG.
J1051....................  INJECTION, MEDROXYPROGESTERONE     0.00006464
                            ACETATE, 50 MG.
J1094....................  INJECTION, DEXAMETHASONE           0.00347947
                            ACETATE, 1 MG.
J1100....................  INJECTION, DEXAMETHASONE SODIUM    0.05440123
                            PHOSPHATE, 1MG.
J1190....................  INJECTION, DEXRAZOXANE             0.00002421
                            HYDROCHLORIDE, PER 250 MG.
J1200....................  INJECTION, DIPHENHYDRAMINE HCL,    0.00214443
                            50 MG.
J1212....................  INJECTION, DMSO, DIMETHYL          0.00008395
                            SULFOXIDE, 50%, 50 ML.
J1245....................  INJECTION, DIPYRIDAMOLE, PER 10    0.00379554
                            MG.
J1250....................  INJECTION, DOBUTAMINE              0.00052679
                            HYDROCHLORIDE, PER 250 MG.
J1260....................  INJECTION, DOLASETRON MESYLATE,    0.01720675
                            10 MG.
J1335....................  INJECTION, ERTAPENEM SODIUM, 500   0.00013138
                            MG.
J1440....................  INJECTION, FILGRASTIM (G-CSF),     0.00191741
                            300 MCG.
J1441....................  INJECTION, FILGRASTIM (G-CSF),     0.00403536
                            480 MCG.
J1450....................  INJECTION FLUCONAZOLE, 200 MG...   0.00001593
J1580....................  INJECTION, GARAMYCIN,              0.00039560
                            GENTAMICIN, 80 MG.
J1600....................  INJECTION, GOLD SODIUM             0.00005560
                            THIOMALATE, 50 MG.
J1626....................  INJECTION, GRANISETRON             0.01469700
                            HYDROCHLORIDE, 100 MCG.
J1631....................  INJECTION, HALOPERIDOL             0.00020506
                            DECANOATE, PER 50 MG.
J1642....................  INJECTION, HEPARIN SODIUM,         0.06362003
                            (HEPARIN LOCK FLUSH), PER 10
                            UNITS.
J1644....................  INJECTION, HEPARIN SODIUM, PER     0.00351209
                            1000 UNITS.
J1645....................  INJECTION, DALTEPARIN SODIUM,      0.00011417
                            PER 2500 IU.
J1650....................  INJECTION, ENOXAPARIN SODIUM, 10   0.00134336
                            MG.
J1655....................  INJECTION, TINZAPARIN SODIUM,      0.00046724
                            1000 IU.
J1710....................  INJECTION, HYDROCORTISONE SODIUM   0.00006029
                            PHOSPHATE, 50 MG.
J1720....................  INJECTION, HYDROCORTISONE SODIUM   0.00013201
                            SUCCINATE, 100 MG.
J1745....................  INJECTION INFLIXIMAB, 10 MG.....   0.02736596
J1750....................  INJECTION, IRON DEXTRAN, 50 MG..   0.00244189
J1756....................  INJECTION, IRON SUCROSE, 1 MG...   0.01017283
J1885....................  INJECTION, KETOROLAC               0.00326961
                            TROMETHAMINE, PER 15 MG.
J1940....................  INJECTION, FUROSEMIDE, 20 MG....   0.00064751
J1956....................  INJECTION, LEVOFLOXACIN, 250 MG.   0.00008548
J2001....................  INJECTION, LIDOCAINE HCL FOR       0.00076795
                            INTRAVENOUS INFUSION, 10 MG.
J2010....................  INJECTION, LINCOMYCIN HCL, 300     0.00061870
                            MG.
J2150....................  INJECTION, MANNITOL, 25% IN 50     0.00028934
                            ML.
J2260....................  INJECTION, MILRINONE LACTATE, 5    0.00004912
                            MG.
J2300....................  INJECTION, NALBUPHINE              0.00026092
                            HYDROCHLORIDE, PER 10 MG.
J2324....................  INJECTION, NESIRITIDE, 0.25 MG..   0.00027147
J2353....................  INJECTION, OCTREOTIDE, DEPOT       0.00193262
                            FORM FOR INTRAMUSCULAR
                            INJECTION, 1 MG.
J2354....................  INJECTION, OCTREOTIDE, NON-DEPOT   0.00008332
                            SUBCUTANEOUS OR INTRAVENOUS
                            INJECTION, 25 MCG.
J2405....................  INJECTION, ONDANSETRON             0.01360054
                            HYDROCHLORIDE, PER 1 MG.
J2430....................  INJECTION, PAMIDRONATE DISODIUM,   0.00155307
                            PER 30 MG.
J2505....................  INJECTION, PEGFILGRASTIM, 6 MG..   0.00064498
J2550....................  INJECTION, PROMETHAZINE HCL, 50    0.00068031
                            MG.
J2680....................  INJECTION, FLUPHENAZINE            0.00014971
                            DECANOATE, 25 MG.
J2765....................  INJECTION, METOCLOPRAMIDE HCL,     0.00011029
                            10 MG.
J2780....................  INJECTION, RANITIDINE              0.00087713
                            HYDROCHLORIDE, 25 MG.
J2820....................  INJECTION, SARGRAMOSTIM (GM-       0.00215849
                            CSF), 50 MCG.
J2912....................  INJECTION, SODIUM CHLORIDE,        0.00673579
                            0.9%, PER 2 ML.
J2916....................  INJECTION, SODIUM FERRIC           0.00060556
                            GLUCONATE COMPLEX IN SUCROSE
                            INJECTION, 12.5 MG.

