Medicare Program; Competitive Acquisition of Outpatient Drugs and Biologicals Under Part B: Interpretation and Correction, 52930-52935 [05-17655]
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Federal Register / Vol. 70, No. 171 / Tuesday, September 6, 2005 / Rules and Regulations
ARIZONA—CARBON MONOXIDE—Continued
Designation
Classification
Designated area
Date
Type
Date
Type
23. thence, easterly along the southern line of Township 1 South to a point where
the south line of Township 1 South intersects with the western line of Range 1
East, which line is generally the southern boundary of Estrella Mountain Regional
Park;
24. thence, southerly along the western line of Range 1 East to the southwest corner of Section 18, Township 2 South, Range 1 East, said line is the western
boundary of the Gila River Indian Reservation;
25. thence, easterly along the southern boundary of the Gila River Indian Reservation which is the southern line of Sections 13, 14, 15, 16, 17, and 18, Township 2
South, Range 1 East, to the boundary between Maricopa and Pinal Counties as
described in Arizona Revised Statutes Sections 11–109 and 11–113, which is the
eastern line of Range 1 East;
26. thence, northerly along the eastern boundary of Range 1 East, which is the
common boundary between Maricopa and Pinal Counties, to a point where the
eastern line of Range 1 East intersects the Gila River;
27. thence, southerly up the Gila River to a point where the Gila River intersects
with the southern line of Township 2 South; and
28. thence, easterly along the southern line of Township 2 South to the point of beginning which is a point where the southern line of Township 2 South intersects
with the easter line Range 7 East;
29. except that portion of the area defined by paragraphs 1 through 28 above that
lies within the Gila River Indian Reservation.
*
*
*
*
*
SUPPLEMENTARY INFORMATION:
[FR Doc. 05–17539 Filed 9–2–05; 8:45 am]
I. Background
BILLING CODE 6560–50–P
A. Clarification of Timeline for
Implementation of CAP
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
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Interim final rule; interpretation
and correction.
AGENCY:
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.
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11:56 Sep 02, 2005
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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.
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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 https://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
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Federal Register / Vol. 70, No. 171 / Tuesday, September 6, 2005 / Rules and Regulations
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
§ 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
52931
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 physicianadministered 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
J0150
J0152
J0170
J0207
J0215
J0280
J0290
.......
.......
.......
.......
.......
.......
.......
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INJECTION,
INJECTION,
INJECTION,
INJECTION,
INJECTION,
INJECTION,
INJECTION,
Weight
ADENOSINE FOR THERAPEUTIC USE, 6 MG .........................................................................................
ADENOSINE FOR DIAGNOSTIC USE, 30 MG ..........................................................................................
ADRENALIN, EPINEPHRINE, 1 ML AMPULE ............................................................................................
AMIFOSTINE, 500 MG ................................................................................................................................
ALEFACEPT, 0.5 MG ..................................................................................................................................
AMINOPHYLLIN, 250 MG ...........................................................................................................................
AMPICILLIN SODIUM, 500 MG ...................................................................................................................
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0.00069338
0.00455133
0.00007823
0.00015946
0.00082595
0.00081312
0.00012537
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Federal Register / Vol. 70, No. 171 / Tuesday, September 6, 2005 / Rules and Regulations
ADDENDUM A—SINGLE DRUG CATEGORY LIST—Continued
HCPCS
J0475
J0540
J0550
J0570
J0585
J0587
J0600
J0637
J0640
J0670
J0690
J0692
J0696
J0698
J0702
J0704
J0735
J0800
J0880
J0895
J1000
J1020
J1030
J1040
J1051
J1094
J1100
J1190
J1200
J1212
J1245
J1250
J1260
J1335
J1440
J1441
J1450
J1580
J1600
J1626
J1631
J1642
J1644
J1645
J1650
J1655
J1710
J1720
J1745
J1750
J1756
J1885
J1940
J1956
J2001
J2010
J2150
J2260
J2300
J2324
J2353
J2354
J2405
J2430
J2505
J2550
J2680
J2765
J2780
J2820
J2912
J2916
.......
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VerDate Aug<18>2005
Long description
Weight
INJECTION, BACLOFEN, 10 MG .....................................................................................................................................
