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 Department of Health and Human Services Centers for Medicare & Medicaid Services CMS-1325-IFC2 42 CFR Part 414
RIN 0938-AN58
 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 
                    ( print page 52931)
                    constitute an “exigent circumstance” for purposes of allowing a physician to elect to participate in the CAP and select a CAP vendor at a time other than the annual election period. B. Corrections to the July 6, 2005 Interim Final Rule In FR Doc. 05-12938 of July 6, 2005 (70 FR 39022), we identified errors to Addendum A and Addendum B that are corrected under “Correction of Addenda Errors” in section III of this document. These corrections are effective as if they had been included in the document published July 6, 2005. II. Delay in Implementation Date On March 4, 2005, we published a proposed rule (70 FR 10746) to implement a CAP program, as required by section 1847B of the Act, as added by section 303(d) of the MMA, for certain Medicare Part B drugs not paid on a cost or prospective payment system basis. In response to the proposed rule, commenters expressed concern about the short timeframe for implementation of the CAP, that is, the proposed January 1, 2006 effective date stated in the July 6, 2005 interim final rule. These commenters suggested we delay the effective date of the CAP to allow us to fully structure the CAP to meet congressional objectives and benefit physicians without compromising beneficiary access to drug therapies and treatment. We responded to those comments in the July 6, 2005 interim final rule (70 FR 39025) by stating that we recognized that the timeframe for implementation was ambitious but we believed that the regulatory framework provided a firm basis for implementing the CAP in January 2006. We also stated that the statute requires that we coordinate the physicians' election to participate in the CAP with the Medicare Participating Physician Process described in section 1842(h) of the Act. However, upon further consideration of these comments, as well as additional feedback we have received from potential participants in the program, we have concluded that more time is needed to further refine the program before implementation. After reviewing public comments, we agree that a short delay in implementing the CAP will allow us to improve the efficiency of the program and increase interest in participating in the program. Therefore, in accordance with our authority to phase-in the program as appropriate during 2006, we are delaying implementation of the CAP. The CAP program will not begin on January 1, 2006, and the initial physician election process will not occur in 2005. As noted above, we intend to implement the CAP during 2006 and we expect that the CAP program will begin sometime in or around July 2006. In addition, we expect the initial physician election period to occur in the spring of 2006 rather than in fall 2005. We consider the initial implementation of the CAP program to constitute an “exigent circumstance” for purposes of section 1847B(a)(5)(A)(i) of the Act and § 414.908(a)(2) of our regulations, which allow for a physician election period at times other than the regular, annual