[[Page 52933]]

 
J2920....................  INJECTION, METHYLPREDNISOLONE      0.00030935
                            SODIUM SUCCINATE, 40 MG.
J2930....................  INJECTION, METHYLPREDNISOLONE      0.00076469
                            SODIUM SUCCINATE, 125 MG.
J2997....................  INJECTION, ALTEPLASE               0.00012123
                            RECOMBINANT, 1 MG.
J3260....................  INJECTION, TOBRAMYCIN SULFATE,     0.00018119
                            80 MG.
J3301....................  INJECTION, TRIAMCINOLONE           0.02146050
                            ACETONIDE, PER 10 MG.
J3302....................  INJECTION, TRIAMCINOLONE           0.00171576
                            DIACETATE, PER 5 MG.
J3303....................  INJECTION, TRIAMCINOLONE           0.00093708
                            HEXACETONIDE, PER 5 MG.
J3315....................  INJECTION, TRIPTORELIN PAMOATE,    0.00000707
                            3.75 MG.
J3370....................  INJECTION, VANCOMYCIN HCL, 500     0.00083391
                            MG.
J3396....................  INJECTION, VERTEPORFIN, 0.1 MG..   0.05387196
J3410....................  INJECTION, HYDROXYZINE HCL, 25     0.00040617
                            MG.
J3420....................  INJECTION, VITAMIN B-12            0.01191674
                            CYANOCOBALAMIN, UP TO 1000 MCG.
J3475....................  INJECTION, MAGNESIUM SULFATE,      0.00107478
                            PER 500 MG.
J3480....................  INJECTION, POTASSIUM CHLORIDE,     0.00213669
                            PER 2 MEQ.
J3487....................  INJECTION, ZOLEDRONIC ACID, 1 MG   0.00333297
J7030....................  INFUSION, NORMAL SALINE SOLUTION   0.00101862
                            , 1000 CC.
J7040....................  INFUSION, NORMAL SALINE            0.00240866
                            SOLUTION, (500 STERILE ML=1
                            UNIT).
J7042....................  5% DEXTROSE/NORMAL SALINE (500     0.00049401
                            ML = 1 UNIT).
J7050....................  INFUSION, NORMAL SALINE SOLUTION   0.00983951
                            , 250 CC.
J7051....................  STERILE SALINE OR WATER, 5 CC...   0.00695398
J7060....................  5% DEXTROSE/WATER (500 ML = 1      0.00101887
                            UNIT).
J7070....................  INFUSION, D5W, 1000 CC..........   0.00015744
J7120....................  RINGERS LACTATE INFUSION, 1000     0.00016820
                            CC.
J7317....................  SODIUM HYALURONATE, PER 20 TO 25   0.00189786
                            MG DOSE FOR INTRA-ARTICULAR
                            INJECTION.
J7320....................  HYLAN G-F 20, 16 MG, FOR INTRA     0.00148437
                            ARTICULAR INJECTION.
J9000....................  DOXORUBICIN HCL, 10 MG..........   0.00233616
J9001....................  DOXORUBICIN HYDROCHLORIDE, ALL     0.00032228
                            LIPID FORMULATIONS, 10 MG.
J9031....................  BCG (INTRAVESICAL) PER             0.00048801
                            INSTILLATION.
J9040....................  BLEOMYCIN SULFATE, 15 UNITS.....   0.00003692
J9045....................  CARBOPLATIN, 50 MG..............   0.00564705
J9050....................  CARMUSTINE, 100 MG..............   0.00000881