INJECTION, PENICILLIN G BENZATHINE AND PENICILLIN G PROCAINE, 1,200,000 UNITS ..................................
INJECTION, PENICILLIN G BENZATHINE AND PENICILLIN G PROCAINE, 2,400,000 UNITS ..................................
INJECTION, PENICILLIN G BENZATHINE, 1,200,000 UNITS ........................................................................................
BOTULINUM TOXIN TYPE A, PER UNIT ........................................................................................................................
BOTULINUM TOXIN TYPE B, PER 100 UNITS ..............................................................................................................
INJECTION, EDETATE CALCIUM DISODIUM, 1000 MG ...............................................................................................
INJECTION, CASPOFUNGIN ACETATE, 5 MG ..............................................................................................................
INJECTION, LEUCOVORIN CALCIUM, PER 50 MG ......................................................................................................
INJECTION, MEPIVACAINE HYDROCHLORIDE, PER 10 ML .......................................................................................
INJECTION, CEFAZOLIN SODIUM, 500 MG ..................................................................................................................
INJECTION, CEFEPIME HYDROCHLORIDE, 500 MG ...................................................................................................
INJECTION, CEFTRIAXONE SODIUM, PER 250 MG ....................................................................................................
INJECTION, CEFOTAXIME SODIUM, PER GM ..............................................................................................................
INJECTION, BETAMETHASONE ACETATE & BETAMETHASONE SODIUM PHOSPHATE, PER 3 MG ....................
INJECTION, BETAMETHASONE SODIUM PHOSPHATE, PER 4 MG ..........................................................................
INJECTION, CLONIDINE HYDROCHLORIDE, 1 MG ......................................................................................................
INJECTION, CORTICOTROPIN, 40 UNITS .....................................................................................................................
INJECTION, DARBEPOETIN ALFA, 5 MCG ....................................................................................................................
INJECTION, DEFEROXAMINE MESYLATE, 500 MG .....................................................................................................
INJECTION, DEPO-ESTRADIOL CYPIONATE, 5 MG ....................................................................................................
INJECTION, METHYLPREDNISOLONE ACETATE, 20 MG ...........................................................................................
INJECTION, METHYLPREDNISOLONE ACETATE, 40 MG ...........................................................................................
INJECTION, METHYLPREDNISOLONE ACETATE, 80 MG ...........................................................................................
INJECTION, MEDROXYPROGESTERONE ACETATE, 50 MG ......................................................................................
INJECTION, DEXAMETHASONE ACETATE, 1 MG ........................................................................................................
INJECTION, DEXAMETHASONE SODIUM PHOSPHATE, 1MG ....................................................................................
INJECTION, DEXRAZOXANE HYDROCHLORIDE, PER 250 MG ..................................................................................
INJECTION, DIPHENHYDRAMINE HCL, 50 MG .............................................................................................................
INJECTION, DMSO, DIMETHYL SULFOXIDE, 50%, 50 ML ...........................................................................................
INJECTION, DIPYRIDAMOLE, PER 10 MG ....................................................................................................................
INJECTION, DOBUTAMINE HYDROCHLORIDE, PER 250 MG .....................................................................................
INJECTION, DOLASETRON MESYLATE, 10 MG ...........................................................................................................
INJECTION, ERTAPENEM SODIUM, 500 MG ................................................................................................................
INJECTION, FILGRASTIM (G–CSF), 300 MCG ..............................................................................................................
INJECTION, FILGRASTIM (G–CSF), 480 MCG ..............................................................................................................
INJECTION FLUCONAZOLE, 200 MG .............................................................................................................................
INJECTION, GARAMYCIN, GENTAMICIN, 80 MG ..........................................................................................................
INJECTION, GOLD SODIUM THIOMALATE, 50 MG ......................................................................................................
INJECTION, GRANISETRON HYDROCHLORIDE, 100 MCG ........................................................................................
INJECTION, HALOPERIDOL DECANOATE, PER 50 MG ..............................................................................................
INJECTION, HEPARIN SODIUM, (HEPARIN LOCK FLUSH), PER 10 UNITS ..............................................................
INJECTION, HEPARIN SODIUM, PER 1000 UNITS .......................................................................................................
INJECTION, DALTEPARIN SODIUM, PER 2500 IU ........................................................................................................
