52930 Federal Register / Vol. 70, No. 171 / Tuesday, September 6, 2005 / Rules and Regulations 

ARIZONA—CARBON MONOXIDE—Continued 

Designated area 

Designation Classification 

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. 

* * * * * 

[FR Doc. 05–17539 Filed 9–2–05; 8:45 am] 

BILLING CODE 6560–50–P 

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 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 

Federal Register / Vol. 70, No. 171 / Tuesday, September 6, 2005 / Rules and Regulations 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 

§ 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 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 Long description Weight 

J0150 ....... INJECTION, ADENOSINE FOR THERAPEUTIC USE, 6 MG ......................................................................................... 0.00069338 

J0152 ....... INJECTION, ADENOSINE FOR DIAGNOSTIC USE, 30 MG .......................................................................................... 0.00455133 

J0170 ....... INJECTION, ADRENALIN, EPINEPHRINE, 1 ML AMPULE ............................................................................................ 0.00007823 

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, 500 MG ................................................................................................................... 0.00012537 

52932 Federal Register / Vol. 70, No. 171 / Tuesday, September 6, 2005 / Rules and Regulations 

ADDENDUM A—SINGLE DRUG CATEGORY LIST—Continued 

HCPCS Long description Weight 

J0475 ....... INJECTION, BACLOFEN, 10 MG ..................................................................................................................................... 0.00024410 

J0540 ....... INJECTION, PENICILLIN G BENZATHINE AND PENICILLIN G PROCAINE, 1,200,000 UNITS .................................. 0.00007140 

J0550 ....... INJECTION, PENICILLIN G BENZATHINE AND PENICILLIN G PROCAINE, 2,400,000 UNITS .................................. 0.00001814 

J0570 ....... INJECTION, PENICILLIN G BENZATHINE, 1,200,000 UNITS ........................................................................................ 0.00004561 

J0585 ....... BOTULINUM TOXIN TYPE A, PER UNIT ........................................................................................................................ 0.03707810 

J0587 ....... BOTULINUM TOXIN TYPE B, PER 100 UNITS .............................................................................................................. 0.00149279 

J0600 ....... INJECTION, EDETATE CALCIUM DISODIUM, 1000 MG ............................................................................................... 0.00004417 

J0637 ....... INJECTION, CASPOFUNGIN ACETATE, 5 MG .............................................................................................................. 0.00008403 

J0640 ....... INJECTION, LEUCOVORIN CALCIUM, PER 50 MG ...................................................................................................... 0.01054437 

J0670 ....... INJECTION, MEPIVACAINE HYDROCHLORIDE, PER 10 ML ....................................................................................... 0.00038034 

J0690 ....... INJECTION, CEFAZOLIN SODIUM, 500 MG .................................................................................................................. 0.00042009 

J0692 ....... INJECTION, CEFEPIME HYDROCHLORIDE, 500 MG ................................................................................................... 0.00024611 

J0696 ....... INJECTION, CEFTRIAXONE SODIUM, PER 250 MG .................................................................................................... 0.00662508 

J0698 ....... INJECTION, CEFOTAXIME SODIUM, PER GM .............................................................................................................. 0.00014738 

J0702 ....... INJECTION, BETAMETHASONE ACETATE & BETAMETHASONE SODIUM PHOSPHATE, PER 3 MG .................... 0.00284989 

J0704 ....... INJECTION, BETAMETHASONE SODIUM PHOSPHATE, PER 4 MG .......................................................................... 0.00056519 

J0735 ....... INJECTION, CLONIDINE HYDROCHLORIDE, 1 MG ...................................................................................................... 0.00033826 

J0800 ....... INJECTION, CORTICOTROPIN, 40 UNITS ..................................................................................................................... 0.00360503 

J0880 ....... INJECTION, DARBEPOETIN ALFA, 5 MCG .................................................................................................................... 0.11998845 

J0895 ....... INJECTION, DEFEROXAMINE MESYLATE, 500 MG ..................................................................................................... 0.00024217 

J1000 ....... INJECTION, DEPO-ESTRADIOL CYPIONATE, 5 MG .................................................................................................... 0.00020815 

J1020 ....... INJECTION, METHYLPREDNISOLONE ACETATE, 20 MG ........................................................................................... 0.00126125 

J1030 ....... INJECTION, METHYLPREDNISOLONE ACETATE, 40 MG ........................................................................................... 0.00587530 