J9060....................  CISPLATIN, POWDER OR S0LUTION,     0.00094491
                            PER 10 MG.
J9062....................  CISPLATIN, 50 MG................   0.00025190
J9065....................  INJECTION, CLADRIBINE, PER 1 MG.   0.00008065
J9070....................  CYCLOPHOSPHAMIDE, 100 MG........   0.00062098
J9080....................  CYCLOPHOSPHAMIDE, 200 MG........   0.00004921
J9090....................  CYCLOPHOSPHAMIDE, 500 MG........   0.00008048
J9091....................  CYCLOPHOSPHAMIDE, 1.0 GRAM......   0.00005001
J9092....................  CYCLOPHOSPHAMIDE, 2.0 GRAM......   0.00000525
J9093....................  CYCLOPHOSPHAMIDE, LYOPHILIZED,     0.00091804
                            100 MG.
J9094....................  CYCLOPHOSPHAMIDE, LYOPHILIZED,     0.00009103
                            200 MG.
J9095....................  CYCLOPHOSPHAMIDE, LYOPHILIZED,     0.00017529
                            500 MG.
J9096....................  CYCLOPHOSPHAMIDE, LYOPHILIZED,     0.00013845
                            1.0 GRAM.
J9097....................  CYCLOPHOSPHAMIDE, LYOPHILIZED,     0.00001347
                            2.0 GRAM.
J9098....................  CYTARABINE LIPOSOME, 10 MG......   0.00000809
J9100....................  CYTARABINE, 100 MG..............   0.00012887
J9110....................  CYTARABINE, 500 MG..............   0.00002056
J9130....................  DACARBAZINE, 100 MG.............   0.00009340
J9140....................  DACARBAZINE, 200 MG.............   0.00006957
J9150....................  DAUNORUBICIN, 10 MG.............   0.00000485
J9170....................  DOCETAXEL, 20 MG................   0.00254788
J9178....................  INJECTION, EPIRUBICIN HCL, 2 MG.   0.00120764
J9181....................  ETOPOSIDE, 10 MG................   0.00229277
J9182....................  ETOPOSIDE, 100 MG...............   0.00052610
J9185....................  FLUDARABINE PHOSPHATE, 50 MG....   0.00030358
J9190....................  FLUOROURACIL, 500 MG............   0.00392446
J9200....................  FLOXURIDINE, 500 MG.............   0.00000405
J9201....................  GEMCITABINE HCL, 200 MG.........   0.00491490
J9202....................  GOSERELIN ACETATE IMPLANT, PER     0.00285868
                            3.6 MG.
J9206....................  IRINOTECAN, 20 MG...............   0.00316077
J9208....................  IFOSFAMIDE, 1 GM................   0.00007818
J9209....................  MESNA, 200 MG...................   0.00036520
J9211....................  IDARUBICIN HYDROCHLORIDE, 5 MG..   0.00000315
J9213....................  INTERFERON, ALFA-2A,               0.00008006
                            RECOMBINANT, 3 MILLION UNITS.
J9214....................  INTERFERON, ALFA-2B,               0.00668813
                            RECOMBINANT, 1 MILLION UNITS.
J9219....................  LEUPROLIDE ACETATE IMPLANT, 65     0.00006464
                            MG.
J9245....................  INJECTION, MELPHALAN               0.00000157
                            HYDROCHLORIDE, 50 MG.
J9250....................  METHOTREXATE SODIUM, 5 MG.......   0.00184935
J9260....................  METHOTREXATE SODIUM, 50 MG......   0.00050963
J9263....................  INJECTION, OXALIPLATIN, 0.5 MG..   0.07249359
J9265....................  PACLITAXEL, 30 MG...............   0.00551428
J9268....................  PENTOSTATIN, PER 10 MG..........   0.00000639