INJECTION, ENOXAPARIN SODIUM, 10 MG .................................................................................................................
INJECTION, TINZAPARIN SODIUM, 1000 IU .................................................................................................................
INJECTION, HYDROCORTISONE SODIUM PHOSPHATE, 50 MG ...............................................................................
INJECTION, HYDROCORTISONE SODIUM SUCCINATE, 100 MG ..............................................................................
INJECTION INFLIXIMAB, 10 MG .....................................................................................................................................
INJECTION, IRON DEXTRAN, 50 MG .............................................................................................................................
INJECTION, IRON SUCROSE, 1 MG ..............................................................................................................................
INJECTION, KETOROLAC TROMETHAMINE, PER 15 MG ...........................................................................................
INJECTION, FUROSEMIDE, 20 MG ................................................................................................................................
INJECTION, LEVOFLOXACIN, 250 MG ..........................................................................................................................
INJECTION, LIDOCAINE HCL FOR INTRAVENOUS INFUSION, 10 MG ......................................................................
INJECTION, LINCOMYCIN HCL, 300 MG .......................................................................................................................
INJECTION, MANNITOL, 25% IN 50 ML .........................................................................................................................
INJECTION, MILRINONE LACTATE, 5 MG .....................................................................................................................
INJECTION, NALBUPHINE HYDROCHLORIDE, PER 10 MG ........................................................................................
INJECTION, NESIRITIDE, 0.25 MG .................................................................................................................................
INJECTION, OCTREOTIDE, DEPOT FORM FOR INTRAMUSCULAR INJECTION, 1 MG ...........................................
INJECTION, OCTREOTIDE, NON-DEPOT SUBCUTANEOUS OR INTRAVENOUS INJECTION, 25 MCG .................
INJECTION, ONDANSETRON HYDROCHLORIDE, PER 1 MG .....................................................................................
INJECTION, PAMIDRONATE DISODIUM, PER 30 MG ..................................................................................................
INJECTION, PEGFILGRASTIM, 6 MG .............................................................................................................................
INJECTION, PROMETHAZINE HCL, 50 MG ...................................................................................................................
INJECTION, FLUPHENAZINE DECANOATE, 25 MG .....................................................................................................
INJECTION, METOCLOPRAMIDE HCL, 10 MG ..............................................................................................................
INJECTION, RANITIDINE HYDROCHLORIDE, 25 MG ...................................................................................................
INJECTION, SARGRAMOSTIM (GM–CSF), 50 MCG .....................................................................................................
INJECTION, SODIUM CHLORIDE, 0.9%, PER 2 ML ......................................................................................................
INJECTION, SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE INJECTION, 12.5 MG ..................................
0.00024410
0.00007140
0.00001814
0.00004561
0.03707810
0.00149279
0.00004417
0.00008403
0.01054437
0.00038034
0.00042009
0.00024611
0.00662508
0.00014738
0.00284989
0.00056519
0.00033826
0.00360503
0.11998845
0.00024217
0.00020815
0.00126125
0.00587530
0.00522812
0.00006464
0.00347947
0.05440123
0.00002421
0.00214443
0.00008395
0.00379554
0.00052679
0.01720675
0.00013138
0.00191741
0.00403536
0.00001593
0.00039560
0.00005560
0.01469700
0.00020506
0.06362003
0.00351209
0.00011417
0.00134336
0.00046724
0.00006029
0.00013201
0.02736596
0.00244189
0.01017283
0.00326961
0.00064751
0.00008548
0.00076795
0.00061870
0.00028934
0.00004912
0.00026092
0.00027147
0.00193262
0.00008332
0.01360054
0.00155307
0.00064498
0.00068031
0.00014971
0.00011029
0.00087713
0.00215849
0.00673579
0.00060556
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ADDENDUM A—SINGLE DRUG CATEGORY LIST—Continued
HCPCS
J2920
J2930
J2997
J3260
J3301
J3302
J3303
J3315
J3370
J3396
J3410
J3420
J3475
J3480
J3487
J7030
J7040
J7042
J7050
J7051
J7060
J7070
J7120
J7317
J7320
J9000
J9001
J9031
J9040
J9045
J9050
J9060
J9062
J9065
J9070
J9080
J9090
J9091
J9092
J9093
J9094
J9095
J9096
J9097
J9098
J9100
J9110
J9130
J9140
J9150
J9170
J9178
J9181
J9182
J9185
J9190
J9200
J9201
J9202
J9206
J9208
J9209
J9211
J9213
J9214
J9219
J9245
J9250
J9260
J9263
J9265
J9268
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VerDate Aug<18>2005
Long description
Weight
INJECTION, METHYLPREDNISOLONE SODIUM SUCCINATE, 40 MG .......................................................................