election period. We are specifying the initial election period as an “exigent circumstance” because we intend the program to run on a calendar year basis, as stated in the July 2005 interim final rule, after the initial implementation of the CAP in 2006. In later years, the annual CAP election period will be coordinated with the annual Medicare Participating Physician Enrollment Process described in section 1842(h) of the Act, which occurs in the fall of each year, as specified in the July 2005 interim final rule. We believe that, after the initial election period in 2006, an annual election period that ends on November 15 before the beginning of each CAP year is still necessary to allow time for the carrier, the designated carrier, the vendors, and our claims processing system to complete tasks in preparation for that CAP year. We expect to include the dates of the initial physician election period in the final rule. Physicians will then be provided with a second election period in 2006 for participation in the CAP in 2007. In the July 6, 2005 interim final rule, we stated in several other places in the preamble that the CAP would begin on January 1, 2006. For example, we referred to a January 1, 2006 start date in our discussion of the activities that would be necessary to implement the CAP on that date. These included CAP operations, analysis and coding of the CAP claims processing system, and educating beneficiaries and physicians about the program. In the July 2005 interim final rule, we specified that in response to the March 2005 proposed rule, several commenters expressed concern about introducing the CAP so quickly without any formal testing or analysis of the program. Other commenters expressed concern about education and outreach efforts relating to the CAP. Our decision to suspend the current vendor bidding process and delay the start date of the CAP will allow time for refining CAP operations, additional testing of the claims processing system, and for further beneficiary, physician, and vendor applicant educational efforts. We believe this additional preparation time will greatly improve and ease the implementation process. III. Correction of Addenda Errors In the July 6, 2005 interim final rule, Addendum A “Single Drug Category List” does not include the column reflecting the weights assigned to each CAP drug that will be used in computing the composite bids. In this interim final rule, we are correcting the error by republishing Addendum A in its entirety, with the third column included. In addition, in Addendum B, “New Drugs for CAP Bidding for 2006,” we inadvertently included J7518 (mycophenolic acid), which should be excluded from this list because it is an orally administered immunosuppressive agent rather than a physician-administered drug. We are correcting this error by republishing Addendum B, which reflects the omission of J7518 (mycophenolic acid). In FR Doc. 05-12938 of July 6, 2005 (70 FR 39022), make the following corrections: 1. On pages 39099 through 39102, Addendum A is corrected to read as follows: Addendum A—Single Drug Category List
HCPCS
Long description
WeightJ0150
INJECTION, ADENOSINE FOR THERAPEUTIC USE, 6 MG
0.00069338J0152
INJECTION, ADENOSINE FOR DIAGNOSTIC USE, 30 MG
