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

A RIZONA



### —C ARBON 

### M ONOXIDE



### —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; and28. 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


### 52931 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 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 immunosuppressiveagent 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:



### A DDENDUM 

### A

— S INGLE 

### D RUG 

### C ATEGORY 

### L IST

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

A DDENDUM 

### A

— S INGLE 

### D RUG 

### C ATEGORY 

### L IST



### —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 .................................. 0.00 007140 J0550 ....... INJECTION, PENICILLIN G BENZATHINE AND PENICILLIN G PROCAINE, 2,400,000 UNITS .................................. 0.00 001814 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 .............................................................................................................. 0.00 191741 J1441 ....... INJECTION, FILGRASTIM (G

– CSF), 480 MCG .............................................................................................................. 0.00 403536 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 ........................................... 0.001 93262 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 .................................. 0.0006055 6


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

A DDENDUM 

### A

— S INGLE 

### D RUG 

### C ATEGORY 

### L IST



### —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 ..................................... 0.001897 86 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

A DDENDUM 

### A

— S INGLE 

### D RUG 

### C ATEGORY 

### L IST



### —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:



### A DDENDUM 

### B

— N EW 

### D RUGS FOR 

### CAP B IDDING 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


### 52935 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**

**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.