INJECTION, METHYLPREDNISOLONE SODIUM SUCCINATE, 125 MG .....................................................................
INJECTION, ALTEPLASE RECOMBINANT, 1 MG ..........................................................................................................
INJECTION, TOBRAMYCIN SULFATE, 80 MG ...............................................................................................................
INJECTION, TRIAMCINOLONE ACETONIDE, PER 10 MG ...........................................................................................
INJECTION, TRIAMCINOLONE DIACETATE, PER 5 MG ..............................................................................................
INJECTION, TRIAMCINOLONE HEXACETONIDE, PER 5 MG ......................................................................................
INJECTION, TRIPTORELIN PAMOATE, 3.75 MG ...........................................................................................................
INJECTION, VANCOMYCIN HCL, 500 MG .....................................................................................................................
INJECTION, VERTEPORFIN, 0.1 MG ..............................................................................................................................
INJECTION, HYDROXYZINE HCL, 25 MG ......................................................................................................................
INJECTION, VITAMIN B–12 CYANOCOBALAMIN, UP TO 1000 MCG ..........................................................................
INJECTION, MAGNESIUM SULFATE, PER 500 MG ......................................................................................................
INJECTION, POTASSIUM CHLORIDE, PER 2 MEQ ......................................................................................................
INJECTION, ZOLEDRONIC ACID, 1 MG .........................................................................................................................
INFUSION, NORMAL SALINE SOLUTION , 1000 CC ....................................................................................................
INFUSION, NORMAL SALINE SOLUTION, (500 STERILE ML=1 UNIT) .......................................................................
5% DEXTROSE/NORMAL SALINE (500 ML = 1 UNIT) ..................................................................................................
INFUSION, NORMAL SALINE SOLUTION , 250 CC ......................................................................................................
STERILE SALINE OR WATER, 5 CC ..............................................................................................................................
5% DEXTROSE/WATER (500 ML = 1 UNIT) ..................................................................................................................
INFUSION, D5W, 1000 CC ..............................................................................................................................................
RINGERS LACTATE INFUSION, 1000 CC ......................................................................................................................
SODIUM HYALURONATE, PER 20 TO 25 MG DOSE FOR INTRA-ARTICULAR INJECTION .....................................
HYLAN G–F 20, 16 MG, FOR INTRA ARTICULAR INJECTION ....................................................................................
DOXORUBICIN HCL, 10 MG ...........................................................................................................................................
DOXORUBICIN HYDROCHLORIDE, ALL LIPID FORMULATIONS, 10 MG ...................................................................
BCG (INTRAVESICAL) PER INSTILLATION ...................................................................................................................
BLEOMYCIN SULFATE, 15 UNITS ..................................................................................................................................
CARBOPLATIN, 50 MG ....................................................................................................................................................
CARMUSTINE, 100 MG ...................................................................................................................................................
CISPLATIN, POWDER OR S0LUTION, PER 10 MG ......................................................................................................
CISPLATIN, 50 MG ...........................................................................................................................................................
INJECTION, CLADRIBINE, PER 1 MG ............................................................................................................................
CYCLOPHOSPHAMIDE, 100 MG ....................................................................................................................................
CYCLOPHOSPHAMIDE, 200 MG ....................................................................................................................................
CYCLOPHOSPHAMIDE, 500 MG ....................................................................................................................................
CYCLOPHOSPHAMIDE, 1.0 GRAM ................................................................................................................................
CYCLOPHOSPHAMIDE, 2.0 GRAM ................................................................................................................................
CYCLOPHOSPHAMIDE, LYOPHILIZED, 100 MG ...........................................................................................................