0.00455133J0170
INJECTION, ADRENALIN, EPINEPHRINE, 1 ML AMPULE
0.00007823J0207
INJECTION, AMIFOSTINE, 500 MG
0.00015946J0215
INJECTION, ALEFACEPT, 0.5 MG
0.00082595J0280
INJECTION, AMINOPHYLLIN, 250 MG
0.00081312J0290
INJECTION, AMPICILLIN SODIUM, 500 MG
0.00012537( print page 52932)J0475
INJECTION, BACLOFEN, 10 MG
0.00024410J0540
INJECTION, PENICILLIN G BENZATHINE AND PENICILLIN G PROCAINE, 1,200,000 UNITS
0.00007140J0550
INJECTION, PENICILLIN G BENZATHINE AND PENICILLIN G PROCAINE, 2,400,000 UNITS
0.00001814J0570
INJECTION, PENICILLIN G BENZATHINE, 1,200,000 UNITS
0.00004561J0585
BOTULINUM TOXIN TYPE A, PER UNIT
0.03707810J0587
BOTULINUM TOXIN TYPE B, PER 100 UNITS
0.00149279J0600
INJECTION, EDETATE CALCIUM DISODIUM, 1000 MG
0.00004417J0637
INJECTION, CASPOFUNGIN ACETATE, 5 MG
0.00008403J0640
INJECTION, LEUCOVORIN CALCIUM, PER 50 MG
0.01054437J0670
INJECTION, MEPIVACAINE HYDROCHLORIDE, PER 10 ML
0.00038034J0690
INJECTION, CEFAZOLIN SODIUM, 500 MG
0.00042009J0692
INJECTION, CEFEPIME HYDROCHLORIDE, 500 MG
0.00024611J0696
INJECTION, CEFTRIAXONE SODIUM, PER 250 MG
0.00662508J0698
INJECTION, CEFOTAXIME SODIUM, PER GM
0.00014738J0702
INJECTION, BETAMETHASONE ACETATE & BETAMETHASONE SODIUM PHOSPHATE, PER 3 MG
0.00284989J0704
INJECTION, BETAMETHASONE SODIUM PHOSPHATE, PER 4 MG
0.00056519J0735
INJECTION, CLONIDINE HYDROCHLORIDE, 1 MG
0.00033826J0800
INJECTION, CORTICOTROPIN, 40 UNITS
0.00360503J0880
INJECTION, DARBEPOETIN ALFA, 5 MCG
0.11998845J0895
INJECTION, DEFEROXAMINE MESYLATE, 500 MG
0.00024217J1000
INJECTION, DEPO-ESTRADIOL CYPIONATE, 5 MG
0.00020815J1020
INJECTION, METHYLPREDNISOLONE ACETATE, 20 MG
0.00126125J1030
INJECTION, METHYLPREDNISOLONE ACETATE, 40 MG
0.00587530J1040
INJECTION, METHYLPREDNISOLONE ACETATE, 80 MG
0.00522812J1051
INJECTION, MEDROXYPROGESTERONE ACETATE, 50 MG
0.00006464J1094
INJECTION, DEXAMETHASONE ACETATE, 1 MG
0.00347947J1100
INJECTION, DEXAMETHASONE SODIUM PHOSPHATE, 1MG
0.05440123J1190
INJECTION, DEXRAZOXANE HYDROCHLORIDE, PER 250 MG
0.00002421J1200
INJECTION, DIPHENHYDRAMINE HCL, 50 MG
0.00214443J1212
INJECTION, DMSO, DIMETHYL SULFOXIDE, 50%, 50 ML
0.00008395J1245
INJECTION, DIPYRIDAMOLE, PER 10 MG
0.00379554J1250
INJECTION, DOBUTAMINE HYDROCHLORIDE, PER 250 MG
0.00052679J1260
INJECTION, DOLASETRON MESYLATE, 10 MG
0.01720675J1335
INJECTION, ERTAPENEM SODIUM, 500 MG
0.00013138J1440
INJECTION, FILGRASTIM (G-CSF), 300 MCG
0.00191741J1441
INJECTION, FILGRASTIM (G-CSF), 480 MCG
0.00403536J1450
INJECTION FLUCONAZOLE, 200 MG
0.00001593J1580
INJECTION, GARAMYCIN, GENTAMICIN, 80 MG
0.00039560J1600
INJECTION, GOLD SODIUM THIOMALATE, 50 MG
0.00005560J1626
INJECTION, GRANISETRON HYDROCHLORIDE, 100 MCG
0.01469700J1631
INJECTION, HALOPERIDOL DECANOATE, PER 50 MG
0.00020506J1642
INJECTION, HEPARIN SODIUM, (HEPARIN LOCK FLUSH), PER 10 UNITS
0.06362003J1644
INJECTION, HEPARIN SODIUM, PER 1000 UNITS
0.00351209J1645
INJECTION, DALTEPARIN SODIUM, PER 2500 IU
0.00011417J1650
INJECTION, ENOXAPARIN SODIUM, 10 MG
0.00134336J1655
INJECTION, TINZAPARIN SODIUM, 1000 IU
0.00046724J1710
INJECTION, HYDROCORTISONE SODIUM PHOSPHATE, 50 MG
0.00006029J1720
INJECTION, HYDROCORTISONE SODIUM SUCCINATE, 100 MG
0.00013201J1745
INJECTION INFLIXIMAB, 10 MG
0.02736596J1750
INJECTION, IRON DEXTRAN, 50 MG
0.00244189J1756