J1040 ....... INJECTION, METHYLPREDNISOLONE ACETATE, 80 MG ........................................................................................... 0.00522812 

J1051 ....... INJECTION, MEDROXYPROGESTERONE ACETATE, 50 MG ...................................................................................... 0.00006464 

J1094 ....... INJECTION, DEXAMETHASONE ACETATE, 1 MG ........................................................................................................ 0.00347947 

J1100 ....... INJECTION, DEXAMETHASONE SODIUM PHOSPHATE, 1MG .................................................................................... 0.05440123 

J1190 ....... INJECTION, DEXRAZOXANE HYDROCHLORIDE, PER 250 MG .................................................................................. 0.00002421 

J1200 ....... INJECTION, DIPHENHYDRAMINE HCL, 50 MG ............................................................................................................. 0.00214443 

J1212 ....... INJECTION, DMSO, DIMETHYL SULFOXIDE, 50%, 50 ML ........................................................................................... 0.00008395 

J1245 ....... INJECTION, DIPYRIDAMOLE, PER 10 MG .................................................................................................................... 0.00379554 

J1250 ....... INJECTION, DOBUTAMINE HYDROCHLORIDE, PER 250 MG ..................................................................................... 0.00052679 

J1260 ....... INJECTION, DOLASETRON MESYLATE, 10 MG ........................................................................................................... 0.01720675 

J1335 ....... INJECTION, ERTAPENEM SODIUM, 500 MG ................................................................................................................ 0.00013138 

J1440 ....... INJECTION, FILGRASTIM (G–CSF), 300 MCG .............................................................................................................. 0.00191741 

J1441 ....... INJECTION, FILGRASTIM (G–CSF), 480 MCG .............................................................................................................. 0.00403536 

J1450 ....... INJECTION FLUCONAZOLE, 200 MG ............................................................................................................................. 0.00001593 

J1580 ....... INJECTION, GARAMYCIN, GENTAMICIN, 80 MG .......................................................................................................... 0.00039560 

J1600 ....... INJECTION, GOLD SODIUM THIOMALATE, 50 MG ...................................................................................................... 0.00005560 

J1626 ....... INJECTION, GRANISETRON HYDROCHLORIDE, 100 MCG ........................................................................................ 0.01469700 

J1631 ....... INJECTION, HALOPERIDOL DECANOATE, PER 50 MG .............................................................................................. 0.00020506 

J1642 ....... INJECTION, HEPARIN SODIUM, (HEPARIN LOCK FLUSH), PER 10 UNITS .............................................................. 0.06362003 

J1644 ....... INJECTION, HEPARIN SODIUM, PER 1000 UNITS ....................................................................................................... 0.00351209 

J1645 ....... INJECTION, DALTEPARIN SODIUM, PER 2500 IU ........................................................................................................ 0.00011417 

J1650 ....... INJECTION, ENOXAPARIN SODIUM, 10 MG ................................................................................................................. 0.00134336 

J1655 ....... INJECTION, TINZAPARIN SODIUM, 1000 IU ................................................................................................................. 0.00046724 

J1710 ....... INJECTION, HYDROCORTISONE SODIUM PHOSPHATE, 50 MG ............................................................................... 0.00006029 

J1720 ....... INJECTION, HYDROCORTISONE SODIUM SUCCINATE, 100 MG .............................................................................. 0.00013201 

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 TROMETHAMINE, PER 15 MG ........................................................................................... 0.00326961 

J1940 ....... INJECTION, FUROSEMIDE, 20 MG ................................................................................................................................ 0.00064751 

J1956 ....... INJECTION, LEVOFLOXACIN, 250 MG .......................................................................................................................... 0.00008548 

J2001 ....... INJECTION, LIDOCAINE HCL FOR INTRAVENOUS INFUSION, 10 MG ...................................................................... 0.00076795 

J2010 ....... INJECTION, LINCOMYCIN HCL, 300 MG ....................................................................................................................... 0.00061870 

J2150 ....... INJECTION, MANNITOL, 25% IN 50 ML ......................................................................................................................... 0.00028934 

J2260 ....... INJECTION, MILRINONE LACTATE, 5 MG ..................................................................................................................... 0.00004912 

J2300 ....... INJECTION, NALBUPHINE HYDROCHLORIDE, PER 10 MG ........................................................................................ 0.00026092 

J2324 ....... INJECTION, NESIRITIDE, 0.25 MG ................................................................................................................................. 0.00027147 