CYCLOPHOSPHAMIDE, LYOPHILIZED, 200 MG ...........................................................................................................
CYCLOPHOSPHAMIDE, LYOPHILIZED, 500 MG ...........................................................................................................
CYCLOPHOSPHAMIDE, LYOPHILIZED, 1.0 GRAM .......................................................................................................
CYCLOPHOSPHAMIDE, LYOPHILIZED, 2.0 GRAM .......................................................................................................
CYTARABINE LIPOSOME, 10 MG ..................................................................................................................................
CYTARABINE, 100 MG ....................................................................................................................................................
CYTARABINE, 500 MG ....................................................................................................................................................
DACARBAZINE, 100 MG ..................................................................................................................................................
DACARBAZINE, 200 MG ..................................................................................................................................................
DAUNORUBICIN, 10 MG .................................................................................................................................................
DOCETAXEL, 20 MG .......................................................................................................................................................
INJECTION, EPIRUBICIN HCL, 2 MG .............................................................................................................................
ETOPOSIDE, 10 MG ........................................................................................................................................................
ETOPOSIDE, 100 MG ......................................................................................................................................................
FLUDARABINE PHOSPHATE, 50 MG .............................................................................................................................
FLUOROURACIL, 500 MG ...............................................................................................................................................
FLOXURIDINE, 500 MG ...................................................................................................................................................
GEMCITABINE HCL, 200 MG ..........................................................................................................................................
GOSERELIN ACETATE IMPLANT, PER 3.6 MG ............................................................................................................
IRINOTECAN, 20 MG .......................................................................................................................................................
IFOSFAMIDE, 1 GM .........................................................................................................................................................
MESNA, 200 MG ..............................................................................................................................................................
IDARUBICIN HYDROCHLORIDE, 5 MG ..........................................................................................................................
INTERFERON, ALFA–2A, RECOMBINANT, 3 MILLION UNITS .....................................................................................
INTERFERON, ALFA–2B, RECOMBINANT, 1 MILLION UNITS .....................................................................................
LEUPROLIDE ACETATE IMPLANT, 65 MG ....................................................................................................................
INJECTION, MELPHALAN HYDROCHLORIDE, 50 MG ..................................................................................................
METHOTREXATE SODIUM, 5 MG ..................................................................................................................................
METHOTREXATE SODIUM, 50 MG ................................................................................................................................
INJECTION, OXALIPLATIN, 0.5 MG ................................................................................................................................
PACLITAXEL, 30 MG .......................................................................................................................................................
PENTOSTATIN, PER 10 MG ...........................................................................................................................................
0.00030935
0.00076469
0.00012123
0.00018119
0.02146050
0.00171576
0.00093708
0.00000707
0.00083391
0.05387196
0.00040617
0.01191674
0.00107478
0.00213669
0.00333297
0.00101862
0.00240866
0.00049401
0.00983951
0.00695398
0.00101887
0.00015744
0.00016820
0.00189786
0.00148437
0.00233616
0.00032228
0.00048801
0.00003692
0.00564705
0.00000881
0.00094491
0.00025190
0.00008065
0.00062098
0.00004921
0.00008048
0.00005001
0.00000525
0.00091804
0.00009103
0.00017529
0.00013845
0.00001347
0.00000809
0.00012887
0.00002056
0.00009340
0.00006957
0.00000485
0.00254788
0.00120764
0.00229277
0.00052610
0.00030358
0.00392446
0.00000405
0.00491490
0.00285868
0.00316077
0.00007818
0.00036520
0.00000315
0.00008006
0.00668813
0.00006464
0.00000157
0.00184935
0.00050963
0.07249359
0.00551428
0.00000639
11:56 Sep 02, 2005
Jkt 205001
PO 00000
Frm 00041
Fmt 4700
Sfmt 4700
E:\FR\FM\06SER1.SGM
06SER1
52934
Federal Register / Vol. 70, No. 171 / Tuesday, September 6, 2005 / Rules and Regulations
ADDENDUM A—SINGLE DRUG CATEGORY LIST—Continued
HCPCS
Long description
Weight
J9280 .......
J9290 .......
J9291 .......
J9293 .......
J9310 .......
J9320 .......
J9340 .......
J9350 .......
J9355 .......
J9360 .......
J9370 .......