INJECTION, IRON SUCROSE, 1 MG
0.01017283J1885
INJECTION, KETOROLAC TROMETHAMINE, PER 15 MG
0.00326961J1940
INJECTION, FUROSEMIDE, 20 MG
0.00064751J1956
INJECTION, LEVOFLOXACIN, 250 MG
0.00008548J2001
INJECTION, LIDOCAINE HCL FOR INTRAVENOUS INFUSION, 10 MG
0.00076795J2010
INJECTION, LINCOMYCIN HCL, 300 MG
0.00061870J2150
INJECTION, MANNITOL, 25% IN 50 ML
0.00028934J2260
INJECTION, MILRINONE LACTATE, 5 MG
0.00004912J2300
INJECTION, NALBUPHINE HYDROCHLORIDE, PER 10 MG
0.00026092J2324
INJECTION, NESIRITIDE, 0.25 MG
0.00027147J2353
INJECTION, OCTREOTIDE, DEPOT FORM FOR INTRAMUSCULAR INJECTION, 1 MG
0.00193262J2354
INJECTION, OCTREOTIDE, NON-DEPOT SUBCUTANEOUS OR INTRAVENOUS INJECTION, 25 MCG
0.00008332J2405
INJECTION, ONDANSETRON HYDROCHLORIDE, PER 1 MG
0.01360054J2430
INJECTION, PAMIDRONATE DISODIUM, PER 30 MG
0.00155307J2505
INJECTION, PEGFILGRASTIM, 6 MG
0.00064498J2550
INJECTION, PROMETHAZINE HCL, 50 MG
0.00068031J2680
INJECTION, FLUPHENAZINE DECANOATE, 25 MG
0.00014971J2765
INJECTION, METOCLOPRAMIDE HCL, 10 MG
0.00011029J2780
INJECTION, RANITIDINE HYDROCHLORIDE, 25 MG
0.00087713J2820
INJECTION, SARGRAMOSTIM (GM-CSF), 50 MCG
0.00215849J2912
INJECTION, SODIUM CHLORIDE, 0.9%, PER 2 ML
0.00673579J2916
INJECTION, SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE INJECTION, 12.5 MG
0.00060556( print page 52933)J2920
INJECTION, METHYLPREDNISOLONE SODIUM SUCCINATE, 40 MG
0.00030935J2930
INJECTION, METHYLPREDNISOLONE SODIUM SUCCINATE, 125 MG
0.00076469J2997
INJECTION, ALTEPLASE RECOMBINANT, 1 MG
0.00012123J3260
INJECTION, TOBRAMYCIN SULFATE, 80 MG
0.00018119J3301
INJECTION, TRIAMCINOLONE ACETONIDE, PER 10 MG
0.02146050J3302
INJECTION, TRIAMCINOLONE DIACETATE, PER 5 MG
0.00171576J3303
INJECTION, TRIAMCINOLONE HEXACETONIDE, PER 5 MG
0.00093708J3315
INJECTION, TRIPTORELIN PAMOATE, 3.75 MG
0.00000707J3370
INJECTION, VANCOMYCIN HCL, 500 MG
0.00083391J3396
INJECTION, VERTEPORFIN, 0.1 MG
0.05387196J3410
INJECTION, HYDROXYZINE HCL, 25 MG
0.00040617J3420
INJECTION, VITAMIN B-12 CYANOCOBALAMIN, UP TO 1000 MCG
0.01191674J3475
INJECTION, MAGNESIUM SULFATE, PER 500 MG
0.00107478J3480
INJECTION, POTASSIUM CHLORIDE, PER 2 MEQ
0.00213669J3487
INJECTION, ZOLEDRONIC ACID, 1 MG
0.00333297J7030
INFUSION, NORMAL SALINE SOLUTION , 1000 CC
0.00101862J7040
INFUSION, NORMAL SALINE SOLUTION, (500 STERILE ML=1 UNIT)
0.00240866J7042
5% DEXTROSE/NORMAL SALINE (500 ML = 1 UNIT)
0.00049401J7050
INFUSION, NORMAL SALINE SOLUTION , 250 CC
0.00983951J7051
STERILE SALINE OR WATER, 5 CC
0.00695398J7060
5% DEXTROSE/WATER (500 ML = 1 UNIT)
0.00101887J7070
INFUSION, D5W, 1000 CC
0.00015744J7120
RINGERS LACTATE INFUSION, 1000 CC
0.00016820J7317
SODIUM HYALURONATE, PER 20 TO 25 MG DOSE FOR INTRA-ARTICULAR INJECTION
0.00189786J7320
HYLAN G-F 20, 16 MG, FOR INTRA ARTICULAR INJECTION
0.00148437J9000
DOXORUBICIN HCL, 10 MG
0.00233616J9001
DOXORUBICIN HYDROCHLORIDE, ALL LIPID FORMULATIONS, 10 MG
0.00032228J9031
BCG (INTRAVESICAL) PER INSTILLATION
0.00048801J9040
BLEOMYCIN SULFATE, 15 UNITS
0.00003692J9045
CARBOPLATIN, 50 MG
0.00564705J9050
CARMUSTINE, 100 MG
0.00000881J9060
CISPLATIN, POWDER OR S0LUTION, PER 10 MG
0.00094491J9062
CISPLATIN, 50 MG
0.00025190J9065
INJECTION, CLADRIBINE, PER 1 MG
0.00008065J9070
CYCLOPHOSPHAMIDE, 100 MG
0.00062098J9080