J2353 ....... INJECTION, OCTREOTIDE, DEPOT FORM FOR INTRAMUSCULAR INJECTION, 1 MG ........................................... 0.00193262 

J2354 ....... INJECTION, OCTREOTIDE, NON-DEPOT SUBCUTANEOUS OR INTRAVENOUS INJECTION, 25 MCG ................. 0.00008332 

J2405 ....... INJECTION, ONDANSETRON HYDROCHLORIDE, PER 1 MG ..................................................................................... 0.01360054 

J2430 ....... INJECTION, PAMIDRONATE DISODIUM, PER 30 MG .................................................................................................. 0.00155307 

J2505 ....... INJECTION, PEGFILGRASTIM, 6 MG ............................................................................................................................. 0.00064498 

J2550 ....... INJECTION, PROMETHAZINE HCL, 50 MG ................................................................................................................... 0.00068031 

J2680 ....... INJECTION, FLUPHENAZINE DECANOATE, 25 MG ..................................................................................................... 0.00014971 

J2765 ....... INJECTION, METOCLOPRAMIDE HCL, 10 MG .............................................................................................................. 0.00011029 

J2780 ....... INJECTION, RANITIDINE HYDROCHLORIDE, 25 MG ................................................................................................... 0.00087713 

J2820 ....... INJECTION, SARGRAMOSTIM (GM–CSF), 50 MCG ..................................................................................................... 0.00215849 

J2912 ....... INJECTION, SODIUM CHLORIDE, 0.9%, PER 2 ML ...................................................................................................... 0.00673579 

J2916 ....... INJECTION, SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE INJECTION, 12.5 MG .................................. 0.00060556 

Federal Register / Vol. 70, No. 171 / Tuesday, September 6, 2005 / Rules and Regulations 52933 

ADDENDUM A—SINGLE DRUG CATEGORY LIST—Continued 

HCPCS Long description Weight 

J2920 ....... INJECTION, METHYLPREDNISOLONE SODIUM SUCCINATE, 40 MG ....................................................................... 0.00030935 

J2930 ....... INJECTION, METHYLPREDNISOLONE SODIUM SUCCINATE, 125 MG ..................................................................... 0.00076469 

J2997 ....... INJECTION, ALTEPLASE RECOMBINANT, 1 MG .......................................................................................................... 0.00012123 

J3260 ....... INJECTION, TOBRAMYCIN SULFATE, 80 MG ............................................................................................................... 0.00018119 

J3301 ....... INJECTION, TRIAMCINOLONE ACETONIDE, PER 10 MG ........................................................................................... 0.02146050 

J3302 ....... INJECTION, TRIAMCINOLONE DIACETATE, PER 5 MG .............................................................................................. 0.00171576 

J3303 ....... INJECTION, TRIAMCINOLONE HEXACETONIDE, PER 5 MG ...................................................................................... 0.00093708 

J3315 ....... INJECTION, TRIPTORELIN PAMOATE, 3.75 MG ........................................................................................................... 0.00000707 

J3370 ....... INJECTION, VANCOMYCIN HCL, 500 MG ..................................................................................................................... 0.00083391 

J3396 ....... INJECTION, VERTEPORFIN, 0.1 MG .............................................................................................................................. 0.05387196 

J3410 ....... INJECTION, HYDROXYZINE HCL, 25 MG ...................................................................................................................... 0.00040617 

J3420 ....... INJECTION, VITAMIN B–12 CYANOCOBALAMIN, UP TO 1000 MCG .......................................................................... 0.01191674 

J3475 ....... INJECTION, MAGNESIUM SULFATE, PER 500 MG ...................................................................................................... 0.00107478 

J3480 ....... INJECTION, POTASSIUM CHLORIDE, PER 2 MEQ ...................................................................................................... 0.00213669 

J3487 ....... INJECTION, ZOLEDRONIC ACID, 1 MG ......................................................................................................................... 0.00333297 

J7030 ....... INFUSION, NORMAL SALINE SOLUTION , 1000 CC .................................................................................................... 0.00101862 

J7040 ....... INFUSION, NORMAL SALINE SOLUTION, (500 STERILE ML=1 UNIT) ....................................................................... 0.00240866 

J7042 ....... 5% DEXTROSE/NORMAL SALINE (500 ML = 1 UNIT) .................................................................................................. 0.00049401 