[[Page 52934]]

 
J9280....................  MITOMYCIN, 5 MG.................   0.00004038
J9290....................  MITOMYCIN, 20 MG................   0.00003448
J9291....................  MITOMYCIN, 40 MG................   0.00006085
J9293....................  INJECTION, MITOXANTRONE            0.00024882
                            HYDROCHLORIDE, PER 5 MG.
J9310....................  RITUXIMAB, 100 MG...............   0.00405692
J9320....................  STREPTOZOCIN, 1 GM..............   0.00000666
J9340....................  THIOTEPA, 15 MG.................   0.00002429
J9350....................  TOPOTECAN, 4 MG.................   0.00018095
J9355....................  TRASTUZUMAB, 10 MG..............   0.00538210
J9360....................  VINBLASTINE SULFATE, 1 MG.......   0.00035474
J9370....................  VINCRISTINE SULFATE, 1 MG.......   0.00019564
J9375....................  VINCRISTINE SULFATE, 2 MG.......   0.00011406
J9390....................  VINORELBINE TARTRATE, PER 10 MG.   0.00109985
J9395....................  INJECTION, FULVESTRANT, 25 MG...   0.00125472
J9600....................  PORFIMER SODIUM, 75 MG..........   0.00000029
Q0136....................  INJECTION, EPOETIN ALPHA, (FOR     0.24898913
                            NON ESRD USE), PER 1000 UNITS.
Q0137....................  INJECTION, DARBEPOETIN ALFA, 1     0.03803750
                            MCG (NON-ESRD USE).
Q3025....................  INJECTION, INTERFERON BETA-1A,     0.00077522
                            11 MCG FOR INTRAMUSCULAR USE.
------------------------------------------------------------------------

    2. On page 39102, Addendum B is corrected to read as follows:

             Addendum B--New Drugs for CAP Bidding for 2006
------------------------------------------------------------------------
               CODE                           2005 Description
------------------------------------------------------------------------
J0128.............................  Abarelix injection.
J0180.............................  Agalsidase beta injection.
J0878.............................  Daptomycin injection.
J1931.............................  Laronidase injection.
J2357.............................  Omalizumab injection.
J2469.............................  Palonosetron HCl.
J2794.............................  Risperidone, long acting.
J9035.............................  Bevacizumab injection.
J9041.............................  Bortezomib injection.
J9055.............................  Cetuximab injection.
J9305.............................  Pemetrexed injection.
------------------------------------------------------------------------