J9375 .......
J9390 .......
J9395 .......
J9600 .......
Q0136 ......
Q0137 ......
Q3025 ......
MITOMYCIN, 5 MG ...........................................................................................................................................................
MITOMYCIN, 20 MG .........................................................................................................................................................
MITOMYCIN, 40 MG .........................................................................................................................................................
INJECTION, MITOXANTRONE HYDROCHLORIDE, PER 5 MG ....................................................................................
RITUXIMAB, 100 MG ........................................................................................................................................................
STREPTOZOCIN, 1 GM ...................................................................................................................................................
THIOTEPA, 15 MG ...........................................................................................................................................................
TOPOTECAN, 4 MG .........................................................................................................................................................
TRASTUZUMAB, 10 MG ..................................................................................................................................................
VINBLASTINE SULFATE, 1 MG ......................................................................................................................................
VINCRISTINE SULFATE, 1 MG .......................................................................................................................................
VINCRISTINE SULFATE, 2 MG .......................................................................................................................................
VINORELBINE TARTRATE, PER 10 MG ........................................................................................................................
INJECTION, FULVESTRANT, 25 MG ..............................................................................................................................
PORFIMER SODIUM, 75 MG ...........................................................................................................................................
INJECTION, EPOETIN ALPHA, (FOR NON ESRD USE), PER 1000 UNITS .................................................................
INJECTION, DARBEPOETIN ALFA, 1 MCG (NON-ESRD USE) ....................................................................................
INJECTION, INTERFERON BETA–1A, 11 MCG FOR INTRAMUSCULAR USE ............................................................
0.00004038
0.00003448
0.00006085
0.00024882
0.00405692
0.00000666
0.00002429
0.00018095
0.00538210
0.00035474
0.00019564
0.00011406
0.00109985
0.00125472
0.00000029
0.24898913
0.03803750
0.00077522
2. On page 39102, Addendum B is
corrected to read as follows:
ADDENDUM B—NEW DRUGS FOR CAP
BIDDING FOR 2006
CODE
J0128
J0180
J0878
J1931
J2357
J2469
J2794
J9035
J9041
J9055
J9305
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
2005 Description
11:56 Sep 02, 2005
Jkt 205001
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).
Abarelix injection.
Agalsidase beta injection.
Daptomycin injection.
Laronidase injection.
Omalizumab injection.
Palonosetron HCl.
Risperidone, long acting.
Bevacizumab injection.
Bortezomib injection.
Cetuximab injection.
Pemetrexed injection.
VI. Regulatory Impact Statement
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
VerDate Aug<18>2005
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.
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
PO 00000
Frm 00042
Fmt 4700
Sfmt 4700
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
E:\FR\FM\06SER1.SGM
06SER1
Federal Register / Vol. 70, No. 171 / Tuesday, September 6, 2005 / Rules and Regulations
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
DEPARTMENT OF HOMELAND
SECURITY
Federal Emergency Management
Agency
44 CFR Part 64
[Docket No. FEMA–7891]
Suspension of Community Eligibility
Federal Emergency
Management Agency, Emergency
Preparedness and Response Directorate,
Department of Homeland Security.
ACTION: Final rule.
AGENCY:
SUMMARY: This rule identifies
communities, where the sale of flood
insurance has been authorized under
the National Flood Insurance Program
(NFIP), that are scheduled for
suspension on the effective dates listed
within this rule because of
noncompliance with the floodplain
management requirements of the
program. If the Federal Emergency
Management Agency (FEMA) receives
documentation that the community has
adopted the required floodplain
management measures prior to the
effective suspension date given in this
rule, the suspension will not occur and
a notice of this will be provided by
publication in the Federal Register on a
subsequent date.
EFFECTIVE DATES: The effective date of
each community’s scheduled
suspension is the third date (‘‘Susp.’’)
listed in the third column of the
following tables.
VerDate Aug<18>2005
11:56 Sep 02, 2005
Jkt 205001
If you want to determine
whether a particular community was
suspended on the suspension date,
contact the appropriate FEMA Regional
Office or the NFIP servicing contractor.
FOR FURTHER INFORMATION CONTACT:
Michael M. Grimm, Mitigation Division,
500 C Street, SW., Room 412,
Washington, DC 20472, (202) 646–2878.