J7050 ....... INFUSION, NORMAL SALINE SOLUTION , 250 CC ...................................................................................................... 0.00983951 

J7051 ....... STERILE SALINE OR WATER, 5 CC .............................................................................................................................. 0.00695398 

J7060 ....... 5% DEXTROSE/WATER (500 ML = 1 UNIT) .................................................................................................................. 0.00101887 

J7070 ....... INFUSION, D5W, 1000 CC .............................................................................................................................................. 0.00015744 

J7120 ....... RINGERS LACTATE INFUSION, 1000 CC ...................................................................................................................... 0.00016820 

J7317 ....... SODIUM HYALURONATE, PER 20 TO 25 MG DOSE FOR INTRA-ARTICULAR INJECTION ..................................... 0.00189786 

J7320 ....... HYLAN G–F 20, 16 MG, FOR INTRA ARTICULAR INJECTION .................................................................................... 0.00148437 

J9000 ....... DOXORUBICIN HCL, 10 MG ........................................................................................................................................... 0.00233616 

J9001 ....... DOXORUBICIN HYDROCHLORIDE, ALL LIPID FORMULATIONS, 10 MG ................................................................... 0.00032228 

J9031 ....... BCG (INTRAVESICAL) PER INSTILLATION ................................................................................................................... 0.00048801 

J9040 ....... BLEOMYCIN SULFATE, 15 UNITS .................................................................................................................................. 0.00003692 

J9045 ....... CARBOPLATIN, 50 MG .................................................................................................................................................... 0.00564705 

J9050 ....... CARMUSTINE, 100 MG ................................................................................................................................................... 0.00000881 

J9060 ....... CISPLATIN, POWDER OR S0LUTION, PER 10 MG ...................................................................................................... 0.00094491 

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, 100 MG ........................................................................................................... 0.00091804 

J9094 ....... CYCLOPHOSPHAMIDE, LYOPHILIZED, 200 MG ........................................................................................................... 0.00009103 

J9095 ....... CYCLOPHOSPHAMIDE, LYOPHILIZED, 500 MG ........................................................................................................... 0.00017529 

J9096 ....... CYCLOPHOSPHAMIDE, LYOPHILIZED, 1.0 GRAM ....................................................................................................... 0.00013845 

J9097 ....... CYCLOPHOSPHAMIDE, LYOPHILIZED, 2.0 GRAM ....................................................................................................... 0.00001347 

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 3.6 MG ............................................................................................................ 0.00285868 

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, RECOMBINANT, 3 MILLION UNITS ..................................................................................... 0.00008006

J9214 ....... INTERFERON, ALFA–2B, RECOMBINANT, 1 MILLION UNITS ..................................................................................... 0.00668813

J9219 ....... LEUPROLIDE ACETATE IMPLANT, 65 MG .................................................................................................................... 0.00006464 

J9245 ....... INJECTION, MELPHALAN HYDROCHLORIDE, 50 MG .................................................................................................. 0.00000157 

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 

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 ....... MITOMYCIN, 5 MG ........................................................................................................................................................... 0.00004038 

J9290 ....... MITOMYCIN, 20 MG ......................................................................................................................................................... 0.00003448 

J9291 ....... MITOMYCIN, 40 MG ......................................................................................................................................................... 0.00006085 

J9293 ....... INJECTION, MITOXANTRONE HYDROCHLORIDE, PER 5 MG .................................................................................... 0.00024882 

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 NON ESRD USE), PER 1000 UNITS ................................................................. 0.24898913 

Q0137 ...... INJECTION, DARBEPOETIN ALFA, 1 MCG (NON-ESRD USE) .................................................................................... 0.03803750 

Q3025 ...... INJECTION, INTERFERON BETA–1A, 11 MCG FOR INTRAMUSCULAR USE ............................................................ 0.00077522 

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 

Federal Register / Vol. 70, No. 171 / Tuesday, September 6, 2005 / Rules and Regulations 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 

DEPARTMENT OF HOMELAND 

SECURITY 

Federal Emergency Management 

Agency 

44 CFR Part 64 

[Docket No. FEMA–7891] 

Suspension of Community Eligibility 

AGENCY: Federal Emergency 

Management Agency, Emergency 

Preparedness and Response Directorate, 

Department of Homeland Security. 

ACTION: Final rule. 

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. 

ADDRESSES: 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 

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: 

PART 64—[AMENDED] 

■ 1. The authority citation for Part 64 

continues to read as follows: 

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.