IV. Waiver of Delay in Effective Date

    We ordinarily provide an effective date 30 days after the 
publication of an interim final rule in the Federal Register. We can 
waive this delay, however, if we find good cause that it is 
impracticable, unnecessary, or contrary to the public interest and 
incorporate a statement of the finding and the reasons for it into the 
notice issued.
    We find a delay in the effectiveness of this rule unnecessary 
because this rule merely provides further clarification of and 
technical corrections to the interim final rule with comment published 
July 6, 2005. We also find that a delay in the effectiveness of this 
interpretation would be contrary to the public interest: a delay in the 
effectiveness of this rule would defeat the purpose of this rule, which 
is to delay the implementation of the CAP in order to consider further 
public comment and issue a final rule before beginning this major new 
payment system. Therefore, for all of these reasons, we find good cause 
to waive the delay in the effective date of this rule. It will take 
effect on the same day as the July 6, 2005 interim final rule with 
comment.

V. Collection of Information Requirements

    This document does not impose information collection and 
recordkeeping requirements. Consequently, it need not be reviewed by 
the Office of Management and Budget under the authority of the 
Paperwork Reduction Act of 1995 (44 U.S.C. 35).

VI. Regulatory Impact Statement

    We have examined the impact of this rule as required by Executive 
Order 12866 (September 1993, Regulatory Planning and Review), the 
Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-354), 
section 1102(b) of the Social Security Act, the Unfunded Mandates 
Reform Act of 1995 (Pub. L. 104-4), and Executive Order 13132.
    Executive Order 12866 directs agencies to assess all costs and 
benefits of available regulatory alternatives and, if regulation is 
necessary, to select regulatory approaches that maximize net benefits 
(including potential economic, environmental, public health and safety 
effects, distributive impacts, and equity). A regulatory impact 
analysis (RIA) must be prepared for major rules with economically 
significant effects ($100 million or more in any 1 year). This rule 
does not reach the economic threshold and thus is not considered a 
major rule.
    The RFA requires agencies to analyze options for regulatory relief 
of small businesses. For purposes of the RFA, small entities include 
small businesses, nonprofit organizations, and small governmental 
jurisdictions. Most hospitals and most other providers and suppliers 
are small entities, either by nonprofit status or by having revenues of 
$6 million to $29 million in any 1 year. Individuals and States are not 
included in the definition of a small entity. We are not preparing an 
analysis for the RFA because we have determined that this rule will not 
have a significant economic impact on a substantial number of small 
entities.
    In addition, section 1102(b) of the Act requires us to prepare a 
regulatory impact analysis if a rule may have a significant impact on 
the operations of a substantial number of small rural hospitals. This 
analysis must conform to the provisions of section 604 of the RFA. For 
purposes of section 1102(b) of the Act, we define a small rural 
hospital as a hospital that is located outside of a Core-Based 
Statistical Area and has fewer than 100 beds. We are not preparing an 
analysis for section 1102(b) of the Act because we have determined that 
this rule will not have a significant impact on the operations of a 
substantial number of small rural hospitals.
    Section 202 of the Unfunded Mandates Reform Act of 1995 also 
requires that agencies assess anticipated costs and benefits before 
issuing any rule that may result in expenditure in any 1 year by State, 
local, or tribal governments, in the aggregate, or by the private 
sector, of $110 million. This rule will have no consequential effect on 
the governments mentioned or on the private sector.
    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

[[Page 52935]]

governments, preempts State law, or otherwise has Federalism 
implications. Since this regulation does not impose any costs on State 
or local governments, the requirements of E.O. 13132 are not 
applicable.
    In accordance with the provisions of Executive Order 12866, this 
regulation was reviewed by the Office of Management and Budget.

(Catalog of Federal Domestic Assistance Program No. 93.773, 
Medicare--Hospital Insurance; and Program No. 93.774, Medicare--
Supplementary Medical Insurance Program)

    Dated: August 23, 2005.
Mark B. McClellan,
Administrator, Centers for Medicare & Medicaid Services.
    Approved: August 31, 2005.
Michael O. Leavitt,
Secretary.
[FR Doc. 05-17655 Filed 9-1-05; 9:14 am]
BILLING CODE 4120-01-P