SUPPLEMENTARY INFORMATION: The NFIP
enables property owners to purchase
flood insurance which is generally not
otherwise available. In return,
communities agree to adopt and
administer local floodplain management
aimed at protecting lives and new
construction from future flooding.
Section 1315 of the National Flood
Insurance Act of 1968, as amended, 42
U.S.C. 4022, prohibits flood insurance
coverage as authorized under the NFIP,
42 U.S.C. 4001 et seq.; unless an
appropriate public body adopts
adequate floodplain management
measures with effective enforcement
measures. The communities listed in
this document no longer meet that
statutory requirement for compliance
with program regulations, 44 CFR part
59 et seq. Accordingly, the communities
will be suspended on the effective date
in the third column. As of that date,
flood insurance will no longer be
available in the community. However,
some of these communities may adopt
and submit the required documentation
of legally enforceable floodplain
management measures after this rule is
published but prior to the actual
suspension date. These communities
will not be suspended and will continue
their eligibility for the sale of insurance.
A notice withdrawing the suspension of
the communities will be published in
the Federal Register.
In addition, FEMA has identified the
Special Flood Hazard Areas (SFHAs) in
these communities by publishing a
Flood Insurance Rate Map (FIRM). The
date of the FIRM, if one has been
published, is indicated in the fourth
column of the table. No direct Federal
financial assistance (except assistance
pursuant to the Robert T. Stafford
Disaster Relief and Emergency
Assistance Act not in connection with a
flood) may legally be provided for
construction or acquisition of buildings
in identified SFHAs for communities
not participating in the NFIP and
identified for more than a year, on
FEMA’s initial flood insurance map of
the community as having flood-prone
areas (section 202(a) of the Flood
Disaster Protection Act of 1973, 42
U.S.C. 4106(a), as amended). This
prohibition against certain types of
Federal assistance becomes effective for
ADDRESSES:
PO 00000
Frm 00043
Fmt 4700
Sfmt 4700
52935
the communities listed on the date
shown in the last column. The
Administrator finds that notice and
public comment under 5 U.S.C. 553(b)
are impracticable and unnecessary
because communities listed in this final
rule have been adequately notified.
Each community receives 6-month,
90-day, and 30-day notification letters
addressed to the Chief Executive Officer
stating that the community will be
suspended unless the required
floodplain management measures are
met prior to the effective suspension
date. Since these notifications were
made, this final rule may take effect
within less than 30 days.
National Environmental Policy Act
This rule is categorically excluded
from the requirements of 44 CFR Part
10, Environmental Considerations. No
environmental impact assessment has
been prepared.
Regulatory Flexibility Act
The Administrator has determined
that this rule is exempt from the
requirements of the Regulatory
Flexibility Act because the National
Flood Insurance Act of 1968, as
amended, 42 U.S.C. 4022, prohibits
flood insurance coverage unless an
appropriate public body adopts
adequate floodplain management
measures with effective enforcement
measures. The communities listed no
longer comply with the statutory
requirements, and after the effective
date, flood insurance will no longer be
available in the communities unless
remedial action takes place.
Regulatory Classification
This final rule is not a significant
regulatory action under the criteria of
section 3(f) of Executive Order 12866 of
September 30, 1993, Regulatory
Planning and Review, 58 FR 51735.
Paperwork Reduction Act
This rule does not involve any
collection of information for purposes of
the Paperwork Reduction Act, 44 U.S.C.
3501 et seq.
List of Subjects in 44 CFR Part 64
Flood insurance, Floodplains.
Accordingly, 44 CFR part 64 is
amended as follows:
I
PART 64—[AMENDED]
1. The authority citation for Part 64
continues to read as follows:
I
Authority: 42 U.S.C. 4001 et seq.;
Reorganization Plan No. 3 of 1978, 3 CFR,
1978 Comp.; p. 329; E.O. 12127, 44 FR 19367,
3 CFR, 1979 Comp.; p. 376.
E:\FR\FM\06SER1.SGM
06SER1
]]>Agencies
[Federal Register Volume 70, Number 171 (Tuesday, September 6, 2005)]
[Rules and Regulations]
[Pages 52930-52935]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-17655]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://
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