CYCLOPHOSPHAMIDE, 200 MG
0.00004921J9090
CYCLOPHOSPHAMIDE, 500 MG
0.00008048J9091
CYCLOPHOSPHAMIDE, 1.0 GRAM
0.00005001J9092
CYCLOPHOSPHAMIDE, 2.0 GRAM
0.00000525J9093
CYCLOPHOSPHAMIDE, LYOPHILIZED, 100 MG
0.00091804J9094
CYCLOPHOSPHAMIDE, LYOPHILIZED, 200 MG
0.00009103J9095
CYCLOPHOSPHAMIDE, LYOPHILIZED, 500 MG
0.00017529J9096
CYCLOPHOSPHAMIDE, LYOPHILIZED, 1.0 GRAM
0.00013845J9097
CYCLOPHOSPHAMIDE, LYOPHILIZED, 2.0 GRAM
0.00001347J9098
CYTARABINE LIPOSOME, 10 MG
0.00000809J9100
CYTARABINE, 100 MG
0.00012887J9110
CYTARABINE, 500 MG
0.00002056J9130
DACARBAZINE, 100 MG
0.00009340J9140
DACARBAZINE, 200 MG
0.00006957J9150
DAUNORUBICIN, 10 MG
0.00000485J9170
DOCETAXEL, 20 MG
0.00254788J9178
INJECTION, EPIRUBICIN HCL, 2 MG
0.00120764J9181
ETOPOSIDE, 10 MG
0.00229277J9182
ETOPOSIDE, 100 MG
0.00052610J9185
FLUDARABINE PHOSPHATE, 50 MG
0.00030358J9190
FLUOROURACIL, 500 MG
0.00392446J9200
FLOXURIDINE, 500 MG
0.00000405J9201
GEMCITABINE HCL, 200 MG
0.00491490J9202
GOSERELIN ACETATE IMPLANT, PER 3.6 MG
0.00285868J9206
IRINOTECAN, 20 MG
0.00316077J9208
IFOSFAMIDE, 1 GM
0.00007818J9209
MESNA, 200 MG
0.00036520J9211
IDARUBICIN HYDROCHLORIDE, 5 MG
0.00000315J9213
INTERFERON, ALFA-2A, RECOMBINANT, 3 MILLION UNITS
0.00008006J9214
INTERFERON, ALFA-2B, RECOMBINANT, 1 MILLION UNITS
0.00668813J9219
LEUPROLIDE ACETATE IMPLANT, 65 MG
0.00006464J9245
INJECTION, MELPHALAN HYDROCHLORIDE, 50 MG
0.00000157J9250
METHOTREXATE SODIUM, 5 MG
0.00184935J9260
METHOTREXATE SODIUM, 50 MG
0.00050963J9263
INJECTION, OXALIPLATIN, 0.5 MG
0.07249359J9265
PACLITAXEL, 30 MG
0.00551428J9268
PENTOSTATIN, PER 10 MG
0.00000639( print page 52934)J9280
MITOMYCIN, 5 MG
0.00004038J9290
MITOMYCIN, 20 MG
0.00003448J9291
MITOMYCIN, 40 MG
0.00006085J9293
INJECTION, MITOXANTRONE HYDROCHLORIDE, PER 5 MG
0.00024882J9310
RITUXIMAB, 100 MG
0.00405692J9320
STREPTOZOCIN, 1 GM
0.00000666J9340
THIOTEPA, 15 MG
0.00002429J9350
TOPOTECAN, 4 MG
0.00018095J9355
TRASTUZUMAB, 10 MG
0.00538210J9360
VINBLASTINE SULFATE, 1 MG
0.00035474J9370
VINCRISTINE SULFATE, 1 MG
0.00019564J9375
VINCRISTINE SULFATE, 2 MG
0.00011406J9390
VINORELBINE TARTRATE, PER 10 MG
0.00109985J9395
INJECTION, FULVESTRANT, 25 MG
0.00125472J9600
PORFIMER SODIUM, 75 MG
0.00000029Q0136
INJECTION, EPOETIN ALPHA, (FOR NON ESRD USE), PER 1000 UNITS
0.24898913Q0137
INJECTION, DARBEPOETIN ALFA, 1 MCG (NON-ESRD USE)
0.03803750Q3025
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 DescriptionJ0128
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 
                    ( print page 52935)
                    governments, preempts State law, or otherwise has Federalism implications. Since this regulation does not impose any costs on State or local governments, the requirements of E.O. 13132 are not applicable. In accordance with the provisions of Executive Order 12866, this regulation was reviewed by the Office of Management and Budget. (Catalog of Federal Domestic Assistance Program No. 93.773, Medicare—Hospital Insurance; and Program No. 93.774, Medicare—Supplementary Medical Insurance Program) Dated: August 23, 2005. Mark B. McClellan, Administrator, Centers for Medicare & Medicaid Services. Approved: August 31, 2005. Michael O. Leavitt, Secretary.


[FR Doc. 05-17655 Filed 9-1-05; 9:14 am] BILLING CODE 4120-01-P