Centers for Medicare & Medicaid Services (CMS), HHS.
Interim final rule; interpretation and correction.
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.”
This rule is effective September 6, 2005.Start Further Info
FOR FURTHER INFORMATION CONTACT:
Lia Prela, (410) 786-0548.End Further Info End Preamble Start Supplemental Information
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 Start Printed Page 52931constitute 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).
1. On pages 39099 through 39102, Addendum A is corrected to read as follows:
|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|
|Start Printed Page 52932|
|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|
|Start Printed Page 52933|
|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|
|Start Printed Page 52934|
|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:
|J0180||Agalsidase beta injection.|
|J2794||Risperidone, long acting.|
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 Start Printed Page 52935governments, 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.Start Signature
(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,
[FR Doc. 05-17655 Filed 9-1-05; 9:14 am]
BILLING CODE 4120-01-P